Journaal
Stoffen &
Preparaten
Chief-editor:
Drs. A.C.H. van Peski
Editorial Board:
Dr. M.M. Kops-Werkhoven
Drs. H.A.F. van Well
Dr. J.A.S.J. Razenberg
Dr. L.J.M. Rodenburg
Drs. G.A. Schouten
Drs. J. Zawierko
Advisory Board:
K. E. Armstrong (U.S.A.)
Dr. R. Fielding (United Kingdom)
Drs. A. Gondová
Dr. C. van Lint (Australia)
Dan Liu (U.S.A.)
S. Park (S.-Korea)
H. Sano (Japan)
S. Savary (Canada)
J. Simpson (Australia)
Dr. U. Schumacher (China)
P.G. Tse (New Zealand)
No. 1
Februari 2009
Volume 6
Part of Stoffennieuws.nl
Content
ARTICLES
[2009/0001] Region Profile: EU/EEA / 3
[2009/0002] Substances hazardous to water (WGK and
GAM) / 11
European Union
[2009/0003] REACH: ECHA New Publications
December-January 2008 / 12
[2009/0004] EU-GHS or CLP Regulation (EC)
No. 1272/2008 published / 13
[2009/0005] Belgium: Dimethyl fumarate / 15
[2009/0006] EU Toys Directive: German BfR
comments / 15
[2009/0007] Germany: Limit Value List 2008
(BGIA-Report 6/2008) / 16
International
[2009/0008] GHS Country Update (January 2009) / 16
[2009/0009] USA: revision to definition of Volatile
Organic Compounds – exclusion of propy-
lene carbonate and dimethyl carbonate / 17
[2009/0010] Canada (Ontario): Cosmetic Pesticides Ban
Act 2008 / 17
[2009/0011] Japan: Review of the Chemical Substances
Control Law / 17
PUBLICATIONS
[2009/0012] The Australian Dangerous Goods Code 7th
edition / 18
Internet
[2009/0013] Ciba EUREG Bulletin Version 08/01 / 18
[2009/0014] Norway: REACH-ordbok / 19
[2009/0015] ADR 2009 / 19
[2009/0016] USA: OSHA Field Operations Manual
revised / 19
Journaal
Stoffen &
Preparaten
Chief-editor:
Drs. A.C.H. van Peski
Editorial Board:
Dr. M.M. Kops-Werkhoven
Drs. H.A.F. van Well
Dr. J.A.S.J. Razenberg
Dr. L.J.M. Rodenburg
Drs. G.A. Schouten
Drs. J. Zawierko
Advisory Board:
K. E. Armstrong (U.S.A.)
Dr. R. Fielding (United Kingdom)
Drs. A. Gondová
G. Koh (Singapore)
Dr. C. van Lint (Australia)
Dan Liu (U.S.A.)
S. Park (S.-Korea)
H. Sano (Japan)
S. Savary (Canada)
C. Sieger (Germany)
J. Simpson (Australia)
Dr. U. Schumacher (China)
P.G. Tse (New Zealand)
No. 2
March2009
Volume 6
Part of Stoffennieuws.nl
Content
ARTICLES
[2009/0028] Data Sharing, SIEF formation and working
in SIEFs: a Dutch Chemical industry
perspective / 35
[2009/0029] Malaysia: The Malaysian Chemicals
Register / 39
ACTUALITIES
European Union
[2009/0030] ATP 31 to 67/548/EEC / 44
[2009/0031] Again corrigendum to REACH text / 44
International
[2009/0032] USA: New Children’s Product Safety Laws on
lead and phthalates / 45
[2009/0033] USA: Occupational Exposure to Hexavalent
Chromium / 46
[2009/0034] Canada: Update on Batch 4 chemicals
Challenge Program / 47
[2009/0035] Canada: Melamine standard / 48
[2009/0036] Canada and the use of nanomaterials / 48
[2009/0037] OECD: Polymers of Low Concern / 49
[2009/0038] Global Update on New Chemicals
Regulations (December 2008) / 50
PUBLICATIONS
Internet
[2009/0039] DHL: Dangerous Goods Regulations
overview / 55
OFFICIAL PUBLICATIONS
[2009/0040] The Netherlands (period January 2009) / 55
[2009/0041] Belgium (period January 2009) / 55
[2009/0042] United Kingdom (Period December
2008-January 2009) / 56
 content

[2009/0043] European Union (period January 2009) / 57

[2009/0044] United States of America (period January 2009) / 57

[2009/0045] Calendar of events & important data/ 64

34 Journal Chemicals Management march 2009, No. 2 Sdu Uitgevers

articles
articles
Data Sharing, SIEF formation
and working in SIEFs: a Dutch
Chemical industry perspective
[2009/0028]
by Dirk van Well*
With the unexpectedly high amount of
REACH pre-registrations, the mandatory data
sharing and working of Substance Informa-
tion Exchange Forums (SIEFS) has become
extremely challenging. While by no means
comprehensive, this article addresses some
of the main operational and legal features of
data sharing under REACH, forming of and
working in SIEFs from the perspective of the
Dutch Chemical Industry.
Introduction
At the time of conception of the Regulation
(EC) no. 1907/2006 concerning Registration,
Evaluation, Authorisation and Restriction of
Chemicals (hence: the REACH regulation)1,
the need was identified to share information
for the purpose of registration, so as to avoid
unnecessary duplication of studies, particu-
larly those involving vertebrate animals test-
ing. In order to enable and facilitate (man-
datory) exchange of information in view of
the registration requirements and establish a
harmonized classification and labelling, the
REACH regulation provides for the pre-reg-
istration of substances for the purpose of data
sharing in so called Substance Information
Exchange Forums (SIEFs). REACH requires
potential registrants (i.e. manufacturers, im-
porters and only representatives), third party
Sdu Uitgevers
representatives, downstream users and other
data holders who have submitted information
for a phase-in substance2, to share and ex-
change information for the purpose of regis-
tration and establishing agreed classifications
and labelling. In addition, also those who have
registered (before 1 December 2008) a phase-
in substance or have submitted information
on a phase in substance that is listed as active
ingredient and co-formulant in the Annexes
to the EU Plant protection product- and bio-
cides legislation are required to meet the data
sharing obligations under REACH. Article
29 of REACH stipulates that aforementioned
actors shall be participants in a Substance
Information Exchange Forum (SIEF). These
SIEF participants “shall provide other partici-
pants with existing studies, react to requests
by other participants for information, collec-
tively identify needs for further studies for the
purposes of paragraph 2(a) and arrange for
such studies to be carried out”. In view of the
different deadlines for registration of phase-
in substances, each SIEF shall be operational
until (at least) 1 June 2018. SIEFS are formed
and operated by industry. It is left to indus-
try to establish the organisational form. Apart
from the information sharing duties of SIEF
participants, the legal requirements for SIEF
members are limited to a limited number of
general cost sharing provisions
* Drs. H.A.F. van Well is Senior Chemicals Policy Advi-
sor at the Vereniging van de Nederlandse Chemische
Industrie (Association of the Dutch Chemical Industry)
in The Hague]
1 OJ L 396, 30.12.2006
2 Substance listed on the EINECS, manufactured be-
tween 1991 and 2006 in countries that have accessed
the EU on January 1995 or on May 2004 or is a “no
longer polymer”
Journaal Stoffen en Preparaten maart 2009, Nr. 2 35

Pre-registration and Pre-SIEFS
On 1 December 2008, the pre-registration pe-
riod ended. The purpose of this pre-registra-
tion is first of all to allow potential registrants
to benefit from the transitional regime for
phase-in substances. But in addition to that,
pre-registration is a prerequisite for SIEF-
formation as well; the identity and a limited
number of other data submitted by the pre-
registrant of a substance is channelled within
the REACH-IT system of the ECHA into a vir-
tual group of of pre-registrants of a substance
with the same EINECS number or other same
identifier, called a pre-SIEF.
Data holders
After the pre-registration period, downstream
users and other data holders may submit in-
formation on substances. By doing so, these
data holders become automatically participant
of the Pre-SIEF. It should be noted that, after a
SIEF has been formed, these data holders can
benefit from cost sharing by making available
this information, but do not have the same
rights and obligations as potential registrants
and third party representatives. For obvious
reasons, these data holders will not register
and will therefore have no role in generating
missing information, dossier formation and
joint submission of a registration.
SIEF formation and the role of the SIEF For-
mation Facilitator
After a pre-SIEF has been formed, its members
shall subsequently review the information and
agree on whether each member of the group
intends to register the same substance. These
discussions on the ‘sameness’ of the substance
can be carried out under leadership of a pre-
registrant who indicated, at the time of the
preregistration, its willingness to lead this ef-
fort. It is important to note at this time, that
3 http://echa.europa.eu/doc/reachit/sief_key_principles.
pdf
36 Journal Chemicals Management march 2009, No. 2
 
articles
this ‘SIEF Formation Facilitator (SFF)’ has no
formal role under REACH and can derive no
rights from being a SFF with respect a pos-
sible future role as lead registrant or compen-
sation from the work to be done in the SIEF.
The ECHA recently published3 a useful clari-
fication on the relation between SIEFs en pre-
SIEFs and the role of the SFF.
Sameness discussions
The aim of a SIEF is to facilitate -for the pur-
pose of registration- the exchange of certain
information required for that registration.
This implies that, before a SIEF is established,
its participants agree that the substances have
the same chemical identity to the extent that
they may share the same data to be submit-
ted in a registration. Useful parameters for
establishing the sameness of a substance are
identifiers such as EINECS and CAS registry
numbers but may also include information
on impurities or even hazard data themselves.
The sameness discussion may lead to one or
more participants splitting from the pre-SIEF
(either to form a SIEF of its own or merge with
another SIEF) These discussions may also
lead to the conclusion that the entire pre-SIEF
should merge with another one (in case for
instance that two EINECS entries represent
the same substance). When the discussions on
the sameness finish, and SIEF members agree
that they all have the same substance, the SIEF
is formed and the corresponding rights and
obligations start to apply.
SIEF formation in practice
During the pre-registration period, over
2.5  million pre-registrations covering 150
000 substances (including many reaction
masses) have been submitted by more than
65 000 companies. There are more than 100
pre-SIEFs with more than 1000 participants.
Close to 5000 pre-SIEFs have 100 participants
or more. With these numbers, the task of SIEF
formation, and thus for the SFF, is formida-
ble. To facilitate SIEF-formation, web based
Sdu Uitgevers
articles
systems like SIEFreach4 have been developed.
Before joining and starting to work in SIEFs,
individual companies need to establish their
role in SIEFs. Cefic, the European Chemical
Industry Council, has designed a simple man-
agement system5 that helps companies first of
all to establish their role. Those who prereg-
istered substances but do not intend to regis-
ter (for instance because they are not manu-
facturing or importing the pre-registered
substances, or those who had to pre-register
due to the so-called ‘double pre-registration’)
probably will not want to participate actively
in SIEFS. Their role is ‘dormant‘ and is limited
to providing, upon request, information. Oth-
ers, who do have an interest in getting their
pre-registered substances registered, will par-
ticipate more actively in data sharing, data gap
analysis, and data generation. Again, several
roles can be distinguished. It is advisable (and
in the case of joint submission of registration
mandatory) that one company takes the role
of ‘lead registrant(s)’. Others may want to be
actively involved in discussions. Companies
who have no resources to actively participate
can decide to have a passive role. Each com-
pany is invited to inform about its role in the
SIEF upon the SFF request.
Many other issues need to be taken into ac-
count by individual companies. Based on the
role a company intends to have, it will need to
allocate resources, both human (skills needed,
such as technical, legal, financial and mana-
gerial) as well as financial. Companies may
choose to outsource several of these compe-
tencies or may decide to outsource all registra-
tion activities. At this time (or later), a com-
pany may also decide to opt not to participate
in a joint submission of certain registration
data (see “Joint registrations and opt-out”).
Both Cefic6 and the ECHA7 have published
guidances to help companies with these type
of decisions.
Sdu Uitgevers
Working in SIEFs
As soon as a SIEF has been formed, partici-
pants need to agree on a number of issues.
Who will be the lead registrant? What will be
the organisational form of the SIEF? How to
define data gaps? How to evaluate and valuate
data? Which data need to be generated? What
cost sharing mechanisms should be in place?
How to deal with confidential business infor-
mation? This chapter does not comprehen-
sively cover all these aspects. The author refers
to aforementioned Guidances of both Cefic
as well as the European Chemicals Agency
ECHA.
Organizing SIEFS: SIEFS vs Consortia
Since many SIEFs will probably have many
participants, managing and operating of, and
working together in SIEFs is no easy task. In
order to manage working in SIEFs efficiently,
Several systems, (like for instance aforemen-
tioned SIEFreach) are in place that facilitate the
work. In addition, SIEF members may want to
consider to form a (or join an existing) con-
sortium8. The difference between a SIEF and
a consortium is that SIEFs are mentioned in
the REACH-regulation whereas consortia are
not. A consortium, usually a (formal) organi-
sation, possibly established under private law
contract, does not have a formal role under
REACH. Joining a consortium is not manda-
tory, but SIEF participants may benefit from
joining because the nature of a consortium
4 https://www.siefreach.com/wps/portal
5 http://www.cefic.be/Templates/shwNewsFull.
asp?HID=1&NSID=707
6 http://cefic.org/Templates/shwStory.asp?NID=
719&HID=714
7 http://guidance.echa.europa.eu/docs/guidance_docu-
ment/data_sharing_en.htm?time=1233582363
8 Ihme W.: REACH Consortia – How to success-
fully manage them! Journaal Stoffen en Preparaten,
2007/7
Journaal Stoffen en Preparaten maart 2009, Nr. 2 37

will allow for a more structured cooperation.
Consortia do not necessarily limit their activi-
ties to REACH. Both consortia and SIEFs will
closely need to take into account the EU com-
petition law requirements (see below).
Data Sharing and Cost Sharing
REACH requires SIEF participants to share
studies involving vertebrate animals. In addi-
tion, REACH allows participants to share oth-
er studies as well. While the latter is not man-
datory, it is advisable to share all relevant in-
formation, including non-animal data such as
results from (Q)SARs for cost saving reasons.
At this stage, inclusion of information from
chemicals which are assumed to have compa-
rable properties (so called ‘read across’), may
be considered. On the basis of the informa-
tion provided by participants, data gaps can
be identified and additional information
needs per volume band can be agreed upon.
It may be that the available data suffices for
lower band registrations, in which case com-
panies who only register for these limited vol-
umes are not required to share in the cost for
the additional studies.
Cost sharing
The cost made by a SIEF may include man-
agement cost, compensation of data holders
and cost of additional testing. Apart from
these costs, individual companies will have
to take care of their own management costs
and registration fees payable to ECHA. Com-
pensation of costs made by data holders in
the past, may be depending on the number
of tests available per end point, the quality
of the test and the number of registrants that
will make use of the test. Cost sharing is not
provided for extensively in REACH itself; the
only requirement is that costs of sharing in-
formation are determined in a fair, transpar-
ent and non-discriminatory way. Again, avail-
able guidances provide valuable information
and advice about cost sharing.
38 Journal Chemicals Management march 2009, No. 2
articles
Dealing with confidential business
information
Confidential Business Information (CBI) is
defined as information that:
(a) is secret in the sense that it is not, as a body
or in the precise configuration and assem-
bly of its components, generally known
among or readily accessible to persons
within the circles that normally deal with
the kind of information in question;
(b) has commercial value because it is secret;
and
(c) has been subject to reasonable steps under
the circumstances, by the person lawfully
in control of the information, to keep it
secret.
REACH does contain a specific single article or
section on protection of CBI. There are how-
ever provisions in REACH aimed at protect-
ing CBI. While the ‘public right to know’ pro-
visions of Regulation (EC) No. 1049/2001 are
applicable to documents held by the ECHA,
article 118 also specifies that ‘disclosure of
certain information shall normally be deemed
to undermine the commercial interests of the
concerned person: this information includes
details of composition, specific use, functions
and application if substances, precise tonnage
and business relations’. Furthermore, regis-
trants can claim confidential treatment of
certain information (article 10). Finally, un-
der article 11 and 19, registrants are allowed
to opt out from joint submission because of
the risk of disclosing CBI (see point below).
A manufacturer, importer or where relevant
downstream user, who does not want to be
identified, may want to appoint a so called
third party representative (TPR) for discus-
sions (for instance in SIEFs and consortia)
with other stakeholders. The actor appoint-
ing the TPR will retain full responsibility (and
liability) however for all obligations under
REACH. Finally, SIEF-participants may want
to enter into confidentiality agreements.
Sdu Uitgevers
articles
Joint registrations and opt-out
In cases where a substance is manufactured
and/or imported by more than one registrant,
certain information shall be submitted jointly
by the lead registrant, acting on behalf of the
other registrants: information in classification
and labelling, study summaries, robust study
summaries and testing proposals. REACH
also allows information on safe use and the
Chemical Safety Report to be submitted
jointly. REACH allows registrants to submit
all aforementioned information separately if
joint submission would be disproportionately
costly, if submitting the information jointly
would lead to disclosure of CBI or if the regis-
trant disagrees with the lead registrant on the
selection of information. This “opt-out” must
be justified. It should be mentioned that opt-
ing out automatically leads to a higher regis-
tration fee and being prioritised for the dos-
sier evaluation.
Competition law
While REACH encourages companies to work
together to perform certain tasks under the
regulation, EU competition law applies to
REACH. Competition law should be closely
considered at any stage of the registration, in
particular in SIEF and consortia discussions.
Competitors may not be unduly excluded
from SIEF membership. SIEFs and Consortia
should not be used as platform for cartel-like
arrangements. Discussions within SIEFs and
consortia should be well moderated and min-
uted. Discussing business related issues, such
as prices, sales information, production cost
and marketing strategy should be avoided at
all cost, even if they are impacted by REACH.
In general, it is strongly advised to limit the
exchange of information to what is strictly
necessary under REACH. Cefic has issued a
useful REACH competition law compliance
guidance.
http://www.cefic.org/files/downloads/compe-
tition_law_compliance_guidance.pdf
Sdu Uitgevers
Malaysia: The Malaysian
Chemicals Register
[2009/0029]
Malaysia is using the experiences obtained
from the European Union REACH registra-
tion programme in setting up an own notifi-
cation scheme.
Announcement to Chemical Industry in
Malaysia: Is your company a manufacturer of
environmentally hazardous substances (EHS)? 
Is your company an importer of environmen-
tally hazardous substances or an importer
of chemical mixtures or finished chemical
products containing environmentally hazard-
ous substances as their constituents? If your
company meets one of these criteria, then a
notification of these substances must be made
to the Department of Environment Malaysia,
through the online EHS Notification and Reg-
istration Scheme.
Definition of EHS: An EHS is a substance
that is included in the EHS Reference List, or
if not on the list, must be assigned a hazard
category under the GHS classification scheme,
as implemented by the Department of Occu-
pational Safety and Health Malaysia
The HS Notification and Registration
Scheme: The objective of the Malaysian HS
Notification and Registration Scheme is to
collect information from industry about the
hazardous substances that are on the Malay-
sian market by introducing a notification
requirement for such substances manufac-
tured in or imported to Malaysia.
Purpose: The purpose of the notification and
registration scheme in Malaysia is to provide
the necessary information to the Malaysian
Government that will enable the Department
of Environment and other agencies involved
in chemicals management to identify substan-
ces of concern in the country and make deci-
sions about how to manage these substances
in a safe and sound manner.
Journaal Stoffen en Preparaten maart 2009, Nr. 2 39

Based on the information submitted by indu-
stry, the Department of Environment (DOE)
will establish the Malaysian Chemicals Regis-
ter. The Malaysian Chemicals Register will
contain information about the identity of sub-
stances that have been notified to DOE, their
uses in Malaysia, their hazard classification
and the accumulated amounts placed on the
market in Malaysia. Information in the Che-
micals Register will be available to the public
through the Internet. Accumulated amounts
manufactured or imported will only be publi-
cised for substances notified by three or more
manufacturers or importers. A particular use
of a substance will likewise only be publicised
if notified by three or more manufacturers or
importers.
Scope: The notification scheme covers:
– All substances not covered by other noti-
fication/registration schemes in Malaysia
and fulfilling the criteria for classification
as hazardous according to the Globally
Harmonised System of Classification and
Labelling (GHS), or until GHS is fully
implemented, the classification according
to the current classification requirements
for chemicals in Malaysia.
– Other substances that are considered sub-
stances of concern due to properties not
covered by the GHS classification scheme.
The notification requirement does not apply
to substances for which information is already
submitted to a Government agency in Malay-
sia by means of other legislations. This regards
substances notified/registered under the follo-
Applicable to All Industry Sectors
Annual Tonnages (MT) Year of Implementation of EHS Notification
2009 2010
> 100 Voluntary /+
Notifica-
10 – 100 /+
tion and
1 – 10 /+
Registra-
0.1 – 1 tion /+
40 Journal Chemicals Management march 2009, No. 2
articles
wing legislations: The Pesticides Act 1974 (Act
149), The Poisons Act 1952 (Act 366), and The
Chemical Weapons Convention Act 2005 (Act
641).
Only substances manufactured or imported in
certain amounts by the individual manufac-
turer/importer will require notification. For
other exemptions to the notification require-
ment, please refer to the ‘Guidance Document
for Industry’.
The notification requirement will be phased
in over a number of years. The first phase will
include substances that are defined as environ-
mentally hazardous substances (EHS) under
The Environmental Quality Act (1974).
Output: Parallel to the notification and regi-
stration scheme, the Department of Envi-
ronment (DOE) is also introducing a scheme
for risk assessment of chemical substances of
concern in Malaysia. The chemicals of con-
cern that will be considered in the risk assess-
ment scheme will be prioritised based on their
classification according to the Globally Har-
monised System of Classification and Label-
ling (GHS) or until GHS is fully implemented,
classification according to the current classifi-
cation requirements for chemicals in Malay-
sia, and in addition the total annual tonnage
of substance manufactured or imported to
Malaysia. Substances of concern due to effects
which are not covered by the GHS classifica-
tion criteria will be prioritised based on annu-
al tonnage and use in the country. Based on
the outcome of the risk assessment, DOE and
other agencies in chemicals management will
2011 2012 2013 2014 2015 2016
/+
/+
/+
/+
Sdu Uitgevers
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decide upon the risk reduction strategy and
the risk reduction actions to be implemented.
Implementation Plan for EHS Notification
and Registration: The Notification and Regi-
stration of EHS by chemical industries in
Malaysia will be implemented in phases. Ini-
tially the scheme will be on a voluntary basis,
where in 2009 all chemical industries, irrespec-
tive of the tonnage imported or manufactu-
red, can register to participate in the scheme.
However, beginning Year 2010, the notification
of EHS by manufacturers and importers will
only be based on the total tonnage of EHS
manufactured and imported. The phase-in
year for the notification based on tonnage is
given in the Table below.
All substances that, under GHS classification,
are assigned an aquatic toxicity classification
of “chronic 1” (/) or are suspected or known
human carcinogens, reproductive toxicants
or mutagens (+) must also be notified during
years 2010 and 2011.
EHS Register: The EHS Register is a listing of
all chemical substances, notified by manufac-
turers and importers in Malaysia, which are
hazardous to human health and the environ-
ment. Due to confidentiality requirements,
only substances which are notified by three or
more companies are presented in this output.
The default list includes all substances which
have been notified since the scheme was start-
ed in 2007. The hazard classification catego-
ry of Malaysia is based on the Occupational
Safety and Health (Chemicals Classification,
Labelling and Safety Data Sheet) Regulation
(CLASS).
EHS Reference List: The EHS Reference List
adopted by the Department of Environment
Malaysia is based on the published European
Annex I to the Substance Directive (Directive
67/548/EEC). Annex I is a comprehensive list
of dangerous substances classified with har-
monised classification and labelling; compris-
ing of 2550 existing substances and 700 new
Sdu Uitgevers
substances. This list is published on: http://
www.e-ehs.doe.gov.my/homepage/ehs_list/.
Guidelines for HS Notification &
Registration
Chemical manufacturers and importers
making the notification and registration of
EHS are encouraged to follow the steps given
below:
A. Pre-notification
(1) Compile an inventory (list) of all indivi-
dual chemical substances manufactured and/
or imported by the company during the year
of notification. The substances to be listed,
together with their identification number (e.g.
CAS No or EC No), may be in pure form or as
part of mixtures or in finished products.
(2) Check whether each of the listed chemical
substances is hazardous or not. There are two
ways to achieve this:
Log into the Department of Environment’s
on-line EHS Notification and Registration
System. In the EHS Reference List box, type
the identification number (CAS No or EC
No) of the substance and click on the Search
button. A result of the search function will be
displayed to the user. If the substance is on the
EHS Reference List and already has an agreed
GHS hazard classification, as shown by the
displayed chemical name, classification code
and other properties, a basic notification of
the substance is required from the company.
The basic notification is however not required
if the annual tonnage of the substance is below
the tonnage trigger point currently enforced
by the Department of Environment Malaysia
(see Implementation). The information can
be notified by completing the form under the
sub-menu “Basic Notification of EHS”. (Note:
A chemical company needs to register with
the EHS system first before a notification is
permitted - See Step 4).
Next, type the identification number (CAS
No or EC No) of the substance in the CMR
Reference List and click on the Search button.
If the substance is on the CMR Reference List
Journaal Stoffen en Preparaten maart 2009, Nr. 2 41

and already has an agreed GHS hazard clas-
sification, as shown by the displayed chemical
name, classification code and other properties,
a basic notification of the said substance is
also required from the company; irrespective
of the annual tonnage produced or imported
by the company.
(3) If the substance is not on the EHS and
CMR Reference Lists or which do not have an
agreed GHS classification, as indicated by the
message “Record Not Found”, the manufactu-
rer or importer will then be required to assess
that substance against the GHS classification
criteria. If the substance is assigned a GHS
classification, the manufacturer or importer
will then be required to supply the infor-
mation that they have used to carry out the
classification, the classification itself and the
data on tonnage per annum (as defined in the
basic notification of EHS). The manufacturer
or importer can also refer to the Safety Data
Sheet (SDS) of the given substance or mixtu-
re/product, where in Section 2 on “Composi-
tion/Information on Ingredients”, a listing of
the hazardous substances in the mixture/pro-
ducts is documented. Note: There is a need to
differentiate between the SDS of a substance
and a SDS of a mixture or product. The EHS
Notification and Registration Scheme is for
environmentally hazardous substances only.
If in doubt about the properties given in the
SDS, please contact the supplier or manufac-
turer of the substance or mixture/product. If
through any of the above ways the substance
is determine to be hazardous, a detail notifi-
cation of the substance is required from the
company. The information can be notified by
completing the form under the sub-menu on
“Detail Notification of EHS”.   pany private domain or window is obtained,
(4) For those substances which are not assig-
ned a GHS classification in Step 3, the manu-
facturer or importer shall however be required
to retain the data used to make their GHS
assessment for a minimum of 5 years, after
the assessment has been made. The data must
42 Journal Chemicals Management march 2009, No. 2
articles
be made available for inspection on request by
the Department of Environment Malaysia.
For some substances, it is recognized that the
producer and/or importer may be unable to
carry out a GHS classification (e.g. because of
insufficient data or uncertainty in the struc-
ture of the substance). In this case, the pro-
ducer or importer should submit all of the
available data, including tonnage, and submit
them to the DOE with an explanation of why
it was not possible to assign a GHS classifica-
tion.
(5) Finalize the list of all hazardous substances
manufactured and/or imported by your com-
pany. The list shall have, at least, all the infor-
mation required for basic notification of EHS,
i.e. name of chemical, ID no, annual tonnage,
occurrence, source, uses, etc. 
Full details and guidance on the Notification
and Registration Process are available in the
Guidance Document which can be downloa-
ded from this website.
B. Notification
(1) Register your company with the Depart-
ment of Environment Malaysia to partici-
pate in the EHS Notification and Registration
Scheme. This can be done by logging into the
DOE website (http://www.doe.gov.my) and
activating the menu on EHS Notification and
Registration. Select the option on Company
Registration in the resultant output to regis-
ter your company. A letter of approval, sent by
e-mail, will be communicated to you once the
registration is verified and approved by the
Department.
(2) A two stage approach is recommended to
chemical industries for the Notification and
Registration of EHS. Once access to your com-
i.e. after entering the User ID and Password,
follow the procedures listed below:
Activate the menu on Basic Notification of
EHS to undertake a basic notification for each
hazardous substance which you have finalized
in Step 5. On completion of data entry, check
for correctness of your data before submit-
Sdu Uitgevers
articles
Importer or manufacturer of individual substances
• The substance is included in the EHS Reference List
• The substance is not included in the EHS Reference List
but is classified as hazardous according to GHS criteria
as outlined in CLASS regulation/guidance document
• The substance is not exempted from notification
• The EHS is manufactured or imported annually in
amounts exceeding the defined tonnage trigger point
and covered by phase-in criteria (see Implementa-
tion)
ting the information to DOE, since informa-
tion once submitted will not be subject to any
changes. Repeat the basic notification for all
substances in your list. A display listing all
substances entered into the system and noti-
fied by your company is available for your
viewing and printing, if required. Explana-
tory texts to assist you in entering the data as
well as how to proceed with the notification
process are given the system.
Once the basic notification has been comple-
ted, a detail notification can then be underta-
ken. In this case, the substances which require
detail notification will be listed when the
menu Detail Notification of EHS is activa-
ted. Select a particular substance to begin the
detail notification process. (Note: All six sets
of data, i.e. EHS Identification, Physical Che-
mical Properties, Physical Hazards, Hazards to
Human Health, Hazards to Aquatic Environ-
ment and Overall GHS Classification must be
completed before submitting the data to the
Department of Environment Malaysia).
If a substance had been previously notified in
detail (e.g. in the previous year), a detail noti-
fication of the said substance is not required
anymore. However a new detail notification
of the substance should be made if new data
are available to the company.
Sdu Uitgevers
Importer of substances as part of a mixture or finished product
• The substance is included in the EHS Reference List
• The substance is not included in the EHS Reference List
but is classified as hazardous according to GHS criteria
as outlined in CLASS regulation/guidance document
• The substance is not exempted from notification
• The cumulated annual amount of the EHS in mixtures
and/or products where the concentration of the sub-
stance exceeds 1 % (0.1 % for carcinogenic substan-
ces, substances toxic to reproduction, and category 1
and 2 mutagens) is above the defined tonnage trigger
point and covered by phase-in criteria (see Implemen-
tation)  
In this case, detail data previously notified can
be accessed and edited to reflect the changes
Registration of Companies: Company regi-
stration in the EHS Notification and Registra-
tion Scheme of the Department of Environ-
ment Malaysia is aimed solely at manufacturers
and importers of chemical substances and
importers of chemical substances as part of
a mixture or finished product. Registration
may be required for companies belonging to
the following categories:
1) The company is a manufacturer of EHS
and these EHS are used by the company
or sourced by other companies (local
or overseas) down the supply chain, to
trade or formulate/manufacture chemical
mixtures or products. Chemical indus-
tries involved only in the manufacture
of chemical mixtures or products using
locally manufactured EHS or imported
EHS sourced from local suppliers as raw
materials are not subject to notification
and registration of EHS.
2) The company is an importer of individual
EHS and/or chemical mixtures or finished
products containing EHS as constituents.
Chemical companies involved only in the
formulation, distribution, retailing and
Journaal Stoffen en Preparaten maart 2009, Nr. 2 43
 actualities

use of EHS or EHS containing mixtures/

products are not subject to notification
and registration of EHS. 
Registration is required if the chemical com-
actualities
pany categorized above also fulfills the follo-
wing conditions:
References: http://www.e-ehs.doe.gov.my/
EHS Reference List: http://www.e-ehs.doe. European Union
gov.my/homepage/ehs_list/
EHS Register: http://www.e-ehs.doe.gov.
my/homepage/ehs_register/ ATP 31 to 67/548/EEC
See also: Journaal Stoffen en Preparaten, 2009, 9,
item 2007/0343 (on CLASS) [2009/0030]

The Official Journal of the European Union

L11 of 16 January 2009 published Directive
2009/2/EC, the 31st ATP to the Dangerous
Substances Directive 67/548/EEC. Member
States shall bring into force the laws, regula-
tions and administrative provisions necessary
to comply with this Directive by 1 June 2009
at the latest.

Nickel compounds
The classifications of the nickel compounds
listed in this Directive are based on the effects
originating from the Ni(2+) ion and on the
available data for nickel compounds. The
classifications were derived bij grouping nic-
kel compounds into categories on the basis of
water solubility (e.g. groups insoluble, slightly
soluble and soluble nickel compounds respec-
tively). Water solubility was used as an initial
criterion to define these categories, based on
the argument that nickel substances having
similar water solubility will indicate similar
bioavailability of the Ni(2+) ion and similar
systemic toxicity. This justifies a read across
within groups from the substances for which
the available adequate test data demonstrate a
specific systemic effect to those lacking such
test data. For some effects, read across bet-
ween groups is justified, as similar effects have
been observed across the range of water solu-
bility. For example, epidemiological studies
show that both soluble and insoluble nickel

44 Journal Chemicals Management march 2009, No. 2 Sdu Uitgevers

actualities
compounds (at opposite ends of the range
of solubility) have local carcinogenic effects
in the respiratory tract. There is, therefore,
good reason to conclude that slightly soluble
compounds (at the middle of this range) have
similar carcinogenic properties.
As part of an evaluation of all the available
information for the nickel compounds, water
solubility can be used as an approximation of
systemic bioavailability of the Ni(2+) ion for
many effects and substances.
Reference: http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=OJ:L:2009:011:0006:0082:EN
:PDF
Again corrigendum to REACH text
[2009/0031]
Corrigendum to Regulation (EC) No1907/2006
concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals
(REACH), establishing a European Chemi-
cals Agency, amending Directive 1999/45/
EC and repealing Council Regulation (EEC)
No. 793/93 and Commission Regulation
(EC) No 1488/94 as well as Council Direc-
tive 76/769/EEC and Commission Directi-
ves 91/155/EEC, 93/67/EEC, 93/105/EC and
2000/21/EC (Official Journal of the European
Union L 396 of 30  December 2006, p. 1; cor-
rected by OJ L 136, 29.5.2007, p. 3)
The following reference is to the publica-
tion in OJ L 136, 29.5.2007, as amended by
Regulation (EC) No 1354/2007 (OJ L 304,
22.11.2007, p. 1) and as corrected by the May
2008 corrigendum to Article 3(20)(c) (OJ L
141, 31.5.2008, p. 22).
This corrigendum cancels and replaces the
corrigendum published in OJ L 141, 31.5.2008,
p. 22, as follows:
On page 21, Article 3(20)(c):
for: ‘(c) it was placed on the market in the
Community, or in the countries acceding
to the European Union on 1 January 1995,
Sdu Uitgevers
on 1 May 2004 or on 1 January 2007, by the
manufacturer or importer at any time bet-
ween 18  September 1981 and 31 October
1993 inclusive, and before the entry into force
of this Regulation it was considered as having
been notified in accordance with the first
indent of Article 8(1) of Directive 67/548/EEC
in the version of Article 8(1) resulting from
the amendment effected by Directive 79/831/
EEC, but it does not meet the definition of a
polymer as set out in this Regulation, provi-
ded the manufacturer or importer has docu-
mentary evidence of this;’,
read: ‘(c) it was placed on the market in the
Community, or in the countries acceding
to the European Union on 1 January 1995,
on 1 May 2004 or on 1 January 2007, by the
manufacturer or importer before the entry
into force of this Regulation and it was con-
sidered as having been notified in accordance
with the first indent of Article 8(1) of Direc-
tive 67/548/EEC in the version of Article 8(1)
resulting from the amendment effected bij
Directive 79/831/EEC, but it does not meet
the definition of a polymer as set out in this
Regulation, provided the manufacturer or
importer has documentary evidence of this,
including proof that the substance was placed
on the market by any manufacturer or impor-
ter between 18 September 1981 and 31 Octo-
ber 1993 inclusive;’.
Reference: http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=OJ:L:2009:036:0084:0084:EN
:PDF
International
USA: New Children’s Product
Safety Laws on lead and phthalates
[2009/0032]
On 10 February 2009, new requirements of the
Consumer Product Safety Improvement Act
(CPSIA) take effect. Manufacturers, import-
Journaal Stoffen en Preparaten maart 2009, Nr. 2 45

ers and retailers are expected to comply with
the new Congressionally-mandated laws.
Under the new law, children’s products with
more than 600 ppm total lead cannot lawfully
be sold in the United States on or after 10 Feb-
ruary 2009, even if they were manufactured
before that date. The total lead limit drops to
300 ppm on 14 August 2009.
Certain children’s products manufactured on
or after February 10, 2009 cannot be sold if
they contain more than 0.1% of certain spe-
cific phthalates or if they fail to meet new
mandatory standards for toys [(a)…any chil-
dren’s toy or child care article that contains
concentrations of more than 0.1 percent of
di-(2-ethylhexyl) phthalate (DEHP), dibutyl
phthalate (DBP), or benzyl butyl phthalate
(BBP); (b) … until a final rule is promulgat-
ed…. any children’s toy that can be placed in
a child’s mouth or child care article that con-
tains concentrations of more than 0.1 percent
of diisononyl phthalate (DINP), diisodecyl
phthalate (DIDP), or di-n-octyl phthalate
(DnOP).]
While the U.S. Consumer Product Safety
Commission (CPSC) expects every company
to comply fully with the new laws resellers
should pay special attention to certain prod-
uct categories. Among these are recalled chil-
dren’s products, particularly cribs and play
yards; children’s products that may contain
lead, such as children’s jewelry and painted
wooden or metal toys; flimsily made toys that
are easily breakable into small parts; toys that
lack the required age warnings; and dolls and
stuffed toys that have buttons, eyes, noses or
other small parts that are not securely fas-
tened and could present a choking hazard for
young children.
Reference: http://www.cpsc.gov/cpscpub/prerel/
prhtml09/09086.html
Legal text: http://www.cpsc.gov/cpsia.Pdf
46 Journal Chemicals Management march 2009, No. 2
actualities
USA: Occupational Exposure to
Hexavalent Chromium
[2009/0033]
This NIOSH criteria document is derived from
reviews of information from human, animal,
and experimental studies of the toxicity of
hexavalent chromium (Cr(VI)) compounds
and is intended to describe the potential health
effects of occupational exposure to this group
of chemical compounds. Cr(VI) compounds
include a large group of chemicals with vary-
ing chemical properties, uses, and workplace
exposures. The major chromium-containing
materials in the marketplace are chromite ore,
chromium chemicals, ferroalloys, and metal.
The United States is a major World producer
of chromium metal, chromium chemicals, and
stainless steel. Sodium dichromate is the most
common chromium chemical from which
other Cr(VI) compounds may be produced.
Cr(VI) compounds commonly manufactured
include sodium dichromate, sodium chroma-
te, potassium dichromate, potassium chro-
mate, ammonium dichromate, and Cr(VI)
oxide. Other Cr(VI)-containing materials
commonly manufactured include various
paint and primer pigments, graphic art sup-
plies, fungicides, corrosion inhibitors, and
wood preservatives.
NIOSH recommends that airborne exposure
to all Cr(VI) compounds be limited to a con-
centration of 0.2 μg Cr(VI)/m3 for an 8-hr
TWA exposure, during a 40-hr workweek.
Due to the residual risk of lung cancer at the
REL, NIOSH further recommends that all
reasonable efforts be made to reduce expo-
sures to Cr(VI) compounds below the REL
through the use of engineering controls and
work practices.
In addition to limiting airborne concentra-
tions of Cr(VI) compounds, NIOSH recom-
mends that dermal exposure to Cr(VI) be
prevented in the workplace to reduce the
risk of adverse dermal health effects inclu-
Sdu Uitgevers
actualities
ding irritation, ulcers, skin sensitization, and
allergic contact dermatitis. Skin notations of
SK-DIR(COR) (causing corrosion by direct
skin contact) and SK-SEN (causing allergic
contact dermatitis or other allergic effects due
to dermal exposure) are recommended for all
Cr(VI) compounds.
References: NIOSH Hexavalent Chromium Criteria
Document Update External Review Draft
September 2008 http://www.cdc.gov/
niosh/review/public/144/pdfs/DRAFT-
Criteria-Document-Update-Occupational-
Exposure-to-Hexavalent-Chromium.pdf
http://www.cdc.gov/niosh/review/
public/144/
Canada: Update on Batch 4
chemicals Challenge Program
[2009/0034]
On 24 January 2009 notices were published
in Canada Gazette regarding draft screen-
ing assessment for Batch 4 chemicals of the
Challenge Program. This batch includes 18
chemicals substances out of which the follow-
ing 13 were identified as persistent, bioaccu-
mulative and inherently toxic to non human
organisms and believed to be in commercial
use in Canada: Phenol, 4,4 -(3H-2,1-benzoxa-
thiol-3-ylidene)bis[2,6-dibromo-, S,S-dioxide
(CAS 115-39-9); Phenol, 4,4 -(3H-2,1-benzo-
xathiol-3-ylidene)bis[2-bromo-6-methyl-,
S,S-dioxide (CAS 115-40-2); Phenol, 4,4
-(3H-2,1-benzoxathiol-3-ylidene)bis[2,5-
dimethyl-, S,S-dioxide (CAS 125-31-5); Benz-
amide, 3,5-dichloro-N-(3,4-dichlorophenyl)-
2-hydroxy-(3,3’,4’,5-tetrachlorosalicylanilide)
(CAS 1154-59-2); Benzoic acid, 2-[(3,5-dibro-
mo-4-hydroxyphenyl)(3,5-dibromo-4-oxo-
2,5-cyclohexadien-1-ylidene)methyl]-, ethyl
ester (CAS 1176-74-5); 5H-Dibenz[b,f]
azepine-5-propanamine, 3-chloro-10,11-di-
hydro-N,N-dimethyl-, monohydrochloride
(CAS 17321-77-6); Phenol, 4,4 -(3H-1,2-
Sdu Uitgevers
benzoxathiol-3-ylidene)bis[2,6-dibromo-
3-methyl-, S,S-dioxide, monosodium salt
(CAS 62625-32-5); ; Adenosine, N-benzoyl-5
-O-[bis(4-methoxyphenyl)phenylmethyl]-2
-deoxy- (CAS 64325-78-6); Amines, tallow
alkyl, ethoxylated, phosphates (CAS 68308-
48-5); Amines, C18-22-tert-alkyl, ethoxylated
(CAS 68443-10-7); Benzenamine, N-phenyl-,
reaction products with styrene and 2,4,4-tri­
methylpentene (CAS 68921-45-9); 2-Butanone,
4-[[[1,2,3,4,4a,9,10,10a-octahydro-1,4a-di­
methyl-7-(1-methylethyl)-1-phenanthrenyl]
methyl](3-oxo-3-phenylpropyl)amino]-,
[1R-(1a,4aß,10aa)]- (CAS 70776-86-2); and
Amines, C18-22-tert-alkyl, (chloromethyl)
phosphonates (2:1) (CAS 79357-73-6).
The other five were identified as a high hazard
to humans and presenting a high likelihood
of exposure to individuals in Canada: Sul-
furic acid, diethyl ester (CAS 64-67-5); Pro-
pane, 2-methyl- (CAS 75-28-5); Sulfuric acid,
di­methyl ester (CAS 77-78-1); Butane (CAS
106-97-8); and Hexane (CAS 110-54-3).
Risk management scope documents are also
available for public comment about the fol-
lowing substances: Benzenamine, N-phenyl-,
reaction products with styrene and 2,4,4-tri­
methylpentene (CAS 68921-45-9), Sulfuric
acid, diethyl ester (CAS 64-67-5) and Sulfu-
ric acid, dimethyl ester (CAS 77-78-1). These
documents are open to public comment from
24 January 2009 to 25 March 2009. The final
screening assessment report and the proposed
risk management approach document are
expected to be released by July 2009.
A Notice of Intent was published in the
Canada Gazette to amend the DSL by delet-
ing the following Batch 4 Substances,  and
by applying the SNAc Provisions of CEPA
1999 to them: Benzamide, 3,5-dichloro-
N-(3,4-dichlorophenyl)-2-hydroxy- (CAS
1154-59-2); Benzoic acid, 2-[(3,5-dibromo-
4-hydroxyphenyl)(3,5-dibromo-4-oxo-2,5-
cyclohexadien-1-ylidene)methyl]-, ethyl ester
(CAS 1176-74-5); Adenosine, N-benzoyl-5–-
Journaal Stoffen en Preparaten maart 2009, Nr. 2 47

O-[bis(4-methoxyphenyl) phenylmethyl]-2‘-
deoxy- (CAS 64325-78-6); Amines, C18-22-
tert-alkyl, ethoxylated (CAS 68443-10-7);
and 5. 2-Butanone, 4-[[[1,2,3,4,4a,9,10,10a-
octahydro-1,4a-dimethyl-7-(1-methylethyl)-
1-phenanthrenyl]methyl](3-oxo-3-phenyl-
propyl) amino]-, [1R-(1a,4aß,10aa)]- (CAS
70776-86-2).
Under the SNAc provision, any activity involv-
ing more than 100kg of any of these five sub-
stances in any calendar year is subject to spe-
cific information disclosure, at least 90 days,
before the day on which the quantity exceeds
100kg. There is an assessment period of 90
days once the Minister receives the required
information.
The Chemical Substance Public Summaries
are a series of short fact sheets about chemi-
cal substances that are being (or have been)
assessed in Canada for their possible risks to
human health and the environment (Chemi-
cals at a glance).
References: Canada gazette, Part I, Volume 143, No.4,
http://canadagazette.gc.ca
Chemical Substances in Batch 4 of the
Challenge, http://www.chemicalsubstanc-
eschimiques.gc.ca/
Chemicals at a glance: http://www.chemi-
calsubstanceschimiques.gc.ca/interest-
interet/index_e.html
Canada: Melamine standard
[2009/0035]
Canada is the first country to lower its mela-
mine standards in order to match those set
recently by the World Health Organization
(WHO).
The WHO, at a meeting in Ottawa in Decem-
ber 2008, determined that the tolerable daily
intake (TDI) of melamine that a person
can ingest without appreciable health risk
is 0.2  mg per kg of body weight. Under this
48 Journal Chemicals Management march 2009, No. 2
actualities
formula, a 110-pound person could tolerate
10 milligrams of melamine per day. Canada,
which like many other countries had slight-
ly higher guidelines, will adopt the WHO
recommendations.
Canada will reduce the amount of melamine
it allows in infant formula to 0.5 parts per
million (ppm) from one ppm, even though
the WHO had determined that one ppm in
infant formula and other foods is safe.
The new standards come as China copes
with a melamine crisis. The country’s health
ministry said six babies died after consuming
milk powder tainted with melamine, while
294 000 were sickened. The scandal exposed
the practice of adding melamine to watered
down milk to boost the apparent protein con-
tent in routine tests.
Reference: http://www.cbc.ca/health/
story/2008/12/05/melamine-who.html
See also: http://www.cbc.ca/health/
story/2008/11/28/fda-formula.html
Canada and the use of
nanomaterials
[2009/0036]
The Canadian government could become
the first in the world to require companies to
report the use of potentially harmful nano-
material in their products, an expert group
in the U.S. reported Wednesday 28 January
2009. The Washington, D.C.-based Project on
Emerging Nanotechnologies said Ottawa has
been working with industry to develop the
new regulations. The government is reported-
ly planning to release the plans in February.
The group, a watchdog organization that
monitors the development and commerciali-
zation of nanotechnologies, said governments
worldwide lack information on the type,
quantity and possible risks of nanomaterials
in commercial products. Information col-
lected under the requirement will be used to
Sdu Uitgevers
actualities
evaluate the risks the materials may pose to
health and the environment, the group said.
It is estimated that more than 800 consumer
products containing nanomaterials are being
sold around the world. They include skin care
products, cosmetics, electronics, food addi-
tives and medical therapies. Nanotechnology
is the science of manipulating particles smaller
than 100 nanometres — more than 800 times
smaller than the width of a human hair.
Reference: http://www.cbc.ca/health/
story/2009/01/28/nanotech.
html#socialcomments
OECD: Polymers of Low Concern
[2009/0037] could be achieved with improved data quality
In March 2007, the OECD Task Force on New
Chemicals Notification and Assessment orga-
nised an Expert Group Meeting on polymers,
held in Tokyo, Japan. At this meeting, the
Expert Group agreed to carry out a prelimi-
nary analysis of data on polymers with a view
to share experiences and provide evidence for
countries to reconsider their rule regarding
identification of Polymers of Low Concern
(PLCs). Data for 205 polymers were collated
from Australia, Canada, Japan, Korea and US.
Countries classified the polymers under two
categories (PLCs and non-PLCs) using the US
EPA criteria. The analysis was aimed at iden-
tifying correlations between polymer charac-
teristics and potential for health or ecotoxico-
logical concern.
Definition: “Polymers of low concern are
those deemed to have insignificant environ-
mental and human health impacts. Therefore,
these polymers should have reduced regula-
tory requirements.”
Data of variable quality were collected. Sever-
al health effects were reported for polymers,
and it was not possible to critically evaluate
the quality of this data based on what was
available. Also, examination of specific effects
Sdu Uitgevers
was not possible, so a conservative approach
– grouping polymers into low concern and
potential concern groups – was used in this
initial analysis. Polymers that were considered
to be PLCs showed generally low concern for
health or ecotoxicological effects, although
some effects of potential health concern were
reported.
Amongst the polymers that met the PLC cri-
teria, 87.8% showed low health concern and/
or low ecotoxicological concern. This value
represents the outcome of this initial analysis,
given the level of confidence in the available
data. It is noteworthy that such a large propor-
tion of PLCs were clearly of low health con-
cern despite the use of conservative assumpti-
ons. It is likely that a higher level of confidence
and analytical techniques.
One of the most striking findings related to
the number-average molecular weight (Mn)
of a polymer; the lower the Mn, the higher the
potential for health or ecotoxicological con-
cern. Similar results were obtained when the
contents of low molecular weight, oligomeric
species were investigated – the higher the con-
tent, the more likely a polymer was to display
concern. Trends were not clearly observed bet-
ween polymer class and any observed toxicity,
but many classes were each represented by
only a few polymers. No potential for health
concern was observed amongst the polyesters
of the dataset.
Reactive functional groups were more often
seen in potential health and ecotoxicologi-
cal concern polymers than amongst the low
health concern polymers, but the level of data
available was insufficient to confidently ana-
lyse any specific reactive functional groups. No
confident trends were observed between the
functional group equivalent weight (FGEW)
of a polymer and its potential for concern.
However, there was some suggestion that
higher concern polymers had lower FGEWs
than low concern polymers.
Journaal Stoffen en Preparaten maart 2009, Nr. 2 49

A higher proportion of polymers with interme-
diate water solubility values (10-10000 mg/l)
displayed potential health concern. Polymers
with water solubilities <10 mg/l showed gene-
rally low health concern. No correlation could
be drawn between ecotoxicological concern
and water solubility.
Overall, this initial analysis has provided sci-
entific evidence that builds confidence in the
PLC criteria (where sufficient data were avai-
lable). The instances where potential concern
was observed for PLCs do not invalidate this
conclusion. The hypothesis that polymers
meeting the PLC criteria are likely to have
insignificant human health or environmental
impacts is thus supported, and suggests that
regulatory requirements might be reduced for
these polymers.
Reference: Data Analysis of the Identification of Cor-
relations between Polymer Characteristics
and Potential for Health or Ecotoxicologi-
cal Concern. https://www.oecd.org/data-
oecd/3/23/42081261.pdf
Global Update on New Chemicals
Regulations (December 2008)
[2009/0038]
From October to December 2008, approxi-
mately 460 new regulations relating to chemi-
cals management were adopted or published
worldwide. These involve implementation of
GHS, updates to chemical inventories, new
priority chemicals, several changes to the
requirements on transport and handling, and
last but not least restrictions on the marketing
and use of chemicals like arsenic, chloroflu-
orocarbons, etc.
Further information on any of these new regu-
lations and what they require from industry
can be found in the Enhesa Update published
by ENHESA (www.enhesa.com).
50 Journal Chemicals Management march 2009, No. 2
actualities
Australia
QLD: Water and Other Legislation Amend-
ment Act 2007 will enter into force on
17 August 2009 14-Nov-2008
QLD: Environmental Protection Regulation
2008 published 07-Nov-2008
NSW: Dangerous Goods (Road and Rail
Transport) Act 2008 passed 03-Dec-2008
QLD: Environmental Protection and Other
Legislation Amendment Act (No. 2) 2008
23-Oct-2008
SA: Dangerous Substances (Transport of
Dangerous Goods) Regulations 2008 publis-
hed to adopt 7th Edition of the ADG Code
01-Sep-2008
VIC: Transport of Dangerous Goods legisla-
tion amended 18-Dec-2008
QLD: Workplace Health and Safety and Other
Legislation Amendment Act 2008 published
25-Nov-2008
SA: Industrial Chemicals (Notification and
Assessment) Regulations amended
QLD: Transport Operations (Road Use
Management—Dangerous Goods) Regula-
tion 2008 published repealing the 1998 Regu-
lation 12-Dec-2008
QLD: Environmental Protection (Air) Policy
2008 published 12-Dec-2008
QLD: Environmental Protection (Noise) Poli-
cy 2008 published 12-Dec-2008
QLD: Transport and Other Legislation Amend-
ment Act 2008 published to amend several pie-
ces of legislation 01-Dec-2008
QLD: Environmental Protection and Other
Legislation Amendment Regulation (No. 2)
2008 published 12-Dec-2008
Austria
Ordinance on Prohibited Chemicals amended
with regard to mercury 10-Oct-2008
Chemicals Ordinance amended 13-Nov-2008
Amendment to Ordinance on Waste Catalo-
gue adopted 23-Dec-2008
Amendment to WEEE Ordinance adopted
23-Dec-2008
Sdu Uitgevers
actualities
Brazil
Resolution CONAMA establishing the maxi-
mum lead, cadmium and mercury content for
batteries and accumulators published 04-Nov-
2008
Rules on the enforcement of legislation on
conformity assessment of packaging for road
transport of dangerous goods adopted 03-Oct-
2008
IBAMA Normative Instruction on control of
the import of HCFCs adopted 19-Nov-2008
Rules on conformity assessment of bulk inter-
mediate containers used in the road transport
of dangerous goods revised 03-Oct-2008
Bulgaria
Requirements for marketing of batteries and
accumulators and for treatment and trans-
portation of waste batteries and accumulators
amended 30-May-2008
Law on Technical Requirements for Products
adopted 26-Oct-2007
Ordinance on EMAS adopted 29-Oct-2008
Ordinance on the Register of operators pur-
suant to the Law on Environmental Liability
adopted 12-Dec-2008
Law on Protection of Environment amended
27-Nov-2008
Canada
Ministerial Condition No. 15193 regarding
benzene, 1,1’-(1,2-ethanediyl)bis(2,3,4,5,6-
pentabromo)-, CAS 84852-53-9 published
04-Oct-2008
Significant New Activity Notice No. 15253
regarding fatty acids, tall-oil, reaction pro-
ducts with alkylamine and 2-propenoic acid
adopted 01-Nov-2008
Ministerial Condition No. 15275 regarding
amide of 3-(trimethylaminium)-1-propyla-
mine, chloride salt published 04-Oct-2008
Significant New Activity Notice No. 15282
for supramolecular complex of di(bisalkyl­
sulfosuccinate) barium salt published 11-Oct-
2008
Significant New Activity Notice No. 15290 for
methanone, [1,1’-biphenyl]-4-ylphenyl-, CAS
2128-93-0 published 18-Oct-2008
Sdu Uitgevers
Ministerial Condition No. 15350 on poly (oxy-
1,2-ethanediyl), _-[3-[1,3,3,3-tetramethyl-1-
[(trimethylsilyl) oxy]disiloxanyl]propyl]-_-
hydroxy- adopted 08-Nov-2008
Orders Amending the Domestic and Non-
Domestic Substances Lists adopted 12-Nov-
2008
Significant New Activity Notice No. 15278
regarding the substance alkanes, C14-16, CAS
90622-46-1 adopted 22-Nov-2008
Significant New Activity Notice No. 11449
adopted regarding oxirane, CAS 71033-08-4
06-Dec-2008
Significant New Activity Notices No. 15312
and 15313 regarding substance 2-Propenoic
acid adopted 29-Nov-2008
Significant New Activity Notice No. 15314
regarding the substance polyfluoroacrylate,
polymer with chloroethene adopted 29-Nov-
2008
Significant New Activity Notice No. 15367
adopted in respect of the substance ferra-
te(1-), CAS 102561-69-3 27-Dec-2008
ONT: Regulation amending the Propane
Storage and Handling Regulation adopted
27-Dec-2008
China
Latest Inventory of Existing Chemicals (2008
version) available 25-Dec-2008
Fire Prevention Law amended 28-Oct-2008
List of Severely Restricted Toxic Chemicals for
Export and Import (2009) 31-Dec-2008
57 Ozone Depleting Substances and 96 Con-
trolled Used Mechanical and Electronic Pro-
ducts subject to Import Licensing in 2009
10-Dec-2008
Colombia
Law 1252 on integrated waste and hazardous
waste management adopted 27-Nov-2008
Law 1259 on the procedures to punish infrin-
gers of norms regarding health, cleaning and
collection of waste adopted 19-Dec-2008
Croatia
Law of the Environmental Protection adopted
03-Oct-2007
Journaal Stoffen en Preparaten maart 2009, Nr. 2 51

Law on the REACH Regulation EC/1907/2006
adopted 25-Apr-2008
Regulation on Management with Waste Elec-
trical and Electronic Devices and Equipment
(WEEE) adopted 13-Jul-2007
Czech Republic
Amendment of Air Protection Act detailing
EU Regulations on fluorocarbons adopted
10-Dec-2008
Regulation on chemical substances and pre-
parations with regards to testing amended
27-Oct-2008
Estonia
Regulation on requirements for ozone-deple-
ting substances amended 03-Jan-2008
Methods and procedure for labeling batteries
and accumulators issued 21-Dec-2007
Requirements for handling used batteries and
accumulators issued 10-Jan-2008
Finland
Adopted a Decree amending the Decree on
restricting hazardous substances in vehicles
09-Oct-2008
Adopted a Decree amending the Decree on
the classification and labelling of chemicals
28-Oct-2008
Adopted the Decree bringing into force the
ILO Convention No. 187 concerning the pro-
motional framework for occupational safety
and health 19-Dec-2008
Adopted a Decree bringing into force the
changes made to the European Agreement
on the international transport of dangerous
goods by road (ADR 2009) 19-Dec-2008
France
Order relating to the affixing of a pictogram
on the packaging of certain pharmaceutical
products 03-Oct-2008
Environmental and safety requirements
applying to certain warehouses storing com-
bustible substances and products adopted
23-Dec-2008
Environmental and safety requirements
applying to certain installations storing paper
and cardboard adopted 30-Sep-2008
52 Journal Chemicals Management march 2009, No. 2
actualities
Order relating to the annual declaration of
manufacturers, importers and users of PFOS
to the administration adopted 26-Nov-2008
Environmental and safety requirements
applying to certain installations of filling or
distribution of flammable liquids subject to
declaration adopted 19-Dec-2008
Order on the transport of dangerous goods by
road amended 09-Dec-2008
Environmental and safety requirements
applying to certain installations using or sto-
ring chlorine and subject to declaration adop-
ted 17-Dec-2008
Environmental and safety requirements
applying to certain flammable liquid storage
tanks adopted 22-Dec-2008
Environmental and safety requirements apply-
ing to certain installations storing ammonium
nitrate and subject to declaration adopted
18-Dec-2008
Decree relating to the placing on the mar-
ket of substances and preparations adopted
14-Dec-2008
Hungary
Act on chemical safety with regard to REACH
amended 01-Jun-2008
Amendment to Decree on dangerous substan-
ces and preparations with regard to REACH
adopted 03-Oct-2008
Amendment to Decree on the treatment of
electrical and electronic waste published
10-Dec-2008
Amendment to WEEE Take-back Decree
published 10-Dec-2008
Act on the promulgation of the ADR 2007
adopted 06-Nov-2007
Decree regulating activities with ozone deple-
ting substances and certain fluorinated green-
house gases published 20-Dec-2008
Decree on the restriction of dangerous sub-
stances and preparations amended with
regard to mercury 30-Oct-2008
Amendment to Decree on the restriction of
use of certain hazardous substances in elec-
trical and electronic equipment published
10-Dec-2008
Sdu Uitgevers
actualities
Decree on regulations on the content of
organic solvents in certain paints, varnishes
and vehicle refinishing products amended
28-Nov-2008
India
Hazardous Wastes (Management, Handling
and Transboundary Movement) Rules, 2008
entered into force 24-Sep-2008
Ireland
The Waste Management (Battery and Accu-
mulator) (Amendment) Regulations 2008
adopted 17-Dec-2008
Italy
Legislative Decree implementing the Batteries
Directive approved 03-Dec-2008
Decree transposing Directive 2007/51/EC
banning mercury in measuring devices adop-
ted 18-Oct-2008
Italy ratifies the Ban Amendment to the Basel
convention 10-Nov-2008
Simplified procedures for recovery of waste
printing toners 12-Nov-2008
Japan
127 more chemicals covered under pollutant
release and transfer register 21-Nov-2008
Latvia
Regulations on Registration Procedures of
Producers of Batteries and Accumulators and
on the Holder of the Register adopted 10-Jul-
2008
Regulations on Requirements for Use and
Labeling of Different Types of Equipment
and Products Containing Hazardous Chemi-
cal Substances adopted 22-Sep-2008
Regulations on the Procedures for Registra-
tion of Producers of Electric and Electronic
Equipment amended 21-Oct-2008Amend-
ments to the Chemical Substances and Che-
mical Preparations Law regarding REACH
adopted 01-Nov-2007
Amendment to Environmental Protection
Law concerning EMAS adopted 14-Nov-2008
Lithuania
Order concerning records of chemicals amen-
ded 17-Oct-2008
Sdu Uitgevers
Order concerning chemicals recording appro-
ved 02-Jul-2008
Requirements for Placing on Market of Batte-
ries and Accumulators amended 22-Oct-2008
Governmental resolution on REACH adopted
11-Jul-2007
Luxembourg
Law on Batteries and Accumulators and Waste
Batteries and Accumulators issued 30-Dec-
2008
Malaysia
The Customs (Prohibition of Imports) Order
2008 adopted 31-Mar-2008
The Customs (Prohibition of Exports) Order
2008 adopted 31-Mar-2008
Poland
Act amending the Act on Electric and Electro-
nic Equipment Waste adopted 21-Nov-2008
Ordinance on production, marketing and
use of dangerous substances amended with
regards to mercury and toluene 03-Oct-2008
Ordinance on Minimum Levels of Collection
of Waste Household Electric and Electronic
Equipment issued 22-Dec-2008
Portugal
Decree Law on batteries and accumulators
and waste batteries and accumulators adopted
06-Jan-2009
Romania
Ordinance regarding chemicals classification,
packaging and labeling to be repealed in futu-
re 04-Nov-2008
Slovakia
Regulation on placing on the market of pyro-
technic articles adopted 06-Nov-2008
Slovenia
Decree on the management of batteries and
accumulators and waste batteries and accu-
mulators adopted 17-Jul-2008
Decree on the use of products and equipment
containing ozone depleting substances or
fluorinated greenhouse gases adopted 17-Jul-
2008
South Korea
Detailed GHS requirements set for dangerous
goods 13-Nov-2008
Journaal Stoffen en Preparaten maart 2009, Nr. 2 53

Hazard assessment of existing chemicals con-
tinued 09-Dec-2008
Spain
Royal Decree on the notification of new sub-
stances, classification, packaging and labeling
of dangerous substances adopted 03-Nov-
2008
Amendments to the International Maritime
Dangerous Goods Code (IMDG) published
12-Nov-2008
Switzerland
Ordinance relating to the transport of dange-
rous goods by road amended 30-Sep-2008
Ordinance relating to the safety advisers for
the transport of dangerous goods by road, rail
or inland waterway amended 22-Oct-2008
Taiwan
GHS Labeling and MSDS requirements for
1062 dangerous and harmful materials ente-
red into force 19-Oct-2007
Requirements on flammable pressurized gases
detailed 17-Oct-2008
649 dangerous materials subject to GHS
requirements published 05-Dec-2008
Turkey
Notification on import of Ozone Depleting
Substances 2009/14 published to introduce
more stringent provisions 31-Dec-2008
Notification on Import of Chemical Substan-
ces Attached to the Chemical Weapons Agree-
ment 2009/17 published 31-Dec-2008
Notification on Import of Dyestuffs 2009/15
published to introduce risk assessment
31-Dec-2008
Notification on Import of Substances Affecting
Health and Safety at Work 2009/13 published
31-Dec-2008
Notification on Import of Solvents and some
Petrol Products 2008/12 repealed 31-Dec-
2008
Notification on the Control of Chemicals due
to Environmental Protection 2009/6 publis-
hed 31-Dec-2008
New Regulation on Reduction of Ozone
Depleting Substances published 12-Nov-2008
54 Journal Chemicals Management march 2009, No. 2
actualities
Notification on Import of Batteries and Accu-
mulators 2009/15 published 31-Dec-2008
Notification on import of certain explosives
2009/11 published 31-Dec-2008
Notification on the registration of user certifi-
cates obtained for dual use goods and techno-
logies 2009/12 published 31-Dec-2008
New Regulation on Restrictions of Produc-
tion, Placing on the Market, and Use of Cer-
tain Hazardous Substances, Preparations and
Goods published 26-Dec-2008
New Regulation on Inventory and Control of
Chemicals published to introduce risk assess-
ment of new substances 26-Dec-2008
Regulation on Safety Information Forms
published to comply with the REACH Regu-
lation 26-Dec-2008
Regulation on Classification, Packaging and
Labelling of Hazardous Preparations and Che-
micals transposing 67/548/EEC and 1999/45/
EC published 26-Dec-2008
Ukraine
Adopted Technical Regulation on Personal
Protective Equipment 27-Aug-2008
Adopted Lists of Chemicals and Goods the
Import and Export of Which is Subject to
Licencing 27-Dec-2008
United States
CAL: 2,4,6–Trinitrotoluene added to Proposi-
tion 65 List 19-Dec-2008
CAL: Hexavalent Chromium added to Propo-
sition 65 List; Chlorpyrifos, Particulate Mat-
ter, and Total Trihalomethanes remain under
consideration 19-Dec-2008
VIR Adopted revisions to restrictions on lead-
containing paint 19-Dec-2008
Vietnam
Decree implementing a number of articles of
the Chemical Law adopted 07-Oct-2008
Sdu Uitgevers
official publications

official
publications
publications

INTERNET The Netherlands

(period January 2009)

DHL: Dangerous Goods [2009/0040]

Regulations overview
[2009/0039]
DHL has published on its website an over-
view about the Dangerous Goods Regulations
worldwide:
Reference: http://www.dhl.com/publish/etc/medialib/
g0/downloads/integration.Par.0016.File.
tmp/dangerous_goods_product_service_
capability_matrix.pdf
Staatscourant 2009 nr. 660 15 januari 2009:
Actualisering Lijst kankerverwekkende stof-
fen, Lijst mutagene stoffen, en niet-limitatieve
lijst van voor de voortplanting giftige stoffen
Reference: http://eb.sdu.nl/eb/show.
do?key=SC91028&type=op
Belgium (period January 2009)
[2009/0041]

Staatsblad 27 januari 2009: Besluit van de

Vlaamse Regering van 19 september 2008
tot wijziging van het besluit van de Vlaamse
Regering van 6 februari 1991 houdende vast-
stelling van het Vlaams reglement betref-
fende de milieuvergunning, van het besluit
van de Vlaamse Regering van 1 juni 1995
houdende algemene en sectorale bepalingen
inzake milieuhygiëne en van het besluit van
de Vlaamse Regering van 14 december 2007
houdende vaststelling van het Vlaams regle-
ment betreffende de bodemsanering en de
bodembescherming ter doorvoering van tech-
nische actualisering
Staatsblad 30 januari 2009: Ministerieel
besluit van 23 januari 2009 tot wijziging van de
bijlage I van het koninklijk besluit van 22 mei
2003 betreffende het op de markt brengen en
het gebruiken van biociden, met het oog op de
opname van clothianidine en etofenprox

Sdu Uitgevers Journaal Stoffen en Preparaten maart 2009, Nr. 2 55


United Kingdom (Period
December 2008-January 2009)
[2009/0042]
Proposals for new Chemical (Hazard
Information and Packaging for Supply)
Regulations
The Health and Safety Executive is seeking
comments on proposed Chemical (Hazard
Information and Packaging for Supply) Regu-
lations 2009 to be known as CHIP 4.
The purpose of CHIP 4 is to align the CHIP
regulations with the European Regulation on
the Classification, Labelling and Packaging of
Substances and Mixtures, known as the CLP
Regulation. The CLP Regulation adopts in the
European Union, the internationally agreed
Global Harmonised System on the classifica-
tion and labelling of chemicals, known as the
‘GHS’. The CLP Regulation introduces some
new scientific criteria to identify hazardous
properties of chemicals, hazard warning pic-
tograms (symbols), new standardised warn-
ing and precautionary text for labels, different
terminology, e.g. ‘mixtures’ instead of ‘prepa-
rations’, ‘hazardous’ instead of ‘dangerous’,
‘hazard statement’ instead of ‘risk phrase’ and
‘precautionary statement’ instead of ‘safety
phrase’. Although the CLP Regulation is
directly acting on Member States, without the
need for transposition, the proposed amend-
ments will allow CHIP to be aligned with the
transitional period of the CLP Regulation
and ensure that the provisions of the CLP
Regulation can be enforced in Great Britain,
both throughout the transitional period and
beyond.
The consensus of the proposals under this con-
sultation is that the UK should allow adoption
of the rules applicable to the proposed new
EU Regulation (see European Union Mat-
ters/Directives, Regulations and Commission
Decisions) to be included in CHIP 4.
The consultation is to seeks opinion on each
proposed amendment and to ask if these will
56 Journal Chemicals Management march 2009, No. 2
official publications
cause any difficulties. The consultation also
seeks to estimated costs and benefits of CHIP
4 and ends February 13. Implementation of
the regulations is proposed to occur on 6 April
2009.
Reference: http://www.hse.gov.uk/consult/condocs/
cd220.htm
Biocides
The Biocidal Products Directive (BPD), which
is implemented into UK law through the Bio-
cidal Products Regulations (BPR), requires
that biocidal products containing active sub-
stances listed in Annex I/IA of that directive
for the uses specified (i.e. Product Types, PTs)
be authorised or registered. Several active
substances in various product types have been
reviewed under BPD and are to be included
in Annex I. The consequence of this is that
products containing these actives will, in the
relatively near future, come under the scope
of BPD and will require authorisation to be
placed on the market in the EU. There are also
implications for products containing these
actives which are currently approved under
UK national legislation the Control of Pesti-
cides Regulations 1986 (COPR).
The UK Competent Authority provides a lists
of these active substances and presents impor-
tant dates which now apply to products con-
taining them under COPR and BPD;-
http://www.hse.gov.uk/biocides/liveissues/
authorisation-app1.htm
The authority also points out that 21 August
2009 is the deadline under the Biocidal
Products Directive for products containing
“unsupported” active substances in the bio-
cidal products directive review programme.
All stakeholders of products containing active
substances in the 2nd phase of the Biocidal
Products Directive (BPD) review programme
are reminded that certain biocidal products
(those in product types 16, 18, 19 and 21)
containing active substances for which, no
Sdu Uitgevers
official publications

dossier was submitted by 30th April 2006, or
for which all participants have withdrawn,
or none of the dossiers submitted could be
accepted as complete under BPD and no-one
has taken over the role of participant cannot
be placed on the EU market or subsequently
stored for any purpose (except for export and
disposal) from
21 August 2009.
Reference: http://www.hse.gov.uk/biocides/liveissues/
unsupported.htm
Federal Register, 27 January 2009, Vol. 74,
No.16, 4751: Availability of the Report ‘ATS-
DR Studies on Chemical Releases in the Great
Lakes Region’. Agency for Toxic Substances
and Disease Registry (ATSDR), Department
of Health and Human Services (HHS). Notifi-
cation of publication.

European Union
(period January 2009)

[2009/0043]

O.J. 2009, L23: Commission Decision

2009/65/EC of 26  January 2009 concerning
the non-inclusion of 2-Naphtyloxyacetic
acid in Annex I to Council Directive 91/414/
EEC and the withdrawal of authorisations
for plant protection products containing that
substance

United States of America

(period January 2009)

[2009/0044]

Federal Register, 21 January 2009, Vol. 74,

No.12, 3437: Air Quality: Revision to Defini-
tion of Volatile Organic Compounds – Exclu-
sion of Propylene Carbonate and Dimethyl
Carbonate. Environmental Protection Agency
(EPA).Final rule.
Federal Register, 21 January 2009, Vol. 74,
No.12, 33938: Occupational Exposure to Dia-
cetyl [CAS 431-03-8] and Food Flavorings
Containing Diacetyl. Occupational Safety and
Health Administration (OSHA), Department
of Labor. Advance notice of proposed rulema-
king.

Sdu Uitgevers Journaal Stoffen en Preparaten maart 2009, Nr. 2 57

 Opslag van gevaarlijke stoffen

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Citeertitel
Journaal Stoffen en Preparaten jaartal/nummer
(voorbeeld: Journaal Stoffen en Preparaten 2009/1)

ISSN 1574-1079
 content

[2009/0017] The Netherlands (period December 2008) / 20

[2009/0018] Belgium (Period December 2008-January 2009) / 20
[2009/0019] United Kingdom (Period November-December 2008) / 21
[2009/0020] European Union (period November 2008-January 2009) / 22
[2009/0021] United States of America (period November 2008-January 2009) / 25

[2009/0022] Calendar of events & important data / 32

2 Journal Chemicals Management februari 2009, No. 1 Sdu Uitgevers

articles
articles
Region Profile: EU/EEA
[2009/0001]
by Henk van Peski
European Union
The historical roots of the European Union
lie in the Second World War (1940-1945).
Europeans are determined to prevent such
killing and destruction ever happening again.
Soon after the war, Europe is split into East and
West as the 40-year-long Cold War begins.
West European nations create the Council of
Europe in 1949. This international organisati-
on now consists of 47 democratic countries of
Europe, representing 800 million Europeans.
It is a first step towards cooperation between
them, but six countries want to go further.
Based on the plan of the French Foreign
Minister Robert Schuman, six countries sign
a treaty to run their heavy industries – coal
and steel – under a common management
(18 April 1951). In this way, none can on its
own make the weapons of war to turn against
the other, as in the past. The six are Germany,
France, Italy, the Netherlands, Belgium and
Luxembourg.
Building on the success of the Coal and Steel
Treaty, the six countries expand cooperation to
other economic sectors. They sign the Treaty
of Rome, creating the European Economic
Community (EEC), or ‘common market’ (25
March 1957). The idea is for people, goods
and services to move freely across borders.
Denmark, Ireland and the United Kingdom
join the European Union on 1 January 1973,
raising the number of member states to nine.
Now, early 2009, the European Union has
Sdu Uitgevers
27 Member States and 23 official languages.
Each Member State, when it joins the Union,
stipulates which language or languages it
wants to have declared official languages of
the EU.
The European Union member states are:
Austria, Belgium, Bulgaria, Cyprus, the Czech
Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, and the
United Kingdom. There are three official
candidate countries: Croatia, the Former
Yugoslav Republic of Macedonia, and Turkey.
Region: Europe
Population: 491 018 683 (July 2008 est.)
Area: total: 4 324 782 sq km
Official languages: Bulgarian, Czech,
Danish, Dutch, English, Estonian, Finnish,
French, Gaelic, German, Greek, Hungarian,
Italian, Latvian, Lithuanian, Maltese, Polish,
Portuguese, Romanian, Slovak, Slovene,
Spanish, Swedish
Internet region code: eu
References: www.coe.int.
https://www.cia.gov/library/publications/
the-world-factbook/geos/ee.html
Ciba EUREG Bulletin 08/01
http://www.ciba.com/eureg_07_01.pdf
European Economic Area:
The European Economic Area (EEA) unites
the 27 EU Member States and the three EEA
EFTA States (Iceland, Liechtenstein, and
Norway.) into an Internal Market governed
by the same basic rules. These rules aim to
enable goods, services, capital, and persons
to move freely about the EEA in an open
and competitive environment, a concept
referred to as the four freedoms. The EEA
adds two languages to the already 23 EU ones:
Norwegian and Icelandic.
Iceland
Size: 103 000 km²
Population: 304 334 (July 2006)
Journaal Stoffen en Preparaten februari 2009, Nr. 1 3
 articles

Capital: Reykjavik Registration (Notification) of chemical

Language: Icelandic substances
Internet country code: is On 18 December 2006 the Council of Minis-
Kingdom of Norway ters adopted a new EU regulatory framework
Size: 323 802 km2 for the Registration, Evaluation, Authorisation
Population: 4 644 457 (2008) and Restriction of Chemicals (REACH).
Capital: Oslo Under the new chemicals policy, the manu-
Official languages: Bokmal Norwegian, facture or import of more than 1 tonne per
Nynorsk Norwegian annum of a chemical substances on its own,
Internet country code: no in a preparation or in an article from which
Principality of Liechtenstein it is intentionally released has to be registered
Size: 160 km2 with European Chemicals Agency (ECHA),
Population: 34 498 (2008) unless the Regulation indicates otherwise. An
Capital: Vaduz up to 11 year phase-in period is available to
Officiallanguage: German companies
Internet country code: li that have submitted a pre-registration for such
substances.
European Free Trade Association, role of REACH implementation (key dates):
Switzerland: 1 June 2007: REACH Regulation (EC)
Although Switzerland is surrounded by Euro- No. 1907/2006 entered
pean Union countries and it is a member of the into force.
EFTA (member states: Iceland, Liechtenstein, 1 December 2010: Deadline for manufactur-
Norway and Switzerland), it is not a member ers/importers supplying
of the EEA. This means that EU legislation a substance above 1000
with EEA relevance is not automatically appli- tonnes per year, or a CMR
cable to Switzerland. Recent examples are the cat. 1 or 2 substance above
REACH Regulation (EC) no. 1907/2006 and 1 tonne per year, or an
the CLP Regulation (EC) no. 1272/2008. For R50-53 substance above
these regulations no bilateral agreement bet- 100 tonnes per year.
ween the European Union and Switzerland is 1 June 2013: Deadline for manufactur-
(yet) existing, so no uniformity in the notifica- ers/importers supplying a
tion of chemical substances (REACH) and no substance above 100
harmonization on the classification, labelling tonnes per year.
and packaging of chemical substances (CLP). 1 June 2018: Deadline for manufactur-
Bilateral agreements are needed to remove ers/importers supplying a
these barriers. substance above 1 tonne
Switzerland per year.
Size: 41 290 km2 The REACH legislation:
Population: 7 581 520 (2008) First text: The first issue of the final text of
Capital: Bern REACH was on 30 December 2006 in the Offi-
Official languages: German, French, Italian, cial Journal of the European Union L 396 with
and Romansch the long title: “Regulation (EC) No 1907/2006
Internet country code: ch of the European Parliament and of the Coun-
References: http://www.efta.int/content/about-efta/ cil of 18 December 2006 concerning the Regi-
member-states stration, Evaluation, Authorisation and Res-
http://www.efta.int triction of Chemicals (REACH), establishing

4 Journal Chemicals Management februari 2009, No. 1 Sdu Uitgevers

articles
a European Chemicals Agency, amending
Directive 1999/45/EC and repealing Council
Regulation (EEC) No 793/93 and Commission
Regulation (EC) No 1488/94 as well as Council
Directive 76/769/EEC and Commission Direc-
tives 91/155/EEC, 93/67/EEC, 93/105/EC and
2000/21/EC” (text with EEA relevance) (849
pages).
Article 141(1) stated: This Regulation shall
enter into force on 1 June 2007.
In the same Journal the “Directive 2006/121/EC
of the European Parliament and of the Coun-
cil of 18  December 2006 amending Council
Directive 67/548/EEC on the approximation of
laws, regulations and administrative provisi-
ons relating to the classification, packaging and
labelling of dangerous substances in order to
adapt it to Regulation (EC) No 1907/2006 con-
cerning the Registration, Evaluation, Authori-
sation and Restriction of Chemicals (REACH)
and establishing a European Chemicals Agen-
cy” was published (pages 850-857).
Due to the time pressure it hasn’t been pos-
sible to adapt the layout in line with the other
O.J.-documents, the typewritten text was used
as “camera-ready”text for printing.
Corrigendum: In the O.J. L136 of 29 May 2007
corrigenda of both texts were published in the
right O.J. format, just in time before its entry
into force on 1 June 2007: “Corrigendum to
Regulation (EC) No 1907/2006 of the European
Parliament and of the Council of 18 December
2006 concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals
(REACH), establishing a European Chemi-
cals Agency, amending Directive 1999/45/EC
and repealing Council Regulation (EEC) No
793/93 and Commission Regulation (EC) No
1488/94 as well as Council Directive 76/769/
EEC and Commission Directives 91/155/EEC,
93/67/EEC, 93/105/EC and 2000/21/EC (OJ L
396, 30.12.2006) (pages 1-278)”, in 22 langu-
ages (the additional languages are mentioned
in the References).
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Also a corrigendum to Directive 2006/121/
EEC was present in the same O.J. (pages 281-
282).
Amendments: Regulation (EC) No 1907/2006
was adopted prior to the accession of Bulga-
ria and Romania to the European Union, and
requires adaptation by reason of this acces-
sion:
“Council Regulation (EC) No  1354/2007 of
15 November 2007 adapting Regulation (EC)
No 1907/2006 of the European Parliament and
of the Council on the Registration, Evaluation,
Authorisation and Restriction of Chemicals
(REACH), by reason of the accession of Bul-
garia and Romania” (O.J. L304 of 22 Novem-
ber 2007), changing Article 3(20), points (b)
and (c).
More corrigenda: A new corrigendum
appeared in the O.J. L141 0f 31 May 2008: “Cor-
rigendum to Regulation (EC) No 1907/2006 of
the European Parliament and of the Council
of 18  December 2006 concerning the Regi-
stration, Evaluation, Authorisation and Res-
triction of Chemicals (REACH), establishing
a European Chemicals Agency, amending
Directive 1999/45/EC and repealing Council
Regulation (EEC) No 793/93 and Commission
Regulation (EC) No 1488/94 as well as Council
Directive 76/769/EEC and Commission Direc-
tives 91/155/EEC, 93/67/EEC, 93/105/EC and
2000/21/EC (OJ L 396, 30.12.2006, p. 1) (Cor-
rected version in OJ L 136, 29.5.2007, p.  3)”.
This time again Article 3(20)(c) was the tar-
get.
Revisions of Annexes IV and V: “Commission
Regulation (EC) No  987/2008 of 8  October
2008 amending Regulation (EC) No 1907/2006
of the European Parliament and of the Coun-
cil on the Registration, Evaluation, Authorisa-
tion and Restriction of Chemicals (REACH)
as regards Annexes IV and V.” (O.J. L268 of
9 October 2008).
Annex XIV: On 14 January 2009 ECHA has
launched a public consultation on the first draft
recommendation of substances to be included
Journaal Stoffen en Preparaten februari 2009, Nr. 1 5

in the list of substances subject to authorisa-
tion (Annex XIV or Authorisation List).
Annex XV: A registry of intentions for Annex
XV dossiers dossiers for identification of Sub-
stances of Very High Concern (SVHC) can be
found on the ECHA website.
Changes due to EU-GHS acceptance: “Regu-
lation (EC) No  1272/2008 of the European
Parliament and of the Council of 16 Decem-
ber 2008 on classification, labelling and pac-
kaging of substances and mixtures, amending
and repealing Directives 67/548/EEC and
1999/45/EC, and amending Regulation (EC)
No  1907/2006.”  (O.J. L353 of 31 December
2008) (in particular article 57 is of immediate
importance.)
Supporting REACH legislation:
Board of Appeal of the European Chemicals
Agency (ECHA): “Commission Regulation
(EC) No  771/2008 of 1  August 2008 laying
down the rules of organisation and procedure
of the Board of Appeal of the European Chemi-
cals Agency (O.J. L 206 of 2 August 2008).”
Test methods: “Council Regulation (EC)
No 440/2008 of 30  May 2008 laying down
test methods pursuant to Regulation (EC)
No 1907/2006 of the European Parliament and
of the Council on the Registration, Evaluation,
Authorisation and Restriction of Chemicals
(REACH)”. (739 pages). (O.J. L 142 of 31 May
2008). And a corrigendum: ´Corrigendum
to Council Regulation (EC) No 440/2008 of
30 May 2008 laying down test methods pur-
suant to Regulation (EC) No 1907/2006 of
the European Parliament and of the Council
on the Registration, Evaluation, Authorisa-
tion and Restriction of Chemicals (REACH)”,
changing Council Regulation in Commission
Regulation. (O.J. L143 of 3 June 2008).
Fees and charges: “Commission Regulation
(EC) No 340/2008 of 16 April 2008 on the fees
and charges payable to the European Che-
micals Agency pursuant to Regulation (EC)
No 1907/2006 of the European Parliament and
of the Council on the Registration, Evaluation,
6 Journal Chemicals Management februari 2009, No. 1
articles
Authorisation and Restriction of Chemicals
(REACH)” (O.J. L 107 of 17 April 2008).
Article 22: The fees and charges provided for in
this Regulation shall be reviewed annually by
reference to the inflation rate as measured by
means of the European Index of Consumer
Prices as published by Eurostat pursuant to
Regulation (EC) No 2494/95. A first review
shall be carried out by 1 June 2009.
Guidance on REACH:
REACH guidance documents provide supple-
mentary information to the legal text. They
cover all technical aspects of REACH. These
documents have been produced with the
assistance and endorsement of the Member
States authorities, the European Commission
and industry. Therefore companies should use
the guidance documents as the primary source
of information when they need advice on how
to fulfil their REACH duties.
This information (together with other infor-
mation like guidance fact sheets, software
tools, a database on frequently asked questi-
ons, helpdesks, legislation, and so on) can be
found on the website of the European Chemi-
cals Bureau.
Also the wensite of the European Commission
contains a lot of additional information.
Reverences: http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=OJ:L:2006:396:0001:0849:EN
:PDF
http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=OJ:L:2007:136:0003:0280:EN
:PDF
http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=OJ:L:2008:268:0014:0019:EN
:PDF
Annex XIV: http://echa.europa.eu/doc/
press/pr_09_01_consultation_substan-
ces_authorisation_20090114.pdf
Annex XV: http://www.echa.europa.eu/
chem_data/reg_intentions_en.asp.
ECHA REACH Guidance:
http://www.echa.europa.eu/reach_en.asp
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articles
European Commission REACH informa-
tion: http://ec.europa.eu/environment/
chemicals/reach/reach_intro.htm
– Bulgarian REACH text: http://eur-lex.
europa.eu/LexUriServ/LexUriServ.do?
uri=DD:13:60:32006R1907:BG:PDF
– Romanian REACH text: http://eur-lex.
europa.eu/LexUriServ/LexUriServ.do?
uri=DD:13:60:32006R1907:RO:PDF
– Norwegian REACH text: http://www.
regjeringen.no/upload/UD/Vedlegg/
eu/forordning306r1907.pdf
– Icelandic REACH text:: http://www.
reglugerd.is/interpro/dkm/WebGuard.
nsf/Attachment/B_nr_750_2008_
fylgiskjal/$FILE/B_nr_750_2008_fyl-
giskjal.pdf
Classification and Labelling: The classifcation
and labelling of substances is still regulated by
the EU Directives 67/548/EEC (and its several
adaptations) for substances and the Direc-
tive 1999/45/EC (the former 88/379/EEC)
for the mixtures (preparations). But changes
are on its way. GHS has been adapted, result-
ing in the its EU version: “Regulation (EC)
No  1272/2008 of the European Parliament
and of the Council of 16 December 2008 on
classification, labelling and packaging of sub-
stances and mixtures, amending and repealing
Directives 67/548/EEC and 1999/45/EC, and
amending Regulation (EC) No  1907/2006.”
(O.J. L353 of 31 December 2008).
A major change was made by the 30the
ATP: “Commission Directive 2008/58/EC of
21  August 2008 amending, for the purpose
of its adaptation to technical progress, for the
30th time, Council Directive 67/548/EEC on
the approximation of the laws, regulations
and administrative provisions relating to the
classification, packaging and labelling of dan-
gerous substances. “(O.J. L 246 of 15 Septem-
ber 2008), changing the classification of many
substances, in particular those of nickel and
borates. Member States shall bring into force
the laws, regulations and administrative provi-
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sions necessary to comply with this Directive
by 1 June 2009 at the latest.These changes are
incorporated in the ESIS database on http://
ecb.jrc.ec.europa.eu/esis/.
The final draft of the 31st ATP has been pub-
lished and can be found on http://ecb.jrc.
ec.europa.eu/classification-labelling. Also this
ATP will enter into force on 1 June 2009 at the
latest.
Annex I of the Dangerous Substances Directive
67/548/EEC will be transposed to Annex  VI
(Harmonised classification and labelling for
certain hazardous substances) of the CLP
Regulation.
Until now, the directive 67/548/EEC has been
amended nine times and adapted to technical
progress 30 times. The services of the Euro-
pean Commission have prepared an unofficial
consolidated version which takes into account
changes up to 1 August 2008.
An unofficial consolidated version of Direc-
tive 1999/45/EC which takes into account
changes up to 1 June 2007 is also available on
Internet.
The Directives 67/548/EEC and 1999/45/EC
will be repealed by 1 June 2015.
References: Consolidated 67/548/EEC: http://
ec.europa.eu/environment/chemicals/dan-
sub/pdfs/67_548_en.pdf
Consolidated 1999/45/EC: http://eur-lex.
europa.eu/LexUriServ/LexUriServ.do?uri=
CONSLEG:1999L0045:20070601:EN:PDF
Safety Data Sheets: The Safety Data Sheet
Directice 91/155/EEEC (and its amendments
93/112/EC and 2001/58/EC) has been repealed
on 1 June 2007 and replaced by REACH Arti-
cle 31 and Annex II. Although no transition
period is given, themember states will appy a
flexible and pragmatic approach to enforcing
the administrative changes. The“Commission
Working Group on the Practical Preparations
for REACH” has decided that this informal
transition period for non-substantial changes
will end on 1 December 2010.
Journaal Stoffen en Preparaten februari 2009, Nr. 1 7

Occupational exposure limit values: The
Commission of the European Communities
establishes two kinds of occupational expo-
sure limit values or OELs (indicative OELs
and binding OELs) which are published in
various directives. The currently applicable
indicative limit values can be found in the
following directives: Directive 2000/39/EC;
Directive 2006/15/EC. The Third list will be
published soon.
Reference: http://www.dguv.de/bgia/en/fac/luft/gren-
zwerte/index.jsp
Restrictions on Marketing and Use: The
RMU Directive 76/769/EEC and its amend-
ments will be repealed with effect from 1 June
2009 and replaced by Annex XVII of the
REACH Regulation.
ROHS Directive: An unofficial consolidat-
ed version of “Directive 2002/95/EC of the
European Parliament and of the Council of
27 January 2003 on the restriction of the use
of certain hazardous substances in electrical
and electronic equipment’ which takes into
account changes up to 24 May 2008 is avail-
able.
Frequently Asked Questions on Directive
2002/95/EC on the Restriction of the Use of
certain Hazardous Substances in Electrical
and Electronic Equipment (RoHS) and Direc-
tive 2002/96/EC on Waste Electrical and Elec-
tronic Equipment (WEEE)
References: ROHS: http://eur-lex.europa.eu/LexU-
riServ/LexUriServ.do?uri=CONSLEG:20
02L0095:20080524:EN:PDF FAQs: http://
ec.europa.eu/environment/waste/pdf/
faq_weee.pdf
See also: http://ec.europa.eu/environment/waste/
weee/index_en.htm
Drug Precursors: European Community
legislation
A new legal arsenal has been put in place in
the EU with the entry into force in August
2005 of a set of three regulations aiming at
8 Journal Chemicals Management februari 2009, No. 1
articles
closely monitoring trade in drug precursors
both within the EU and between the EU and
the rest of the world.
“Council Regulation (EC) No  111/2005 of
22 December 2004 laying down rules for the
monitoring of trade between the Commu-
nity and third countries in drug precursors”
lays down rules for the monitoring of trade
in drug precursors between the EU and coun-
tries outside the Union. It requires that all
imports – including transhipment, exports
and intermediary activities involving drug
precursors be documented by operators, and
that precursors be clearly identified as such.
In addition, businesses trading in precursors
have to hold a licence or be registered.
The Regulation (EC) No 273/2004 of the
European Parliament and of the Council of
11  February 2004 on drug precursors lays
down the rules for the monitoring of trade
within the EU.
The third regulation “Commission Regula-
tion (EC) No 1277/2005 of 27 July 2005 lay-
ing down implementing rules for Regulation
(EC) No  273/2004 of the European Parlia-
ment and of the Council on drug precursors
and for Council Regulation (EC) No 111/2005
laying down rules for the monitoring of trade
between the Community and third coun-
tries in drug precursors“ lays down detailed
implementing rules for the two regulations
mentioned above, in order to establish the
necessary procedures regarding licensing, and
further detailed rules concerning the moni-
toring of trade. Imports and exports require
prior individual authorisations where specific
forms must be used. For transhipment con-
signments the operator must be able to dem-
onstrate the licit purposes of the transaction.
References: Different types of administrations are
involved in drug precursor control, notably
Health, Police, and Customs. Today, pre-
cursor specific controls through Customs
at the EU external frontier are more impor-
tant than ever. When the EU precursor
legislation came into force more than a
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articles
decade ago, the EU used to be an exporter
of drug precursors. Today this is still the
case, but the EU also imports drug precur-
sors. Especially those precursors than can
be misused in the illicit manufacture of
Amphetamine type Stimulants (ATS) are
generally not produced locally and must be
brought into the EU. This situation requi-
res particular attention from EU Customs
when securing the EU external frontier.
References: http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=OJ:L:2005:022:0001:0010:EN
:PDF
http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=OJ:L:2004:047:0001:0010:EN
:PDF
http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=OJ:L:2005:202:0007:0033:EN
:PDF
See also: http://ec.europa.eu/enterprise/
chemicals/legislation/precursors/index_
en.htm
http://ec.europa.eu/taxation_customs/cus-
toms/customs_controls/drugs_precursors/
legislation/index_en.htm
FAQs: http://ec.europa.eu/taxation_cus-
toms/resources/documents/customs/
customs_controls/drugs_precursors/legis-
lation/drug_precursor_faq_en.pdf
Chemical Weapons: The European Coun-
cil of 12 and 13 December 2003 adopted the
strategy against proliferation of weapons of
mass destruction, which in particular relates
to combating chemical weapons. The present
Joint Action follows on from the European
Union (EU) commitment to support the
activities of the Organisation for the Prohi-
bition of Chemical Weapons (OPCW) and
identifies seven priority projects.
“Council Regulation (EC) No 1334/2000 of
22 June 2000 setting up a Community regime
for the control of exports of dual-use items
and technology”. An unofficial consolidated
version which takes into account changes up
to 21 November 2007 is available.
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Council Regulation (EC) No  1167/2008 of
24  October 2008 amending and updating
Regulation (EC) No  1334/2000 setting up a
Community regime for the control of exports
of dual-use items and technology
‘Dual-use items’ shall mean items, including
software and technology,which can be used
for both civil and military purposes, and shall
include all goods which can be used for both
nonexplosive uses and assisting in any way in
the manufacture of nuclear weapons or other
nuclear explosive devices
References: http://europa.eu/scadplus/leg/en/lvb/
l33247.htm
http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=CONSLEG:2000R1334:2007
1121:EN:PDF
http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=OJ:L:2008:325:0001:0251:EN
:PDF
Ozone-depleting substances: “Regulation
(EC) No 2037/2000 of the European Parlia-
ment and of the Council of 29 June 2000 on
substances that deplete the ozone layer”. An
unofficial consolidated version which takes
into account changes up to 31 July 2007 is
available.
Reference: http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=CONSLEG:2000R2037:2007
0731:EN:PDF
Transport: “Directive 2008/68/EC of the
European Parliament and of the Council of
24 September 2008 on the inland transport of
dangerous goods” (text with EEA relevance).
This Directive shall apply to the transport of
dangerous goods by road, by rail or by inland
waterway within or between Member States,
including the activities of loading and unload-
ing, the transfer to or from another mode of
transport and the stops necessitated by the
circumstances of the transport. It shall not
apply to the transport of dangerous goods: (a)
by vehicles, wagons or vessels belonging to or
under the responsibility of the armed forces;
Journaal Stoffen en Preparaten februari 2009, Nr. 1 9

(b) by seagoing vessels on maritime water-
ways forming part of inland waterways; (c)
by ferries only crossing an inland waterway or
harbour; or (d) wholly performed within the
perimeter of an enclosed area.
For the purposes of this Directive ‘ADR’ shall
mean the European Agreement concerning the
International Carriage of Dangerous Goods by
Road, concluded at Geneva on 30 September
1957, as amended; ‘RID’ shall mean the Regu-
lations concerning the International Carriage of
Dangerous Goods by Rail, appearing as Appen-
dix C to the Convention concerning Interna-
tional Carriage by Rail (COTIF) concluded at
Vilnius on 3 June 1999, as amended; and ‘ADN’
shall mean the European Agreement concerning
the International Carriage of Dangerous Goods
by Inland Waterways, concluded at Geneva on
26 May 2000, as amended;
Member States shall bring into force the laws,
regulations and administrative provisions
necessary to comply with this Directive by
30 June 2009 at the latest.
Prior Informed Consent: The EU Council has
adopted the “Regulation (EC) No 689/2008 of
the European Parliament and of the Council
of 17 June 2008 concerning the export and
import of dangerous chemicals” to replace
Regulation (EC) No 304/2003, which was
annulled. Implementation of the new regula-
tion will change the legal basis for the export
and import controls of certain hazardous sub-
stances and pesticides. The replacement regu-
lation implements the Prior Informed Con-
sent (PIC) procedure for certain hazardous
chemicals and pesticides in international trade
but goes further than the provisions of the
Rotterdam Convention on which the former
is based. The provisions apply to all countries,
not just those that have signed the Rotterdam
Convention. At the moment 39  chemicals
are covered; 24 pesticides, 4 severely hazard-
ous pesticide formulations and 11 industrial
chemicals.
10 Journal Chemicals Management februari 2009, No. 1
articles
References: http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=OJ:L:2008:204:0001:0035:EN
:PDF
Rotterdam Convention: http://www.pic.int/
home.php?type=t&id=5&sid=16
Biocidal Products: An unofficial consolidat-
ed version of the “Directive 98/8/EC of the
European Parliament and of the Council of
16 February 1998 concerning the placing of
biocidal products on the market” which takes
into account changes up to 7 March 2008 is
available on Internet. Biocidal products are
defined as: Active substances and preparations
containing one or more active substances, put
up in the form in which they are supplied to the
user, intended to destroy, deter, render harm-
less, prevent the action of, or otherwise exert a
controlling effect on any harmful organism by
chemical or biological means.
Reference: http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=CONSLEG:1998L0008:2008
0307:EN:PDF
Cosmetic Products: An unofficial consoli-
dated version (up to Commission Direc-
tive 2008/14/EC) of the Cosmetics Directive
76/768/EEC can be found on the Europa/
EUR-Lex website.
A ‘cosmetic product’ shall mean any substance
or preparation intended to be placed in contact
with the various external parts of the human
body (epidermis, hair system, nails, lips and
external genital organs) or with the teeth and
the mucous membranes of the oral cavity with
a view exclusively or mainly to cleaning them,
perfuming them, changing their appearance
and/or correcting body odours and/or protect-
ing them or keeping them in good condition.
Reference: http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=CONSLEG:1976L0768:2008
0307:EN:PDF
Detergents: Detergent’ means any substance
or preparation containing soaps and/or other
surfactants intended for washing and cleaning
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articles
processes. Detergents may be in any form (liq-
uid, powder, paste, bar, cake, moulded piece,
shape, etc.) and marketed for or used in house-
hold, or institutional or industrial purposes.
“Regulation (EC) No 648/2004 of the Europe-
an Parliament and of the Council of 31 March
2004 on detergents”; “Commission Regulation
(EC) No 907/2006 of 20 June 2006 amending
Regulation (EC) No 648/2004 of the European
Parliament and of the Council on detergents,
in order to adapt Annexes III and VII thereto”;
” Question and agreed answers concerning the
correct implementation of Regulation (EC)
No 648/2004 on detergents (July 2008)”
References: http://ec.europa.eu/enterprise/chemicals/
legislation/detergents/legislation/regula-
tion_648_detergents.pdf
http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=OJ:L:2006:168:0005:0010:EN
:PDF
http://ec.europa.eu/enterprise/chemicals/
legislation/detergents/docs/july08_faq_
detergent_regulation.pdf
Waste: The List of Wastes (formerly named
the European Waste Catalogue) is established
with Commission Decision 2000/532/EC of 3
May 2000 replacing Decision 94/3/EC estab-
lishing a list of wastes pursuant to Article 1(a)
of Council Directive 75/442/EEC on waste
and Council Decision 94/904/EC establish-
ing a list of hazardous waste pursuant to Arti-
cle 1(4) of Council Directive 91/689/EEC on
hazardous waste.
The List of Waste is amended by the Commis-
sion Decisions 2001/118/EU, 2001/119/EU
and 2001/573/EU. The List of Wastes contains
both hazardous and non-hazardous wastes.
Any waste marked in the list with an asterisk
(*) is considered as hazardous waste. A con-
solidated version is available.
Reference: http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=CONSLEG:2000D0532:2002
0101:EN:PDF
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Substances hazardous to water
(WGK and GAM)
[2009/0002]
Introduction
Some European countries have own national
systems for the protection of surface waters
and apply for the assessment own classifica-
tion systems of hazardous substances. In The
Netherlands the ����������������������
Algemene Beoordelings-
methodiek (ABM) or General Assessment
Methodology (GAM) is being used, Germany
has its Water Hazard Classes System. Both sys-
tems are base don the Dangerous Substances
Directive 67/548/EEC, so in the near future
an adaptation will occur in order to sunchro-
nize the results with the CLP Regulation (EU)
No.1272/2008.
The German VwVwS
The Administrative Regulation on the Clas-
sification of Substances Hazardous to Waters
into Water Hazard Classes (Verwaltungsvor-
schrift wassergefährdende Stoffe – VwVwS) of
17 May 1999 has been published on 29  May
1999 in the Bundesanzeiger 98a; it entered
into force on 1 June 1999. The VwVwS as
amended on 27 July 2005 has been published
on 30 July in the Bundesanzeiger 142a; it ente-
red into force on 01 August 2005.
The VwVwS contains four annexes:
– annex 1: list of substances non-hazard-
ous (nicht wassergefährdend – nwg) to
waters,
– annex 2: list of substances hazardous to
waters, classified into Water Hazard Class-
es (Wassergefährdungsklassen) 1 to 3,
– annex 3: description of the classification
procedure on basis of R-phrase classifica-
tions according to European Hazardous
Substances Regulations for all substances
that are not listed in annex 1 or 2,
– annex 4: description of the procedure in
order to classify preparations and mix-
tures.
Journaal Stoffen en Preparaten februari 2009, Nr. 1 11

The Internet database Rigoletto v. 2.1 of 2 June
2008 of the Umweltbundesamt (�������������
Federal Envi-
ronment Agency) enables a quick search for
the WGK-classification of substances.
The WGK of a mixture of substances can be
determined according to annex 4 of the new
VwVwS either by using a calculating rule and
the WGK of each compound of the mixture
or on basis of ecotoxicological test data deter-
mined on the mixture.
The Dutch GAM
The lead-up to the grant of a permit under
the Dutch Pollution of Surface Waters Act
(Wet Verontreiniging Oppervlaktewateren,
WVO) comprises three phases: information
provision, establishing measures to be taken
to control emissions, and assessing any resid-
ual emissions. The assessment of substances
and preparations relates mainly to the ‘infor-
mation provision’ phase. However, the data
required to assess a substance or preparation
are equally relevant to the assessment of resid-
ual emissions (immission assessment). The
implementation of the Pollution of Surface
Waters Act demands an understanding of the
toxicity of individual substances and prepara-
tions to the aquatic environment.
A calculation tool Algemene beoordelings-
methodiek versie 1.04: is available (in Dutch).
References: Germany: http://www.umweltbundesamt.
de/wgs-e/vwvws.htm
http://webrigoletto.uba.de/rigoletto/public/
language.do?language=english
The Netherlands: http://www.helpdeskwa-
ter.nl/emissiebeheer/industrieel/afvalwater/
beoordelen_emissies/abm ;
Tool Algemene beoordelingsmethodiek
versie 1.04:
http://www.helpdeskwater.nl/emissiebe-
heer/industrieel/afvalwater/beoordelen_
emissies/abm?ActItmIdt=1471
12 Journal Chemicals Management februari 2009, No. 1
actualities
actualities
European Union
REACH: ECHA New Publications
December-January 2008
[2009/0003]
List of Pre-Registered Substances Published
On 19 Decemver 2008 the European Chemi-
cals Agency (ECHA) has published on its
website a list of pre-registered substances. The
list contains about 150 000 substances which
were pre-registered by 65 000 companies
between 1 June and 1 December 2008. ECHA
has been screening part of the information
submitted and due to the high number of pre-
registrations ECHA will continue to check the
information into 2009.
During the six month period from 1 June
to 1 December 2008, ECHA received about
2.75  million preregistrations for about
150 000 substances. As provided by the
REACH regulation, ECHA has published the
list of pre-registered substances before 1 Janu-
ary 2009. The pre-registrations cover all the
EU “existing substances” (EINECS) and the
list of notified new substances (ELINCS),
together about 105 000 substances. The
remainder of the substances on the list are not
in these inventories and are currently being
screened. The screening process will continue
beyond 1 January 2009 and ECHA will update
the list as the checking progresses. Companies
are reminded that not all of the preregistered
substances on the list may fall within the
scope of REACH, and some of them may have
been registered without taking into account
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actualities
the volume trigger set by the regulation for
manufacturing or importing.
During the screening process ECHA removes
those pre-registrations that are in all evidence
not substances (for example, pre-registrations
that are articles, such as “shoes”). Moreover,
pre-registrations not submitted bij EU/EEA
companies will be deleted.
The List of pre-registered substances can be
accessed via a dedicated page in the ECHA
CHEM section of the Agency website.
References: http://echa.europa.eu/doc/press/pr_08_59_
publication_pre-registered_substances_
list_20081219.pdf
http://apps.echa.europa.eu/preregistered/
pre-registered-sub.aspx.
The Guidance for Downstream Users
available in 22 EU languages
The Guidance for Downstream Users is now
available in 22 EU languages. One can access
the different language version by changing
the language of the guidance web pages. The
guidance pages in Bulgarian and Romanian
will be loaded in early 2009. Currently the
pages in these language versions contain text
in English.
Reference: http://guidance.echa.europa.eu/guidance_
en.htm
ECHA Newsletter
ECHA Newsletter, the bimonthly newsletter
of the European Chemicals Agency, provides
regular information on the Agency’s activities
as well as lively stories and pictures of daily
life within ECHA. No.1 was published in Ju;y/
August 2008, No.2 in September/October
2008 and No. 3 in Novemver/December 2008.
References: http://echa.europa.eu/publications_en.asp
ECHA Newsletter No. 3: http://echa.euro-
pa.eu/doc/press/newsletter/echa_newslet-
ter_2008_12_11.pdf
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EU-GHS or CLP Regulation (EC)
No. 1272/2008 published
[2009/0004]
On New Years Eve 2008 the final text of EU-
GHS was published in the Official Journal of
the European Union 2008, L353: “Regulation
(EC) No  1272/2008 of the European Parlia-
ment and of the Council of 16 December 2008
on classification, labelling and packaging of
substances and mixtures, amending and repeal-
ing Directives 67/548/EEC and 1999/45/EC,
and amending Regulation (EC) No 1907/2006,
a document of 1355 pages.
The term ‘mixture’ as defined in this Regu-
lation should have the same meaning as the
term ‘preparation’ previously used in Com-
munity legislation.
CLP implementation (key dates):
20 January 2009: CLP Regulation (EC) No.
1272/2008 entered into
force
1 December 2010: CLP Titles II, III and IV
shall apply in respect of
substances
1 June 2015: CLP Titles II, III and IV
shall apply in respect of
mixtures
This Regulation follows various declarations
whereby the Community confirmed its inten-
tion to contribute to the global harmonisation
of criteria for classification and labelling, not
only at UN level, but also through the incor-
poration of the internationally agreed Global-
ly Harmonised System of Classification and
Labelling of Chemicals (GHS) criteria into
Community law.
This Regulation will replace the Dangerous
Substances Directive 67/548/EEC as well as the
Dangerous Preparations Directive 1999/45/
EC It should maintain the overall current level
of protection of human health and the envi-
ronment provided by those Directives. There-
fore, some hazard classes which are covered by
Journaal Stoffen en Preparaten februari 2009, Nr. 1 13

those Directives but are not yet included in the
GHS will be maintained in this Regulation.
The two instruments foreseen by this Regula-
tion to be used to communicate the hazards
of substances and mixtures are labels and the
safety data sheets provided for in REACH
Regulation (EC) No 1907/2006. Of these two,
the label is the only tool for communication to
consumers, but it may also serve to draw the
attention of workers to the more comprehen-
sive information on substances or mixtures
provided in safety data sheets. Since the provi-
sions on safety data sheets are included in the
REACH Regulation which uses the safety data
sheet as the main communication tool within
the supply chain of substances, it is appropri-
ate not to duplicate the same provisions in
this Regulation.
Manufacturers, importers and downstream
users shall classify substances or mixtures in
accordance with Title II before placing them
on the market.
If a substance is subject to harmonised classi-
fication and labelling in accordance with Title
V through an entry in Part 3 of Annex VI, that
substance shall be classified in accordance
with that entry, and a classification of that
substance in accordance with Title II shall not
be performed for the hazard classes or differ-
entiations covered by that entry.
Differences between Purple Book and CLP:
Annex I: Not all emenents of the GHS Purple
Book Rev. 2 (2007) have been incorporated in
CLP:
– Flammable liquids: Category 4
– Acute toxicity, oral/skin/inhalation: Cat-
egory 5
– Skin corrosion/irritation: Category 3
– Serious eye damage/irritation: Catego-
ry 2B
– Aspiration hazard: Category 2
– Aquatic toxicity (acute): Category 2, Cate­
gory 3
Furthermore
14 Journal Chemicals Management februari 2009, No. 1
actualities
– Skin corrosion/irritation: Categories 1A,
1B and 1C have been taken together to
Category 1A/1B/1C
– Serious eye damage/irritation: Catego-
ry 2A renamed to Category 2
– Germ cell mutagenicity/Carcinogenic-
ity/Toxic to reproduction: Categories 1A
and 1B have been taken together to Cate­
gory 1A or Category 1B
One element has been added to CLP: Hazard-
ous to the Ozone Layer (Danger. EUH059:
Hazardous to the Ozone Layer).
Supplemental hazard information:
EUH001 Explosive when dry
EUH006 Explosive with or without contact
with air
EUH014 Reacts violently with water
EUH018 In use, may form flammable/
explosive vapour-air mixture
EUH019 May form explosive peroxides
EUH029 Contact with water liberates toxic
gas
EUH031 Contact with acids liberates toxic
gas
EUH032 Contact with acids liberates very
toxic gas
EUH044 Risk of explosion if heated under
confinement
EUH066 Repeated exposure may cause skin
dryness or cracking
EUH070 Toxic by eye contact
EUH071 Corrosive to the respiratory tract
EUH201 Contains lead. Should not be used
on surfaces liable to be chewed or
sucked by children
EUH201A Warning! Contains lead
EUH202 Cyanoacrylate. Danger. Bonds
skin and eyes in seconds. Keep out
of the reach of children
EUH203 Contains chromium (VI). May
produce an allergic reaction
EUH204 Contains isocyanates. May pro-
duce an allergic reaction
EUH205 Contains epoxy constituents. May
produce an allergic reaction
Sdu Uitgevers
actualities
EUH206 Warning! Do not use together with
other products. May release dan-
gerous gases (chlorine)
EUH207 Warning! Contains cadmium.
Dangerous fumes are formed dur-
ing use. See information supplied
bij the manufacturer. Comply with
the safety instructions
EUH208 Contains <name of sensitising
substance>. May produce an aller-
gic reaction
EUH209 Can become highly flammable in
use
EUH209A Can become flammable in use
EUH210 Safety data sheet available on
request
EUH401 To avoid risks to human health
and the environment, comply with
the instructions for use.
Note: Pictograms have been published in the
Official Journal in monochrome (contrarily
to the UN GHS Purple Book). However, in
Annex I, section 1.2 it does state that the pic-
tograms shall have a red border.
Reference: http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=OJ:L:2008:353:0001:1355:EN
:PDF
Belgium: Dimethyl fumarate
[2009/0005]
In the Staatsblad (Official Journal of Belgium)
a decision has been published on the restric-
tion on marketing on dimethyl fumarate (CAS
624-49-7, EINECS 210-849-0) for the period
12 January 2009-12 July 2009 because of its
allergenic properties. This substance has been
banned as a biocide according to Regulation
(EC) No. 1451/2007.
Dimethyl fumarate (DMF; 2-butenedioic acid,
dimethyl ester) has been found to be a sensi-
tizer at very low concentrations, producing
extensive, pronounced eczema that is diffi-
cult to treat. Concentrations as low as 1 ppm
Sdu Uitgevers
may produce allergic reactions. There are only
a handful of equally potent sensitizers. The
extreme sensitizing risk was brought to public
attention by the “poison chair” incident, where
Chinese manufacturer Linkwise produced two-
seater sofas with dimethyl fumarate sachets
inside to inhibit mould while they were in stor-
age or transport. In Finland where the chairs
were sold from 2006-2007, sixty users were
given serious rashes. The cause was identified
as dimethyl fumarate -induced allergic reaction
by Tapio Rantanen, M.D. from Finland, and his
original article became the cover story in the
July 2008 issue of British Journal of Dermatol-
ogy (Volume 159 Issue 1,Pages 218-221). In the
United Kingdom, sofas sold by Argos, Land of
Leather and Walmsley Furnishing containing
the chemical caused over a hundred injuries.
References: http://staatsbladclip.zita.be/staatsblad/wet-
ten/2009/01/12/wet-2009024003.html
http://en.wikipedia.org/wiki/Dimethyl_
fumarate
EU Toys Directive: German BfR
comments
[2009/0006]
The provisions concerning the chemical safety
of toys approved in the new EU Toys Directive
in 18 December 2008 are not sufficient. Some
of them even lead to a worsening of consumer
protection. This is the conclusion of the Fed-
eral Institute for Risk Assessment (BfR). BfR is
particularly critical of the new limit values for
heavy metals in children’s toys. According to
the new Directive toys may, in future, actually
release more lead than in the provisions in force
up to now. The Directive does not afford chil-
dren sufficient protection against fragrances
and nickel that can cause allergies either.
The Directive does stipulate that CMR sub-
stances – these are substances that can trigger
cancer (carcinogenic), damage the genotype
(mutagenic) or impair reproduction (repro-
Journaal Stoffen en Preparaten februari 2009, Nr. 1 15

toxic) – may not be used in toys. On the other
hand, the limit values of chemical legislation
are to apply in future to toys. According to
that, toys may contain up to 0.1 percent of
these CMR substances. This is not sufficient
to protect children’s health.
Many substances can also be taken up through
the skin. They include CMR substances, bio-
cides or allergens. This should be borne in
mind especially in the case of toys that come
into prolonged and intensive contact with the
skin like fingerpaints or play-dough.
The development of allergies can only be
prevented by keeping contact with allergenic
substances as far as possible to a minimum.
The new Toys Directive does contain a list of
55 banned allergenic substances. However,
in reality this ban on use is partially revoked
through the introduction of a limit value of
0.01 percent for admissible trace levels.
Reference: http://www.bfr.bund.de/cd/27588
Germany: Limit Value List 2008
(BGIA-Report 6/2008)
[2009/0007]
The ‘2008 List of Limit Values’ issued by the
BGIA – Institute for Occupational Safety and
Health of the German Social Accident insur-
ance contains the most important limit values
for chemical, biological and physical agents
which have an impact on health and safety in
the workplace. The list contains a table of the
limit values for hazardous substances (occu-
pational exposure limit value [AGW] and
biological limit value [BGW]) from the fol-
lowing points in the technical code of practice
on hazardous substances (TRGS) TRGS 900,
TRGS 903 „biological limit value“ and also the
classifications of TRGS 905. Also included are
limit values for indoor air, noise, vibration,
thermal stress tolerance, radiation, electricity,
bio-mechanical stress tolerance and notes on
the effects of biological agents.
16 Journal Chemicals Management februari 2009, No. 1
actualities
Reference: Grenzwerteliste 2008 – Sicherheit und
Gesundheitsschutz bei der Arbeit (BGIA-
Report 6/2008)
For download or ordering a hardcopy:
http://www.dguv.de/bgia/de/pub/rep/
rep07/bgia0608/index.jsp
International
GHS Country Update
(January 2009)
[2009/0008]
Norway
The EU-GHS or CLP regulation 1272/2008 is
not yet translated into Norwegian. However,
the work is ongoing, and wneb finalised it will
be published  at www.sft.no hopefully before
summer.
Iceland
The EU-GHS or CLP regulation 1272/2008 is
not yet translated into Icelandic.
Taiwan: New format MSDS
1. To correspond with the implementation
of the global hazardous substances (GHS)
rules slated to take effect on 31Decem-
ber 2008, the Environmental Protection
Administration (EPA) announced the
Regulations for Marking of Packaging
and Handling Sites and Facilities of Toxic
Chemical Substances and Establishment
of Materials Safety Data Sheets on 17
December 2007, and will go into effect on
31 December 2008.
2. Pursuant to Article 12 of the aforemen-
tioned regulations, the EPA announced
Material Safety Data Sheet Format, which
will go into effect on 31 December 2008.
Reference: http://www.epa.gov.tw/en/epashow.aspx?b
usin=113&path=11472&guid=ec45bb0a-
1a70-4b7b-af5a-fafa9b51195f&lang=en-us
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actualities
See also: Country Profile Taiwan in Journaal Stoffen
en Preparaten, 2008/6
USA: revision to definition of
Volatile Organic Compounds –
exclusion of propylene carbonate
and dimethyl carbonate
[2009/0009]
On 13 January 2009 the Environmental Pro-
tection Agency (EPA) issued a final rule that
no longer requires propylene carbonate [CAS
108-32-7] and dimethyl carbonate [ CAS 616-
38-6] to be regulated as volatile organic com-
pounds (VOCs) under the Clean Air Act for
purposes of meeting the national ambient air
quality standard for ozone.
EPA is excluding these two compounds as
VOCs because scientific evidence shows they
are “negligibly reactive,” meaning they con-
tribute little or nothing to the formation of
smog.
By excluding these compounds as VOCs,
today’s action will make it easier and less
expensive for industry to use these com-
pounds as solvents in a variety of products
including paints, inks and adhesives. These
compounds may possibly be used as a substi-
tute for other solvents which are more harm-
ful to the environment and which are more
strictly regulated.
Reference: http://www.epa.gov/ttn/oarpg/t1/fact_
sheets/voc_exemp01011309.pdf
Canada (Ontario): Cosmetic
Pesticides Ban Act 2008
[2009/0010]
Ontarians were given until 22 December 2008
to comment on:
– proposed lists of products and ingredients
to be banned for use
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– proposed lists of products and ingredients
to be banned or restricted for sale
– the rules for pesticide use on golf courses
– the exceptions to the ban for public health
or safety reasons.
The comments are now being reviewed and
will help finalize a regulation to enforce the
ban. The ban would eliminate the use of con-
ventional pesticides for cosmetic purposes on
lawns, gardens, school yards and parks. There
are lower risk alternatives to maintain lawns
and gardens and this is the direction that the
Ontario government is taking.
The Cosmetic Pesticides Ban Act 2008 was
introduced on Earth Day (22 April 2008) and
passed by the Ontario Legislative Assembly in
June 2008.The proposed ban includes excep-
tions for agriculture, forestry, health or safety,
specialty turf, trees and protection of natural
areas. Golf courses are also excepted but must
report on their pesticide use, and sports fields
hosting national or international events may
be able to obtain an exception.
For a proper understanding of this Act the
meaning of ‘cosmetic’ is important: cosmetic
means non-essential (esthétique).
References: http://www.ontla.on.ca/bills/bills-files/39_
Parliament/Session1/b064ra.pdf
http://www.ene.gov.on.ca/en/land/pestici-
des/Factsheet-pesticides.pdf
Japan: Review of the Chemical
Substances Control Law
[2009/0011]
On 22 December 2008 the Joint Committee to
Review the Act on the Evaluation of Chemi-
cal Substances and Regulation of Their Manu-
facture, etc. (‘Chemical Substances Control
Law’ or CSCL), established bij the Ministry
of Health, Labour and Welfare, the Ministry
of Economy, Trade and Industry (METI), and
the Ministry of the Environment released a
report.
Journaal Stoffen en Preparaten februari 2009, Nr. 1 17

Conclusions:
– Although the current system is reasonably
effective, it allows a situation where exist-
ing chemical substances (approximately
20 000 chemical substances were in circu-
lation in Japan in 1973, the year when the
Chemical Substance Evaluation Act was
instituted) are produced and used without
sufficient safety evaluation. The system
should be changed in a way that basically
will subject all the chemical substances to
step-by-step risk assessment.
– Notification to the authorities should
be made mandatory with regard to all
chemical substances that are produced or
imported in excess of certain amounts.
Information contained in notifica-
tions should be used to perform screen-
ing assessment for narrowing down the
‘Chemical Substances for Priority Evalua-
tion’ (provisional name). The government
should collect safety information on these
substances step by step, in cooperation
with the companies concerned, and per-
form risk assessment on them.
– The government should restrict the pro-
duction, import and use of substances
posing a high risk.
– By 2020, the government should finish
taking general measures for all chemical
substances.
References: http://www.meti.go.jp/english/press/
data/20081222_02.html
http://www.meti.go.jp/policy/chemical_
management/english/2nd_joint_commit-
tee_to_review_cscl.html
18 Journal Chemicals Management februari 2009, No. 1
publications
publications
The Australian Dangerous Goods
Code 7th edition
[2009/0012]
The 7th edition of the Australian Dangerous
Goods Code (ADG 7) has been endorsed by
the Australian Transport Council and it is
expected to be implemented in most juris-
dictions by 31 December 2008. Other juris-
dictions have agreed to implement it as soon
as possible after this date on a best endeavors
basis. There will be a transitional period of
12 months in each State and Territory, com-
mencing when ADG 7 is implemented, where
compliance with either the 6th edition or
the 7th edition will be acceptable. Start and
end dates for this transitional period should
be checked with the Competent Authority in
the relevant State or Territory. An electronic
version of ADG 7 is available at no charge
from 1 January 2009. It can be accessed from
the National Transport Commission web-
site: http://www.ntc.gov.au/ViewPage.aspx?
documentid=01147
INTERNET
Ciba EUREG Bulletin
Version 08/01
[2009/0013]
EUREG is a Ciba Regulatory Services publica-
tion aimed at keeping its clients and industry
contacts up to date on regulatory changes in
European Union and United Kingdom leg-
islation. The publication is geared towards
Sdu Uitgevers
publications

professionals involved in Product Safety and road (ADR) 2009 can now be accessed/down-
Regulatory Affairs as well as Environment, loaded in pdf format via the UNECE website.
Health and Safety. It will also be of interest to Reference: http://www.unece.org/trans/danger/publi/
specialists in Research & Development, Tech- adr/adr2009/09ContentsE.html
nical Operations, Supply Chain and Legal
functions.
In addition to summarising what’s new since USA: OSHA Field Operations
EUREG Bulletin 07/01, this edition (90 pages, Manual revised
September 2008) provides additional infor-
mation on the development of key EU and [2009/0016]
UK chemicals legislation, thereby establishing
a baseline and reference for future editions A revised OSHA Field Operations Manual
of the Bulletin which will focus more on new (formerly called the Field Inspection Reference
developments, new topics and their impact. Manual) is now available to provide OSHA
Reference: http://www.cibaexpertservices.com/Soluti- (U.S. Department of Labor’s Occupational
ons/Regulatory.aspx?contentID=2 or Safety and Health Administration) Compli-
http://www.ciba.com/index/exs-index/exs- ance Officers with a single source of updated
reg/exs-reg-regulatorybulletins.htm information and guidance to more effectively
protect employees from occupational injuries,
illnesses, and fatalities. The manual assists
Norway: REACH-ordbok Compliance Officers in scheduling and con-
ducting inspections, enforcing regulations,
[2009/0014] and encouraging continual improvement in
workplace safety and health.
On the website of the Norwegian Pollution Reference: http://www.osha.gov/OshDoc/Directive_
Control Authority (�������������������������
Statens forurensningstil- pdf/CPL_02-00-148.pdf
syn) an English-Norwegian dictionary (ord-
bok) of REACH terms has been published.
Examples:
Bringe i omsetning – Placing on the market
Fyllestgjørende undersøkelsessammendrag –
Robust study summary
Innfasingsstoff – Phase-in-substance
Nedstrømsbruker – Downstream user
Stoffer som gir stor grunn til bekymring –
Substances of Very High Concern, SVHC:
Reference: http://www.sft.no/seksjonsartikkel_41237.
aspx

ADR 2009

[2009/0015]
The European Agreement concerning the
international carriage of dangerous goods bij

Sdu Uitgevers Journaal Stoffen en Preparaten februari 2009, Nr. 1 19


official
publications
The Netherlands
(period December 2008)
[2009/0017] Stcrt 2008, 245, rectificatie in Stcrt 2008, 253:
Tractatenblad 2008, 203: Verdrag inzake de
bescherming van het mariene milieu in het
noordoostelijk deel van de Atlantische Oce-
aan.
Tractatenblad 2008, 218: Europese Overeen-
komst betreffende het internationale vervoer
van gevaarlijke goederen over de weg (ADR).
Staatsblad 2008, 478: Wet van 24 oktober
2008 tot wijziging van de Wet milieubeheer
(enkele wijzigingen betreffende afvalstoffen).
Stcrt. 2008, 226: Besluit van de Minister
van Sociale Zaken en Werkgelegenheid van
7 november 2008, nr. ARBO/A&V/2008/14423,
tot vaststelling van een beleidsregel met
betrekking tot arbeidsomstandighedencata-
logi (Beleidsregel arbocatalogi).
Stcrt. 2008, 240: Regeling van de Minister
van Volksgezondheid, Welzijn en Sport van
26  november 2008, nr. VGP/PSL 2893617,
houdende een wijziging van de Regeling Ver-
pakkingen- en gebruiksartikelen (Warenwet)
in verband met richtlijn nr. 2008/39/EG.
Stcrt. 2008, 242: Regeling van de Minister
van Sociale Zaken en Werkgelegenheid van
2 december 2008, nr. ARBO/A&V/2008/28840,
tot wijziging van de Arbeidsomstandigheden-
regeling in verband met de erkenning van
buitenlandse bewijzen van vakbekwaamheid
en enige andere wijzigingen, en van de Subsi-
dieregeling stimulering totstandkoming arbo-
catalogi.
20 Journal Chemicals Management februari 2009, No. 1
official publications
Stcrt. 2008, 244: Besluit van de Minister
van Sociale Zaken en Werkgelegenheid van
5 december 2008, Directie Arbeidsomstandig-
heden, nr. ARBO/A&V/33192/2008/, tot wij-
ziging van de Beleidsregels arbeidsomstandig-
hedenwetgeving in verband met de wijziging
van het Arbeidsomstandighedenbesluit in
verband met het wegnemen van wetstechni-
sche onvolkomenheden en de erkenning van
buitenlandse bewijzen van vakbekwaamheid.
Regeling van de Minister van Volkshuisves-
ting, Ruimtelijke Ordening en Milieubeheer
van 5 december 2008, nr. RB\2008119957,
houdende wijziging van de Regeling externe
veiligheid inrichtingen.
[Met deze regeling wordt tabel 3 van bijlage 1 van de Rege-
ling externe veiligheid inrichtingen gewijzigd. In deze tabel
zijn afstanden vastgesteld die in acht genomen moeten
worden bij inrichtingen waar verpakte gevaarlijke stoffen
worden opgeslagen in een hoeveelheid groter dan 10000
kg per opslagplaats, de zogenaamde PGS 15 inrichtingen.
Ook is een nieuwe versie van de Handleiding Risicobe-
rekeningen Bevi van toepassing verklaard. Tot slot zijn
enkele wijzigingen aangebracht die verband houden met
de wijziging van het Besluit externe veiligheid inrichtingen
(Stb. 2008, 380).]
Stcrt. 2008,. 246: Toepassing zorgplicht Wbb
bij MTBE- en ETBE-verontreinigingen
[Uit monitoringsgegevens van drinkwaterleidingbedrijven
is gebleken dat Methyl-tert-butylether (MTBE, CAS 1634-
04-4) en de laatste jaren ook Ethyl-tert-butylether (ETBE,
CAS 637-92-3) in lage concentraties wordt aangetroffen in
grond- en oppervlaktewater. De aanwezigheid van MTBE
en ETBE als milieuvreemde stof in de bodem vormt de
aanleiding voor deze circulaire.]
Belgium (Period December
2008-January 2009)
[2009/0018]
Staatsblad 3 december 2008: Koninklijk
besluit van 9 september 2008 tot vaststelling
van de financiële bijdrage van België voor het
Sdu Uitgevers
official publications
jaar 2008 aan de organisatie voor economi-
sche samenwerking en ontwikkeling in het
kader van vrijwillige financiering van het pro-
gramma over nanomaterialen.
Staatsblad 10 december 2008: Koninklijk
besluit Van 8 juni 2007 tot wijziging van het
koninklijk besluit van 16 maart 2006 betref-
fende de bescherming van de werknemers
tegen de risico’s van blootstelling aan asbest.
– Duitse vertaling.
Staatsblad 12 december 2008: Besluit van de
Waalse Regering van 6 november 2008 tot wij-
ziging van Boek II van het Leefmilieuwetboek
dat het Waterwetboek inhoudt
Staatsblad 12 januari 2009: Ministerieel
besluit van 5 januari 2009 betreffende het ver-
bod van het in de handel brengen van artike-
len en producten die dimethylfumaraat bevat-
ten.
[Artikel 1. Het is verboden om artikelen en producten die
dimethylfumaraat (Eng.: dimethyl fumarate, CAS 624-49-
7) bevatten op de markt te brengen.]
Reference: http://staatsbladclip.zita.be/staatsblad/wet-
ten/2009/01/12/wet-2009024003.html
United Kingdom (Period
November-December 2008)
[2009/0019] and technical notes for guidance on the assess-
REACH
The UK REACH enforcement regulations (SI
2008:2852) came into force 1 December 2008.
These regulations put in place the enforcing
authorities, set out their powers of enforce-
ment, and provide a list of offences along with
the penalties for non-compliance.
The HSE have published guidance on the role
of distributors under the REACH Regula-
tions and information on claiming a REACH
registration number, transfer of information
from NCD to IUCLID 5, the status of notified
polymers under REACH, updating registra-
tions and outstanding information for NONS
notifications.
Sdu Uitgevers
References: http://www.opsi.gov.uk/si/si2008/pdf/
uksi_20082852_en.pdf
http://www.hse.gov.uk/reach/resources/
distributors.pdf
http://www.hse.gov.uk/reach/nons.htm
Biocides and Pesticides
The Health & Safety Executive has relaunched
its web pages providing improved facilities
and information on biocides and pesticides.
There is new page of information set out as
answers to frequently asked questions.
There is also an updated list of those compa-
nies liable for the General Industry Charge
(GIC) for biocides. These are companies sup-
plying active substances or biocidal products
to the UK market. The GIC (£333 per year)
is levy to recover the costs of implementing
98/8/EC.
A report providing information on incidents
and complaints involving pesticides inves-
tigated by the Field Operations Directorate
(FOD) of the Health and Safety Executive
(HSE) between 1 April 2007 and 31 March
2008.
And a free to subscribe e-bulletin for current
information on biocides.
The latest edition includes new Biocidal Prod-
ucts Directive (BPD) non inclusion decisions
ment of technical equivalence.
References: http://www.hse.gov.uk/biocides/index.htm
http://www.hse.gov.uk/biocides/faq.htm
http://www.hse.gov.uk/biocides/bpd/giclist.
htm
http://www.hse.gov.uk/fod/pir0708.pdf
http://www.hse.gov.uk/biocides/ebulletin/
index.htm
Journaal Stoffen en Preparaten februari 2009, Nr. 1 21

European Union (period
November 2008-January 2009)
[2009/0020] O.J. 2008, L325: Council Regulation (EC)
O.J. 2008, L295: Commission Decision
2008/832/EC of 3 November 2008 concerning
the non-inclusion of bromuconazole [CAS
116255-48-2] in Annex I to Council Directive
91/414/EEC and the withdrawal of authorisa-
tions for plant protection products containing
that substance.
O.J. 2008, L302: Council Joint Action
2008/858/CFSP of 10  November 2008 in
support of the Biological and Toxin Weap-
ons Convention (BTWC), in the framework
of the implementation of the EU Strategy
against the Proliferation of Weapons of Mass
Destruction.
O.J. 2008, L304: Regulation (EC) No
1102/2008 of the European Parliament and of
the Council of 22 October 2008 on the ban-
ning of exports of metallic mercury [CAS
7439-97-6] and certain mercury compounds
and mixtures and the safe storage of metallic
mercury.
O.J. 2008, L307: Commission Decision
2008/865/ECof 10  November 2008 concern-
ing the non-inclusion of chlorate in Annex I
to Council Directive 91/414/EEC and the
withdrawal of authorisations for plant protec-
tion products containing that substance.
O.J. 2008, L316: Commission Directive
2008/107/EC of 25  November 2008 amend-
ing Council Directive 91/414/EEC to include
abamectin [Abamectin CAS 71751-41-2;
avermectin B1a CAS 65195-55-3; Avermec-
tin B1b CAS 65195-56-4], epoxiconazole
[CAS 135319-73- 2 (formerly 106325-08-0)],
fenpropimorph [CAS 67564-91-4], fenpy-
roximate [CAS 134098-61-] and tralkoxydim
[CAS 87820-88-0] as active substance.
O.J. 2008, L317: Commission Directive
2008/108/EC of 26 November 2008 amending
Council Directive 91/414/EEC to include flu-
tolanil [CAS 66332-96-5], benfluralin [CAS
22 Journal Chemicals Management februari 2009, No. 1
official publications
1861-40-1], fluazinam [CAS 79622-59-6],
fuberidazole [CAS 3878-19-1] and mepiquat
[CAS 15302-91-7] as active substances.
No 1167/2008 of 24 October 2008 amending
and updating Regulation (EC) No 1334/2000
setting up a Community regime for the con-
trol of exports of dual-use items and tech-
nology.
O.J. 2008, L326: Commission Decision of
7 November 2008 concerning the non-inclu-
sion of napropamide [CAS 15299-99-7] in
Annex I to Council Directive 91/414/EEC and
the withdrawal of authorisations for plant
protection products containing that sub-
stance.
O.J. 2008, L327: Directive 2008/103/EC of
the European Parliament and of the Coun-
cil of 19  November 2008 amending Direc-
tive 2006/66/EC on batteries and accumula-
tors and waste batteries and accumulators as
regards placing batteries and accumulators on
the market.
O.J. 2008, L328: Directive 2008/99/EC of the
European Parliament and of the Council of
19  November 2008 on the protection of the
environment through criminal law.
O.J. 2008, L333: Commission Decision
2008/934/EC of 5 December 2008 concerning
the non-inclusion of certain active substances
in Annex I to Council Directive 91/414/EEC
and the withdrawal of authorisations for
plant protection products containing these
substances.
O.J. 2008, C317: Commission communica-
tion 2008/C 317/02 on the enquiry and regis-
tration under Regulation (EC) No 1907/2006
(REACH) of substances that were lawfully
on the market before 1 June 2008 but which
do not have phase-in status.
[Regulation (EC) No 1907/2006 of the European Parlia-
ment and of the Council concerning the Registration,
Evaluation, Authorisation and Restriction of Chemicals
(REACH) requires that substances that do not fall under
the definition of ‘phase-in substance’ that are manufac-
tured or imported into the Community, on their own, in
Sdu Uitgevers
official publications
preparations or in articles, in quantities of one tonne or
more per year are registered as from 1 June 2008 in accord-
ance with Article 10 of the REACH Regulation.
Prior to the registration of non phase-in substances, an
enquiry to the European Chemicals Agency – as foreseen
under Article 26 of the REACH Regulation – is required.
It is noted that the provisions of the REACH Regulation
governing the enquiry process entered into force on 1 June
2008. It follows that it was impossible in practice for a non
phase-in substance to be registered on 1 June 2008. In
addition, it is also noted that the regulation containing the
test methods for use under REACH, in accordance with
Article 13(3) of Regulation (EC) No 1907/2006, was only
adopted on 30 May 2008.
Some substances that have been lawfully manufactured
and/or placed on the market before 1 June 2008 may not
qualify as ‘phase-in substances’ under Article 3(20) of the
REACH Regulation. To avoid disruptions of trade and
manufacturing activities regarding such substances, and
provided that it is demonstrated that the substance was
legally on the Community market before 1 June 2008,
potential registrants are reminded of the obligation to
submit an enquiry to the European Chemicals Agency. For
any specific information item missing, the registrant will
provide a justification. The missing information will be
submitted without undue delay.]
O.J. 2008, L335: Commission Decision
2008/941/EC of 8 December 2008 concerning
the non-inclusion of certain active substances
in Annex I to Council Directive 91/414/EEC
and the withdrawal of authorisations for
plant protection products containing these
substances.
O.J. 2008, L335: Commission Decision
2008/943/EC of 12 December 2008 concern-
ing the non-inclusion of bone oil [CAS 8001-
85-2] in Annex I to Council Directive 91/414/
EEC and the withdrawal of authorisations
for plant protection products containing that
substance.
O.J. 2008, L337: Commission Directive
2008/116/EC of 15  December 2008 amend-
ing Council Directive 91/414/EEC to include
aclonifen [CAS 74070-46-5], imidacloprid
[CAS 138261-41-3] and metazachlor [CAS
67129-08-2] as active substances.
Sdu Uitgevers
O.J. 2008, C320: Council Decision 2008/C
320/02 of 27 November 2008 appointing three
members of the Management Board of the
European Chemicals Agency.
O.J. 2008, L338: Commission Decision
2008/953/EC of 8 December 2008 recognising
in principle the completeness of the dossiers
submitted for detailed examination in view of
the possible inclusion of Aureobasidium pul-
lulans and disodium phosphonate in Annex I
to Council Directive 91/414/EEC.
O.J. 2008, L340: Commission Directive
2008/123/EC of 18 December 2008 amending
Council Directive 76/768/EEC, concerning
cosmetic products, for the purpose of adapt-
ing Annexes II and VII thereto to technical
progress.
[Directive 76/768/EEC is amended as follows: (1). In
Annex II, entry 167 ‘Esters of 4-aminobenzoic acid, with
the free amino group, with the exception of that given in
Annex VII, Part 2’ is replaced by ‘4-aminobenzoic acid and
its esters, with the free amino group’.(2). In Annex VII,
entry 1 is deleted. (3). In Annex VII, in entry 28 the words
‘in sunscreen products’ are deleted from column ‘c’.]
O.J. 2008, L344: Commission Directive
2008/125/EC of 19  December 2008 amend-
ing Council Directive 91/414/EEC to include
aluminium phosphide [cas 20859-73-8],
calcium phosphide [cas 1305-99-3], magne-
sium phosphide [cas 12057-74-8], cymoxanil
[cas 57966-95-7], dodemorph [1593-77-7],
2,5-dichlorobenzoic acid methylester [cas
2905-69-3], metamitron [CAS 41394-05-2],
sulcotrione [CAS 99105-77-8], tebuconazole
[CAS 107534-96-3] and triadimenol [CAS
55219-65-3] as active substances.
O.J. 2008, L344: Commission Decision
2008/967/EC of 12 December 2008 concern-
ing the non-inclusion of carbon monox-
ide [CAS 630-08-0] in Annex I to Council
Directive 91/414/EEC and the withdrawal of
authorisations for plant protection products
containing that substance.
O.J. 2008, L344: Commission Directive
2008/127/EC of 18 December 2008 amending
Journaal Stoffen en Preparaten februari 2009, Nr. 1 23

Council Directive 91/414/EEC to include sev-
eral active substances
O.J. 2008, L348: Decision No 1348/2008/EC
of the European Parliament and of the Coun-
cil of 16 December 2008 amending Council
Directive 76/769/EEC as regards restrictions
on the marketing and use of 2-(2-meth-
oxyethoxy)ethanol, 2-(2-butoxyethoxy)
ethanol, methylenediphenyl diisocyanate,
cyclohexane and ammonium nitrate.
[In Annex I to Directive 76/769/EEC, the following points
are added:
53. 2-(2-methoxyethoxy) ethanol (DEGME) CAS 111-77-
3: Shall not be placed on the market after 27 June 2010,
for supply to the general public, as a constituent of paints,
paint strippers, cleaning agents, self-shining emulsions or
Floor sealants in concentrations equal to or greater than
0,1 % by mass.
54. 2-(2-butoxyethoxy) ethanol (DEGBE) CAS 112-34-5:
(1) Shall not be placed on the market for the first time
after 27 June 2010, for supply to the general public, as a
constituent of spray paints or spray cleaners in aerosol
dispensers in concentrations equal to or greater than 3 %
by mass. (2) Spray paints and spray cleaners in aerosol dis-
pensers containing DEGBE and not conforming to para-
graph 1 shall not be placed on the market for supply to
the general public after 27 December 2010. (3) Without
prejudice to other Community legislation concerning the
classification, packaging and labelling of dangerous sub-
stances and preparations, paints, other than spray paints,
containing DEGBE in concentrations equal to or greater
than 3 % by mass that are placed on the market for supply
to the general public shall be visibly, legibly and indelibly
marked by 27 December 2010 as follows:
“Do not use in paint spraying equipment”.
55. Methylenediphenyl diisocyanate (MDI) CAS 26447-40-
5: (1) Shall not be placed on the market after 27 December
2010, as a constituent of preparations in concentrations
equal to or greater than 0,1% by mass for supply to the
general public, unless the packaging: (a) contains protec-
tive gloves which comply with the requirements of Coun-
cil Directive 89/686/EEC of 21 December 1989 on the
approximation of the laws of the Member States relating
to personal protective equipment. (b) is marked visibly,
legibly and indelibly as follows, and without prejudice to
other Community legislation concerning the classifica-
24 Journal Chemicals Management februari 2009, No. 1
official publications
tion, packaging and labelling of dangerous substances and
preparations: “- Persons already sensitised to diisocyanates
may develop allergic reactions when using this product. –
Persons suffering from asthma, eczema or skin problems
should avoid contact, including dermal contact, with this
product. – This product should not be used under con-
ditions of poor ventilation unless a protective mask with
an appropriate gas filter (i.e. type A1 according to stand-
ard EN 14387) is used.” (2) By way of derogation, para-
graph 1(a) shall not apply to hot melt adhesives.
56. Cyclohexane CAS 110-82-7: (1) Shall not be placed on
the market for the first time after 27 June 2010, for supply
to the general public, as a constituent of neoprene-based
contact adhesives in concentrations equal to or greater
than 0,1 % by mass in package sizes greater than 350 g. (2)
Neoprene-based contact adhesives containing cyclohex-
ane and not conforming to paragraph 1 shall not be
placed on the market for supply to the general public after
27 December 2010. (3) Without prejudice to other Com-
munity legislation concerning the classification, packaging
and labelling of dangerous substances and preparations,
neoprenebased contact adhesives containing cyclohexane
in concentrations equal to or greater than 0,1 % by mass
that are placed on the market for supply to the general
public after 27 December 2010 shall be visibly, legibly and
indelibly marked as follows: “- This product is not to be
used under conditions of poor ventilation. – This product
is not to be used for carpet laying.”
57. Ammonium nitrate (AN) CAS 6484-52-2: (1) Shall not
be placed on the market for the first time after 27 June
2010 as a substance, or in preparations that contain more
than 28 % by mass of nitrogen in relation to ammonium
nitrate, for use as a solid fertiliser, straight or compound,
unless the fertiliser complies with the technical provisions
for ammonium nitrate fertilisers of high nitrogen content
set out in Annex III to Regulation (EC) No 2003/2003 of
the European Parliament and of the Council of 13 Octo-
ber 2003 relating to fertilisers (2) Shall not be placed on
the market after 27 June 2010 as a substance, or in prepa-
rations that contain 16 % or more by mass of nitrogen
in relation to ammonium nitrate except for supply to:
(a)  downstream users and distributors, including natu-
ral or legal persons licensed or authorised in accordance
with Council Directive 93/15/EEC of 5 April 1993 on the
harmonisation of the provisions relating to the placing
on the market and supervision of explosives for civil use;
Sdu Uitgevers
official publications
(b) farmers for use in agricultural activities, either full time
or part time and not For the purposes of this subpara-
graph: (i) “farmer” shall mean a natural or legal person, or
a group of natural or Legal persons, whatever legal status
is granted to the group and its members bij national law,
whose holding is situated within Community territory, as
referred to in Article 299 of the Treaty, and who exercises
an Agricultural activity, (ii) “agricultural activity” shall
mean the production, rearing or growing of agricultural
products including harvesting, milking, breeding animals
and keeping animals for farming purposes, or maintaining
the land in good agricultural and environmental condi-
tion as established under Article 5 of Council Regulation
(EC) No 1782/2003 of 29 September 2003 establishing
common rules for direct support schemes under the com-
mon Agricultural policy and establishing certain support
schemes for farmers; (c) natural or legal persons engaged
in professional activities such as horticulture, plant grow-
ing in greenhouses, maintenance of parks, gardens or sport
pitches, forestry or other similar activities. (3) However,
for the restrictions in paragraph 2, Member States may
until 1 July 2014, for socioeconomic reasons, apply a limit
of up to 20 % by mass of nitrogen in relation to ammo-
nium nitrate for substances and preparations placed on
the market within their territories. They shall inform the
Commission and other Member States thereof. ]
O.J. 2008, L352: Commission Decision
2008/986/EC of 15 December 2008 concern-
ing the non-inclusion of antraquinone [CAS
84-65-1] in Annex I to Council Directive
91/414/EEC and the withdrawal of authorisa-
tions for plant protection products containing
that substance.
O.J. 2008, L353: Regulation (EC)
No  1272/2008 of the European Parliament
and of the Council of 16  December 2008
on classification, labelling and packag-
ing of substances and mixtures, amending
and repealing Directives 67/548/EEC and
1999/45/EC, and amending Regulation (EC)
No 1907/2006.
O.J. 2008, L354: Regulation (EC) No
1336/2008 of the European Parliament and
of the Council of 16 December 2008 amend-
ing Regulation (EC) No 648/2004 in order to
adapt it to Regulation (EC) No 1272/2008 on
Sdu Uitgevers
classification, labelling and packaging of sub-
stances and mixtures.
O.J. 2009, L5: Commission Decision 2009/9/
EC of 8  December 2008 concerning the
non-inclusion of nicotine [CAS 54-11-5] in
Annex I to Council Directive 91/414/EEC and
the withdrawal of authorisations for plant
protection products containing that sub-
stance.
United States of America (period
November 2008-January 2009)
[2009/0021]
Federal Register, November 17, 2008, Vol. 73,
No. 222, 67730: Labeling Requirement for
Toy and Game Advertisements; Final Rule.
Consumer Product Safety Commission. Final
rule.
Reference: http://edocket.access.gpo.gov/2008/pdf/
E8-26964.pdf
Federal Register, November 19, 2008, Vol. 73,
No. 224, 69532: Use of Ozone-Depleting Sub-
stances; Removal of Essential-Use Designa-
tion (Epinephrine). Food and Drug Adminis-
tration, HHS. Final rule.
Federal Register, November 24, 2008, Vol. 73,
No. 227, 71003: National Toxicology Program
(NTP); NTP Interagency Center for the Eval-
uation of Alternative Toxicological Methods
(NICEATM); Availability of the Interagency
Coordinating Committee on the Validation of
Alternative Methods (ICCVAM) Test Method
Evaluation Report: Validation Status of Five
In Vitro Test Methods Proposed for Assess-
ing Potential Pyrogenicity of Pharmaceuticals
and Other Products and Final Background
Review.
Document: Validation Status of Five In Vitro
Test Methods Proposed for Assessing Potential
Pyrogenicity of Pharmaceuticals and Other
Products; Notice of Transmittal of ICCVAM
Test Method Recommendations to Federal
Agencies. National Institute of Environmental
Journaal Stoffen en Preparaten februari 2009, Nr. 1 25

Health Sciences (NIEHS), National Institutes
of Health (NIH). Availability of the ICCVAM
Test Method Evaluation Report and Final
Background Review Document.
Federal Register, December 2, 2008, Vol. 73,
No. 232, 73329: Proposed Substances To Be
Evaluated for Set 23 Toxicological Profiles.
Agency for Toxic Substances and Disease
Registry (ATSDR), Department of Health
and Human Services (HHS). Request for
comments on the proposed substances to be
evaluated for Set 23 toxicological profiles [80
substances will be evaluated].
Federal Register, December 4, 2008, Vol. 73,
No. 233, 73620: Formaldehyde [CAS 50-00-0]
Emissions From Pressed Wood Products.
Environmental Protection Agency (EPA).
Advance notice of proposed rulemaking and
notice of public meetings.
Federal Register, December 4, 2008, Vol. 73,
No. 234, 73930: An Exposure Assessment of
Polybrominated Diphenyl Ethers. Environ-
mental Protection Agency (EPA). Notice of
Public Comment Period.
[The draft ‘‘An Exposure Assessment of Polybrominated
Diphenyl Ethers ‘‘is available primarily via the Internet
on the National Center for Environmental Assessment’s
home page under the Recent Additions and the Data and
Publications menus at http://www.epa.gov/ncea.]
Federal Register, December 8, 2008, Vol.  73,
No. 236, 74350: Regulation of Fuel and Fuel
Additives: Gasoline and Diesel Fuel Test Meth-
ods. Environmental Protection Agency (EPA).
Direct final rule.
Federal Register, December 8, 2008, Vol.   3,
No. 236, 74403: Regulation of Fuel and Fuel
Additives: Gasoline and Diesel Fuel Test
Methods. Environmental Protection Agency
(EPA). Proposed rule.
Federal Register, December 8, 2008, Vol.  73,
No. 236, 74485: Final Risk and Exposure
Assessment Report for Nitrogen Dioxide
(NO2)[CAS 10102-44-0]. Environmental
Protection Agency (EPA). Notice of availabil-
ity of final report.
26 Journal Chemicals Management februari 2009, No. 1
official publications
[This final report has two primary purposes. The first is
to convey the approaches taken to characterize human
exposures and health risks associated with ambient NO2
and to present the results of these analyses. The second is
to present a discussion of the NO2 scientific evidence and
the exposureand risk-based information specifically as it
relates to the current and potential alternative NO2 stand-
ards. This final document is available online at: http://
www.epa.gov/ttn/naaqs/standards/nox/s_nox_cr_rea.html.]
Federal Register, December 8, 2008, Vol. 73,
No. 236, 74488: U.S. Government’s Proc-
ess for Obtaining Stakeholder Information
for Chemicals Proposed for Addition to the
Stockholm Convention on Persistent Organic
Pollutants. Environmental Protection Agency
(EPA). Notice.
Federal Register, December 12, 2008, Vol. 73,
No. 240, 75568: Clarification of Employer
Duty To Provide Personal Protective Equip-
ment and Train Each Employee. Occupational
Safety and Health Administration (OSHA),
U.S.Department of Labor. Final rule.
[In this rulemaking, OSHA is amending its standards to
add language clarifying that the personal protective equip-
ment (PPE) and training requirements impose a compli-
ance duty to each and every employee covered by the stand-
ards and that noncompliance may expose the employer to
liability on a per-employee basis. The amendments consist
of new paragraphs added to the introductory sections
of the listed Parts and changes to the language of some
existing respirator and training requirements. This action,
which is in accord with OSHA’s longstanding position, is
being taken in response to recent decisions of the Occupa-
tional Safety and Health Review Commission indicating
that differences in wording among the various PPE and
training provisions in OSHA safety and health standards
affect the Agency’s ability to treat an employer’s failure to
provide PPE or training to each covered employee as a
separate violation. The amendments add no new compli-
ance obligations. Employers are not required to provide
any new type of PPE or training, to provide PPE or train-
ing to any employee not already covered bij the existing
requirements, or to provide PPE or training in a different
manner than that already required. The amendments sim-
ply clarify that the standards apply to each employee.]
Sdu Uitgevers
official publications
Federal Register, December 16, 2008, Vol. 73,
No. 242, 76220: National Emission Stand-
ards for Hazardous Air Pollutant Emissions:
Group  I Polymers and Resins (Polysulfide
Rubber Production, Ethylene Propylene Rub-
ber Production, Butyl Rubber Production,
Neoprene Production); National Emission
Standards for Hazardous Air Pollutants for
Epoxy Resins Production and Non-Nylon
Polyamides Production; National Emis-
sion Standards for Hazardous Air Pollutants
for Source Categories: Generic Maximum
Achievable Control Technology Standards
(Acetal Resins Production and Hydrogen
Fluoride Production) (Risk and Technology
Review). Environmental Protection Agency
(EPA). Final rule.
Federal Register, December 16, 2008, Vol. 73,
No. 242, 76361: Draft Guidance for Industry
on Genotoxic and Carcinogenic Impurities in
Drug Substances and Products: Recommend-
ed Approaches; Availability. Food and Drug
Administration, HHS. Notice.
Federal Register, December 19, 2008, Vol. 73,
No. 245, 77492: Ban of Lead-Containing Paint
and Certain Consumer Products Bearing
Lead-Containing Paint. Consumer Product
Safety Commission. Final rule.
[Lead-containing paint means paint or other similar sur-
face coating materials containing lead or lead compounds
and in which the lead content (calculated as lead metal) is
in excess of 0.06 percent (0.06 percent is reduced to 0.009
percent effective August 14, 2009) by weight of the total
nonvolatile content of the paint or the weight of the dried
paint film.]
Federal Register, December 22, 2008, Vol. 73,
No. 246, 78261: TSCA Section 5 Premanufac-
ture and Significant New Use Notification
Electronic Reporting; Revisions to Notifica-
tion Regulations. Environmental Protection
Agency (EPA). Proposed rule.
[EPA is proposing amendments to the Toxic Substances
Control Act (TSCA) section 5 Premanufacture and Sig-
nificant New Use Notification regulations to facilitate the
introduction and use of electronic reporting. This action
is intended to streamline and reduce the administrative
Sdu Uitgevers
costs and burdens of TSCA section 5 notifications for both
industry and EPA by establishing standards and require-
ments for the use of EPA’s Central Data Exchange (CDX)
to electronically submit premanufacture notices (PMNs)
and other TSCA section 5 notices and support documents
to the Agency. EPA is also proposing to amend the TSCA
section 5 User Fee regulations to add a new User Fee Pay-
ment Identity Number field to the PMN form, which
would enable the Agency to match more easily a particular
user fee with its notice submission. Lastly, EPA is propos-
ing to remove the Agent signature block field on the PMN
form, and thus the requirement for designated Agents to
sign the form.]
Federal Register, December 24, 2008, Vol. 73,
No. 248, 78994: National Volatile Organic
Compound Emission Standards for Aerosol
Coatings. Environmental Protection Agency
(EPA). Final rule; withdrawal of direct final
rule.
Federal Register, December 31, 2008, Vol. 73,
No. 251, 80428: Commerce in Explosives; List
of Explosive Materials (2008R–17T)
[Pursuant to 18 U.S.C. 841(d) and 27 CFR 555.23, the
Department of Justice (Bureau of Alcohol, Tobacco, Fire-
arms and Explosives (ATF)) must publish and revise at
least annually in the Federal Register a list of explosives
determined to be within the coverage of 18 U.S.C. 841 et
seq. The list covers not only explosives, but also blasting
agents and detonators, all of which are defined as explo-
sive materials in 18 U.S.C. 841(c). This notice publishes
the 2008 List of Explosive Materials.]
Federal Register, January 2, 2009, Vol. 74,
No. 1, 21: Protection of Stratospheric Ozone:
Notice 23 for Significant New Alternatives
Policy Program. Environmental Protection
Agency (EPA). Determination of Acceptabil-
ity.
Federal Register, January 2, 2009, Vol. 74,
No. 1, 41: Identification of Non-Hazardous
Materials that are Solid Waste. EPA. Advanced
notice of proposed rulemaking.
Federal Register, January 9, 2009, Vol. 74,
No. 61, 900: Announcement of Final Priority
Data Needs for Two Priority Hazardous Sub-
stances. Agency for Toxic Substances and Dis-
Journaal Stoffen en Preparaten februari 2009, Nr. 1 27
 official publications

ease Registry (ATSDR), U.S. Department of

Health and Human Services (HHS). Notice.
[Acrolein [CAS 107-02-8]: Exposure levels in humans
living near hazardous waste sites and other populations.
Exposure levels in children. Dose-response data for chron-
ic duration (365 days or more) via inhalation exposure.
Barium [CAS 7440-39-3]: Dose-response data for acute
duration (14 days or less) via oral exposure.]
Federal Register, January 13, 2009, Vol. 74,
No. 8, 1770: Hazardous Materials: Improving
the Safety of Railroad Tank Car Transporta-
tion of Hazardous Materials. Pipeline and
Hazardous Materials Safety Administration.
Final Rule
Note: To find archive copies of the Federal Regis-
ter, go to: http://www.gpoaccess.gov/fr/
index.html

28 Journal Chemicals Management februari 2009, No. 1 Sdu Uitgevers

Sdu Uitgevers Journaal Stoffen en Preparaten februari 2009, Nr. 1 29
30 Journal Chemicals Management februari 2009, No. 1 Sdu Uitgevers
Sdu Uitgevers Journaal Stoffen en Preparaten februari 2009, Nr. 1 31
CALENDAR OF EVENTS &
IMPORTANT DATA
[2009/0022]
EU Presidencies:
January-June 2009: The Czech Repub-
lic http://www.eu
2009.cz/en/
July-December 2009: Sweden
January-June 2010: Spain
July-December 2010: Belgium
January-June 2011: Hungary
July-December 2011: Poland
January-June 2012: Denmark
July-December 2012: Cyprus
REACH:
REACH implementation (key dates):
1 December 2010: over recente wijzigingen in wet- en regelgeving rond chemische stoffen. De
Deadline for manufacturers/importers
supplying a substance above 1000 tonnes
per year, or a CMR cat. 1 or 2 substance
above 1 tonne per year, or an R50-53
substance above 100 tonnes per year.
1 June 2013: Subscriptions:
Deadline for manufacturers/importers
supplying a substance above 100 tonnes
per year.
1 June 2018: voudigd, opgeslagen in een geautomatiseerd gegevensbestand, of openbaar
Deadline for manufacturers/importers
supplying a substance above 1 tonne per
year.
CLP (EU-GHS):
CLP implementation (key dates):
20 January 2009: CLP Regulation (EC)
No. 1272/2008 entered into force
1 December 2010: en uitgever deswege geen aansprakelijkheid.
CLP Titles II, III and IV shall apply in
respect of substances
1 June 2015: ISSN 1574-1079
CLP Titles II, III and IV shall apply in
respect of mixtures
Colofon
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Postbus 20025 www.sdu.nl/service
2500 EA Den Haag
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Drs. H.A.F. van Well
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Drs. J. Zawierko
Uitgever:
Ph. A. van Borselen
Abonnementen:
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© Sdu Uitgevers 2008
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van artikel 16b Auteurswet 1912 jo het Besluit van 20 juni 1974, Stb. 351,
zoals laatstelijk gewijzigd bij het Besluit van 22 december 1997, Stb. 764 en
artikel 17 Auteurswet 1912, dient men de daarvoor wettelijk verschuldigde
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Citeertitel
Journaal Stoffen en Preparaten jaartal/nummer
(voorbeeld: Journaal Stoffen en Preparaten 2008/1)
Journal
Chemicals
Management
Journaal
Stoffen & Preparaten
Chief-editor:
Drs. A.C.H. van Peski
Editorial Board:
Dr. M.M. Kops-Werkhoven
Drs. H.A.F. van Well
Dr. J.A.S.J. Razenberg
Dr. L.J.M. Rodenburg
Drs. G.A. Schouten
Drs. J. Zawierko
Advisory Board:
K. E. Armstrong (U.S.A.)
Dr. R. Fielding (United Kingdom)
Drs. A. Gondová (The Netherlands)
G. Koh (Singapore)
Dr. C. van Lint (Australia)
Dan Liu (U.S.A.)
S. Park (S.-Korea)
H. Sano (Japan)
S. Savary (Canada)
C. Sieger (Germany)
J. Simpson (Australia)
Dr. U. Schumacher (China)
E. Snyman (South Africa)
P.G. Tse (New Zealand)
No. 3
April 2009
Volume 6
Part of Stoffennieuws.nl
Content
Actualities
European Union
[2009/0048] 30th and 31st ATP to DSD and 1st ATP to CLP
Regulation / 63
[2009/0049] EU Harmonised Classification and
Labelling / 63
[2009/0050] REACH Annex XI adaptation / 64
[2009/0051] REACH, polymers and monomers: Case
C‑558/07 / 65
[2009/0052] Two food additives have previously
unrecognized estrogen-like effects / 66
[2009/0053] Belgium: ADR and RID 2009 / 66
International
[2009/0054] Switzerland: GHS introduction / 67
[2009/0055] USA: Enhancing the effectiveness of
TSCA / 68
[2009/0056] P.R. of China: Inventory of Existing Chemical
Substances 2008 / 69
[2009/0057] P.R. of China: List of Severely Restricted
Toxic Chemicals for Export and
Import 2009 / 69
[2009/0058] P.R. of China: List of Goods subject to
Import Licence 2009 / 69
[2009/0059] South-Korea: Hazard Assessment of Existing
Chemicals / 70
[2009/0060] Singapore: draft standards on Occupational
safety and health (OSH) management
systems / 70
[2009/0061] Canada: CAN-NEW-Database on ototoxic
substances / 70
[2009/0047] Canada: use of engineered nanomaterials / 71
[2009/0062] Canada: Batch 2 substances / 71
[2009/0063] Australia: Hazardous Substances Information
System Update / 72
[2009/0064] Australia: Low Regulatory Concern
Chemicals / 72
 content

[2009/0065] Australia: Chemicals and Plastics Regulation: Supplement to

Research Report / 73
[2009/0066] Australia: Review of Mutual Recognition Schemes / 73
[2009/0067] New Zealand: methylarsinic acid and azinphos methyl / 77
[2009/0068] OECD (Q)SAR Application Toolbox / 77
[2009/0069] Global Update on New Chemicals Regulations (January 2009) / 78

PUBLICATIONS

Book review
[2009/0070] Fundamental principles of occupational health and safety. 2nd edition / 80

Proceedings
[2009/0071] REACH and GHS – VCI-Seminar / 83

Internet
[2009/0072] United Kingdom: Risk management of carbon nanotubes / 83
[2009/0073] U.S. Army Corps of Engineers Publishes New Safety Manual / 83
[2009/0074] Toxipedia and WLT / 83

OFFICIAL PUBLICATIONS

[2009/0075] The Netherlands (Period January-February 2009) / 84

[2009/0076] Belgium (Period February 2009) / 85
[2009/0077] United Kingdom (Period January-February 2009) / 85
[2009/0078] European Union (Period February 2009) / 86
[2009/0079] USA (Period February 2009) / 86

[2009/0080] CALENDAR OF EVENTS & IMPORTANT DATA / 88

62 Journal Chemicals Management April 2009, No. 3 Sdu Uitgevers

actualities
actualities
European Union
30th and 31st ATP to DSD and 1st
ATP to CLP Regulation
[2009/0048]
The 30th and 31st ATPs amended Annex I to
Directive 67/548/EEC (DSD) by introducing
new and updated harmonised classifications.
These harmonised classifications could not
be incorporated into Annex VI to the Clas‑
sification, Labelling and Packaging Regula‑
tion (CLP Regulation (EC) No. 1272/2008, OJ
L353/1, 31.12.2008).
Therefore, the Commission is currently pre‑
paring a proposal for a first ATP to the CLP
Regulation with a view to transferring the
harmonised classifications contained in the
30th and 31st ATPs into Annex VI to the CLP
Regulation. This ATP will take the form of a
Regulation and, therefore, be directly applica‑
ble throughout the EU.
On the issue of deletion of Annex I to Direc‑
tive 67/548/EEC (and by extension deletion of
the two implementing directives):
– Annex I is indeed deleted by Article 55(11)
of EC Regulation (EC) No. 1272/2008 as
of its entry into force (20 January 2009).
However, the gap created by this deletion
should be short-lived. It should be filled
once the 1st ATP of the CLP Regulation
enters into force – hopefully by the middle
of 2009.
– In the meantime, companies should be
strongly encouraged to apply the harmo‑
nised classifications contained in the 30th
Sdu Uitgevers
and 31st ATPs for the substances not yet
listed in Annex VI of the CLP Regulation.
– Directive 67/548/EEC (as in future the
CLP Regulation) sets forth the basic prin‑
ciple of self-classification based on avail‑
able information. In this case, the fact that
the classifications have been harmonised
and will be included in Annex VI soon
would be a very strong reason to self-
classify the substance by using the newly
harmonised classifications listed in the
30th and 31st ATPs for the substances not
covered by an existing entry in Annex VI
of the CLP Regulation.
The 1st ATP to the CLP Regulation will most
likely apply from 1 December 2010.
EU Harmonised Classification and
Labelling
[2009/0049]
Suppliers of chemicals (substances and
mixtures) across Europe have a legal obligation
to evaluate the hazards of chemicals and to
classify and label them in an appropriate
way before placing them on the market.
However, individual EU Member States (via
their competent authorities) or industry may
ask for the classification and labelling of a
substance to be harmonised across Europe.
This may happen in three situations:
– Where the substance is either: carcinogenic;
mutagenic; toxic for reproduction; and/or
respiratory sensitizer.
– When the substance is a biocide or
pesticide (so it is designed to control
harmful organisms) or
– When there is a need to harmonise the
classification at the EU level, for example
when the suppliers classify the same
substance in a different or an incorrect
way.
Journaal Stoffen en Preparaten april 2009, Nr. 3 63

On 23 February 2009 ECHA has published on
its website the first public consultation on a
proposal to harmonise the classification and
labelling of two chemical substances. The two
substances in this consultation are:
– Epoxiconazole (CAS 135319-73-2 or
133855-98-8) – a pesticide, used in
agriculture to control types of fungus
– Diantimony trioxide (CAS 1309-64-4) –
used as a flame retardant in plastics, PVC,
rubber and textiles; as an additive in glass;
and in the manufacture of pigments and
paints.
Reference: http://echa.europa.eu/doc/press/pr_09_02_
cl_consultation_20090223.pdf
REACH Annex XI adaptation
[2009/0050]
Annex XI allows registrants, under certain
conditions, to omit testing in accordance
with sections 8.6 and 8.7 of Annex VIII and
in accordance with Annex IX and Annex X to
Regulation (EC) No 1907/2006. Based on ex‑
perience gained through the development of
guidance for the chemicals safety assessment
under Regulation (EC) No 1907/2006, three
different criteria for exposure-based waiv‑
ing have been identified. The First criterion
requires that it is demonstrated and docu‑
mented that exposure in all scenarios is well
below an appropriate derived no-effect level
(DNEL) or predicted no-effect concentration
(PNEC) derived under specific conditions.
The second criterion requires that it is dem‑
onstrated and documented that strictly con‑
trolled conditions apply throughout the life
cycle. The third criterion requires that where
the substance is incorporated in an article, the
substance is incorporated in such a way that
no exposure can take place and the substance
is not released during its life cycle and is han‑
dled under strictly controlled conditions dur‑
ing all manufacturing and production stages.
64 Journal Chemicals Management April 2009, No. 3

actualities

Consequently, these criteria for justification
for the omission of testing should be incorpo‑
rated in Regulation (EC) No 1907/2006.
Section 3 of Annex XI to Regulation (EC)
No 1907/2006 is replaced by the following:
3. SUBSTANCE-TAILORED EXPOSURE-
DRIVEN TESTING
3.1. Testing in accordance with Sections 8.6
and 8.7 of Annex VIII and in accordance with
Annex IX and Annex X may be omitted, based
on the exposure scenario(s) developed in the
Chemical Safety Report.
3.2. In all cases, adequate justification and
documentation shall be provided. The justifi‑
cation shall be based on a thorough and rigor‑
ous exposure assessment in accordance with
section 5 of Annex I and shall meet any one of
the following criteria:
(a) the manufacturer or importer demon‑
strates and documents that all of the
following conditions are fulfilled: (i) the
results of the exposure assessment cover‑
ing all relevant exposures throughout the
life cycle of the substance demonstrate the
absence of or no significant exposure in
all scenarios of the manufacture and all
identified uses as referred to in Annex VI
section 3.5; (ii) a DNEL or a PNEC can
be derived from results of available test
data for the substance concerned taking
full account of the increased uncertainty
resulting from the omission of the infor‑
mation requirement, and that DNEL or
PNEC is relevant and appropriate both to
the information requirement to be omit‑
ted and for risk assessment purposes (*);
(iii) the comparison of the derived DNEL
or PNEC with the results of the expo‑
sure assessment shows that exposures are
always well below the derived DNEL or
PNEC;
(b) where the substance is not incorporated
in an article the manufacturer or importer
demonstrates and documents for all rel‑
evant scenarios that throughout the life
Sdu Uitgevers
actualities
cycle strictly controlled conditions as set
out in Article 18(4)(a) to (f) apply;
(c) where the substance is incorporated in an
article in which it is permanently embed‑
ded in a matrix or otherwise rigorously
contained by technical means, it is dem‑
onstrated and documented that all of the
following conditions are fulfilled: (i) the
substance is not released during its life
cycle; (ii) the likelihood that workers or
the general public or the environment are
exposed to the substance under normal or
reasonably foreseeable conditions of use is
negligible; and (iii) the substance is han‑
dled according to the conditions set out
in Article 18(4)(a) to (f) during all manu‑
facturing and production stages including
the waste management of the substance
during these stages.
3.3. The specific conditions of use must be
communicated through the supply chain in
accordance with Article 31 or 32, as the case
may be.
(*) For the purpose of subparagraph 3.2(a)(ii), without
prejudice to column 2 of Section 8.7 of Annexes IX
and X, a DNEL derived from a screening test for re‑
productive/developmental toxicity shall not be con‑
sidered appropriate to omit a prenatal developmental
toxicity study or a two-generation reproductive tox‑
icity study. For the purpose of subparagraph 3.2(a)
(ii), without prejudice to column 2 of section 8.6 of
Annexes IX and X, a DNEL derived from a 28-day
repeated dose toxicity study shall not be considered
appropriate to omit a 90-day repeated dose toxicity
study.’
REACH, polymers and monomers:
Case C‑558/07
[2009/0051]
Preliminary ruling from the High Court of
Justice of England and Wales, Queen’s Bench
Division (Administrative Court) on the con‑
cept of ‘monomer substance’:
Sdu Uitgevers
Questions referred
1. In light of the fact that the registration
requirements in Title II of the REACH
Regulation (1) do not apply to polymers
by virtue of Article 2(9) of the Regula‑
tion, does the reference to ‘monomer sub-
stances’ in Article 6(3) mean: (a) reacted
monomers, that is monomers which have
reacted together such that they are indis‑
sociable from the polymer of which they
form part; (b) unreacted monomers,
that is monomers that are residual to the
polymerisation process and which retain
their own chemical identities and proper‑
ties separate from the polymer after that
process is complete; or (c) both reacted
and unreacted monomers?
2. If the answer to question 1 is either (a)
or (c), is the application of Article 6(3) to
manufacturers or importers of polymers
unlawful by reason that the requirements
are irrational, discriminatory or dispro‑
portionate?
I Introduction
1. The High Court of Justice of England and
Wales asks the Court what is to be under‑
stood by the term ‘monomer substance’.
2. At first sight the reference for a prelimi‑
nary ruling appears peculiar. One might
have expected the question to be addressed
to a chemist. However, a closer examina‑
tion shows that the question can and must
be answered with the tools of Community
law.
3. The Court must therefore, for the first
time, interpret Regulation (EC) No
1907/2006 of the European Parliament
and of the Council of 18 December 2006
concerning the Registration, Evaluation,
Authorisation and Restriction of Chemi‑
cals (‘the REACH Regulation’).
V Conclusion
I therefore propose that the Court gives the
following answer to the reference for a pre‑
liminary ruling:
Journaal Stoffen en Preparaten april 2009, Nr. 3 65

(1) The term ‘monomer substances’ in Article
6(3) of Regulation (EC) No 1907/2006
concerning the Registration, Evaluation,
Authorisation and Restriction of Chemi‑
cals refers only to reacted monomers, that
is, monomers which have reacted together
in such a way that they are bound in the
polymer of which they are components.
(2) Consideration of Question 2 has not dis‑
closed anything capable of affecting the
validity of Article 6(3) of Regulation No
1907/2006 having regard to the princi‑
ples of legal certainty, proportionality and
non-discrimination.
References: http://eur-lex.europa.eu/LexUriServ/LexU‑
riServ.do?uri=OJ:C:2008:051:0036:0037:E
N:PDF
http://curia.europa.eu/jurisp/cgi-bin/form.
pl?lang=EN&Submit=Rechercher$docrequ
ire=alldocs&numaff=C-558/07&datefs=&d
atefe=&nomusuel=&domaine=&mots=&r
esmax=100
Two food additives have previously
unrecognized estrogen-like effects
[2009/0052]
Scientists in Italy are reporting development
and successful use of a fast new method to
identify food additives that act as so-called
“xenoestrogens”- substances with estrogen-
like effects that are stirring international
health concerns. They used the method in a
large-scale screening of additives that discov‑
ered two additives with previously unrecog‑
nized xenoestrogen effects.
In the study, Pietro Cozzini and colleagues
cite increasing concern about identifying
these substances and about the possible health
effects. Synthetic chemicals that mimic natu‑
ral estrogens (called “xenoestrogens”, liter‑
ally, “foreign estrogens”) have been linked to
a range of human health effects. They range
66 Journal Chemicals Management April 2009, No. 3
actualities
from reduced sperm counts in men to an in‑
creased risk of breast cancer in women.
The scientists used the new method to search
a food additive database (the Joint FAO-WHO
expert committee database) of 1500 substanc‑
es, and verified that the method could iden‑
tify xenoestrogens. In the course of that work,
they identified two previous unrecognized
xenoestrogens. One was propyl gallate (CAS
121-79-9), a preservative used to prevent fats
and oils from spoiling. The other was 4-hexy‑
lresorcinol (CAS 136-77-6), used to prevent
discoloration in shrimp and other shellfish.
References: http://www.sciencedaily.com/relea‑
ses/2009/03/090302125924.htm
http://pubs.acs.org/doi/abs/10.1021/
tx800048m
Belgium: ADR and RID 2009
[2009/0053]
The European Agreement concerning the In‑
ternational Carriage of Dangerous Goods by
Road (ADR) has been published in French and
Dutch in the Belgian official journal Belgisch
Staatsblad of 11 February 2009.
– ADR en vigueur le 1er janvier 2009. ��� Ac‑
cord européen relatif au transport inter‑
national des marchandises dangereuses
par route.
– ADR in voege op 1 januari 2009. Europees
Verdrag betreffende het internationaal
vervoer van gevaarlijke goederen over de
weg.
Also the Regulation on the International Car‑
riage of Dangerous Goods by Rail (RID) in
the French and Dutch language can be found
on a Belgian website.
References: http://staatsbladclip.zita.be/staatsblad/wet‑
ten/2009/02/11/wet-2008014377.html
http://www.mobilit.fgov.be/fr/index.htm 
Rail
http://www.mobilit.fgov.be/nl/index.htm 
Spoor
Sdu Uitgevers
actualities
International
Switzerland: GHS introduction
[2009/0054]
Eventually, Switzerland has incorporated the
first elements of the GHS Regulations in its
legislation.
In order to avoid technical barriers to trade,
the Federal Council has revised the Ordinance
on Chemicals (ChemV) , taking into account
the development of the European Union/
EEA chemicals legislation. The introduction
of the REACH and the introduction of EU-
GHS or CLP in the EU have strongly changed
the demands on the marketing of chemical
products. A partial adjustment of the Swiss
chemicals legislation was necessary in order
to harmonize existing rules and at the same
time to keep the health and environmental
protection at a high level.
These are the main changes:
– The requirements for testing of new
chemical substances been adopted to
the European provisions. The use of
alternative methods allows the reduction
of experiments with laboratory animals.
– The safety data sheet includes the
identification of substances that are
particularly persistent and bioaccumu-
lative, and well as more detailed
information concerning the use of
hazardous substances. This information
will enable professional users to take more
appropriate risk management measures.
– Thanks to the possibility to use of the
new GHS system for chemical substances
intended for professional users, a re-
labeling can be avoided. The full adoption
of the GHS is foreseen in the coming
years.
Sdu Uitgevers
The ‘�������������������
Verordnung des EDI über �������������
die Ein‑
stufung und Kennzeichnung von Stoffen’
(Ordinance on the classification and labeling
of substances) of 28 June 2005 had to be
adjusted, because the reference to Annex I of
Directive 67/548/EEC by the introduction of
the new CLP Regulation is no longer valid.
The amendment of 9 December 2008 was
published in the Amtliche Sammlung des
Bundesrechts (Recueil official) of 27 January
2009, pages 433-434:
Art. 2
European classifications and labelling
instructions
1 For substances, listed in the Annex VI, Part  3
of the Regulation (EC) No 1272/2008 of the
European Parliament and of the Council of
16 December 2008 on classification, labelling
and packaging of substances and mixtures,
amending and repealing Directives 67/548/
EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006 (CLP
Regulation), the classifications and labelling
instructions given in this Regulation will
apply.
2 When the CLP-Regulation will be amended,
the Federal Ministry of Health, after having
consulted the Federal Ministry of the
Environment and the Federal Secretary
of Economic Affairs, will determine the
applicable edition.
This amendment entered into force on
1 February 2009.
Reference: http://www.admin.ch/ch/d/as/2009/
index0_4.html
Journaal Stoffen en Preparaten april 2009, Nr. 3 67

USA: Enhancing the effectiveness
of TSCA
[2009/0055]
The U.S. Congress passed the Toxic Substanc‑
es Control Act (TSCA) in 1976, authorizing
the Environmental Protection Agency (EPA)
to obtain information on the risks of indus‑
trial chemicals and to control those that EPA
determines pose an unreasonable risk. How‑
ever, EPA does not have sufficient chemical
assessment information to determine whe­
ther it should establish controls to limit pub‑
lic exposure to many chemicals that may pose
substantial health risks. In reports on TSCA,
the United States Government Accountability
Office (GAO) has recommended statutory
changes to, among other things, provide EPA
with additional authorities to obtain health
and safety information from the chemical
industry and to shift more of the burden to
chemical companies for demonstrating the
safety of their chemicals. The most important
recommendations aimed at providing EPA
with the information needed to support its
assessments of industrial chemicals have not
been implemented a key factor leading GAO
in January 2009 to add transforming EPA’s
process for assessing and controlling toxic
chemicals to its list of high-risk areas war‑
ranting attention by Congress and the execu‑
tive branch. This testimony, which is based on
prior GAO work, addresses EPA’s implemen‑
tation of TSCA and options for (1) obtaining
information on the risks posed by chemicals
to human health and the environment, (2)
controlling these risks, and (3) publicly dis‑
closing information provided by chemical
companies under TSCA.
TSCA generally places the burden of obtaining
data on existing chemicals on EPA, rather than
on the companies that produce the chemicals.
For example, the act requires EPA to demon‑
strate certain health or environmental risks
68 Journal Chemicals Management April 2009, No. 3
actualities
before it can require companies to further
test their chemicals. As a result, EPA does not
routinely assess the risks of the roughly 80,000
industrial chemicals in use. Moreover, TSCA
does not require chemical companies to test
the approximately 700 new chemicals intro‑
duced into commerce annually for their toxic‑
ity, and companies generally do not voluntar‑
ily perform such testing. Further, the proce‑
dures EPA must follow in obtaining test data
from companies can take years to complete. In
contrast, the European Union’s chemical con‑
trol legislation generally places the burden on
companies to provide health effects data on
the chemicals they produce.
Giving EPA more authority to obtain data
from the companies producing chemicals, as
GAO has in the past recommended that Con‑
gress consider, remains a viable option for
improving the effectiveness of TSCA. While
TSCA authorizes EPA to issue regulations that
may, among other things, ban existing toxic
chemicals or place limits on their production
or use, the statutory requirements EPA must
meet present a legal threshold that has proven
difficult for EPA and discourages the agency
from using these authorities. For example, EPA
must demonstrate “unreasonable risk”, which
EPA believes requires it to conduct extensive
cost-benefit analyses to ban or limit chemical
production. Since 1976, EPA has issued regu‑
lations to control only five existing chemicals
determined to present an unreasonable risk.
Further, its 1989 regulation phasing out most
uses of asbestos was vacated by a federal ap‑
peals court in 1991 because it was not based
on “substantial evidence”. In contrast, the Eu‑
ropean Union and a number of other coun‑
tries have largely banned asbestos, a known
human carcinogen that can cause lung cancer
and other diseases.
GAO has previously recommended that Con‑
gress amend TSCA to reduce the evidentiary
burden EPA must meet to control toxic sub‑
Sdu Uitgevers
actualities
stances and continues to believe such change
warrants consideration. EPA has a limited
ability to provide the public with information
on chemical production and risk because of
TSCA’s prohibitions on the disclosure of con‑
fidential business information. About 95 per‑
cent of the notices companies have provided
to EPA on new chemicals contain some in‑
formation claimed as confidential. Evaluating
the appropriateness of confidentiality claims
is time- and resource-intensive, and EPA does
not challenge most claims. State environmen‑
tal agencies and others have said that informa‑
tion claimed as confidential would help them
in such activities as developing contingency
plans to alert emergency response personnel
to the presence of highly toxic substances at
manufacturing facilities. The European Un‑
ion’s chemical control legislation generally
provides greater public access to the chemical
information it receives, and GAO has previ‑
ously recommended that Congress consider
providing EPA additional authorities to make
more chemical information publicly avail‑
able.
References: http://www.gao.gov/products/GAO-
09-428T
http://www.gao.gov/new.items/d09428t.pdf
See also: http://www.americanchemistry.com/s_acc/
sec_news_article.asp?CID=206&DID=9174
P.R. of China: Inventory of
Existing Chemical Substances
2008
[2009/0056]
The Registration Centre of the Ministry of
Environmental Protection has published the
2008 version of the ‘Inventory of Existing
Chemicals’ (IECSC 2008 ) on 25 December
2008. If any company manufactures or im‑
ports any chemical substances that is not on
this list, it has to register the chemical.
Sdu Uitgevers
The inventory contains 45290 substances, of
which 3080 are marked as confidential. 37125
substances have a CAS number.
The Inventory can be ordered on CD, but can
also be accessed by Internet.
References: http://www.crc-mep.org.cn/news/NEWS_
detailT0.aspx?TitID=113&T0=2&T1=2&T
2=0&T3=0&T4=0&T5=0&T6=0&Languag
eType=CH
Webversion: http://www.crc-mep.org.cn/iecscweb/
default0.aspx
P.R. of China: List of Severely
Restricted Toxic Chemicals for
Export and Import 2009
[2009/0057]
The List of Severely Restricted Toxic Chemi‑
cals for Export and Import (2009 version)
was published Ministry of Environmental
Protection on 28 December 2008 and came
into force on 1 January 2009. Any import and/
or export of these listed chemicals requires a
Certificate on Import of Toxic Chemicals and
the Clearance Notification for Environmental
Management on the Import/Export of Toxic
Chemicals from the Chemical Registration
Centre.
References: http://www.mep.gov.cn/info/bgw/
bgg/200812/t20081231_133205.htm
List: http://www.mep.gov.cn/info/bgw/
bgg/200812/W020081231576247755536.
pdf
P.R. of China: List of Goods
subject to Import Licence 2009
[2009/0058]
The Ministry of Commerce, the General Ad‑
ministration of Customs, and the General Ad‑
ministration of Quality Supervision, Inspec‑
tion and Quarantine have issued the List of
Journaal Stoffen en Preparaten april 2009, Nr. 3 69

Goods subject to Import License Control in
2009 on 10 December 2008. An import license
is required if importing any of the 57 ozone
depleting substances and 96 controlled used
mechanical and electronic products listed in
the “List of Goods subject to Import License
Control in 2009”.
References: http://beijing.mofcom.gov.cn/aarticle/sjton
gzhigg/200901/20090105994295.html
http://www.zhb.gov.cn/info/bgw/
bl/200812/t20081216_132482.htm
South-Korea: Hazard Assessment
of Existing Chemicals
[2009/0059]
On 9 December 2008, the National Institute
of Environmental Research .issued the Pub‑
lic Notice on Results of Hazard Assessment
of Existing Chemicals. This Notice contains
hazard assessment results of 13 existing chem‑
icals, which include phosphoric acid, sorbitol,
calcium silicide, trisodium orthophosphate,
tripotassium orthophosphate, and tripotas-
sium hexafluoroaluminate.
Reference: http://www.me.go.kr
Singapore: draft standards on
Occupational safety and health
(OSH) management systems
[2009/0060]
– Occupational safety and health (OSH)
management systems – Part 1 : Require-
ments (Revision of SS 506 : Part 1 : 2004)
This standard specifies requirements for an
occupational safety and health (OSH) man‑
agement system to enable an organisation to
control its OSH risks and improve its OSH
performance. It does not state specific OSH
performance criteria, nor does it give detailed
70 Journal Chemicals Management April 2009, No. 3
actualities
specifications for the design of a management
system.
All the requirements in this standard are in‑
tended to be incorporated into any OSH man‑
agement system. The extent of the application
will depend on such factors as the OSH policy
of the organisation, the nature of its activities
and the risks and complexity of its opera‑
tions.
This standard is intended to address occupa‑
tional safety and health, and is not intended
to address other safety and health areas such
as employee well-being/wellness programs,
product safety, property damage or environ‑
mental impacts.
This standard is applicable to any organisa‑
tion that wishes to establish an OSH manage‑
ment system to eliminate or minimize risks
to personnel and other interested parties who
could be exposed to OSH hazards associated
with its activities.
– Occupational safety and health (OSH)
management systems – Part 2 : General
guidelines for the implementation of OSH
management system (SS 506 : Part 2  :
2004)
This standard provides generic advice on the
application of SS 506 : Part 1. It explains the
underlying principles of SS 506 : Part 1 and
describes the intent, typical inputs, processes
and typical outputs, against each requirement
of SS 506 : Part 1. This is to aid the under‑
standing and implementation of SS 506 : Part
1. It is proposed to review the standard so as to
align the requirements with those of the cur‑
rent BS OHSAS 18002 : 2008.
Reference: http://www.spring.gov.sg/Content/Web‑
Page.aspx?id=0074748d-0996-43d6-95d2-
522fb0456ce0
Sdu Uitgevers
actualities
Canada: CAN-NEW-Database on
ototoxic substances
[2009/0061]
There is accumulating epidemiological evi‑
dence that exposure to some solvents, metals,
asphyxiants and other substances in humans
is associated with an increased risk of hearing
loss. A project was undertaken to develop a
toxicological database allowing the identifica‑
tion of possible ototoxic substances present in
the work environment. Critical toxicological
data were compiled for chemical substances
included in the Quebec Occupational Health
Regulation.
From the report:
Ethylbenzene: Possibly ototoxic substance
Lead and inorganic compounds (as Pb):
Ototoxic substance
n-Hexane: Possibly ototoxic substance
Styrene (monomer): Ototoxic substance
Toluene: Ototoxic substance
Trichloroethylene: Ototoxic substance
Xylene (o-,m-,p-isomers): Possibly ototoxic
substance
References: http://www.irsst.qc.ca/en/utOto.htm
http://osha.europa.eu/en/riskobserva‑
tory/new_database_ototoxic_substan‑
ces_01.05032009
Canada: use of engineered
nanomaterials
[2009/0047]
Canada is reportedly planning in February
2009 to become the first nation in the world
to require companies to detail their use of
engineered nanomaterials. The information
gathered under the requirement will be used
to evaluate the risks of engineered nanoma‑
terials and will help to develop appropriate
safety measures to protect human health and
the environment.
Sdu Uitgevers
The one-time request will gather information
that will be used towards the development of
a regulatory framework and will target com‑
panies and institutions that manufactured or
imported a total quantity greater than 1 kg of
a nanomaterial during the 2008 calendar year,
according to a spokesperson for Environment
Canada. The upcoming requirement is not a
regulation or rule that will require users to
submit information on a continual basis.
Project on Emerging Nanotechnologies (PEN)
experts have been urging increased oversight
of nanotechnologies in recent years, and note
the move by the Canadian government is a
significant step for consumer and environ‑
mental protection.
Canada’s action comes shortly after the U.S.
Environmental Protection Agency (EPA) is‑
sued an interim report on its Nanoscale Mate‑
rials Stewardship Program, a voluntary infor‑
mation submission program that has received
limited industry participation. The EPA report
notes the lack of data the program garnered
and says the agency will consider how best to
use the federal Toxic Substances Control Act
(TSCA) to gather more risk data. Previous
studies by PEN experts have concluded that
TSCA is “extremely deficient”, and that EPA
has not effectively used the tools it has under
that law to address nanotechnology, keeping
the agency from identifying which substances
are nanomaterials and whether they pose a
hazard.
Reference: http://www.nanotechproject.org/news/
archive/7061/
Canada: Batch 2 substances
[2009/0062]
Of the final assessments for the 16 substances
(excluding bisphenol A) included in Batch 2,
five are of concern to human health (thiou‑
rea (CAS 62-56-6), Pigment Yellow 34 (CAS
1344-37-2), Pigment Red 104 (molybdate
Journaal Stoffen en Preparaten april 2009, Nr. 3 71

orange, CAS 12656-85-8), isoprene (CAS 78-
79-5) and epichlorohydrin (CAS 106-89-8))
and three are of concern to the environment
(siloxanes D4 (CAS 556-67-2) and D5 (CAS
541-02-6), TTBP (2,4,6-tri-tert-butylphenol,
CAS 732-26-3)). The publication of final as‑
sessments moves these substances into risk
management and plans will be developed to
control their release to the environment and
impact on human health.
Although Canadians’ exposure is very low
for the five substances of concern to human
health, the Government is proposing that
regulations similar to Significant New Activity
(SNAc) provisions be applied to four of these
substances. The provisions will prevent these
substances being used in the future without
undergoing new health and environmental
assessments. Two of these substances, epichlo‑
rohydrin and isoprene, will also be added to
the Cosmetic Ingredient Hotlist to prevent
their future use in cosmetics. For isoprene,
Health Canada is proposing that manufactur‑
ers use the best-available technology to con‑
trol releases.
The final assessment concludes that vinyl
acetate (CAS 108-05-4) is not a concern for
human health.
Reference: http://www.ecoaction.gc.ca/news-
nouvelles/20090130-2-eng.cfm
Australia: Hazardous Substances
Information System Update
[2009/0063]
The Australian Safety and Compensation
Council (Department of Education, Employ‑
ment and Workplace Relations) (ASCC) is
about to update the Hazardous Substances In‑
formation System (HSIS) online database to
include information to reflect changes in Eu‑
rope’s 30th Adaptation to Technical Progress
to Directive 67/548/EEC.
72 Journal Chemicals Management April 2009, No. 3
actualities
The HSIS online database is an Internet re‑
source that allows users to find information on
substances that have been classified in accord‑
ance with the Approved Criteria for Classifying
Hazardous Substances [NOHSC:1008(2004)]
3rd Edition and/or have National Exposure
Standards declared under the NOHSC Adopt‑
ed National Exposure Standards for Atmos‑
pheric Contaminants in the Occupational
Environment [NOHSC:1003(1995)].
The update comprises of a total of 956 entries
of which there are 568 amendments to exist‑
ing entries, 385 new entries and 3 deletions.
Also, the HSIS Guidance Material for Hazard
Classifications has been updated to reflect
amendments to Notes H, J and P in the label‑
ling column. It is anticipated all changes will
be finalised by mid 2009.
A full list of the schedule of changes for the
HSIS online database update can be found at
www.hsis.ascc.gov.au.
Reference: http://www.ascc.gov.au/ascc/HealthSafety/
HazardousSubstances/HSIS/
Australia: Low Regulatory
Concern Chemicals
[2009/0064]
Over the past few years NICNAS has im‑
plemented a number of recommendations
from the Low Regulatory Concern Chemicals
(LRCC) reform initiative detailed in the 2003
LRCC Final Report and Recommendations.
However, certain recommendations required
further technical development and consulta‑
tion before they could be implemented. The
Low Regulatory Concern Chemicals (LRCC)
Final Report and Recommendations on the
outstanding reforms was published in the No‑
vember 2007 issue of the Chemical Gazette.
Amendment of the Regulations will now al‑
low:
Sdu Uitgevers
actualities
– Increase in volume for low hazardous
chemicals introduced under the Low Vol‑
ume Chemical (LVC) Permit system;
– Introduction of highly controlled low risk
chemicals under the Controlled Use Per‑
mit (CUP) system;
– Extension of the Early Introduction Per‑
mit system to low hazardous and highly
controlled low risk chemicals;
– Modular assessment (for certificate cat‑
egories) of chemicals for which another
assessment is available, for example, as‑
sessed by another assessment authority or
introduction of an analogue of a chemical
previously assessed by NICNAS; and
– Free Early Introduction Permit for non-
hazardous chemicals and polymers and
polymers of low concern.
Reference: http://www.nicnas.gov.au/Publications/
Chemical_Gazette/Chemical_Gazette_
December_2008.asp
Australia: Chemicals and Plastics
Regulation: Supplement to
Research Report
[2009/0065]
Chemicals and Plastics Regulation: Lessons for
National Approaches to Regulation. Supple-
ment to research report
The Productivity Commission has prepared a
supplement to its July 2008 report, Chemicals
and Plastics Regulation, that elaborates on na‑
tional approaches to regulation that arose in
the report. This supplement was released on
22 January 2009.
Reference: http://www.pc.gov.au/__data/assets/
pdf_file/0004/85297/chemicals-plastics-
supplement.pdf
See also: JSP, 2008/8, page 215.
Sdu Uitgevers
Australia: Review of Mutual
Recognition Schemes
[2009/0066]
Productivity Commission Research Report,
6 February 2009
The Mutual Recognition Agreement and the
Trans-Tasman Mutual Recognition Arrange‑
ment (TTMRA) are innovative mechanisms
for reducing the costs of regulatory differences
among Australian jurisdictions and between
Australia and New Zealand. In this second five
yearly review of the schemes, the Commission
found that the schemes had brought benefits
through increased mobility of labour and
merchandise, but that there remained scope
to further enhance their operations. Key areas
are: bringing greater certainty to the way the
schemes operate in relation to occupations;
and facilitating interactions between regula‑
tors, governments, tribunals and the public.
In conducting its review, the Commission
consulted with a wide range of stakeholders
from industry, government and the commu‑
nity in both Australia and New Zealand. The
study benefited from the preparedness of all
parties to engage in an open and constructive
dialogue.
From the report:
7.1 Hazardous substances, industrial
chemicals and dangerous goods
Background
The issues underpinning the special exemp‑
tion for hazardous substances, industrial
chemicals and dangerous goods – collectively
termed ‘industrial chemicals’ in this chapter –
primarily concern requirements for: notifica‑
tion and assessment of industrial chemicals,
and industrial chemical classification, label‑
ling, packaging and safety data sheets.
Efforts to resolve the issues underpinning the
industrial chemicals special exemption are
managed through a cooperation program.
Australia’s lead agency for the industrial
Journaal Stoffen en Preparaten april 2009, Nr. 3 73

chemicals cooperation program is the Office
of the Australian Safety and Compensation
Council (OASCC). In New Zealand, this re‑
sponsibility lies with the Environmental Risk
Management Authority (ERMA). Both the
OASCC and ERMA are assisted by various
other agencies – such as government depart‑
ments for agriculture and health – due to the
diversity of issues associated with chemicals
regulation.
The Productivity Commission’s 2003 review
of the mutual recognition schemes found
that various deficiencies in Australia’s chemi‑
cal regulations – particularly duplication
and inconsistency between different agen‑
cies and jurisdictions – were a major obstacle
to achieving mutual recognition with New
Zealand. The Commission recently reviewed
Australia’s chemicals regulations and recom‑
mended a national approach to overcome
the problems with existing arrangements. A
key aspect of the recommended reforms was
a new governance framework that clearly
divides responsibilities between numerous
agencies and jurisdictions according to task
(such as standard setting) and area (such as
workplace safety). In contrast, New Zealand
has a single agency (ERMA) to deal with most
assessment and standard-setting functions,
no states to which tasks are delegated, and
fewer regulators to administer and enforce
the regulations. In response to the Commis‑
sion’s recommendations, Australian heads of
government agreed in early October 2008 that
‘improved and better coordinated governance
structures are required’ for Australian chemi‑
cals regulation. […]
Notification and assessment of industrial
chemicals
In 2004, a five year work plan was established
under the auspices of the industrial chemicals
cooperation program to resolve issues under‑
pinning the TTMRA special exemption for
industrial chemicals. The work plan largely
focuses on notification and assessment ar‑
74 Journal Chemicals Management April 2009, No. 3
actualities
rangements, and is primarily undertaken by
ERMA and Australia’s NICNAS (National
Industrial Chemicals Notification and As‑
sessment Scheme). A key element of the work
plan has been a comparison of arrangements
in both countries. The Australian Government
Department of Health and Ageing (DOHA)
noted that this exercise revealed fundamental
differences in the regulatory regimes:
– Australia assesses all new chemicals and
priority existing chemicals, both hazard‑
ous and nonhazardous […]
– New Zealand assesses only hazardous
chemical substances as identified by the
manufacturer or importer
– the definition of ‘hazardous’ is not the
same for Australia and New Zealand, with
New Zealand adopting the GHS [Globally
Harmonised System for Classification and
Labelling of Chemicals] definition which
currently is more conservative than the
Australian workplace classification (cur‑
rently aligned with European Union defi‑
nitions)
– NICNAS, like [regulators in] all other
OECD countries, but unlike New Zealand,
is a chemical-entity based scheme (that is,
not product registration). New Zealand
assess products as well as chemical enti‑
ties
– �����������������������������������������
New Zealand must have regard in their as‑
sessment for the principles of the Treaty
of Waitangi with the legislation requiring
an assessment to provide any known and
possible adverse effects throughout the life
cycle of the hazardous substance (or new
organism) on the relationship of Maori
and their culture and traditions
– differences between the New Zealand and
Australian ecosystems may result in differ‑
ent risk assessment outcomes.
DOHA also expressed a concern that New
Zealand does not require the notification and/
or assessment of some chemicals that, while
technically classified as nonhazardous, are not
necessarily safe:
Sdu Uitgevers
actualities
Furthermore, notwithstanding the difference
in definition of ‘hazardous’, some nonhazard‑
ous chemicals (substances) are not subject to
notification and/or assessed in New Zealand
but do require notification and/or assessment
in Australia. Mutual recognition would al‑
low these chemicals (substances) to be sold in
Australia without the need for the risk assess‑
ment deemed necessary. Even if a chemical
is classified as nonhazardous in Australia, it
may still be recommended that certain safety
and risk information be required – ‘nonhaz‑
ardous’ does not necessarily mean safe for all
purposes. Australia’s regulatory system covers
the broad spectrum of chemicals where non‑
hazardous substances still require labelling for
consumers. This illustrates the difficulties that
would be likely to arise if mutual recognition
was applied while there are still fundamental
differences in what Australia and New Zealand
consider to be appropriate ways to control
chemical-related risks. Community expecta‑
tions about those risks are such that achieving
wholesale mutual recognition seems unlikely,
unless it is accompanied by a high degree of
regulatory harmonisation, if not uniformity.
[…]
Accord Australasia claimed that there would
be significant benefits from removing cosmet‑
ics from the industrial chemicals special ex‑
emption, and that this is feasible because the
relevant regulations are now closely harmo‑
nised between Australia and New Zealand:
Since the Australian Government finalised its
reforms to cosmetic products at the thera‑
peutic interface in September 2007 and New
Zealand introduced the Cosmetic Products
Group Standard on 1 July 2006, the regula‑
tory controls for cosmetic products are now
closely harmonised and there is a strong case
for TTMRA to apply to this class of consumer
goods. The application of TTMRA for this
class of low-risk, fast-moving consumer prod‑
ucts will have significant benefits in facilitat‑
ing trade and reducing unnecessary barriers.
However, cosmetics are subject to Australia’s
Sdu Uitgevers
notification and assessment regime for indus‑
trial chemicals, and so the abovementioned
differences identified bij NICNAS and ERMA
are relevant. […]
Chemical classification, labelling, packaging
and safety data sheets
The Australian Government Department of
Education, Employment and Workplace Re‑
lations (DEEWR) and the New Zealand Gov‑
ernment noted that a key step towards resolv‑
ing the industrial chemicals special exemption
will be for Australia to implement the Global‑
ly Harmonised System for Classification and
Labelling of Chemicals.
No country has fully implemented the GHS,
although New Zealand has made the most
progress, and the European Union began
phasing in the GHS in December 2008 over a
period of about seven years: The new Europe‑
an regulation on classification, labelling and
packaging which is based on the GHS came
into effect on 1 December 2008; the deadline
for substance classification according to the
new criteria is 1 December 2010 whereas for
mixtures the deadline is 1 June 2015. New
Zealand has applied the hazard-classification
aspects of the original version of the GHS to
all sectors, and is now updating its arrange‑
ments to the latest revised edition. In Austral‑
ia, the Australian Safety and Compensation
Council (ASCC) has proposed that the GHS
(first revised edition) be adopted as part of a
new national framework for regulating chem‑
icals in workplaces. Progress in finalising this
proposal has been slow, and its implementa‑
tion would involve a long phase-in period:
Work on the new workplace chemicals frame‑
work has been ongoing for several years, and
while significant progress is being made, this
has occurred slowly […]. Once a new GHS-
based national standard for workplace chemi‑
cals has been declared […] GHS implemen‑
tation in Australia would not actually occur
until the new standard has been adopted into,
or given effect by, the relevant state and terri‑
Journaal Stoffen en Preparaten april 2009, Nr. 3 75

tory legislation and regulations. This process
can take a number of years to occur.
In 2006, a draft regulation impact statement
(RIS) supporting the ASCC’s proposal was re‑
leased for public comment. The Commission
examined the RIS as part of its recent review
of Australia’s chemical regulations, and con‑
cluded that the benefits of adopting the GHS
in the immediate future were overstated. Im‑
plementing the GHS now would impose sig‑
nificant costs on industry without offsetting
trade benefits, due to the limited adoption of
the GHS by other countries. The Commission
recommended that a further RIS should be
prepared when some of Australia’s key trading
partners, such as China and the United States,
have commenced implementing GHS-based
regulatory regimes for workplace chemicals.
There has been even less progress in applying
the GHS to domestic poisons and agricultural
and veterinary (agvet) chemicals in Australia.
New Zealand has a GHS-based code of prac‑
tice for labelling agvet chemicals, but the use
of GHS label elements (such as pictograms)
is not mandatory, and the code allows for al‑
ternative approaches to labelling. A major is‑
sue for Australia is that domestic poisons and
agvet chemicals are currently classified and
labelled according to the risk they pose (tak‑
ing into account the probability of harm and
the magnitude of the consequences), whereas
the GHS only identifies hazards (potential for
harm).
Application of the GHS to domestic poi‑
sons is currently being considered as part of
the abovementioned five year work plan for
industrial chemicals under the TTMRA. In
Australia, this is being managed by DOHA in
cooperation with state and territory govern‑
ments, and with New Zealand as a participant
in discussions.
December 2009 is the target date for a deci‑
sion on how the GHS would be applied to do‑
mestic poisons and agvet products (NICNAS
2008). DOHA observed that this work has al‑
ready led it to conclude that there is little pros‑
76 Journal Chemicals Management April 2009, No. 3
actualities
pect of mutual recognition being achieved
with New Zealand in relation to the GHS for
domestic poisons: […] work in regard to the
implementation of the […] GHS has demon‑
strated that [its] adoption […] in Australia is
likely to require different approaches [com‑
pared to New Zealand] to classification and
labelling for consumer chemicals that reflect
different legislative arrangements (eg state/
territory framework for poisons scheduling),
differences in risk-management approaches
and the need to align with trading partners.
Consequently, the Department of Health and
Ageing also sees little likelihood of mutual
recognition being achieved in relation to the
GHS in the consumer-chemical sector. The
New Zealand Government claimed that Aus‑
tralia’s current consideration of how to apply
GHS classification criteria ‘creates an oppor‑
tunity to harmonise the assessments relating
to the intrinsic hazardous properties of [do‑
mestic and agvet] chemicals’. […]
The industrial chemicals cooperation pro‑
gram has made progress in a range of areas,
particularly in establishing greater coopera‑
tion between regulators on process issues.
However, the cooperation program has also
revealed fundamental differences in how
Australia and New Zealand control chemical-
related risks.
Wholesale mutual recognition seems unlikely
unless it is accompanied by a high degree of
regulatory harmonisation, if not uniformity.
Some areas – particularly the GHS classifi‑
cation and labelling of workplace chemicals
– are already in the process of being harmo‑
nised, but this is expected to take several years
(which is desirable from Australia’s perspec‑
tive, given the limited adoption of the GHS by
its major trading partners). Harmonisation of
many other important areas appears unlikely
in the foreseeable future, unless New Zealand
is prepared to align itself closely with the re‑
formed regulatory regime Australia adopts
following the Commission’s recent review of
chemical regulations.
Sdu Uitgevers
actualities
Reference: http://www.pc.gov.au/__data/assets/
pdf_file/0007/85759/mutual-recognition-
schemes.pdf
New Zealand: methylarsinic acid
and azinphos methyl
[2009/0067]
The Environmental Risk Management
Authority is calling for public submissions
on the use of the herbicide methylarsinic acid
(CAS 124-58-3 , sodium salt CAS 2163-80-
6) and the insecticide azinphos methyl (CAS
86-50-0) as part of its five-year programme to
review hazardous substances.
ERMA New Zealand staff have compiled
detailed information on the health and
environmental risks associated with methyl­­
arsinic acid and azinphos methyl in the
reassessment application documents for the
two chemicals.
Methylarsinic acid is used in New Zealand
to control paspalum and kikuyu in fine turf.
ERMA’s recommendation is that existing
approvals for methylarsinic acid be revoked,
based on the persistency of arsenic, its
potential to accumulate in the environment,
and to impact on human health.
Approval for its use has been withdrawn
in the European Union and Canada and
the United States is preparing to cancel
re-registration of all arsenical pesticides.
Overseas reviews and subsequent actions were
based on concerns of increasing arsenic levels
in soil and groundwater due to repeated use of
methylarsinic acid.
Azinphos methyl is a broad-spectrum
organo-phosphate insecticide used in New
Zealand for controlling insects on crops such
as strawberries, summerfruit and potatoes.
ERMA New Zealand staff ’s preliminary
assessment is that the risks of azinphos
methyl – to operators, re-entry workers,
bystanders and the environment – outweigh
Sdu Uitgevers
the benefits of its use and need to be managed.
It is recommending the approval for azinphos
methyl be revoked, with a controlled, five-year
phase out.
Its approval for use in the European Union has
been withdrawn and Canada and the United
States will phase it out by the end of 2012.
The deadline for submissions on methylarsinic
acid is 1 April 2009.
The Authority has extended the timeframe
for submissions on the azinphos methyl
application at the request of industry to allow
it more time to prepare submissions.
Reference: http://www.ermanz.govt.nz/news-events/
archives/media-releases/2009/mr-20090218.
html
OECD (Q)SAR Application
Toolbox
[2009/0068]
The Organisation for Economic Co-operation
and Development (OECD) has been working
on several activities aimed at promoting the
acceptance of (Q)SAR approaches for the reg‑
ulatory assessment of chemicals. In November
2004, they published the OECD principles for
(Q)SAR Validation and in February 2007, they
published a guidance document to help inter‑
pret those principles.
More recently they have been working on de‑
veloping a (Q)SAR Application Toolbox as a
means of making QSAR technology readily
accessible and transparent. With funding from
the European Commission, a proof-of-concept
version of the Toolbox was developed by the
Laboratory of Mathematical Chemistry group
in Bourgas, Bulgaria. Version 1 has incorporat‑
ed information and tools from various sources
in a structured workflow to facilitate the devel‑
opment and evaluation of chemical categories.
The workflow actually mirrors that described
for development of chemical groups in both
the REACH guidance and HPV manual.
Journaal Stoffen en Preparaten april 2009, Nr. 3 77

Version 1 of the Toolbox was publically re‑
leased at the end of March 2008. A first up‑
date, version 1.1 was released in December
2008. The second phase of the project to de‑
velop a more comprehensive Toolbox which
fully implements the capabilities of the first
version was launched in November 2008.
Further information, including training pres‑
entation slides is also available there.
Phase 2 of the Toolbox will be funded by
ECHA, the new Chemicals Agency in Helsin‑
ki. This is foreseen to be a 4 year project with
2 subsequent versions of the Toolbox being
released in October 2010 and October 2012.
The Toolbox is a software application intended
to be used by governments, chemical industry
and other stakeholders in filling gaps in (eco)
toxicity data needed for assessing the hazards
of chemicals. The Toolbox incorporates infor‑
mation and tools from various sources into a
logical workflow. Crucial to this workflow is
grouping chemicals into chemical categories.
A chemical category is a group of chemicals
whose physicochemical and human health
and/or environmental toxicological proper‑
ties and/or environmental fate properties are
likely to be similar or follow a regular pattern
as a result of structural similarity. Category
approach, not every chemical needs to be
tested for every endpoint. Rather, the overall
data for that category must prove adequate
to support a hazard assessment. The over‑
all data set must allow the estimation of the
hazard for the untested endpoints. Data gap
filing can be done using read-across from one
tested chemical to an untested chemical. De‑
tailed guidance on grouping of chemicals has
also been published in the series on Testing
and Assessment Number 80 and Number 102
(ENV/JM/MONO(2007)28 and ENV/JM/
MONO(2009)5).
The ‘Report of the Workshop on Structural
Alerts for the OECD (Q)SAR Application
78 Journal Chemicals Management April 2009, No. 3
actualities
Toolbox’, 15-16 May 2008, Utrecht, the Neth‑
erlands (2009) is also available.
References: Download Toolbox: http://www.oecd.org/d
ocument/23/0,3343,fr_2649_34379_33957
015_1_1_1_1,00.html#Download_QSAR_
AT or http://toolbox.oasis-lmc.org/
Guidance on grouping of chemicals: http://
www.oecd.org/dataoecd/53/62/39850072.
pdf
http://www.olis.oecd.org/olis/2009doc.nsf/
LinkTo/NT00000CAA/$FILE/JT03260091.
PDF
For training: http://www.qsari.org/
Workshop: http://www.olis.oecd.org/olis/2009doc.
nsf/ENGREFCORPLOOK/
NT000009D6/$FILE/JT03258460.PDF
Global Update on New Chemicals
Regulations (January 2009)
[2009/0069]
In January 2009, approximately 152 new reg‑
ulations relating to chemicals management
were adopted or published worldwide. These
involve implementation of GHS, updates to
chemical inventories, new priority chemicals,
several changes to the requirements on trans‑
port and handling, and last but not least re‑
strictions on the marketing and use of chemi‑
cals like arsenic, chlorofluorocarbons, etc.
The following overview provides the indica‑
tive title in English and the date of. Further
information on any of these new regulations
and what they require from industry can be
found in the Enhesa Update published by EN‑
HESA (www.enhesa.com). To be kept ahead
of new policy initiatives and developments
and their implications on your business con‑
tact ENHESA at +32 2 775 9797.
(Selection only)
Australia
Water Amendment Bill 2008 introduced
12-Dec-2008
Sdu Uitgevers
actualities
NSW: Environmental Planning and Assess‑
ment Regulation 2000 amended for comply‑
ing developments 23-Jan-2009
Clarification on the chemical identity infor‑
mation required by NICNAS 03-Feb-2009
Austria
Ordinance on emissions register for surface
wastewater discharges adopted 29-Jan-2009
Brazil
Adopted rules on toiletries, cosmetics and
perfumes manufactured to be exported 09-
Dec-2008
Use of asbestos by the Ministry of the Envi‑
ronment prohibited 28-Jan-2009
Bulgaria
Law on the Protection of Ambient Air Puri‑
ty with regards to VOCs, certain fluorinated
greenhouse gases and ozone-depleting sub‑
stances amended 16-Jan-2009 Requirements
for marketing of batteries and accumulators,
for the treatment and transport of waste bat‑
teries and accumulators and WEEE amended
30-Dec-2008 Canada
Ministerial Condition No. 15300 adopted
regarding benzene, 1,1′-(1,2-ethanediyl)
bis(2,3,4,5,6-pentabromo)-, CAS. 84852-53-9
03-Jan-2009
Significant New Activity Notice No. 15095
adopted regarding 2,4,7,9-Tetramethyl-4,7-
decanediol, CAS 17913-76-7 10-Jan-2009
Significant New Activity Notice No. 15330
adopted regarding phosphoric acid, iron (2+)
lithium salt (1:1:1) 10-Jan-2009
Orders adopted to amend the Domestic Sub‑
stances List and Non-Domestic Substances
List 07-Jan-2009
Significant New Activity Notice No. 15310
adopted regarding silane homopolymer, hy‑
drolysis products with magnesium hydroxide
24-Jan-2009
Significant New Activity Notice No. 15329
adopted regarding carbamic acid, [(butylthio)
thioxomethyl]-, butyl ester, CAS 1001320-38-
2 24-Jan-2009
Sdu Uitgevers
Significant New Activity Notice No. 15345
adopted regarding tin titanium zinc oxide
24-Jan-2009
Significant New Activity Notice No. 15365
adopted regarding 1-hexadecanol, manuf. of,
distn. lights, CAS 189233-30-5 24-Jan-2009
Significant New Activity Notice No. 15416
adopted regarding cobalt lithium manganese
nickel oxide, CAS 346417-97-8 24-Jan-2009
Notice with respect to Batch 8 Challenge Sub‑
stances published 31-Jan-2009
China
Phenfluoramine hydrochloride banned in
pharmaceutical intermediates and medica‑
ments 08-Jan-2009
Croatia
Regulation on Management with Wasted Elec‑
trical and Electronic Devices and Equipment
amended 11-Nov-2008
Estonia
Water Act amended 03-Dec-2008
Finland
Out-of-date Decisions on type approvals of
containers for the transport of dangerous
goods repealed 22-Jan-2009
France
Order relating to the declaration, classifica‑
tion, packaging and labeling of dangerous
substances amended 16-Jan-2009
Germany
Ministry of Labour issues notice on relation
between the European CLP Regulation and
the Ordinance on Dangerous Substances
(GefStoffV) 15-Jan-2009
Hungary
Revised rules on the requirements and con‑
formity of personal protective equipment
adopted 03-Dec-2008
National Institute of Chemical Safety (OKBI)
as competent GHS authority appointed 20-
Jan-2009
India
Explosive Rules 2008 published to introduce
the UN classification of explosives 31-Dec-
2008
Journaal Stoffen en Preparaten april 2009, Nr. 3 79

Italy
New transport document will be required for
the transport of any kind of goods 15-Jan-
2009
Temporarily extended the definition of sec‑
ondary raw materials 03-Jan-2009
Lithuania
Order on the attestation system of personnel
handling fluorinated GHG issued 13-Jan-
2009
Luxembourg
Restrictions on the marketing and use of per‑
fluorooctane sulfonates adopted 08-Jan-2009
New Zealand
New Zealand Inventory of Chemicals updated
and its usability improved 01-Dec-2007
Poland
Ordinance on Assessment of the Level of Sub‑
stances in the Air issued 17-Dec-2008
Russia
Legislation on wastes amended 30-Dec-2008
South Africa
National Environmental Laws Amendment
Act published 05-Dec-2008
South Korea
Exposure to asbestos under stricter health and
safety control 06-Feb-2009
Sweden
Mercury and articles that contain mercury
will be banned 27-Jan-2009
Regulation (SFS 2006:311) on transport of
dangerous goods amended 09-Dec-2009
Taiwan
Recycling of pharmaceuticals’ containers re‑
quired 13-Jan-2009
Thailand
Act on liability for damages caused by unsafe
products published 13-Feb-2008 Ukraine
Chemicals (Hazard Information and Packag‑
ing for Supply) Regulations 2002 will be re‑
placed.
80 Journal Chemicals Management April 2009, No. 3
publications
publications
BOOK REVIEW
Fundamental principles of
occupational health and safety.
2nd edition
[2009/0070]
Part of the executive summary:
Occupational safety and health: A global
perspective
Around 270 million people in the world fall
victim to occupational injuries, fatal and non-
fatal every year. A recent International Labour
Organization (ILO) report estimates that ap‑
proximately 2 million occupational fatalities
occur across the world annually. The social
and economic cost to the workplace as well as
to individuals is considerable.
Occupational injuries and accidents are all
caused by preventable factors which could be
eliminated by implementing measures and
methods that already exist. Many industrial
countries have extensive and comprehensive
systems of occupational safety and health
(OSH) management, and this is demonstrat‑
ed by consistently reduced accident rates. An
increasing proportion of occupational inju‑
ries in the world are occurring in developing
countries. A factory worker in Pakistan, for
example, is eight times more likely to be killed
at work than a factory worker in France. The
degree of protection against occupational haz‑
ards varies not only by nation but also by eco‑
nomic sector and size of the enterprise. The
highest rates of occupational accidents occur
in agriculture, forestry, mining and construc‑
Sdu Uitgevers
publications
tion, and generally, small enterprises have a
worse safety record than large ones. The eco‑
nomic costs of these injuries and deaths are
colossal and involve individuals, enterprises
and nations and indeed the entire world. Tak‑
ing into account compensation, lost working
time, interruption of production, training
and retraining, medical expenses, and so on,
estimates of these losses are routinely put at
roughly 4 per cent of global GNP every year,
and possibly much more.
Nobody is completely unaffected by occupa‑
tional hazards and accidents. In addition to
the available traditional measures and meth‑
ods to protect workers, good OSH systems are
those that constantly update their mechanisms
to account for new risks and hazards that ap‑
pear in the workplace. Over the last decade,
the scope, direction and magnitude of OSH
have evolved significantly both at national
and international levels.
Why are there constant shifts in the nature
of hazards, affected populations and people’s
perception of occupational safety and health?
Are there different ways in which the topic of
OSH is being perceived by national and in‑
ternational bodies and different mechanisms
and methods of prevention? How is the ILO
addressing these changes? Fundamental prin-
ciples of occupational health and safety brings
together comprehensive knowledge and facts
on the subject at national, enterprise and glo‑
bal levels. The first edition has been expand‑
ed and updated to include recent workplace
concerns and advances. This second edition
introduces new ILO instruments promot‑
ing OSH and details national OSH policies
and their implementation, as well as opera‑
tional methods. It is written with the goal of
addressing existing and emerging issues and
concerns, such as HIV/AIDS and the world
of work, and many other important develop‑
ments in the field of OSH, both within and
outside the ILO.
Sdu Uitgevers
Globalization and OSH
One of the most recent phenomena affecting
workers is globalization of the world’s econo‑
mies. Its repercussions have been perceived as
the greatest force for change in the world of
work, and consequently in the scope of occu‑
pational safety and health, in both positive and
negative ways. Liberalization of world trade,
rapid technological progress, significant de‑
velopments in transport and communication,
shifting patterns of employment, changes in
work organization practices, the different em‑
ployment patterns of men and women, and
the size, structure and life cycles of enterprises
and of new technologies can all generate new
types and patterns of hazards, exposures and
risks. Demographic changes and population
movements and the consequent pressures on
the global environment can also affect safety
and health in the world of work.
Promotional framework for OSH
Convention
A recent development in the field of OSH is the
adoption of the Promotional Framework for
Occupational Safety and Health Convention
(No. 187) and its accompanying Recommen‑
dation (No. 197) by the International Labour
Conference in 2006. This book recognizes the
purpose of this Convention as being the in‑
tegration of the ILO’s fundamental strategies
to promote the continuous improvement of
OSH. The content of the Convention, pro‑
motional rather than prescriptive, highlights
two complementary strategies, namely the
development and maintenance of a preventive
safety and health culture, and the application
at the national level of a systems management
approach to occupational safety and health.
National policy frameworks
Another development presented in the book is
the changing focus of national policy frame‑
works that countries design and implement to
prevent occupational accidents and diseases.
In the past, many of these frameworks were
Journaal Stoffen en Preparaten april 2009, Nr. 3 81

hampered by fragmented ideals and organi‑
zation and could not keep up with the shift‑
ing demands of the world of work, therefore
having little impact. Traditional strategies
and methods for prevention and control need
radical updating to respond effectively to the
fast and continuous changes in the workplace.
In addition, there is a perpetual need to train
new generations of workers as they replace re‑
tiring ones. Mechanisms and strategies must
therefore be developed to always keep occu‑
pational safety and health at the forefront of
national and enterprise priorities. Convention
No. 187’s focus on not only the development
but also the maintenance of OSH culture ad‑
dresses this need.
OSH management systems
The book expands on the OSH management
systems which help companies accept and
administer the building and maintenance of
a culture of health and safety as their prime
responsibility. The new edition offers samples
of how a comprehensive evaluation system
would include baseline evaluations, auditing,
self-inspection and self-correction, incident
investigation, medical surveillance and man‑
agement review activities.
Chemical safety
This edition also includes a new section on
international chemical safety. Amid grow‑
ing concerns for human and environmental
health, the prevention of exposure to haz‑
ardous chemicals in the workplace is a major
focus of occupational safety and health. In‑
ternational Chemical Safety Cards (ICSCs),
designed to serve as an international reference
for chemical safety information, summarize
essential safety and health information on
chemical substances in a clear way and are
intended for use at the shop-floor level by
workers and by those responsible for work‑
place safety and health. In recent years, small
and medium-sized enterprises especially in
emerging economies are increasingly rely‑
82 Journal Chemicals Management April 2009, No. 3
publications
ing on chemical production and use. In these
settings, access to people with experience in
assessing and controlling exposure to chemi‑
cals is limited. Therefore, a new approach to
the control of chemicals, control banding, has
been developed. It is a complementary ap‑
proach to protecting workers’ health by focus‑
ing resources on exposure controls and bands
chemicals in different groups according to
their dustiness/volatility. This method forms
the basis of the ILO’s International Chemical
Control Toolkit (ICCT).
Conclusion
This book aims to serve as a guide or reference
for the development of OSH policies and pro‑
grammes, including those devoted specifically
to HIV/AIDS. It covers the fundamental prin‑
ciples of occupational safety and health, based
on the ILO’s philosophy of prevention and
protection, which stems from the Organiza‑
tion’s mandate in the field. The Conventions,
Recommendations and codes of practice that
make up the set of “core” ILO instruments on
OSH embody all the principles, provisions
and technical guidance necessary to establish,
implement and manage OSH systems. They
are presented in this edition in a form that will
be useful for those involved in policymaking
(governments, and employers’ and workers’
organizations), those within enterprises who
are concerned with the practical implemen‑
tation of measures to promote and protect
the safety and health of workers (managers,
supervisors, workers’ representatives), legisla‑
tors and labour inspectors as well as academic
institutions.
Reference: Benjamin O. Alli:Fundamental principles
of occupational health and safety, 2nd ed.,
2008,ISBN 978-92-2-120454-1.
http://www.ilo.org/global/What_we_do/
Publications/ILOBookstore/Orderonline/
Books/lang--en/WCMS_093550/index.htm
Sdu Uitgevers
publications
PROCEEDINGS
REACH and GHS – VCI-Seminar
[2009/0071]
REACH and GHS – VCI-Seminar 2-3 March
2009 in Frankfurt a.M., Germany
(in German).
Reference: https://extranet.vci.de/reach/Veranstaltun‑
gen/Seiten/REACH_und_GHS–VCI-Infor‑
mationsveranstaltung_vom_2_3_Maerz.
aspx
INTERNET
United Kingdom: Risk
management of carbon nanotubes
[2009/0072]
This information sheet of the U.K. Health
and Safety Executive is specifically about the
manufacture and manipulation of carbon
nanotubes (CNTs) and has been prepared in
response to emerging evidence about the toxi‑
cology of these materials.
Carbon nanotubes (CNTs) are molecular-
scale manufactured forms of carbon. There
are two general groups: single-walled (SWC‑
NTs); and multi-walled (MWCNTs).
CNTs can differ in terms of chemical compo‑
sition. They may be pure carbon or contain
metals or other materials. They can be sixty
times stronger than steel, yet six times lighter.
CNTs have chemical, physical and bioactive
characteristics of considerable research and
commercial interest.
There has been much discussion about the
similarities between CNTs and asbestos within
the scientific and regulatory community. This
is because some CNTs are similar in shape to
asbestos fibres; and similar in their ability to
persist in the lungs of laboratory animals.
Sdu Uitgevers
However, the risk management principles
detailed in this information sheet are equally
applicable to other nanodimensioned bio-
persistent fibres with a similar aspect ratio.
Reference: http://www.hse.gov.uk/pubns/web38.
pdf?ebul=hsegen/09-mar-2009&cr=9
U.S. Army Corps of Engineers
Publishes New Safety Manual
[2009/0073]
The U.S. Army Corps of Engineers (USACE)
has published an updated version of their
‘Safety and Health Requirements Manual
(EM385-1-1)’. The 1050 page book is used
during construction, operations, mainte‑
nance, and research projects conducted by
the USACE. The manual was last revised in
2003, the 2008 version parallels OSHA regu‑
lations for general industry and construction
as well as including guidance based on other
national standards. The guidelines included in
the manual only deviate from these standards
when research and/or accident experience
deem it necessary.
Reference: http://federalconstruction.phslegal.com/
uploads/file/EM-385-1-1_2008(1).pdf
Toxipedia and WLT
[2009/0074]
Toxipedia has won the right to manage the
National Library of Medicine’s World Library
of Toxicology (WLT). The WLT is a reposi‑
tory of public health links from over 40 coun‑
tries. In collaboration with the International
Union of Toxicology, and with financial sup‑
port from the National Library of Medicine,
Toxipedia will manage the WLT, strengthen its
content, increase the number of participating
countries, and expand its focus to highlight
Journaal Stoffen en Preparaten april 2009, Nr. 3 83
 official publications

issues of environmental and public health sig‑

nificance to these countries.
Reference: http://www.toxipedia.org/wiki/display/
official
toxipedia/Toxipedia
publications

The Netherlands (Period January-

February 2009)

[2009/0075]

Tractatenblad 2009, 6: Europees Verdrag in‑

zake het internationale vervoer van gevaarlijke
goederen over de binnenwateren (ADN)

Staatscourant 2009 nr. 15 23 januari 2009:

Bekendmaking van de Minister van Volks‑
gezondheid, Welzijn en Sport van 15 januari
2009, nr. VGP/PSL 2906757, houdende be‑
kendmaking van de implementatie van richt‑
lijn 2008/47/EG, betreffende aerosols
Staatscourant 2009 nr. 18 28 januari 2009:
Besluit van ..., tot wijziging van het Uitvoe‑
ringsbesluit EG-verordening PRTR en PRTR-
protocol en enkele andere besluiten met het
oog op integratie van verplichtingen op het
terrein van milieuverslaglegging
Staatscourant 2009 nr. 27 10 februari 2009:
Wijziging Beleidsregel arbocatalogi in verband
met toevoegen enkele nieuwe arbocatalogi
Staatscourant 2009 nr. 41 2 maart 2009:
Ontwerpbesluit houdende wijziging van het
Besluit algemene regels voor inrichtingen mi‑
lieubeheer (nieuwe activiteiten in en repara‑
ties van het Besluit algemene regels voor in‑
richtingen milieubeheer)
Staatscourant 2009 nr. 41 2 maart 2009:
Ontwerpregeling houdende wijziging van de
Regeling algemene regels voor inrichtingen
milieubeheer

84 Journal Chemicals Management April 2009, No. 3 Sdu Uitgevers

official publications
Belgium (Period February 2009)
[2009/0076]
Staatsblad 11 februari 2009: ADR in voege
op 1 januari 2009. Europees Verdrag betref‑
fende het internationaal vervoer van gevaar‑
lijke goederen over de weg
Staatsblad 17 februari 2009: Besluit van de
Vlaamse Regering van 16 januari 2009 tot wij‑
ziging van het besluit van de Vlaamse Rege‑
ring van 1 juni 1995 houdende algemene en
sectorale bepalingen inzake milieuhygiëne
[Artikel 1. Aan deel 2 van het besluit van de Vlaamse Rege‑
ring van 1 juni 1995 houdende algemene en sectorale be‑
palingen inzake milieuhygiëne, het laatst gewijzigd bij het
besluit van de Vlaamse Regering van 19 september 2008,
wordt een hoofdstuk 2.13 toegevoegd, dat luidt als volgt:
Hoofdstuk 2.13. Beleidstaken voor de beperking van het
gebruik van perfluoroctaansulfonaten ]
Staatsblad 9 maart 2009: Koninklijk besluit
van 9 februari 2009 tot wijziging van het ko‑
ninklijk besluit van 15 oktober 1997 betref‑
fende cosmetica
United Kingdom (Period January-
February 2009)
[2009/0077]
UK Policy & REACH
The UK Government policy for identifying
and managing risks arising from chemicals
and their use, is developed and publicised by
the Department for Environment, Food and
Rural Affairs (DEFRA). Neither the main page
of the DEFRA website that provides links to
policy information; nor any of the sub pages
that give guidance on UK, EU and internation‑
al chemicals policy or specific chemical issues
have been updated since May/June last year.
However the sub page for REACH was revised
0n 17 February 2009 with updated guidance
for the status of recovered waste substances,
and contains recently revised links to consul‑
Sdu Uitgevers
tation documents (ECHA) on the first draft
recommendation for priority substances for
authorisation and guidance for the formation
of industry Substance Information Exchange
Fora (SIEFs).
References: http://www.defra.gov.uk/environment/
chemicals/index.htm
http://www.defra.gov.uk/environment/
chemicals/reach/index.htm
CHIP 4
A consultation on proposals to revise the UK
regulations that implement the packaging and
labelling requirements of the DSD and DPD to
bring them into line with the new the Europe‑
an Regulation on the Classification, Labelling
and Packaging of Substances and Mixtures,
(Regulation (EC) No. 1272/2008), known as
the CLP Regulation. Has closed (13 Febru‑
ary 2009). The CLP Regulation adopts in the
European Union, the internationally agreed
Global Harmonised System on the classifica‑
tion and labelling of chemicals, known as the
‘GHS’. The implementing UK regulation will
be known as Chemical (Hazard Information
and Packaging for Supply) Regulations 2009
or CHIP 4.
The proposed amendments are required to al‑
low CHIP to be aligned with the transitional
period of the CLP Regulation and to ensure
that the provisions of the CLP Regulation can
be enforced in Great Britain, both throughout
the transitional period and beyond.
The Health & Safety Executive has developed
a web page for GHS;and has set out the next
steps in the program of work required or ex‑
pected (from the UK perspective) under CLP
as a “legislative dossier under implementa‑
tion”.
References: http://www.hse.gov.uk/ghs/index.htm
http://www.hse.gov.uk/aboutus/europe/
euronews/dossiers/ghs.htm
Journaal Stoffen en Preparaten april 2009, Nr. 3 85

European Union (Period February
2009)
[2009/0078]
O.J. 2009, L36: Commission Directive 2009/6/
EC of 4 February 2009 amending Council
Directive 76/768/EEC, concerning cosmetic
products, for the purpose of adapting Annexes
II and III thereto to technical progress
O.J. 2009, L36: Corrigendum to Regulation
(EC) No 1907/2006 of the European Parlia‑
ment and of the Council of 18 December
2006 concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals
(REACH), establishing a European Chemi‑
cals Agency, amending Directive 1999/45/EC
and repealing Council Regulation (EEC) No
793/93 and Commission Regulation (EC) No
1488/94 as well as Council Directive 76/769/
EEC and Commission Directives 91/155/EEC,
93/67/EEC, 93/105/EC and 2000/21/EC
[See also JSP 2009/2, page 44]
O.J. 2009, L46: Commission Regulation (EC)
No 134/2009 of 16 February 2009 amending
Regulation (EC) No 1907/2006 of the Euro‑
pean Parliament and of the Council on the
Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH) as regards
Annex XI
O.J. 2009, C38E: Common Position (EC) No
3/2009 of 20 November 2008 adopted by the
Council, acting in accordance with the pro‑
cedure referred to in Article 251 of the Treaty
establishing the European Community, with
a view to the adoption of a Regulation of the
European Parliament and of the Council con‑
cerning statistics on plant protection prod‑
ucts
O.J. 2009, L48: Commission Directive
2009/11/EC of 18 February 2009 amend‑
ing Council Directive 91/414/EEC to include
bensulfuron [CAS 83055-99-6], sodium 5-ni‑
troguaiacolate [CAS 67233-85-6], sodium
o-nitrophenolate [CAS 824-39-5], sodium
p-nitrophenolate [CAS 824-78-2] and te‑
86 Journal Chemicals Management April 2009, No. 3
official publications
bufenpyrad [CAS 119168-77-3] as active sub‑
stances
O.J. 2009, L49: Corrigendum to Council
Regulation (EC) No 1167/2008 of 24 Octo‑
ber 2008 amending and updating Regulation
(EC) No 1334/2000 setting up a Community
regime for the control of exports of dual-use
items and technology
O.J. 2009, L56: Council Decision 2009/166/
EC of 27 November 2008 concerning the
conclusion of the Agreement between the Eu‑
ropean Community and the Government of
the People’s Republic of China on drug pre‑
cursors and substances frequently used in the
illicit manufacture of narcotic drugs or psy‑
chotropic substances. Agreement between the
European Community and the Government
of the People’s Republic of China on drug
precursors and substances frequently used in
the illicit manufacture of narcotic drugs or
psychotropic substances
[contains list of drug precursors]
USA (Period February 2009)
[2009/0079]
Federal Register, Vol. 74, No. 23, February
5, 2009, 6154: Draft Toxicological Review of
Halogenated Platinum Salts and Platinum
Compounds: In Support of the Summary
Information in the Integrated Risk Informa‑
tion System (IRIS). Environmental Protection
Agency (EPA). Notice of public comment pe‑
riod.
Federal Register, Vol. 74, No. 30, February 17,
2009, 7450: Phonetic Orthographic Compu‑
ter Analysis Software Program for Review of
Proprietary Drug and Biologic Names; Avail‑
ability. Food and Drug Administration, HHS.
Notice.
[The Food and Drug Administration (FDA) is announc‑
ing the availability of the source code and supporting
technical documentation for the Phonetic Orthographic
Computer Analysis (POCA) software program. POCA is
Sdu Uitgevers
official publications

an analytic tool designed to help identify drug and bio‑ termines that it is not technologically feasible to have this
logic names and medical terminology that are phonetically lower limit. Paint, coatings, or electroplating may not be
and orthographically similar to one another. POCA is one considered a barrier that would make the lead content of
analytic tool that FDA uses to review proposed proprietary a product inaccessible to a child or prevent the absorption
drug and biologic names.] of any lead in the human body through normal and rea‑
Federal Register, Vol. 74, No. 30, Febru- sonably foreseeable use and abuse of the product.]
ary 17, 2009, 7386: Schedules of Controlled
Substances: Placement of Tapentadol [CAS
175591-23-8] Into Schedule II. Drug Enforce‑
ment Administration, Department of Justice.
Notice of proposed rulemaking.
[Tapentadol has dual modes of action namely, mu (�������
�����
) opi‑
oid receptor agonistic action and inhibition of reuptake
of norepinephrine at the norepinephrine transporter.
The chemical name of its monohydrochloride salt form
is 3- [(1R,2R)-3-(dimethylamino)-1-ethyl-2- methylpro‑
pyl]phenol hydrochloride.]
Federal Register, Vol. 74, No. 34, February
23, 2009, 8106: In the Matter of Certain R–
134a Coolant (Otherwise Known as 1,1,1,2–
Tetrafluoroethane [CAS 811-97-2]); Enforce‑
ment Proceeding; Order. International Trade
Commission.
Federal Register, Vol. 74, No. 37, February
26, 2009, 8781: Tracking Labels for Children’s
Products Under Section 103 of the Consumer
Product Safety Improvement Act; Notice of
Inquiry; Request for Comments and Informa‑
tion. Consumer Product Safety Commission.
Federal Register, Vol. 74, No. 46, March 11,
2009, 10475: Children’s Products Containing
Lead; Final Rule; Procedures and Require‑
ments for a Commission Determination or
Exclusion. Consumer Product Safety Com‑
mission. Final rule.
[The Consumer Product Safety Improvement Act (CP‑
SIA) establishes specific limits on lead in children’s prod‑
ucts. Section 101(a) of the CPSIA provides that after
10 February 2009, products designed or intended prima‑
rily for children 12 years of age or younger may not con‑
tain more than 600 ppm of lead by weight for any part of
the product. After 14 August 2009, products designed or
intended primarily for children 12 years of age or younger
cannot contain more than 300 ppm of lead by weight for
any part of the product. On 14 August 2011, the limit will
be further reduced to 100 ppm unless the Commission de‑

Sdu Uitgevers Journaal Stoffen en Preparaten april 2009, Nr. 3 87

 Colofon
CALENDAR OF EVENTS &
IMPORTANT DATA Redactiesecretariaat
Sdu Uitgevers Tel. (070) 378 92 31
Postbus 20025 www.sdu.nl/service
[2009/0080] 2500 EA Den Haag

17 June 2009 Hoofdredactie:

Conference on EU and world-wide rules
for classification, labelling and packaging
of chemicals
Brussels, Belgium
Organised by the European Commission
The event is planned to be webstreamed
live.
Info: http://ec.europa.eu/enterprise/
reach/information/events/in‑
dex_en.htm
Drs. A.C.H. van Peski
Redactie:
Mw. dr. M.M. Kops-Werkhoven
Drs. H.A.F. van Well
Dr. J.A.S.J. Razenberg
Drs. J. Zawierko
Uitgever:
Drs. A. van Dijk
Abonnementen:
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site, een e-mail nieuwsbrief en een tijdschrift. Op de site vindt u artikelen
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© Sdu Uitgevers 2009

Alle rechten voorbehouden. Niets uit deze uitgave mag worden verveel‑
voudigd, opgeslagen in een geautomatiseerd gegevensbestand, of openbaar
gemaakt, in enige vorm of op enige wijze, hetzij elektronisch, mechanisch,
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Voorzover het maken van kopieën uit deze uitgave is toegestaan op grond
van artikel 16b Auteurswet 1912 jo het Besluit van 20 juni 1974, Stb. 351,
zoals laatstelijk gewijzigd bij het Besluit van 22 december 1997, Stb. 764 en
artikel 17 Auteurswet 1912, dient men de daarvoor wettelijk verschuldigde
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dient ment zich tot de uitgever te wenden. Hoewel bij de samenstelling van
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en uitgever deswege geen aansprakelijkheid.

Citeertitel
Journaal Stoffen en Preparaten jaartal/nummer
(voorbeeld: Journaal Stoffen en Preparaten 2009/1)

ISSN 1574-1079
Journal
Chemicals
Management
Journaal
Stoffen & Preparaten
Chief-editor:
Drs. A.C.H. van Peski
Editorial Board:
Dr. M.M. Kops-Werkhoven
Drs. H.A.F. van Well
Dr. J.A.S.J. Razenberg
Dr. L.J.M. Rodenburg
Drs. G.A. Schouten
Drs. J. Zawierko
Advisory Board:
K. E. Armstrong (U.S.A.)
Dr. R. Fielding (United Kingdom)
Drs. A. Gondová (The Netherlands)
G. Koh (Singapore)
Dr. C. van Lint (Australia)
Dan Liu (U.S.A.)
S. Park (S.-Korea)
H. Sano (Japan)
S. Savary (Canada)
Dr. U. Schumacher (China)
C. Sieger (Germany)
J. Simpson (Australia)
E. Snyman (South Africa)
P.G. Tse (New Zealand)
No. 4
May 2009
Volume 6
Part of Stoffennieuws.nl
Content
ARTICLES
[2009/0081] ChemCon Asia Conference 2009: a summary
on GHS implementation / 91
Actualities
European Union
[2009/0082] Health Council of The Netherlands Reports
(Period August-December 2008) / 101
[2009/0083] 1st ATP to CLP / 103
[2009/0084] ECHA Publishes an Updated List of
Pre-Registered Substances / 103
[2009/0085] ETUC earmarks priority chemicals for
REACH authorisation / 104
[2009/0086] PINFA: new Cefic Sector Group / 105
International
[2009/0087] The U.S. Environmental Protection Agency’s
Strategic Plan for Evaluating the Toxicity of
Chemicals / 105
[2009/0088] OECD Guidance Manual for the Control of
Transboundary Movements of Recoverable
Wastes / 106
[2009/0089] Australia: GHS and SUSDP / 106
[2009/0090] Singapore: Strategic Goods (Control) Order
2009 / 108
PUBLICATIONS
[2009/0091] Acute systemic toxicity determination / 109
OFFICIAL PUBLICATIONS
[2009/0092] The Netherlands (Period March 2009) / 110
[2009/0093] Belgium (Period March 2009) / 111
[2009/0094] United Kingdom (Period March 2009) / 112
 content

[2009/0095] European Union (Period March 2009) / 113

[2009/0096] USA (Period March 2009) / 114

[2009/0097] CALENDAR OF EVENTS AND IMPORTANT DATA / 116

90 Journal Chemicals Management May 2009, No. 4 Sdu Uitgevers

articles
articles
ChemCon Asia
Conference 2009:
a summary on GHS
implementation
[2009/0081]
by Henk van Peski
ChemCon Conferences was initiated in 1996
to serve the chemical sector as a regular event
dealing with issues of regulatory affairs. Legal
compliance of chemical substances and prod-
ucts in a worldwide market is a great chal-
lenge. So this platform was created to enable
an exchange of experience, hear and discuss
political views and opinions as well as legal in-
terpretations between the authorities and the
companies. After establishing the conference
on a biannual basis in Europe (since 1996)
and the Asian branch (since 2003) an Ameri-
cas branch was created (since 2007). For many
years already an exhibition is accompanying
the Conferences, enabling the regulatory af-
fair managers of the chemical sector to get
in touch with companies offering services to
the chemical sector like Contract Research
Organisations and IT compliance solution
providers and to get an easy overview of the
different services offered.
Today ChemCon as such is said to be the
world’s leading global conference series in
the field of chemical control regulation that
brings together hundreds of experts of com-
petent authorities, international organizations
Sdu Uitgevers
and institutions as well as company and scien-
tific experts, lawyer and politicians to discuss
chemical control legislation around the globe
with the overall aim of harmonisation in clas-
sification, labelling and risk communication
to secure high and harmonised standards for
environment, health and safety for all related
to handling chemical substances, preparations
or products.
Accordingly ChemCon Conferences cover a
variety of aspects of international chemical
control around the globe with a focus on new
chemicals’ notification, chemical inventories,
existing chemicals’ assessment, classifica-
tion and labelling, hazard communication,
product registration and risk assessment. In
addition several seminars or workshops ac-
companying the conference sessions (on the
pre-conference day) detailed training on spe-
cific issues is offered.
This year ChemCon ASIA 2009 was held in
Kuala Lumpur, Malaysia from 2-6 March, with
around 120 participants from 24 countries. It
is without saying, that the main topics were
GHS and REACH, with a special focus onto
the Asian-Pacific region.
The next ChemCon EUROPE will be in spring
2009 and the next ChemCon The Americas in
fall 2009.
Reference: Proceedings ChemCon Asia 2009 Confe-
rence, Kuala Lumpur, Malaysia,
2-6 March 2009.
www.chemcon.net
Drs. A.C.H. (Henk) van Peski has retired in November 2004
after a career spanning over 45 years with the photographic
industry. His latest position was Director Environmental,
Health and Safety Affairs Eu/Af/As/Au of Kodak Polychrome
Graphics, Bunschoten, The Netherlands. He is now an inde-
pendant consultant. Clients are ChemWatch, Caulfield, Vic.,
Australia, GBK Gefahrgut Büro GmbH,Ingelheim, Germany
and TetraQ, Brisbane, Australia. He is adjunct-professor at
the CIPDD/School of Pharmacy, University of Queensland,
Australia.]
Journaal Stoffen en Preparaten mei 2009, Nr. 4 91

Malaysia
Two lectures were presented on the guest
country Malaysia, one by Dato’ lr. Dr. Johari
Bin Basri of the Department of Occupational
Safety and Health (DOSH) on Malaysian Oc-
cupational Safety and Health Regulations
updates and aspects of GHS, a second one by
Hanili Ghazali and Lee Heng Keng of the De-
partment of Environment (DOE) on Sched-
uled Waste Regulations and Environmentally
Hazardous Substances Notification and Reg-
istration Scheme.
The adoption of the Globally Harmonised
System on chemical classification and label-
ling (GHS) is underway in Malaysia. A draft
set of the Occupational Safety & Health
(Chemicals Classification, Labelling and Safe-
ty Data Sheet) Regulations 20xx (or CLASS
Regulations, in short) is being promulgated.
When CLASS Regulations is finally gazetted,
it will replace the existing Occupational Safety
and Health (Classification, Packaging and La-
belling of Hazardous Chemicals) Regulations
1997. The building block approach adopted in
the CLASS Regulations is similar to the EU‘s
proposal. This regulation is applicable only to
chemical products supplied to a place of work.
It stipulates the duty of formulator, manufac-
turer and importer to classify chemicals. To
complement the regulation, the Director Gen-
eral of DOSH will issue a technical specifica-
tion on chemical classification, labelling and
formulation of Safety Data Sheet that includes
a list of classified substances. It is anticipated
that the CLASS Regulations will be gazetted
by 2010 and be implemented in stages. A grace
period of one year from the gazette date will
be given for substances, and three years for
mixtures. Chemicals for trial purposes not ex-
ceeding five litres are exempted from the regu-
lation. The size of the label is not specified by
the CLASS Regulations, but the size of hazard
pictograms is. A supplier has to maintain a
chemical inventory that need to be submitted
to DOSH on an annual basis.
92 Journal Chemicals Management May 2009, No. 4
 
articles
The Malaysian standard on GHS was finalised
by the Malaysian Standards Committee and
is currently awaiting approval by the Minis-
ter. This standard has been developed based
on the second revised edition of the Purple
Book.
References: www.doe.gov.my
Japan
As a part of the lecture on ‘Revision of Chem-
icals Legislation in Japan’ Michihiro Oi and
Eisaku Toda of the Ministry of the Environ-
ment also presented an update of the Japanese
progress in implementing GHS.
The Government of Japan started a number
of activities to implement GHS in the chemi-
cal management system, starting with the
amendment to the Industrial Safety and
Health Law in 2005-2006 and publication of
Japan Industrial Standard (JIS) Z 7250 in 2005
in line with GHS with a transitional period up
to the end of 2010, in which the MSDS in the
former JIS format remains valid. In 2006 JIS
Z 7251 on labelling was introduced. A draft
new JIS for classification according to GHS
2nd revised edition will be ready in FY 2008
(Z XXXX-2009).
One of the activities was a project jointly un-
dertaken by the Ministry of Agriculture, For-
estry and Fishery, Ministry of Health, Labour
and Welfare, Ministry of Economy, Trade and
Industry, and the Ministry of the Environ-
ment, to publish a harmonized classification
of 1424 substances using the GHS criteria. The
aim of this project is to assist industry in pro-
viding safety data sheets (MSDS) in line with
GHS. MSDSs are required for approximately
1500 chemicals which are regulated under the
Industrial Health and Safety Law, the Poison-
ous and Deleterious Substances Control Law,
and the Chemical Management Law.
In order to do this, these ministries first pub-
lished a manual describing the priorities of
data sources and providing guidance on how
to interpret this data for classification pur-
poses. Using the results of this project is not
Sdu Uitgevers
articles
compulsory; industry may use their own data
to classify chemicals on the basis of their own
judgments.
References: http://www.safe.nite.go.jp/english/ghs_
index.html
http://www.meti.go.jp/policy/chemical_
management/int/ghs.html
P.R. of China
Two lectures were dealing with chemicals
management in the P.R. of China, one on
Chemicals Control Legislation and aspects of
GHS by Zhang Aitong of the China Chamber
of Commerce of Metals, Minerals & Chemi-
cals Importers & Exporters (CCCMC), and
one on the new Chemical Notification System
of CRC-MEP by Andrew Burgess of LSR As-
sociates.
CCCMC – with a membership of more than
4,700 companies – acts as a bridge between
government and enterprises. It was founded
in Beijing in 1988 and was named as REACH
Consultancy Centre of the Ministry of Com-
merce in 2008. CCCMC Europe in Helsinki,
Finland was set up in 2008 and acts as Only
Representative for Chinese manufacturers.
Current developments and Government’s
planning for GHS in China:
– Ministry of Environmental Protection
In March 2008 the State Administration of
Environmental Protection (SAEP) was up-
graded to Ministry of Environmental Pro-
tection (MEP). The tasks of MEP are among
others to formulate and amend environmen-
tal protection regulations and standards con-
cerning chemicals in China; to be responsible
for the classification and implementation ac-
cording to the environmental hazard part of
GHS; to be involved in the development of
responding measures and related scientific re-
search, to provide environmental impact data
of chemicals; build and to improve relevant
laboratories. A current activity is the compari-
son of the GHS classification of imported and
exported toxic chemicals.
Sdu Uitgevers
MEP has tested new chemicals’ eco-toxicolo-
gy and assessed their environmental hazard,
built eco-toxicology testing institutes and
good laboratory practise testing (GLP) fa-
cilities, compiled a test manual for chemicals’
eco-toxi­cology as well as testing method of
chemicals by reference to the GHS require-
ments for aquatic environmental hazards and
the relevant technical guidance of OECD.
– AQSIQ
The State General Administration of the P.R. of
China for Quality Supervision and Inspection
and Quarantine (AQSIQ) is a law enforcement
administrative organ of the State Council in
the field of quality, metrology, entry-exit com-
modities inspection, entry-exit health quaran-
tine, entry-exit animal and plant quarantine,
certification and accreditation and standardi-
zation.
AQSIQ has begun to build key laboratories
in Tianjin, Shanghai and Guangdong Prov-
ince for the implementation of GHS and to
respond to REACH; established relevant data­
bases, websites and information platform of
chemical data.
Other departments, like the State Administra-
tion of Work Safety, the Ministry of Public
Health (MOH), the Ministry of Public Secu-
rity (MPS) and the Ministry of Communica-
tion (MOC) are actively participating in the
related work of GHS.
– GHS Standards
A series of Safety Rules for Classification and
Labelling of Chemicals, implementing GHS,
came into force on 1 January 2008. This series
of standards includes 16 types of physical haz-
ards and 10 types of health hazards. It has be-
come the basis for uniform classification and
labelling of chemicals and provides technical
guidance.
New Chemical Notifications
During the last six years, notifiers of new
chemical substances in the P.R. of China
have become familiar with the processes for
registering and exempting new chemical
Journaal Stoffen en Preparaten mei 2009, Nr. 4 93

substances. As notifiers and CRC-MEP both
gain experience with the regulations and fil-
ing processes, minor modifications have been
made to the implementing guideline bringing
efficiencies into both the application and re-
view processes.
The ‘New Chemical Substances Environmen-
tal Management Regulation’ became effective
in October 2003. The lead regulatory agency
is CRC-MEP (Chemical Registration Centre
of the Ministry of Environmental Protection).
An implementation guidance ‘Guidance for
New Chemical Substance Notification’ was is-
sued in October 2004.
The agency refers to four standards to guide
applicants in the registration process. The
first three were implemented on June 1,
2004. HJ/T 153-2004, ‘Guidelines for Test-
ing Chemical Products’ provides a standard-
ized testing approach of chemical products to
protect human health and the environment.
HJ/T 155-2004, ‘Guidelines for Conformance
with Good Laboratory Practices for Testing
of Chemical Products’ focuses on assuring
the accuracy and authenticity of test data on
chemical products. It also addresses standard-
izing quality control in laboratories that test
chemical products. HJ/T 154-2004, ‘Guide-
lines for Hazard Evaluation of New Chemical
Substances’ is the most useful guidance for
preparing chemical registration notifications.
This guideline standardizes the hazard evalu-
ation of new chemical substances to safeguard
health and to protect the environment. The
most recent guidance was issued by the MEP
(Ministry of Environmental Protection) on
April 1, 2008. HJ/ T 420-2008, ‘Guideline for
the Generic Naming of New Chemical Sub-
stances’ proposes to standardize the process
for assigning a generic name to a new chemi-
cal substance when the applicant requests
confidentiality. These guidelines are only
available in Chinese so care needs to be exer-
cised with working with a translation, to en-
sure that the original meaning is retained.
94 Journal Chemicals Management May 2009, No. 4
articles
References: www.cccmc.org.cn
http://english.mep.gov.cn
http://www.aqsiq.gov.cn
Taiwan
An overview on chemical control legisla-
tion and aspects of GHS in Taiwan (Taipei)
was given by Jowitt Z. Li and Jung-Pin Yu
of the Safety and Health Technology Centre
(SAHTECH), Hsinchu, Taiwan. SAHTECH
was founded in March 2007 and aims to be
a major player in the field of SH technology
and service in Far East and serves as techni-
cal supports of public agencies, promotes SH
technologies and helps customers with inter-
national standards. SAHTECH plays a major
role in amendment and promotion of the
globally harmonized system of classification
and labelling of chemicals (GHS), and UN
Strategic Approach to International Chemical
Management (SAICM) in Taiwan. A national
GHS inquiry centre, with the support from
the Council of Labour Affairs (CLA), was set
up to provide services to industry.
By 31 December 2008 the 3-year Interagency
GHS Implement Plan, led by the Council of
Labour Affairs, Executive Yuan (CLA), was
concluded by the first stage of implementa-
tion entering into force. This stage of imple-
mentation includes mandatory compliance
of 1062 hazard chemical substances and its
mixtures. In addition, after 2 years of stud-
ies and public hearing procedures, a national
chemical inventory program is at a pilot stage
to invite nomination. In 2008, the CLA has
drafted amendment in the Labour Safety and
Health Act to include new chemical notifica-
tion which has been lacking in Taiwan’s life­
cycle chemical management system.
GHS milestones:
30 October 2006: Published National Stand-
ard CNS 15030 Chemical Classification and
Labelling based on 2005 GHS 1st revised ver-
sion. Revised National Standard CNS 6864
Labels of Dangerous Materials based on 2005
14th edition of UNRTDG for transport
Sdu Uitgevers
articles
19 October 2006: CLA announced the amend-
ed regulation with new title ‘Regulation of
Labelling and Hazard Communication of
Dangerous and Harmful Materials’ adopting
GHS.
15 November 2007: 2nd interagency coor-
dination meeting of GHS implementation.
Determined the enforcement date of the first
stage implementation (CLA, EPA (Environ-
mental Protection Administration) and NFA
(National Fire Agency)). COA (Council of
Agriculture, Executive Yuan): plant protec-
tion agents) is pending on WHO and FAO’s
harmonization works. MOEA (Ministry of
Economic Affairs) will announce a labelling
guideline later in 2008 adopting GHS for
chemical consumer products. The need for
developing a national hazard chemical in-
ventory for future GHS implementation was
identified. CLA is taking the lead for develop-
ing a national chemical inventory.
19 December 2007: Executive Yuan approved
the implementation date of 31 December
2008. It will enter a transitional period from
1 January 2008 to convert from current sys-
tem to GHS.
29 December 2008: CNS 15030 standards have
been amended by the Bureau of Standards,
Metrology and Inspection, MOEA, to adopt
the GHS Purple Book 2007 2nd revised edi-
tion
31 December 2008: Regulations of CLA, EPA
and NFA enter into force to bringing in GHS
classifications, MSDS and labelling. CLA’s
‘Regulation of Labelling and Hazard Commu-
nication of Dangerous and Harmful Materi-
als’ (the Regulation) has entered into effect on
December 31st, 2008. The Regulation adopts
all GHS elements (except the environmental
aquatic hazard pictogram which is regulated
by the EPA) including classifications, label-
ling, MSDS/SDS, and mixture classifications.
With staged implementation approach, cur-
rent phase of mandatory compliance applies
to only 1,062 prioritized chemicals specified
by the CLA. Voluntary compliance beyond
Sdu Uitgevers
this 1,062 chemical list is also welcomed ac-
cording to the
CLA. GHS has become Taiwan’s common
standards in most chemical hazard commu-
nication schemes as recommended by the UN
Purple Book.
It should be noted that GHS has not been fully
adopted in agropesticide and chemical con-
sumer product due to the progress of interna-
tional harmonization work, i.e. World Health
Organization (WHO), UN Food and Agricul-
ture Organization (FAO) and others.
Reference: http://www.sahtech.org
http://ghs.myweb.hinet.net/EN_GHS/
Taiwan_2008_GHS_Implementation%20
Update.pdf
http://ghs.cla.gov.tw/en/index.php
The CLA list of 1062 prioritized hazardous
chemicals subject to GHS compliance by
31 December 2008: http://
www.cla.gov.tw/cgi-bin/Message/MM_
msg_control?mode=viewnews&ts=495847
69:1c6&theme=
South-Korea
The paper of OK-Sun Jung of Safe Chemi-
cals Co. Ltd., Australia introduced the three
new laws for the management of hazardous
chemicals, information on the change in the
new chemical notification system, and aspect
of Korean GHS. In South-Korea, six minis-
tries and an agency (Ministry of Environ-
ment (MOE), Ministry of Health, Welfare,
and Family Affairs (MOHWFA), Ministry of
Labour (MOL), National Emergency Man-
agement Agency (NEMA), Ministry of Know­
ledge Economy (MKE), Ministry of Food,
Agriculture, Forestry and Fisheries (MAFF),
and Ministry of Education, Science and Tech-
nology (MEST)) with their laws are involved
in managing chemicals to protect human
health or the environment from the hazard
of chemicals. Also, recently several laws have
been implemented for the adoption of the
international agreements such as Stockholm
Convention, Rotterdam Convention, GHS,
Journaal Stoffen en Preparaten mei 2009, Nr. 4 95

etc., and for the regulation of hazardous sub-
stances in consumer products.
Industrial Safety and Health Law (ISHL):
Subject to certain exceptions, before any new
chemical is manufactured or imported for
use at a workplace, the business owner of the
workplace must submit a ‘Hazard Danger
Review Report for New Chemical (i.e. new
chemical notification)’ to MOE (since 2006
all documents have to be submitted to the
National Institute of Environmental Research
(NIER),). MOE sends a copy to MOL for fur-
ther review. The manufacture or use of cer-
tain chemicals hazardous to workers’ health is
prohibited or requires approval by MOL. Ex-
amples are crocidolite (prohibited) and PCB
(requiring permit).
The GHS system was introduced with minor
differences among the regulations published
by three authorities: ‘Regulation on Classifica-
tion and Label of Toxic Chemicals, etc. (NIER
Notice No. 2008-26)’ under TCCL (Toxic
Chemicals Control Law), ‘Standards for Pre-
paring and Keeping on File the Material Safety
Data Sheet, etc. (MOL Notice No, 2008-29)’
under ISHL, and ‘Standard on Classification
and Label of Dangerous Substances (NEPA
Notice No. 2008-18)’ under DSML. However,
enforcement of GHS system under TCCL and
ISHL is delayed as follows:
TCCL: – Substances: 1 July 2011 – Mixtures:
1 July 2013
MOL: – Substances: 1 July 2010 – Mixtures:
1 July 2013
Before these dates both the present and GHS
system can be used. The GHS system of DSML
(Dangerous Material Management Law) has
been in force since 13 November 2008 for
Dangerous Substances classified under DSML
only. In case a warning label is attached in
accordance with one of the three laws men-
tioned, the warning label is admitted mutu-
ally under the three laws. However for ‘Toxic
Chemical’ designated under TCCL, the label
96 Journal Chemicals Management May 2009, No. 4
articles
must follow the form published by MOE.
NIER will publish this year the label forms
in accordance with ‘Regulation on Classifica-
tion and Label of Toxic Chemicals, etc. (NIER
Notice No. 2008-26)’ for all designated ‘Toxic
Chemicals’.
The Philippines
John H. Moore of Lubrizol Company and
Flordeliz Y. Guarin, reported on the develop-
ment of the chemicals management systems
in The Philippines. A December 2007 draft
Joint Administrative Order adopts the GHS
elements for labels and MSDSs. The Adoption
and Implementation of GHS defines the roles
of government authorities, specifies GHS for-
mat for labels and MSDSs, and allows claims
for confidential business information. The
Philippine Board of Investments (BOI) chairs
the National GHS Implementation Commit-
tee. The Department of Environment and
Natural Resources (DENR) – Environmental
Management Bureau (EMB) is the head of the
Subcommittee on Legislation which will un-
dertake the amendment of existing environ-
mental legislation relevant to GHS. National
trade association (chemical industry) has been
working closely with the BOI to pilot projects
in relation to GHS. Indications are that GHS
will be implemented in 2009 with a two year
transition period after publication.
Reference: http://www.emb.gov.ph/
Viet Nam
John H. Moore of Lubrizol Company report-
ed on the development of the chemicals man-
agement systems in the Socialist Republic of
Vietnam.
Vietnam has issued a new law on chemi-
cals (Reference: 2008/QH 12). This law will
provide regulations on the safe handling of
chemicals, obligations of organisations and
individuals engaged in chemical activities and
endorses that state management procedures
be put in place. It applies to all organisations
and individuals handling and engaged in ac-
Sdu Uitgevers
articles
tivities related to chemicals within Vietnam.
The chemical law was adopted on 1 July 2008.
Decree No. 108/2008/ND-CP of 7 October
2008, detailing and guiding the implementa-
tion of a number of articles of the Chemical
Law, was issued to provide guidelines for the
implementation of the Chemical Law.
Classification is in line with GHS and labelling
is according to the law and regulations on la-
belling of goods Decree Number 89/2006ND-
CP. Hazardous chemicals should be labelled
according to the law and regulations on la-
belling of goods. The labelling guidelines for
chemicals apply to domestic, imported and
exported goods. It applies to interior and ex-
terior packages but is not applicable to food-
stuffs. The intent is product identification,
selection and directions for use; the content
is the most critical, with list % – high to low;
name of manufacturer; import; weights/
measures; expiry date; storage conditions;
use instructions; quality, health and environ-
mental information must be included. For the
language, Vietnamese is mandatory but other
languages are allowed but must be in smaller
font. Export only chemicals may be labelled
in the language of the country of import. It
is understood that the revision of the Circu-
lar 12/2006/TT-CN for detailed guidance of
GHS implementation is still being worked on
by the government, with a view for adoption
during July 2009. However, the implementa-
tion guidelines, Decree No 108-2008/ND-CP,
contains no specific information on adop-
tion.
See also JSP 2008/04, item 2008/0098,
page 107.
Cambodia
A summary of chemical legislation of the
Kingdom of Cambodia was presented by
Karon E. Armstrong of 3M, U.S.A. The Royal
Government draft of the sub-decree on clas-
sification and labelling chemicals adopts the
principles of GHS, including label elements
and provisions for Safety Data Sheets. Chemi-
Sdu Uitgevers
cals or chemical consumer products must be
labelled and accompanied by a Safety Data
Sheet (all in Khmer language). There is no
date mentioned for implementation.
Reference: http://www2.unitar.org/cwm/publications/
cbl/ghs/Documents_2ed/E_GHS_Capaci-
ty_Building_Projects_and_Initiatives/487_
Cambodia_CT-report.pdf
Indonesia
A summary of chemical legislation of the Re-
public of Indonesia was presented by Karon E.
Armstrong of 3M, U.S.A. A draft ‘Presidential
Decree on Application of GHS Classification
and Labelling of Chemicals’ provides back-
ground, definitions and guidance to appli-
cability (industrial and consumer), elements
(classification, labelling with symbols, signal
words, hazard and precautionary phrases, and
SDS). While the stated date of GHS imple-
mentation is 2008, the draft makes continu-
ous reference to be ‘determined further in rel-
evant Ministerial Regulations.’
Reference: http://www.kn-rci.or.id/index.
php?page=static&id=29
Singapore
Again it was Karon E. Armstrong of 3M,
U.S.A., who informed the audience on Singa-
pore.
The Workplace Safety and Health (General
Provisions) Regulations 2006 mandates the
provision of SDS for hazardous substances,
and adopted the GHS SDS format.
SS 586 : 2008 Singapore Standard on the Haz-
ard Communication for Hazardous Chemi-
cals and Dangerous Goods was published
on 23 October 2008, providing guidelines on
Singapore’s Implementation of Globally Har-
monised System of Classification and Label-
ling of Chemicals (GHS) & Caution Labelling
for the Transport and Storage of Dangerous
Goods
SS 586 : 2008 is the result of the revision of SS
286 : 1984 on Caution Labelling for Hazard-
ous Substances (five parts) and CP 98 : 2003
Journaal Stoffen en Preparaten mei 2009, Nr. 4 97

on Preparation and Use of Material Safety
Data Sheets (MSDS).
Reference: http://www.spring.gov.sg/Content/Module-
Page.aspx?group=nw&id=a064e55c-b2dd-
44df-8ae1-81cc465b11e8
For ordering the standards set: http://
www.singaporestandardseshop.sg/package/
PackageView.aspx?id=14c06a79-5fdc-4015-
a320-73dc6dd96317
See also JSP 2008/10, item [2008/0215] on
page 262.
Thailand
Karon E. Armstrong of 3M, U.S.A. told in
her paper that Thailand implements GHS in
a stepwise manner. Phase I requires GHS la-
bel and SDS for single substances only from
July 2008. Informal information from the au-
thorities indicates that they will implement all
physical hazards and some health and envi-
ronment hazards in this first step. Phase II for
mixtures from 2009 at which time additional
hazard categories may be added.
India
S.K. Hazra of Aegis Logistics Ltd. (Mumbai)
brought us up-to-date with the Indian situa-
tion.
Under the Environmental Protection Act of
1986 (after the Bhopal disaster of 3 December
1984) several Chemical control legislations
have been formulated e.g. the Manufacture,
Storage and Im[port of Hazardous Chemicals
Rules 1989 (amended 2000), the Hazardous
Waste (Management and Handling Rule 1989,
in 2008 superseded by the Hazardous Waste
(Management, Handling and Transboundary
Movement Rules and the Chemical Accidents
(Emergency Planning, Preparedness and Re-
sponse) Rules 1996.
In the transportation sector, the Central Mo-
tor Vehicle Rules 1989 have been amended to
bring classification and packaging require-
ments mostly in tune with GHS.
98 Journal Chemicals Management May 2009, No. 4
articles
The Indian Railway Act and the Red Tariff
Rule (No. 20) are also being amended for haz-
ardous goods from time to time.
A specific legislation complying with GHS is
being worked on by Federal Government.
Russia/CIS
Prof. Alexander D. Kozlov of the Russian Sci-
entific and Technical Centre for Information
on Standardization, Metrology and Conform-
ity Assessment ‘Standartinform’ gave its pres-
entation on the existing Russian system of safe
handling of chemicals.
The Commonwealth of Independent States
Standard GOST CIS 30333-2007 ‘Chemical
production Safety Passport. General require-
ments’ (safety data sheets) and GOST CIS
31340-2007 ‘Labelling of chemicals. General
requirements’ are implementations of the UN
Purple Book recommendations. GOST CIS
30333-2007 complies with the REACH Regu-
lation Annex II. The CIS states are: Azerbai-
jan, Armenia, Belarus, Georgia, Kazakhstan,
Kyrgyzstan, Moldova, Russia, Tajikistan, Turk-
menistan, Uzbekistan and Ukraine.
Five Russian national GOST R Standards on
classification of chemicals will be approved
before the end of this year.
The Coordinating Informational Service
Centre for CIS Enterprises (CISC) offers:
(1) Consultations on the registration of sub-
stances at the European Chemical Agency and
(2) Consultation on the GHS recommenda-
tions (Establishment and Registration of SDS
(Passports of Safety); Hazardous classification
of products; Services for the product identifi-
cation (EC and CAS numbers); Labelling).
Reference: http://www.wereach.ru/en/index.html
Turkey, Israel, Saudi Arabia, Oman and
Pakistan
Tamar Szeps-Znaider of 3E provides a brief
country overview on some of the Middle East
states.
– Turkey: Before the final publication of
GHS, Turkey expressed interest in receiv-
Sdu Uitgevers
articles
ing assistance with GHS Capacity Build-
ing, but there has been no traceable devel-
opment toward GHS implementation in
Turkey since.
– Israel: There has been no official GHS
activity in Israel. However, a 2005 report
by the Israeli Institute for Occupational
Safety and Hygiene does mention that a
number of ministries were collaborating
on identifying the capacity for Israeli GHS
implementation through the identifica-
tion of existing national legislation.
– Saudi Arabia: Saudi Arabia has expressed
some interest in GHS, and participated in
the Regional Workshop on Chemical Haz-
ard Communication and GHS Implemen-
tation for Arab Countries (Alexandria,
Egypt, 2006).
– Oman: In terms of GHS activities, Oman
participated in the Regional Workshop on
Chemical Hazard Communication and
GHS Implementation for Arab Countries
(Alexandria, Egypt, 2006). Oman has also
expressed interest in Capacity Building as-
sistance from UNITAR/ILO.
– Pakistan: There has been no significant
movement on GHS in Pakistan. From
2006-2009 Pakistan has allegedly been
receiving capacity building advice from
UNITAR/ILO/SAICM, however, there are
no reports documenting this activity.
Australia
Marion J. Healy of the National Industrial
Chemicals Notification and Assessment
Scheme (NICNAS), Department of Health
and Ageing, informed us on industrial chemi-
cal control; and GHS in Australia.
Australia is considering the implications of
implementing of the GHS across workplace,
consumer and agricultural chemicals. In the
workplace sector, national standards and
codes of practice relating to the use of chemi-
cals in the workplace have been revised with
a view to consolidating the requirements for
workplace hazardous substances and dan-
Sdu Uitgevers
gerous goods into a combined standard. The
revised standard is also integrating the clas-
sification, labelling and safety data sheet re-
quirements of the hazardous substances and
dangerous goods frameworks, using guidance
from the GHS documentation. The revised
draft standard has been subject to public con-
sultation and a regulatory impact statement is
being developed. It is expected that the stand-
ard will be finalised in 2009 and the revised
standard will be integrated into the national
occupational health and safety framework,
which is currently under development. The
implementation timetable has yet to be devel-
oped and will be informed by arrangements
for implementation of the GHS in Australia’s
trading partners.
For agricultural and veterinary chemicals,
the Australian government is working with
stakeholders to consider the implications of
the GHS for Australia’s risk-based labelling
system for these chemicals. The impact on the
labelling requirements for consumer products
and poisons is also under consideration as
there are implications for the signal words and
precautionary statements currently used. The
considerations include the implementation
schedules of major trading partners.
New Zealand
From the introduction by John Frangos of
Toxikos Pty Ltd, Australia.
New Zealand was the first country to im-
plement a system of hazard classification
based on international agreements, in par-
ticular the original revision of the global
harmonised scheme for classifying chemicals
(GHS). The key dilemma for the regulators
was that HSNO (Hazardous Substances and
New Organisms) legislation was enacted in
1996 and the legislative process required the
regulations to be in place by 2001. Thus the
regulations produced in 2001 do have some
points of difference with the current GHS
(revision 2). However for practical purposes
the New Zealand system reflects the GHS clas-
Journaal Stoffen en Preparaten mei 2009, Nr. 4 99
 articles

sification criteria. The thresholds and classifi- mentation. (Mercosur full members: Argen-
cation schemes for explosiveness, flammability tina, Brazil, Paraguay, Uruguay, full member
and oxidising capacity are based on the Unit- pending ratification: Venezuela, associate
ed Nations Recommendations for the Trans- members: Bolivia, Chile, Colombia, Ecuador,
port of Dangerous Goods. New Zealand have Peru). Ecuador is accepting GHS labels, Ar-
adopted the lowest hazard classification cut- gentina MSDS guidelines meet the GHS lay-
offs available within the GHS (e.g. flashpoint out requirements.
of ≤ 93°C, acute oral LD50 of 5000 mg/kg).
There are differences in the GHS criteria for
ecotoxicity and those specified within the
HSNO regulations. A revision to align with
GHS 2007 is underway.
The HSNO legislation does not prescribe a
format for MSDS. However an approved code
of practice for preparing MSDS has recently
been approved by ERMA NZ. Since July 2008,
New Zealand specific information must be
provided on all MSDS supplied with any haz-
ardous substance in New Zealand. These man-
datory requirements include the New Zealand
supplier’s contact details, an emergency con-
tact number and the HSNO approval number
or title of the Group Standard, together with
the significant Controls.
New Zealand specific product labels for haz-
ardous substances are not required until
31 December 2010 if the product is covered by
a Group Standard and the labels comply with
the labelling requirements of Europe, Austral-
ia, USA or Canada. The New Zealand require-
ments for labelling include pictograms, signal
word, and hazard and precautionary state-
ments based on GHS, first revision 2005.

Latin America
Markus Flink of TechniData AG covered in his
presentation on Middle and South America
also the GHS implementation of that region.
In Brazil the SDS standard NBR 14725 is un-
der revision in order to implement the GHS
requirements (since December 2007. After its
official publication, the transition period will
be 18 months.
In cooperation with the German ‘Gesellschaft
für Technologische Zusammenarbeit’ the
Mercosur members are working on imple-

100 Journal Chemicals Management May 2009, No. 4 Sdu Uitgevers

actualities
actualities
European Union
Health Council of The
Netherlands Reports (Period
August-December 2008)
[2009/0082]
Gamma-butyrolactone (CAS 96-48-0).
Health-based recommended occupational
exposure limit
At request of the Minister of Social Affairs
and Employment, the Dutch expert Commit-
tee on Occupational Exposure Safety (DECOS),
one of the permanent committees of experts
of the Health Council, proposes health-based
recommended occupational exposure limits
for chemical substances in the air in the work-
place. These recommendations serve as basis in
setting legally binding occupational exposure
limits by the minister. In this advisory report,
the committee evaluates the consequences of
exposure to γ-butyrolactone (GBL), and de-
rives a health-based recommended occupa-
tional exposure limit (HBR-OEL).
In a first step the toxicity of the compound is
evaluated. This is done in cooperation with
the Nordic Expert Group for Criteria Docu-
mentation of Health Risks from Chemicals. The
results of the evaluation, which are published
in 2004, are included in part 2 of this advisory
report. In the first part, the DECOS describes
the most relevant data, supplied by newly pre-
sented data, and advices on an HBR-OEL. The
conclusions of the DECOS are based on scien-
tific papers published before April 2008.
The DECOS of the Health Council recom-
mends a health-based occupational exposure
Sdu Uitgevers
limit for exposure to γ-butyrolactone of 65
mg/m3, as a 15-min TWA, and of 10 mg/m3,
as an 8-hour TWA. Gamma-butyrolactone is
easily taken up by the body through dermal
exposure. The DECOS recommends applying
a skin notation for γ-butyrolactone.
Reference: Health Council of the Netherlands. Gam-
ma-Butyrolactone; Health-based recom-
mended occupational exposure limit. The
Hague: Health Council of the Netherlands,
2008; publication no. 2008/13OSH.
http://www.gr.nl/pdf.php?ID=1787&p=1
Uncertainty factors in risk assessment
This advisory report is concerned with sci-
entific developments that are important in
relation to the use of so-called ‘uncertainty
factors’ for the determination of health-based
recommended exposure limits and for toxico-
logical risk assessment. Such factors are used
to make allowance for differences between
laboratory animal species and humans, for
inter-personal sensitivity variations and for
shortcomings in the research data.
The report covers various scientific disciplines
and methodologies. Toxicological insight into
substance kinetics and dynamics is increas-
ing all the time: the absorption, dispersion,
metabolism and excretion of substances are
increasingly well understood, as are the mech-
anisms by which substances can be toxic to
organisms that are exposed to them. Various
molecular analysis techniques, cell culture
techniques and computer modelling methods
are proving valuable in this context. In more
and more cases, such methodologies make it
possible to specify the qualitative and quanti-
tative differences between laboratory animals
and humans.
The report also reviews current scientific
thinking with regard to appropriate numeric
values for the various uncertainty factors. The
basic principle advocated is that case-specific
values should be assigned where possible, and
default values used otherwise.
Journaal Stoffen en Preparaten mei 2009, Nr. 4 101

Epidemiologists are also looking for new ways
of enhancing research quality and increasing
the evidential value of research data. Impor-
tant developments include the emergence of
validated methods for the estimation of past
exposure, the use of biomarkers (early effects
known to serve as predictors of subsequent
health deterioration) and statistical analysis
techniques for the combination of data from
various studies. An uncertainty factor for
shortcomings in the data can then become
smaller or can even become superfluous.
In parallel with the developments outlined
above, probabilistic methodologies are enter-
ing increasingly widespread use. The problem
with default uncertainty factors is that it is
unclear how conservative the assigned values
are. This issue can be addressed by combining
probability distributions, rather than absolute
estimates, and then calculating a health-based
recommended exposure limit on the basis of
an acceptably low degree of probability that
adverse effects will occur. Good communica-
tion with regulatory bodies is very important
in this context, because such methodologies
have yet to gain formal approval.
It is sometimes the case that little is known
about the toxicity of a substance.
The next chapter of the report accordingly
outlines a number of methods by which it
can sometimes nevertheless be possible to cal-
culate recommended exposure limits (albeit
provisional or indicative limits) under such
circumstances. The final chapter of the report
summarises the main recommendations of
the committee responsible for the report:
– Allometric scaling factors should be used
wherever possible.
– The definition of chemical-specific ad-
justment factors (CSAFs) is preferable
whenever enough is known about the
toxic activity of a substance. International
cooperation in the definition of CSAFs
should be encouraged.
– Understanding of toxic activity can be
advanced by the application of new toxi-
102 Journal Chemicals Management May 2009, No. 4
actualities
cological analysis techniques, such as (Q)
SARs and in vitro methodologies, as well
as modelling techniques, such as physi-
ologically based kinetic modelling.
– At the same time, more widespread use
and further development of probabilistic
methodologies is desirable. These meth-
odologies promise a major improvement
on the ‘classic’ approach, based on the use
of default values for uncertainty factors.
– In recent years, there has been increasing
interest in methods for the health-based
assessment of substances in the absence of
ample toxicity.
Reference: Health Council of the Netherlands. Uncer-
tainty factors in risk assessment. The
Hague: Health Council of the Netherlands,
2008; publication no. 2008/13.
http://www.gr.nl/pdf.php?ID=1763&p=1
Prudent precaution
Does the disappearance of many animal and
plant species threaten ecosystem function-
ing and human health? Is the cultivation of
genetically modified crops a threat to people
and the environment? Are people working in
the cosmetics industry at risk from nanopar-
ticles? Can variant Creutzfeldt-Jakob’s disease
be communicated in blood and blood pro­
ducts? Science cannot currently answer these
and many other questions. However, the un-
certainty that surrounds such issues does not
mean that they can be relegated to the bottom
of the political and policy agenda. In recent
decades, there have been increasingly insistent
calls for the precautionary principle to be ap-
plied in cases of scientific uncertainty, for the
protection of public health and the environ-
ment. The European Union has incorporated
the principle into its treaty and the environ-
mental movement is constantly asking for the
precautionary principle to be used to address
potential hazards in our surroundings.
Application of the precautionary principle
has, however, been the subject of considerable
debate. Critics argue that the precautionary
Sdu Uitgevers
actualities
principle is vague and unscientific, promotes
arbitrary decision-making and inhibits tech-
nological development and progress. The
principle is also perceived by some to interfere
with the efficient use of scarce resources. It is
accordingly suggested that policy based on the
principle is more likely to have a negative ef-
fect on public health than a positive one. The
counterargument is that a precautionary ap-
proach is often the only way of ensuring that
modern technology does not cause serious
irreversible harm.
Against this background, the President of the
Health Council established a committee to
carry out a scientific analysis of the precau-
tionary principle and to make appropriate
recommendations regarding its application.
The committee was also asked to assess the
significance of the principle for public health
policy in its broadest sense, i.e. including the
environmental protection, food safety, occu-
pational health and safety and preventive and
curative health care domains.
In this report, the committee explains what
it believes the precautionary principle en-
tails, identifies the types of issue to which it
can be constructively applied and sets out
the relevant considerations. The report con-
cludes with a brief assessment of what can be
achieved by application of the precautionary
principle, as defined and in the manner pro-
posed by the committee. The intention is that
the report should serve primarily to guide
policy-makers and politicians when consider-
ing application of the precautionary principle
in government policy. Nevertheless, the com-
mittee hopes that the report will be helpful to
everyone that is in some
Reference: Health council of the Netherlands. Pru-
dent precaution (Voorzorg met rede). The
Hague, 2008; publication no. 2008/18.
http://www.gr.nl/pdf.php?ID=1746&p=1
Sdu Uitgevers
1st ATP to CLP
[2009/0083]
The draft 1st ATP to the CLP has been pre-
pared and can be found at the following loca-
tions.
http://members.wto.org/crnattachments/
2009/tbt/EEC/09_1027_00_e.pdf
http://members.wto.org/crnattachments/
2009/tbt/EEC/09_1027_01_e.pdf
http://members.wto.org/crnattachments/
2009/tbt/EEC/09_1027_02_e.pdf
http://members.wto.org/crnattachments/
2009/tbt/EEC/09_1027_03_e.pdf
http://members.wto.org/crnattachments/
2009/tbt/EEC/09_1027_04_e.pdf
http://members.wto.org/crnattachments/
2009/tbt/EEC/09_1027_05_e.pdf
Where file ending with -00 is the draft regula-
tion text and files ending -01 to -05 are the
draft Annexes.
This is basically the former 30th and 31st
ATPs to the Dangerous Substances Directive
67/548/EEC, but with the entry for 607-674-
00-0 (branched C10-alkyl benzoates) which
had been included in error. Other detail
changes may exist.
The ATP contains not only the DSD classifi-
cations for these substances but the new CLP
(GHS) style. The new classifications must be
applied to any products supplied on or after
from 1 December 2010, however they may be
applied before 1 December 2010.
Meanwhile earlier voluntary adoption of the
new classifications is being promoted.
ECHA Publishes an Updated List
of Pre-Registered Substances
[2009/0084]
On 27 March 2009 an updated version of the
List of Pre-registered Substances was published
on the ECHA website. It contains around 143
Journaal Stoffen en Preparaten mei 2009, Nr. 4 103

000 substances which were pre-registered
by 65 000 companies between 1 June and
1 December 2008. The new list is important
for companies who manufacture or import
substances and who wish to find the correct
SIEF (Substance Information Exchange Fo-
rum) for their substance. The list will help
verify whether, in reality, certain pre-SIEFS
cover the same substance and hence whether
they should merge. Finally, it will also help
identify similar substances for read-across
and formation of chemical categories. As a
result, the list will help to ensure that data is
shared and hence to minimise animal testing.
Please note that the list is made up of pre-reg-
istrations submitted by industry. In ECHA’s
opinion the list contains many preparations
and substances that did not require registra-
tion. ECHA advises companies to verify what
registrations they need to make.
Reference: http://apps.echa.europa.eu/preregistered/
prsDownload.aspx
ETUC earmarks priority chemicals
for REACH authorisation
[2009/0085]
On 31 March 2009, the European Trade Un-
ion Confederation (ETUC) presented a list
of priority chemicals for authorisation under
REACH to the European Parliament. ETUC is
calling on the Member States and European
Commission for the 306 substances of very
high concern on its list – especially the 191
that cause recognised occupational diseases –
to be included on the candidate list of sub-
stances for authorisation under the REACH
rules.
Chemicals bring benefits with which our so-
ciety could not do without and there is no
denying that the EU chemicals industry also
contributes to our economic prosperity in
terms of trade and jobs. However, European
workers pay a high price for the use of chemi-
104 Journal Chemicals Management May 2009, No. 4
actualities
cals in workplaces. About one in three of the
occupational diseases recognised each year
in Europe is due to the exposure to hazard-
ous chemicals, according to ‘REACHing the
workplace’, a study published by the European
Trade Union Institute in 2006.
For chemicals of very high concern, industri-
alists must also get authorisation for each use
in order to continue marketing them. An esti-
mated 30,000 or so chemicals will have to be
REACH-registered. The number of substances
of very high concern on the European market
could be anywhere between 1500 and 2000.
Although the European Chemical Industry
Council (Cefic) contributes actively to the ap-
plication of the legislation on occupational
safety and of REACH, it regrets the publica-
tion of such a list, which has no legal value and
is not part of the REACH process. It includes a
whole range of high volume substances, which
are only used as intermediates and therefore
do not even fall under authorisation.
The REACH process is governed by the Euro-
pean Chemicals Agency, which is the sole body
responsible for publishing the Candidate List
of substances that will undergo further evalu-
ation and which might end up on the official
Candidate List, i.e. the substances eligible to
come under the authorisation element of
REACH. On 30 June 2008 ECHA published
a first list including sixteen substances. This
list will be complemented by additional sub-
stances proposed by the member states.
References: http://hesa.etui.org/uk/newsevents/newsfi-
che.asp?pk=1224
http://www.cefic.org/Files/NewsReleases/
Chem_Industry-REACH_list.doc
REACHing the workplace: http://hesa.etui-
rehs.org/uk/publications/files/REACH-EN.
pdf
Trade Union Priority List for REACH Aut-
horisation:
http://hesa.etui.org/uk/newsevents/files/
Trade%20Union%20Priority%20List%20
for%20REACH%20authorisation-final.
doc.pdf
Sdu Uitgevers
actualities
See also: SIN: Journaal Stoffen en Preparaten, 2008,
08, item 2008/0185, page 222.
PINFA: new Cefic Sector Group
[2009/0086] plates/shwNewsFull.
The European Chemical Industry Council
(Cefic) has formed a new sector group: the
Phosphorus, Inorganic and Nitrogen Flame
Retardants Association (PINFA). Phosphorus
(non-halogenated), inorganic and nitrogen
flame retardants (PIN FRs) are additives that
can be added to or applied as a treatment to
organic materials such as plastics and textiles
to impart fire protection to these materials.
The members of PINFA believe that their
products form an essential part of environ-
mentally compatible fire safety solutions and
share the common concept of an ideal flame
retardant as one which is not toxic to humans,
animals and plants, does not migrate out of
finished products, does not release additional
toxic or corrosive gases in case of fire, does
no impede the recycling of finished articles,
and is either degradable in the environment
or remains neutral as naturally occurring sub-
stances.
The main objective of the sector group is to
co-operate with members of the value chain
including industry organisations involved in
the use of non-halogenated phosphorus, in-
organic and nitrogen flame retardants in or-
der to communicate the advantages of this
technology for the safe use of otherwise eas-
ily flammable materials. Member companies
include Chemische Fabrik Budenheim, Ciba
Inc., Clariant Produkte (D) GmbH, Ital-
match Chemicals S.p.A., Lanxess Deutschland
GmbH and Nabaltec AG.
As part of its starting activities, PINFA will
be organising a workshop on ‘Green Elec-
tronics & Innovative Flame Retardants’ on 24
June 2009, in Brussels. The workshop aims at
interacting with the direct users of PIN FRs
Sdu Uitgevers
and other stakeholders such as regulators. The
objective is to establish a cooperative dialogue
with OEMs (Original Equipment Manufac-
turers) in order to identify their needs and
technologies they are looking for.
Reference: http://www.cefic.org/Tem-
asp?HID=1&NSID=711&P=1&NID=469
International
The U.S. Environmental Protection
Agency’s Strategic Plan for
Evaluating the Toxicity
of Chemicals
[2009/0087]
To fulfill its mission to protect human health
and the environment, EPA must evaluate the
risks of adverse health effects resulting from
exposure to chemicals in the environment.
The traditional risk assessment approach relies
heavily on data generated through the inten-
tional dosing of experimental animals. While
this approach has provided EPA with sound
science to support regulatory decision making
over the past several decades, EPA must ad-
dress ever-increasing demands, including con-
sideration of complex issues such as cumula-
tive exposures, life-stage vulnerabilities, and
genetic susceptibilities, not to mention the
increasing number of chemicals and cost of
toxicity testing. A new approach is proposed to
address these demands, an approach based on
the application of advances in molecular biol-
ogy and computational sciences to transform
toxicity testing and risk assessment practices.
This Strategic Plan is centered on three in-
terrelated components: (1) the use of toxic-
ity pathways identification and use of this
information in screening and prioritization
of chemicals for further testing; (2) the use
of toxicity pathways information in risk as-
Journaal Stoffen en Preparaten mei 2009, Nr. 4 105

sessment; and (3) the institutional transition
necessary to implement such practices across
EPA. This Strategic Plan describes an ambi-
tious and substantive improvement in the
efficiency and effectiveness of the process by
which environmental pollutants are evaluated
for toxicity and risk.
Reference: Report # K-09/001. March 2009. Office of
the Science Advisor Science Policy Council
U.S. Environmental Protection Agency
Washington, DC 20460
http://www.epa.gov/osa/spc/toxicitytesting/
docs/toxtest_strategy_032309.pdf
OECD Guidance Manual for
the Control of Transboundary
Movements of Recoverable Wastes
[2009/0088]
The successive amendments of Council
Decision C(2001)107/FINAL [C(2004)20;
C(2005)141; and C(2008)156] on the control
of transboundary movements of waste des-
tined for recovery operations, which concern
the lists of wastes, necessitate the update of the
relevant Guidance Manual for the implemen-
tation of this Decision. This document is a re-
vised version of the former Guidance Manual
[ENV/EPOC/WGWPR(2001)6/FINAL].
Reference: OECD 2009 http://www.oecd.org/data-
oecd/57/1/42262259.pdf
Australia: GHS and SUSDP
[2009/0089]
The Australian Office of Chemical Safety and
Environmental Health is seeking public com-
ment on a Discussion Paper which outlines
possible options for the adoption of the Glo-
bally Harmonised System of Classification
and Labelling of Chemicals (GHS) within the
system of public health regulation of domes-
106 Journal Chemicals Management May 2009, No. 4
actualities
tic and consumer chemicals, including pesti-
cides.
This discussion paper explores the options
and possible implications that might arise
from the adoption of the GHS in respect to
domestic and consumer chemicals (includ-
ing pesticides) within the Australian regula-
tory framework for the uniform scheduling
of drugs and poisons. The paper also provides
a comparative analysis of the health hazard
criteria used in the current system of poisons
scheduling for domestic and consumer chem-
icals in Australia with those proposed in the
Globally Harmonised System of Classification
and Labelling of Chemicals (GHS). The pa-
per outlines the options for possibly adopting
the GHS, the likely costs and benefits of those
options and a technical assessment of the
similarities and differences between current
poisons scheduling criteria and GHS criteria
which may have a bearing on the scope of any
future proposal to implement the GHS.
The considerations in this document recog-
nise the fact that the toxicological assessment
of chemicals for classification purposes is
undertaken at a Commonwealth level while
scheduling (based on classification proposals)
and elements of chemical labelling such as
signal words, pictograms, hazard and precau-
tionary statements as defined by the Standard
for the Uniform Scheduling of Drugs and Poi-
sons (SUSDP) are implemented under State
and Territory legislation. The main purpose
of the GHS is to introduce an internationally
harmonised approach to classification and
labelling of chemical substances which will
provide the foundation for the development
of national programs to ensure the safe man-
agement of chemicals during their entire life
cycle. The GHS is intended to cover hazard-
ous chemicals, either in their pure form, as
dilute solutions or in mixtures. Human and
veterinary pharmaceuticals, food additives,
pesticide residues in food and cosmetics are
not covered by the GHS in terms of labelling
Sdu Uitgevers
actualities
at the point of intake/administration. How-
ever, the GHS may apply to these chemicals in
the manufacturing environment where work-
place health and safety and/or public health is-
sues may be of prime importance. The need to
adopt a single classification system within the
scheduling framework and desirably across all
sectors may, however, have consequences for
the classification and scheduling of classes e.g.
veterinary medicines which are to be exempt-
ed from the GHS harmonisation process.
The GHS specifies criteria for classifying
chemicals according to their physical, health
and environmental hazards and for harmo-
nised hazard communication. Adoption of
the GHS system places certain obligations on
government authorities in terms of the clas-
sification criteria specified by the GHS. How-
ever, competent authorities are allowed some
degree of flexibility in the adoption of the
various labelling elements.
In examining the appropriateness of adopt-
ing the GHS in relation to domestic use and
consumer chemicals (including pesticides), a
number of possible options for implementa-
tion of the GHS have been previously con-
sidered by the National Drugs and Poisons
Schedule Committee (NDPSC) in an effort
to promote a harmonised approach between
States and Territories in regard to the GHS.
The NDPSC is mindful that there may be a
range of options for achieving integration of
the GHS within the scheduling system. How-
ever, having regard to the extensive NDPSC
discussion to date, the operating environment
for the scheduling of domestic and consumer
chemicals and the possible impact changes in
scheduling practices and procedures may have
on existing legislation and other elements of
the wider regulatory system, including the im-
plications for users of chemicals both profes-
sional and the general public, the NDPSC has
identified four options for further discussion.
Consideration of other options is not pre-
cluded. The four options now identified for
further consideration include: (1). Maintain-
Sdu Uitgevers
ing the status quo ie rejecting the adoption of
the GHS classification criteria and labelling
elements. (2). Adoption of GHS classification
criteria, adoption of the GHS hazard and pre-
cautionary statements, rejection of the GHS
signal words and pictograms, preserving exist-
ing SUSDP Schedules 5, 6 and 7 with GHS clas-
sification criteria being appropriately aligned
with these existing schedules. (3). Adoption
of GHS classification criteria (with significant
change to schedules 5, 6 and 7 to align with
GHS criteria), acceptance of the GHS hazard
and precautionary statements, rejection of the
GHS signal words and pictograms. (4). Full
adoption of the GHS through adoption of the
GHS classification criteria and GHS labelling
elements with a consequential overhaul of the
current poisons scheduling system to align
with GHS categories.
Of these, option 2 is considered by the NDPSC
to be the most pragmatic approach for Aus-
tralia, considering the overall need to main-
tain existing standards in protecting public
health, as well as balancing the likely risks,
benefits and costs involved in implementing
the GHS.
Based on the present analysis, adoption of
the GHS classification system into the poi-
sons scheduling framework provides for an
improved classification system representing
best practice approaches. Only slight changes
to the current poisons scheduling criteria are
required. Overall, there would be minimal
impact to existing regulation and industry
arising from the need to amend product la-
bels to comply with a GHS-aligned classifica-
tion (scheduling) system. There would also be
minimal, if any, impact on the States and Ter-
ritories as no change to legislation would be
required and little or no necessity for retrain-
ing of chemical users in label interpretation.
Certain GHS labelling elements are identi-
fied as not adding value or in fact, potentially
weakening the current level of protection
achieved through existing SUSDP require-
ments. As such, GHS signal words and picto-
Journaal Stoffen en Preparaten mei 2009, Nr. 4 107

grams, which have not been evaluated for user
comprehensibility within the Australian com-
munity would not be recommended for adop-
tion at this time. However, hazard and precau-
tionary statements are generally in alignment
with existing statements and offer opportuni-
ties to further enhance and harmonise label
text. Not adopting GHS signal words and
pictograms would, however, prevent Australia
from being considered ‘fully harmonised’ with
the GHS in regard to domestic and consumer
chemicals labelling.
The favoured approach offered by way of
adoption of option 2 into the SUSDP is
evaluated as maintaining existing standards
of public health protection, having minimal
impact on existing scheduling classifications
and product labelling (with consequent im-
plications for industry) and avoiding the need
for amendment to State/Territory legislation
and the training of chemical users, including
the broad public, in the interpretation of new
and unfamiliar label elements. The lack of
Australian data on user comprehension and
acceptance of GHS pictograms is of particular
concern.
It is stressed that risk based labelling would be
retained and in relation to the responsibilities
of the NDPSC would continue to be guided by
legislative provisions outlined in S52E of the
Therapeutic Goods Act, 1989, which include:
(a) the toxicity and safety of a substance;
(b) the risks and benefits associated with the
use of a substance; (c) the potential hazards
associated with the use of a substance; (d)
the extent and patterns of use of a substance;
(e) the dosage and formulation of a substance;
(f) the need for access to a substance, taking
into account its toxicity compared with other
substances available for a similar purpose;
(g) the potential for abuse of a substance;
(h) the purposes for which a substance is to
be used; (i) any other matters that the Com-
mittee considers necessary to protect public
health, including the risks (whether imminent
or long-term) of death, illness or injury result-
108 Journal Chemicals Management May 2009, No. 4
actualities
ing from its use. The labelling, packaging and
presentation of a substance may also be taken
into account.
Reference: Discussion Paper: Possible Adoption within
the Public Health Sector of the Globally
Harmonised System for the Classification
and Labelling of Chemicals (GHS) in
regard to Domestic and Consumer Chemi-
cals (including Pesticides). An Analysis of
the Possible Implications Associated with the
Adoption of GHS Classification Criteria and
Labelling Elements within the Framework
for the Uniform Scheduling of Drugs and
Poisons (SUSDP). Paper Prepared by the
Office of Chemical Safety and Environ-
mental Health, Department of Health and
Ageing http://www.health.gov.au/internet/
main/publishing.nsf/Content/ghs-discussi-
on-paper.html
For the SUSDP: see Journaal Stoffen en
Preparaten, 2009, no.8, item 2008/0172,
page 203.
Singapore: Strategic Goods
(Control) Order 2009
[2009/0090]
The Strategic Goods (Control) Order 2007
has been replaced with the Strategic Goods
(Control) Order 2009 which has come into
effect on 1 April 2009.
The new Strategic Goods Control List with
Product Codes is available on the STGC web-
site.
Reference: http://www.customs.gov.sg/stgc/leftNav/
str/
Sdu Uitgevers
publications

Reference: Anna Bulgheroni c.s.: Estimation of

acute oral toxicity using the No Observed

publications Adverse Effect Level (NOAEL) from the

28 day repeated dose toxicity studies in
rats. Regulatory Toxicology and Pharmaco-
logy 53 (2009) 16–19

Acute systemic toxicity

determination

[2009/0091]

Acute systemic toxicity is one of the areas of

particular concern due to the 2009 deadline
set by the 7th Amendment of the Cosmetics
Directive (76/768/EEC), which introduces a
testing and marketing ban of cosmetic prod-
ucts with ingredients tested on animals. The
scientific community is putting considerable
effort into developing and validating non-ani-
mal alternatives in this area. However, it is un-
likely that validated and regulatory accepted
alternative methods and/or strategies will be
available in March 2009. Following the initia-
tives undertaken in the pharmaceutical indus-
try to waive the acute oral toxicity testing
before going to clinical studies by using in-
formation from other in vivo studies, we
proposed an approach to identify non-toxic
compounds (LD50 > 2000 mg/kg) using in-
formation from 28 days repeated dose toxicity
studies. Taking into account the high preva-
lence of non-toxic substances (87%) in the
New Chemicals Database, it was possible to
set a NOAEL threshold of P200 mg/kg that
allowed the correct identification of 63% of
non-toxic compounds, while < 1% of harm-
ful compounds were misclassified as non-
toxic. Since repeated dose toxicity studies can
be performed in vivo until 2013, the proposed
approach could have an immediate impact for
the testing of cosmetic ingredients.

Sdu Uitgevers Journaal Stoffen en Preparaten mei 2009, Nr. 4 109


official
publications
The Netherlands (Period March
2009)
[2009/0092] 19° Warenwetregeling nadere eisen kinderbedden en
Staatsblad 2009, 109: Wet van 14 februari
2009 tot wijziging van de Wet milieubeheer
en enkele andere wetten met het oog op in-
tegratie van verplichtingen op het terrein van
milieuverslaglegging
Staatsblad 2009, 158: Wet van 12 maart 2009
tot wijziging van de Wet milieubeheer (imple-
mentatie en derogatie luchtkwaliteitseisen)
Staatscourant 2009, 50: Bekendmaking van
wijzigingen van Codes van de IMO. 2 maart
2009 Nr. CEND/HDJZ-2009/248 sector SCH
Staatscourant 2009, 57: Besluit van de Minis-
ter van Landbouw, Natuur en Voedselkwaliteit
van 20 maart 2009, nr. TRCJZ/2009/762, tot
wijziging van het Besluit houdende beleidsre-
gels omtrent openbaarmaking van controle-
gegevens door de VWA
[... Toevoeging onderdeel o aan artikel 1:
o. productveiligheidsregels en -eisen: regels en eisen waaraan
een natuurlijk persoon of een rechtspersoon die produc-
ten verhandelt, niet zijnde levensmiddelen, op basis van
de volgende van toepassing zijnde besluiten en regelingen
dient te voldoen:
1° Warenwetbesluit attractie- en speeltoestellen,
2° Nadere regels attractie- en speeltoestellen,
3° Warenwetbesluit algemene productveiligheid,
4° Besluit draagbaar klimmaterieel (Warenwet),
5° Regeling nadere eisen draagbaar klimmaterieel (Wa-
renwet),
6° Besluit gastoestellen,
7° Gasslangbesluit (Warenwet),
8° Spaanplaatbesluit (Warenwet),
9° Warenwetbesluit algemene chemische produktveilig-
heid,
110 Journal Chemicals Management May 2009, No. 4
official publications
10° Warenwetregeling algemene chemische produktvei-
ligheid,
11° Warenwetbesluit Azo-kleurstoffen,
12° Warenwetbesluit benzine,
13° Warenwetbesluit deponering informatie preparaten,
14° Warenwetregeling preparaat informatie formulier,
15° Warenwetbesluit elektrotechnische produkten,
16° Warenwetregeling formaldehyde in textiel,
17° Warenwetbesluit imitatieprodukten,
18° Warenwetbesluit Kinderbedden en -boxen,
-boxen kinderopvang,
20° Warenwetbesluit cosmetische producten,
21° Warenwetregeling cosmetische producten,
22° Warenbesluit machines,
23° Warenwetbesluit Pentachloorfenol,
24° Warenwetbesluit persoonlijke beschermingsmidde-
len,
25° Warenwetbesluit Speelgoed,
26° Warenwetregeling CE-markering voor speelgoed,
27° Warenwetbesluit containers,
28° Warenwetbesluit drukvaten van eenvoudige vorm,
29° Warenwetbesluit drukapparatuur,
30° Warenwetregeling drukapparatuur,
31° Warenwetbesluit tatoeagekleurstoffen; ... ]
Staatscourant 2009, 58: Regeling van de Mi-
nister van Volkshuisvesting, Ruimtelijke or-
dening en Milieubeheer van 11 maart 2009,
nr. BJZ2009019648, houdende wijziging van
de Regeling algemene regels voor inrich-
tingen milieubeheer van 9 november 2007,
nr. DJZ2007104180
[ ... Artikel 4.8 komt te luiden:
1. De opslag van gevaarlijke stoffen in verpakking en
CMR-stoffen in verpakking in een voor het publiek
toegankelijke verkoopruimte is brandveilig.
2. Aan het eerste lid wordt voldaan indien: a. gevaarlijke
stoffen in verpakking of CMR-stoffen in verpakking
zijn opgeslagen in een voorziening die voldoet aan
PGS 15, dan wel aan de artikelen 4.3 tot en met 4.5
van deze regeling; of b. gevaarlijke stoffen in verpak-
king en CMR-stoffen in verpakking niet in grotere
hoeveelheden in een verkoopruimte zijn opgeslagen
dan is aangegeven in tabel 4.8, opgenomen aan het
slot van dit artikel.
Sdu Uitgevers
official publications
3. Dit artikel is niet van toepassing op verpakkingen met
producten bestemd voor de persoonlijke verzorging,
waaronder spuitbussen.
4. Het bevoegd gezag kan maatwerkvoorschriften stel-
len met betrekking tot een andere wijze van opslag
dan genoemd in het tweede lid op basis van een door
de inrichtinghouder ingediend Programma van Ei-
sen met betrekking tot de bouwkundige, installatie-
technische en organisatorische maatregelen, waarin
is aangetoond dat de opslag van gevaarlijke stoffen
in verpakking en CMR-stoffen in verpakking in een
voor het publiek toegankelijke verkoopruimte brand-
veilig is. Voordat de betreffende verkoopruimte in ge-
bruik wordt genomen, is door een inspectieinstelling,
die geaccrediteerd is door een accreditatie-instelling
volgens NEN-EN-ISO/IEC 17020, door middel van
een goedkeurend inspectierapport aangetoond dat de
met het oog op de brandveiligheid getroffen voorzie-
ningen en maatregelen zijn uitgevoerd overeenkom-
stig het Programma van Eisen. Dit inspectierapport is
binnen de inrichting aanwezig.
5. Een lekbak als bedoeld in tabel 4.8 is onbrandbaar
en productbestendig en kan ten minste 100% van de
daarboven opgeslagen vloeistoffen bevatten. ...]
Staatscourant 2009, 61: Regeling tot wijzi-
ging van de Regeling vervoer over de spoor-
weg van gevaarlijke stoffen in verband met de
tweejaarlijkse revisie van internationale voor-
schriften en de inwerkingtreding van de richt-
lijn nr. 2008/68/EG. 25 maart 2009 Nr. CEND/
HDJZ-2009/223 Sector I&O
Staatscourant 2009, 64: Regeling tot wijziging
van de Regeling vervoer over land van gevaar-
lijke stoffen in verband met de tweejaarlijkse
revisie van internationale voorschriften en de
inwerkingtreding van de richtlijn nr. 2008/68/
EG. 25 maart 2009 Nr. CEND/HDJZ-2009/222
sector I&O
Staatscourant 2009, 66: Circulaire vertrouwe-
lijke behandeling bedrijfs-, fabricage- en naw-
gegevens [naw= Naam, Adres, Woonplaats]
[Voor de uitvoering van het milieubeleid is het noodza-
kelijk dat bestuursorganen beschikken over informatie
van bedrijven, onder meer in het kader van vergunning-
verlening, toezicht, monitoring van milieuconvenanten
en milieuverslaglegging. Daarbij kan een spanningsveld
Sdu Uitgevers
ontstaan tussen de belangen van bedrijven en het belang
van openbaarheid van milieu-informatie. Regelmatig wil-
len bedrijven uit concurrentieoverwegingen hun brand-
stofgebruik, energiegegevens, productiegegevens en emis-
siegegevens op installatieniveau alleen ter beschikking
stellen aan hun bevoegd gezag (het bestuursorgaan) en
niet openbaar maken. Tegelijkertijd kunnen derden, zoals
milieuorganisaties, verzoeken om toegang tot dergelijke
informatie. In de praktijk bestaat nog veel onduidelijkheid
over de wet- regelgeving die hierbij van toepassing is. Met
deze circulaire wordt beoogd de relevante wet- en regelge-
ving toe te lichten.]
Kamerstuk 2008-2009, 31894, nr. 4, Tweede
Kamer: Uitbreiding en wijziging van de Wet
milieubeheer in verband met de uitvoering
van de verordening (EG) nr. 1272/2008 van
het Europees Parlement en de Raad van de
Europese Unie van 16 december 2008 betref-
fende de indeling, etikettering en verpakking
van stoffen en mengsels en tot wijziging en
intrekking van de Richtlijnen 67/548/EEG
en 1999/45/EEG en tot wijziging van Veror-
dening (EG) nr. 1907/2006 alsmede daarmee
samenhangende wijzigingen van andere wet-
ten (Uitvoeringswet EG-verordening inde-
ling, etikettering en verpakking van stoffen en
mengsels).
Belgium (Period March 2009)
[2009/0093]
Staatsblad 23 maart 2009: Koninklijk be-
sluit van 8 maart 2009 tot wijziging van het
koninklijk besluit van 3 juli 2005 betreffende
materialen en voorwerpen van kunststof be-
stemd om met voedingsmiddelen in aanra-
king te komen
Staatsblad 2 april 2009: Wet van 4 juni 2007
houdende instemming met het Samenwer-
kingsakkoord van 2 maart 2007 betreffende
de uitvoering van de overeenkomst tot verbod
van de ontwikkeling, de productie, de aanleg
van voorraden en het gebruik van chemische
Journaal Stoffen en Preparaten mei 2009, Nr. 4 111

wapens en inzake de vernietiging van deze wa-
pens
Staatsblad 9 april 2009: Wet van 16 februari
2009 houdende instemming met het Proto-
col betreffende registers inzake de uitstoot en
overbrenging van verontreinigende stoffen,
gedaan te Kiev op 21 mei 2003
United Kingdom (Period March
2009)
[2009/0094]
CHIP 4
On 6 April 2009 new regulations, The Chemi-
cals (Hazard Information and Packaging for
Supply) Regulations 2009 (or CHIP 4) came
into force. These regulations consolidate am-
mendements made under CHIP 3, and make
provisions for the transition to that form of
the Globally Harmonised System that has
been implemented throughout the EU by
Regulation (EC) No 1272/2008 on classifica-
tion, labelling and packaging of substances
and mixtures (16 December 2008). Although
the CLP Regulation is directly acting on
Member States, without the need for trans-
position, the new regulation aligns CHIP with
the transitional period of the CLP Regulation
and ensures that the provisions of the CLP
Regulation can be enforced in Great Britain,
both throughout the transitional period and
beyond.
Reference: http://www.opsi.gov.uk/si/si2009/pdf/
uksi_20090716_en.pdf
Chemical Carcinogens Workshop Report
This report summarises presentations given
during a stakeholder workshop in June 2008,
involving technical experts, academics, union
representatives, industry experts, industry as-
sociations and government departments. The
workshop sought agreement on criteria for
setting priorities for future activities and pos-
sible interventions to tackle the risk of expo-
112 Journal Chemicals Management May 2009, No. 4
official publications
sure to chemical carcinogens. The report pro-
vides an overview of the issues discussed and
the main outcomes and agreements reached
in both plenary and syndicate groups during
the workshop.
Reference: http://www.hse.gov.uk/drp/workshop08.
pdf
Chemicals Regulation Directorate
A new Chemicals Regulation Directorate
(CRD) has been formed (effective 1 April
2009), by merger of the Pesticides Safety Di-
rectorate (PSD) and the Chemicals Assess-
ment Schemes Unit (CASU). The merger
brings together the delivery of HSE responsi-
bilities for pesticides, biocides detergents and
industrial chemicals into one directorate. The
objective of the merger is to provide all stake-
holders with a better regulatory service.
Reference: http://www.hse.gov.uk/press/2009/e09026.
htm
REACH – Substance Selection Criteria
REACH provides the opportunity for national
authorities to propose substances to be con-
sidered under REACH for authorisation (via
adding to the Candidate List of Substances
of Very High Concern, SVHC), restriction or
(from 2011) evaluation. National authorities
can also propose substances for harmonised
classification and labelling, though usu-
ally only for carcinogenic, mutagenic and/
or reproductive toxicity (CMR) and respira-
tory sensitisation properties unless there is
strong justification for considering another
endpoint(s).
UK REACH CA Steering Committee has es-
tablished the process and criteria by which
substances can be proposed for authorisation,
restriction, evaluation or harmonised classifi-
cation and labelling. The Steering Committee
confirms the annual work programme of the
UK REACH CA that is then delivered by the
CA. One component of this programme is the
progression of work on individual substances
for introduction into EU REACH processes.
Sdu Uitgevers
official publications
In this context, the Steering Committees has
developed a process and criteria by which na-
tionally the UK can develop a list of priority
substances on which the UK REACH CA will
work.
Reference: http://www.hse.gov.uk/reach/substances.
htm
REACH – Bitesize advice
A set of brief leaflets has been produced by
the UK HSE in collaboration with other UK
Government Departments. They are intended
to cover the key issues of various aspects of
REACH:
Number 1 – REACH is here
Number 2 – What REACH means for manu-
facturers
Number 3 – What REACH means for EU im-
porters
Number 4 – What REACH means for users of
chemicals
Number 5 – REACH – The basics
Number 6 – REACH – Timeline
Number 7 – REACH – Pre-registration
Number 8 – REACH – Exemptions
Number 9 – REACH – Articles
Number 10 – REACH – Guidance for dis-
tributors
Number 11 – REACH – Creating an inventory
for downstream users
Number 12 – REACH – Substances of very
high concern (SVHCs)
Number 13 – REACH – Safety data sheets
(SDS)
Number 14 – REACH – Substances recovered
from waste
Number 15 – REACH – Guidance on biodie-
sel
Reference: http://www.hse.gov.uk/reach/bitesize.htm
Sdu Uitgevers
European Union (Period March
2009)
[2009/0095]
OJ 2009, L71: Commission Decision
2009/240/EC of 4 March 2009 authorising
Member States to adopt certain derogations
pursuant to Directive 2008/68/EC of the Eu-
ropean Parliament and of the Council on the
inland transport of dangerous goods.
OJ 2009, L71: Commission Decision
2009/240/EC of 16 March 2009 concern-
ing the non-inclusion of triflumuron [CAS
64628-44-0] in Annex I to Council Directive
91/414/EEC and the withdrawal of authorisa-
tions for plant protection products containing
that substance.
OJ 2009, L74: Commission Decision
2009/251/EC of 17 March 2009 requiring
Member States to ensure that products con-
taining the biocide dimethylfumarate [CAS
624-49-7] are not placed or made available
on the market.
Reference: http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=OJ:L:2009:074:0032:0034:
EN:PDF
See also: – Journaal Stoffen en Preparaten, 2009,
No.1, item 2009/0005, p. 15 (Belgium)
– French legislation: ‘Arrêté du 4 décem-
bre 2008 portant suspension de mise
sur le marché des sièges et des articles
chaussants contenant du fumarate de
diméthyle’.
– Risk Alert Announcement No.1 of
2009 of the General Administration
of Quality Supervision, Inspection
and Quarantine – Announcement
on the Decisions of the European
Commission on Prohibiting Products
Containing Dimethylfumarate from
Launching into Market. (30 March
2009).
– iSinoLaw Weekly, Vol. 11, 20 March-5
April 2009.
Journaal Stoffen en Preparaten mei 2009, Nr. 4 113

OJ 2009, L79: Commission Decision 2009/292/
EC of 24 March 2009 establishing the condi-
tions for a derogation for plastic crates and
plastic pallets in relation to the heavy metal
concentration levels established in Directive
94/62/EC of the European Parliament and
of the Council on packaging and packaging
waste
OJ 2009, L85: Statement of revenue and ex-
penditure of the European Chemicals Agency
for the financial year 2009 (2009/279/EC)
OJ 2009, L91: Commission Directive 2009/25/
EC of 2 April 2009 amending Council Direc-
tive 91/414/EEC as regards an extension of
the use of the active substance pyraclostrobin
[CAS 175013-18-0].
OJ 2009, L91: Commission Decision 2009/311/
EC of 2 April 2009 allowing Member States to
extend provisional authorisations granted for
the new active substances topramezone [CAS
210631-68-8], sulfuryl fluoride [CAS 2699-
79-8] and zucchini yellow mosaic virus — weak
strain
OJ 2009, L95: Commission Decision 2009/321/
EC of 8 April 2009 setting a new deadline for
the submission of dossiers for certain sub-
stances to be examined under the 10-year
work programme referred to in Article 16(2)
of Directive 98/8/EC of the European Parlia-
ment and of the Council [Margosa ext. (CAS
84696-25-3); Reaction product of dimethyl
adipate, dimethyl glutarate, dimethyl succi-
nate with hydrogen peroxide/Perestane (CAS
--, EC number 432-790-1)].
OJ 2009, L95: Commission Decision of
8 April 2009 concerning the non-inclusion of
certain substances in Annexes I, IA or IB to
Directive 98/8/EC of the European Parliament
and of the Council concerning the placing of
biocidal products on the market.
114 Journal Chemicals Management May 2009, No. 4
official publications
USA (Period March 2009)
[2009/0096]
Federal Register, Vol. 74, No. 50, 17 March
2009, 11329: Occupational Exposure to
Diacetyl and Food Flavorings Containing
Diacetyl. Occupational Safety and Health Ad-
ministration (OSHA), Department of Labor.
Advance Notice of Proposed Rulemaking;
withdrawal.
Federal Register, Vol. 74, No. 53, 20 March
2009, 11944: Diiodomethyl p-tolyl sulfone
(Amical 48), Busan 77, Organic Esters of
Phosphoric Acid Reregistration Eligibility De-
cisions; Notice of Availability. Environmental
Protection Agency (EPA). Notice.
Federal Register, Vol. 74, No. 56, 25 March
2009, 12847: Notice of Availability for the U.S.
Environmental Protection Agency’s Strategic
Plan for Evaluating the Toxicity of Chemicals.
Notice of document availability.
[The U.S. Environmental Protection Agency (EPA) is an-
nouncing the availability of the final document The U.S.
Environmental Protection Agency’s Strategic Plan for Evalu-
ating the Toxicity of Chemicals (EPA 100/K– 09/001). The
purpose of the Strategic Plan is to serve as a blueprint for
EPA in incorporating advances in molecular biology and
computational sciences into toxicity testing and risk as-
sessment practices across the Agency. The Strategic Plan
is centered on three interrelated components: (1) Toxic-
ity pathways identification and use of this information in
screening and prioritization of chemicals for further test-
ing, (2) the use of toxicity pathways information in risk
assessment, and (3) the institutional transition necessary
to implement such practices across EPA.]
Federal Register, Vol. 74, No. 60, 31 March
2009, 14551: Guidance on the Development,
Evaluation, and Application of Environmen-
tal Models. Environmental Protection Agency
(EPA). Notice of Document Availability.
[The U.S. Environmental Protection Agency (EPA) is an-
nouncing the availability of the final ‘Guidance Document
on the Development, Evaluation, and Application of Reg-
ulatory Environmental Models,’ EPA/100/K–09/003 (here-
inafter ‘‘Models Guidance’’). EPA’s Council for Regulatory
Sdu Uitgevers
official publications

Environmental Modeling (CREM) developed the Models

Producenten-
Guidance and its companion product, the ‘Models Know­
ledge Base’ (hereinafter ‘Models KBase,’ http://cfpub.epa.
verantwoordelijkheid in
gov/crem/ knowledge_base/knowbase.cfm), to improve the de afvalstoffenwetgeving
practices associated with the development, evaluation, and Producentenverantwoordelijkheid
application of models for environmental decision making. is een van de instrumenten om
Furthermore, bij providing access to its tools and methods, milieuverantwoord afvalbeleid te
EPA increases transparency and can improve the public’s stimuleren.
understanding of how science is used to make environ-
In deze uitgave leest u over de
mental decisions.
achtergronden en de invoering van
While the Models Guidance does not impose legally bind- de producentenverantwoordelijkheid.
ing requirements on EPA or the public, it provides recom- U krijgt een zo volledig mogelijk beeld
mendations on the principles of good modeling practice, van zowel de Nederlandse als de
stressing the importance of model quality, documentation, Europese regelgeving op dit gebied.
and transparency with the aim of helping to determine
Met deze uitgave hebt u de beschikking
when and how a model can be used to inform a decision.
over een helder en actueel overzicht
The Models Guidance is available electronically through
van de relevante regelgeving en
the CREM Web site: http://www.epa.gov/crem] praktische informatie over dit nog
Federal Register, Vol. 74, No. 62, 2 April 2009, steeds in beweging zijnde aspect van
14941: The National Volatile Organic Com- afvalbeheer(sing).
pound Emission Standards for Aerosol Coat-
ings. Environmental Protection ISBN: 978 90 12 38081 2
Prijs: € 25,–
Agency (EPA). Proposed rule. Auteur: drs. ing. Annet M. Sluer
Federal Register, Vol. 74, No. 68, 10 April
2009, 16448: Mandatory Reporting of Green-
house Gases.Environmental Protection Agen-
cy (EPA). Proposed rule.

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IMPORTANT DATA Redactiesecretariaat
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[2009/0097] 2500 EA Den Haag

27 May 2009: Hoofdredactie:

ECHA Second Stakeholders´ Day
Helsinki, Finland
Info: http://echa.europa.eu/news/
events/2nd_stakeholders_day_
en.asp
27-29 May 2009:
The first Helsinki Chemicals Forum
Helsinki, Finland
Info: http://finnexpo.multiedition.fi/
wwwcem/cem/
14-17 June 2009:
Occupational and Environmental Expo-
sure of Skin to Chemicals 2009
Edinburgh, Scotland
Info: http://www.oeesc2009.org/
Drs. A.C.H. van Peski
Redactie:
Mw. dr. M.M. Kops-Werkhoven
Drs. H.A.F. van Well
Dr. J.A.S.J. Razenberg
Drs. J. Zawierko
Uitgever:
Drs. A. van Dijk
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Brussels, Belgium
Info: http://ec.europa.eu/enterprise/
reach/information/events/index_
en.htm
30 September – 1 October 2009:
REACH Exposure Scenarios & Safe Han-
dling Advice
Brussels, Belgium
Info: http://www.bohs.org/event­
Details.aspx?event=164
Alle rechten voorbehouden. Niets uit deze uitgave mag worden verveel-
voudigd, opgeslagen in een geautomatiseerd gegevensbestand, of openbaar
gemaakt, in enige vorm of op enige wijze, hetzij elektronisch, mechanisch,
door fotokopieën, opnamen, of enig andere manier, zonder voorafgaande
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Voorzover het maken van kopieën uit deze uitgave is toegestaan op grond
van artikel 16b Auteurswet 1912 jo het Besluit van 20 juni 1974, Stb. 351,
zoals laatstelijk gewijzigd bij het Besluit van 22 december 1997, Stb. 764 en
artikel 17 Auteurswet 1912, dient men de daarvoor wettelijk verschuldigde
vergoedingen te voldoen aan de Stichting Reprorecht (Postbus 3060, 2130 KB
Hoofddorp). Voor het overnemen van gedeelten(n) uit deze uitgave in bloem-
lezingen, readers en andere compilatiewerken (artikel 16 Auteurswet 1912)
dient ment zich tot de uitgever te wenden. Hoewel bij de samenstelling van
deze uitgave de uiterste zorg is nagestreefd, kan voor eventuele (druk)fouten
en onvolledigheden niet worden ingestaan en aanvaarden auteurs, redacteuren
en uitgever deswege geen aansprakelijkheid.

Citeertitel
Journaal Stoffen en Preparaten jaartal/nummer
(voorbeeld: Journaal Stoffen en Preparaten 2009/1)

ISSN 1574-1079
 Journal
Chemicals
Management
Journaal Content
Stoffen & Preparaten

ARTICLES
Chief-editor:
Drs. A.C.H. van Peski [2009/0098] Chemical Categories: Filling data gaps by
Read-across and Trend analysis / 119
Editorial Board:
[2009/0099] Recent progress in GHS implementation –
Dr. M.M. Kops-Werkhoven
Republic of South Korea / 129
Drs. H.A.F. van Well
Dr. J.A.S.J. Razenberg
Dr. L.J.M. Rodenburg ACTUALITIES
Drs. G.A. Schouten
Drs. J. Zawierko European Union
[2009/0100] The Netherlands: Changes in Product
Advisory Board: Registration / 131
K. E. Armstrong (U.S.A.) [2009/0101] Updated version of the EC inventory and the
Dr. R. Fielding (United Kingdom) ‘list numbers’ available / 132
Drs. A. Gondová (The Netherlands) [2009/0102] Nanomaterials: EU, Emergnano, VCI &
G. Koh (Singapore) OECD reports / 132
Dr. C. van Lint (Australia)
Dan Liu (U.S.A.) International
S. Park (S.-Korea) [2009/0103] GHS third revised edition / 133
H. Sano (Japan) [2009/0104] Safe Work Australia / 133
S. Savary (Canada) [2009/0105] New Zealand: Group Standard Amendment
Dr. U. Schumacher (China) Consultation / 134
C. Sieger (Germany) [2009/0106] Global Update on New Chemicals
J. Simpson (Australia)
Regulations (February-March 2009) / 134
E. Snyman (South Africa)
P.G. Tse (New Zealand)
PUBLICATIONS

Books
[2009/0107] REACH + GHS, 3. Auflage / 140
No. 5 [2009/0108] ADR 2009. Vervoer van gevaarlijke stoffen
over de weg. VLG/ADR / 140
June 2009 [2009/0109] The Dangerous Goods Emergency Action
Volume 6 Codes List 2009 / 140
Part of Stoffennieuws.nl

Journaal JSP 5_09.indd 117 05-06-2009 10:00:58

Proceskleur Zwart
 content

Internet
[2009/0110] Pesticide Action Network UK List of Lists / 141
[2009/0111] CEFIC ERICards / 141
[2009/0112] CAS Common Chemistry / 141

OFFICIAL PUBLICATIONS

[2009/0113] The Netherlands (Period April 2009) / 142

[2009/0114] Belgium (Period April 2009) / 143
[2009/0115] United Kingdom (Period April 2009) / 143
[2009/0116] European Union (Period April 2009) / 145
[2009/0117] USA (Period April 2009) / 146

[2009/0118] CALENDER OF EVENTS & IMPORTANT DATA / 148

118 Journal Chemicals Management June 2009, No. 5 Sdu Uitgevers

Journaal JSP 5_09.indd 118 05-06-2009 10:00:59

Proceskleur Zwart
 articles
articles
Chemical Categories:
Filling data gaps by
Read-across and Trend
analysis
[2009/0098]
by Bob Diderich and Rob Visser
Abstract
The first step in making a hazard assessment
of a substance is to ensure that there is ade-
quate information on each of the endpoints. If
adequate information is not available then ad-
ditional data is needed to complete the dataset
for this substance. One approach is to consider
closely related chemicals as a group, or chemical
category, rather than as individual chemicals. In
the category approach, not every chemical needs
to be tested for every required endpoint. Rather,
the data for chemicals and endpoints that have
been tested are used to estimate the correspon-
ding properties for the untested chemicals and
endpoints. The overall category data and rati-
onale need be adequate to support a screening-
level hazard assessment.
The present document is a summary of the
OECD Guidance for Grouping of Chemicals
[http://appli1.oecd.org/olis/2007doc.nsf/linkto/
env-jm-mono(2007)28]
Explanation of the chemical category
approach
A chemical category is a group of chemicals
whose physico-chemical and human health
Sdu Uitgevers
Journaal JSP 5_09.indd 119
Proceskleur Zwart
and/or environmental toxicological proper-
ties and/or environmental fate properties are
likely to be similar or follow a regular pattern
as a result of structural similarity (or other
similarity characteristic). In principle, more
members are generally present in a chemi-
cal category, enabling the detection of trends
across endpoints. Categories of chemicals are
selected based on the hypothesis that the pro-
perties of a series of chemicals with common
structural features will show coherent trends
in their physicochemical properties, and more
importantly, in their toxicological (human
health/ecotoxicity) effects or environmental
fate properties. Common behaviour or con-
sistent trends are generally associated with a
common underlying mechanism of action, or
where a mechanism of action exhibits inten-
sity changes in a consistent manner across the
different members of a category.
The use of a category approach will mean that
it is possible to identify properties which are
common to at least some members of the ca-
tegory. The approach also provides a basis on
which to identify possible trends in properties
across the category. As a result, it is possible
to extend the use of measured data to similar
untested chemicals, and reliable estimates that
are adequate for classification and labelling
and/or risk assessment can be made without
further testing.
The assessment of chemicals by using a cate-
gory approach differs from the approach of
assessing them on an individual basis, since
the effects of the individual chemicals within
a category are assessed on the basis of the eva-
luation of the category as a whole, rather than
Any opinions expressed in this paper do not necessarily re-
present those of the Organisation for Economic Co-opera-
tion and Development (OECD) or its member countries.
Robert Diderich is Principal Administrator, Environment,
Health and Safety Division, Environment Directorate,
OECD, Paris, France; Dr. Robert Visser is Deputy Director,
Environment Directorate, OECD, Paris, France.
Rob Visser has presented this paper at the ChemCon Asia
2009 Conference in Kuala Lumpur 2-6 March 2009.
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based on measured data for any one particular
substance alone.
The successful use of a category approach
should lead to the identification and charac-
terisation (qualitative or quantitative) of the
hazards for all the members of the category.
A category of chemicals will often show the
presence, absence or modulation of a parti-
cular effect for all members of the category,
based on the presumption of a common me-
chanism of action. This can be expected to
apply to many different categories of chemi-
cals for many aliphatic hydrocarbons, alipha-
tic amines, nitriles, aldehydes, alcohols, and
ethers.
If the data for a category includes one or
more exceptions to the effects expected from
a common mechanism of action, a review of
the toxicological data for the category should
be able to explain the difference in behaviour.
The presence of such ‘outlying’ effects under-
lines the importance of developing an under-
standing of the (toxic) mechanisms of action
within categories.
In principle, a category is not endpoint-spe-
cific, since the structural changes across the
category would be expected to produce chan-
ges that would affect the whole spectrum of
properties of the individual members in a co-
herent and consistent manner. The changes in
properties across a category, for each parame-
ter, would be the result of related rather than
purely arbitrary differences. However, it is re-
cognised that in practice it may be possible to
identify the trends and changes for some but
not all of the properties of potential interest,
and hence it may not be possible to use a cate-
gory approach to identify all relevant effects.
For some series of compounds, the lower or
upper end of the series may show marked
changes in effects. At the lower end of the
series, the methyl analogue may have excep-
tional properties. Examples are the differences
shown in acute toxicity between methyl alco-
hol and ethyl alcohol, and for carcinogenicity
between butter yellow and its ethyl homolo-
120 Journal Chemicals Management June 2009, No. 5
Journaal JSP 5_09.indd 120
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redactionele bijdrage
articles
gue or between methylcarbamate and ethyl-
carbamate. This may be the result of specific
differences in metabolism, such as the dif-
ferences in carcinogenicity between benzene
and toluene, due to the possibility of meta-
bolism of the methyl group with carboxylate
formation.
The presence of a breakpoint can indicate a
change in the mode of action or the effect of a
consistent tendency across a category. In a ho-
mologous series of organic compounds, there
is often a breakpoint e.g. the loss of aquatic
toxicity as carbon chain length increases and
solubility decreases.
The importance of a common mechanism of
action is also a factor in deciding what che-
micals would not be expected to be relevant
members of a category. Variations in chemi-
cal structure can affect both toxicokinetics
(uptake and bioavailability) and toxicody-
namics (e.g. interactions with receptors and
enzymes). For example, the introduction of a
carboxylate or sulphate function often decre-
ases bioavailability and toxicity to mammals,
whilst halogen substituents tend to increase
lipophilicity and increase toxicological acti-
vity.
Approaches to data gap filling in chemical
categories
Within a chemical category, data gaps may
be filled by read-across, trend analysis and
QSARs. Read-across is a technique used to
predict endpoint information for one che-
mical by using data from the same endpoint
from another chemical which is considered to
be ‘similar’ in some way (on the basis of struc-
tural similarity and similar properties and/or
activities). For a given category endpoint, the
category members are often related by a trend
(e.g. increasing, decreasing or constant) in an
effect, and a trend analysis can be carried out
using a model based on the data for the mem-
bers of the category. Data gaps can also be
filled by an external QSAR model, where the
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 articles
Chemical 1 Chemical 2
Structure xxxxxx xxxxxx
Property 1
Property 2
Property 3
Activity 1
Activity 2
Activity 3
Existing data point Missing data point
Figure 1. Graphical representation of a chemical category and some approaches for filling data
gaps
category under examination is a subcategory
of the wider QSAR.
A chemical category can be described by a
matrix consisting of the category members and
by a corresponding set of properties and/or
effects data (the category endpoints). (See Fi-
gure 1).
In certain cases, the application of these tech-
niques to assess a particular chemical may
benefit from the generation of test data for
one or more other chemicals in the category.
In other words, the generation of additional
experimental data by strategic testing may be
useful.
In the read-across technique, endpoint infor-
mation for one chemical is used to predict the
same endpoint for another chemical, which is
considered to be ‘similar’ in some way (usu-
ally on the basis of structural similarity). A
chemical being used to make an estimate can
be referred to as a source chemical, whereas a
chemical for which an endpoint is being esti-
mated can be referred to as a target chemical.
Read-across can be qualitative or quantitative.
In qualitative read-across, the presence (or
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Proceskleur Zwart
Chemical 3 Chemical 4
xxxxxx xxxxxx
SAR/Read-across
Interpolation
Extrapolation
SAR/Read-across
Interpolation
Extrapolation
absence) of a property/activity for the target
chemical is inferred from the presence (or ab-
sence) of the same property/activity for one
or more source chemicals. Qualitative read-
across gives a ‘yes/no’ answer. In quantitative
read-across, the known value(s) of a property
for one or more source chemicals is used to
estimate the unknown value of the same pro-
perty for the target chemical. Quantitative
read-across is used to obtain a quantitative
value for an endpoint, such as a dose-response
relationship.
In principle, it is possible to predict the pre-
sence or absence of a property/effect by ap-
plying the read-across approach. Read-across
from a negative result is regarded as equally
valid and convincing as a positive result provi-
ded the test design, concentrations tested etc.
have been chosen adequately. For example, if
all tested chemicals of a category are shown
not to be mutagenic and if there is scientific
justification that the untested chemical rightly
belongs in the category, it is justified to as-
sume that the untested chemical is also not
mutagenic. However, if the mutagenicity test
system that has been used is inappropriate to
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demonstrate the genotoxicity of the group of
chemicals, then a conclusion that the category
would not be mutagenic would not be valid.
It is particularly important to adequately
justify read-across of negative findings. The
read-across approach is most robust when a
quantitative trend between the analogues can
be established.
It is important to provide supporting informa-
tion to strengthen the rationale for the read-
across. Thus, in addition to the property/
endpoint being read-across, it is also useful
to show that additional properties, relevant to
the endpoint, are also (qualitatively or quanti-
tatively) similar between the source and target
chemicals. Such properties could be known or
suspected determinants of the endpoint, or
they could be limiting factors.
Relevant molecular properties of the source
chemical should be of comparable value to
those of the target chemical. The selection of
relevant molecular properties depends on the
endpoint for which the read-across is being
performed. The identification of these pro-
perties could be based on expert knowledge,
or could be based on the use of properties
(molecular descriptors) that have been found
to be useful predictors of the endpoint in
QSAR models.
In the case of single substances, irrespective of
the endpoint being read-across, useful consi-
derations might include:
a) the presence or absence of additional func-
tional groups or substituents that could
influence the behaviour of a chemical;
b) similarity in physicochemical profiles (e.g.
MW, logKow, water solubility);
c) similarity in other toxicological and/or
ecotoxicological data;
d) the likely toxicokinetics of the substances,
including the possibility of different meta-
bolic pathways coming into play, needs to
be considered where possible;
e) information from valid (Q)SARs may be
used where possible to inform decisions
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Journaal JSP 5_09.indd 122
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articles
on the need, extent and type of additional
testing.
For a given category endpoint, the category
members are often related by a trend (e.g. in-
creasing, decreasing or constant). The trend
could be related to molecular mass, carbon
chain length, or to some other physicochemi-
cal property. For larger categories, it is possi-
ble that several different relationships can be
established for a single endpoint, thereby defi-
ning subcategories. A chemical that identifies
a turning point in a trend is called a break-
point chemical. Category members falling at
the opposite extremes of a trend and within
which interpolations are considered reliable
are called sentinel (boundary) chemicals.
A demonstration of consistent trends in the
behaviour of a group of chemicals is one of
the desirable attributes of a chemical category
and one of the indicators that a common me-
chanism for all chemicals is involved. When
some chemicals in a category have measured
values and a consistent trend is observed, mis-
sing values can be estimated by simple scaling
from the measured values to fill in the data
gaps.
The observation of a trend (increasing, decre-
asing or constant) in the experimental data for
a given endpoint across chemicals can be used
as the basis for interpolation and possibly also
extrapolation (see Figure 1). Interpolation is
the estimation of a value for a member using
measured values from other members on
‘both sides’ of that member within the defined
category spectrum, whereas extrapolation re-
fers to the estimation of a value for a member
that is near or at the category boundary using
measured values from internal category mem-
bers. Interpolation between measured analo-
gues may give a more reliable result depen-
ding on the reliability of the measured data.
Interpolation can be performed when the
series of values is monotonic (all increasing
or decreasing) or when non-monotonic (e.g.
parabolic). In such circumstances the extent
to which the available data describe the trend
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 articles
will determine the level of confidence in the
prediction.
When establishing trends in data, laboratory
and experimental variations should be consi-
dered. Similar species/strains, endpoints and
test protocols should be compared. Deviati-
ons from a trend should be clearly identified
and possible reasons for the deviations laid
out in the category analysis.
In principle, it is possible to predict the presen-
ce or absence of a property/effect by applying
trend analysis. The category approach is most
robust when a quantitative trend between the
category members can be established. A lack
of observed toxic effects for a chemical sub-
stance in a study of a specific endpoint (espe-
cially if no dose-relationship can be establis-
hed because no effects are observed at some
of the doses tested) requires further conside-
ration and. in such circumstances, the data
need to be carefully evaluated. It is important
to distinguish between cases where the lack of
response can be explained on the basis of the
mechanistic understanding for that endpoint,
or whether the tests have failed to demonstra-
te the absence of an effect for the category as
a whole.
The larger the category, the more likely that
there may be breaks in trends which may af-
fect the reliability of interpolation or extrapo-
lation. The observation of a ‘break’ in a trend
among some members of a category is a war-
ning sign, but is not necessarily an indication
that the chemicals with different trends exhibit
different toxicity pathways. Bioassay measure-
ments frequently are only comparable over a
narrow range of chemical properties with the
result that different pharmacodynamic factors
are controlling the bioassay results for diffe-
rent chemicals. The bilinear or multilinear na-
ture of trends in measured data, if observed,
can be used to confine the methods for scaling
intensity of the endpoint to specific members
of the category.
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General guidance on a stepwise procedure to
develop categories
In order to use the results from a category, it is
necessary to demonstrate that a chemical ca-
tegory is robust, and to do this, certain types
of information should be documented. In or-
der to collect this information in a systematic
and transparent manner, it is recommended
to follow a stepwise approach (Figure 2).
Step 0: Check whether the chemical is a mem-
ber of an existing category
Before considering whether to develop a ca-
tegory for a group of substances, the first
step should be to determine whether the
chemical(s) is (are) a named member of a
category that has already been evaluated. In-
formation sources on existing categories in-
clude:
a) US HPV Challenge Program
b) OECD HPV Chemicals Program.
The results from both programmes are acces-
sible via the OECD Global Portal to Informa-
tion on Chemical Substances (eChemPortal,
http://www.oecd.org/ehs/eChemPortal).
If the chemical is a member of a category that
has already been evaluated, its inclusion into
the new category should be justified. It is usu-
ally sufficient to refer to the evaluation of the
category when assessing the chemical, and to
refer to the results that have been agreed for
the category, taking account of the position of
the chemical in the category. Where new data
are available for some endpoints, these may be
used to verify the existing category and could,
depending on the results, lead to a revision of
the category.
In some cases, a relevant category may exist,
but where the chemical of interest has not
been specifically included in the category. In
this case, it would be appropriate to extend
the membership of the currently defined cate-
gory to include the chemical of interest.
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Step 1: Develop category hypothesis and
definition and identify category members
The first step in developing a category is to
develop a basis for the proposed grouping of
chemicals. The category definition should list
all of the substances and endpoints covered.
Chemical category definitions have referred
to chemical classes with a common functio-
nal group (e.g. epoxides) or chemicals with an
incremental and constant change across the
category (e.g. a chain-length category).
Although the chemical structure is usually
the starting point, a category definition could
also refer to a group of chemicals related by
a mechanism of action (e.g. non-polar nar-
cotics) or a particular property. In practice,
this particular property is largely related to
the chemical structure. For example, in the
case of hydrocarbon solvents, products were
separated into categories based on basic hy-
drocarbon structure – aliphatic or aromatic –
and then further separated based on boiling
ranges, carbon number, and other properties.
In some cases, the aliphatic hydrocarbon cate-
gories were further separated into subcatego-
ries based on specific aliphatic structure such
as normal or branched aliphatics.
Some categories have been defined in terms of
a metabolic pathway, i.e. they have a stepwise
metabolic pathway producing the different
members within the category with each me-
tabolic step.
In addition, the category definition should
describe the molecular structure a chemical
must have to be included in the category, in-
cluding criteria such as carbon chain length,
functionality, and chemical or metabolite
equivalence considerations.
It is possible to develop and propose a cate-
gory for a specific endpoint, or a selection of
endpoints, rather than for all of the endpoints
required for the substance in question, alt-
hough this restriction should only be applied
where strictly necessary. In particular, all the
endpoints that can be expected to be relevant
for the category should be included. Since a
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Journaal JSP 5_09.indd 124
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articles
category is based on an underlying hypothesis
of a common mechanism of action, the wi-
der the range of endpoints covered, the more
robust the results that are obtained from the
category approach.
The category hypothesis should also address:
a) the chemical similarities (analogies) and
trends in properties and/or activities that
collectively generate an association be-
tween the members. These features can be
regarded as the parameters that hold the
category members together.
b) the specific instances of read-across and
trend analysis (interpolations and extrap-
olations), and any specific computational
methods that have been used
c) the set of inclusion and/or exclusion rules
that identify the ranges of values within
which reliable estimations can be made
for category members for the given end-
point. These rules, can be described as the
applicability domain for an endpoint and
provide a means of extending the category
membership to chemicals not explicitly
included in the current definition of a cat-
egory.
Depending on the basis for the category, the
individual members of the category are iden-
tified.
It is important that information on the purity
and impurity profiles of all potential category
members is collected at the same time as de-
tails of the molecular structure. Differing pu-
rity or impurities could influence the overall
toxicity. For example, a category member may
contain a particularly toxic impurity that is
not present in the other substances making it
difficult or impossible to draw conclusions on
the toxicity of other substances in the category.
It is therefore important that category mem-
bers have similar purity profiles or, where they
differ, the effect of the differing purity profiles
is known.
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Step 2: Gather data for each category
member
For each member of the category, published
and unpublished data should be gathered on
physicochemical property(ies), environmen-
tal fate parameter(s), toxicological (human
health) and ecotoxicity (environmental spe-
cies) effect(s). This should include all exi-
sting relevant data and not be limited to the
endpoints that are mandatory within a given
programme. In some cases where estimated
data have been included in an internationally
accepted evaluation, these estimates can be
included on the same basis as other data that
have been critically evaluated.
Step 3: Evaluate available data for adequacy
Available data should be evaluated for its
adequacy using e.g. the OECD Guidance for
Determining the Quality of Data for the SIDS
Dossier (see section 3.1 of the OECD Manual
for Investigation of HPV Chemicals,
http://www.oecd.org/document/7/0,3343,en_
2649_34379_1947463_1_1_1_1,00.html).
In evaluating the available data for a category,
a number of additional factors will apply that
are not relevant when evaluating test results
for individual compounds.
– Different types of data may be available
for the same endpoint. It is clear that the
scope of the estimated results for a mem-
ber of a category cannot exceed the scope
of the underlying data for the other mem-
bers of the category, e.g. if for genotoxic-
ity, only in vitro results are available for
some members of the category (source
chemicals), only conclusions on in vitro
genotoxicity can be reached for the mem-
bers of the category for which experimen-
tal results are lacking (target chemical). If
the scope of the underlying experimental
results for an endpoint vary (e.g. a mix
of results from screening tests and high-
er tier tests), it is necessary to clarify the
scope of the estimated results for the cat-
egory members for which no experimen-
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Proceskleur Zwart
tal results are available. It may be possible
to apply a weight-of-evidence approach to
all the data, which could lead to the same
hazard identification for all the members
of the category, irrespective of the data
available for the individual compounds.
– An effect that is defined by a particular
numerical cut-off may lead to different
conclusions for individual compounds.
This type of data should be studied
carefully to ensure that the compounds
are evaluated in a way that reflects the
underlying trends across a category. For
instance, a series of compounds may give
rise to data that shows a borderline posi-
tive irritant effect for some members of
the category and a borderline negative
effect for others. The data should be care-
fully evaluated to decide whether (a) this
reflects accurately a trend across the whole
category or whether (b) the uncertainties
in the experimental data justify allocating
the compounds to different subcategories
(in this example, classifying some catego-
ry members as irritant and not classifying
others). If the second option is considered
as the most biologically plausible explana-
tion, the conclusion of the evaluation will
lead in some cases to a different conclu-
sion than that based on a simple evalua-
tion of the data taken in isolation. Hence,
a borderline positive effect can be inter-
preted as a negative effect in the light of
evidence from other compounds in the
category. Similarly, a borderline negative
effect can be interpreted as positive taking
into account the data from the whole cat-
egory.
– Where the data suggests possible break-
points, the data should be evaluated to
ensure that these reflect a genuine change
in properties or effects and are not due to
comparison of results from testing carried
out in different laboratories, at different
times, with different animal strains, etc.
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– The data set may contain an apparent out-
lier, i.e. one category member where there
are experimental data that shows the pres-
ence of an effect not seen in other category
members. This difference can be real, and
provide evidence of special conditions
relevant to the particular substance (e.g.
the chronic and reproductive toxicity of
hexane compared to other lower alkanes).
Such results need to be evaluated with par-
ticular care to establish whether the result
reflects a real difference in a mechanism of
action across the category or whether the
test result should be questioned.
Step 4: Construct a matrix of data
availability
A matrix of data availability (category end-
points vs. members) should be constructed
with the category members arranged in a
suitable order (e.g. according to molecular
weight). The ordering of the members should
reflect any trends or progression seen within
the category. The cells of the matrix should
indicate whether data are available or unavai-
lable. If possible, the cells should also indicate
the available reliable key study results.
Step 5: Perform a preliminary evaluation of
the category and fill data gaps
A preliminary assessment of the category
should be carried out to determine whether:
a) the category rationale is supported, i.e. the
category does in fact exhibit one or more
of trends postulated in Step 1; and
b) the category is sufficiently robust (i.e. con-
tains sufficient, relevant and reliable infor-
mation on the category members) for the
assessment purpose.
This assessment should be carried out for each
endpoint, as the category rationale may lead
to a relevant assessment for some endpoints
and not for others. This assessment is largely
a matter of expert judgement. Assessment of
the category rationale and robustness of the
category for the particular regulatory purpose
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Journaal JSP 5_09.indd 126
Proceskleur Zwart
articles
is closely related to the approach chosen for
filling data gaps for any particular endpoint. If
the initial assessment indicates that both cri-
teria are satisfied for a particular endpoint, the
data gaps can be filled.
In applying these techniques, the background
for the basis on which the category is formed
should be reflected in the way techniques are
chosen and applied. Hence for some effects,
where the test data suggest a uniform property
across a group, read-across from the existing
data would normally be considered appropri-
ate. In other cases, where there is a trend in
aquatic toxicity related to a change in logKow
and based on a narcotic mechanism of action,
the data gaps may be filled by data from a va-
lid QSAR for the category. Alternatively, the
category can be sub-divided into a number of
subcategories defined by the breakpoints in
the category, and members evaluated within
each subcategory.
If the initial category does not satisfy both of
these criteria, the following options should be
considered:
a) If further examination of the data sug-
gests that there is a pattern of effects for a
limited number of chemicals in the group,
then the analysis might suggest that the
category should be modified e.g. divided
into subcategories (return to step 1).
b) If adequate data do not exist, but the
structure-based category is reliable for
one or more endpoints, then a category
approach may still be proposed for these
endpoints. Testing of some chemical cat-
egory members for some endpoints would
still be necessary (go to Step 6). The choice
of chemicals and endpoints for testing
should be scientifically motivated, but is
also likely to involve animal welfare and
financial considerations, especially in the
case of more ‘expensive’ endpoints.
c) If there are adequate data for a given end-
point, but no apparent pattern, the pro-
posed category may not be appropriate
and so testing may be required for all re-
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 articles

Figure 2. Stepwise approach to category development

START

Step 0: Check whether

the chemical is a member YES
STOP
of a suitable category that
has already been defined

YES, but new data are available NO

Step 1: Develop category

hypothesis and definition,
and identify individual
members of the category

Step 2: Gather data for

Revise category by
each category member
adding and/or removing
members and/or
endpoints

Step 3: Evaluate available

data for adequacy

Step 4: Construct a
matrix of data availability

Not adequate

Not adequate Step 5: Perform a

preliminary evaluation of
Step 6: Propose and the category and fill data
perform testing gaps
Step 7: Perform a further
assessment of the category

Adequate Not adequate

Step 8: Document the

finalisedcategory and its Category approach
may not be feasible
rationale

STOP

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Proceskleur Zwart
 articles

maining category members for that end- Step 7: Perform a further assessment of
point (i.e. the category is abandoned). the category
If new test data are generated, the category
Step 6: Perform and/or propose testing should be revised and further assessment to
If the preliminary assessment supports the ca- determine whether the criteria outlined in
tegory rationale (i.e. a pattern or trend is ob- Step 5 are satisfied and therefore whether the
served), but the category does not appear to category can be finalised and documented. If
contain sufficient, relevant and reliable infor- the results support the category, the testing
mation to assess all category members, it may phase is complete and the chemical category
be necessary to perform or propose testing. can be finalised and documented. Remaining
In proposing additional testing, a number of data gaps can be filled. If the results do not
factors should be taken into consideration. support the category, further testing may be
– Since a category may contain com- carried out, members of the category may be
pounds of different production volumes, changed (e.g. dividing the category as appro-
the standard information requirements priate), or the category proposal may be drop-
may vary from compound to compound ped altogether. The latter implies that testing
within a category. However, there may be will then be done to fill all appropriate end-
strong scientific reasons that the recom- points for each category member.
mended testing should be conducted on
lower tonnage category member(s) in Step 8: Document the finalised category
order to identify the actual hazards of the The finalised category should be documented
category. in the form of a suitable reporting format.
– The choice of test will be influenced by
the results of the preliminary evaluation
of the category.
– If there are no data for any of the mem-
bers of a category for a particular end-
point, full testing of a limited number of
carefully selected category members may
be considered appropriate.
– When data are already available indicat-
ing the presence or absence of a particular
effect, tests may be chosen to provide evi-
dence that compounds selected for testing
show the effects that have been predicted
from the trend of the property. Hence, for
a substance in a category where e.g. skin
irritation is predicted, a simple in vitro test
would be sufficient to provide confirma-
tion of the effect.
When selecting a sample to test, it should be
representative of the substance marketed, in-
cluding the presence of any manufacturing
impurities.

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Proceskleur Zwart
 articles
Recent progress in
GHS implementation
– Republic of South
Korea
[2009/0099]
by Jeong-Sun Yang and Cheol Hong Lim
Amendment of relevant Korean legislation
The Industrial Safety and Health Act (ISHA)
which deals with classification and labelling
and safety data sheets was first revised in ac-
cordance with GHS in December 2006. The
Ministry of Environment (MOE) amended
the Toxic Chemical Control Act (TCCA) in
November 2007. The National Emergency
Management Agency (NEMA) newly pub-
lished the amendment of the Dangerous
Goods Safety Management Act (DGSMA)
implemented regarding GHS on November
2008. The major three authorities have fin-
ished the amendment of legislation in accord-
ance with GHS in Korea.
Transition period
ISHA : Until 30 June 2010 for substances and
30 June 2013 for mixtures. (Information on
the relevant Notice : www.kosha.or.kr/eng-
lish/legis/legis01_list.jsp?menuId=1)
TCCA : 30 June 2011 for substances and 30
June 2013 for mixtures
DGSMA : Labels according to IMDG or GHS
can be accepted. If GHS can’t cover DGs’ clas-
sified under DGSMA, DGSMA label should
be attached for the DGs.
Building blocks
Korea does not adopt all hazard classification
building blocks of GHS as is written in the
Purple Book. The building blocks which is not
same as the Purple Book are :
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– Flammable liquid : Category 1 ~ 3 (not
adopting 4)
– Acute Toxicity : Category 1 ~ 4 (not adopt-
ing 5)
– Skin Corrosion/Irritation : Category 1 & 2
(not adopting 1A, 1B, 1C and 3)
– Serious Eye Damage/Eye Irritation : Cat-
egory 1 & 2A (not adopting 2B)
– Aquatic Toxicity(Acute) : Category 1 (not
adopting 2, 3)
Other Hazards : Same as the Purple Book
Korea has a GHS inter-ministerial Committee
that has discussed the building blocks that it
adopts. Each ministry has its own responsibil-
ity to control each hazardous chemical. For ex-
ample, the management of flammable liquid
has been controlled under DGSMA for special
storage & transport regulations. The National
Emergency Management Agency (NEMA)
decide that they do not need to include flam-
mable liquid category 4 under DGSMA for
special management on storage and transport
of flammable liquid. TTCA under MOE also
excludes acute toxicity category 5 and aquatic
toxicity category 2&3 for the same reason.
Maximum number & size of pictograms in
label
Pictograms: 4 (The total size of pictograms
should be over 1/40 of the size of label. If the
number of pictograms is below 3, the total
size should be over 1/20)
Hazard & precautionary statements: 4 for each
Prevention, Response, Storage, Disposal
GHS implementation milestones (workplace
and others)
2005
– Research projects to analyze the impact of
GHS implementation
Dr. Jeong-Sun Yang is Director, Chemical Safety and
Health Research Center, Korea Occupational Safety and
Health Agency (KOSHA), #104-8 Munji-Dong, Yuseong-
Gu, Daejeon, s-Korea, yjs@kosha.net; limch@kosha.net
Journaal Stoffen en Preparaten juni 2009, Nr. 5 129
05-06-2009 10:01:02
 articles

– Creation of an inter-ministerial Commit- – Provide MSDS editing tools that could

tee to coordinate the process of harmo- compose GHS MSDS using MSDSs from
nization of existing legislation with the KOSHA.NET DB or customized MSDSs
GHS made by user through web or PC based
2006 Program
– Publication of the first edition of the GHS – Launching of a GHS classification and
in Korean labelling project for 5000 chemicals
– Amend Industrial Safety and Health Reg- – Launching of a GHS classification and
ulation labelling project for mixtures
– Amend Notification of Standard on the – Provide intensive GHS MSDS course or
Classification, Labelling and Material Safe- seminar to accelerate GHS implementa-
ty Data Sheet of Chemicals (12.12.2006, tion
The MOL public Notice No. 2008-01)
– Publication of Standard KSM 1069:2006
(Labelling of Chemicals based on GHS);
– GHS classification and labelling project
started for 910 regulated substances
2007
– Launching of a GHS classification and
labelling project for 2500 chemicals
– Providing open seminar and training pro-
gram for more than 2200 people
– Revision of the Toxic Chemical Control
Act in accordance with GHS
2008
– Amend Notice: Prolong transition peri-
od until 30 June 2010 for substance and
30 June 2013 for mixture (27 June 2008)
– Provide GHS classification information
for 3410 substances (information only,
not mandatory) through www.kosha.net):
(Korean, members only)
– Provide MSDS editing tools that could
compose GHS MSDS (in Korean) and
label (both in Korean and English)
– Build intensive GHS MSDS course under
KOSHA (16 hr, 10 times, 438 people)
– Amendment of the Dangerous Goods
Safety Management Act in accordance
with GHS
2009
– Provide GHS classification information
for 6314 substances (information only,
not mandatory) through www.kosha.net
(Korean, members only)

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Proceskleur Zwart
 actualities
actualities
EUROPEAN UNION
The Netherlands: Changes in
Product Registration
[2009/0100]
Companies introducing hazardous products
on the Dutch market are obliged to notify
product information to the National Poisons
Information Centre (NVIC).
The product information is used by the NVIC
to inform medical personnel (physicians, vet-
erinarians, pharmacists) about symptoms and
treatment of accidental intoxications with the
products. Especially knowledge of the exact
composition and toxicological properties of
the products is necessary to adequately per-
form this task.
Notification requirements
Article 45 of EU-GHS or CLP Regulation
1272/2008 (that will replace the Dangerous
Preparations Directive 1999/45/EC) states
that each European Member State must ap-
point an authority where information re-
garding hazardous mixtures must be notified.
The appointed authority is responsible for
supplying information intended for medical
purposes of a curative and preventive nature.
In the Netherlands, the National Poisons In-
formation Centre (NVIC) is appointed in the
Food and Drug Act Registration of Product
Information (Warenwetbesluit Deponering
informatie preparaten, Staatsblad 1996, 38) as
the competent authority to receive informa-
tion of hazardous products.
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Proceskleur Zwart
Those introducing hazardous products on the
market (both existing and new) are obliged to
notify information with the NVIC. Addition-
ally, changes in name and changes in compo-
sition need to be notified. Notification of date
of market withdrawal is voluntary. The imple-
mentation of the Act within industry will be
checked by the Food and Consumer Product
Safety Authority.
According to the Food and Drug Act Product
Information Sheet (Warenwetregeling Pre-
paraat Informatie Formulier, Staatsblad, 1996,
243) a special Product Information Sheet
should be used for notification and the com-
plete composition of a product should be no-
tified. Recent discussions with several Dutch
trade organisations to improve the product
notification by companies to the NVIC, led to
new guidelines for product notification.
New guidelines for product notification
An agreement was reached on both the re-
quired format of the product information and
about the requirements on the composition
of the notified products.
On the required format it was decided to ac-
cept a Material Safety Data Sheet (MSDS)
with additional information on the composi-
tion of the product. The MSDS and the ad-
ditional information can either be supplied as
two separate documents or combined in an
improved MSDS. It is also still possible to use
a Product Information Sheet. It is obligatory
that these documents meet the requirements
on composition and concentration as indi-
cated below.
Furthermore, all these documents can only
be supplied as pdf-files. Other file formats
(Word, Excel, etc.) will not be accepted.
On the requirements on the composition of
the product it was decided to stress the im-
portance of detailed information but to also
define the minimum requirements.
Companies should be aware that detailed in-
formation on the composition of a product
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05-06-2009 10:01:03

is essential to perform an adequate risk as-
sessment in case of an accidental intoxication
with their product.
– Optimal requirements:
Exact composition: all ingredients without
concentration threshold
Exact concentrations of all ingredients
– Alternative requirements:
Exact composition: all ingredients without
concentration threshold
Exact concentration for ingredients in hazard
class: T+, T, C, Xi, Xn. Translated in CLP this
corresponds to all health hazard classes.
Defined concentration ranges for the other
ingredients
– Minimum requirements:
Exact composition: all ingredients without
concentration threshold
Defined concentration ranges:
<0,1%, 0,1-1%, 1-5%, 5-10%, 10-20%, 20-
30%, 30-50%, 50-75%, 75-100%
Alternative: <0,1%, 0,1-1%, 1-5%, 5-10%, 10-
15%, 15-30%, 30-60%,60-100%
The internationally accepted chemical names
for the ingredients must be used with the cor-
responding CAS-numbers.
In exceptional cases products can be notified
in groups. For example with paints of different
colours and almost the same composition.
Reference: https://www.productnotification.nl/opn/
legislation.htm
Updated version of the EC
inventory and the ‘list numbers’
available
[2009/0101]
A new version of the EC inventory (version 1.1)
is now available for downloading at the IU-
CLID website. This version of the EC inven-
tory contains the whole of the European
INventory of Existing commercial Chemical
Substances (EINECS) and the No-Longer Pol-
ymer (NLP) inventories as published on ESIS.
132 Journal Chemicals Management June 2009, No. 5
Journaal JSP 5_09.indd 132
Proceskleur Zwart
actualities
In addition it contains the European LIst of
Notified Chemical Substances (ELINCS) in-
ventory numbers that were allocated up until
January 2009. Additional information such
as the chemical name is only present if pub-
lished in the 6th publication of ELINCS. This
updated version of the EC inventory contains
106 208 entries.
In addition, the ‘list numbers’ assigned to pre-
registered substances without a current EC
number have been gathered in two ‘list num-
bers’ IUCLID files. A first file contains 17087
substances that have been pre-registered with
a CAS number (series 600 of the ‘list num-
bers’) while the second file contains 22015
substances pre-registered as multi-constitu-
ent substances or with only a chemical name
as identifier (series 900 of the ‘list numbers’).
The ‘list numbers’ should be used to make the
registration of these substances easier.
Reference: The new EC inventory and the ‘list num-
bers’ IUCLID files can be downloaded
from http://iuclid.echa.europa.eu/index.
php?fuseaction=home.ecinventory
Nanomaterials: EU, Emergnano,
VCI & OECD reports
[2009/0102]
EU: regulatory aspects
The European Parliament is conducting
work in the area of nanomaterials. The ‘Re-
port on regulatory aspects of nanomaterials
(2008/2208(INI))’ of the Committee on the
Environment, Public Health and Food Safety
(7 April 2009) is available on the europar.eu-
ropa.eu website.
U.K.: Emergnano report
‘A review of completed and near completed en-
vironment, health and safety research on nano-
materials and nanotechnology’
The Emergnano report was commissioned
by Department for Environment, Food, and
Sdu Uitgevers
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 actualities
Rural Affairs (Defra) and prepared by a con-
sortium led by the Institute of Occupational
Medicine, to review the worldwide progress
made towards the environment, health and
safety research objectives set by the Nanote-
chnologies Research Co-ordination Group
(NRCG) in 2005. The NRCG co-ordinates and
develops the UK’s evidence base on nanotech-
nologies relating to environmental, health and
safety research. Emergnano considered the
completed and ongoing research into nano-
materials and nanotechnology between 2004
and 2008, making specific recommendations
for new research to further increase our un-
derstanding of engineered nanomaterials and
their effects. These will now be considered by
the NRCG who will work with funding part-
ners and other stakeholders to take forward
future research in the UK.
VCI: Responsible Production and Use of
Nanomaterials
German Chemical Industry Association (VCI):
Responsible Production and Use of Nanomate-
rials. 11 March 2008
OECD: Safety of Manufactured
Nanomaterials, No. 8
‘Preliminary Analysis of Exposure Measure-
ment and Exposure Mitigation in Occupational
Settings: Manufactured Nanomaterials, ENV/
JM/MONO (2009)6’ provides analyses and
recommendations as well as brief summary
of background documents listed. The report
is Number 8 of the Series on the Safety of
Manufactured Nanomaterials produced by
OECD’s Working Party on Manufactured Na-
nomaterials on the implications of the use of
nanomaterials for human health and environ-
ment safety, focusing on testing and assess-
ment methods.
References: http://www.europarl.europa.eu/
sides/getDoc.do?pubRef=-//EP//
NONSGML+REPORT+A6-2009-
0255+0+DOC+PDF+V0//EN
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Proceskleur Zwart
http://www.defra.gov.uk/environment/
nanotech/research/reports/index.
htm#emergano
http://www.chemikalia.gov.pl/files/
VCI_Nanomaterial_Papers_-_Comprehen-
sive_Document_(11.03.2008).pdf
http://www.oecd.org/data-
oecd/36/36/42594202.pdf
INTERNATIONAL
GHS third revised edition
[2009/0103]
The amendments adopted at the UN Decem-
ber 2008 session form the third revision of the
Purple Book. The GHS 3rd Revision will be
available in June 2009.
Reference: http://www.unece.org/trans/doc/2009/
ac10/ST-SG-AC10-36a3e.pdf
Safe Work Australia
[2009/0104]
At the 80th meeting of the Workplace Rela-
tions Ministers’ Council (WRMC) on 3 April
2009, Ministers noted the creation of the Safe
Work Australia Council. Ministers also noted
the creation of Safe Work Australia, the inde-
pendent body that will support the Council.
Outcomes of the meeting are available in the
WRMC Communiqué. Safe Work Australia
will be established as an Executive Agency
prescribed under the Financial Management
and Accountability Act 1997. An Intergovern-
mental Agreement for Regulatory and Op-
erational reform in Occupational Health and
Safety (IGA) formalises cooperation between
the Commonwealth, state and territory gov-
ernments on the harmonisation of occupa-
tional health and safety (OHS) legislation and
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05-06-2009 10:01:03

establishes appropriate governance arrange-
ments to support this cooperation.
Through a partnership of governments, em-
ployers and employees, the Safe Work Austral-
ia Council drives national policy development
on OHS and workers’ compensation matters
and specifically to: (a) achieve significant
and continual reductions in the incidence of
death, injury and disease in the workplace; (b)
achieve national uniformity of the OHS legis-
lative framework complemented by a nation-
ally consistent approach to compliance policy
and enforcement policy; and (c) improve na-
tional workers’ compensation arrangements.
Reference: http://www.safeworkaustralia.gov.au/swa/
New Zealand: Group Standard
Amendment Consultation
[2009/0105]
ERMA (Environmental Risk Management
Authority) New Zealand is commencing pub-
lic consultation on a proposed amendment
to the group standards. This amendment has
been requested by ACCORD Australasia Ltd.,
an organization that represents manufactur-
ers and distributors of consumer, cosmetic,
hygiene and specialty products. The proposal
affects a number of the group standards pub-
lished by ERMA New Zealand on 1 July 2006.
The applicant is seeking an amendment which
would extend the exemption from labelling
requirements of a group standard if a sub-
stance complies with:
1. The relevant current labelling requirements
of Australia, USA, Canada, the European Un-
ion or any other country as approved by the
Authority, as if the substances were for sale or
supply in those countries, and
2. The group standard requirement to pro-
vide the product name, 24 hour emergency
number, information on New Zealand im-
porter, supplier or manufacturer and direc-
tions for use.
134 Journal Chemicals Management June 2009, No. 5
Journaal JSP 5_09.indd 134
Proceskleur Zwart
actualities
The current exemption expires on 31 Decem-
ber 2010, the applicant is proposing that this
date is extended to 31 December 2020.
This public consultation is in accordance with
Part 6A of the Hazardous Substances and New
Organisms Act 1996. A copy of the consulta-
tion document is available from the website
http://www.ermanz.govt.nz/consultations/
amendgrpstnd.html. The closing date for sub-
missions on the proposed amendment to the
group standards is 5 June 2009.
Global Update on New Chemicals
Regulations (February-March
2009)
[2009/0106]
In February and March 2009, approximately
300 new regulations relating to chemicals ma-
nagement were adopted or published world-
wide. These involve implementation of GHS,
updates to chemical inventories, new priority
chemicals, several changes to the require-
ments on transport and handling, and last but
not least restrictions on the marketing and
use of chemicals.
The following overview (selection only) pro-
vides the indicative title in English and the
date of adoption. Further information on any
of these new regulations and what they requi-
re from industry can be found in the Enhesa
Update published by ENHESA (www.enhesa.
com). To be kept ahead of new policy initia-
tives and developments and their implications
on your business contact ENHESA at +32 2
775 9797.
Argentina
Limit to the content of lead in paints, lacquers
and varnishes adopted 13-Jan-2009
Order ANMAT 143/2009 on pesticide of ex-
clusive use in public health adopted 20-Jan-
2009
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 actualities
Buenos Aires Province: Resolution on the re-
covery of vegetable oils used for biodiesel is-
sued 19-Feb-2009
Limits on pollutants emissions, noise and ra-
diations from vehicles adopted 23-Feb-2009
Resolution 54 establishing quotas for the im-
port of ODS adopted 24-Feb-2009
Australia
NICNAS issues alert on Perfluorooctane sul-
fonate and Perfluoroalkyl sulfonate 01-Dec-
2008
Ozone depleting substances regulations
amended to include new offences and record-
keeping requirements 05-Feb-2009
Greenhouse gas emissions data under further
scrutiny 25-Feb-2009
Hazardous Substances Information System
(HSIS) being updated 01-Mar-2009
Austria
ADR 2009 published 27-Feb-2009
Brazil
Ordinance INMETRO on conformity assess-
ment of re-conditioned packaging for road
transport of dangerous goods adopted 19-
Dec-2008
Ordinance INMETRO on conformity assess-
ment of large packaging for road transport of
dangerous goods adopted 19-Dec-2008
Ordinance INMETRO on conformity assess-
ment of portable containers used in the road
transport of dangerous goods adopted 19-
Dec-2008
Requirements for toxicological test methods
for toys 27-Sep-2007
CONAMA composition and internal organi-
zation modified 10-Mar-2009
Bulgaria
Regulation on Classification, Labeling and
Packaging of substances and mixtures (CLP)
adopted 16-Dec-2008
Law on Protection from the Harmful Impact
of Chemical Substances and Preparations
amended 28-Sep-2007
Amended Annex III of the Convention on the
PIC Procedure for Certain Hazardous Chemi-
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Proceskleur Zwart
cals and Pesticides in International Trade is-
sued 20-Mar-2009
Canada
ONTARIO: Amendments to the Pesticides Act
to ban the use and sale of pesticides for cos-
metic purposes enter into force 22-Apr-2009
Regulations Adding Perfluorooctane Sulfo-
nate and Its Salts to the Virtual Elimination
List adopted 04-Feb-2009
Notice with respect to Batch 9 Challenge Sub-
stances published 14-Mar-2009
ONTARIO: Regulation 63/09 adopted to im-
plement the Cosmetic Pesticides Ban Act 2008
03-Mar-2009
Significant New Activity Notice No. 15274
adopted regarding lithium cobalt manganese
nickel oxide, CAS No. 182442-95-1 21-Feb-
2009
Significant New Activity Notice EAU-455
adopted regarding benzoic acid, 2-hydroxy-,
2-butyloctyl ester, CAS No. 190085-41-7
14-Feb-2009
Orders adopted to amend the Domestic Sub-
stances List and Non-domestic Substances
List 04-Mar-2009
Significant New Activity Notice No. 14503
adopted regarding aliphatic alkyl diester of
succinic acid 28-Feb-2009
BRITISH COLUMBIA: Recycling Regulation
amended with regard to an expanded list of
electronic products 10-Dec-2009
QUEBEC: 2007 fees on the marketing of pac-
kaging published 13-Mar-2009
Chile
Amendment to the Water Code issued 02-
Mar-2009
China
Regulation on Recycling and Treatment of
Discarded Electrical and Electronic Products
adopted 25-Feb-2009
National Standards published in 2008 30-Jan-
2009
2008 Update List of Air Environmental Pro-
tection Standards 01-Jul-2008
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05-06-2009 10:01:03

Regulation on Discarded Electric and Electro-
nic Products Recycling and Disposal publis-
hed 25-Feb-2009
Supervision and Inspection for Toys Import
and Export required 02-Mar-2009
Colombia
Decree 377 adopting the Stockholm Conven-
tion on Persistent Organic Pollutants issued
09-Feb-2009
Croatia
Act on General Safety of Products adopted
20-Feb-2009
Regulation on Management of Waste Elec-
trical and Electronic Devices and Equipment
(WEEE) amended 04-Mar-2009
Regulation on Management of Waste Batteries
and Accumulators amended 04-Mar-2009
Regulation on Management of Packaging and
Packaging Waste amended 05-Apr-2009
Regulation on Conditions and Manner of
Implementation of Security Measures for the
Storage of Explosives adopted 23-Feb-2009
Regulation on Amendments and Supplements
of the Regulation on Waste Oil Management
adopted 04-Mar-2009
Denmark
Statutory Order amending the Statutory Or-
der on shipment of waste has been adopted
27-Nov-2008
Statutory Order on batteries and accumula-
tors and discarded batteries and accumulators
has been adopted 11-Dec-2008
Statutory Order banning mercury in measu-
ring devices adopted 12-Feb-2009
Ecuador
Technical Standard on environmental decla-
rations and labeling issued 03-Mar-2009
Egypt
Amendment of Law No.4 of 1994 on Protec-
tion of the Environment published 01-Mar-
2009
Finland
Adopted a Decree repealing regulation 24(a)
of Decree 1512/1991 on radiation 26-Feb-
2009
136 Journal Chemicals Management June 2009, No. 5
Journaal JSP 5_09.indd 136
Proceskleur Zwart
actualities
Adopted a Decree on the transport of dange-
rous goods by road 04-Mar-2009
France
Environmental and safety requirements ap-
plying to installations storing or using organic
peroxides and subject to declaration adopted
10-Nov-2008
Notice relating to the approval of certain
combination packagings intended for the
transport of dangerous goods published
08-Feb-2009
Scope of the Order on the operation report of
classified installations amended 18-Feb-2009
Order on the limited cases where mercury,
cadmium, lead, chromium VI, PBB and PBDE
can be used in EEA amended 25-Feb-2009
Decree amending certain parts of the Labour
Code adopted 13-Mar-2009
Germany
HH: New version of the Act on Access to In-
formation published 27-Feb-2009
Srl: Ordinance on Inspections for Risk Avoi-
dance published replacing Ordinance on Fire
Inspections 26-Feb-2009
Th: Administrative Guideline Implementing
the Ordinance on Storage of Water Hazardous
Substances published 02-Feb-2009
Hungary
Decree on the authorization of transboundary
shipment of radioactive waste and spent fuel
adopted 21-Feb-2009
Indonesia
Technical Guidance and Monitoring Procedu-
re for the Implementation of Non CFC and/or
Non Halon Logos 14-Nov-2008
Ireland
The Arsenic, Cadmium, Mercury, Nickel and
Polycyclic Aromatic Hydrocarbons in Am-
bient Air Regulations 2009 adopted 12-Feb-
2009
Israel
Adopted Regulations to make environmental
information available to the public 02-Feb-
2009
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 actualities
Italy
Urgent Decree converted into ordinary law in-
troduces many changes in EHS requirements
30-Dec-2008
Renewal of personal licenses for the use of
toxic gases issued in the year 2004 02-Mar-
2009
Decree on procedures applicable to trans-
boundary shipments of radioactive waste and
spent nuclear fuel published 20-Feb-2009
National commission on best available tech-
niques issues four new guidance for IPPC in-
stallations 03-Mar-2009
Japan
Five new poisonous and ten deleterious sub-
stances added 08-Apr-2009
Abamectin, isotianil and metaldehyde desig-
nated as deleterious substances 08-Apr-2009
Latvia
Regulations on Registration Procedures of
Producers of Batteries and Accumulators
and on the Holder of the Registry amended
24-Mar-2009
Regulations regarding the Management of
Waste Electric and Electronic Equipment
amended 17-Feb-2009
Regulations on the Procedures for Registra-
tion of Producers of Electric and Electronic
Equipment amended 17-Feb-2009
Requirements on Environmental Monitoring,
Establishment of the Register of Polluting
Substances and Public Access to Information
adopted 17-Feb-2009
Lithuania
Order concerning chemicals records amended
04-Feb-2009
Luxembourg
Grand-Ducal Regulation on phytosanitary
measures for wood packaging material im-
ported from non-EU Member States amen-
ded 09-Mar-2009
Requirements on the transport of dangerous
goods by road (ADR 2009) published 19-Feb-
2009
Fire prevention requirements adopted
01-Mar-2009
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European Pollutant Release and Transfer Re-
gister implemented 13-Mar-2009
Malaysia
The Poisons (Amendment of Poisons List)
Order 2009 09-Feb-2009
Mexico
Clarification to NOM-004-SCT-2008 regar-
ding the identification system of units for
transport of substances, materials and hazar-
dous waste issued 26-Feb-2009
Clarification to the NOM-003-SCT-2008 on
characteristics of labels and packaging for
transport of hazardous substances, materials
and waste issued 26-Feb-2009
Agreement to establish the symbol ‘Made in
Mexico’ in products issued 23-Feb-2009
UNEP training programme on ecolabelling
launched 01-Apr-2009
Draft NOM-009-SCT2-2008 establishing
compatibility provisions for storage and trans-
port of explosives proposed 26-Mar-2009
Morocco
Circular on activation of the Implementing
Regulation to Law No.12-03 on Environ-
mental Impact Assessment of Projects issued
17-Mar-2009
Panama
National Implementation plan of the Stock-
holm Convention submitted 10-Feb-2009
Peru
Regulation on transparency, access to envi-
ronmental public information, public parti-
cipation and consultation on environmental
issues adopted 17-Jan-2009
Law on Water Resources adopted 31-Mar-
2009
Water law adopted 23-Mar-2009
Poland
Ordinance on public aid for environmental
management systems or implementation of
environmental product certificates adopted
08-Jan-2009
Act detailing REACH Regulation
EC/1907/2006 adopted 09-Jan-2009
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Portugal
Ordinance on phytosanitary measures revie-
wed 20-Nov-2008
Decree Law on plastic materials and articles
intended to come into contact with food
amended 02-Feb-2009
Romania
Decision on waste electrical and electronic
equipment adopted 19-May-2005
Russia
New Rules for conducting environmental ex-
pert assessment adopted 30-Oct-2008
Decree on Water Abstraction and Wastewater
Discharge Limits (Quotas) adopted 10-Mar-
2009
Adopted list of products for which fire safety
conformity certification is required 17-Mar-
2009
New State Standard on MSDS adopted
01-Jan-2009
Singapore
Amended the list of hazardous substances on
Environmental Protection and Management
Act 31-Jan-2008
Regulations on toxic industrial waste amen-
ded 20-Feb-2009
Slovakia
Order implementing Act on chemical sub-
stances and chemical preparations amended
15-Jan-2009
New Regulation on aerosol dispensers adop-
ted 28-Jan-2009
Slovenia
List of biocidal substances I, IA and IB amen-
ded 23-Jan-2009
Decree on Disposal of Polychlorinated Biphe-
nyls and Polychlorinated Terphenyls amended
29-Jan-2009
Decree on Environmental Tax for Environ-
mental Pollution Due to Use of Volatile Orga-
nic Compounds amended 19-Feb-2009
South Africa
National Environmental Management: Waste
Act, 2008 adopted 10-Mar-2009
138 Journal Chemicals Management June 2009, No. 5
Journaal JSP 5_09.indd 138
Proceskleur Zwart
actualities
South Korea
Life-cycle assessment of products required
06-Apr-2009
GHS classification and labeling determined
for 2,2’dimethylbenzidine and butanenitrile
26-Mar-2009
Asbestos cosmetics and asbestos pharmaceu-
ticals under fire 03-Apr-2009
Spain
Order on the marketing restrictions of certain
measuring devices containing mercury adop-
ted 06-Feb-2009
Sweden
Ordinance (SFS 2005:209) on producer res-
ponsibility for electrical and electronic pro-
ducts amended 01-Jan-2009
Ordinance on producer responsibility for bat-
teries enters into force 01-Jan-2009
Amendments to Regulation (1998:944) prohi-
biting the import and placing on the market
of products that contain dimethylfumarate
(DMF) 31-Mar-2009
Taiwan
Life cycle analysis taken into account for re-
source recycling and reuse 21-Jan-2009
Chemicals under Chemical Weapon Conven-
tion added to the List of Strategic High-Tech
Commodities for export control 26-Dec-
2008
Import permit required for potassium chlo-
rate and potassium perchlorate 22-Jan-2009
Environmental impact assessment informa-
tion disclosure required for concerned deve-
lopment projects 11-Mar-2009
Thailand
Land Transportation Act entered into force
30-Jan-2008
Turkey
Notification on Import of Chemical Substan-
ces Attached to the Chemical Weapons Agree-
ment 2009/17 amended 31-Dec-2008
Regulation on Professional Proficiency Trai-
ning for Transport Activities on Roads amen-
ded 20-Feb-2009
Sdu Uitgevers
05-06-2009 10:01:04
 actualities

Notification on the Control of Chemicals due for a Commission determination or exclusion

to Environmental Protection 2009/6 amended 11-Mar-2009
to delete Annex 1/B 31-Dec-2008 CALIFORNIA: Adopted Best Management
Turkey ratified the Kyoto Protocol 17-Feb- Practices for Perchlorate 31-Dec-2009
2009 Consumer Products and Safety Commission
Ukraine withdraws proposed exemptions for lead con-
Adopted Technical Regulation on Simple taining children’s electronics and issues new
Pressure Vessels 25-Mar-2009 exemptions 09-Feb-2009
United Kingdom Vietnam
ENG/SCOT/WALES: Adopted the Health and Circular guiding strategic environmental as-
Safety at Work etc. Act 1974 (Application to sessment, environmental impact assessment
Environmentally Hazardous Substances) and environmental protection commitment
(Amendment) Regulations 2009 17-Feb-2009 adopted 08-Dec-2008
ENG, WAL: The Renewables Obligation Or- Decree implementing the Law on products
der 2009 adopted 24-Mar-2009 and goods quality adopted 31-Dec-2008
Adopted the Fluorinated Greenhouse Gases
Regulations 2009 04-Feb-2009
ENG,WAL,SCOT: Adopted the Ozone-Deple-
ting Substances (Qualifications) Regulations
2009 04-Feb-2009
ENG: Adopted the Environmental Damage
(Prevention and Remediation) Regulations
2009 29-Jan-2009
ENG: The Hazardous Waste (England and
Wales) (Amendment) Regulations 2009 adop-
ted 10-Mar-2009
The Restriction of the Use of Certain Hazar-
dous Substances in Electrical and Electronic
Equipment (Amendment) Regulations 2009
adopted 11-Apr-2009
ENG, SCO, WAL: The Health and Safety (Mis-
cellaneous Amendments and Revocations)
Regulations 2009 adopted. 16-Apr-2009
ENG, SCO, WAL: The Chemicals (Hazard In-
formation and Packaging for Supply) Regula-
tions 2009 adopted 16-Mar-2009
United States
CALIFORNIA: Adopted amendments to con-
solidate universal waste regulations and au-
thorized treatment of electronic hazardous
waste regulations 13-Feb-2009
TEXAS: Adopted remediation standards for
leaking aboveground and underground stora-
ge tanks 21-Nov-2008
Adopted rules regarding children’s products
containing lead: procedures and requirements

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Journaal JSP 5_09.indd 139 05-06-2009 10:01:04

Proceskleur Zwart
 publications

climate change consultancy, AEA, has been

commissioned by the Department for Com-
munities and Local Government (CLG) to
publications produce the Dangerous Goods Emergency
Action Code List 2009, published by The Sta-
tionary Office (TSO). The 2009 edition of the
Dangerous Goods Emergency Action Code
BOOKS List outlines the application of appropriate
Hazchem Emergency Actions Codes (EACs)
in Britain. The list is an essential compliance
REACH + GHS, 3. Auflage document for the emergency services, local
government and for those who may control
[2009/0107] the planning for, and prevention of, emergen-
cies involving dangerous goods NCEC has
REACH-Verordnung; Einführung zur REACH- been at the heart of the UK EAC system since
Verordnung; REACH-Gebührenverordnung; its inception in the early 1970s, and until 1996
GHS-Verordnung; Stoff-Richtlinie. Stand: 15. published the list of codes on behalf of the
Januar 2009 UK Government. This task then passed on to
560 pages (in German), Lexxion, Berlin, Ger- various Government Departments before an
many (2009), ISBN 978-3-939804-72-7 agreement was reached in late 2008 for NCEC
Reference: http://www.lexxion.de/stoffrecht. to resume managing the publication.
html#REACH The EAC List 2009 supersedes the 2007 list
and is effective from 1 July 2009. The 2007 List
should no longer be used from that date.
ADR 2009. Vervoer van gevaarlijke Duty holders are required to use the 2009 EAC
stoffen over de weg. VLG/ADR List for the application of the appropriate
EACs under the Carriage of Dangerous Goods
[2009/0108] and Use of Transportable Pressure Equipment
Regulations 2009 (CDG 2009) – also effective
ADR 2009. Vervoer van gevaarlijke stoffen from 1st July 2009. These regulations imple-
over de weg. VLG/ADR, redactie: mr. J.G. ment the Regulations Concerning the Inter-
Buissing. 2 volumes, 1340 pages (in Dutch). national Carriage of Dangerous Goods by Rail
Sdu Uitgevers, ’s-Gravenhage (2009), ISBN (RID), and the European Agreement Con-
978-90-125-8097-7. cerning the International Carriage of Danger-
Reference: http://www.sdu.nl/catalo- ous Goods by Road (ADR).
gus/9789012580977 As well as the published volume, a free PDF
download of the publication will be made
available from the NCEC website.
The Dangerous Goods Emergency Reference: http://the-ncec.com/the-dangerous-goods-
Action Codes List 2009 emergency-action-codes-list-2009/

[2009/0109]

NCEC (National Chemical Emergency Cen-

tre), the UK’s national response unit for
chemical emergencies, and part of energy and

140 Journal Chemicals Management June 2009, No. 5 Sdu Uitgevers

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Proceskleur Zwart
 publications
INTERNET
Pesticide Action Network UK List
of Lists
[2009/0110]
The List of Lists – 3rd edition, 2009, a cata-
logue of lists of pesticides identifying those as-
sociated with particularly harmful or environ-
mental impacts by the Pesticide Action Net-
work UK provides a reference for identifying
those pesticides associated with particularly
harmful health and environmental impacts.
Compiled primarily from official sources,
such as the World Health Organisation, and
the US Environmental Protection Agency, it
also includes several lists from public interest
organisations which have been influential in
drawing attention to hazardous pesticides.
Reference: http://www.pan-uk.org/List%20of%20
Lists.html
CEFIC ERICards
[2009/0111]
The CEFIC Emergency Response Intervention
Cards (ERICards or ERIC’s) provide guidance
on initial actions for fire crews when they first
arrive at the scene of a chemical transport ac-
cident without having appropriate and reli-
able product specific emergency information
at hand.
ERICards may be reproduced without further
permission provided that: the cards are repro-
duced in their entirety, without alteration; no
copies of cards are being sold; due reference is
made to the guiding principles for the use of
the cards and to the disclaimer.
Update 10 April 2009: ERICards have been
brought in line with ADR 2009 by introducing
new UN entries and by adapting classification
data for a number of substances.
Sdu Uitgevers
Journaal JSP 5_09.indd 141
Proceskleur Zwart
Note that ERICards cannot be used as ‘In-
structions in writing’ for the driver (ADR Sec-
tion 5.4.3).
Reference: http://www.ericards.net/
CAS Common Chemistry
[2009/0112]
Common Chemistry from Chemical Ab-
stracts Service (CAS) is a web resource that
contains CAS Registry Numbers for approxi-
mately 7800 chemicals of widespread general
public interest. Common Chemistry is helpful
to non-chemists who know either a name or
CAS Registry Number of a common chemical
and want to pair both pieces of information.
The CAS Registry Number is the universally
recognized unique identifier of chemical sub-
stances and is often found on packaging and
on articles of commerce.
While not a comprehensive CAS Registry
Number lookup service, Common Chemistry
does provide a way to quickly and easily find
names or CAS Registry Numbers for chemi-
cals of general interest.
CAS has collaborated with Wikipedia in devel-
oping this resource and encourages you to use
the Wikipedia link (when available) or other
sources of general information on chemistry,
to learn more about these chemicals.
Reference: http://www.commonchemistry.org/
Journaal Stoffen en Preparaten juni 2009, Nr. 5 141
05-06-2009 10:01:04

official
publications
The Netherlands (Period April
2009)
[2009/0113]
Tractatenblad 2009, 67: Verdrag van Rotter-
dam inzake de procedure met betrekking tot
voorafgaande geïnformeerde toestemming
ten aanzien van bepaalde gevaarlijke chemi-
sche stoffen en pesticiden in de internationale
handel
[… Satisfied that all the requirements for listing in Annex
III of the Rotterdam Convention have been met with re-
spect to tributyltin compounds,
1. Decides to amend Annex III of the Rotterdam Conven-
tion to list the following chemicals in the three columns
after the entry for ‘Toxaphene’: All tributyltin compounds
(Category Pesticide), including: Tributyltin oxide CAS
56-35-9; Tributyltin fluoride CAS 1983-10-4; Tributyltin
methacrylate CAS 2155-70-6; Tributyltin benzoate CAS
4342-36-3; Tributyltin chloride CAS 1461-22-9; Tribu-
tyltin linoleate CAS 24124-25-2; Tributyltin naphthenate
CAS 85409-17-2;
2. Decides that this amendment shall enter into force for all
Parties on 1 February 2009. …]
Kamerstuk 2008-2009, 21501-08, nr. 305,
Tweede Kamer: Milieuraad; Brief minister
over de belangrijkste ontwikkelingen in het
REACH dossier
Kamerstuk 2008-2009, 31894, nr. 5, Tweede
Kamer: Uitbreiding en wijziging van de Wet
milieubeheer in verband met de uitvoering
van de verordening (EG) nr. 1272/2008 van
het Europees Parlement en de Raad van de
Europese Unie van 16 december 2008 betref-
fende de indeling, etikettering en verpakking
van stoffen en mengsels en tot wijziging en
intrekking van de Richtlijnen 67/548/EEG
142 Journal Chemicals Management June 2009, No. 5
Journaal JSP 5_09.indd 142
Proceskleur Zwart
official publications
en 1999/45/EEG en tot wijziging van Veror-
dening (EG) nr. 1907/2006 alsmede daarmee
samenhangende wijzigingen van andere wet-
ten (Uitvoeringswet EG-verordening inde-
ling, etikettering en verpakking van stoffen en
mengsels)
Staatsblad 2009, 195: Besluit van 16 april
2009, houdende wijziging van het Besluit
organisch-halogeengehalte van brandstoffen,
het Besluit overige niet-meldingplichtige ge-
vallen bodemsanering en het P.C.B.-P.C.T.- en
chlooretheen-besluit milieubeheer in verband
met een wijziging van de Wet verontreiniging
zeewater (wijziging amvb’s vanwege wijziging
Wet verontreiniging zeewater)
Staatsblad 2009, 199: Wet van 29 april 2009
tot wijziging van de Waterschapswet, de Wet
verontreiniging oppervlaktewateren en de
Wet modernisering waterschapsbestel, tot
aanbrenging van verbeteringen van wetstech-
nische en inhoudelijk ondergeschikte aard
Staatscourant 2009, 74: Besluit van de Minis-
ter van Sociale Zaken en Werkgelegenheid van
25 maart 2009, nr. G&VW/AA/2009/6681, tot
wijziging van de Beleidsregel arbocatalogi in
verband met de toevoeging van enkele nieuwe
arbocatalogi
Staatscourant 2009, 80: Regeling van de Mi-
nister van Sociale Zaken en Werkgelegenheid
van 17 april 2009, nr. AI//2009/7285, houden-
de de inrichting van de directie AI Major Ha-
zard Control alsmede de toedeling van taken
en vertegenwoordigingsbevoegdheden aan de
onder de directeur ressorterende functionaris-
sen (Organisatie-, mandaat- en volmachtbe-
sluit directie AI Major Hazard Control 2009)
Staatscourant 2009, 80: Regeling van de Mi-
nister van Volksgezondheid, Welzijn en Sport
van 15 april 2009, VGP/PSL 2923751, hou-
dende tijdelijke regels inzake producten die
dimethylfumaraat [dimethylfumarate, CAS
624-49-7] bevatten ter uitvoering van beschik-
king 2009/251/EG (Warenwetregeling DMF)
Sdu Uitgevers
05-06-2009 10:01:04
 official publications
Belgium (Period April 2009)
[2009/0114]
Belgisch Staatsblad 27 april 2009, Editie N.
145: Koninklijk besluit tot wijziging van het
koninklijk besluit van 5 juli 2006 betreffende
de aanwijzing en de beroepsbekwaamheid van
veiligheidsadviseurs voor het vervoer van ge-
vaarlijke goederen over de weg, per spoor of
over de binnenwateren,
Belgisch Staatsblad 30 april 2009, Editie N.
152: Koninklijk besluit tot instelling van een
systeem voor de identificatie en de traceer-
baarheid van springstoffen voor civiel ge-
bruik
Belgisch Staatsblad 8 mei 2009, Editie N.
161: Ministerieel besluit van 6 mei 2009 tot
wijziging van de bijlage I van het koninklijk
besluit van 22 mei 2003 betreffende het op de
markt brengen en het gebruiken van biociden,
met het oog op de opname van tebuconazool
[CAS 107534-96-3] en thiabendazool [CAS
148-79-8]
[Implementation of 2008/85/EC and 2008/86/EC]
United Kingdom (Period April
2009)
[2009/0115]
by Dr Ross Fielding
The Chemicals (Hazard Information and
Packaging for Supply) Regulations 2009
The UK Competent Authority (HSE) has
produced a ‘Transition Note’ for CHIP4. This
explains the background to the package of
amendments in the CHIP regulations (CHIP4)
that came into force on 6 April 2009. These in-
clude enforcing Regulations for the European
Classification, Labelling and Packaging Regu-
lation (the ‘CLP Regulation’), changes which
have been required as a result of implement-
ing the Council Directive 2006/121/EC and
Sdu Uitgevers
Journaal JSP 5_09.indd 143
Proceskleur Zwart
Article 43 of Regulation (EC) No 1272/2008.
The revocation of the ‘notification of new
substances’ (NONS) scheme and changes in
the provision of safety data sheets which have
been given effect as part of the UK arrange-
ments for enforcing REACH, through the
REACH Enforcement Regulations 2008 (SI
2008 No. 2852). Also, concerning the classifi-
cation and labelling of substances – they ad-
just the references to the test methods follow-
ing repeal of Annex V of Directive 1967/548/
EEC (the ‘Dangerous Substances Directive’),
and their reinstatement through a new Com-
mission Regulation.
Reference: http://www.hse.gov.uk/aboutus/further-
info/policy/transposition/tn220409.htm
CHIP4 Approved Classification and
Labelling Guide
The approved classification and labelling
guide provides guidance on the CHIP regula-
tions. This is a document that is updated as
the regulations are revised. It has previously
only been available to purchase from HSE
Books.
The latest version of the guide (6th Edition,
April 2009) has been updated for CHIP4 and
is currently available free to download.
Reference: http://www.hse.gov.uk/chip/classification.
pdf
REACH
The UK REACH Competent Authority Steer-
ing Committee has established the process and
criteria by which substances can be proposed
for authorisation, restriction, evaluation or
harmonised classification and labelling.
The UK Competent authority has also pro-
duced two guidance notes.
One for companies who have pre-registered
substances under REACH and are now au-
tomatically part of a Substance Information
Exchange Forum (SIEF). The UK Competent
Authority is not involved in the operation of
SIEFs; however this leaflet is a starting point
to help UK business to understand things
Journaal Stoffen en Preparaten juni 2009, Nr. 5 143
05-06-2009 10:01:04

what they should consider when operating
within a SIEF.
Another is a starting point to help understand
what needs to do to fulfil registration duties
under Registration, Evaluation, Authorisation
& restriction of Chemicals (REACH).
References: http://www.hse.gov.uk/reach/substances.
htm
http://www.hse.gov.uk/reach/
resources/17sief.pdf
http://www.hse.gov.uk/reach/
resources/16registration.pdf
Working Group on Action to Control
Chemicals (WATCH)
Papers and minutes from the most recent (17
June 2008) meeting of the sub-committee of
the Advisory Committee on Toxic Substances
are now available.
Reference: http://www.hse.gov.uk/aboutus/meetings/
iacs/acts/watch/170608/agenda.htm
Natural Gas Storage (COMAH)
The COMAH Competent Authority (com-
prising of the Health and Safety Executive,
Environment Agency and the Scottish Envi-
ronmental Protection Agency) has recently
concluded that the on-shore storage of natu-
ral gas in underground natural strata, such as
depleted reservoirs, is subject to the Control
of Major Accident Hazards Regulations 1999
(COMAH). This decision was effected from
26 February 2009.
The decision follows an announcement by the
European Commission in October 2008 that
it expects Member States to apply the Seveso
II Directive (96/83/EC) to such storage sites
to ensure that equivalent regulatory require-
ments apply across the European Union. The
Directive is implemented in Great Britain
through the COMAH Regulations.
Underground storage sites will come within
the scope of COMAH if the quantity of natu-
ral gas stored meets or exceeds the thresholds
in Schedule 1, Part 2 of the Regulations i.e. 50
tonnes (lower tier) and 200 tonnes (top tier).
144 Journal Chemicals Management June 2009, No. 5
Journaal JSP 5_09.indd 144
Proceskleur Zwart
official publications
In practice, all sites are likely to be top tier
sites.
The decision means that the same regulatory
regime applies to storage in man-made (salt)
caverns and natural strata.
Reference: http://www.hse.gov.uk/comah/gasstorage.
htm
Biocidal Products
A guide has been produced for applicants who
wish to seek product authorisation for biocid-
al products.
Reference: http://www.hse.gov.uk/biocides/bpd/pdfs/
applicationguide.pdf
Chemical Carcinogens Workshop Report
The report of a stakeholder workshop in June
2008, involving technical experts, academics,
union representatives, industry experts, in-
dustry associations and government depart-
ments which sought agreement on criteria
for setting priorities for future activities and
possible interventions to tackle the risk of
exposure to chemical carcinogens has been
published.
Reference: http://www.hse.gov.uk/drp/workshop08.
pdf
A Report on the State of Hazardous Product
Labelling and Packaging in the UK
The Chemical Hazards Communication So-
ciety (CHCS) has made available the report
of a specially commissioned, independent,
systematic, objective and quantitative review
of the state of hazardous product labelling in
the UK.
Broadly, the objective of the research was to
determine the overall fitness for purpose of
product labelling and packaging. i.e.: Do the
labels convey adequate, relevant and useful
information, and is the packaging ‘adequate’
bearing in mind the hazardous properties of
the contents? And also to assess the level of
detailed compliance with the CHIP regula-
tions (accuracy).
Sdu Uitgevers
05-06-2009 10:01:05
 official publications
The study sampled 50 products that were of
a type that might be found in any home. The
sampling was directed towards purchase of
‘common, inexpensive high volume products’
from ‘big name’ high street stores and super-
markets. It was, perhaps, to be expected that
these products would exhibit a high level of
compliance. In terms of fitness for purpose,
this is indeed what was found and the report
concludes that the labelling of leading brand
products, on sale to the general public in the
UK is mostly safe.
However in detail nearly all (98%) were de-
ficient. The deficiencies were largely (but not
always) of a trivial nature. The main areas of
concern were the incorrect and unnecessary
use of Safety phrases and the use of chemi-
cal names. In themselves these are not failures
that significantly impact upon the safe use of
the products, but the fact that the defects were
so numerous, and so common is evidence of
a systematic failure on the part of the product
suppliers and manufacturers to properly un-
derstand and implement the detailed technical
requirements set out in the CHIP regulations.
More worryingly, even in the relatively small
sample, a small number of potentially dan-
gerous cases where important hazard, risk, or
safety advice was missing were found.
The survey was unable to pass much com-
ment on the classification of any product,
but the fact that so many minor, a small but
significant number of more serious and such
a wide range of deficiencies were detected by
the survey, is indicative that quite possibly
even greater failings exist.
The findings are interpreted as evidence of
a widespread, poor understanding of, or lax
and casual application of what the regulations
require, and partly to the complexity of the
regulations.
There may also be an over dependence on
computer database systems (and their suppli-
ers) for deriving classification and developing
label content. Such systems possibly either
contain data that has not been sufficiently well
Sdu Uitgevers
Journaal JSP 5_09.indd 145
Proceskleur Zwart
checked for errors or allow users to change
data that should not be changed.
The solution is that both more training and
also simpler, more direct and less ambiguous
regulations are required. It is a matter of con-
jecture whether or not these will ever be deliv-
ered. Certainly in the latest (and last) edition
of the CHIP regulations this is not the case.
While the latest CHIP regulations combine
and consolidate all earlier versions, they do
not offer any simplification.
The report will be of interest to all who are
involved in the supply of chemical products in
the UK, and since the UK classification and la-
beling and packaging requirements are based
upon the EU scheme set out in the Dangerous
Substances and Dangerous Preparations Di-
rectives, it will also be of interest to the wider
European community.
The report from that study is now available
(for a limited period) free to download from
the CHCS web site.
Reference: http://www.chcs.org.uk/reports/chcs-label-
project-report-0309.pdf
European Union (Period April
2009)
[2009/0116]
O.J. 2009, L96: Commission Regulation
(EC) No 304/2009 of 14 April 2009 amend-
ing Annexes IV and V to Regulation (EC)
No 850/2004 of the European Parliament
and of the Council as regards the treatment
of waste containing persistent organic pollut-
ants in thermal and metallurgical production
processes
O.J. 2009, L96: Commission Decision
2009/324/EC of 14 April 2009 concerning the
non-inclusion of certain substances in Annex I,
IA or IB to Directive 98/8/EC of the European
Parliament and of the Council concerning the
placing of biocidal products on the market
Journaal Stoffen en Preparaten juni 2009, Nr. 5 145
05-06-2009 10:01:05

(Product-type 18 (Insecticides, acaricides
and products to control other arthropods):
Propoxur [CAS114-26-1], Fenitrothion [CAS
122-14-5], 5,5-dimethyl-perhydro-pyrimi-
din-2-one.alpha.-(4- trifluoromethylstyryl)-.
alpha.- (4-trifluoromethyl)cinnamylide-ne-
hydrazone/Hydramethylnon [CAS 67485-29-
4];
Product-type 19 (Repellents and attractants):
Linalool [CAS 78-70-6], Methyl anthranilate
[CAS 134-20-3], Oct-1-ene-3-ol [CAS 3391-
86-4])
O.J. 2009, L97: Commission Regulation (EC)
No 308/2009 of 15 April 2009 amending, for
the purposes of adaptation to scientific and
technical progress, Annexes IIIA and VI to
Regulation (EC) No 1013/2006 of the Euro-
pean Parliament and of the Council on ship-
ments of waste
O.J. 2009, L98: Commission Directive
2009/36/EC of 16 April 2009 amending Coun-
cil Directive 76/768/EEC, concerning cosmetic
products, for the purpose of adapting Annex
III thereto to technical progress
[… In Part 1 of Annex III the reference numbers 189 – 205
(hair dye substances …) are added …]
O.J. 2009, L103: Corrigendum to Commis-
sion Directive 2009/36/EC of 16 April 2009
amending Council Directive 76/768/EEC,
concerning cosmetic products, for the pur-
pose of adapting Annex III thereto to techni-
cal progress
O.J. 2009, L114: Directive 2009/3/EC of the
European Parliament and of the Council of
11 March 2009 amending Council Directive
80/181/EEC on the approximation of the
laws of the Member States relating to units of
measurement
USA (Period April 2009)
[2009/0117]
Federal Register, 23 April 2009, Vol. 74,
No. 77: Second Draft Risk and Exposure As-
146 Journal Chemicals Management June 2009, No. 5
Journaal JSP 5_09.indd 146
Proceskleur Zwart
official publications
sessment Report for Sulphur Dioxide (SO2).
Environmental Protection Agency (EPA). No-
tice of second draft report for public review
and comment.
Federal Register, 6 May 2009, Vol. 74, No. 86:
Organic Arsenicals; Amendment to Reregis-
tration Eligibility Decision
[This notice announces EPA’s decision to modify certain
provisions of the 2006 Reregistration Eligibility Decision
(RED) for the organic arsenical pesticides monosodium
methanearsonate (MSMA), disodium methanearsonate
(DSMA), calcium acid methanearsonate (CAMA), and ca-
codylic acid and its sodium salt. EPA has reached an agree-
ment in principle with the technical registrants of these
pesticides to implement the 2006 RED, which is being re-
vised in part under the terms of the agreement for these
pesticides. The Agency’s revisions to the organic arsenicals
RED reflect public comments received during the com-
ment period on the RED and new data and information
submitted by the registrants and other stakeholders.]
Federal Register, 7 May 2009, Vol. 74, No. 87:
Draft Toxicological Review of 1,4- Dioxane
[CAS 123-91-1]: In Support of the Summary
Information in the Integrated Risk Informa-
tion System (IRIS)
Federal Register, 7 May 2009, Vol. 74,
No. 87: Draft Toxicological Review of Pen-
tachlorophenol [CAS 87-86-5]: In Support of
the Summary Information in the Integrated
Risk Information System (IRIS)
Sdu Uitgevers
05-06-2009 10:01:05
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ISSN 1574-1079

Journaal JSP 5_09.indd 148 05-06-2009 10:01:06

Proceskleur Zwart
Journal
Chemicals
Management
Journaal
Stoffen & Preparaten
Chief-editor:
Drs. A.C.H. van Peski
Editorial Board:
Dr. M.M. Kops-Werkhoven
Drs. H.A.F. van Well
Dr. J.A.S.J. Razenberg
Dr. L.J.M. Rodenburg
Drs. G.A. Schouten
Drs. J. Zawierko
Advisory Board:
K. E. Armstrong (U.S.A.)
Dr. R. Fielding (United Kingdom)
Drs. A. Gondová (The Netherlands)
G. Koh (Singapore)
Dr. C. van Lint (Australia)
Dan Liu (U.S.A.)
S. Park (S.-Korea)
H. Sano (Japan)
S. Savary (Canada)
Dr. U. Schumacher (China)
C. Sieger (Germany)
J. Simpson (Australia)
E. Snyman (South Africa)
P.G. Tse (New Zealand)
No. 6
July 2009
Volume 6
Part of Stoffennieuws.nl
CONTENT
ACTUALITIES
The Netherlands
[2009/0125] Standard for test method of PFOS / 151
[2009/0124] The Netherlands and RMU (Annex XVII of
REACH) / 151
European Union
[2009/0123] REACH and BUSINESSEUROPE / 152
[2009/0122] Echa Recommends Strict Control for Seven
Substances of Very High Concern / 153
[2009/0121] ECHA: Questions and Answers to
EU-GHS (CLP) / 154
International
[2009/0120] China P.R.: Updated law on Environmental
Management of New Chemical
Substances / 155
[2009/0119] Stockholm Convention on POPs / 156
[2009/0127] IMDG Code Training Requirements
2010 / 160
[2009/0128] IPCS: draft Risk Assessment of Combined
Exposures to Multiple Chemicals / 160
[2009/0129] 1-Bromopropane / 162
[2009/0130] Diacetyl / 162
[2009/0131] Occupational Exposure Limit values: update
for DE, CA-AB and CA-BC (May 2009) / 162
[2009/0132] The Philippines: GHS implementation / 163
[2009/0133] Australia: Cargo Containers. Quarantine
aspects and procedures / 163
[2009/0134] Canada: Ontario toxics legislation passes
third reading / 164
[2009/0135] Canada Challenge Program Update
(May 2009) / 164
[2009/0136] Global Update on New Chemicals
Regulations (April 2009) / 166
 content

PUBLICATIONS

Books
[2009/0146] Room for improvement in EU standards for industrial chemical risk
assessment   / 168

Conference Proceedings
[2009/0147] Conference on EU and world-wide rules for classification, labelling and
packaging of chemicals / 169
[2009/0148] REACH Europe 2009 / 169

Internet
[2009/0137] New Jersey: Right to Know Hazardous Substance Fact Sheets / 169
[2009/0138] GADSL 2009 / 170
[2009/0139] Citizens’ Report: Global Outreach Campaign on the Strategic Approach to
International Chemicals Management (SAICM) / 170
[2009/0149] Managing Hazardous Chemicals: Longer-Range Challenges / 170

OFFICIAL PUBLICATIONS

[2009/0140] The Netherlands (Period May 2009) / 171

[2009/0141] Belgium (Period May-June 2009) / 171
[2009/0142] United Kingdom (Period May-June 2009) / 171
[2009/0143] European Union (Period May 2009) / 173
[2009/0144] USA (Period May 2009) / 175

[2009/0145] CALENDER OF EVENTS & IMPORTANT DATA / 176

150 Journal Chemicals Management July 2009, No. 6 Sdu Uitgevers

actualities
actualities
The Netherlands
Standard for test method of PFOS
[2009/0125] The Netherlands and RMU
PFOS is the generally accepted abbreviation
for perfluoro-octane sulfonates. This sub-
stance can be found in various materials and
is highly toxic for the environment. Therefore
the European Commission has decided to ban
the use and marketing of PFOS in Europe.
The NEN (Nederlands Normalisatie-Insti-
tuut, Dutch Institute of Standardization) is
developing a test method to detect the pres-
ence of PFOS in various materials. PFOS are
fluorinated compounds which have been used
extensively in numerous applications in con-
sumer products like textile and paper. They
are known for their repellant qualities and are
used daily in many consumer products. PFOS
are also used in some specific industrial appli-
cations in various products and processes like
microchips, fire-fighting foams, the plating
industry and hydraulic liquids for the avia-
tion industry. These chemical substances are
highly toxic, persistent and bio-accumulative,
and have properties which could cause unac-
ceptable risk for health and environment.
European industries already have been pro-
ducing consumer products without PFOS
for several years. For products from outside
Europe, the presence of PFOS is not always
obvious, and therefore should be tested. On
a European level NEN is performing the
preparatory work to develop a test method
in order to identify the presence of PFOS in
several materials. The aim of this standard is
Sdu Uitgevers
to reduce the marketing and use of PFOS and
related substances. The European standard
focuses on the following materials: textiles;
leather; carpets; paints and varnishes; paper
and cardboard; fire-fighting foams.
The draft version of the standard will be
published shortly for comment. For more
information you can contact NEN Material
Technology, telephone +31 15 2690 107 or
e-mail: chemistry@nen.nl
(Annex XVII of REACH)
[2009/0124]
Existing and more stringent national provi-
sions notified according to the Treaty that the
Netherlands may maintain until 1 June 2013
in relation to the restrictions on the manufac-
ture, placing on the market and use of certain
dangerous substances, mixtures and articles
listed in Annex XVII of Regulation (EC)
No 1907/2006:
- 31. (a) Creosote; wash oil CAS No 8001-58-
9 EC No 232-287-5 (b) Creosote oil; wash oil
CAS No 61789-28-4 EC No 263-047-8 (c) Dis-
tillates (coal tar), naphthalene oils; naphtha-
lene oil CAS No 84650-04-4 EC No 283-484-8
(d) Creosote oil, acenaphthene fraction; wash
oil CAS No 90640-84-9 EC No 292-605-3 (e)
Distillates (coal tar), upper; heavy anthracene
oil CAS No 65996-91-0 EC No 266-026-1; (f)
Anthracene oil CAS No 90640-80-5 EC No
292-602-7 (g) Tar acids, coal, crude; crude
phenols CAS No 65996-85-2 EC No 266-019-
3 (h) Creosote, wood CAS No 8021-39-4 EC
No 232-419-1 (i) Low temperature tar oil,
alkaline; extract residues (coal), low tempera-
ture coal tar alkaline CAS No 122384-78-5 EC
No 310-191-5.
More stringent national provisions: – Prohi-
bition of the placing on the market and use
of creosote-treated wood for applications in-
volving contact with surface water or ground-
Journaal Stoffen en Preparaten juli 2009, Nr. 6 151

water (irrespective of the composition of the
coal tar distillate). – Prohibition of the plac-
ing on the market for reuse or the reuse of
old treated wood in applications involving
contact with surface water or groundwater if
it is removed from the existing place of appli-
cation (irrespective of the composition of the
coal tar distillate). – Prohibition of the placing
on the second-hand market for reuse of old
wood treated with substances and mixtures
which contain: – Benzo[a]pyrene at a concen-
tration of 0,005 % or more by weight, and –
Water-extractable phenols at a concentration
of 3 % or more by weight – 42. Alkanes, C10
–C13, chloro- (short-chain chlorinated par-
affins) (SCCPs) EC No 287-476-5 CAS No
85535-84-8:
More stringent national provisions: Restric-
tion on the use of short-chain chlorinated
paraffins: – as flame retardants in rubber,
plastic or textiles; – as plasticisers in paints,
coatings or sealants
Reference: O.J. 2009, C130. Communication (2009/C
130/03) from the Commission pursuant
to Article 67(3) of Regulation (EC) No
1907/2006 of the European Parliament and
of the Council on the Registration, Evalu-
ation, Authorisation and Restriction of
Chemicals (REACH)
http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=OJ:C:2009:130:0003:0004:E
N:PDF
European Union
REACH and BUSINESSEUROPE
[2009/0123] to avoid legal uncertainty. A strong and
Two years after its entry into force, BUSINESS­
EUROPE, the Confederation of European
Business a.i.s.b.l., has carried out a first as-
sessment of the implementation of REACH,
which concerns not only the chemical indus-
152 Journal Chemicals Management July 2009, No. 6

actualities

try but also all other manufacturing industry
sectors.
Active in European affairs since 1958, the
Confederation represents more than 20 mil-
lion small, medium and large companies.
Members are 40 central industrial and em-
ployers’ federations from 34 countries.
On the occasion of the second European
Chemicals Agency (ECHA)’s Stakeholders’
day in Helsinki (27 May 2009), BUSINESS­
EUROPE makes the following two main com-
ments:
1. The financial burden of REACH should
be reduced by introducing phased pay-
ment of registration fees. This could save
around € 200 million for companies which
have to register chemical substances.
2. Companies are still left with legal uncer-
tainties because of inconsistency or lack
of coordination between different pieces
of legislation. Consistent European chem-
icals legislation and accurate guidance
about REACH obligations need to be put
in place in order to guarantee legal cer-
tainty.
BUSINESSEUROPE has identified seven pri-
ority areas for action:
1. The financial burden on companies
should be reduced. Phased payment of
registration fees first and lowering of fees
in the longer term is required.
2. Consistent European chemicals legislation
needs to be guaranteed. Chemicals rules
must be set using uniform criteria and
consistently in one place. REACH must be
this place.
3. The quality of guidance about industry’s
REACH obligations should be improved
timely representation of industry in Part-
ners Experts Groups and translation of
Technical Guidance Documents into all
EU languages will help improve the situ-
ation.
4. Truly harmonised REACH rules across
Member States should be ensured, espe-
Sdu Uitgevers
actualities
cially in terms of enforcement activities.
Attention should be given to industry’s
practical experiences.
5. The efforts of the European Chemicals
Agency (ECHA) and the Commission to
involve industry are much appreciated.
The REACH Helpdesk Correspondents’
Network should involve industry better.
6. Impacts of REACH on international trade
should be looked at very carefully. Clarity
about non-European companies’ obliga-
tions and full compliance with WTO rules
must be ensured with a view to a real level
playing field.
7. ECHA’s online platform to submit data
and dossiers on chemical substances
(REACH-IT) must be fully operational.
Making the system available in all EU lan-
guages is worth close consideration, espe-
cially for facilitating SMEs’ work.
References: http://www.businesseurope.eu/Content/
Default.asp?
http://212.3.246.117/docs/2/DPKF-
MACCCBMGDLKBOHLIPDJHP-
DBG9DWY7D9LTE4Q/UNICE/docs/
DLS/2009-01190-E.pdf
Echa Recommends Strict Control
for Seven Substances of Very High
Concern
[2009/0122] CPs [CAS 85535-84-8] (PBT and vPvB).
The European Chemicals Agency recom-
mends that seven chemical substances of very
high concern should not be used without
specific authorisation. Three of the recom-
mended substances are classified as toxic to
reproduction, one as carcinogenic and three
fulfil the criteria for being persistent, bioac-
cumulative and toxic (PBT) or very persistent
and very bioaccumulative (vPvB). They are
all used in products to which consumers and
workers are exposed.
Sdu Uitgevers
The authorisation process seeks to ensure
that the risks from substances of very high
concern are properly controlled and that the
substances are progressively replaced. From
its list of 15 candidate substances ECHA pri-
oritised the seven substances based on their
hazardous properties, the volumes used and
the likelihood of exposure to humans or the
environment. The Agency took into account
the comments received from interested par-
ties during a public consultation which took
place earlier this year. It also took into account
the opinion of the Member State Committee
who shared the Agency´s view on the priority
of these seven substances.
The final decision on the inclusion of the sub-
stances in the Authorisation List will be taken
by the European Commission following the
comitology procedure (regulatory procedure
with scrutiny). Substances on this List will in
future only be able to be used within the EU
when “authorised” for specific purposes.
The seven substances are:
– musk xylene [CAS 81-15-2] (vPvB).
A fragrance enhancer which is used for ex-
ample in detergents, fabric softeners and
fabric conditioners;
– 4,4`-diaminodiphenylmethane – MDA
[CAS 101-77-9] (carcinogenic). A hard-
ener which is used for example in epoxy
resins and adhesives;
– short chained chlorinated paraffins – SC-
A substance mostly used as flame retar-
dant and/or plasticiser in various appli-
cations such as highperformance rubber,
sealants, paints or textile coating;
– hexabromocyclododecane – HBCDD[CAS
25637-99-4, etc.] (PBT). A flame retardant
which is used for example in polystyrene,
which is then further processed for the
production of insulation panels/boards or
packaging products, and in textile applica-
tions;
– bis(2-ethylhexyl)phthalate – DEHP [CAS
117-81-7] (Toxic for reproduction).
Journaal Stoffen en Preparaten juli 2009, Nr. 6 153

A plasticiser which is used in a wide range
of PVC and other polymers applications,
such as for example flooring, roofing,
coated fabrics, medical devices or primary
packaging of medicinal products, as well
as in various preparations such as for ex-
ample sealants, adhesives and inks;
– benzylbutylphthalate – BBP [CAS 85-68-
7] (Toxic for reproduction). A plasticiser
which is used for example in polymer
products, and in particular in PVC for
flooring applications, in textile and leather
coating, as well as in various other prepa-
rations such as sealants, coating and inks
or adhesives;
– dibutylphthalate – DBP [CAS 84-74-2]
(Toxic for reproduction). A specialist
plasticiser which is used in particular in
various polymer (PVC/non-PVC) appli-
cations (such as floor covering or primary
packaging of medicinal products), and as
a component of various preparations such
as adhesives or paints.
Reference: ECHA Press Release 02 June 2009.
http://echa.europa.eu/doc/press/pr_09_07_
annex_xiv_rec_20090602.pdf
See also JCM/JSP 2008, nr. 9, item 2008/01986 and
nr.10, item 2008/0216.
ECHA: Questions and Answers to
EU-GHS (CLP)
[2009/0121] tification of classification to the C&L In-
Questions (for the answers see the Refer-
ence):
– Background: What is the EU legislation
on classification, labelling and packag-
ing about? Why did the UN develop the
Globally Harmonised System (GHS) for
classification and labelling of chemicals?
Why did the EU develop a new legislation
on classification, labelling and packaging?
Which non-EU countries are implement-
ing GHS? Does the CLP Regulation fa-
154 Journal Chemicals Management July 2009, No. 6
actualities
cilitate trade between the EU and non-EU
countries?
– Scope: What is a classification? And what
is a harmonised classification? What is
the difference between hazard assessment
and risk assessment? What are the main
changes compared to the previous legis-
lation, i.e. the Dangerous Substances Di-
rective 67/548/EEC (DSD) and the Dan-
gerous Preparations Directive 1999/45/
EC (DPD)? Will there be a change of
protection level under CLP? Have all GHS
hazard categories been introduced in the
CLP? Why is there no additional labelling
of PBT and vPvB substances? Will all sub-
stances and mixtures be within the scope
of CLP? Should articles be classified?
– Obligations: What are the main obliga-
tions under CLP for companies supplying
substances or mixtures? What is the tran-
sitional period and what is it for? Why is
there no tonnage threshold for classifica-
tion and labelling in CLP?
– Inventory: What is the Classification &
Labelling Inventory and what can it be
used for? What will the Classification &
Labelling Inventory contain? Why must a
notifier indicate the reason for non-clas-
sification? Do those who have to classify
also have to notify to the Classification &
Labelling Inventory? Which substances
have to be notified to the C&L Inventory?
Why is there no quantitative limit for no-
ventory?
– Labelling: Why is labelling based on haz-
ard and not on risk? Why are there differ-
ent deadlines for re-labelling and re-pack-
aging?
– Collection and Evaluation of Data: Can
classifications derived under transport leg-
islation be used for the purposes of CLP?
Is animal testing required for health and
environmental classifications under CLP?
Is testing required for determining physi-
Sdu Uitgevers
actualities
cal hazards? How can alternative methods
to animal testing be used?
– Safety Data Sheets: Do Safety Data Sheets
need to reflect the new classification and
labelling elements according to the CLP
rules?
– Harmonised Classification: Within the
EU, classifications have been harmonised
for decades. What happens to Annex I to
the Dangerous Substance Directive (DSD)
which contains harmonised classifications
of about 8,000 substances? On entry into
force of the CLP Regulation on 20 January
2009, Annex I to Directive 67/548/EEC was
deleted and transferred to the CLP Regu-
lation. What should a supplier do with the
substances from the 30th and 31st Adap-
tation to Technical Progress (ATP) of DSD
which are not yet included in Annex VI to
CLP? Who can make proposals for har-
monised classification and labelling under
CLP? Is it possible to harmonise classifi-
cations for all substances? Why were the
generic concentration limits (GCLs) con-
tained in Annex I to DSD not transferred
to Table 3.2 of Annex VI to CLP? What is
an M-factor? Should there be a UN list of
harmonised classifications?
Reference: Questions & Answers on Regulation (EC)
No 1272/2008 on classification, labelling
and packaging of substances and mixtures
http://echa.europa.eu/doc/classification/
questions_and_answers_clp_20090526.pdf
International
China P.R.: Updated law on
Environmental Management of
New Chemical Substances
[2009/0120] – ‘Joint notification’ would also be possible
The ‘Provisions of Environmental Manage-
ment of New Chemical Substances’ has been
revised recently and the draft version of ‘Meas-
Sdu Uitgevers
ures of Environmental Management of New
Chemical Substances’ (Decree 17) has been
issued for comments on 21 May 2009. Lots of
changes have been made comparing to the old
version. It may have big effect on the chemical
industry we believe. Now it is open to public
comments before submission for comments
of WTO. The deadline is June  28, 2009. The
proposed measures of 21 May 2009 contain
provisions impacting and likely disadvantag-
ing foreign companies to a large extent.
Amongst others, the most significant changes
in the proposed Measures of 21 May 2009 are
as follows:
– A risk management concept for new
chemicals in the Chinese chemical control
system, i.e. hazard and exposure
– Chemicals would be classified into three
categories, i.e. general chemicals, hazard-
ous chemicals, and chemicals of environ-
mental concern
– Basics of notification and registration sys-
tem for new chemicals would remain the
same as it was. However, detailed ‘general
notification’ would be required for new
chemicals depending on tonnage (e.g.
1-10 ton, 10-100 tons, 100-1000 tons,
>1000 tons) of the chemicals imported
or produced. The principle of notification
information would be ‘higher volume,
more information request’.
– Simplified notification would be available
for new chemicals imported or produced
less than 1 ton per year. Separate research
and development notification would be
available when producing or importing a
new chemical substance less than 0.1 ton
per year.
– Notification of new chemicals could only
be done by a registered Chinese entity.
under the concept of ‘Easy Notification’.
– In case of a producer or an importer who
has registered hazardous chemicals or
chemicals of environmental concern, s/he
Journaal Stoffen en Preparaten juli 2009, Nr. 6 155

would have to prepare and submit an an-
nual production or import report and an
annual production or import plan to the
Chemical Registration Center.
The most potentially problematic issues for
foreign chemical manufacturers or exporters
are that:
– Only China-generated ecotoxicological
data would be acceptable for registration
– Harmonisation between registration
through Chinese entities only and CBI
protection would be difficult.
It is clear that the differences between the EU
REACH Regulation and the Legal require-
ments for (new) chemicals in countries like
P.R. of China are becoming smaller.
References: E-mail of Chemical HSE Regulation Affairs
Dept. of CNCIC: heyan@cheminfo.gov.cn;
heyan@cncic.gov.cn, liangmy@cheminfo.
gov.cn; wangrh@cheminfo.gov.cn.
E-mail of Korea Environmental Council in
Europe (Korea-helpdesk.eu) 9 June 2009:
China REACH: Earlier than Expected!
Stockholm Convention on POPs
[2009/0119] (IFCS) and the International Programme
The fourth Conference of the Parties (COP4)
to the Stockholm Convention on Persistent
Organic Pollutants (POPs) was held from
4-8 May 2009, in Geneva, Switzerland. Over
800 participants, representing more than 149
governments, as well as intergovernmental
and non-governmental organizations, and
UN agencies, attended the meeting. COP4
considered several reports on activities within
the Convention’s mandate and adopted 33
decisions on, inter alia, nine new chemicals,
financial resources, guidance to the financial
mechanism, implementation plans, technical
assistance, synergies and effectiveness evalua-
tion.
History
156 Journal Chemicals Management July 2009, No. 6
actualities
During the 1960s and 1970s, the use of chemi-
cals and pesticides in industry and agriculture
increased dramatically. In particular, a cat-
egory of chemicals known as POPs attracted
international attention due to a growing body
of scientific evidence indicating that exposure
to very low doses of POPs can lead to cancer,
damage to the central and peripheral nerv-
ous systems, diseases of the immune system,
reproductive disorders and interference with
normal infant and child development. POPs
are chemical substances that persist in the
environment, bioaccumulate in living organ-
isms, and can cause adverse effects to human
health and the environment. With further
evidence of the long-range transport of these
substances to regions where they have never
been used or produced, and the consequent
threats they pose to the global environment,
the international community called for urgent
global action to reduce and eliminate their re-
lease into the environment.
In March 1995, the United Nations Envi-
ronment Programme’s Governing Council
(UNEP GC) adopted Decision 18/32 inviting
the Inter-Organization Programme on the
Sound Management of Chemicals, the Inter-
governmental Forum on Chemical Safety
on Chemical Safety to initiate an assessment
process regarding a list of 12 POPs. The IFCS
Ad Hoc Working Group on POPs concluded
that sufficient information existed to dem-
onstrate the need for international action to
minimize risks from the 12 POPs, includ-
ing a global legally-binding instrument. The
meeting forwarded a recommendation to the
UNEP GC and the World Health Assembly
(WHA) that immediate international action
be taken on these substances. In February
1997, the UNEP GC adopted Decision 19/13C
endorsing the conclusions and recommen-
dations of the IFCS. The GC requested that
UNEP, together with relevant international
organizations, convene an intergovernmen-
tal negotiating committee with a mandate to
Sdu Uitgevers
actualities
develop, by the end of 2000, an international
legally-binding instrument for implementing
international action, beginning with the list of
12 POPs. In May 1997, the WHA endorsed the
recommendations of the IFCS and requested
that the World Health Organization partici-
pate actively in the negotiations.
Negotiation of the Convention
The Intergovernmental Negotiating Com-
mittee (INC) met five times between June
1998 and December 2000 to elaborate the
convention. The Conference of the Plenipo-
tentiaries convened from 22-23 May 2001, in
Stockholm, Sweden, where delegates adopted:
the Stockholm Convention; resolutions ad-
dressing interim financial arrangements and
issues related to the Basel Convention on the
Control of Transboundary Movement of Haz-
ardous Waste and their Disposal; resolutions
forwarded by the Preparatory Meeting; and
the Final Act.
The Stockholm Convention calls for interna-
tional action on 12 POPs grouped into three
categories: 1) pesticides: aldrin, chlordane,
DDT, dieldrin, endrin, heptachlor, mirex and
toxaphene; 2) industrial chemicals: hexachlo-
robenzene (HCB) and polychlorinated biphe-
nyls (PCBs); and 3) unintentionally produced
POPs: dioxins and furans.
The Convention can list chemicals in three
annexes: Annex A contains chemicals to be
eliminated; Annex B contains chemicals to be
restricted; and Annex C calls for the minimiza-
tion of unintentional releases of listed chemi-
cals. The Stockholm Convention entered into
force on 17 May 2004, and currently has 163
parties, including the European Community.
Conferences History
– COP1: The first Conference of the Parties
(COP1) to the Stockholm Convention was
held from 2-6 May 2005 in Punta del Este,
Uruguay.
– POPRC-1: The first meeting of the PO-
PRC (POPRC-1) was held in Geneva,
Sdu Uitgevers
Switzerland, from 7-11 November 2005.
The Committee considered five chemicals
proposed for inclusion in the Conven-
tion and agreed that intersessional work-
ing groups would develop risk profiles
on these chemicals, to be assessed by the
Committee at its second meeting.
– COP2: This meeting took place from 1-5
May 2006 in Geneva, Switzerland.
– POPRC-2: POPRC-2 was held in Ge-
neva, Switzerland, from 6-10 November
2006. The Committee adopted the risk
profiles for pentabromodiphenyl ether
(pentaBDE), chlordecone, hexabromobi-
phenyl (HBB), lindane, and perfluorooc-
tane sulfonate (PFOS) and agreed that
intersessional working groups would
develop draft risk management evalua-
tions for these chemicals to be assessed by
POPRC-3. The Committee also agreed to
consider five newly proposed chemicals
for inclusion in the Convention: alpha
hexachlorocyclohexane (alphaHCH), beta
hexachlorocyclohexane (betaHCH), pen-
tachlorobenzene (PeCB), commercial
octabromodiphenyl ether (c-octaBDE)
and short-chained chlorinated paraffins
(SCCPs), and agreed that intersessional
working groups would develop risk pro-
files on these chemicals to be assessed by
the Committee at its third meeting.
– COP3: Stockholm Convention COP3 was
held from 30 April – 4 May 2007 in Dakar,
Senegal.
– POPRC-3: This meeting took place from
19-23 November 2007, in Geneva, Swit-
zerland. The Committee approved the risk
management evaluation for five chemicals,
and recommended that COP-4 consider
listing under Annexes A, B, or C: lindane;
chlordecone; HBB; pentaBDE; and PFOS,
its salts and PFOS fluoride. Risk profiles
were approved for four chemicals, and
POPRC-3 adopted a work programme
to prepare draft risk management evalu-
ations for those chemicals, namely on:
Journaal Stoffen en Preparaten juli 2009, Nr. 6 157

c-octaBDE, PeCB, and alphaHCH and
betaHCH, and agreed that intersessional
working groups would develop draft risk
profiles on these chemicals to be assessed
by the Committee at its fourth meeting.
The Committee decided that a proposal
by the European Community and its
member states to consider endosulfan for
inclusion in Annex A, B, or C would be
considered by POPRC-4.
– Basel Convention COP-9: This meeting
was held from 23-27 June 2008 in Bali, In-
donesia.
– POPRC-4: This meeting convened from
13-17 October 2008, in Geneva, Swit-
zerland. POPRC-4 considered several
operational issues, including conflict-of-
interest procedures, toxic interactions
between POPs, and activities undertaken
for effective participation of parties in
its work. The Committee approved the
risk management evaluations for four
chemicals, and recommended that COP-
4 consider listing under Annexes A, B, or
C: c-octaBDE, PeCB, and alphaHCH and
betaHCH. A draft risk profile for SCCPs
was discussed and the Committee agreed
to forward it to POPRC-5 for further
consideration. POPRC-4 also evaluated
a proposal to list endosulfan under the
Convention and agreed, by vote, that it
met the Annex D criteria for listing and
that a draft risk profile should be prepared
for consideration by POPRC-5. POPRC-4
also began an exchange of views on a pro-
posal to list hexabromocyclododecane
(HBCD).
– Rotterdam Convention COP-4: This
meeting convened from 27-31 October
2008 in Rome, Italy. COP-4 adopted 13
decisions, including the addition of trib-
utyl tin compounds, pesticides used in
antifouling paints for ship hulls that are
toxic to fish, mollusks and other aquatic
organisms, to Annex III of the Convention
(Chemicals subject to the PIC procedure).
158 Journal Chemicals Management July 2009, No. 6
actualities
Issues unresolved and forwarded to COP-
5 included those on: compliance; effective
implementation; and listing of chrysotile
asbestos, the most commonly used form
of asbestos and cause of mesothelomia,
and endosulfan, a pesticide widely used in
cotton production, in Annex III.
COP4
The recommendation to list nine new chemi-
cals to Annexes A, B or C of the Convention
was the culmination of four meetings of
the POPs Review Committee (POPRC), the
31-member expert group established under
the Convention to review whether global ac-
tion on a substance is warranted. As COP4
was the first opportunity to consider expand-
ing the scope of the Convention, deliberations
on these chemicals were seen by some as a lit-
mus test of the POPRC process. Entering the
week, delegates expected that those chemicals
no longer in production, the so-called “dead”
chemicals, would likely be approved more
easily than those “live” chemicals in wide
production and use, such as PFOS, which is
used in a variety of industrial, firefighting and
pest-control applications. A contact group
convened throughout the week to finalize the
recommendations for listing, and predictably
many hours were devoted to the study of the
uses of PFOS, for which alternatives may not
be available or affordable.
Many delegates were surprised by the difficul-
ties posed by the proposed listing of bromi-
nated diphenyl ethers (BDEs), namely c-pent-
aBDE and c-octaBDE. These substances, used
as flame retardants in bulk plastics and foam
rubber, are no longer in production, but are
ubiquitous in products. Concerns were raised
at the beginning of the week that listing these
chemicals might substantially impact the plas-
tics recycling industry as the Convention pre-
cludes the recycling of POPs. Yet it is very dif-
ficult to separate BDE-containing plastic from
BDE-free plastic. Negotiators had to develop
legal language that protects human health and
Sdu Uitgevers
actualities
the environment from BDE releases arising
from recycling, but, at the same time, balances
potential adverse impacts on the plastics recy-
cling industry. In addition to these technical
and economic concerns, developing countries
stressed the heavy financial burden they would
need to shoulder in implementing their new
commitments arising from the listing of addi-
tional POPs. Eventually, these many concerns
were overcome, and agreement was reached to
list all nine candidate POPs.
EU legislation: Regulation (EC) No 850/2004
of the European Parliament and of the Coun-
cil of 29 April 2004 on persistent organic pol-
lutants and amending Directive 79/117/EEC.
Reference: Consolidated version 2007:
http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=CONSLEG:2004R0850:2007
0416:EN:PDF
The Nine New POPs:
Listed on Annex A for elimination
1. α-hexachlorocyclohexane
[CAS 319-
84-6], unintended byproduct of lindane
manufacture
2. α-hexachlorocyclohexane
[CAS 319-
85-7], unintended byproduct of lindane
manufacture
3. commercial octaBDE [CAS 32536–52–0]
(hexabromodiphenyl ether and heptabro-
modiphenyl ether), used as a flame retard-
ant
4. commercial pentaBDE used as a flame
retardant. Commercial pentabromodip-
henyl ether (C-PentaBDE) refers to mix-
tures of bromodiphenyl ether congeners
in which the main components are 2,2’,
4,4’- tetrabromodiphenyl ether (BDE-47,
CAS 40088-47-9) and 2,2’,4,4’,5-pentabro-
modiphenyl ether (BDE-99, CAS 32534-
81-9), which have the highest concentra-
tion by weight with respect to the other
components of the mixture.
5. Chlordecone (1,1a,3,3a,4,5,5,5a,5b,6-de-
cachloro-octahydro-1,3,4-metheno-2H-
Sdu Uitgevers
cyclobuta[cd]pentalen-2-one), an agricul-
tural pesticide [CAS 143-50-0]
6. hexabromobiphenyl (hexabromo -1,1’-bi­
phenyl ) [CAS 36355-01-8], trade names:
FireMaster BP-6, FireMaster FF-1, a flame
retardant
7. lindane (γ-hexachlorocyclohexane (HCH)
[CAS 58-89-9], used in creams for treat-
ment head lice; previously used in agri-
culture (“specific exemption” for phar-
maceutical use as to control head lice and
scabies)
8. pentachlorobenzene [CAS 608-93-5],
used as a dyestuff carrier, fungicide, and a
flame retardant
Listed on Annex B for restriction:
9. PFOS (perfluorooctane sulphonic acid)
[CAS 307-35-7], its salts and perfluorooc-
tane sulphonyl fluoride (with specific
exemptions for: photo masks in the
semiconductor and liquid crystal display
(LCD) industries, metal plating, electric
and electronic parts for some printers and
colour copiers, insecticides for certain fire
ants and termites, oil production, carpets,
leather and apparel, textiles and uphol-
stery, paper and packaging, coatings and
coating additives, and rubber and plastics;
and “acceptable purposes”: photo imaging,
photo-resist and anti reflective coatings
for semiconductors, etching agents for
compound semiconductor and ceramic
filter, aviation hydraulic fluids, metal plat-
ing in closed-loop systems, certain medi-
cal devices, fire-fighting foams, insect bait
for control of certain leaf-cutting ants).
The Dirty Dozen POPs listed in the original
Stockholm Convention
Listed on Annex A for elimination
Aldrin [CAS 309-00-2]
Chlordane [CAS 57-74-9]
Dieldrin [CAS 60-57-1]
Endrin [CAS 72-20-8]
Heptachlor [CAS 76-44-8]
Journaal Stoffen en Preparaten juli 2009, Nr. 6 159

Hexachlorobenzene (HCB) [CAS 118-
74-1]
Mirex [CAS 2385-85-5]
Toxaphene [CAS 8001-35-2]
Polychlorinated biphenyls (PCBs) [CAS
1336-36-3]
Listed on Annex B for elimination:
DDT (with specific exemption for disease
vector control, and as a site-limited,
closed system intermediate) [DDT (di-
chlorodiphenyltrichlooroethane),4,4’-iso-
mer, CAS 50-29-3]
Listed on Annex C to reduce or eliminate re-
leases:
Polychlorinated dioxins
Polychlorinated furans
Hexachlorobenzene (HCB) [CAS 118-
74-1]
Polychlorinated biphenyls (PCBs) [CAS
1336-36-3 and others]
References: http://chm.pops.int/
http://www.iisd.ca/download/pdf/
enb15174e.pdf
ww.endseurope.com/docs/90511c.doc
The Dirty Dozen: http://www.uspops-
watch.org/global/dirty-dozen.htm
IMDG Code Training
Requirements 2010
[2009/0127] zations can use them as the basis for taking
With the mandatory adoption of the 2008
edition of the International Maritime Danger-
ous Goods (IMDG) Code on the 1st of Janu-
ary 2010 training will be mandatory for shore
based personnel engaged in the transport of
dangerous goods by sea. The training require-
ments are contained in chapter 1.3 of the
IMDG code: “Shore based personnel engaged in
the transport of dangerous goods intended to be
transported by sea shall receive training in the
contents of the dangerous goods provisions
commensurate with their responsibilities.”.
160 Journal Chemicals Management July 2009, No. 6
actualities
References: http://www.ivw.nl/actueel/nieuws/training-
gevaargoedoverzeevoorwalpersoneelvanaf-
2010verplicht.aspx
http://www.fpaa.com.au/events/docs/A%20
Shultz-Altmann.pdf
IPCS: draft Risk Assessment of
Combined Exposures to Multiple
Chemicals
[2009/0128]
The International Programme on Chemical
Safety (IPCS), established in 1980, is a joint
programme of three Cooperating Organiza-
tions (WHO, ILO and UNEP), implement-
ing activities related to chemical safety. WHO
is the Executing Agency of the IPCS, whose
main roles are to establish the scientific basis
for safe use of chemicals, and to strengthen
national capabilities and capacities for chemi-
cal safety.
Chemicals assessment
The objective of chemicals assessment is to
provide a consensus scientific description of
the risks of chemical exposures. These de-
scriptions are published in assessment reports
and other related documents so that govern-
ments and international and national organi-
preventive actions against adverse health and
environmental impacts. For example the doc-
uments are often used as the basis for estab-
lishing guidelines and standards for the use of
chemicals and for standards for drinking wa-
ter and can assist with the implementation of
international agreements such as the Globally
Harmonized System of Classification and La-
belling of Chemicals (the GHS).
IPCS works cooperatively with other interna-
tional organizations, such as the Organization
for Economic Cooperation and Development
(OECD), under the auspices of the Inter-Or-
ganizational Programme for the Sound Man-
Sdu Uitgevers
actualities
agement of Chemicals avoiding duplication
and thereby optimizing the use of assessment
resources.
Assessment series
– Concise International Chemical Assess-
ment Documents
– Environmental Health Criteria
– Health and Safety Guides
– International Chemical Safety Cards
– Pesticide Safety Data Sheets
– The WHO Recommended Classification
of Pesticides by Hazard
Methods for chemicals assessment
In the field of methodology, the work of the
IPCS aims at promoting the development,
harmonization and use of generally accept-
able, scientifically sound methodologies for
the evaluation of risks to human health and
the environment from exposure to chemicals.
The results of such work enhance mutual ac-
ceptance of risk assessment products. The
work includes the development of general
principles of various areas of risk assessment,
published as Environmental Health Criteria,
the IPCS Harmonization Project and ad-
dressing the risk assessment uncertainties and
challenges associated with new and emerging
scientific issues, such as toxicogenomics. With
foresight, international collaboration in this
latter area can avoid the need for subsequent
harmonization. To ensure best use of limited
resources, the IPCS and OECD have devel-
oped a framework for cooperation in the field
of risk assessment methodologies, which en-
sures complementarily, mutual support and
mutual involvement in the projects conducted
by each organization.
Assessment of combined exposures
(Aggregate/cumulative risk assessment)
The draft WHO/IPCS Framework for Risk As-
sessment of Combined Exposures to Multiple
Chemicals is now available for public and peer
review comments.
Sdu Uitgevers
The document is accompanied by two case
studies which illustrate the application of the
framework. The first case study (case study A)
is on polybrominated diphenyl ethers (PB-
DEs), and the second (case study B) is on car-
bamates.
The draft framework was prepared under the
guidance of an international group of experts
and will be finalized by an expert meeting. In
March 2007, IPCS convened an international
workshop on current issues in aggregate/cu-
mulative risk assessment. The workshop dis-
cussed methods for assessing the combined
risk from exposure to one or more agents
(with or without a common mechanism-of-
action) via all relevant routes and pathways,
and initiated the development of a framework
for such assessments.The two case studies
have been worked out to illustrate the draft:
case study A is on polybrominated diphenyl
ethers (PBDEs) and prepared by the Existing
Substances Division for the Safe Environ-
ments Programme, Canada; case study B is on
carbamates (N-methyl carbamate (NMC) in-
secticides ) and prepared by the EPA/US and
Bayer Cropscience, on behalf of the European
Centre for Ecotoxicology and Toxicology of
Chemicals (ECETOC). Please use the table
template provided for submission of your
comments, and send this as an email-attach-
ment to ipcsharmonize@who.int. (Subject:
Combined Exposure Document). Comments
to the draft must be received no later than
30 September 2009.
Reference: (JZ)
http://www.who.int/ipcs/methods/harmo-
nization/areas/aggregate/en/index.html
http://www.who.int/ipcs/methods/harmo-
nization/areas/workshopreportdocument7.
pdf
http://www.who.int/ipcs/methods/harmo-
nization/areas/casestudya.pdf
http://www.who.int/ipcs/methods/harmo-
nization/areas/casestudyb.pdf
Journaal Stoffen en Preparaten juli 2009, Nr. 6 161

1-Bromopropane
[2009/0129] CA-BC (May 2009)
1-Bromopropane [CAS 106-94-5] is a new
solvent intended to act as a substitute for sol-
vents like trichloroethane and some freons
that damage the upper ozone layer.
The effects of 1-bromopropane on human
health have not been well studied. However,
a few human case reports suggest that 1-bro-
mopropane can harm the nervous system.
Note: 1-bromopropane (RTK Substance
No.4198) will be added to the State of New
Jersey Right to Know Hazardous Substance
List (RTKHSL) with the next revision of the
list.
References: http://www.cdc.gov/mmwr/preview/
mmwrhtml/mm5748a2.htm
http://www.cdph.ca.gov/programs/hesis/
Documents/bpropane.pdf
http://web.doh.state.nj.us/rtkhsfs/rtkhsl.
aspx
Diacetyl
[2009/0130]
Commercial flavourings used in the food ser­
vice industry are often complex mixtures of
flavouring chemicals, many of which are vola-
tile, meaning that they evaporate into the air
from their liquid or solid form. Diacetyl (bu-
tane-2,3-dione, CAS 431-03-8) is a prominent
chemical ingredient in butter flavourings and
is a component of the vapours coming from
these and other flavourings. Inhalation of
butter flavouring chemical mixtures, includ-
ing diacetyl, has been associated with severe
obstructive lung disease popularly known as
“popcorn lung”.
Reference: http://www.cdc.gov/niosh/blog/
nsb111008_diacetyl.html
162 Journal Chemicals Management July 2009, No. 6
actualities
Occupational Exposure Limit
values: update for DE, CA-AB and
[2009/0131]
Germany: TRGS 900 February 2009
An update on the Technical Rules for Hazar-
dous Substances (TRGS) 900 on Occupatio-
nal exposure limits (Arbeitsplatzgrenzwerte)
(February 2009) has been published.
Reference: http://www.baua.de/de/Themen-von-A-Z/
Gefahrstoffe/TRGS/TRGS-900.html_
nnn=true
Canada-Alberta: OHS Code 2009
As of July 1, 2009, the Alberta Occupational
Health and Safety (OHS) Code 2009 will re-
place the OHS Code 2006. Under the OHS
Code 2009, OEL values for nearly 150 sub-
stances have been revised based on ACGH
Threshold limit Values as indicated on Table
2 of Schedule 1. Summary of these revisions
features:
– Adoption of ‘new Ceiling’ OEL instead of
an 8-hour TWA for Acetic anhydride
– Adoption of ‘total’ OELs instead of ‘inhal-
able’ OELs for the following substan-
ces: Borates, Calcium sulphate, Captan,
Diquat, O-Ethyl O-4-nitrophenyl phenyl
phosphonothioate (EPN), Flour dust,
Glass fibres, Molybdenum, Natural rub-
ber latex, Nickel and Silicon carbide, non-
fibrous.
– No change was reported in OEL values
for Asphalt, 2,2-Dichloropropionic acid,
Formaldehyde, Hydrogen sulphide, Mag-
nesium oxide, Ozone, Polymethylene
Polyphenyl Isocyanate (PAPI), Particu-
lates not otherwise regulated (PNOR),
Sulphur, Sulphuric acid, 1,1,1-Trifluoro-
2,2-dichloroethane and Wood dust.
Among other significant changes are: the use
of multiple methods to measure air contam-
inants, and the requirement for respiratory
Sdu Uitgevers
actualities
protection against airborne biohazardous ma-
terials.
References: The Alberta Gazette, Part II, April 30, 2009
available at : http://www.qp.alberta.ca/
documents/gazette/2009/pdf/08_Apr30_
Part2.pdf
Worksafe Alberta: http://employment.
alberta.ca/cps/rde/xchg/hre/hs.xsl/307.html
Canada-British Columbia: occupational
exposure limits 2008
Each year, the American Conference of Gov-
ernmental Industrial Hygienists (“ACGIH”)
publishes a list of substances for which they
have set new or revised threshold limit values
(“TLVs”). A TLV is the exposure limit which
is the maximum allowed airborne concentra-
tion for a particular substance, and may be
an 8-hour time weighted average, short-term
exposure limit or ceiling limit. In accord-
ance with section 5.48 of the Canada-British
Columbia Occupational Health and Safety
Regulation, these new or revised TLVs are
automatically adopted as WorkSafeBC occu-
pational exposure limits (“OELs”) unless oth-
erwise determined by the Board of Directors
of WorkSafeBC , the Workers’ Compensation
Board of BC Safety at Work. WorkSafeBC is
requesting stakeholder feedback on the new or
revised 2008 OELs until 15 September 2009.
All stakeholder feedback will be presented to
the Board of Directors of WorkSafeBC.
References: Worksafe BC, May 2009, http://www.work-
safebc.com
http://www.worksafebc.com/regula-
tion_and_policy/policy_consultation/
law_40_10_650.asp
http://www.worksafebc.com/regulation_
and_policy/policy_consultation/assets/pdf/
oels.pdf
Sdu Uitgevers
The Philippines: GHS
implementation
[2009/0132]
A draft Joint Administrative Order is being
prepared which would adopt the GHS ele-
ments for labeling and safety data sheets. The
draft has not yet been published. It is expected
to be implemented as part of the Toxic Sub-
stances and Hazardous Nuclear Wastes Act of
1990 (Republic Act No.6969) and will be the
responsibility of the Environmental Manage-
ment Bureau. The indications are that GHS
will be implemented in The Philippines in
2009 with a 2-year transition period to com-
ply.
Reference: ENHESA Update, May 2009.
Australia: Cargo Containers.
Quarantine aspects and
procedures
[2009/0133]
The information contained in the document
‘Cargo Containers. Quarantine aspects and
procedures’ of 15 April 2009 covers the Au-
stralian Quarantine and Inspection Service
(AQIS) requirements for timber used as cra-
tes, pallets, and in containers as lining, floor-
ing, and skids, and any other articles descri-
bed as packaging and dunnage. Importers
must satisfy Australian quarantine concerns
and comply with quarantine conditions ap-
plicable at the time of entry. Changes to this
document are published on the 1st and 15th of
the month, as required, and is directly availa-
ble on the AQIS website.
Cargo Containers: Quarantine aspects and
procedures deals with containers and the ma-
terials they are constructed from as a poten-
tial means of introducing serious pests and
diseases to Australia. Timber insects pose a
significant quarantine risk to Australia, and
Journaal Stoffen en Preparaten juli 2009, Nr. 6 163

accordingly all timber in FCL containers, in-
cluding exposed timber components, must be
treated before the container can be considered
for immediate release. Quarantine is also con-
cerned with the external and internal cleanli-
ness of containers. As containers age and usage
becomes even more widespread, the risks for
quarantine are expected to multiply, and the
need for quarantine vigilance will increase.
Reference: http://www.aqis.gov.au/cargoqap.
Canada: Ontario toxics legislation
passes third reading
[2009/0134]
Ontario’s plan to help protect people and
the environment from toxic substances has
passed third reading in the Ontario Legisla-
ture. The Toxics Reduction Act (Bill 167: An
Act to promote reductions in the use and cre-
ation of toxic substances and to amend other
Acts; Projet de loi 167: Loi visant à promou-
voir une réduction de l’utilisation et de la
création de substances toxiques et à modifier
d’autres lois) is part of Ontario’s strategy to
reduce toxics in air, land, water and consumer
products. When the act is in place, regulations
would require designated facilities to track
and evaluate their current use and creation of
toxics, develop plans to reduce the use of tox-
ics, and make summaries of their plans avail-
able to the public.
References: http://www.ene.gov.on.ca/en/toxics/index.
php
http://www.ontla.on.ca/bills/bills-files/39_
Parliament/Session1/b167.pdf
164 Journal Chemicals Management July 2009, No. 6
actualities
Canada Challenge Program
Update (May 2009)
[2009/0135]
Order 2009-87-02-01 Amending the
Domestic Substances List
The DSL has been amended by removal on
Part 1 of the following Challenge Batch 2 sub-
stances:
Benzenesulfonic acid, [(9,10-dihydro-9,10-
dioxo-1,4-anthracenediyl)bis(imino-4,1-
phenyleneoxy)]bis-, disodium salt (Acid
Green 40:1), CAS 70161-19-2, and Ben-
zenesulfonic acid, 2,2 -[(9,10-dihydro-5,8-
dihydroxy-9,10-dioxo-1,4-anthracenediyl)di-
imino]bis[5-(1,1-dimethylethyl)-, disodium
salt (ADIBSS), CAS 83006-67-1.
Results of the final screening assessment of
batch 2 chemicals reported these two sub-
stances to be persistent, bioaccumulative and
inherently toxic to non-human organisms.
Thus, by Order 2009-87-02-01, these two sub-
stances were placed under the Significantly
New Activity Provision (SNAc) and added to
Part 2 of DSL under: CAS 70161-19-2 S’ and
CAS 83006-67-1 S, respectively.
Consequently, a person who intends to use,
manufacture or import any of these substan-
ces for a significant new activity in quantities
exceeding 100 kg per year must provide the
Minister of the Environment the prescribed
information prior to the use, manufacture or
import.
Reference: Canada Gazette, Part II, Vol.143. No.11,
May 27, 2009
http://canadagazette.gc.ca/rp-pr/
p2/2009/2009-05-27/html/sor-dors135-
eng.html
Proposed Order to add Batch 2 substances to
Schedule 1 of CEPA 1999
A proposed Order was published in Canada
Gazette for the purpose of adding the follow-
ing eight substances to Schedule 1
1. Thiourea, CAS 62-56-6.
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actualities
2. 1,3-Butadiene, 2-methyl-, CAS 78-79-5.
3. Oxirane, (chloromethyl-), CAS 106-89-8
4. Colour Index Pigment Yellow 34, CAS
1344-37-2
5. Colour Index Pigment Red 104, CAS
12656-85-8
6. Cyclopentasiloxane, decamethyl-, CAS
541-02-6
7. Cyclotetrasiloxane, octamethyl-, CAS 556-
67-2
8. Phenol, 2,4,6-tris(1,1-dimethylethyl-),
CAS 732-26-3
Reference: Canada Gazette, Part II- Vol. 143, No. 20 –
May 16, 2009
Risk Management Scope Documents for
Batch 6 substances
Risk Management Scope Documents have
been released for public review until 29 July
2009 for the following two substances:
Benzene, chloromethyl-, CAS 100-44-7 and
1, 2-Benzenedicarboxylic acid, di-C7,11-
branched and linear alkyl esters, CAS 68515-
42-4.
Reference: Canada Gazette Part I, Vol. 143 No. 22
http://www.chemicalsubstanceschimiques.
gc.ca
Release of Batch 9 substances
Seventeen substances were included in the
Batch 9 challenge. The following twelve were
characterized as persistent, bioaccumulative,
and inherently toxic to non-human organ-
isms:
– B e n zo [ h ] b e n z [ 5 , 6 ] a c r i d i n o [ 2 , 1 , 9 ,
8-klmna]acridine-8,16-dione, CAS 475-
71-8
– Spiro[isobenzofuran-1(3H),9’-[9H]
xanthen]-3-one, 3’,6’-bis(diethylamino),
CAS 509-34-2
– Spiro[isobenzofuran-1(3H),9’-[9H]
xanthen]-3-one, 2’,4’,5’,7’-tetrabromo-3’,6’
-dihydroxy-, lead salt, CAS 1326-05-2
– Benzoic acid, 2,3,4,5-tetrachloro-6-(2,4,
5,7-tetrabromo-6-hydroxy-3-oxo-3H-
xanthen-9-yl), CAS 2134-15-8.
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– Benzo[b]thiophen-3(2H)-one, 6-chloro-
2-(6-chloro-4-methyl-3-oxobenzo[b]
thien-2(3H)-ylidene)-4-methyl, CAS 2379
-74-0.
– Oxirane, 2,2’,2”,2”’ -[1,2-ethanediylide-
netetrakis (4,1-phenyleneoxymethylene)]
tetrakis, CAS 7328-97-4.
– Benzo[b]thiophen-3(2H)-one, 4,7-di-
chloro-2-(4,7-dichloro-3-oxobenzo[b]
thien-2(3H)-ylidene), CAS 14295-43-3
– Nickel, bis[1-[4-(dimethylamino)phenyl]-
2-phenyl-1,2-ethenedithiolato(2-)-S,S’],
CAS 38465-55-3.
– Decanedioic acid, bis(1,2,2,6,6-pentam-
ethyl-4-piperidinyl) ester, CAS 41556-
26-7
– Benzoic acid, 4-[1-[[(2,4-dichlorophenyl)
amino]carbonyl]-3,3-dimethyl-2-oxobu-
toxy], CAS 58161-93-6
– 7-Oxa-3, 20-diazadispiro [5.1.11.2]
heneicosan-21-one, 2,2,4,4-tetramethyl,
CAS 64338-16-5.
– 2-Naphthalenesulfonic acid, 7-[[4,6-bis[
[3-(diethylamino)propyl]amino]-1,3,5-
triazin-2-yl]amino]-4-hydroxy-3-[[4-
(phenylazo)phenyl]azo]-, monoacetate
(salt), CAS 71032-95-6.
The following five substances were categor-
ized as highly hazardous to human:
– 2-Pyrrolidinone, 1-ethenyl, CAS 88-12-0
– Benzene, 1,2-dimethoxy-4-(2-propenyl),
CAS 93-15-2
– Antimony oxide (Sb2O3), CAS 1309-64-4
– Vanadium oxide (V2O5), CAS 1314-62-1
– Bromic acid, potassium salt, CAS 7758-
01-2
Industry and interested stakeholders are in-
vited to submit until 10 September 2009 any
information regarding the scientific proper-
ties of these substances, or best management
practices associated with the use of these sub-
stances.
Reference: Canada Gazette, Part I, Vol. 143, No. 11 —
March 14, 2009
http://www.chemicalsubstanceschimiques.
gc.ca/challenge-defi/batch-lot_9_e.html
Journaal Stoffen en Preparaten juli 2009, Nr. 6 165

Global Update on New Chemicals
Regulations (April 2009)
[2009/0136]
In April 2009, approximately 150 new regula-
tions relating to chemicals management were
adopted or published worldwide. These invol-
ve implementation of GHS, updates to chemi-
cal inventories, new priority chemicals, several
changes to the requirements on transport and
handling, and last but not least restrictions on
the marketing and use of chemicals.
The following overview (selection only)
provides the indicative title in English and
the date of adoption. Further information
on any of these new regulations and what
they require from industry can be found in
the Enhesa Update published by ENHESA
(www.enhesa.com). To be kept ahead of new
policy initiatives and developments and their
implications on your business contact ENHE-
SA at +32 2 775 9797.
Argentina
Limit to the content of lead in paints, lacquers
and varnishes adopted 13-Jan-2009
Amendment to Law 4980 establishing rules
for marketing of products adopted 21-Apr-
2009
Australia
NSW: Dangerous Goods (Road and Rail
Transport) Regulation 2009 enters into force
17-Apr-2009
Brazil
Dangerous products classified in Classes for
their transport 09-Apr-2009
Canada
Significant New Activity Notice No. 15446
adopted regarding 2-propenoic acid 04-Apr-
2009
Orders amending the Domestic Substances
List and Non-domestic Substances List adop-
ted 15-Apr-2009
Significant New Activity Notice No. 15359 re-
garding organic silicone intermediate 18-Apr-
2009
166 Journal Chemicals Management July 2009, No. 6
actualities
Significant New Activity Notice No. 15441 re-
garding 2-propenoic acid 18-Apr-2009
British Columbia: Hazardous Waste Regula-
tion amended 31-Dec-2008
China
National Standards published in 2008 30-
Apr-2009
DDT, Chloradane, Hexachlorobenzene (HCB)
and Mirex are banned 16-Apr-2009
Procedures for importing used mechanical
and electronic equipment simplified 10-Apr-
2009 Costa Rica
Circular DAC-UPS-03-09 establishing requi-
rements for the person in charge of the Cos-
metic products register announced 13-Apr-
2009
Croatia
Ordinance on Rapid Exchange of Official In-
formation about Products Representing Risk
to Health and Safety of Consumers adopted
25-Mar-2009
New Regulation on Safety Data Sheets adop-
ted 17-Mar-2009
[On 17 March 2009, Regulation on Safety Data Sheet
was issued by the Ministry of Health and Social Welfare
with an approval of the Ministry of Economy, Labour
and Entrepreneurship. It specified a new format for the
safety data sheets (SDS) to be used as of 8 October 2009.
EC/1907/2006 Regulation (REACH) is not applicable to
Croatia at present but it is detailed by Annex to the Re-
gulation of 17 March 2009, which is based on the Annex
II of the REACH Regulation. The Regulation of 17 March
2009 requires that an SDS must be compiled by an expert.
Entities marketing dangerous substances and preparati-
ons have to provide the training to the experts. The details
of the training are not established by the Regulation of
17 March 2009.]
Ordinance on Categories, Types and Classifi-
cation of Waste using a Waste Catalog and the
List of Hazardous Waste amended 25-Mar-
2009
Denmark
Statutory Order prohibiting the import and
placing on the market of products that con-
tain dimethylfumarate (DMF) has been adop-
ted 28-Apr-2009
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actualities
Estonia
Provisions on collection, take-back, recovery
or disposal of waste electrical and electronic
equipment, targets and meeting them adop-
ted 20-Apr-2009
France
Circular on the reduction of hazardous sub-
stances in wastewater discharges of classified
installations subject to authorization issued
01-May-2009
Decree relating to the prevention and reme-
diation of certain environmental damages
adopted 23-Apr-2009
Germany
Products containing dimethyl fumarate
(DMF) banned under the Act on Safety of
Technical Equipment and Consumer Pro-
ducts (GPSG) 08-May-2008
Greece
Decision on REACH penalties issued 31-Mar-
2009
Hungary
Decree on the ban to place on the market pro-
ducts containing dimethylfumarate (DMF)
entered into force 29-Apr-2009
Indonesia
The government sets a regulation on the in-
dustrial areas 03-Mar-2009
The Minister Regulation about environmen-
tal laboratories 06-Apr-2009
International
IMO Material Safety Data Sheet requirement
for maritime cargo containing MARPOL
73/78 Annex I shipments to go into effect as
of 1 July 2009 01-Oct-2007
Israel
Polluter pays Law adopted 11-Aug-2008
Local authorities law concerning enforcement
authorities adopted 11-Jun-2008
Italy
Directive on protection of groundwater
against pollution transposed 04-Apr-2009
Fund for projects aiming at substitution of
Substances of Very High Concern (SVHC)
under REACH created 08-Apr-2008
New labels for detergents approved
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Luxembourg
Law relating to environmental liability adop-
ted 27-Apr-2009
Norway
Revised Regulations related to transport on
ground of hazardous goods have been adop-
ted 01-Apr-2009
Poland
Amendment to Ordinance limiting the use of
substances negatively impacting the environ-
ment in electrical and electronic equipment
adopted 01-Apr-2009
Ordinance on Labeling of Chemical Substan-
ces and Some Chemical Preparations issued
05-Mar-2009
Russia
Amended the Law on International Transpor-
tation of Goods by Road 05-Apr-2009
The list of objects which are subject to the
state environmental supervision (control) is
changed 31-Mar-2009
Adopted Administrative Regulation on the
State Supervision of Major Hazard Installati-
ons 30-Oct-2008
Slovenia
Rules on professional training of personnel
repairing equipment containing ozone de-
pleting substances or fluorinated greenhouse
gases issued 10-Feb-2009
South Africa
Consumer Protection Act, 2008 adopted, ma-
king way for environmental labelling, provi-
sion of information and product liability 15-
May-2008
National Environmental Management
Amendment Act changing requirements for
environmental authorisations and manage-
ment programmes comes into effect 09-Jan-
2009
Mine Health and Safety Amendment Act
adopted 17-Apr-2009
South Korea
KC Mark, unified national product quality
mark, adopted 01-Apr-2009
[On 1 April 2009, amendments to the National Standards
Framework Act were adopted by the National Assembly.
Journaal Stoffen en Preparaten juli 2009, Nr. 6 167

Amongst others, the amended Act of 1 April 2009 intro-
duced “KC Mark”, i.e. unified Korea Certification Mark. By
the end of 2010, the KC Mark will replace the existing 18
compulsory marks (e.g. Electric Appliances Safety Control
Act, Act on the Rational Use of Energy, Industrial Safety
and Health Act, Noise and Vibration Control Act, Phar-
maceutical Affairs Act) on a phase-in basis.]
Turkey
Notification on Export of Ozone Depleting
Substances published 29-Apr-2009
Ukraine
Adopted a list of products and chemicals the
import shipment of which is subject to envi-
ronmental, sanitary and phytosanitary con-
trol 27-Mar-2009
Adopted Criteria for Evaluating the Degree of
Health and Safety Risk Caused by a Particular
Activity 28-Apr-2009
United States
California: Adopted no significant risk levels
for ethylbenzene 17-Apr-2009
New Jersey: Adopted-amendments, rules, and
repeal of rules on the control and prohibition
of air pollution by VOCs and oxides of nitro-
gen 20-Apr-2009
Washington: Adopted – new rules on recycla-
ble materials 21-Apr-2009
Indiana: Electronic waste legislation signed
into law 13-May-2009
168 Journal Chemicals Management July 2009, No. 6
publications
publications
Books
Room for improvement in EU
standards for industrial chemical
risk assessment  
[2009/0146]
Thesis title: Evaluating uncertainties in an in-
tegrated approach for chemical risk assessment
under REACH: more certain decisions? Disser-
tation by Theo Vermeire. Faculty of Veterinary
Medicine, University of Utrecht, The Nether-
lands, 11 June 2009. ISBN 978-90-39350-58-4.
Chemicals are an integral part of our daily
lives. In the European Union, the effects of the
use of industrial chemicals on humans and the
environment are evaluated using the REACH
system: Registration, Evaluation and Authori-
sation and restriction of CHemicals. This sys-
tem is applied to all chemicals produced in or
imported into the European Union.
Theo Vermeire studied risk assessment of in-
dustrial chemicals and came to the conclusion
that there is room for improvement. Chemi-
cal risk management includes all of the ob-
ligatory and voluntary measures used to limit
the risks posed by chemicals. Risk managers in
government and industry are assisted in this
process by experts in various fields, including
risk assessment.
Both the risk managers and their consultants
admit that the issue is too complex and the
available data are too limited to be able to
have a thorough understanding of all of the
risks involved in chemical risk assessment.
The purpose of Vermeire’s dissertation was to
Sdu Uitgevers
publications
study how the scientific process of risk assess-
ment can help to improve the decision-mak-
ing process by taking these uncertainties into
consideration. An important aspect of the
decision-making process is the consideration
of whether precautionary measures should be
taken.
The recommendations described in Vermeire’s
dissertation are geared towards realising a
more transparent decision-making process
and reducing the communication problems
between various stakeholders, such as the
government, industry and the general popu-
lation. The current European legal framework
REACH leaves some room for improved risk
assessment, both in the process and in the
methodology of risk assessment.
The process can be improved through the ap-
plication of a framework for risk assessment
that includes extra attention for the uncer-
tainties. The methodology can be improved by
using a phased approach to the analysis of the
uncertainties, starting with a simple approach
and then moving on to a deeper analysis and
a statistical approach as necessary. Vermeire’s
dissertation also describes the qualitative and
quantitative instruments that are currently
available to help improve industrial chemical
risk assessment.
Conference Proceedings
Conference on EU and world-wide
rules for classification, labelling
and packaging of chemicals
[2009/0147] new format. The Quick Reference (last page
EU Regulation on Classification, Labelling
and Packaging (CLP) of Substances and Mix-
tures based on the UN Globally Harmonised
System (GHS). 17 June 2009, Brussels. Orga-
nised by the European Commission.
References: http://ec.europa.eu/enterprise/reach/infor-
mation/events/index_en.htm
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The main features of the CLP Regulation:
http://ec.europa.eu/enterprise/reach/docs/
events/clp_conf_jensen_korte.pdf
REACH Europe 2009
[2009/0148]
REACH Europe 2009. Fifth International
Conference on the Registration, Evaluation
and Authorisation of Chemicals. Amsterdam,
24-25 June 2009.
Published by iSmithers/Smithers Rapra. ISBN
978-1-84735-393-1.
Internet
New Jersey: Right to Know
Hazardous Substance Fact Sheets
[2009/0137]
The Fact Sheets are prepared for substanc-
es on the New Jersey Right to Know Hazardous
Substance List.   More than 1600 Fact Sheets
have been completed and more than 800 have
been translated into Spanish. The Fact Sheets
are prepared on pure substances and contain
information on health hazards, exposure lim-
its, personal protective equipment, proper
handling, first aid, and emergency procedures
for fires and spills.
Emergency Responders can now access the
Emergency Responders Quick Reference for all
Fact Sheets that have been converted to the
of the RtK Hazardous Substance Fact Sheet)
provides comprehensive safety and health
information on a hazardous substance when
responding to a chemical emergency. Please
note that health and safety information is also
available for Fact Sheets in the old format.
The list of substances with a Quick Reference
Journaal Stoffen en Preparaten juli 2009, Nr. 6 169

is updated as Fact Sheets are converted to the
new format.
Reference: http://web.doh.state.nj.us/rtkhsfs/indexfs.
aspx
GADSL 2009
[2009/0138] University, 42 pages.
The updated ‘Global Automotive Declarable
Substance List (GSDSL)’ is available.
Both the reference list (2009 GADSL
Version 1.0) as well as the 2009 GADSL Ver-
sion 1.1, incorporating the latest revisions in
March, 2009, can be downloaded.
References: Version 1.0 :http://www.gadsl.org/files/
GADSL_Document.pdf
Version 1.1: http://www.gadsl.org/files/
ReferenceList.xls
Citizens’ Report: Global Outreach
Campaign on the Strategic
Approach to International
Chemicals Management (SAICM)
[2009/0139] policies and management approaches is ulti-
A report published by the International Persis-
tent Organic Pollutants Elimination Network
(IPEN) summarises more than 300 activities
undertaken by NGOs around the world to
promote the goals of the Strategic Approach
to International Chemicals Management (SA-
ICM). Project have aimed at awareness-raising
and capacity building.
Reference: http://www.ipen.org/campaign/docu-
ments/education/citzreport_09.pdf
170 Journal Chemicals Management July 2009, No. 6
publications
Managing Hazardous Chemicals:
Longer-Range Challenges
[2009/0149]
Henrik Selin :Managing Hazardous Chemicals:
Longer-Range Challenges
The Pardee Papers / No. 5 / March 2009. Boston
Abstract: Improving global chemicals manage-
ment is a significant sustainable development
issue, involving many longer-range challenges.
This paper examines some of these challenges.
It begins by describing hazardous chemicals
as a longer-range problem. This is followed
by an outline of the global policy framework
for managing hazardous chemicals. Next, the
paper discusses four sets of management chal-
lenges for better environmental and human
health protection: 1) Enhancing ratification
and implementation of existing regulations;
2) Expanding risk assessments and controls;
3) Improving management capacity and rais-
ing awareness; and 4) Minimizing generation
of hazardous chemicals and wastes.
Furthermore, the paper argues that the adop-
tion of more proactive and precautionary
mately needed to achieve necessary environ-
mental and human health protection stan-
dards. While some such policy and regulatory
changes are under way in the European Union
and other regions, they are not yet sufficiently
reflected in international law.
Reference: http://www.bu.edu/pardee/documents/PP-
005-Wastes.pdf
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official publications
official
publications
The Netherlands (Period May
2009)
[2009/0140] ring van ontplofbare en radioactieve stoffen
Tractatenblad 1996, 342: Europese Overeen-
komst betreffende het internationaal vervoer
van gevaarlijke goederen over de weg (ADR)
Tractatenblad 2009, 71: Europees Verdrag in-
zake het internationale vervoer van gevaarlijke
stoffen over de binnenwateren (ADN)
Kamerstuk 2008-2009, 25883, nr. 149, Twee-
de Kamer: Arbeidsomstandigheden; Brief
minister over het eindverslag van het door de
Arbeidsinspectie uitgevoerde inspectieproject
‘Gegaste Containers 2008’
[see also: http://docs.minszw.nl/pdf/129/2009/129_2009
_3_13005.pdf (in Dutch)]
Staatscourant 2009, 84: Bekendmaking van
de Minister van Volksgezondheid, Welzijn en
Sport van 28 april 2009, nr. VGP/PSL2928992,
houdende de uitvoering van richtlijn
nr. 2009/36/EG
[… dat genoemde richtlijn reeds volledig in de Neder-
landse regelgeving is geïmplementeerd door middel van
artikel 8, eerste lid, van de Warenwetregeling nadere eisen
cosmetische producten.]
Staatscourant 2009, 89: Rectificatie Circulai-
re vertrouwelijke behandeling bedrijfs-, fabri-
cage- en naw-gegevens [see also Staatscourant
2009, 66 (JCM/JSP No. 4/2009)]
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Belgium (Period May-June 2009)
[2009/0141]
Belgisch Staatsblad 29 mei 2009, Editie
N. 182: Koninklijk besluit van 20 mei 2009
tot wijziging van het koninklijk besluit van
9 maart 2003 betreffende het vervoer van ge-
vaarlijke goederen over de weg, met uitzonde-
Belgisch Staatsblad 29 mei 2009, Editie N.
182: Koninklijk besluit van 6 mei 2009 tot wij-
ziging van het koninklijk besluit van 15 okto-
ber 1997 betreffende cosmetic
Belgisch Staatsblad 9 juni 2009, Editie N.
194: Milieubeleidsovereenkomst van 17 ok-
tober 2008 betreffende de aanvaardingsplicht
voor afgedankte elektrische en elektronische
apparatuur (AEEA)
Belgisch Staatsblad 11 juni 2009: Koninklijk
besluit van 19 mei 2009 tot wijziging van het
koninklijk besluit van 11 maart 2002 betref-
fende de bescherming van de gezondheid en
de veiligheid van de werknemers tegen de ri-
sico’s van chemische agentia op het werk.
http://www.ejustice.just.fgov.be/mopdf/
2009/06/11_1.pdf
United Kingdom (Period May-
June 2009)
[2009/0142]
by Dr Ross Fielding
Dichloromethane (DCM), CAS 75-09-2
The current state of the European legislative
process that will ban the placing on the mar-
ket of dichloromethane (DCM)-based paint
strippers for use by both consumers and pro-
fessionals, with the option for Member States
to permit continued use subject to certain
conditions; (for example in industrial instal-
lations) is set out.
Journaal Stoffen en Preparaten juli 2009, Nr. 6 171

Reference: http://www.hse.gov.uk/aboutus/europe/
euronews/dossiers/dichloromethane.htm
Dangerous Substances and Explosive
Atmospheres Regulations (DSEAR)
The HSE has updated and made public its
own guidance to its Health and Safety Inspec-
tors to bring this into line with changes in leg-
islation and associated guidance. As guidance
for Inspectors, this is not a substitute for the
specific and detailed DSEAR ACoPs (L133,
L134, L135, L136, L137, L138) but it does pro-
vide a useful and up to date overview of the
regulations, the obligations arising and how
these are expected to be met.
BDP: 12 Months to go to 1st June 2010
1 June 2010 is the deadline for withdrawal
under the BPD of products containing “un-
supported” active substances in the review
programme. The UK biocides Competent
Authority (the HSE) reminds stakeholders of
products containing active substances in the
2nd phase of the Biocidal Products Direc-
tive (BPD) review programme that biocidal
products of types 16, 18, 19 and 21 contain-
ing active substances for which no dossier was
initially submitted by 30 April 2006 and; a
new participant came forward but no suitable
dossier was subsequently submitted; cannot
be placed on the EU market or subsequently
stored for any purpose (except for export and
disposal) from 1 June 2010.
References: http://news.hse.gov.uk/2009/05/29/europe-
an-legislative-dossier-on-dichloromethane-
updated/
http://www.hse.gov.uk/foi/internalops/fod/
oc/200-299/284-7.htm
http://www.hse.gov.uk/biocides/liveissues/
unsupported0409.htm
Working Group on Action to Control Chemi-
cals (WATCH)
Papers and minutes from the most recent
(23 - 24 October 2008 and 24 February 2009)
meetings of the sub-committee of the Advi-
172 Journal Chemicals Management July 2009, No. 6
official publications
sory Committee on Toxic Substances are now
available.
Reference: http://www.hse.gov.uk/aboutus/meetings/
iacs/acts/watch/agendas.htm
Carriage of Dangerous Goods Manual Up-
dated
The Health & Safety Executive has given notice
that the carriage of dangerous goods manual
has undergone a major revision.
The Carriage of Dangerous Goods and Use
of Transportable Pressure Equipment Regu-
lations 2009 (CDG 2009) are the UK imple-
menting regulations for the European agree-
ment (“Accord européen relatif au transport
international des marchandises dangereuses
par route”, known as ADR). Together these
regulate the carriage of dangerous goods on
UK roads, and both are highly prescriptive.
The regulations were substantially restruc-
tured for 2009 with direct referencing to ADR
for the main duties.
Although the guidance is intended for en-
forcement officers (it provides guidance for
officers when discussing compliance with
duty holders and deciding when to take fur-
ther action), it is also of use and relevance to
duty holders as a guide to the process and to
help make informed judgements about the
extent of compliance.
CDG 2009 now cross-refers almost totally to
ADR, however the regulations allow certain
exemptions that arise from the way the EU
Dangerous Goods Directive is worded and
the UK derogations from that directive are ex-
plained. The guidance does not include refer-
ence to the carriage of radioactive substances.
Reference: http://www.hse.gov.uk/cdg/manual/index.
htm
Control of Substances Hazardous to Health
(COSHH)
The UK regulations that are intended to con-
trol exposure to hazardous substances in the
work place are the The Control of Substances
Hazardous to Health Regulations 2002 (SI
2002:2677). The HSE has a web site that pro-
Sdu Uitgevers
official publications
vides support and guidance for these regula-
tions, in particular, through the provision of
an on line risk assessment tool “COSHH Es-
sentials”.
The COSHH website has been re-launched
with lots of additional information.
Reference: http://www.hse.gov.uk/coshh/index.htm
Status of HSE Guidance Documents
As the Competent Authority for much chemi-
cal legislation, the Health and Safety Execu-
tive (HSE) has historically seen duty holders
as important stakeholders and customers, and
as well as producing free to access web sites,
and occasional free publications, the HSE has
also produced detailed and technical guidance
(Approved Codes of Practice or ACOPs) for
much of the legislation it has to enforce. This
higher level guidance has historically been
only available to purchase.
The Executive has announced that from Sep-
tember 2009 around 250 priced publications
that contain health and safety advice and
guidance will be made freely available from
HSE’s website in PDF format to view and
print. The publications cover the full range of
HSE’s guidance as well as approved codes of
practice and guidance on regulations.
Those that wish to will still have the option to
buy professionally produced printed versions
from HSE Books.
European Union (Period May
2009)
[2009/0143] market for supply to the general public or to
O.J. 2009, L124: Commission Decision
2009/395/EC of 14 May 2009 concerning the
placing on the market for essential use of bio-
cidal products containing temephos in the
French overseas departments
[Article 1: By way of derogation from Article 4(1) of Regu-
lation (EC) No 1451/2007, France may allow the placing
on the market of biocidal products containing Temephos
Sdu Uitgevers
(EC 222-191-1; CAS 3383-96-8), for vector mosquito
control in the French overseas departments until 14 May
2010.]
O.J. 2009, L127: Commission Directive
2009/51/EC of 25 May 2009 amending Coun-
cil Directive 91/414/EEC as regards the speci-
fication of the active substance nicosulfuron
[CAS 111991-09-4]
O.J. 2009, L135: Commission Regulation
(EC) No 450/2009 of 29 May 2009 on active
and intelligent materials and articles intended
to come into contact with food
[For the purpose of this Regulation, the following defini-
tions shall apply: (a) ‘active materials and articles’ means
materials and articles that are intended to extend the shelf-
life or to maintain or improve the condition of packaged
food; they are designed to deliberately incorporate compo-
nents that would release or absorb substances into or from
the packaged food or the environment surrounding the
food; (b) ‘intelligent materials and articles’ means materi-
als and articles which monitor the condition of packaged
food or the environment surrounding the food;(c) …]
O.J. 2009, L137: Decision No 455/2009/EC of
the European Parliament and of the Council
of 6 May 2009 amending Council Directive
76/769/EEC as regards restrictions on the
marketing and use of dichloromethane
[In Annex I to Directive 76/769/EEC, the fol-
lowing entry is added: (58) Dichloromethane
CAS No: 75-09-2 EC No: 200-838-9:
(1) Paint strippers containing dichlo-
romethane in a concentration equal to or
greater than 0,1 % by weight shall not be: (a)
placed on the market for the first time for
supply to the general public or to profession-
als after 6 December 2010; (b) placed on the
professionals after 6 December 2011; (c) used
by professionals after 6 June 2012. For the
purposes of this entry: (i) ‘professional’ means
any natural or legal person, including workers
and self-employed workers undertaking paint
stripping in the course of their professional
activity outside an industrial installation; (ii)
‘industrial installation’ means a facility used
for paint stripping activities.
Journaal Stoffen en Preparaten juli 2009, Nr. 6 173

(2) By way of derogation from paragraph 1,
Member States may allow on their territories
and for certain activities the use, by specifi-
cally trained professionals, of paint strippers
containing dichloromethane and may allow
the placing on the market of such paint strip-
pers for supply to those professionals. Member
States making use of this derogation shall de-
fine appropriate provisions for the protection
of the health and safety of those profession-
als using paint strippers containing dichlo-
romethane and shall inform the Commis-
sion thereof. Those provisions shall include
a requirement that a professional shall hold
a certificate that is accepted by the Member
State in which that professional operates, or
provide other documentary evidence to that
effect, or be otherwise approved by that Mem-
ber State, so as to demonstrate proper training
and competence to safely use paint strippers
containing dichlo-romethane. The Commis-
sion shall prepare a list of the Member States
that have made use of the derogation in this
paragraph and make it publicly available over
the Internet.
(3) A professional benefiting from the dero-
gation referred to in paragraph 2 shall oper-
ate only in Member States which have made
use of that derogation. The training referred
to in paragraph 2 shall cover as a minimum:
(a) awareness, evaluation and management
of risks to health, including information on
existing substitutes or processes, which under
their conditions of use are less hazardous to
the health and safety of workers; (b) use of
adequate ventilation; (c) use of appropriate
personal protective equipment that complies
with Directive 89/686/EEC. Employers and
self-employed workers shall by preference re-
place dichloromethane with a chemical agent
or process which, under its conditions of use,
presents no risk, or a lower risk, to the health
and safety of workers. The professional shall
apply all relevant safety measures in prac-
tice, including the use of personal protective
equipment.
174 Journal Chemicals Management July 2009, No. 6
official publications
(4) Without prejudice to other Community
worker protection legislation, paint strippers
containing dichloromethane in concentra-
tions equal to or greater than 0,1 % by weight
may be used in industrial installations only if
as a minimum the following conditions are
met: (a) effective ventilation in all process-
ing areas, in particular for the wet processing
and the drying of stripped articles: local ex-
haust ventilation at strip tanks supplemented
by forced ventilation in those areas, so as to
minimise exposure and to ensure compliance,
where technically feasible, with relevant occu-
pational exposure limits; (b) measures to min-
imise evaporation from strip tanks compris-
ing: lids for covering strip tanks except during
loading and unloading; suitable loading and
unloading arrangements for strip tanks; and
wash tanks with water or brine to remove
excess solvent after unloading; (c) measures
for the safe handling of dichloromethane in
strip tanks comprising: pumps and pipework
for transferring paint stripper to and from
strip tanks; and suitable arrangements for safe
cleaning of tanks and removal of sludge; (d)
personal protective equipment that complies
with Directive 89/686/EEC comprising: suit-
able protective gloves, safety goggles and pro-
tective clothing; and appropriate respiratory
protective equipment where compliance with
relevant occupational exposure limits cannot
be otherwise achieved; (e) adequate informa-
tion, instruction and training for operators in
the use of such equipment.
(5) Without prejudice to other Community
provisions concerning the classification, la-
belling and packaging of substances and mix-
tures, by 6 December 2011 paint strippers
containing dichloromethane in a concentra-
tion equal to or greater than 0,1 % by weight
shall be visibly, legibly and indelibly marked
as follows: ‘Restricted to industrial use and to
professionals approved in certain EU Member
States – verify where use is allowed.’
O.J. 2009, L138: Commission Decision
2009/424/EC of 28 May 2009 amending, for
Sdu Uitgevers
official publications

the purpose of adapting to technical prog- tegrated Risk Information System (IRIS). En-
ress, Annex I to Council Directive 76/769/ vironmental Protection Agency (EPA). Notice
EEC as regards restrictions on the marketing of listening session.
and use of lamp oils and grill lighter fluids
O.J. 2009, L138: Commission Decision
2009/425/EC of 28 May 2009 amending
Council Directive 76/769/EEC as regards
restrictions on the marketing and use of or-
ganostannic compounds for the purpose of
adapting its Annex I to technical progress
O.J. 2009, L141: Directive 2009/32/EC of the
European Parliament and of the Council of
23 April 2009 on the approximation of the
laws of the Member States on extraction sol-
vents used in the production of foodstuffs and
food ingredients (Recast)
O.J. 2009, C130: Communication (2009/C
130/03) from the Commission pursuant to Ar-
ticle 67(3) of Regulation (EC) No 1907/2006
of the European Parliament and of the Coun-
cil on the Registration, Evaluation, Authorisa-
tion and Restriction of Chemicals (REACH)
[A European Commission Communication has been pub-
lished today listing more stringent Dutch restrictions on
certain hazardous substances than those listed in Annex
XVII of the REACH Regulation. The restrictions, which
are approved until 1 June 2013, affect coatings containing
polyaromatic hydrocarbons as well as short-chain chlori-
nated paraffins.]

USA (Period May 2009)

[2009/0144]

Federal Register, 9 June 2009, Vol. 74,

No. 109, 27313: Draft Toxicological Review of
1,4-Dioxane [CAS 123-91-1]: In Support of
the Summary Information in the Integrated
Risk Information System (IRIS). Environ-
mental Protection Agency (EPA). Notice of
Listening Session and Peer Review Workshop.
Federal Register, 9 June 2009, Vol. 74,
No. 109, 27317: Draft Toxicological Review of
Pentachlorophenol [CAS 87-86-5]: In Sup-
port of the Summary Information in the In-

Sdu Uitgevers Journaal Stoffen en Preparaten juli 2009, Nr. 6 175


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IMPORTANT DATA
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14 July 2009
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Chemical Hazards Communication
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Info: www.chcs.org.uk/events.htm
26-29 August 2009
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Nanotechnology Occupational and
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Finnish Institute of Occupational
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Info: http://www.ttl.fi/Internet/English/
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15-16 September 2009
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ence.
Shanghai, China.
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Management
Journaal CONTENT
Stoffen & Preparaten
ARTICLES
[2009/0150] Evaluating uncertainties in an integrated
Chief-editor: approach for chemical risk assessment under
Drs. A.C.H. van Peski REACH: more certain decisions? / 181

Editorial Board: ACTUALTIES

Dr. M.M. Kops-Werkhoven European Union
Drs. H.A.F. van Well [2009/0151] ELINCS – final edition / 185
Dr. J.A.S.J. Razenberg [2009/0152] European biocides information
Dr. L.J.M. Rodenburg network / 186
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Drs. J. Zawierko chemical substances: Handovers from
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K. E. Armstrong (U.S.A.) unnecessary animal testing / 188
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Drs. A. Gondová harmonised classification and labelling / 188
G. Koh (Singapore)
Dr. C. van Lint (Australia) International
Dan Liu (U.S.A.) [2009/0156] USA: Perchlorate / 189
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S. Savary (Canada) Guidelines. Cleaning and Custodial
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Dr. U. Schumacher (China) C&L and SDS / 191
E. Snyman (South Africa) [2009/0160] ICMM guidance on Health Risk
P.G. Tse (New Zealand) Assessment / 192
[2009/0161] International Material Data System
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[2009/0166] United Kingdom (period July 2009) / 200
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[2009/0169] CALENDER OF EVENTS AND IMPORTANT DATA / 204

180 Journal Chemicals Management September 2009, No. 7 Sdu Uitgevers

articles
articles
Evaluating
uncertainties in an
integrated approach
for chemical risk
assessment under
REACH: more certain
decisions?
[2009/0150]
Dissertation by T.G. Vermeire. Faculty of Vete-
rinary Medicine, University of Utrecht, The Ne-
therlands, 11 June 2009. ISBN 978-90-39350-
58-4. Summary.
Introduction
Chemicals are important in our everyday life.
The chemical industry is the third largest in-
dustrial sector in the world. Chemicals add
value to our lives, but also add costs due to
adverse effects to health and the environment
from exposure at production and use and at
the waste stage. Chemicals control covers all
regulatory and voluntary measures taken to
minimize the risks of chemicals to human
health and the environment. In this process,
risk managers, both in the public sector and
in industry, need to be advised by experts of
various disciplines. A major discipline is risk
assessment. With regard to chemicals, risk can
be defined as the probability of adverse effects
in an organism, system or (sub)population
Sdu Uitgevers
caused under specified circumstances by ex-
posure to an agent. Both risk managers and
risk assessors nowadays recognise that uncer-
tainties are part and parcel of risk assessment
advice.
The thesis of Theo Vermeire concentrates
on uncertainty and variability in the risk as-
sessment methodology for industrial chemi-
cals as applied within the current regulatory
framework for industrial chemicals in Europe,
REACH (Registration, Evaluation, Authorisa-
tion and Restriction of Chemicals, Regulation
(EC) no. 1907/2006). The methodological
approaches discussed address the risk assess-
ment for both humans and the environment.
The aim of this thesis is to investigate in what
way the scientific process of risk assessment
can improve decision-making knowing that
uncertainties are inherently linked to risk
assessment. An important element of this
decision-making is consideration of precau-
tionary measures in the event of reasonable
grounds for concern of a potential risk that
cannot, or not in time, be determined with
sufficient certainty. The investigation is built
on two frameworks: the International Pro-
gramme on Chemical Safety IPCS)/WHO
framework for Integrated Risk Assessment
(IRA) and the framework for Uncertainty
Management of Walker et al. (Integr Assess
4:5-17, 2003).
The framework of Integrated Risk Assess-
ment was developed to improve the quality
and efficiency of the assessment of risks of
adverse effects on human health and the en-
vironment from chemicals, physical factors,
and other environmental stressors and to pro-
vide more complete and coherent inputs to
the decision making process. The underlying
idea is that both the scientific discussion and
Dr. Theo Vermeire is deputy head of the National Institute
for Public Health and the Environment (RIVM) Expertise
Group for Substances SEC, Bilthoven, The Netherlands.
Journaal Stoffen en Preparaten september 2009, Nr. 7 181

the regulatory responses can benefit from a
more integrated, interdisciplinary approach
leading to sharing of information, decreased
uncertainties and fully informed decisions.
The Uncertainty Management framework
closely parallels the stages in the Integrated
Risk Assessment scheme and is considered
very useful for highlighting different types of
uncertainty in risk assessment.
Chapter 1 (Introduction) introduces the sub-
ject and explains the two frameworks used.
It provides the historical and legal context
of chemical control and risk assessment at
UN, OECD and EU level. This chapter also
provides summary information on REACH
and on one of its basic principles, the Pre-
cautionary Principle. It is explained that the
Precautionary principle can be applied when
there exist considerable scientific uncertain-
ties about causality, magnitude, and nature of
harm and that some form of scientific analysis,
including a thorough uncertainty analysis, is
mandatory. Essential is an evaluation of the
reliability of the assessment as well as the re-
maining uncertainties and a correct typology
of the uncertainties.
Chapter 2 (Integrated human and ecological
risk assessment. A case study of organophospho-
rous pesticides in the environment) illustrates
the concept of integrated human and ecologi-
cal risk assessment. The concept is applied to
a case study of the use of organophosphorous
pesticides in a typical farming community.
This case study was developed to commu-
nicate the IRA approach, to illustrate how.
IRA assessments might be conducted, and to
analyse the benefits and drawbacks of integra-
tion. It is argued that this integrated approach
helps both the risk manager and the risk asses-
sor in looking more broadly, towards the risk
of the use of organophosphorous esters. The
first stage, problem formulation, is particularly
relevant, for both information sharing and de-
fining what information and advice is required
182 Journal Chemicals Management September 2009, No. 7
redactionele bijdrage
articles
for an optimal regulatory decision. Problem
formulation is the process by which the risk
assessment is defined and the plan for analys-
ing and characterising the risk is developed.
The methodology used in Chapter 2 is based
on the risk assessment methodology devel-
oped and harmonised in Europe as described
in the EU Technical Guidance Documents and
implemented in the PC-application European
Union System for the Evaluation of Substances
– EUSES.
The 2004 version of EUSES is described in
Chapter 3 (European Union System for the Eval-
uation of Substances (EUSES): the second ver-
sion). Adaptations considered necessary for a
full application under REACH are discussed
in Chapter 7. In a discussion on the validation
status the models used are considered to be
state-of-the-art, providing deterministic con-
servative estimates for standard scenarios based
on limited data requirements.
In the EU risk assessment of industrial chem-
icals, it is current practice to characterise
risks using a deterministic quotient of the
exposure concentration, or the dose, and a
no-effect level. A sense of uncertainty is tack-
led by introducing worst-case assumptions in
the methodology.
Chapter 4 (Opportunities for a probabilistic
risk assessment of chemicals in the European
Union) explains how chemical risk manage-
ment can benefit from considering those un-
certainties, which can be characterised by dis-
tributions, in a probabilistic risk assessment
(PRA.). It discusses the advantages and pos-
sibilities of PRA and illustrates this by provid-
ing an example calculation.
Chapter 5 (A probabilistic human health risk
assessment for environmental exposure to dib-
utyl phthalate) continues this demonstration
of the advantages and drawbacks of PRA, tak-
ing the EU risk assessment of the plasticizer
Sdu Uitgevers
articles
dibutyl phthalate (DBP, CAS Number 84-
74-2) as starting point. This example shows
the possibility of including and comparing
the various uncertainties involved in a typi-
cal risk assessment, covering the uncertainty in
the exposure estimate, the uncertainty in the
effect parameter modelled by a Benchmark
approach, and the uncertainty in assessment
factors used in the extrapolation from exper-
imental animals to sensitive human beings.
One important aspect of uncertainty analysis
is the widely used application of assessment
factors to derive human and ecotoxicological
no-effect levels. This subject is reviewed exten-
sively in Chapter 6 (Assessment factors for hu-
man health risk assessment: a discussion paper)
with regard to human assessment factors. In
addition, this chapter discusses more exten-
sively the probabilistic approach to establish
a human health limit value based on Bench-
mark modelling as applied in Chapter 5.
Chapter 7(Evaluating uncertainties in an in-
tegrated approach for chemical risk assessment
under REACH: more certain decisions?) finally
discusses the relevant methodological aspects
of risk assessment and uncertainty analysis.
The EU risk assessment methodology as im-
plemented in EUSES is compared to the new
REACH guidance.
Although EUSES is based on the Technical
Guidance Documents operating until mid-
2008 under the pre-REACH EU legislation,
much of it is still in line with the updated
Guidance for REACH. Important changes
and implications for EUSES are discussed this
chapter. It further shows how the REACH risk
assessment framework can benefit from the
1RA-framework and how the IRA-framework
in its turn can be improved by taking into ac-
count the current understanding of the role of
uncertainty analysis in risk assessment and
risk management. Uncertainty Management,
including a method for classification of un-
certainties and a tiered approach, is presented
Sdu Uitgevers
as an additional layer in the IRA framework
aiming to improve the management and com-
munication of uncertainty in decision-mak-
ing processes.
The main, general conclusion of this thesis is
that both the process and the methodology
of risk assessment as a decision-support tool
under REACH can be improved. The proc-
ess can be improved by the introduction of
an IRA framework with a strong uncertainty
management component (IRA*). The meth-
odology can be improved by a tiered approach
for uncertainty analysis, starting with simple
deterministic approaches and, if necessary,
classification and prioritisation of uncertain-
ties and probabilistic approaches. Qualitative
and quantitative tools for uncertainty assess-
ment were shown to be available.
Conclusions and recommendations on
the process:
The most important of the perceived benefits
of IRA are increased assessment efficiency
with regard to data collection and methodol-
ogy, increased cost-effectiveness of assessment
activities in view of shared resources, and
increased coherence of assessment results in
view of shared methodology and risk charac-
terization. Decisions should be based on all
data available and searching for communali-
ties. This will prevent risk reduction or pri-
oritisation decisions which do not protect all
human and environmental targets. Or even
increase the risk to specific targets. In regis-
tering chemicals under REACH, it is strongly
recommended that industry will interact with
regulatory bodies and other stakeholders in a
problem formulation approach. The intensity
of such communication, especially at registra-
tion, should be proportional to the complexity
of the Chemical Safety Assessment, the degree
of risk foreseen and the degree of uncertainty
due to lack of knowledge. Further demonstra-
tions of the scientific, economic and regulatory
benefits of the IRA approach are needed. It is
Journaal Stoffen en Preparaten september 2009, Nr. 7 183

recommended to perform cost-benefit stud-
ies to this regard.
The integration of information could also
help to develop testing strategies with the
aim of avoiding vertebrate testing where pos-
sible. An important aim of REACH, the re-
duction of the use of experimental animals.
is an important driver towards integrated ap-
proaches combining knowledge front in vivo,
in vitro, in silico experiments, exposure data
and information on mechanisms of action
across species. Further work is needed to in-
vestigate when and how the total Weight-of-
Evidence from such integration will show a
positive balance with regard to costs and ani-
mals saved.
The uncertainty management scheme can
be regarded as an additional layer in the IRA
framework aiming to improve the management
and communication of uncertainty in IRA deci-
sion-making processes. This IRA–-framework
stimulates interactions between risk assessors,
decision-makers and stakeholders and facili-
tates the analysis and prioritisation of uncer-
tainties, supported by robust tools for a tiered
integrated risk and uncertainty assessment.
This approach is also needed to support deci-
sion-making on the basis of the Precautionary
Principle. The Precautionary Principle should
be considered as a risk management tool sup-
ported by a risk assessment framework which
includes a scientific evaluation, as complete as
possible, and an identification of the degree of
uncertainty at each stage as proposed in the
IRA+-framework.
Conclusions and recommendations on
methodology:
The risk assessment tool EUSES has been
shown to be fit for purpose under REACH
with some modifications, specifically with
regard to the implementation of the Expo-
sure Scenario concept and more risk reduc-
tion options. More work needs to be done to
increase the domain of applicability. in view of
184 Journal Chemicals Management September 2009, No. 7
articles
the limited use of EUSES outside the domain of
the persistent, non-dissociating substances of
intermediate lipophilicity.
It has also been shown that a probabilistic
risk assessment in the EU framework assess-
ment of industrial chemicals is feasible with
currently available techniques. PRA potentially
gives better decision-support to risk manag-
ers, because it gives more quantitative insight
into the range of possible outcomes in a risk
assessment and the degree of cumulated con-
servatism in the deterministic risk assess-
ment. Sensitivity analysis is able to reveal the
relative impact of. uncertainties in parameters
on the final result, where the risk assessment
can be improved in the most time- and cost-
efficient manner and whether it is neces-
sary and achievable to reduce the uncertainty
further. The examples discussed show a high
contribution to the overall quantifiable un-
certainty from uncertainty and variability in
emission estimation and in the application of
default assessment factors.
For a further implementation of ’ PRA, it is
necessary to build up experience. If the tiered
REACH Guidance is followed, PRAs on more
substances wilt become available. Important
research areas are the characterisation of
both default and chemical-specific distribu-
tions for exposure and effects input param-
eters and methods to address environmen-
tal and human variability in the REACH CSA
and to separately address variability, based
on experimental data, and uncertainty due
to lack of knowledge. The different stages of
uncertainty analysis and PRA would be greatly
facilitated if firmly integrated with risk assess-
ment tools like EUSES.
In any uncertainty analysis a clear separation
needs to be made between quantifiable and
non-quantifiable uncertainties and between
true uncertainty (lack of knowledge) and
variability to be able to answer different risk
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articles
questions. Further, it should be made very
clear which uncertainties are included in the
assessment and which not.
In risk assessment, an important tool for
characterizing and reducing uncertainty
due to lack of knowledge is the Weight-of-
Evidence (WoE) process, usually carried out
by experts. Unfortunately, formal procedures
and consistent terminology for WoE-process-
es are lacking. As shown, international efforts
are ongoing to improve this situation and it is
strongly recommended to support these ini-
tiatives.
An important difficulty in the application of
this process and methodology is the know-
ledge gap: both risk assessors and risk managers
often are unfamiliar with these new approaches
and have to learn new skills. This should first
of all be solved by training of both risk asses-
sors and risk managers. It further requires a
more formalised process to apply IRA with a
tiered approach, graphical support and high
communication skills of both expert and
risk assessors. The guidance available should
be extended by showing real-life applications,
preferably prepared in regulator-industry-
stakeholder expert working groups. Experts
and risk managers need to investigate together
how to use the results of uncertainty analysis
in decision-making and how to communicate
these in a transparent way.
If process and methodology follow the direc-
tion shown, decision-support will be more
transparent, will lead to less communication
problems and will improve the trust between
various parties involved. Decisions which fully
take into account the uncertainties in the as-
sessments performed, including the influence
of divergent opinions and assumptions of
experts and stakeholders, win be better in-
formed and will lead to transparent decisions
which can be communicated in a clear way.
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actualities
ELINCS – final edition
[2009/0151]
In accordance with Commission Decision
85/71/EEC [pursuant to Directive 92/32/EEC,
the 7th amendment to Directive 67/548/EEC
(hereinafter “the Directive”) on the approxi-
mation of the laws, regulations and adminis-
trative provisions relating to the classification,
packaging and labelling of dangerous sub-
stances] the European List of Notified Chemi-
cal Substances (ELINCS) has been established
with publication in the Official Journal of the
European Union (OJ).
A 5th edition of ELINCS, compiling substan-
ces notified in accordance with the Directive
until 30 June 1995, is the last available update
published in the OJ.
A 6th edition, comprehensive of substances
notified until 30 June 1998, has been pub-
lished as a Commission document. Due to
resource limitations on translating chemical
names into all official EU languages, thereafter
ELINCS was maintained in the English lan-
guage only, and published only as an internet
document by the European Chemicals Bureau
(ECB), where the latest update replaces previ-
ous versions. The current version is indicated
with compilation date, rather than edition
number.
The ECB in co-operation with the national
Competent Authorities of the Member States
has prepared the updated version of ELINCS,
only in English language. This list has no legal
status. Neither the Commission of the Euro-
pean Communities nor any person acting on
behalf of the Commission is responsible for
Journaal Stoffen en Preparaten september 2009, Nr. 7 185

the use, which might be made of the informa-
tion.
This final edition of ELINCS (2009) is com-
prehensive of all notified substances, conclud-
ed by expiry of the Directive on 31 May 2008,
and contains 8433 notifications, representing
5287 substances in total. On 1 June 2008 the
notification scheme was revoked and replaced
by Regulation (EC) No 1907/2006 concerning
the Registration, Evaluation, Authorisation
and Restriction of Chemicals (REACH).
References: 6th ELINCS publication – COM(2003)
642, 29.10.2003: http://ecb.jrc.ec.europa.
eu/DOCUMENTS/New-Chemicals/
ELINCS_PUBLICATION/ELINCS_6/
ENGLISH.pdf
ECB ELINCS: http://ecb.jrc.ec.europa.eu/
elincs/
Final version: http://ecb.jrc.ec.europa.eu/
DOCUMENTS/New-Chemicals/ELINCS_
PUBLICATION/ELINCS_2009.pdf
European biocides information
network
[2009/0152]
The ‘European biocides information network’
(EBIN) is a non-profit network initiative in
cooperation with the Austrian Ministry for
Environment. It has been developed to serve
industry, small and medium enterprises and
authorities and intends to be continuously
enlarged and updated on a regular basis and
such performs as a time saving one-stop-shop
platform with pre-selected and commented
hyperlinks, articles and documents. Thanks to
the commitment of the sponsors of this pro-
ject EBIN can provide free password protected
access to this source of information for all in-
terested parties.
The content covers:
– background, guidance and information
on current and upcoming issues concern-
ing biocides under the EU regime;
186 Journal Chemicals Management September 2009, No. 7
actualities
– information about member states, con-
tact details of the relevant competent
authorities and poison information cen-
tres as well as relevant and publicly avail-
able regulatory inventories and sources of
electronically available legal texts;
– contributions from authorities and in-
dustry experts aiming at a European wide
harmonised understanding and handling
of biocides regulations;
– clarification on specific scope issues;
– information about test-houses;
– contact details of specialised consultants
and overviews of their services;
– information and links to scientific jour-
nals as well as books of relevance to the
biocidal scientific and regulatory world;
– collection of helpful and publicly available
databases;
– highlights and information of interna-
tional organisations with relevant impact
on the biocides regime in Europe such as
OECD and UN; and
– news and facts on meetings and trainings
related to the biocides scientific and regu-
latory world.
Feierl-Herzele GmbH is operator of the plat-
form, managing director is Mag. Robert J.
Feierl.
An advisory committee, the members of which
are all experts in the field of biocidal regula-
tory and scientific issues, advises and controls
and such ensures the quality and high level of
information and continuous development of
this network
Head of committee: Dr. Karl Hruby (Head of
the Austrian Poison Information Centre)
Deputy head of committee: Dr. Edmund
Plattner (Head of Department V/3 (Biocides)
of the Austrian Ministry of Environment)
Deputy head of committee: Dr. Geoff Wilson
(Consultant).
References: www.europeanbiocides.net
www.feierl-herzele.com
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actualities
ECHA: Risk and hazard
information on chemical
substances: Handovers from
Regulation (EEC) 793/93
[2009/0153]
ECHA has published new information on the
risks and hazards of some chemical substanc-
es on its website. The substances concerned
are “handovers” from the previous legislation
(Regulation (EEC) No. 793/93) which were
prioritised due to being produced in large
quantities or having possible persistent, bio-
accumulative and toxic properties.
Where relevant, the evaluating EU Member
State has given a recommendation on how to
reduce the risk. This information is particu-
larly useful for companies who are planning
to register these substances and for Member
States or the European Commission who may
have concerns about them.
Annex XV transitional reports of existing
substance risk assessments and risk reduction
strategies developed under Regulation (EEC)
No 793/93, where the work was not finalised
by 1 June 2008. The substance reports are:
tetrachloroethylene, CAS 128-18-4; styrene,
CAS 100-42-5; ethylbenzene, CAS 100-41-4,
chloroform, CAS 67-66-3; 2-ethoxyethanol,
CAS 110-80-5; amines, tallow alkyl, CAS
61790-33-8; trisodium nitrilotriacetate, CAS
5064-31-3; tert-butyl hydroperoxide (TBHP),
CAS 75-91-2; pitch, coal tar, high-temp., CAS
65996-93-2;
4,4’-isopropylidene-diphenol (bisphenol-A),
CAS 80-05-7; trisodium hexafluoroalumi-
nate (synthetic), CAS 13775-53-6; trisodium
hexafluoroaluminate (natural), CAS 15096-
52-3; alkanes, C14-C17, chloro (MCCP), CAS
85535-85-7; 1-methoxypropan-2-ol (PGME),
CAS 107-98-2; 2-methoxy-1-methylethyl ace-
tate (PGMA), CAS 108-65-6; tris(2-chloro-1-
methylethyl) phosphate (TCPP), CAS 13674-
84-5; tris[2-chloro-1-(chloromethyl)ethyl]
phosphate (TDCP), CAS 13674-87-8; diso-
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dium tetraborate, anhydrous, CAS 1330-43-4;
boric acid, crude, natural, CAS 10043-35-3;
boric acid, CAS 11113-50-1; (Z)-octadec-9-
enylamine, CAS 112-90-3; Octadecylamine,
CAS 124-30-1; Amine, hydrogenated tallow
alkyl, CAS 61788-45-2; Amines, coco alkyl,
CAS 61788-45-2; Diantimony trioxide, CAS
1309-64-4; and tris(nonylphenyl) phosphite
(TNPP); CAS 26523-78-4.
The new web page also contains a list of
the EU Member State Competent Authori-
ties which ECHA has nominated to take
charge of evaluating new data still expected
from industry according to Regulation (EC)
No 465/2008. The results of the evaluations
will be uploaded later.
Austria: CAS 118-82-1: 2,2’,6,6’-tetra-tert-
butyl-4,4’-methylenediphenol
United Kingdom: CAS 15571-58-1: 2-ethyl-
hexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-
dithia-4-stannatetradecanoate
United Kingdom: CAS 3542-36-7: dichlo-
rodioctylstannane
The Netherlands: CAS 50849-47-3: 5-donyl-
salicylaldehyde oxime
France: CAS 83846-43-9: benzoic acid, 2-hy-
droxy-, mono-C>13-alkyl derivs, calcium
salts (2:1)
United Kingdom: CAS 31565-23-8: di(tert-
dodecyl) pentasulphide
France: CAS84929-98-6: magnesium, bis(2-
hydroxybenzoato-O1,O2)-, ar,ar’-di-C>13-
alkyl derivs.
United Kingdom: CAS 556-67-2: octamethyl-
cyclotetrasiloxane
United Kingdom: CAS 61788-44-1; phenol,
styrenated
Finland: CAS 61788-32-7: terphenyl, hydro-
genated
The Netherlands: 3590-84-9: tetraoctyltin
United Kingdom: CAS 25103-58-6: tert.-do-
decanethiol
United Kingdom: 27107-89-7: 2-ethylhexyl
10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxo-
Journaal Stoffen en Preparaten september 2009, Nr. 7 187

ethyl]-thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-
4-stannatetradecanoate
United Kingdom: CAS 31570-04-4: tris(2,4-
di-tert-butylphenyl)phosphite
United Kingdom: CAS 541-02-6: decamethyl-
cyclopentasiloxan (Screening: PBT &vPvB)
Sweden: CAS 38640-62-9: DIPN (diisopro-
pylnaphthalene)
Reference: http://echa.europa.eu/chem_data/tran-
sit_measures_en.asp
ECHA calls for information to
avoid unnecessary animal testing
[2009/0154]
An important new way to avoid unnecessary
animal testing has been put into operation
bij ECHA. The European Chemicals Agency
(ECHA) is calling for health effects informa-
tion on the reproductive toxicity of a specific
chemical substance. This is the first time that
this type of public consultation – foreseen
by the REACH Regulation – is made, and
ECHA expects to make many such calls about
different substances over the coming years.
Anyone with relevant information is invited
to send it to ECHA by the deadline. Organi-
sations that may have testing reports on the
substance (or scientifically valid equivalent
information) include academic institutions,
individual companies and NGOs. The aim of
the call is to give anyone the opportunity to
submit relevant data with a view to make sure
that animal testing is only conducted as a last
resort when the available information is not
sufficient to assess the potentially harmful ef-
fects of this chemical on human health or the
environment.
In this case, the registration dossier concerns
a new substance with a complex and variable
composition manufactured or imported into
the EU in considerable volumes. The reg-
istrant has, as permitted by the legislation,
claimed many of the details of the registration
188 Journal Chemicals Management September 2009, No. 7
actualities
dossier confidential and so they cannot be
made public by ECHA. However, this UVCB
(Unknown or variable compositions, complex
reaction products and biological materials)
substance has the generic chemical name of
‘hydrogenated oligomerisation product in-
cluding dimers and trimers, of tetradec-1-ene
and alkene’. The substance is a component in
lubricants used by professionals and consum-
ers. Based on the available data the registrant
has not classified the substance as dangerous
either for physical-chemical properties, health
effects or for the effects on the environment.
The testing proposal from the registrant con-
cerns information on reproductive toxicity:
i.e. requiring two experimental tests involving
vertebrate laboratory animals (Reproductive
toxicity (developmental toxicity) and Repro-
ductive toxicity (two-generation reproductive
toxicity)).
References: http://echa.europa.eu/consultations/
test_proposals/test_prop_cons_en.asp
http://echa.europa.eu/doc/press/pr_09_10_
animal_testing_proposal_20090810.pdf
ECHA: 2nd public consultation
on harmonised classification and
labelling
[2009/0155]
ECHA has published on its website the second
public consultation on a proposal to
harmonise the classification and labelling of
four chemical substances. The substances and
their proposed classification, as submitted by
two Member States (France and the Nether-
lands) are:
– Di-tert-butyl-peroxide (FR), which is
used for example to bond together poly-
mer chains in polymer synthesis (a cross-
linking agent) or to start a polymerisation
reaction (a free radical polymerisation
initiator), is proposed to be classified as
Sdu Uitgevers
actualities
a Category 3 mutagen ( see below for an
explanation of the Categories).
– Gallium arsenide (FR), which is used for
example in integrated circuit manufacture
in the microelectronics industry, is pro-
posed to be classified as toxic to reproduc-
tion Category 2, carcinogen Category 3,
and as toxic because of the danger of seri-
ous damage to health by prolonged expo-
sure.
– Indium phosphide (FR), which is used for
example as a semiconducting compound
in electronics, is proposed to be classified
as toxic to reproduction Category 3, car-
cinogen Category 2, and as toxic because
of the danger of serious damage to health
by prolonged exposure.
– Trixylyl phosphate (NL), which is used for
example as hydraulic fluid in industrial
power generators, is proposed to be clas-
sified as toxic to reproduction category 2.
The Dutch and French authorities have sub-
mitted to ECHA comprehensive dossiers on
these substances and asked for their classifica-
tion and labelling to be harmonised across the
European Union.
References: http://echa.europa.eu/doc/press/pr_09_08_
second_consultation_cl_20090616.pdf
See also: http://echa.europa.eu/consultati-
ons/harmonised_cl_en.asp
INTERNATIONAL
USA: Perchlorate
[2009/0156]
The U.S. Environmental Protection Agency
EPA is seeking comments on additional ap-
proaches to analyzing data related to EPA’s
perchlorate regulatory determination. On
10 October 2008, EPA published a prelimi-
nary determination not to regulate perchlo-
rate. After reviewing comments received re-
lated to this notice and conducting further
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analyses, the Agency is requesting comment
on alternative approaches for evaluating
whether perchlorate occurs at a frequency
and level of health concern.and whether
there is a meaningful opportunity for health
risk reduction through a national primary
drinking water regulation (NPDWR) for
perchlorate.
The analysis presented in the recent notice
announced more directly evaluates children’s
exposure to perchlorate. This step takes into
account the fact that infants and children
consume more water per body weight than
do adults. EPA is now considering a broader
range of alternatives for interpreting the avail-
able data on the level of health concern, the
frequency of occurrence of perchlorate in
drinking water, and the opportunity for health
risk reduction through a national primary
drinking water standard. These alternative
interpretations may impact the agency’s final
regulatory determination for perchlorate.
CAS 7790-98-9 Ammonium perchlorate; CAS
7791-03-9 Lithium perchlorate; CAS 7778-
74-7 Potassium perchlorate; CAS 7601-89-0
Sodium perchlorate
Reference: http://www.epa.gov/safewater/contami-
nants/unregulated/perchlorate.html
Combustible Dust Hazards
[2009/0157]
Combustible dusts are fine particles that pres-
ent an explosion hazard when suspended in
air under certain conditions. A dust explosion
can cause catastrophic loss of life, injuries, and
destruction of buildings. The U.S. Chemical
Safety and Hazard Investigation Board (CSB)
identified 281 combustible dust incidents be-
tween 1980 and 2005 that led to the deaths
of 119 workers, injured 718, and extensively
damaged numerous industrial facilities. More
recently, additional incidents have occurred.
On 7 February 2008, a sugar dust explosion
Journaal Stoffen en Preparaten september 2009, Nr. 7 189

and subsequent fire at a sugar refinery in Port
Wentworth, Georgia, caused 14 deaths and
left many other workers seriously injured with
severe burns.
In many of these incidents, workers and man-
agers were unaware of the potential for dust
explosions, or failed to recognize the serious
nature of dust explosion hazards. The CSB
reviewed Material Safety Data Sheets (MSDS)
of 140 known substances that produce com-
bustible dusts and found poor or inadequate
transmittal of information regarding poten-
tial dust hazards; 41% of the MSDSs reviewed
by the CSB did not warn users about potential
explosion hazards. Of the remaining 59% of
MSDSs sampled, most of the information was
either not stated in a place or manner clearly
recognized by workers, or was not specific to
hazards related to combustible dusts.
On 28 July 2009 the U.S. Chemical Safety
Board (CSB) has released a new safety video
depicting how accumulations of combusti-
ble dust at worksites can provide the fuel for
devastating explosions that kill and maim
workers, shut down plants, and harm local
economies. Entitled ‘Combustible Dust: An
Insidious Hazard’, the new video is available
online at www.CSB.gov.. It can also be or-
dered free of charge on a new two-DVD set of
all CSB safety videos by filling out the CSB’s
online DVD request form.
For each accident, the animations show how
explosive dust accumulated over years on
plant equipment, pipes, floors, ducts, dust
collectors, and other areas. The video shows
how conditions develop needing only an ig-
nition source to set off a primary explosion,
which lofts the accumulated dust, leading to
deadlier secondary explosions. News footage
and still photographs depict actual damage
caused by these explosions, as well as other
accidents including last year’s tragedy at the
Imperial Sugar Company. The video points
out that dust accumulations – and the result-
ing secondary dust explosions – can be read-
190 Journal Chemicals Management September 2009, No. 7
actualities
ily prevented. National Fire Protection Asso-
ciation standards have long been available to
general industry and, if followed, will prevent
such accidents. The video features comments
by the CSB investigators who led each of the
accident investigations.
The U.S. Occupational Safety and Health Ad-
ministration (OSHA) has published a new
document titled ‘Hazard Communication
Guidance for Combustible Dusts’ that helps
chemical manufacturers and importers recog-
nize the potential for dust explosions, identify
appropriate protective measures, and fulfill
the requirements for disseminating this in-
formation on material safety data sheets and
labels.
References: http://www.csb.gov/videoroom/detail.
aspx?VID=30
http://www.osha.gov/
Publications/3371combustible-dust.pdf
Singapore: Workplace Safety &
Health Guidelines. Cleaning and
Custodial Services
[2009/0158]
This guideline serves as a workplace safety and
health resource for workers, supervisors and
key stakeholders who provide or manage
cleaning and custodial services in housing
estates.
It provides safety and health information,
guidance on the identification of work haz-
ards and the preventive measures that can be
taken. For the handling of hazards specific to
other work environment / industries, read-
ers should refer to other relevant technical
advisories, guidelines or materials where
available.
Reference: http://app.wshc.gov.sg/cms/Portals/0/
WSH_Guidelines-Cleaning_&_Custo-
dial_Services.pdf
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actualities
Australia: Safe Work Draft
National Codes on C&L and SDS
[2009/0159]
Safe Work Australia is seeking feedback on
two draft documents:
– ‘Draft National Code of Practice for the
Labelling of Workplace Hazardous Chem-
icals’ (July 2009, 100 pages),
This labelling code is intended to provide
practical guidance to manufacturers and im-
porters of hazardous chemicals to meet their
obligations under the National Standard for
Workplace Hazardous Chemicals (the National
Standard) to correctly label workplace haz-
ardous chemicals. This document replaces the
National Code of Practice for the Labelling of
Workplace Substances [NOHSC:2012(1994)].
Safe Work Australia agreed to adopt the Glo-
bally Harmonized System of Classification
and Labelling of Chemicals (the GHS) for
workplace hazardous chemicals in 2009. This
Labelling Code conveys the requirements of
the GHS.
This National Standard does not require a de-
termination of whether a substance or mix-
ture can be classified into any of the following
GHS hazard classes/categories:
(a) Acute toxicity – oral – category 5; or
(b) Acute toxicity – dermal – category 5; or
(c) Acute toxicity – inhalation – category 5;
or
(d) Skin corrosion/irritation – category 3; or
(e) Serious eye damage/eye irritation – cat-
egory 2B; or
(f) Aspiration hazard – category 2; or
(g) Flammable gas – category 2; or
(h) Flammable liquid – category 4; or
(i) Acute hazard to the aquatic environment
– categories 1, 2 and 3; or
(j) Chronic hazard to the aquatic environ-
ment – categories 1, 2, 3 and 4.
Note: The ADG Code (Australian Code for
the Transport of Dangerous Goods by Road
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and Rail) also includes classification criteria
for the GHS hazards: Category 1 – Acute haz-
ard to the aquatic environment, and Catego-
ries 1 and 2 – Chronic hazard to the aquatic
environment.
Note: The document ‘Policy Proposal for
Workplace Chemicals Model Regulations
(National Standard for the Control of Work-
place Hazardous Chemicals)’ gives useful
background information.
– draft National Code of Practice for the
Preparation of Safety Data Sheets’. (July
2009, 120 pages)
This Code of Practice aligns the Australian
SDS requirements with the 3rd revised edi-
tion of the “Globally Harmonized System
of Classification and Labelling of Chemicals
(GHS)”, as published by the United Nations
from time to time. It supercedes the previous
National Code of Practice for the Preparation
of Material Safety Data Sheets 2nd Edition
[NOHSC:2011(2003)]. Implementation of
this Code will facilitate the introduction of
GHS-consistent overseas SDS into Australia
and assist Australian exporters to provide
GHS-consistent safety information to over-
seas markets.
An SDS prepared overseas by an overseas
manufacturer or supplier will only be consid-
ered acceptable if it is amended by the writer
to comply with the National Standard and this
Code of Practice.
An overseas SDS must:
– be written in English;
– include classification in accordance with
the Classification Criteria;
– disclose the identities and proportions of
ingredients in a mixture in accordance
with this Code;
– include the Australian Contact details –
name of supplier, address and telephone
number; and
– include the Australian emergency phone
number that can provide further advice
about the product).
Journaal Stoffen en Preparaten september 2009, Nr. 7 191

– include Australian Exposure Standards
where available; and
– include relevant Australian regulatory in-
formation.
Note: The address provided in the SDS should
not be a PO BOX address as this is not a Legal
address and is not acceptable on the SDS.
These documents, and the template for pro-
viding comments, are available from the Safe
Work Australia website.
Reference: http://www.safeworkaustralia.gov.au/
swa/HealthSafety/HazardousSubstances/
Proposed+Revisions/
ICMM guidance on Health Risk
Assessment
[2009/0160]
The International Council on Mining and
Minerals (ICMM ) presents the ‘Good Prac-
tice Guidance on Occupational Health Risk
Assessment (HRA)’ as an information re-
source for those conducting or commission-
ing HRAs.
According to the International Labour Or-
ganization 160 million people in the world
suffer occupation related illnesses every year.
Reducing the number of such cases inside the
mining and metals industry is one of the key
challenges of ICMM members. Occupational
Health Risk Assessment is the structured and
systematic identification and analysis of work-
place hazards to assess their potential risks to
health and determine appropriate control
measures to protect the health and wellbeing
of workers. The document describes 13 key
steps for carrying out a HRA, from identifying
the health hazards and their effects, to assess-
ing exposure levels and analysing the effec-
tiveness of existing control measures. It offers
information on three types of assessments
and includes several check lists and step-by-
192 Journal Chemicals Management September 2009, No. 7
actualities
step guides to aid managers in the design and
implementation of health risk assessments.
ICMM is currently working on a sister publi-
cation ‘Health Impact Assessment Good Prac-
tice Guidance ‘ that will be published later this
year. It focuses on the environmental, social
and health impacts of a mining operation on
the people who live near it and how these haz-
ards must be assessed.
The International Council on Mining and
Metals is a CEO-led industry group that ad-
dresses key priorities and emerging issues
within the industry. It seeks to play a leading
role within the industry in promoting good
practice and improved performance, and
encourages greater consistency of approach
nationally and across different commodities
through its association members and member
companies.
Reference: www.icmm.com
International Material Data
System (IMDS)
[2009/0161]
The International Material Data System
(IMDS) is the automotive industry material
data system. It is a joint development of Audi,
BMW, Daimler, Ford, Opel, Porsche, VW and
the Swedish firm Volvo. Further manufactur-
ers have meanwhile joined the community
and talks are being held with others regarding
their participation in IMDS.
In the IMDS, all materials used for car manu-
facture are archived and maintained. Only in
this way is it possible to meet the obligations
placed on car manufacturers, and thus on
their suppliers, by national and international
standards, laws and regulations.
The materials database set up by the car man-
ufacturers will facilitate the recycling of old
cars in future. The companies listed will get
a detailed overview of the materials used in
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actualities
future old cars. The companies listed have got
together to realise the joint aim – the collec-
tion of materials data. The parent companies
and subsidiaries of the members have also
been integrated into the system.
All material information in IMDS is based on
a list of basic substances. In the IMDS there
are about 8000 substances (status 2006) con-
tained with their names and CAS-Numbers.
As a subset of these substances the IMDS user
can select one of the following substance lists:
– GADSL (Global Automotive Declarable
Substance List)
– VDA 232-101 (List of Declarable Mate-
rials in Automobile Manufacturing)
– Appl. rel. subst. (Application relevant sub-
stances)
These lists can used as a display filter in the in-
gredients screen and for MDS/module analysis
(certificate of expenditure). Currently IMDS
uses GADSL as its default substance list. The
substance attributes “duty-to-declare” and
“prohibited” are always displayed according
to this list, independent of which substance
list the user selected. This substance list allows
the IMDS user to set up a management system
for dangerous substances for his products to
query the current status. This is as important
during the design phase as for the end-of-life
phase. Once the latter has been reached, the
IMDS data can contribute to achieving the re-
cycling level of 95 per cent required from the
year 2015.
References: http://www.mdsystem.com/html/en/
home_en.htm
http:// www.gadsl.org
http://www.mdsystem.com/html/data/
vda_232-101_gadsl_en_08-2005.pdf
Sdu Uitgevers
Global Update on New Chemicals
Regulations (Period May-June
2009)
[2009/0162]
In May and June 2009, approximately 200 new
regulations relating to chemicals management
were adopted or published worldwide. These
involve implementation of GHS, updates
to chemical inventories, new priority che-
micals, several changes to the requirements
on transport and handling, and last but not
least restrictions on the marketing and use of
chemicals.The following overview provides
the indicative title in English and the date of
adoption. Further information on any of these
new regulations and what they require from
industry can be found in the Enhesa Update
published by ENHESA (www.enhesa.com).
To be kept ahead of new policy initiatives and
developments and their implications on your
business contact ENHESA at +32 2 775 9797
(Selection only).
Argentina
Rules on registration medicines reviewed 12-
May-2009
Re-registration of facilities manufacturing or
using drug precursors 19-May-2009
Register of environmental offenders establis-
hed 26-Jun-2009
Restrictions on the transport of goods and ha-
zardous waste adopted 08-Jun-2009
Mercosur Technical Regulation on the trans-
port of infectious substances adopted 29-Jun-
2009
Mercosur Regulation on good practices du-
ring transport of pharmaceutical products
adopted 29-Jun-2009
Criteria to carry out agreements to simplify
the sanitary control process of cleaning pro-
ducts, cosmetics and perfumes adopted 29-
Jun-2009
Journaal Stoffen en Preparaten september 2009, Nr. 7 193

Australia
NICNAS publishes guidance and application
forms for introduction of low regulatory con-
cern chemicals
Amendments made to model regulations for
road transport of dangerous goods 27-Jun-
2009
Brazil
DDT (dichlorodiphenyltrichloroethan) ban
adopted 14-May-2009
Criteria to determine the environmental com-
pensation established 14-May-2009
Rules on health products notification adopted
21-May-2009
Adopted administrative procedures for pesti-
cide evaluation 29-May-2009
Working group established to review Ordi-
nance 518/GM/2004 on the quality of water
for human consumption and limit values 17-
Jun-2009
Bulgaria
Ban on dimethylfumarate (DMF) in imported
consumer products adopted 12-May-2009
Regulation on the implementation of the Law
on the Control on Explosives, Fire Arms and
Ammunition amended 12-May-2009
Act on Waters amended 10-Jun-2009
Canada
Regulations adopted to amend the Consumer
Chemicals and Containers Regulations, 2001
24-Jun-2009
Regulations Amending the Phosphorus Con-
centration Regulations adopted 24-Jun-2009
Measures published as a result of the final
screening assessments of substances in Batch
2 of the Challenge 27-May-2009
QUEBEC: Water protection Law adopted 11-
Jun-2009
Significant New Activity Notice No. EAU-
474 regarding siloxanes and silicones, CAS.
863918-80-3 02-May-2009
Orders amending the Domestic Substances
List and Non-domestic Substances List adop-
ted 27-May-2009
194 Journal Chemicals Management September 2009, No. 7
actualities
Significant New Activity Notices No. 15370
and 15371 adopted regarding butanedioic
acid 16-May-2009
Notice with respect to Batch 10 Challenge
substances published 20-Jun-2009
Quebec: Law amending the occupational he-
alth and safety regime adopted 10-Jun-2009
Significant New Activity Notice No. 15419
regarding dimethyl-2-methyl glutarate, CAS
14035-94-0 27-Jun-2009
Significant New Activity Notice No. 15512 re-
garding vanadium carbide, CAS 12070-10-9
27-Jun-2009
Chile
Pharmaceutical products containing certain
ingredients to update their registry 14-May-
2009
China
SHANGHAI: Integrated Wastewater Dischar-
ge Standard amended 26-May-2009
Standards on excessive package for foods and
cosmetics restrictions published 31-Mar-
2009
SHANGHAI: Mandatory discharge standard
for municipal sewerage system (DB31/425-
2009) published 06-May-2009
Guidelines for standardization of safety work
for hazardous chemicals published 24-Jun-
2009
Legal Explanation of Article 75 of the Water
Pollution Prevention and Control Law 16-
Jun-
List of key monitored hazardous chemical
processes published 12-Jun-2009
SHANGHAI: Notification requirements for
hazardous waste management plan specified
01-Dec-2008
SHANGHAI: New format of hazardous waste
transport manifest issued 20-Nov-2008
Registration of gaseous chemicals on site
emphasized 01-Feb-2009
Costa Rica
Decree No. 35152-S-MINAET-RE adopting
Annexes VIII and IX of the Basel Convention
adopted 04-May-2009
Sdu Uitgevers
actualities
National implementation plan on the Stock-
holm convention issued 04-May-2009
Law 8705 adopting the Rotterdam Conven-
tion adopted 29-Jun-2009
Croatia
Act on the Ratification of the European Agree-
ment on International Carriage of Dangerous
Goods by Inland Waterways adopted 15-Dec-
2008
Regulation on import and export of hazar-
dous chemicals adopted 02-Jun-2009
Regulation on classification, labeling, marking
and packaging of hazardous chemicals amen-
ded 26-May-2009
Dominican Republic
National implementation plan of the Stock-
holm Convention on POPs issued 07-May-
2009
Estonia
Conditions of labeling the electrical and elec-
tronic equipment issued 27-Apr-2009
France
Notice to producers and exporters of biocidal
products regarding free sale certificates issued
04-Jun-2009
Ordinance relating to the registration of cer-
tain classified installations adopted 11-Jun-
2009
Germany
New Batteries Act adopted 30-Jun-2009
Annexes A and B to ADR revised to incorpo-
rate 2009 changes 21-Apr-2009
New Ordinance on Transport of Dangerous
Goods by Road, Rail and Internal Waterways
adopted 24-Jun-2009
Greece
Law on the reorganization of the Labor In-
spectorates provide for health and safety obli-
gations
Hong Kong
Pesticide register updated 01-Jan-2009
Bromochloromethane banned as an ozone
depleting substance 29-May-2009
Hungary
Decree further detailing European Regulation
EC/689/2008 on the registration procedure
Sdu Uitgevers
concerning export and import of dangerous
chemicals adopted 12-Jun-2009
ADR Annexes A and B 2009 promulgated 29-
Jun-2009
Indonesia
Adopted Regulation on permitting procedu-
res for hazardous and toxic waste manage-
ment 22-May-2009
Israel
Clean air law enters into force 1 January 2011
31-Jul-2008
Amendment to regulation on import and
export of hazardous waste adopted 28-May-
2008
Italy
Deadline for registration of battery producers
postponed to September 2009 01-Jul-2009
Japan
Japanese REACH approved by the National
Assembly 20-May-2009
Lithuania
Order on inventory of articles containing as-
bestos issued 11-May-2009
Luxembourg
Adaptation of Luxembourg chemicals legis-
lation to the provisions of REACH 08-May-
2009
Law on the enforcement of Regulation
EC/689/2008 on chemicals on import and
export of dangerous chemicals adopted 28-
May-2009
Morocco
Decree on Protection of Workers Against Ha-
zards of Benzene Issued 04-Jun-2009
Project of Decree on Creation of PolyChlori-
nated Biphenyls (PCB) Commission Adopted
18-Jun-2009
New Zealand
Rules for possessing explosives modified to
require a Controlled Substance Licence 04-
Jun-2009
Norway
Regulations on handling fire hazardous, re-
action hazardous and pressurized substances
have been adopted 08-Jun-2009
Journaal Stoffen en Preparaten september 2009, Nr. 7 195

Panama
National Strategy for Sustainable Develop-
ment 2008-2012 adopted 16-Jun-2009
Peru
National Environmental Policy adopted 25-
May-2009
Environmental quality standards and maxi-
mum allowed limits approved for 2009 07-
Jun-2009
Poland
Act on Batteries and Accumulators manage-
ment adopted 24-Apr-2009
New Ordinance on the Form of a Report on
the Quantity and the Mass of Electronic and
Electrical Equipment Placed on the Market is-
sued 04-May-2009
New Ordinance on Form of Report on Waste
Electrical and Electronic Equipment issued
12-May-2009
Ban on dimethylfumarate (DMF) in consu-
mer products adopted 30-Apr-2009
Ordinance on national monitoring of ground
and surface water issued 13-May-2009
Ordinance on concentration levels of heavy
metals in packaging amended 15-Jun-2009
Portugal
Ordinance on monitoring of air pollutants re-
viewed 23-Jun-2009
Decree Law on cosmetics reviewed 18-May-
2009
Emission limits for industrial installations re-
viewed 23-Jun-2009 [30358]
Romania
Methodology for allocation of greenhouse gas
emission allowances for new entrants appro-
ved 12-Mar-2009
Order regarding EMAS amended 02-Apr-
2009
Decision on limitation of use of certain ha-
zardous substances in EEE modified 05-May-
2009
Russia
Adopted Hygienic Norms for a Number of
Substances in the Air of Residential Areas 09-
Apr-2009
196 Journal Chemicals Management September 2009, No. 7
actualities
Adopted additional Approximate Safe Con-
centration Levels (OBUVs) for substances in
the air of residential areas 27-Apr-2009
Amended some legislation on licencing of ac-
tivities involving waste management and the
term “hazardous wastes” changed and clari-
fied 15-Jun-2009
Slovakia
Annexes A and B to the European Agreement
concerning the International Carriage of
Dangerous Goods by Road (ADR) amended
30-May-2009
Decree on Requirements for Safety of Pro-
ducts Containing the Biocide Dimethyl Fu-
marate adopted 21-May-2009
Order implementing Act on Chemical Sub-
stances and Chemical Preparations amended
15-Apr-2009
Slovenia
Decree concerning the export and import of
dangerous chemicals adopted 29-May-2009
Regulation on implementation of Commis-
sion Decision on ban of products containing
the biocide dimethyl fumarate 07-May-2009
Transport of Dangerous Goods Act amended
29-May-2009
South Africa
National Environmental Laws Amendment
Act, 2009 published 27-May-2009
South Korea
No regulatory hazard identified for 1-penta-
nol, sodium hydrrogensulfite and cobalt oxide
23-Jun-2009
Diphenyliodonium nitrate and di-tert-pentyl
peroxide classifed as hazardous substances
25-May-2009
Spain
Spain’s sustainable mobility strategy 30-May-
2009
Sweden
Chemical Inspectorate’s Regulation (KIFS
2005:7) on classification and labeling of che-
mical products amended 01-Jun-2009
Chemical Inspectorate’s Regulation (KIFS
2005:5) on EC harmonized binding classifica-
Sdu Uitgevers
actualities

tions and labeling (Classification List) repea- CALIFORNIA: Proposal to list 30 substances
led 01-Jun-2009 to Proposition 65 List as a result of court or-
The Swedish Chemical Inspectorate Chemical der 12-Jun-2009
Products and Biotechnical Organisms Regula- CALIFORNIA: Adopted emergency regula-
tions (KIFS 2008:2) amended 01-Jun-2009 tions to allow for the storage of bio-diesel in
Ordinance (SFS 2007:846) on fluorinating USTs 12-Jun-2009
greenhouse gases and substances that deplete Significant new use rules adopted for 23 sub-
the ozone layer amended 29-May-2009 stances 24-Aug-2009
Regulation (NFS 2003:24) on Protection MAINE: Passes producer responsibility bill for
against Ground and Water Pollution when mercury-containing light bulbs 08-Jun-2009
Storing Flammable Fluids amended 28-May- TEXAS: Signed into law legislation requiring
2009 the development of greenhouse gas reduction
Swedish national ban on cadmium repealed strategy 19-Jun-2009
01-Jul-2009
Thailand
Dangerous Substance Act entered into force
25-Feb-2008
Turkey
New Regulation on transport by roads publis-
hed 11-Jun-2009
Transitional long and short term limit values
and alert thresholds laid down in the Regula-
tion on Assessment and Management of Air
Quality amended 06-Jun-2008
United Kingdom
NI: The consolidated Chemicals (Hazard In-
formation and Packaging for Supply) Regula-
tions adopted 18-Jun-2009
United States
WASHINGTON: Adopted amendments to
toxic air pollution regulations 20-May-2009
WASHINGTON: Adopted expedited rule to
amend the Employer Chemical Hazards Com-
munication rule to conform with OSHA’s rule
05-May-2009
TEXAS: Governor signed into law legislation
providing an affirmative defense if in compli-
ance with the general duty clause of federal
OHSA 19-Jun-2009
CALIFORNIA: Established final public health
goal for Chlorite in drinking water 22-May-
2009
Connecticut: Legislature passes ban on bisp-
henol-A effective 1 October 2011 03-Jun-
2009

Sdu Uitgevers Journaal Stoffen en Preparaten september 2009, Nr. 7 197


publications
BOOKS
The Underlying Foundation of
Science used in Regulation of
Industrial Chemicals
[2009/0163]
Joseph E. Plamondon: ‘The Underlying Foun-
dation of Science used in Regulation of In-
dustrial Chemicals’’. Smithers Rapra Publish-
ing, U.K. (2009), ISBN 978-1-84735-147-0
(hardback), 978-1-84735-148-7 (softback),
136 pages.
The author, currently a Senior Scientist at the
law firm of Bergeson & Campbell, P.C. and its
consulting affiliate The Acta Group, L.L.C., re-
views the relevant chemical nomenclature is-
sues in the EU and in the US and their impact
on regulatory compliance. In particular, dur-
ing the pre-REACH period, chemical identi-
ties frequently were described differently by
different manufacturers for the same chemi-
cals.
The importance of having consistent nomen-
clature rules under REACH is related to the
establishment of Substance Information Ex-
change Forums (SIEF) by ECHA after the pre-
registration process, and, ultimately, industry
consortia to meet registration requirements.
If consistency is not established, there is a sub-
stantial risk that multiple registrations for the
same substance will occur in conflict with the
‘One Substance, One Registration’ (OSOR)
principle under REACH.
The book the relationships between and
among various nomenclature systems and
198 Journal Chemicals Management September 2009, No. 7
publications
how chemical identity issues are to be ad-
dressed under REACH, along with compara-
tive examples of chemical issues under TSCA
in the US.
Chemical identity issues are of central impor-
tance to the successful implementation of the
Registration, Evaluation, Authorization and
Restriction of Chemicals (REACH), both for
the regulated community and for the Euro-
pean Chemical Agency (ECHA) responsible
for REACH’s implementation.
A variety of nomenclature systems exists,
some with similar naming convention but
also with critically important differences.
These systems include: International Union of
Pure and Applied Chemistry (IUPAC) which
is used in European Union (EU) countries
and that provides the primary nomenclature
system to be used in the implementation of
REACH; Chemical Abstracts Services Registry
Names and Numbers (CASRN), which is used
in the United States and Canada, and will be
used as an adjunct to IUPAC under REACH;
common names and trade names; and the use
of SMILES (Simplified Molecular Input Line
Entry System) notation designed for comput-
er use by chemists.
Reference: http://www.ismithers.net/book-details.
php?id=WHB073
Sdu Uitgevers
official publications
official
publications
The Netherlands (Period June-July
2009)
[2009/0164]
16-06-2009, Staatsblad 2009, 237: Wijziging
Warenwetbesluit drukverpakkingen in ver-
band met richtlijn nr. 2008/47/EG
21-07-2009, Staatsblad 2009, 307: Besluit van
2 juli 2009 tot wijziging van het Besluit kwik-
houdende producten milieubeheer, het Besluit
stortplaatsen en stortverboden afvalstoffen en
het Inrichtingen- en vergunningenbesluit mi-
lieubeheer in verband met verordening (EG)
nr. 1102/2008 van het Europees Parlement
en de Raad van 22 oktober 2008 inzake het
verbod op de uitvoer van metallisch kwik en
andere kwikverbindingen en -mengsels en de
veilige opslag van metallisch kwik (PbEU L
304/75)
21-07-2009, Staatsblad 2009, 307: Besluit van
3 juli 2009 tot wijziging van het Besluit geflu-
oreerde broeikasgassen milieubeheer en het
Besluit ozonlaagafbrekende stoffen milieube-
heer in verband met de aanvulling en unifor-
mering van regels inzake de diplomering van
personeel en de certificering van bedrijven
(aanvulling en uniformering van regels inzake
diplomering van personeel en certificering
van bedrijven)
11-06-2009: Staatscourant 2009, 105: Rege-
ling van de Minister van Volkshuisvesting,
Ruimtelijke Ordening en Milieubeheer van
28 mei 2009, nr. BJZ2009037173, tot wijziging
van de Uitvoeringsregeling EG-verordening
PRTR en PRTR-protocol en de Regeling ad-
visering Inspectoraat-Generaal VROM in ver-
band met de integratie van
Sdu Uitgevers
verplichtingen op het terrein van milieuver-
slaglegging
30-06-2009, Staatscourant 2009, 117: Lijst
van kankerverwekkende, mutagene, en voor
de voortplanting giftige stoffen SZW
[Nieuw bij ‘Niet-limitatieve lijst van voor de voortplanting
giftige stoffen’: aluminiumverbindingen, oplosbaar: Ont-
wikkeling Cat. 2, Borstvoeding X]
20-07-2009, Staatscourant 2009, 10875: Mul-
tilaterale overeenkomst M205 op grond van
sectie 1.5.1 van het ADR inzake de toepassing
van de afwijking van 1.1.4.2.1 voor het ver-
voer van stoffen van klasse 9 die niet onder-
hevig zijn aan de voorschriften van de IMDG
Code of de Technische Instructies die zee- of
luchtvervoer omvat
[1. In afwijking van de laatste zin van 1.1.4.2.1, behoeven,
– in het geval dat stoffen van klasse 9 die niet onderhevig
zijn aan de voorschriften van de IMDG-Code of de Tech-
nische Instructies van ICAO en worden vervoerd in een
transportketen die zee- of luchtvervoer omvat, – verpak-
kingen, containers, transporttanks en tankcontainers die
dergelijke stoffen bevatten, niet te voldoen aan de voor-
schriften van het ADR wat betreft de verpakking, geza-
menlijke verpakking, kenmerking en etikettering van colli
of het aanbrengen van grote etiketten. 2. Bij ongereinigde,
lege transporttanks en tankcontainers geldt deze bepaling
ook voor de opvolgende verplaatsing aansluitend vervoer
naar een reinigingsbedrijf. 3. In aanvulling op de voorge-
schreven aanduidingen in het vervoerdocument, dient de
afzender in het vervoerdocument te vermelden: ‘Vervoer
overeenkomstig sectie 1.5.1 van het ADR (M205)’. …]
06-08-2009, Staatscourant 2009, 11739: Mul-
tilaterale overeenkomst M206
[In afwijking van de voorschriften van sectie 5.2.1.8 van
het ADR, mogen gevaarlijke stoffen die ingedeeld zijn on-
der UN-nummers 3077 en 3082 worden vervoerd zonder
de kenmerking van milieugevaarlijke stoffen als aangege-
ven in paragraaf 5.2.1.8.3.]
Journaal Stoffen en Preparaten september 2009, Nr. 7 199

Belgium (Period June-July 2009)
[2009/0165]
Staatsblad 30 juni 2009: Koninklijk besluit
van 6 mei 2009 tot wijziging van het konink-
lijk besluit van 30 november 2001 houdende
verbod op sommige dierproeven voor wat be-
treft het testen van huidcorrosiviteit
Staatsblad 30 juni 2009: Koninklijk besluit
van 31 mei 2009 tot wijziging van het konink-
lijk besluit van 15 oktober 1997 betreffende
cosmetica
Staatsblad 30 juni 2009: Koninklijk besluit
van 28 juni 2009 betreffende het vervoer via
de weg of per spoor van gevaarlijke stoffen,
met uitzondering van ontplofbare en radioac-
tieve stoffen
Staatsblad 3 juli 2009: Decreet van 8 mei
2009 houdende wijziging van het decreet van
5 april 1995 houdende algemene bepalingen
inzake milieubeleid en van het decreet van
21 oktober 1997 betreffende het natuurbe-
houd en het natuurlijk milieu, wat de ver-
plichting tot het opstellen van een milieuef-
fectrapportage betreft
Staatsblad 15 juli 2009: Besluit van de
Vlaamse Regering van 24 april 2009 tot wijzi-
ging van het besluit van de Vlaamse Regering
van 6 februari 1991 houdende vaststelling van
het Vlaams reglement betreffende de milieu-
vergunning en van het besluit van de Vlaamse
Regering van 1 juni 1995 houdende algemene
en sectorale bepalingen inzake milieuhygiëne,
ter uitvoering van correcties en ter uitvoering
van bepalingen van het decreet van 12 decem-
ber 2008 houdende diverse bepalingen inzake
energie, leefmilieu, openbare werken, land-
bouw en visserij en tot bepaling van de inwer-
kingtreding van artikel 88 van dit decreet
Staatsblad 17 juli 2009: Koninklijk besluit
van 2 juli 2009 tot wijziging van het koninklijk
besluit van 12 oktober 2004 inzake het voor-
komen van gevaarlijke stoffen in elektrische
en elektronische apparatuur
200 Journal Chemicals Management September 2009, No. 7
official publications
[De bijlage III van het koninklijk besluit van 12 oktober
2004 [ …] wordt aangevuld met volgende tekst:
30. Cadmiumlegeringen als elektrische/mechanische sol-
deerverbindingen met elektrische geleiders die zich direct
op de stemspoel bevinden van transductoren die gebruikt
worden in krachtige luidsprekers met een geluidsvermo-
gensniveau van 100 dB (A) of meer; 31. Lood in soldeer-
materiaal in kwikvrije platte fluorescerende lampen (die
bv. worden gebruikt in LCD-schermen, designverlichting
of industriële verlichting);
32. Loodoxide in fritaansmeltingen van vensters voor ar-
gon- en kryptonlaserbuizen.]
Staatsblad 11 augustus 2009: Ministerieel be-
sluit van 17 juli 2009 tot wijziging van het mi-
nisterieel besluit van 21 maart 2007 houdende
benoeming van de leden van het Comité voor
advies inzake biociden, opgericht krachtens
artikel 2 van het koninklijk besluit van 5 au-
gustus 2006 tot oprichting van een Comité
voor advies inzake biociden en tot wijziging
van het koninklijk besluit van 22 mei 2003
betreffende het op de markt brengen en het
gebruiken van biociden
United Kingdom (period July
2009)
[2009/0166]
by Dr. Ross Fielding
Control of Substances Hazardous to Health
(COSHH)
The UK regulations that are intended to con-
trol exposure to hazardous substances in the
work place are the The Control of Substances
Hazardous to Health Regulations 2002 (SI
2002:2677). The Health and Safety Executive
(HSE) has a website that provides support
and guidance for these regulations. The re-
launch of the COSHH website was reported
in the last issue, but new content continues to
be developed. Newly available are;
– A new advisory leaflet which describes
how to control hazardous substances at
Sdu Uitgevers
official publications

work so that they do not cause ill health. gerous for the environment’. The effect is to
It is intended to help users to understand classify products containing small quantities
what they need to do to comply with of powerful biocides that are typically present
the Control of Substances Hazardous to at concentrations around 0.1 – 0.5% in water-
Health (COSHH) Regulations 2002 (as based products such as emulsion paints, and
amended). at higher concentrations (between 0.5% and
– Examples of COSHH risk assessments for 5%) in products such as anti-fungal paints,
a wide range of workplaces. These include wood preservatives, detergents and pesticides.
a paving company, die caster, warehouse As a consequence, some premises storing sig-
and DIY (Do it yourself) store. nificant quantities of these preparations, such
as very large retail and wholesale warehouses,
Changes to COMAH arising from CHIP could be brought within scope of COMAH
2008 (probably through applying the aggregation
The Chemicals (Hazard Information and rule in Schedule 1 part 3).
Packaging for Supply) (Amendment) Regula- References: http://www.hse.gov.uk/coshh/whatsnews.
tions 2008 came into force on 1 October 2008. htm
These regulations implement into national http://news.hse.gov.uk/2009/06/30/chan-
legislation European Commission Directive ges-to-comah-arising-from-chip-2008/
2006/8/EC, commonly known as the second
Adaptation to Technical Progress of the Dan-
gerous Preparations Directive (the 2nd ATP).
The changes do not affect the main legal du-
ties but do adjust:
– the rules and procedures for classifying
and labelling a chemical preparation con-
taining carcinogens, mutagens and sub-
stances toxic for reproduction;
– the generic concentration limits to be
used for the evaluation of the hazards for
the aquatic environment;
– the classification and labelling require-
ments for preparations containing ozone
depleting substances;
– the specified warning phrases on labels for
certain preparations to make them clearer
and more consistent.
The COMAH Regulations refer to CHIP to
determine categories of dangerous substances
and therefore changes to the way substances
and preparations are classified in CHIP can
affect the scope of COMAH.
One of the changes in CHIP 2008, namely a
lowering of the generic concentration limits
used to evaluate hazards to the aquatic en-
vironment, has the potential to increase the
number of preparations classified as ‘dan-

Sdu Uitgevers Journaal Stoffen en Preparaten september 2009, Nr. 7 201


European Union (Period June-July
2009)
[2009/0167]
O.J. L148,2009: Commission Decision
2009/443/EC of 10 June 2009 amending, for
the purposes of adapting to technical prog-
ress, the Annex to Directive 2002/95/EC of
the European Parliament and of the Coun-
cil [on the restriction of the use of certain
hazardous substances in electrical and elec-
tronic equipment] as regards exemptions for
applications of lead, cadmium and mercury.
[In the Annex to Directive 2002/95/EC, the following
points 33 to 38 are added:
33. Lead in solders for the soldering of thin copper wires of
100 µm diameter and less in power transformers.
34. Lead in cermet-based trimmer potentiometer ele-
ments.
35. Cadmium in photoresistors for optocouplers applied
in professional audio equipment until 31 December 2009.
36. Mercury used as a cathode sputtering inhibitor in DC
plasma displays with a content up to 30 mg per display
until 1 July 2010.
37. Lead in the plating layer of high voltage diodes on the
basis of a zinc borate glass body.
38. Cadmium and cadmium oxide in thick film pastes
used on aluminium bonded beryllium oxide.]
O.J. L164, 2009: Commission Regulation
(EC) No 551/2009 of 25 June 2009 amending
Regulation (EC) No 648/2004 of the European
Parliament and of the Council on detergents,
in order to adapt Annexes V and VI thereto
(surfactant derogation)
[Annex V: list of surfactants that have obtained a dero-
gation: Alcohols, Guerbet, C16-20, ethoxylated, n-butyl
ether (7-8EO) [CAS 147993-59-7]: May be used for the
following industrial applications until 27 June 2019: bottle
washing, cleaning-in-place, metal cleaning]
O.J. L164, 2009: Commission Regulation
(EC) No 552/2009 of 22 June 2009 amend-
ing Regulation (EC) No 1907/2006 of the
European Parliament and of the Council on
the Registration, Evaluation, Authorisation
202 Journal Chemicals Management September 2009, No. 7
official publications
and Restriction of Chemicals (REACH) as
regards Annex XVII
[Article 1: Annex XVII to Regulation (EC) No 1907/2006
is amended in accordance with the Annex to this Regula-
tion.][58 entries]
Reference: http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=OJ:L:2009:164:0007:0031:EN
:PDF
O.J. L164, 2009: Commission Directive
2009/70/EC of 25 June 2009 amending Coun-
cil Directive 91/414/EEC to include difena-
coum [CAS 56073-07-5], didecyldimethylam-
monium chloride [CAS: not allocated] and
sulphur [CAS 7704-34-9] as active substances
O.J. L170, 2009: Directive 2009/48/EC of the
European Parliament and of the Council of
18 June 2009 on the safety of toys
http://eur-lex.europa.eu/LexUriServ/Lex-
UriServ.do?uri=OJ:L:2009:170:0001:0037:EN
:PDF
O.J. L172, 2009: Commission Directive
2009/77/EC of 1 July 2009 amending Coun-
cil Directive 91/414/EEC to include chlorsul-
furon CAS 64902-72-3], cyromazine[ CAS
66215-27-8], dimethachlor [CAS 50563-36-
5], etofenprox [CAS 80844-07-1], lufenuron
[CAS 103055-07-8], penconazole [CAS
66246-88-6], tri-allate [CAS 2303-17-5] and
triflusulfuron [CAS 126535-15-7] as active
substances
O.J. L196, 2009: Council Directive 2009/82/
EC of 13 July 2009 amending Directive
91/414/EEC to include tetraconazole [CAS
112281-77-3 ] as an active substance
O.J. L196, 2009: Council Decision 2009/562/
EC of 13 July 2009 concerning the non-inclu-
sion of metam in Annex I to Directive 91/414/
EEC and the withdrawal of authorisations
for plant protection products containing that
substance
O.J. L197, 2009: Commission Directive
2009/84/EC of 28 July 2009 amending Direc-
tive 98/8/EC of the European Parliament and
of the Council [concerning the placing of
biocidal products on the market ] to include
Sdu Uitgevers
official publications
sulfuryl fluoride [CAS 2699-79-8] as an active
substance in Annex I thereto
O.J. L198, 2009: Commission Directive
2009/85/EC of 29 July 2009 amending Direc-
tive 98/8/EC of the European Parliament and
of the Council to include coumatetralyl [CAS
5836-29-3] as an active substance in Annex I
thereto
O.J. L198, 2009: Commission Directive
2009/86/EC of 29 July 2009 amending Di-
rective 98/8/EC of the European Parliament
and of the Council to include fenpropimorph
[CAS 67564-91-4] as an active substance in
Annex I thereto
O.J. L198, 2009: Commission Directive
2009/87/EC of 29 July 2009 amending Direc-
tive 98/8/EC of the European Parliament and
of the Council to include indoxacarb [CAS S-
enantiomer: 173584-44-6 and R-enantiomer:
185608-75-7] as an active substance in Annex
I thereto
O.J. L198, 2009: Commission Decision
2009/579/EC of 29 July 2009 allowing Mem-
ber States to extend provisional authorisations
granted for the new active substances acequi-
nocyl, aminopyralid, ascorbic acid, benalaxyl-
M, mandipropamid, novaluron, proquinazid,
spirodiclofen and spiromesifen [Council
Directive 91/414/EEC of 15 July 1991 con-
cerning the placing of plant protection prod-
ucts on the market]
O.J. L199, 2009: Commission Directive
2009/88/EC of 30 July 2009 amending Direc-
tive 98/8/EC of the European Parliament and
of the Council to include thiacloprid [CAS
111988- 49-9] as an active substance in Annex
I thereto
O.J. L199, 2009: Commission Directive
2009/89/EC of 30 July 2009 amending Di-
rective 98/8/EC of the European Parliament
and of the Council to include nitrogen [CAS
7727-37-9] as an active substance in Annex I
thereto
O.J. C178, 2009: Council Decision 2009/C
178/10 of 27 July 2009 appointing one mem-
Sdu Uitgevers
ber to the Management Board of the Euro-
pean Chemicals Agency
[Article 1: Mr Johannes Karel Barend Henri Kwisthout of
Dutch nationality, born on 6 June 1964, shall be appointed
to the Management Board of the European Chemicals
Agency in place of Dr Arnoldus Wilhelmus van der Wielen
for the period from 1 August 2009 to 31 May 2013.]
O.J. C178, 2009: Council Decision 2009/C
178/09 of 27 July 2009 appointing one mem-
ber to the Management Board of the Euro-
pean Chemicals Agency
[Article 1: Ms Catherine Mir of French nationality, born
on 20 February 1955, shall be appointed to the Manage-
ment Board of the European Chemicals Agency in place
of Ms Odile Gauthier for the period from 1 August 2009
to 31 May 2013.]
O.J. L201, 2009: Commission Directive
2009/90/EC of 31 July 2009 laying down, pur-
suant to Directive 2000/60/EC of the Euro-
pean Parliament and of the Council, technical
specifications for chemical analysis and moni-
toring of water status
O.J. L201, 2009: Commission Directive
2009/91/EC of 31 July 2009 amending Direc-
tive 98/8/EC of the European Parliament and
of the Council to include disodium tetrabo-
rate [CAS (anhydrous): 1330-43-4, CAS (pen-
tahydrate): 12267-73-1, CAS (decahydrate):
1303-96-4] as an active substance in Annex I
thereto
O.J. L201, 2009: Commission Directive
2009/92/EC of 31 July 2009 amending Direc-
tive 98/8/EC of the European Parliament and
of the Council to include bromadiolone [CAS
28772-56-7] as an active substance in Annex
I thereto
O.J. L201, 2009: Commission Directive
2009/93/EC of 31 July 2009 amending Di-
rective 98/8/EC of the European Parliament
and of the Council to include alphachloralose
[CAS 15879-93-3] as an active substance in
Annex I thereto
O.J. L201, 2009: Commission Directive
2009/94/EC of 31 July 2009 amending Direc-
tive 98/8/EC of the European Parliament and
of the Council to include boric acid [CAS
Journaal Stoffen en Preparaten september 2009, Nr. 7 203
 official publications

10043-35-3] as an active substance in Annex CALENDER OF EVENTS AND

I thereto
O.J. L201, 2009: Commission Directive
2009/95/EC of 31 July 2009 amending Direc-
tive 98/8/EC of the European Parliament and
of the Council to include aluminium phos-
phide [CAS 20859-73-8] releasing phosphine
as an active substance in Annex I thereto
O.J. L201, 2009: Commission Directive
2009/96/EC of 31 July 2009 amending Direc-
tive 98/8/EC of the European Parliament and
of the Council to include disodium octabo-
rate tetrahydrate [CAS 12280-03-4] as an ac-
tive substance in Annex I thereto
O.J. L203, 2009: Commission Directive
2009/98/EC of 4 August 2009 amending Di-
rective 98/8/EC of the European Parliament
and of the Council to include boric oxide
[CAS 1303-86-2] as an active substance in
Annex I thereto
O.J. L203, 2009: Commission Directive
2009/99/EC of 4 August 2009 amending Di-
rective 98/8/EC of the European Parliament
and of the Council to include chlorophaci-
none [CAS 3691-35-8 ] as an active substance
in Annex I thereto
USA (Period August 2009)
[2009/0168]
Federal Register, 7 August 2009, Vol. 74,
No. 151, 39535: Children’s Products Contain-
ing Lead; Interpretative Rule on Inaccessible
Component Parts. Consumer Product Safety
Commission. Final rule.
Federal Register, 7 August 2009, Vol. 74,
No. 151, 39704: Guidance for Industry on
Pharmaceutical Components at Risk for
Melamine Contamination; Availability. Food
and Drug Administration, HSS. Notice.
IMPORTANT DATA
[2009/0169]
13-15 October 2009
In-cosmetics Asia 2009
Singapore, Singapore
Info: http://www.in-cosmeticsasia.com
[A hands-on workshop on cosmetic safety regulations will
be held. The event will review the Asian regulations and
will provide practical demonstrations on how to assess
product safety in accordance with the ASEAN Cosmetics
Directive. The workshop will be led by Johnson & Johnson
Asia Pacific toxicology manager Dr Bashkar Mukerji and
Dr Alain Khaiat. Taking place on 15 October, the last day
of the exhibition, the event aims to give training about the
handling and selection of raw materials, and how to read
and use the safety data provided by suppliers.]
21 October 2009
Sixth Annual IMDS/REACH Summit
Livonia/Michigan, USA
Info: http://www.mdsystem.com/html/
data/09imdsreach.pdf
23-24 November 2009
Biocides 2009. Multinational conference
on legal issues and trade aspects of biocidal
products.
Vienna, Austria
Info: www.feierl-herzele.com
25 November 2009
Workshop on Authorisation/Registration and
Mutual Recognition of Biocidal Products
Vienna, Austria
Info: www.feierl-herzele.com
1-5 March 2010
ChemCon Europe 2010
Prague
Info: www.chemcon.net

204 Journal Chemicals Management September 2009, No. 7 Sdu Uitgevers

official publications

17 – 19 June 2010
International Chemical & Petrochemical
Summit (INACHEM 2010) Exhibition and
Conference
Jakarta, Indonesia
Info: www.ina-chem.com

Sdu Uitgevers Journaal Stoffen en Preparaten september 2009, Nr. 7 205

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Citeertitel
Journaal Stoffen en Preparaten jaartal/nummer
(voorbeeld: Journaal Stoffen en Preparaten 2009/1)

ISSN 1574-1079
Journal
Chemicals
Management
Journaal
Stoffen & Preparaten
Chief-editor:
Drs. A.C.H. van Peski
Editorial Board:
Dr. M.M. Kops-Werkhoven
Drs. H.A.F. van Well
Dr. J.A.S.J. Razenberg
Dr. L.J.M. Rodenburg
Drs. G.A. Schouten
Drs. J. Zawierko
Advisory Board:
K. E. Armstrong (U.S.A.)
Dr. R. Fielding (United Kingdom)
Drs. A. Gondová
G. Koh (Singapore)
Dr. C. van Lint (Australia)
Dan Liu (U.S.A.)
S. Park (S.-Korea)
H. Sano (Japan)
S. Savary (Canada)
Ir. C. Sieger (Germany)
J. Simpson (Australia)
Dr. U. Schumacher (China)
E. Snyman (South Africa)
P.G. Tse (New Zealand)
No. 8
Oktober 2009
Volume 6
Part of Stoffennieuws.nl
CONTENT
ACTUALITIES
European Union
[2009-0170] EU: Safety data sheets: REACH Annex II
amendment
[2009/0171] The 1st ATP to the CLP Regulation
[2009/0172] EU: ATP to REACH test methods
[2009/0173] EuroChlor: Sodium hypochlorite classifi-
cation reviewed
[2009/0174] ECHA: public consultations
International
[2009/0175] Australia: notification of new chemicals
[2009/0176] Taiwan: inventory of new and existing
chemicals (draft)
[2009/0177] Japan: GHS Guidance
[2009/0178] Australia: Hazardous Substances Infor-
mation System Updated - April 2009
[2009/0179] Australian Code for the Transport of Ex-
plosives by Road and Rail
PUBLICATIONS
Proceedings
[2009/0180] Assessment of combined exposures to
multiple chemicals: report of a WHO/IPCS international
workshop on aggregate/cumulative risk assessment (IPCS
Harmonization Project Document 7)
OFFICIAL PUBLICATIONS
[2009/0181]
[2009/0182]
United Kingdom (Period August 2009)
European Union (Period Period August
2009)

actualities
European Union
EU: Safety data sheets: REACH
Annex II amendment
[2009/0170] to technical progress, Regulation (EC) No
The draft Commission Regulation (EC)
No …/.. of […] amending Regulation (EC)
No 1907/2006 of the European Parliament
and of the Council on the Registration,
Evaluation, Authorisation and Restriction of
Chemicals (REACH) on the revision of safety
data sheets has been published.
Reference: This draft proposal to amend Annex II of
REACH in order to align it with the pro-
visions of Regulation (EC) No 1272/2008
on classification, labelling and packaging
of substances and mixtures (CLP) can be
found at: http://ec.europa.eu/enterprise/
tbt/tbt_repository/EEC295_EN_1_1.pdf
The 1st ATP to the CLP Regulation
[2009/0171] A.4. Vapour Pressure.
The first ATP to the Regulation (EC) No
1272/2008 on classification, labelling and
packaging of substances and mixtures (CLP)
has been published in the OJ of 5 September
2009 as Regulation (EC) No. 790/2009. This
brings into effect the 30th & 31st ATPs to the
Dangerous Substance Directive 67/548/EEC.
Note that although the ATP comes into effect
on 25 September 2009, the classifications do
not become legally binding until 01 December
2010, mut mat=y be applied before that date.
208 Journal Chemicals Management Oktober 2009, No. 8
actualities
Reference: http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=OJ:L:2009:235:0001:0439:EN
:PDF
EU: ATP to REACH test methods
[2009/0172]
In the Official Journal of the European Un-
ion L220 of 24 August 2009 the Commission
Regulation (EC) No 761/2009 of 23 July 2009
amending, for the purpose of its adaptation
440/2008 laying down test methods pursuant
to Regulation (EC) No 1907/2006 of the Eu-
ropean Parliament and of the Council on the
Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH) (94 pages)
has been published.
Regulation (EC) No 440/2008 (OJ L 142,
31.5.2008) contains the test methods for the
purposes of the determination of the physico-
chemical properties, toxicity and eco-toxicity
of substances to be applied for the purposes of
REACH. It has been necessary to update this
regulation to include changes to certain test
methods (A.4, C.3) and to include several new
test methods (A.22, B.46, C.25, C.26) . Those
amendments adapt the methods in question
to scientific and technical progress:
The provisions concerning vapour pressure
to include the new effusion method has been
revised. This method is equivalent to OECD
TG 104 (2004).
This revised version of method A.4 includes
one additional method; Effusion method:
isothermal thermogravimetry, designed for
substances with very low pressures (down
to 10–10 Pa). In the light of needs for proce-
dures, especially in relation to obtaining va-
pour pressure for substances with low vapour
pressure, other procedures of this method are
Sdu Uitgevers
actualities
re-evaluated with respect to other applicabil-
ity ranges. At the thermodynamic equilibrium
the vapour pressure of a pure substance is a
function of temperature only. No single meas-
urement procedure is applicable to the entire
range of vapour pressures from less than 10–10
to 105 Pa. Eight methods for measuring va-
pour pressure are included in this method
which can be applied in different vapour pres-
sure ranges. The methods can only be applied
for compounds that do not decompose under
the conditions of the test. In cases where the
experimental methods cannot be applied due
to technical reasons, the vapour pressure can
also be estimated.
[Note: Definition:
– The vapour pressure of a substance is defined as the
saturation pressure above a solid or liquid substance.
The SI unit of pressure, which is the pascal (Pa),
should be used.]
A.22. Length weighted geometric mean
diameter of fibres
It is necessary to add a new method to meas-
ure length weighted geometric mean diameter
of fibres. This method describes a procedure
to measure the Length Weighted Geometric
Mean Diameter (LWGMD) of bulk Man Made
Mineral Fibres (MMMF). As the LWGMD of
the population will have a 95 % probability
of being between the 95 % confidence levels
(LWGMD ± two standard errors) of the sam-
ple, the value reported (the test value) will be
the lower 95 % confidence limit of the sam-
ple (i.e. LWGMD — 2 standard errors). This
measurement method can be used to char-
acterise the fibre diameter of bulk substances
or products containing MMMFs including
refractory ceramic fibres (RCF), man-made
vitreous fibres (MMVF), crystalline and poly-
crystalline fibres.
Length weighting is a means of compensat-
ing for the effect on the diameter distribution
caused by the breakage of long fibres when
sampling or handling the material. Geometric
statistics (geometric mean) are used to meas-
Sdu Uitgevers
ure the size distribution of MMMF diameters
because these diameters usually have size dis-
tributions that approximate to log normal.
Measuring length as well as diameter is both
tedious and time consuming but, if only those
fibres that touch an infinitely thin line on a
scanning electron microscope (SEM) field of
view are measured, then the probability of
selecting a given fibre is proportional to its
length. As this takes care of the length in the
length weighting calculations, the only mea-
surement required is the diameter and the
LWGMD-2SE can be calculated as described.
[Note: Definitions:
– Particle: An object with a length to width ratio of less
than 3:1.
– Fibre: An object with a length to with ratio (aspect
ratio) of at least 3:1.]
B.46. In vitro skin irritation: reconstructed
human epidermis model test
It is appropriate to update Regulation (EC)
No 440/2008 to include with priority a new
in vitro test method for skin irritation, in
order to obtain a reduction of the number
of animals to be used for experimental pur-
poses, in accordance with Council Directive
86/609/EEC on the approximation of laws,
regulations and administrative provisions of
the Member States regarding the protection
of animals used for experimental and other
scientific purposes. Although a draft in vitro
test method for skin irritation is still under
discussion within the OECD, it is appropri-
ate in this exceptional case to include method
B 46 in this Regulation. Method B 46 should
be updated as soon as possible once an agree-
ment has been reached within the OECD or if
further information justifying such a revision
becomes available.
Skin irritation refers to the production of re-
versible damage to the skin following the ap-
plication of a test substance for up to 4 hours
[as defined by the United Nations (UN) Glo-
bally Harmonized System of Classification
Journaal Stoffen en Preparaten oktober 2009, Nr. 8 209

and Labelling of Chemicals (GHS)]. This Test
Method provides an in vitro procedure that,
depending on information requirements,
may allow determining the skin irritancy of
substances as a stand-alone replacement test
within a testing strategy, in a weight of evi-
dence approach.
The assessment of skin irritation has typi-
cally involved the use of laboratory animals
(See Method B.4). In relation to animal wel-
fare concerns, method B.4 allows for the de-
termination of skin corrosion/irritation by
applying a sequential testing strategy, using
validated in vitro and ex vivo methods, thus
avoiding pain and suffering of animals. Three
validated in vitro Test Methods or Test Guide-
lines, B.40, B.40bis and TG 435, are useful for
the corrosivity part of the sequential testing
strategy of B.4.
This Test Method is based on reconstructed
human epidermis models, which in their over-
all design (the use of human derived epider-
mis keratinocytes as cell source, representative
tissue and cytoarchitecture) closely mimic the
biochemical and physiological properties of
the upper parts of the human skin, i.e. the
epidermis. The procedure described under
this Test Method allows the hazard identifi-
cation of irritant substances in accordance
with UN GHS category 2. This Test Method
also includes a set of performance standards
for the assessment of similar and modified
reconstructed human epidermis based test
methods.
The principle of the reconstructed human
epidermis model test is based on the premise
that irritant substances are able to penetrate
the stratum corneum by diffusion and are
cytotoxic to the cells in the underlying layers.
Cell viability is measured by dehydrogenase
conversion of the vital dye MTT [3-(4,5-Di-
methylthiazol-2-yl)-2,5-diphenyltetrazolium
bromide, Thiazolyl blue; EINECS number
206-069-5, CAS number 298-93-1)], into a
blue formazan salt that is quantitatively mea-
sured after extraction from tissues. Irritant
210 Journal Chemicals Management Oktober 2009, No. 8

actualities

substances are identified by their ability to
decrease cell viability below defined threshold
levels (i.e. ≤ 50 %, for UN GHS category 2 irri-
tants). Substances that produce cell viabilities
above the defined threshold level, will not be
classified (i.e. > 50 %, no category).
A list of reference substances is given in the
Annex to the method.
[Note: Definition:
– Skin irritation: The production of reversible damage
to the skin following the application of a test sub-
stance for up to 4 hours. Skin irritation is a locally
arising, non-immunogenic reaction, which appears
shortly after stimulation. Its main characteristic is its
reversible process involving inflammatory reactions
and most of the clinical characteristic signs of irrita-
tion (erythema, oedema, itching and pain) related to
an inflammatory process.]
C.3. Freshwater algae and cyanobacteria,
growth inhibition test
The provisions concerning the algal inhibition
test need to be revised to include additional
species and to meet the requirements for haz-
ard assessment and classification of chemi-
cals. This method is equivalent to OECD TG
201 (2006).
Testing Methods are periodically reviewed
and updated in the light of scientific progress.
Testing Method C.3 needed to be revised to
include additional species and to meet the
requirements for hazard assessment and clas-
sification of chemicals. The revision has been
completed on the basis of extensive practical
experience, scientific progress in the field of
algal toxicity studies, and extensive regulatory
use, which has occurred since the original
adoption.
C.25. Aerobic mineralisation in surface
water – simulation biodegradation test
It is necessary to add a new method to meas-
ure aerobic mineralisation in surface water,
by virtue of a simulation biodegradation test.
This method is equivalent to OECD TG 309
(2004).
Sdu Uitgevers
actualities
The purpose of this test is to measure the time
course of biodegradation of a test substance
at low concentration in aerobic natural water
and to quantify the observations in the form
of kinetic rate expressions. This simulation
test is a laboratory shake flask batch test to de-
termine rates of aerobic biodegradation of or-
ganic substances in samples of natural surface
water (fresh, brackish or marine). It is based
on the ISO/DIS 14592-1 and it also includes
elements from the testing methods C.23 and
C.24. Optionally, with long test times, semi-
continuous operation replaces batch opera-
tion in order to prevent deterioration of the
test microcosm. The principal objective of
the simulation test is to determine the miner-
alisation of the test substance in surface water,
and mineralisation constitutes the basis for
expressing degradation kinetics. However, an
optional secondary objective of the test is to
obtain information on the primary degrada-
tion and the formation of major transforma-
tion products. Identification of transforma-
tion products, and if possible quantification
of their concentrations, are especially impor-
tant for substances that are very slowly min-
eralised (e.g. with half-lives for total residual
14C exceeding 60 days). Higher concentrations
of the test substance (e.g. > 100 μg/l) should
normally be used for identification and quan-
tification of major transformation products
due to analytical limitations.
[Note: Definitions:
– Primary biodegradation: The structural change
(transformation) of a chemical substance by micro-
organisms resulting in the loss of chemical identity.
– Functional biodegradation: The structural change
(transformation) of a chemical substance by micro-
organisms resulting in the loss of a specific property.
– Ultimate aerobic biodegradation: The breakdown of
a chemical substance by microorganisms in the pres-
ence of oxygen to carbon dioxide, water and mineral
salts of any other elements present (mineralisation)
and the production of new biomass and organic mi-
crobial biosynthesis products.
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– Mineralisation: The breakdown of a chemical sub-
stance or organic matter by microorganisms in the
presence of oxygen to carbon dioxide, water and min-
eral salts of any other elements present.]
C.26. Lemna SP. growth inhibition test
It is necessary to add a new method to meas-
ure aerobic mineralisation in surface water, by
virtue of a simulation biodegradation test and
a new method to assess toxicity to the genus
Lemna, by virtue of a growth inhibition test.
This method is equivalent to OECD TG 221
(2006). There has been broad agreement by
EU authorities that the Lemna test is a suit-
able alternative to an algal test for strongly
coloured substances.
This Testing Method is designed to assess the
toxicity of substances to freshwater aquatic
plants of the genus Lemna (duckweed). It
is based on existing guidelines but includes
modifications of those methods to reflect re-
cent research and consultation on a number
of key issues. The proposed method has been
validated by an international ring-test.
[Note: definition:
– ECx: is the concentration of the test substance dis-
solved in test medium that results in an x % (e.g. 50
%) reduction in growth of Lemna within a stated ex-
posure period (to be mentioned explicitly if deviating
from full or normal test duration)].
Reference: http://eur-lex.europa.eu/LexUriServ/LexU-
riServ.do?uri=OJ:L:2009:220:0001:0094:EN
:PDF
EuroChlor: Sodium hypochlorite
classification reviewed
[2009/0173]
The EU Directive 67/548/EEC listed a specific
concentration limit of 25% active chlorine,
above which solutions of sodium hypochlorite
were classified as “Dangerous for the Environ-
ment” and labelled N; R50, whereas solutions
or mixtures containing < 25% active chlo-
Journaal Stoffen en Preparaten oktober 2009, Nr. 8 211

rine were not. When the new EU Regulation
on Classification, Labelling and Packaging
of Substances and Mixtures (EC 1272/2008)
(CLP) came into force in January 2009, it in-
troduced a change in the way that solutions of
sodium hypochlorite had to be classified and
labelled as ‘Dangerous to the Environment’.
The specific concentration limit has been de-
leted in the new regulation and replaced by a
general provision, the ‘M-factor’. The M-fac-
tor is a number allocated to individual highly
toxic substances that is derived from the data
on their acute toxicity to aquatic species.
However, the available eco-toxicity data on so-
dium hypochlorite showed some weaknesses.
As a consequence, it was decided that further
testing was required to realistically assess the
toxicity of sodium hypochlorite solutions (12
– 14 % active chlorine) to aquatic species and
a new acute toxicity study in Daphnia magna
was commissioned.
The new data is considered to be more reli-
able than previous data from invertebrate
toxicity studies. This new result, combined
with other available reliable data, shows that
invertebrates and fish are equally sensitive to
the toxic effects of sodium hypochlorite and
allows one to conclude, based on the weight
of evidence, that the acute toxicity of sodium
hypochlorite to freshwater species lies in the
range: 10 < L(E)C50 ≤ 100 μg/L.
This means that an M-factor of 10 should
be assigned to sodium hypochlorite which,
in turn, means that if classification is based
on the calculation method, solutions of ≥
2.5% active chlorine will need to be clas-
sified as “Dangerous to the Environment
(N; R50). Solutions containing < 2.5% ac-
tive chlorine do not need to be classified
in this way. An M-factor of 10 must also be
applied when classifying mixtures/prepara-
tions containing hypochlorite according to
the calculation method. Other results based
on the testing of specific formulations may
give rise to a different, specific concentration
for the classification of these formulations.
212 Journal Chemicals Management Oktober 2009, No. 8
actualities
The new CLP hazard statements are H314
(Causes severe skin burns and eye damage),
H400 (Very toxic to aquatic life ) (c ≥ 2.5 %)
and EUH031 (Contact with acids liberates
toxic gas) (c ≥ 5 %).
Reference: http://www.eurochlor.org/news/detail/
index.asp?id=302
ECHA: public consultations
[2009/0174]
On 2 September 2009 the European Chemi-
cals Agency has published on its website a
public consultation on the proposal to har-
monise the classification and labelling of three
chemical substances. Comments are welcome
on the proposal within the next 45 days. All
comments will be taken into account in the
subsequent decision-making process. The
substances in this consultation, submitted by
Ireland, France and the Netherlands, are:
– Tris[2-chloro-1-(chloromethyl)ethyl]
phosphate (TDCP, CAS 13674-87-8) (Ire-
land) – which is used as an additive flame
retardant (i.e. it is physically combined
with the material being treated rather than
chemically combined) and is proposed to
be classified as a category 3 carcinogen.
– Tetrahydrofuran (CAS 109-99-9) (France)
– which is used as a solvent or for synthe-
sis (e.g. motor fuels, pharmaceuticals, syn-
thetic perfumes and insecticides) and is
proposed to be classified as a category 3
carcinogen; irritating to the eyes and the
respiratory system; highly flammable; and
because it may form explosive peroxides.
– Abamectin (a combination of Avermectin
B1a and Avermectin B1b) (CAS 71751-
41-2, 65195-55-3, 65195-56-4, 65195-55-
3) (Netherlands) – which is used as an
insecticide and acaricide (a chemical that
kills mites). Abamectin is proposed to be
classified as category 3 for reproductive
toxicity (posing a possible risk of harm to
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actualities

the unborn child); as very toxic when in- – Acrylamide (CAS 79-06-1) Carcinogen,
haled or swallowed; as toxic because of the category 2; mutagen, category 2
danger of serious damage to health of pro- – Aluminiosilicate, Refractory Ceramic Fi-
longed exposure; and as very toxic to the bres (CAS --) Carcinogen, category 2
aquatic environment. Abamectin has to – Zirconia Aluminosilicate, Refractory Ce-
have a harmonised classification because ramic Fibres (CAS --) Carcinogen, cat-
it is a pesticide active substance. egory 2
– 2,4-Dinitrotoluene (CAS 121-14-2) Car-
On 1 September 2009 the European Chemicals cinogen, category 2
Agency (ECHA) has published on its website – Diisobutyl phthalate (CAS 84-69-5)Toxic
proposals to identify chemicals as Substances for reproduction, category 2
of Very High Concern (SVHC). Interested – Lead chromate (CAS 7758-97-6) Carcino-
parties are welcome to comment on these 15 gen, category 2; toxic for reproduction,
substances within the next 45 days. The com- category 1
ments will be taken into account when de- – Lead chromate molybdate sulphate red
ciding whether the substances will be added (C.I. Pigment Red 104) (CAS 12656-85-8)
to the Candidate List from which substances Carcinogen, category 2; toxic for repro-
are selected for authorisation. Nine out of duction, category 1
the 15 substances are proposed to be identi- – Lead sulfochromate yellow (C.I. Pigment
fied as SVHCs because of their carcinogenic, Yellow 34) (CAS 1344-37-2) Carcinogen,
mutagenic and/or reprotoxic (CMR) proper- category 2; toxic for reproduction, catego-
ties, having thus potentially serious effects on ry 1
human health. Five substances are proposed – Tris(2-chloroethyl)phosphate (CAS 115-
to be identified as persistent, bioaccumulative 96-8)Toxic for for reproduction, catego-
and toxic and as very persistent and very bio- ry 2
accumulative (PBT), having potentially seri-
ous negative effects on the environment. One
substance is proposed because it is considered
both as CMR and PBT. The substances are:
– Anthracene oil (CAS 90640-80-5) Persis-
tent, bioaccumulative and toxic
– Anthracene oil, anthracene paste, distn.
lights (CAS 91995-17-4) Persistent, bioac-
cumulative and toxic
– Anthracene oil, anthracene paste, anthra-
cene fraction (CAS 91995-15-2) Persis-
tent, bioaccumulative and toxic
– Anthracene oil, anthracene-low (CAS
90640-82-7) Persistent, bioaccumulative
and toxic
– Anthracene oil, anthracene paste (CAS
90640-81-6) Persistent, bioaccumulative
and toxic
– Coal tar pitch, high temperature (CAS
65996-93-2) Persistent, bioaccumulative
and toxic; carcinogen, category 2

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international
Australia: notification of new
chemicals.
[2009/0175] if potentially harmful effects are identified at
Like many other countries (Canada, USA,
South-Korea, P.R. of China, Japan, The Phil-
ippines, New Zealand, European Union and
in the near future also Taiwan) Australia uses
a system of notification of new industrial
chemicals.
The ‘Australian Inventory of Chemical Sub-
stances’ (AICS) is the legal device that dis-
tinguishes new chemicals from existing ones.
AICS is a listing of all industrial chemicals in
use in Australia between 1 January 1977 and
28 February 1990. In addition, it includes
new assessed chemicals and corrections as
required. The AICS is maintained under the
‘National Industrial Chemicals Notification
and Assessment Scheme’ (NICNAS) and con-
tains over 38 000 chemicals. The AICS is a list
of chemical identity data; it does not contain
information on toxicity, use, manufacturers or
importers. It consists of the non-confidential
(public) section and the confidential section.
Any chemical not included in AICS is re-
garded as a new industrial chemical unless it
is outside the scope of the Industrial Chemi-
cals (Notification and Assessment) Act 1989
or is otherwise exempt from notification. New
industrial chemicals must be notified and as-
sessed before being manufactured or import-
ed into Australia.
Chemicals on the AICS can be imported or
manufactured in Australia without first being
notified to NICNAS as New Chemicals.
214 Journal Chemicals Management Oktober 2009, No. 8
international
Chemicals assessed by NICNAS are identified
in the AICS online by a flag ‘Assessed by NIC-
NAS’. For chemicals where the assessed flag is
‘yes’, there may be secondary notification re-
quirements.
The goal of NICNAS is to aid in the protection
of the Australian people and the environment
by identifying the risks to occupational health,
public health and the environment from in-
dustrial chemicals. These risks are minimised
the earliest possible time – prior to the chemi-
cal’s importation and/or manufacture. Ap-
propriate safe handling methods can then be
devised and implemented.
Adding Chemicals to the AICS: All certificate
assessed chemicals are included on AICS five
years after the certificate date unless the noti-
fier exercises the option for immediate listing.
At the end of five years the notifier, which is
the holder of the certificate, is given the op-
portunity to request that the chemical be list-
ed on the confidential section.
Confidential listing on the AICS: In order to list
a chemical in the confidential section of the
AICS, an application to the Director of NIC-
NAS, on the approved form is required.
If the application is approved, the chemical is
listed for five years. At the end of five years, the
company can apply to re-list the chemical for
another five years by making an application
on the approved form.
The Act: A compilation of the Act was pre-
pared by the Office of Legislative Drafting and
Publishing, Attorney‑General’s Department,
Canberra on 17 September 2007, taking into
account amendments up to Act No. 134 of
2007.
Definitions:
– industrial chemical means a chemical that
has an industrial use, whether or not it also
has an excluded use. This includes spe-
cialty chemicals, dyes, solvents, adhesives,
plastics, laboratory chemicals, chemicals
used in mineral and petroleum processing,
refrigeration, printing and photocopying,
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international

paints and coatings, as well as chemicals
used in the home, such as cleaning prod-
ucts, cosmetics and toiletries.
– excluded use, in relation to a chemical,
means: (a) use as an agricultural chemical
or a constituent of an agricultural chemi-
cal; or (b) use as a veterinary chemical or
a constituent of a veterinary chemical; or
(c) therapeutic use or use as an ingredient
or component in the preparation or man-
ufacture of goods for therapeutic use; or
(d) use as food intended for consumption
by humans or animals or a constituent of
such food; or (e) use as a food additive in
food referred to in paragraph (d).
– relevant industrial chemical means
an industrial chemical: (a) that is not
intended for an excluded use; and (b) that
is not: (i) a naturally‑occurring chemical;
or (ii) biological material; or (iii) an
incidentally‑produced chemical; or (iv) a
reaction intermediate.
The ‘NICNAS Handbook for Notifiers’ assist
manufacturers and importers of industrial
chemicals comply with their obligations un-
der the Industrial Chemicals (Notifications
and Assessment) Act 1989. The complete
handbook is currently being revised, however
the updated 2009 individual sections can al-
ready be downloaded (latest amendment: ver-
sion 8 of March 2009).
New chemical assessments: All new industrial
chemicals must be notified to NICNAS and
assessed prior to their import or manufacture
in Australia. Certain new industrial chemicals
are exempt from notification provided they
meet certain criteria including use; volume;
concentration and risk to human health or
the environment. All exemption categories
have an annual reporting obligation.
In general, the chemicals subject to new chem-
ical assessment under NICNAS are those that
are not listed on the Australian Inventory of
Chemical Substances (AICS) or those whose
importation and/or manufacture is subject to
a condition of use. In general, the chemicals
subject to new chemical assessment under
NICNAS are those that are not listed on the
Australian Inventory of Chemical Substances
(AICS) or those whose importation and/or
manufacture is subject to a condition of use.

Table: Categories that are exempt from notification:

Exemption Volume or concentration restriction Other Advice required Other reporting
criteria prior to requirements
introduction
Research and Development Not more than 100 kg in a period of No No Annual reporting
12 months
Research and Development N/A Yes Yes - Form 6 No
(manufactured)
Transhipment N/A Yes No Annual reporting
Non-Cosmetic Not more than lOO kg in a period of Yes No Annual reporting*
(no unreasonable risk) 12 months (NCE-Fonn 1)
Cosmetic (<1%) Introduced in a product at 1% or less Yes No Annual reporting*
Cosmetic Not more than 10 kg in a period of Yes No Annual reporting*
(no unreasonable risk) 12 months
Cosmetic Greater than l0kg but not more than Yes Yes- Form 15 Annual reporting*
(no unreasonable risk) 100kg in a period of 12 months
*The person who introduces the chemical must keep in writing. for 5 years after the introduction. infollllation availab1e
to the person about occuparional health and safety. public health and the environmental effects of the chemical (refer
to Chapter 15 for infollllation on annual reponing requirements).

Sdu Uitgevers Journaal Stoffen en Preparaten oktober 2009, Nr. 8 215


Chapter Section II– New Chemicals aims to
help to decide whether a substance one is im-
porting or manufacturing is subject to new
chemicals assessment under NICNAS. If it
is, one will need to refer to Chapters 2-8 in
Section II and Section IV in the handbook for
more information about new chemical assess-
ment. If after reading this chapter, one discov-
ers the chemical is not subject to new chemi-
cal assessment, no further action is required
in most cases. However, annual reporting re-
quirements exist for all chemicals introduced
under an exemption category and record
keeping requirements and advice prior to in-
troduction is required for certain exempt cat-
egories. These categories (and the procedures
to follow in order to supply information) are
outlined at the end of this chapter. Any forms
referred to in this chapter can be downloaded
from the NICNAS website.
Determining the Appropriate Notification
Category
– Permit notification
There are a number of categories relating to
notification for a new chemical assessment,
with each category depending on the type of
chemical, the amount being introduced, the
use of the chemical and the period of use re-
quired. Permit notification categories are suit-
able for chemicals which meet certain criteria.
These notification categories result in the issue
of a permit allowing the introduction of fixed
quantities of the chemical for the duration of
the permit. They also result in the publica-
tion of a notice of the permit in the Chemi-
cal Gazette. The chemical is not added to the
AICS. The assessment timeframes for permit
categories are shorter and the fees lower than
certificate notification categories. An applica-
tion to renew an existing permit can be made
in certain circumstances.
– Certificate notificatiom
A special type of permit may be applied for in
certain circumstances in conjunction with an
application for a certificate notification. This
216 Journal Chemicals Management Oktober 2009, No. 8
international
allows introduction of the chemical before the
certificate assessment is complete. The certifi-
cate notification categories are for chemicals
which do not meet the permit criteria or
where the introducer prefers a certificate no-
tification to a permit notification. Certificate
categories result in an assessment report, the
issue of an assessment certificate, publication
of a summary report in the Chemical Gazette
and a full public report on the NICNAS web-
site and the eventual addition of the assessed
chemical to the AICS. There are different fees
for each category.
Overview of Permit Categories
Section II, 3.2 is intended to give an overview
of the different permit categories, the circum-
stances for which each permit category is in-
tended and the criteria that apply:
– Commercial Evaluation Chemical (CEC)
permit notifications are for limited
volume chemicals to be introduced solely for
the purpose of market evaluation where the
maximum quantity to be introduced is 4000
kg in a maximum period of 2 years. A CEC
may be renewed once only provided certain
criteria are met. Although there is no statu-
tory deadline for NICNAS to finalise a CEC
application, the process is usually completed
within 14 days. Examples of possible uses are:
– To test a new polymer in a surface coating
when a large quantity is required to fill paint
lines; or – To evaluate a new process which re-
quires a new industrial chemical.
Information from Part B of the Schedule re-
lating to occupational health and safety risks;
environmental impacts; and public health ef-
fects must be provided. Copies of proposed
labels and a proposed MSDS must also be
submitted for the chemical.No toxicity data
need be generated under this category. How-
ever, copies of existing test reports available to
the notifier must be submitted with the CEC
Notification.
– Low Volume Chemical (LVC) permit noti-
fications are for small volume chemicals
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international
to be introduced at a rate of up to 100 kg per
year or 1000 kg per year for a maximum of 3
years. A LVC permit may be renewed any num-
ber of times provided certain criteria are met.
LVC permits and permit renewals are issued
within 20 days of receipt of a complete noti-
fication. A number of low regulatory concern
chemicals introduced at up to 100 kg per year
are exempt from notification to NICNAS.
The LVC permit allows the chemical to be in-
troduced at a maximum quantity of 1000 kg
per annum where the following low-hazard-
ous criteria are met (otherwise the volume
limit is 100 kg): For chemicals (including
polymers with a NAMW <1000), the chemi-
cal is not a hazardous substance according to
the Approved Criteria for Classifying Hazard-
ous Substance, or is a hazardous chemical that
is classified as R36 (irritating to eyes) or R38
(irritating to skin) according to the Approved
Criteria for Classifying Hazardous Substances
(irritation reversible); and is not a dangerous
good according to the Australian Code for the
Transport of Dangerous Goods by Road and
Rail (ADG code) or is a dangerous good that
is a Class 3 flammable liquid as defined in the
ADG code; and has a very low aquatic toxicity
to fish, aquatic invertebrates and algae, that is,
LC50 or EC50 100 mg/l or greater.
For polymers with NAMW that is 1000 or
greater: see the Handbook.
LVC Notifications must detail the purpose for
which the chemical is being introduced and
include information about its proposed use,
the expected total volume for the first year,
and the total time period for introduction. A
summary of the chemical’s health and envi-
ronmental effects under Part A of the Schedule
is required, as well as additional information
from Part B relating to occupational health
and safety risks; environmental impacts; and
public health effects. Copies of proposed la-
bels and a proposed MSDS must also be sub-
mitted. No toxicity data need be generated
under this category. However, copies of exist-
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ing test reports available to the notifier must
be submitted with the LVC Notification.
– Controlled Use Permit (CUP) notifications
are for the introduction of low risk new
chemicals used in highly controlled cir-
cumstances for a maximum of three years.
There is no volume restriction provided
all the following criteria are met:
(a) the chemical does not have any of the
following hazard classifications for
human health effects: (i) carcinogenic
effects (R40, R45, R49); (ii) mutagenic
effects (R46); (iii) reproductive effects
(R60-64); (iv) toxic and very toxic
acute lethal effects (R23-28); (v) cor-
rosive effects (R34, R35); (vi) sensitis-
ing effects (R42, R43); (vii) non-lethal
irreversible effects after a single expo-
sure (R39, R68); (viii) severe effects
after repeated or prolonged exposure
(R48); AND
(b) the chemical does not have a toxicity:
(i) to fish, expressed as an LC50, that
is less than or equal to10 mg/litre, as
determined using the Fish Acute Tox-
icity Test (continuous exposure of fish
to a series of concentrations of the
chemical in water for 4 days); and (ii)
to aquatic invertebrates, expressed as
an EC50, that is less than or equal to
10 mg/litre, as determined using the
Daphnia sp, Acute Immobilisation
Test and Reproduction Test (daphnids
exposed to a series of concentrations
of the chemical in water); and (iii) to
algae expressed as IC50, that is less
than or equal to 10 mg/litre, as deter-
mined using the Algal Growth Inhibi-
tion Test (algae exposed to a series of
concentrations of the chemical in wa-
ter for at least 3 days); AND
(c) for human exposure: (i) there are no
exposures to consumers or the gen-
eral public inherent in the proposed
manufacturing, processing or uses
of the substance; and (ii) any worker
Journaal Stoffen en Preparaten oktober 2009, Nr. 8 217

exposure that is likely to occur will be
adequately controlled through use of
engineering controls, work practices
and personal protective equipment;
AND
(d) for environmental exposure, all routine
releases from manufacture, processing
and use (including releases associated
with cleaning of equipment and from
disposal or cleaning of containers and
packaging) have been considered and
adequate controls are in place.
A CUP may be renewed any number of times
provided certain criteria are met.
– Controlled Use (Export Only) Permit (EOP)
notifications are for controlled introduc-
tion of a new chemical for export purpos-
es or for its use in controlled formulation
of products in Australia for export of the
entire quantity for a maximum of three
years.
An EOP permit may be renewed any number
of times provided certain criteria are met.
– Early Introduction Permit (EIP) applica-
tions may be made under certain circum-
stances, in conjunction with a certificate
notification. An EIP allows introduction
of a chemical into Australia before the as-
sessment certificate is issued. Under nor-
mal circumstances, an application for an
EIP will be decided within 28 days.
Section 30A (EIP) Permits are for new indus-
trial chemicals which meet certain hazard or
use criteria. Section 30 Permits are for new
chemicals where it can be shown that their
immediate introduction is in the public inter-
est.
Chemicals/polymers which may be eligible for
an EIP are: polymers of low concern (PLC);
non-hazardous chemicals/polymers; chemi-
cals/polymers meeting low-hazardous crite-
ria; or low risk highly controlled chemicals/
polymers.
218 Journal Chemicals Management Oktober 2009, No. 8
international
Overview of Certificate Categories
– Polymers of Low Concern (PLC) notifica-
tions are for polymers for which the fol-
lowing applies : a. Number-average molec-
ular weight. Except for certain polyesters
(see below), a PLC must have a number-
average molecular weight (NAMW) great-
er than 1000.
For polymers with NAMW between 1000 and
10000, the allowable low molecular weight
species (MW below 1000 and 500) for these
polymers is 25% and 10% respectively pro-
vided that the polymer has a limited content
of reactive functional groups. For polymers
with NAMW greater than 10000, the allow-
able low molecular weight species (MW below
1000 and 500) for these polymers remains at
5% and 2% respectively. There is no restric-
tion on the number of reactive functional
groups in the polymer. b. Low charge density.
A polymer has a low charge density if it is
not a cationic polymer or is not reasonably
anticipated to become a cationic polymer in
a natural aquatic environment (4 < pH < 9).
Certain solid materials and polymers with a
low content of cationic groups are allowable
as PLCs. c. Hazard Classification. A PLC must
not be classified as a hazardous chemical. d.
Stability. A polymer is stable under the condi-
tions in which it is used if it does not readily
break down by hydrolysis, thermal degrada-
tion, photodegradation, depolymerisation or
any other means. e. Chemical composition. A
PLC must contain as an integral part of its
composition at least two of the atomic ele-
ments carbon, hydrogen, nitrogen, oxygen,
silicon and sulfur. There are restrictions on
the content of other elements. f. Water absorb-
ing polymers. A water absorbing polymer with
NAMW 10000 and greater cannot be a PLC.
g. Polyesters. A polyester manufactured solely
from one or more allowable reactants may be
a PLC, provided that the polymer meets the
other criteria. It should be noted that each
batch of a particular new polymer must meet
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Categories Other kinds of Applications

Exemptions- CEC LVC CUP EOP PLC Ltd Std Permit Self Early Extension of
renewal Assessment Introduction an Original
Permit Asst
Certificate
Outcome Letter of consent Permit Permit Permit Permit Certificate Certificate Certificate Permit Certificate Permit Certificate
Chemical ≤100 kg/yr ≤ tonnes ≤100 kg/yr Unlimited Unlimited Unlimited ≤ tonne/yr1 > tonne/yr As for pre- As for PLC, As for PLC, As for PLC,
Amount ≤ tonne/yr1 vious LVC, Ltd or Std Ltd or Std Ltd or Std
Introduced for site CEC, CUP
limited che- EOP
micals
Duration of Not applicable Up to 2 36 months 36 months 36 months 5 years 5 years 5 years 36 months 5 years Until certifi- 5 years from
Certificate or years (LVC/CUP/ cate issued, granting
Permit EOP) and or permit of original
up to 2 yrs rescinded certificate
(CEC)
Assessment Not applicable 14 days2 20 days 28 days3 20 days4 90 days 90 days 90 days 20 days (LVC/ 28 days 28 days 45 days
Timeframe EOP), 28
days (CUP)
and 14 days2
(CEC)
For details of current fees see Appendix 4 or the NICNAS website, http://www.nicnas.gov.au/Industry/New_Chemicals/Fees_And_Charges.asp
1 Volume restriction does not apply to synthetic polymers with NAMW > 1000.
2 While there is no legislative time frame for CEC applicationa, they are usually processed within 14 days.
3 While there is no legislative time frame for CUP applicationa, they are usually processed within 28 days.
4 While there is no legislative time frame for EOP applicationa, they are usually processed within 20 days.

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219
 international

the criteria to be eligible for notification and Standard Notifications must include all infor-
assessment as a PLC. mation required under Part A and Part B of
A polymer of low concern can be either a syn- the Schedule, and if the chemical is a polymer,
thetic polymer or biopolymer. In addition, Part D data are also required. In addition, tox-
the residual monomer content will no longer icity studies and other data under Part C must
impact the classification of the polymer as a be submitted. Data required under Part C in-
low concern polymer. However, information clude acute toxicity data; skin/eye irritation
regarding the residual monomer content will and sensitization data; data from a repeated
still need to be provided. dose study; in vitro and in vivo toxicological
Further information on PLC criteria is given and ecotoxicological data; as well as biode-
in Appendix 10 of the NICNAS Handbook for gradability and bioaccumulation data. Tox-
Notifiers. icity results must include observations and
– Limited Notifications are for chemicals results obtained for individual animals. Full
that fit into the following categories: a. reports of all testing must be included and
small volume chemicals, biopolymers and must specify whether good laboratory prac-
low molecular weight synthetic polymers tices were used to obtain data.
(NAMW < 1000), i.e. those which are to
be imported or manufactured at a rate of 2009-2010 Fees and Charges for New Chemi-
up to one tonne per 12 month period (but calsSchedule for Data Requirements.
which do not qualify for a commercial Appendix 4 of the Handbook referms to the
evaluation or low volume chemical per- NICNAS website forfees and charges.
mit); or b. site-limited chemicals, biopoly-
mers and low molecular weight synthetic Price $
polymers (NAMW < 1000), i.e. those re- (see note a)
stricted to their manufacturing site and New Chemical fees
manufactured at a rate of not more than Certificate Apllications
10 tonnes per 12 month period; or c. syn- Standard Assessment 16,199
thetic polymers with NAMW greater than Limited Assessment 13,569
1000 and which do not meet the PLC cri- Polymeer of Low Concern 4,570
teria. Application for Extension of Assessment 2,908
Certficate
Limited Notifications must include all infor-
Self-assessment Certificate Applications
mation required under Part A and Part B of
Self-Assessment Application 9,719
the Schedule, and if the chemical is a polymer, Non-hazardous chemicals
additional data required under Part D must Self-Assessment Application 8,140
also be submitted. Limited Notifications do Non-hazardous polymer
not require new toxicity data to be developed, Polymer of Low Concern (SAPLC) 2,742
but copies of existing test reports available to Self-Assessment Application
the notifier must be submitted with the noti- Permit Applications
fication. Commercial Evaluation (CEC) Permit 3,600
– Standard Notifications are for chemicals, Application
biopolymers and low molecular weight Low Volume Chemical (LVC) Permit 3,600
Application
synthetic polymers imported or manufac-
Controlled Use Permit Application 3,600
tured at greater than one tonne per year
(Export Only)
and which do not fulfil the requirements Controlled Use Permit Application (Other) 3,600
of any other category.

220 Journal Chemicals Management Oktober 2009, No. 8 Sdu Uitgevers

international
Application for Early Introduction Permit
(EIP)
Section 30 Permit Aplication
Permit Renewal Application
Commercial Evaluation (CER) Renewal
Application
Low Volume Chemical (LVCR) Permit
Renewal Application
Controlled Use Prmit Renuwal Application
Others Applications
Secondary notification of new chmicals,
other than synthetic
Secondary notification of a new chemical
that is a synthetic PLC
Reduced Fee Options
Alternate State Law Applicationb
Modular & Foreign Sheme – Standard
Assessment Applicatione Entry fee
Modular & Foreign Sheme – Limited
Assessment Application Entry Fee
Modularc & Foreign Scheme – Polymer of
Low Concern Applicationc Entry Fee
Modular – Secondary Chemicald
New Chemicals Charges
New Chemical Assessment
Variation of Schadule Data Requirements
Nomination of Foreign Scheme
Exempt Information
Application to Vary Assessment Report
Application to Vary Full Public Report
AICS
Confidential Listing of a New Indusrtial
Chemical
Application to Retain Confidential Listing
Application for Early Non-confidential
Listing with fee
Application to be a Holder of a
Confidence
Transfer to Confidential listing
Notes:
a) All NICNAS fees and charges are in Aus-
tralian Dollars and are GST free. All
amounts are rounded to nearest $. 1 AU $
= 0.59 € = 0.86 US $.
b) Whilst fees have been set for this applica-
tion, at present there are no Alternate State
Laws in Australia.
Sdu Uitgevers
693 c) Modular & Foreign Scheme Assessments
entry fees are applicable on the:
7,851
i) Provision of an assessment report
by Environment Canada and Health
711
Canada; or
711 ii) Provision of an assessment report by a
chemicals notification and assessment
711 scheme operating under the OECD
(other than Canada); or
8,971 iii) Provision of an assessment report by
TGA, APVMA and FSANZ; or
3,878 iv) The chemical is similar to a chemical
which has been previously assessed by
NICNAS
9,691
d) Modular – Secondary Chemical fee is ap-
9,719
plicable if the chemical is being notified at
8,140
the same time as a similar chemical (pri-
mary chemical) and for a similar use.
2,742 # The entry fee may not represent the final
fee. The appropriate fee will be advised fol-
711 lowing screening of the application. For more
information on foreign scheme options see
the December 2008 Chemical Gazette and for
1,281 modular assessment options see the May 2009
6,658 Chemical Gazette.
711
711 Schedule for Data Requirements
711 Appendix 12 of the Handbook contains the
Schedule for Data Requirements and provides
1,424 guidance concerning the data necessary to
submit with the application for new or exist-
1,919
ing chemical assessments.
711
Part A requires administrative information, a
639
summary of the chemical’s health and envi-
ronmental effects, and a bibliography of refer-
1,908 ences used in the notification.
Part B requires physico-chemical informa-
tion, information on the chemical’s use and
estimated volume, occupational health and
safety risks, environmental impacts, public
health effects, proposed labels and an MSDS,
and a description of emergency procedures.
Part C requires results of in vitro and in vivo
toxicological and ecotoxicological studies and
biodegradability/bioaccumulation data.
Journaal Stoffen en Preparaten oktober 2009, Nr. 8 221

Part D applies specifically to polymers and re-
quires molecular weight data, residual mono-
mer and impurity data, and stability data.
SCHEDULE PART A
1. Identification of data requirements to be
dealt with in the notification
2. Summary of health and environmental ef-
fects
3. summary of how the chemical meets the
definition of a hazardous substance
4. Details of any notification made in relation
to the chemical in a country other than Aus-
tralia
5. Bibliography
SCHEDULE PART B
1. Identity of the substance
1(a) Chemical name
1(b) Other names
1(c) Marketing name of chemical
1(d) CAS number
1(e) Molecular and structural formulae
1(f) Molecular weight
1(g) Spectral data
2. Composition of the chemical
2(a) Purity
2(b) Toxic or hazardous impurities
2(c) Non-hazardous impurities
2(d) Additives/adjuvants
3. Information on use
4. Precis of appearance
5. Estimated manufacture or import volume
6. Occupational health and safety
6(a) Occupational exposure data
6(a)(i) Number and category of workers
6(a)(ii) Nature of work done
6(a)(iii) Safety procedures to be observed
when handling the chemical
6(a)(iv) Education and training
6(a)(v) Prevalence of work-related Injuries
and diseases related to workers exposed to the
chemical
6(a)(vi) Other occupational hazards
6(b) Health conditions
6(c) Occupational health monitoring
6(c)(i) Atmospheric monitoring
222 Journal Chemicals Management Oktober 2009, No. 8
international
6(c)(ii) Biological monitoring
6(d) Observations on human exposure
7. Environmental Impact
7(a) Manufacturing process
7(a)(i) Identity of the site(s) where the chemi-
cal will be manufactured or reformulated
7(a)(ii) Process description
7(a)(iii) Release of chemicals at each site
7(b) Release to the environment for each use
7(c) Transport and storage
7(d) Disposal
8. Public health
9. Physico-chemical data
9(a) Melting point/boiling point (TG 102, TG
103 or equivalent)
9(b) Specific gravity/density (TG 109 or
equivalent)
9(c) Vapour pressure (TG 104 or equivalent)
9(d) Water solubility (TG 105 or equivalent,
TG 120 for polymers)
9(e) Hydrolysis as a function of pH (TG 111
or equivalent)
9(f) Partition coefficient (n-octanol/water)
(TG 107 or equivalent, TG 117)
9(g) Adsorption and desorption (TG 106 or
equivalent)
9(h) Dissociation constant (TG 112 or equiv-
alent)
9(g) Adsorption and desorption (TG 106 or
equivalent)
9(h) Dissociation constant (TG 112 or equiv-
alent)
9(i) Particle size (distribution)/fibre length
(TG 110 or equivalent)
9(j) Flashpoint (open cup/closed cup)
9(k) Flammability limits (%) (explosive lim-
its)
9(l) Auto ignition temperature
9(m) Explosive properties
9(n) Reactivity
Use of calculated data
10. Methods of detection and determination
11. Label
12. Material safety data sheet
13. Emergency procedures
13(a) Occupational emergency procedures
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international

13(b) Environmental emergency procedures 5. Degradation products

SCHEDULE PART C 6. Loss of monomers, other reactants, addi-
INTRODUCTION tives and impurities
ACUTE TOXICITY DATA DATA REQUIREMENTS FOR POLYMERS
(a) Acute oral toxicity (TG 401 or equivalent) OF LOW CONCERN
(b) Acute dermal toxicity (TG 402 or equiva- (a) Chemical name of the polymer
lent) (b) Marketing or other name(s)
(c) Acute inhalation toxicity (TG 403 or (c) Chemical Abstracts Service (CAS) num-
equivalent) ber
IRRITATION/CORROSION (d) Justification for ‘low concern’ classifica-
(d) Skin irritation (TG 404 or equivalent) tion
(e) Eye irritation (TG 405 or equivalent) (e) Molecular formula
SENSITISATION (f) Structural formula
(f )(i) Skin sensitisation (TG 406 or equiva- (g) Means of identification
lent) (h) Number-average molecular weight
(f)(ii) Respiratory sensitisation (i) Weight percentage of molecules with mo-
(g) Repeated dose toxicity lecular weight less than 1000 daltons and less
GENETIC TOXICOLOGY than 500 daltons
(h) Induction of point mutations (TG 471, (j) Charge density
TG 472 or equivalent) (k) List of polymer constituents
(i) Induction of germ cell damage (TG 478 or (l) Residual monomer content
equivalent) (m) Water solubility
(j) Chromosome damage (TG 473, TG 474, (n) Particle size distribution
TG 479 or equivalent) (o) Stability of the polymer
ECOTOXICITY DATA (p) Residual reactive functional groups
(k) Fish, acute toxicity test (TG 203 or equiva- (q) Intended use(s)
lent) (r) Appearance of the polymer
(l) Daphnia, acute immobilisation test and re- (s) Estimated manufacture or import volume
production test (TG 202 or equivalent) (t) Site of manufacture or reformulation
(m) Algal growth inhibition test (TG 201 or (u) Physico-chemical properties
equivalent) (v) Occupational health and safety data
BIODEGRADATION (w) Environmental Impact
(n) Ready biodegradability (%) (TG 301A-F (x) Public Health
or equivalent) (y) Label
(o) Bioaccumulation (z) Material Safety Data Sheet
SCHEDULE PART D
Part D refers to Polymers. Canada-Australia
IDENTITY AND COMPOSITION OF THE The Cooperative Arrangement between the
POLYMER National Industrial Chemicals Notification
1. Weight-percentage of ingredients and Assessment Scheme of Australia and the
2. Number-average molecular weight of the Department of Environment of Canada and
polymer the Department of Health of Canada is in
3. Maximum weight-percentage of residual keeping with many international efforts aimed
monomer(s) and all other at learning from each others expertise. The Ar-
Reactants rangement focuses on enhancing information
4. Low molecular weight polymer and work sharing as well as working towards

Sdu Uitgevers Journaal Stoffen en Preparaten oktober 2009, Nr. 8 223


greater cooperation and alignment with na-
tional new industrial chemicals schemes.
The Canada/Australia Arrangement first
signed in 2002 and renewed in 2007 is of ben-
efit to industry and both countries. It is recog-
nized that a bilateral Arrangement can increase
the efficiency of new industrial chemical noti-
fication and assessment schemes by providing
greater transparency in assessments, a possible
reduction in animal testing and a reduction in
resources needed for new industrial chemicals
work by governments. Industry can benefit by
shorter product to market times and in effi-
ciencies of resources. This Arrangement is in
keeping with the aims of both governments to
provide the utmost in protection to human
health and the environment.
This Arrangement includes exchanging in-
formation on both Canadian and Australian
new chemical schemes, working cooperatively
through projects of mutual benefit, sharing of
assessment and management related resourc-
es and adopting, when desirable and where
possible, consistent practices and regulatory
approaches.
NICNAS Registration
All importers and/or manufacturers of in-
dustrial chemicals for commercial purposes
must register with NICNAS regardless of the
amount of industrial chemicals imported
and/or manufactured in that registration year.
The registration year runs from 1 September
to 31 August in the following year.
NICNAS registration is not the registration
of individual industrial chemicals or actual
products and should not be confused with
the notification and assessment of industrial
chemicals. NICNAS Registration is the regis-
tration of your business.
NICNAS contact details
NICNAS, 334-336 Illawarra Road , Marrick-
ville  NSW  2204
GPO Box 58 , Sydney  NSW 2001
Phone: +61. (02) 8577 8800
224 Journal Chemicals Management Oktober 2009, No. 8
international
info@nicnas.gov.au; www.nicnas.gov.au
References: General: http://www.socma.com/events/
index.cfm?subSec=162&sub=162&articleI
D=1623#PresentationsAICS: http://www.
nicnas.gov.au/Industry/AICS.asp
Handbook for Notifiers: http://www.nic-
nas.gov.au/Publications/NICNAS_Hand-
book.asp
Fees and charges: http://www.nicnas.gov.
au/Industry/New_Chemicals/Fees_and_
Charges/Fees_Charges_2009_10_PDF.pdf
Consolitade text Act (to 2007): http://www.
austlii.edu.au/au/legis/cth/consol_act/
icaaa1989465.txt
CEC: http://www.nicnas.gov.au/Industry/
New_Chemicals/Permits_And_Permit_
Catagories/Commercial_Evaluation_Che-
mical.asp
LVC: http://www.nicnas.gov.au/Industry/
New_Chemicals/Permits_And_Permit_
Catagories/Low_Volume_Chemicals.asp
LVC-1: http://www.nicnas.gov.au/Forms/
New_Chemicals/LVC/Form_LVC_1_pdf.
pdf
EIP: http://www.nicnas.gov.au/Industry/
New_Chemicals/Permits_And_Permit_
Catagories/Early_Introduction_Permit.asp
EOP: http://www.nicnas.gov.au/Industry/
New_Chemicals/Permits_And_Permit_
Catagories/Export_Only_Permit.asp
Schedules: http://www.khlaw.com/showpu-
blication.aspx?Show=1114 (2004)
Forms: http://www.nicnas.gov.au/Forms.
asp
Certificate categories: http://www.nicnas.
gov.au/Industry/New_Chemicals/Certifi-
cate_Catagories.asp
NICNAS Registration: http://www.nicnas.
gov.au/Industry/Registration.asp
Sdu Uitgevers
international
Taiwan: Draft Proposal of
Guidelines for Existing Chemical
Substance Nomination (ECN)
and New Chemical Substance
Notification (NCN)
[2009/0176] bour workers.
The Council of Labour Affairs (CLA) of Tai-
wan is a cabinet-level unit under the Execu-
tive Yuan. In April, 2008 Wang Ju-hsuan was
apponted as the Minister, Council of Labour
Affairs. One of Wang’s focus points for 2009
is: ‘Establish the promotion plans for na-
tional registration and management system
of chemical substances to protect health of
our citizens and facilitate sustainability of
environment.’ And one of her mid-term ad-
ministration plans for 2009-2012 is: ‘Promote
management and awareness of chemicals to
eliminate chemical hazards: 1. Promote cross-
agency chemicals management of workplace
and develop regulations and system regarding
chemicals management; 2. Promote chemi-
cal hazard prevention plan and establish na-
tional registration and management system
of chemical substances; 3. Strengthen service
information about management mechanism,
precautions, promotion, and websites of
chemicals; realize safety precautions of using
chemicals.’
The Council of Labour Affairs (CLA) an-
nounced two drafts of Guidelines for Exist-
ing Chemical Substance (ECS) Nomination
and Guidelines for New Chemical Substance
(NCS) notification in April 2009. The new
regulations will be drafted to be in a revision
of the existing Labour Safety and Health Act.
The new system is planned to be finalized by
the end of 2009. Although this will create bur-
den to the chemical industry, the procedure
and data requirement for notifying NCS are
not too different from those in US or China.
No additional local testing will be required
and the data requirement appears to be flex-
ible and reasonable.
Sdu Uitgevers
1. Existing Chemical Nomination (ECN)
Definition and Exclusion
Existing Chemical Substances (ECS) are de-
fined as those that have been manufactured or
imported within 15 years prior to the effective
date of the regulation and are handled by la-
The following chemical substances are ex-
cluded from the subject of this regulation:
(a) substances and polymers that occur in na-
ture, without physicochemical treatment;
(b) polymers for which the 2% rule is appli-
cable;
(c) chemical substances contained in experi-
mental machines and equipments;
(d) non-isolated intermediates in reactors or
reaction process;
(e) mixtures (but the new substances in the
mixture are not excluded);
(f) articles;
(g) chemical substances under the supervision
of customs (stored in bonded warehouse
or otherwise not yet cleared through the
Customs of ROC);
(h) chemical substances for military uses;
(i) incidental reaction products (by-prod-
ucts) or impurities with no commercial
value;
(j) wastes.
Nomination Procedure for ECS
Nomination of ECS is, by nature, a ‘grandfa-
thering’ process. Any local or overseas legal
entities are entitled to submit nomination for
ECS. Tailored electronic spreadsheet should
be used. The following information should be
provided:
1) General information of the company and
contact person, including all the contact
details.
2) CAS Registry Number.
3) Chinese and English names of chemi-
cal substance and other commonly used
names. The Chinese name should follow
the standard nomenclature rules. If ap-
plicable, the English name proposed by
Chemical Abstracts (CA) should be used
Journaal Stoffen en Preparaten oktober 2009, Nr. 8 225

for submission. In case no CA proposed
name is available, IUPAC name may also
be used. “Other names” will include ver-
nacular names, abbreviation and trade
name etc.
4) Six tonnage bands are set based on the
average quantity of production/import
in the three years prior to notification: (a)
more than 1000 ton/year; (b) 100 to 1000
ton/year; (c) 10 to 100 ton/year; (d) 1 to
10 ton/year; (e) 10 to 1000 kg/year and (f)
less than 10 kg/year.
Interestingly, although tonnage band needs to
be reported, there is no differentiated data re-
quirement for each tonnage band. And there
is no need to submit the evidence of prior
production/import in submission although
the agency reserves the right to demand such
evidence if necessary.
Data Protection
The general company information of nomi-
nators and the quantity of production/import
will be automatically under protection and
not be publicly accessible. Nominators may
also request protection of the CAS Registry
Number and chemical names of the notified
substances if the following conditions are
met:
(1) The data to be protected are the nomina-
tor’s confidential business information;
(2) The nominator has taken and will con-
tinue to take actions to maintain the con-
fidentiality of the information; and
(3) No third party has acquired the informa-
tion lawfully except at the consent of the
nominator.
A generic name for the nominated substance
should be provided if the nominator requires
protection of the chemical name and the CAS
Registry Number. CLA will review the appro-
priateness of the generic name. If the request
is accepted, the chemical name and the CAS
Registry Number of the substance can be pro-
tected for five years. The nominator may re-
quest an extension of data protection for an-
other five years. Such request should be made
226 Journal Chemicals Management Oktober 2009, No. 8
international
from the time six months prior to the expiry
of protection. Extension will be granted only
once.
2. New Chemical Substance Notification
(NCN)
Definition and Exclusion
New Chemical Substances (NCS) are defined
as those that are not listed on the Taiwan In-
ventory of Existing Chemicals. Manufacturer
or importer of a new chemical substance
should file a prior notification with CLA to-
gether with a risk assessment report to ob-
tain specific permission unless the substance
is categorically excluded from the obligation
of notification. The categorical exclusions are
not different from those for ‘grandfathering’
existing chemical substances. These exclu-
sions are listed as below:
(a) Substances and polymers that occur in na-
ture, without physicochemical treatment;
(b) Chemical substances contained in experi-
mental machines and equipments;
(c) Non-isolated intermediates in reactors or
reaction process;
(d) Chemical substances for military uses;
(e) Incidental reaction products (by-prod-
ucts) or impurities with no commercial
value;
(f) Chemical substances under the supervi-
sion of customs (stored in bonded ware-
house or otherwise not yet cleared thor-
ough the Customs of ROC);
(g) Mixtures (but the only substances in the
mixture are not excluded);
(h) Wastes;
(i) Polymers for which the 2% rule is appli-
cable;
(j) New chemical substances that are regu-
lated by other government agencies (such
as radioactive materials, active ingredients
for pesticides, active ingredients for envi-
ronmental agents, food additives, phar-
maceuticals, controlled drugs and so on)
Notifier
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international
According to the draft regulation, only legal
entities located in Taiwan can file notifications
for new chemical substances.
Types of Notification
There are three types of notification/notice:
Notice, Simplified Notification and Full No-
tification.
I. Notice
New chemical substances manufactured or
imported with quantity between 10 to 100 kg/
year are entitled to this convenient notice pro-
cedure. The following information need to be
included in a notice filing:
(a) Basic information of the manufacturer/
importer and the contact details;
(b) Location of manufacturing or import of
the new substance;
(c) Chemical names in Chinese and English
and CAS Registry Number (if available) of
the new substance;
(d) Description of appearance, colour and
other physical properties of the sub-
stance;
(e) Safe use information (handling, storage
and transportation)
The agency will reserve the right to ask for
more information if needed.
II. Simplified Notification
The following substances are entitled to the
Simplified Notification procedure:
1) Substances with quantity of manufactur-
ing/import between 100 to 1000 kg/year;
2) Polymers that meet the following defini-
tion (low loncern criteria): (i) the number
average molecular weight (Mn) is between
1000 and 10000 Dalton, no active function
group exists, polymers of weight average
molecular weight (MW) below 500 Dal-
ton is less than 10% and polymers of MW
below 1000 Dalton is less than 25%; (ii)
Mn is above 10000 Dalton, no active func-
tion group exists, polymers of MW below
500 Dalton is less than 2% and polymers
of MW below 1000 Dalton is less than
5% or (iii) the blocks and branch chains
Sdu Uitgevers
are all in the existing chemical substances
inventory.
However, if a substance is classified according
to the GHS standards as a CMR substance or
as aqueous hazardous, it will not be entitled to
Simplified Notification procedure.
Data required for filing Simplified Notifica-
tion include the following:
(a) General information about notifier and
the notified substance;
(b) GHS-based classification and labeling;
(c) Safe use information; and
(d) Polymer identification data if the sub-
stance is a polymer.
No toxicological or ecotoxicological data are
needed for Simplified Notification.
III. Full Notification
For any new chemical substances that are not
categorically excluded and not entitled
to the Notice or Simplified Notification pro-
cedure, a Full Notification shall be filed.
A substance will be entitled to an expedited re-
view and registration process if it has already
been listed on at least two Inventories among
the following six jurisdictions: USA, Europe-
an Union, Japan, P.R. of China (PRC), Canada
and Australia. Full data entries accepted by
these agencies as well as the approval docu-
ments should also be provided.
The data required for Full Notification are as
follows:
(a) General information of the notifier and
the notified substance;
(b) GHS-based classification and labeling;
(c) Manufacture, use and exposure;
(d) Physical and chemical properties;
(e) Environmental fate and pathways;
(f) Ecotoxicological information;
(g) Toxicological information;
(h) Analytical methods;
(i) Guidance on safe use;
(j) Literature search
(k) Assessment reports.
Timelines
The timelines for the Notice/Notifications
above are summarized in the following chart:
Journaal Stoffen en Preparaten oktober 2009, Nr. 8 227

Notification Type Conditions Timeframe
Notice: 10 calendar days
Simplified Notification and Substances having
been listed on at least two country Inventories:
30 calendar days
Notification: Substances not satisfying the
conditions above: 90 calendar days In case
there is any data deficiency, the notifier will be
asked to supplement the data within 30 calen-
dar days. Such supplemental submission will
be limited to two times. The timelines above
do not include the time of preparing and sub-
mitting supplemental data.
Registration Certificate and Inventory List-
ing
After the notification process is completed,
the notifier of a new chemical substance will
be granted a Registration Certificate which
will be valid for five years. The notifier may
request an extension of the Registration Cer-
tificate for another five years. Such request
should be made three months prior to its ex-
piry. Upon the expiry of the Registration cer-
tificate, the new substance will be listed on the
Inventory of Existing Chemical Substances.
Data Protection
The stipulations on data protection for New
Chemical Substance Notification are gener-
ally the same as those for nominating existing
chemicals.
3. Overall Plan of Implementation
CLA’s latest plan for implementation is as be-
low:
July 2009: Trial operation of nomination for
Existing Chemical Substances and the web-
site
December 2009: Full operation of nomina-
tion for Existing Chemicals
August 2010: Deadline for nominating Exist-
ing Chemicals
June 2010: Publication of the Inventory of
Existing Chemical Substances – Start of noti-
fication for New Chemicals
References: http://www.khlaw.com/Files/5798_Memo_
Taiwan%20New%20Chemical%20Regi-
stration%20System.pdf
228 Journal Chemicals Management Oktober 2009, No. 8
international
http://www.socma.com/assets/File/socma1/
PDFfiles/gcrc/2009/Grenda-GC09-Taiwan-
Handout.pdf
http://www.socma.com/assets/File/socma1/
PDFfiles/gcrc/2009/Grenda-GC09-Attach-
ment-I-to-Taiwan-Handout.pdf
http://www.socma.com/assets/File/socma1/
PDFfiles/gcrc/2009/Grenda_GC09%20
Attachment-II-to-Taiwan-Handout.pdf
http://www.socma.com/assets/File/socma1/
PDFfiles/gcrc/2009/Grenda_GC09-Attach-
ment-III-to-Taiwan-Handout.pdf
Japan: GHS Guidance
[2009/0177]
‘GHS Classification Guidance for enter-
prises’(classification manual for mixtures) is
now open to for comments from METI Japan.
This guidance is compiled based on new (not
finalized) standard JIS Z 7252-2009
Reference: http://www.meti.go.jp/policy/chemical_
management/int/ghs_tool_01GHSmanual.
html
Australia: Hazardous Substances
Information System Updated –
April 2009
[2009/0178]
The Hazardous Substances Information Sys-
tem (HSIS) is an internet resource that allows
you to find information on substances that
have been classified in accordance with the
‘Approved Criteria for Classifying Hazardous
Substances’ [NOHSC:1008(2004] 3rd Edition
and/or have National Exposure Standards
declared under the NOHSC Adopted Na-
tional Exposure Standards for Atmospheric
Contaminants in the Occupational Environ-
ment [NOHSC:1003(1995)]. In addition to
providing powerful search features, HSIS also
Sdu Uitgevers
international

provides direct access to a consolidated list of
all the classified substances contained in the
HSIS database.
Safe Work Australia has updated the Hazard-
ous Substances Information System (HSIS)
online database to reflect changes in Europe’s
30th Adaptation to Technical Progress to Di-
rective 67/548/EEC.
The update comprised of a total of 958 entries
of which there are 564 amendments to exist-
ing entries, 391 new entries and 3 deletions.
Also, the HSIS Guidance Material for Hazard
Classifications has been updated to reflect
amendments to Notes H, J and P in the label-
ling column.
Reference: http://hsis.ascc.gov.au/TheList.aspx
Australian Code for the Transport
of Explosives by Road and Rail
TI), including the ICAO TI-Supplement, and
the International Air Transport Authority –
Dangerous Goods Regulations (IATA DGR)
apply for air transport. The International
Maritime Dangerous Goods Code (IMDG
Code) applies to transport by sea.
It is envisaged that this Code will be adopted
in the explosives legislation of the Common-
wealth and all States and Territories.
This Code is the primary reference for explo-
sives and has been designed to complement
and be consistent with the 7th Edition of the
Australian Code for the Transport of Danger-
ous Goods by Road and Rail (ADG Code),
which currently includes limited and/or advi-
sory provisions regarding explosives (danger-
ous goods of Class 1).
References: ISBN 978 0 642 32747 5 (online PDF)
ISBN 978 0 642 32753 6 (print)

[2009/0179]

The third edition of the Australian Code for

the Transport of Explosives by Road and Rail
(AE Code) of 2009 replaces the second edi-
tion that was endorsed by the Standing Com-
mittee on Transport (SCOT) in March 2000.
This code has been prepared by the Austral-
ian Forum of Explosives Regulators (AFER)
and was endorsed by the Workplace Relations
Minister’s Council in April 2009. Since 2005,
the Workplace Relations Minister’s Coun-
cil (WRMC) has assumed responsibility for
coordinating national uniform explosives
laws in Australia. Its objective is to provide a
uniform basis for Commonwealth, State and
Territory legislation governing the transport
of explosives and it is designed to apply to all
road and rail transport in Australia. This Code
is applicable to civilian and military explosives
transport. This Code does not apply to the
transport of explosives by air or by sea. The
International Civil Aviation Organisation –
Technical Instructions for the Safe Transport
of Dangerous Goods by Air Doc. 9284 (ICAO

Sdu Uitgevers Journaal Stoffen en Preparaten oktober 2009, Nr. 8 229


publications
Proceedings
Assessment of combined
exposures to multiple
chemicals: report of a WHO/
IPCS international workshop
on aggregate/cumulative risk
assessment (IPCS Harmonization
Project Document 7)
[2009/0180] combined risk from exposure to multiple
A World Health Organization (WHO)/In-
ternational Programme on Chemical Safety
(IPCS) International Workshop on Aggre-
gate/Cumulative Risk Assessment (Combined
Exposures to Multiple Chemicals) was held
in Washington, DC, United States of America
(USA), on 19–21 March 2007. The princi-
pal objective of the workshop was to initiate
development of a framework for the risk as-
sessment of combined exposures to multiple
chemicals.
This Harmonization Project Document re-
ports the outcome of this workshop as an
introduction to the accompanying extended
abstracts to describe the state of the art in this
area and delineation of next steps. In addition
to recommendations relevant to subsequent
development and review of the framework,
terminology was considered in order to fa-
cilitate communication internationally in this
area.
Overview (by Kevin M. Crofton)
1. BACKGROUND
Humans are constantly exposed to a wide va-
riety of chemicals from food, pharmaceuticals,
230 Journal Chemicals Management Oktober 2009, No. 8
publications
air and water. A major challenge in risk assess-
ment is to determine the degree of exposure
to multiple chemicals, the hazards associated
with such combined exposure and the extent
to which chemicals interact. Predicting risk
from exposure to chemical mixtures is com-
plex, as chemicals in mixtures can interact in
terms of both toxicokinetics and toxicody-
namics. Such interactions may result in effects
that are either antagonistic or synergistic. The
temporal nature of the exposures may play a
lead role in determining these interactions.
The World Health Organization (WHO) In-
ternational Programme on Chemical Safety
(IPCS) project on the Harmonization of Ap-
proaches to the Assessment of Risk from Ex-
posure to Chemicals has identified a need to
develop a risk framework for assessing the
chemicals via all relevant routes and pathways.
To begin this process, the WHO/IPCS Inter-
national Workshop on Aggregate/Cumulative
Risk Assessment was convened to discuss the
state of the science for assessing the risk from
combined exposure to multiple chemicals.
2. GOALS
The WHO/IPCS International Workshop on
Aggregate/Cumulative Risk Assessment had
the following goals:
– Discuss and review available methods for
assessing the combined risk from exposure
to one or more agents (with or without a
common mode of action) via all relevant
routes and pathways.
– Review knowledge gained from approach-
es employed to date in different sectors
(e.g. pesticides, industrial chemicals, ther-
apeutics) and disciplines (e.g. consumer
exposure, occupational exposure, envi-
ronmental exposure).
– Focus on the risks from exposure to mul-
tiple chemicals and multiple sources, ex-
cluding consideration of exposure to and
effects of chemicals in combination with
other nonchemical factors (e.g. stress, nu-
trition).
Sdu Uitgevers
publications
– Develop commonly accepted definitions
for the different types of mixtures (e.g.
simple, complex) and exposures (e.g. ag-
gregate, cumulative).
– Develop commonly accepted definitions
for effect outcomes (e.g. antagonism, syn-
ergy).
– Initiate the development of a framework
for combined substance risk assessment.
– Define the next steps for work needed to
inform the framework, including identi-
fying areas where no (adequate) method-
ologies exist, where research is needed and
where data are lacking, in order to stimu-
late efforts to fill these gaps.
3. CURRENT METHODS
There are currently a number of methods
used to determine the risk of combined expo-
sure to chemicals (ILSI, 1998; USEPA, 2000;
Feron & Groten, 2002; DVFA, 2003; Jonker et
al., 2004). These methods can be divided into
those that simply add the risk from individual
chemicals, those that sum effects based on
relative potencies and those that rely only on
indirect evidence. Most of these have been de-
veloped in response to a regulatory need (e.g.
toxic equivalency factor [TEF] and dioxins),
and each has advantages and disadvantages.
The Hazard Index is the sum of hazard quo-
tients for substances that affect the same target
organ or organ system. The hazard quotient is
the ratio of the potential exposure to the sub-
stance to the level at which no adverse effects
are expected (e.g. point of departure, divided
by uncertainty factors). A second method,
the Point of Departure Index, is a simple addi-
tion method that adds the no-observed-effect
levels (or benchmark doses) of individual
chemicals. Neither of these methods includes
possible interactions of chemicals that would
result in antagonism or synergism.
The Toxic Equivalent (TEQ) method was de-
veloped for use with compounds that activate
the aryl hydrocarbon receptor (Haws et al.,
2006; Van den Berg et al., 2006). This is a rela-
tive potency method that assumes the additiv-
Sdu Uitgevers
ity of doses of individual components of the
mixture after normalization of the response
to a reference chemical. The Relative Potency
Factor (RPF) method (USEPA, 2000) is a gen-
eralized form of the TEQ method and has
been used for classes of pesticides and other
chemicals. This method also uses dose addi-
tion as the default assumption for the effects
of mixtures.
Two additional methods have been used when
data limitations prevent the use of the above-
mentioned methods. The Whole Mixture Ap-
proach (Mumtaz et al., 1993) uses effects data
from exposure to the mixture of concern or
a sufficiently similar mixture. These data are
treated in a risk context similarly to single
chemical data. Lastly, the Threshold of Toxico-
logical Concern (TTC) has been proposed for
use with complex mixtures where no effects
data are available (Kroes et al., 2005). This
method uses structure–activity relationships
to assign exposure thresholds for comparison
with the potential exposure level and requires
exposure estimates.
The workshop discussed these and other
methods in the context of exposure to single
or multiple chemicals from all routes. The key
objective of the current effort is to harmonize
the variety of approaches currently used and
to develop a framework in which they can be
used.
4. COMMON NOMENCLATURE?
4.1 Interactions
The lack of a common nomenclature to de-
scribe the outcome of mixtures testing has
been recognized for more than 50 years: “In-
deed, the quantitative problems of combined
drugeffect still persist unchanged, revolving
around the two terms synergism and antag-
onism — which are in need of clarification
as ever before” (Loewe, 1953). Loewe (1953)
listed 10 terms to describe drug interaction,
based on whether the outcome was homo-
dynamic or ahomodynamic (de Jong, 1961).
Earlier, Bliss (1939) had introduced the con-
cept of independent joint action. Since that
Journaal Stoffen en Preparaten oktober 2009, Nr. 8 231
 publications

time, a plethora of terms, with overlapping 5. DEVELOPMENT OF A FRAMEWORK

definitions, have been used to describe the FOR ASSESSING RISK
outcome of testing the effects of mixtures. The major goal of this workshop was to de-
Wessinger (1986) listed over 20 terms com- velop a draft decision framework for assess-
monly used to describe drug–drug interaction ing the combined risk of exposure to multiple
studies. Clearly, a common nomenclature will substances via multiple routes or pathways.
facilitate the development of a framework for To achieve this goal, the workshop defined the
assessing the risk of combined exposures. principles and concepts necessary to develop
this framework. In addition, the workshop in-
4.2 Aggregate and cumulative itiated development of a draft framework and
For the purposes of discussion at the current identified the next steps needed to inform the
workshop, the following definitions of aggre- framework. As a starting point to help focus
gate and cumulative exposure are proposed, discussion, the Workshop Planning Group
each defined within the context of risk: developed a “straw man” decision framework
– Aggregate exposure: The demographic, based on a previous version created by the In-
spatial and temporal characteristics of terdepartmental Group on Health Risks from
exposure to a single chemical through Chemicals (IGHRC, 2006). The Workshop
all relevant pathways (e.g. food, water, Planning Group solicited input (and revi-
residential uses, occupational) and routes sions) to this decision framework.
(e.g. oral, dermal, inhalation). Aggregate Reference: World Health Organization 2009. ISBN 978
risk is the risk associated with multiple 92 4 156383 3
pathways/routes of exposure to a single http://www.who.int/ipcs/methods/harmo-
chemical. nization/areas/workshopreportdocument7.
– Cumulative exposure: Defines the ag- pdf
gregate exposure (see above) to multiple
chemicals. Cumulative risk is the com-
bined risk from aggregate exposure to
multiple chemicals (and may be restricted
to chemicals that have a common mecha-
nism of toxicity).
Assessment of aggregate and cumulative ex-
posures must necessarily consider the tem-
poral nature of both the exposures and the
effects. While some exposures may be concur-
rent, simultaneous exposure is not necessary
for defining aggregate/cumulative risk. Nonsi-
multaneous exposures to chemicals with dis-
parate toxicokinetics or toxicodynamics may
lead to overlap in the time course of the effects
or the repair of damage from exposures (Hat-
tis & Shapiro, 1990; Hattis & Crofton, 1995).
Temporality of exposure/effects is a key con-
cept in aggregate and cumulative exposure as-
sessments.

232 Journal Chemicals Management Oktober 2009, No. 8 Sdu Uitgevers

official publications
official
publications
United Kingdom (Period August
2009)
[2009/0181] on-to-the-biocidal-products-directiveregu-
by Dr. Ross Fielding
Biocides
The Health and Safety Executive (HSE) is the
UK competent authority for European biocid-
al product regulations. The HSE has launched
a 10-week consultation on the European
Commission proposal for a revised regime for
regulating the placing on the market and use
of biocidal products. The Commission pro-
poses a new directly acting European Regula-
tion which will replace the Biocidal Products
Directive 98/8/EC (transposed into UK law
by the Biocidal Products Regulations 2001).
The proposal is a reaction to the view that the
current regulatory regime for biocidal prod-
ucts is not working. The proposal keeps the
concept of assessing active substances at EU
level for inclusion in a positive list and then
authorising biocidal products for the market.
However it aims to improve and update cer-
tain elements of the system.
An explanation of how recent amendments
to the Directive have been automatically im-
plemented into UK law (the Biocidal Prod-
ucts (Amendment) Regulations 2007 (SI
2007/293)) by the ambulatory reference in
Regulation 3(d) can be found at http://www.
hse.gov.uk/biocides/bpd/transposition.htm
The same effect is achieved in Northern Ire-
land by regulation 3(d) of the Biocidal Prod-
ucts (Amendment) Regulations (Northern
Ireland) 2007 (SR 2007/190).
Sdu Uitgevers
The HSE also report the outcome of the recent
mini review of the Biocidal Products Directive
(BPD) which will extend the BPD Transitional
Period to 14th May 2014.
References: HSE Press release: http://www.hse.gov.uk/
press/2009/e09060.htm.
Direct link to the consultation process:
http://www.hse.gov.uk/consult/condocs/
cd222.htm
http://news.hse.gov.uk/2009/08/24/extensi-
lations-transitional-period/
Chemicals Safely – storing packaged danger-
ous substances
The HSE has published revised guidance (4th
edition of HSG71) to help to keep stored
chemicals and other packaged dangerous sub-
stances safe, and to help comply with the legal
duties. This updated guidance sets out con-
trol measures aimed at eliminating or reduc-
ing risks to people, at work or otherwise and
is intended to be independent of the size of
the storage facility. The guidance reflects good
practice for the design of new storage facilities
and, where reasonably practicable, to existing
sites. It applies to transit or distribution ware-
houses, open-air storage compounds and fa-
cilities associated with a chemical production
site or end-user. The new fourth edition has
been updated in the light of changes in legisla-
tion. New sections have been added to reflect
changes to industry practice and also to take
account of the types of chemicals stored.
References: HSE Books, 2009. ISBN 978 0 7176 6237 1
http://www.hsebooks.com/Books/product/
product.asp?catalog%5Fname=HSEBoo
ks&category%5Fname=&product%5Fi
d=5053
http://www.hse.gov.uk/pubns/books/hsg71.
htm
COSHH Case Studies
The HSE has documented examples of some
real life situations where the use of chemicals
or other hazardous substances at work can
Journaal Stoffen en Preparaten oktober 2009, Nr. 8 233

put people’s health at risk, causing diseases in-
cluding asthma, dermatitis or cancer.
Reference: http://www.hse.gov.uk/coshh/casestudies/
index.htm
Storing hazardous wastes at household waste
recycling centres
HSE has produced a free guidance document
to provide practical guidance on the storage
of hazardous waste at household waste recy-
cling centres
Reference: http://www.hse.gov.uk/pubns/waste12.pdf
CHIP
HSE has published a transposition note on
‘The Chemicals (Hazard Information And
Packaging For Supply) Regulations 2009. The
note explains how remaining duties arising
from the directive 2006/121/EC the regu-
lations (EC) No 1907/2006 (REACH) and
(EC) No 1272/2008 (CLP) are implemented
through The Chemicals (Hazard Information
and Packaging for Supply) Regulations 2009
(CHIP).
The changes relate to the revocation of the ‘no-
tification of new substances’ (NONS) scheme
and the provision of safety data sheets. These
have been given effect as part of the UK ar-
rangements for enforcing REACH, through
the REACH Enforcement Regulations 2008
(SI 2008 No. 2852), which entered into force
on 1st December 2008. Aspects concerning
the classification and labelling of substances
– they adjust the references to the test meth-
ods following repeal of Annex V of Directive
1967/548/EEC (the ‘Dangerous Substances
Directive’), and their reinstatement through
a new Commission Regulation.These amend-
ments will be made as part of the changes in
the UK through the enforcing Regulations for
the European Classification, Labelling and
Packaging Regulation (the ‘CLP Regulation’),
which will be implemented through a pack-
age of amendments in the CHIP 4 regulations
coming into force on  6th April 2009.
234 Journal Chemicals Management Oktober 2009, No. 8
official publications
Reference: http://www.hse.gov.uk/aboutus/further-
info/policy/transposition/chemregs.htm
UK Dioxins Strategy Group
The UK Government (Defra) has established
a dioxins strategy group to provide a dialogue
platform to inform Government on further
measures that could be taken in order to
continue reducing the release of dioxins and
dioxin-like polychlorinated biphenyls into the
environment. The Group will appraise the re-
sults of the Government’s scientific research
programmes to underpin policy development
on dioxins and dioxin-like PCBs and will in-
put into the identification of areas for future
action to be included in the Dioxins Action
Plan.
The group has published a report on the ‘Re-
view and Update of the UK Source Invento-
ries of Dioxins, Dioxin Like Polychlorinated
Biphenyls and Hexachlorobenzene for Emis-
sions to Air, Water and Land’.
References: http://www.defra.gov.uk/environment/
chemicals/dioxins-strategygroup.htm
http://www.defra.gov.uk/environment/
chemicals/pdf/dioxins-report090727.pdf
European Union (Period August
2009)
[2009/0182]
O.J. L206, 2009: Commission Decision
2009/603/EC of 5  August 2009 establishing
requirements for registration of producers
of batteries and accumulators in accordance
with Directive 2006/66/EC of the European
Parliament and of the Council
O.J. L208, 2009: Commission Decision
2009/607/EC of 9  July 2009 establishing the
ecological criteria for the award of the Com-
munity eco-label to hard coverings
O.J. L213, 2009: Commission Decision
2009/616/EC of 17  August 2009 concern-
ing the non-inclusion of petroleum oil CAS
Sdu Uitgevers
official publications

92062-35-6 in Annex I to Council Directive

91/414/EEC and the withdrawal of authorisa-
tions for plant protection products containing
that substance
O.J. L213, 2009: Commission Decision
2009/617/EC of 17  August 2009 concerning
the non-inclusion of paraffin oil CAS 64742-
54-7 in Annex I to Council Directive 91/414/
EEC and the withdrawal of authorisations
for plant protection products containing that
substance
O.J. L220, 2009: Commission Regulation
(EC) No 761/2009 of 23 July 2009 amending,
for the purpose of its adaptation to techni-
cal progress, Regulation (EC) No  440/2008
laying down test methods pursuant to Regu-
lation (EC) No  1907/2006 of the European
Parliament and of the Council on the Reg-
istration, Evaluation, Authorisation and Re-
striction of Chemicals (REACH) (Text with
EEA relevance)
O.J. L228, 2009: Commission Directive
2009/115/EC of 31  August 2009 amending
Council Directive 91/414/EEC to include
methomyl [CAS 16752-77-50, S-methyl (EZ)-
N- (methylcarbamoyloxy) thioacetimidate] as
active substance 
O.J. L231, 2009: Commission Decision
2009/685/EC of 2  September 2009 correct-
ing Directive 2002/48/EC amending Council
Directive 91/414/EEC to include iprovalicarb,
prosulfuron and sulfosulfuron as active sub-
stances
O.J. L235, 2009: Commission Regulation
(EC) No 790/2009 of 10 August 2009 amend-
ing, for the purposes of its adaptation to
technical and scientific progress, Regulation
(EC) No  1272/2008 of the European Parlia-
ment and of the Council on classification,
labelling and packaging of substances and
mixtures (Text with EEA relevance) [Part 3
of Annex VI to Regulation (EC) No 1272/2008
is amended]

Sdu Uitgevers Journaal Stoffen en Preparaten oktober 2009, Nr. 8 235

236 Journal Chemicals Management Oktober 2009, No. 8 Sdu Uitgevers
Sdu Uitgevers Journaal Stoffen en Preparaten oktober 2009, Nr. 8 237
Colofon
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Citeertitel
Journaal Stoffen en Preparaten jaartal/nummer
(voorbeeld: Journaal Stoffen en Preparaten 2009/1)

ISSN 1574-1079
Journal
Chemicals
Management
Journaal
Stoffen & Preparaten
Chief-editor:
Drs. A.C.H. van Peski
Editorial Board:
Dr. M.M. Kops-Werkhoven
Drs. H.A.F. van Well
Dr. J.A.S.J. Razenberg
Dr. L.J.M. Rodenburg
Drs. G.A. Schouten
Drs. J. Zawierko
Advisory Board:
K. E. Armstrong (U.S.A.)
Dr. R. Fielding (United Kingdom)
Drs. A. Gondová
G. Koh (Singapore)
Dr. C. van Lint (Australia)
Dan Liu (U.S.A.)
S. Park (S.-Korea)
H. Sano (Japan)
S. Savary (Canada)
Ir. C. Sieger (Germany)
J. Simpson (Australia)
Dr. U. Schumacher (China)
E. Snyman (South Africa)
P.G. Tse (New Zealand)
No. 9
November 2009
Volume 6
Part of Stoffennieuws.nl
CONTENT
ARTICLES
[2009/0183] Country Profile: Serbia / 237
ACTUALITIES
Germany
[2009/0184] Germany: Road transport of Water
Pollutants / 240
European Union
[2009/0185] Cefic GER group: Coherent global approach
to chemical control needed to avoid
unmanageable situation / 240
[2009/0186] An example of bad EU regulation: A nasty
surprise hidden in the new Classification and
Labeling Regulation / 241
[2009/0187] REACH for non-Europeans / 244
International
[2009/0188] Turkey adopts a REACH-like Chemicals
Legislation / 245
[2009/0189] USA: OSHA issues proposed rule to adopt
the GHS System / 246
[2009/0190] Australia: Hazardous Substances Information
System Updated April 2009 / 247
[2009/0191] Australian Code for the Transport of
Explosives by Road and Rail / 248
[2009/0192] Global Update on New Chemicals
Regulations (Period July-September
2009) / 248
OFFICIAL PUBLICATIONS
[2009/0193] The Netherlands (Period August-October
2009) / 253
[2009/0194] Belgium (Period August-September
2009) / 254
[2009/0195] United Kingdom (Period September
2009) / 254
 inhoud

[2009/0196] European Union (Period August-October 2009) / 256

[2009/0197] USA (Period September-October 2009) / 257
INTERNET
[2009/0198] The EU Interactive Terminology database can help find EU-specific terms / 260

[2009/0199] CALENDER OF EVENTS & IMPORTANT DATA / 260

236 Journal Chemicals Management November 2009, No. 9 Sdu Uitgevers

articles

Serbia Proper: Belgrade City (Beograd):

Barajevo, Cukarica, Grocka, Lazarevac, Mlad-
articles enovac, Novi Beograd, Obrenovac, Palilula,
Rakovica, Savski Venac, Sopot, Stari Grad,
Surcin, Vozdovac, Vracar, Zemun, Zvezdara;
Bor: Bor, Kladovo, Majdanpek, Negotin;
Branicevo: Golubac, Kucevo, Malo Crnice,
Country Profile: Serbia Petrovac, Pozarevac, Veliko Gradiste, Zabari,
Zagubica; Grad Nis: Crveni Krst, Mediana,
[2009/0183] Niska Banja, Palilula, Pantelej Jablanica: Bo-
jnik, Crna Trava, Lebane, Leskovac, Medveda,
by Andrea Gondová Vlasotince; Kolubara: Lajkovac, Ljig, Mionica,
Osecina, Ub, Valjevo; Macva: Bogatic, Kocelje-
va, Krupanj, Ljubovija, Loznica, Mali Zvornik,
Sabac, Vladimirci; Moravica: Cacak, Gornkji
Milanovac, Ivanjica, Lucani; Nisava: Aleksinac,
Doljevac, Gadzin Han, Merosina, Nis, Razanj,
Svrljig; Pcinja: Bosilegrad, Bujanovac, Presevo,
Surdulica, Trgoviste, Vladicin Han, Vranje;
Pirot: Babusnica, Bela Palanka, Dimitrovgrad,
Pirot; Podunavlje: Smederevo, Smederevskia
Palanka, Velika Plana; Pomoravlje: Cuprija,
Despotovac, Jagodina, Paracin, Rekovac, Svi-
lajnac; Rasina: Aleksandrovac, Brus, Cicevac,
Krusevac, Trstenik, Varvarin; Raska: Kraljevo,
Novi Pazar, Raska, Tutin, Vrnjacka Banja; Su-
madija: Arandelovac, Batocina, Knic, Kragu-
jevac, Lapovo, Raca, Topola; Toplica: Blace,
Kursumlija, Prokuplje, Zitorada; Zajecar:
Source: https://www.cia.gov/library/publications/the- Boljevac, Knjazevac, Sokobanja, Zajecar; Zlat-
world-factbook/geos/ri.html# ibor: Arilje, Bajina Basta, Cajetina, Kosjeric,
Nova Varos, Pozega, Priboj, Prijepolje, Sjenica,
Official name: conventional long form: Repub- Uzice
lic of Serbia Vojvodina Autonomous Province: South
conventional short form: Serbia Backa: Bac, Backa Palanka, Backi Petrovac,
local long form: Republika Srbija (Република Becej, Beocin, Novi Sad, Sremski Karlovci,
Србија) Srobobran, Temerin, Titel, Vrbas, Zabalj;
local short form: Srbija (Србија) South Banat: Alibunar, Bela Crkva, Kovaci-
former: People’s Republic of Serbia, Socialist
Republic of Serbia Dipl. Eng. Andrea Gondová, MSc is Regulatory Affairs Man-
Region: Europe ager HSE EAMER at Kodak Polychrome Graphics Manu-
Internet country code: .rs facturing B.V., Bunschoten, The Netherlands]
Abstract: This paper provides insight into the chemical leg-
International dialing code: 381
islation in Serbia. It is not a comprehensive analysis of all
Capital: name: Belgrade (Beograd) existing legislation; in fact it highlights the most recent de-
Administrative divisions: 167 municipalities velopment and overview of main legislative rules and regula-
(opcstine, singular – opcstina) tion in Serbia..

Sdu Uitgevers Journaal Stoffen en Preparaten november 2009, Nr. 9 237


ca, Kovin, Opovo, Pancevo, Plandiste, Vrsac;
North Backa: Backa Topola, Mali Idjos, Subot-
ica; North Banat: Ada, Coka, Kanjiza, Kikinda,
Novi Knezevac, Senta; Central Banat: Nova
Crnja, Novi Becej, Secanj, Zitiste, Zrenjanin;
Srem: Indija, Irig, Pecinci, Ruma, Sid, Sremska
Mitrovica, Stara Pazova; West Backa: Apatin,
Kula, Odzaci, Sombor
Population: 7 379 339;
note: does not include the population of Kos-
ovo (July 2009 est.)
Area: total: total: 77 474 sq km
Languages: Serbian 88.3% (official), Hun-
garian 3.8%, Bosniak 1.8%, Romany (Gypsy)
1.1%, other 4.1%, unknown 0.9% (2002 cen-
sus)
note: Romanian, Hungarian, Slovak, Ukrain-
ian, and Croatian all official in Vojvodina.
Environment – international agreements:
party to: Air Pollution, Biodiversity, Climate
Change, ADR, Climate Change-Kyoto Pro-
tocol, Desertification, Endangered Species,
Hazardous Wastes, Law of the Sea, Marine
Dumping, Marine Life Conservation, Ozone
Layer Protection, Ship Pollution, Wetlands;
signed, but not ratified: none of the selected
agreements
Source: https://www.cia.gov/library/publications/the-
world-factbook/geos/ri.html#
European Union Relationship: Accession of
Serbia to the European Union depends on
several factors. While both the Serbian gov-
ernment and the European Union agree that
Serbia could eventually become a member
of the EU, the need for internal reform both
within Serbia and the EU means that Serbia
will not join EU before 2012, and perhaps not
before 2015.
Serbia is currently not recognised as a candi-
date country, but only as ‘potential candidate
country’.
238 Journal Chemicals Management November 2009, No. 9
 
articles
1. Legal Requirements for Producing,
Importing/Exporting and Placing Chemicals
on the Market
Serbia follows the EU requirements for
producing, importing/exporting and plac-
ing chemicals on the market. The currently
adopted Law on Chemicals provides the basis
for the sound management of chemicals in
Serbia; it also establishes the responsibilities
for chemical policy and management as well
as the legal basis for the Chemicals Agency.
2. A List of Laws and Regulations currently
in Force
Following is the list of laws and regulations in
place:
– Law on Environmental Protection of Ser-
bia (1991) (http://www.basel.int/legal-
matters/natleg/serbia-01e.pdf)
– Regulation on methodology for Risk As-
sessment regarding Chemical Accident
and Environmental Pollution, Preven-
tive Measures and Remediation Measures
(1994)
– The Federal Law on the Production of and
Trade in Poisons Substances (1995) (Of-
ficial gazette SRY no.15/95, 28/96 ; SCG
no.37/2002, RS no.101/2005 )
– The Federal Law on the Transport of
Hazardous Substances (1990, 1994, 1996,
1999)
(Official gazette SRY, no.27/90, SCG
no.1/2003)
– The Law on Explosive Substances (1994)
– The Federal Custom Act (1992)
– The Federal Law on Protection against
Ionizing Radiation (1996)
– The Federal Law on Standardization
(1996)
Recent legislative developments
During 2004 and 2005 Laws on chemicals and
biocidal products were drafted. The Swedish
Chemicals Agency (KeMI) helped preparing
legislation on chemicals and biocidal prod-
ucts, subsequently two laws were adopted
Sdu Uitgevers
articles
in May 2009 by the National Assembly; now
Serbia is preparing the associated subsidiary
legislation.
The new Law on Chemicals is harmonized
with the following EU legislation:
1. Regulation (EC) No  1907/2006 concern-
ing the Registration, Evaluation, Au-
thorization and Restriction of Chemicals
(REACH) – this is a partial harmonisation
with the REACH Regulation
2. Regulation (EC) No  1272/2008 on clas-
sification, labelling and packaging of sub-
stances and mixtures
3. Directive 67/548/EEC on the approxima-
tion of laws, regulations and administra-
tive provisions relating to the classifica-
tion, packaging and labelling of dangerous
substances
4. Council Directive 99/45/EC concerning
the approximation of the laws, regula-
tions and administrative provisions of the
Member States relating to the classifica-
tion, packaging and labelling of dangerous
preparations
5. Council Directive 2004/42/EC on the
limitation of emissions of volatile organic
compounds due to the use of organic sol-
vents in certain paints and vehicle refin-
ishing products and amending Directive
1999/13/EC
6. Regulation (EC) no 689/2008 concern-
ing the export and import of dangerous
chemicals
7. Regulation (EC) No 648/2004 on deter-
gents
8. Commission Regulation (EC) laying down
test methods pursuant to Regulation (EC)
No 1907/2006 of the European Parliament
and of the Council on the Registration,
Evaluation, Authorization and Restriction
of Chemicals (REACH)
The new Law on Biocidal products is harmo-
nized with Directive 98/8/EC of the European
Parliament and of the Council of 16 February
1998 concerning the placing of biocidal prod-
ucts on the market.
Sdu Uitgevers
3. New Chemicals Notification Process
There is no new chemical notification scheme
in place and no chemical inventory like EI-
NECS/ELINCS, TSCA, DSL or PICCS…
4. Classification and Labelling; Hazard
Communication (SDS...): Risk Assessment
Serbia follows the EU requirements regarding
classification, labelling, SDS, risk assessment
of chemicals.
5. Industry’s Experience with the System;
Trade Impacts; Problem Areas
Serbia moves toward the full implementation
of the EU legislation regarding chemicals. Ex-
isting laws and regulations are not yet fully
harmonized with the EU ones but lot of initi-
atives are taking place in this respect. There is
no major barrier/impact for the industry that
would restrict chemical businesses.
6. Future Developments in Chemical Safety
Legislation
Serbia’s main strategic objective is to move
forward along with the rest of the region by
working towards full reintegration into the
international community in the near and me-
dium-term; in the medium-term is achieve-
ment of a self-sustaining economy and acces-
sion to the European Union in the long-term.
One of the key priorities is to adequately
control trade, transport and use of chemicals
and harmful substances. The development of
sectoral laws on chemicals regarding classifi-
cation of chemicals and labelling will follow
the GHS system.
New environmental framework has been de-
signed to modernize the legal framework, to
ensure compliance with EU requirements (for
example IPPC-Integrated Prevention & Pollu-
tion Control).
Reference: National Profile for Chemicals Manage-
ment (Updated 2008):
http://www2.unitar.org/cwm/publications/
cw/np/np_pdf/Serbia_National_Pro-
file_2008.pdf
Journaal Stoffen en Preparaten november 2009, Nr. 9 239

actualities
Germany
Germany: Road transport of Water
Pollutants
[2009/0184]
The following amendments to the Highway
Code (Straßenverkehrsordnung (StVO) ) of
05 August 2009 (Federal Law Gazette I No.
52 (BGBl I Nr. 52), in force from 01 Septem-
ber2009 for the sign 269, will apply: The sign
269 is new from a cargo of 20 liters per trans-
port unit. A violation of this provision is pun-
ishable by a fine of 250 euros and three points
and one months driving ban. These changes
also affect individuals and they should be
given special consideration when they are
transporting water endangering (WGK) sub-
stances.
Reference: http://www.gefahrgut-online.de/sixcms/
detail.php?id=869375
240 Journal Chemicals Management November 2009, No. 9
actualities
European Union
Cefic GER group: Coherent global
approach to chemical control
needed to avoid unmanageable
situation
[2009/0185]
Compliance with the present world-wide
regulatory framework already places a tre-
mendous burden on industry. In order for a
company to be compliant with the legislation
in those countries where they undertake busi-
ness they firstly need to be aware of the regu-
latory requirements and then interpret these
in a manner that ensures they’re compliant.
The problem is that industry’s resources will
be further extended, not only by the number
of regulations currently under development,
but also by a lack of harmonisation between
the developing ones and those already in op-
eration. This situation is being further com-
plicated by the implementation of regulatory
elements which may not be the most effective
in rapidly achieving the desired aims.
There are significant differences in both the
number of these regulatory elements which
are being selected, by developing regions, and
their reasons for doing so. This is not too sur-
prising as significant differences already exist
between the regulations adopted in the major
industrialised regions of the world, such as
the EU, USA and Japan. However, if this trend
continues at the current rate, the overall situa-
tion could become unmanageable.
It is true that safety requirements differ be-
tween countries and each has the privilege to
devise regulations which will address its own
particular needs. However, the approaches
which have and are currently being taken by
some regulatory controlled regions cannot
be totally justified on these principles alone.
This situation leads the chemical industry to
strongly advocate the development of chemi-
Sdu Uitgevers
actualities
cal control regulations as similar to, or at least
compatible with, existing regulations, whilst
keeping in mind the requirements of that par-
ticular region.
One of the major roles of the Global Emerg-
ing Regulations (GER) Issue Team of Cefic
(European Chemical Industry Council) is to
raise member’s awareness of new legislation
or amendments. Their second, but equally
important goal is to advocate for the sound
management of chemicals either via regula-
tion or voluntary schemes.
The GER Issue Team is made up of regulatory
professionals from member companies and
has been in existence within Cefic for approxi-
mately 13 years, during which time it has sup-
ported Cefic and its members in developing
their knowledge about global legislation re-
lated to chemicals. The Team has also played
an important role in the development of sev-
eral pieces of chemicals legislation around the
world. The Cefic GER Group proactively seeks
to understand emerging legislation and advo-
cates for the establishment and acceptance of
global standards for the safe management of
chemicals where applicable, so as to facilitate
the ability of member companies to trade
and/or operate in world markets.
Practically, this Group:
– Encourages the development of the sound
management of chemicals based on global
standards in countries in which we trade.
– Advocates for the acceptance of Mutual
Acceptance of Notification and Data to re-
duce duplicative testing of chemicals and
facilitate information sharing and capac-
ity building.
– Co-operates with other industry associa-
tions around the world to achieve these
aims.
– Monitors global, regional and national
legislative developments.
– Acts as a forum for information exchange
and dissemination within Cefic.
The GER Issue Team is presently working
with stakeholders in several countries. These
Sdu Uitgevers
stakeholders may take the form of govern-
mental regulators, institutions such as OECD,
the UN or the EU Commission together with
trade associations in many counties. Over the
coming issues of CEFIC GER will be giving
more details of specific pieces of legislation in
counties such as Malaysia, Taiwan or Turkey.
The first regulatory update will focus on the
People’s Republic of China and their propos-
als to amend their New Substance Notifica-
tion requirements.
Reference: Sunanda Banerjee sba@cefic.be
An example of bad EU regulation:
A nasty surprise hidden in the
new Classification and Labeling
Regulation
[2009/0186]
by Vito Buonsante & Thierry Dumortier
On 20 January 2009, a hidden change in the
EU Regulations was introduced. It triggers
thousands of cleaning products to become
classified as dangerous chemical products and
causes hundreds of industrial facilities in the
EU to become major accident hazard facilities.
As such nothing new, except that it was trig-
gered by hidden change in the text, and that
the competent EU officials seem to attempt to
hide their mistake.
At stake is the Regulation (EC) No. 1272/2008
(the CLP Regulation), which implements the
United Nations Globally Harmonised System
for Classification and Labelling of Chemicals
in the European Union and enters into force
on 20 January 2009. The CLP Regulation will
overhaul the present system of classification
and labelling of substances in 2010. The new
classification and labelling system for mix-
tures and preparations begins in 2015.
While the major reforms do not begin until
2010, immediate consequences for companies
are already appearing. In order to provide
Journaal Stoffen en Preparaten november 2009, Nr. 9 241

operators during the transition period with
only one text to refer to for the harmonized
classification of chemical substances, recital
53 to the CLP Regulation states that “all exist-
ing harmonised classifications should also be
placed unchanged in an annex to this Regu-
lation”. Despite the clear intention to transfer
the harmonized classifications unchanged,
some changes were made in transferring An-
nex I of the Dangerous Substances Directive
67/548/EEC to Annex VI Part III to the CLP
Regulation.
Most significantly, harmonized classifications
no longer include the generic concentration
limits. Generic concentration limits (25%,
2.5% and 0.25%) were introduced by Direc-
tive 1999/45/EC to define the classification
of the preparation based on the quantity of
the component substances and their environ-
mental classification. Also, in the transfer to
the CLP Regulation, the specific concentra-
tion limits that corresponded to the generic
ones were cancelled.
There has been little explanation of these
changes. The changes, and their consequenc-
es, are not mentioned in the Regulation, the
explanatory documents or the web-sites of
the European Commission. More-over the
changes are not mentioned in the interim re-
port from the Technical Working Group on
Seveso and GHS, which was established in
order to review the potential impact of GHS
classification rules in a Seveso context.
Only the Q&A document issued by the Euro-
pean Chemicals Agency (ECHA) in May 2009
makes mention of the change. The ECHA
states that the primary idea behind inclusion
of the generic concentration limits in Annex I
to Directive 67/548/EEC was to provide clas-
sifiers with an “all in one” table. As the CLP
Regulation contains the classifications (in Ta-
ble 3.1 of Annex VI) in accordance with the
CLP criteria which no longer provide for any
generic concentration limits, it was decided to
delete them from Table 3.2 (classifications in
accordance with 67/548/EEC) as well, to avoid
242 Journal Chemicals Management November 2009, No. 9
actualities
confusion and improve readability between
the tables. Thus, according to ECHA, the
elimination of generic concentration limits
was only a cleaning up exercise and no conse-
quence is mentioned.
Despite the silence of the European Commis-
sion on the omission of the generic concen-
tration limits, the changes do have important
consequences. The modification affects many
substances, but it is not immediately obvi-
ous how many nor which ones are affected.
In order to seek clarification, Enhesa experts
called the competent EU official in charge
of classification, but the surprising response
was that the change was known to everyone
and that one could contact the industry asso-
ciations to figure it out. We used to get this
type of response several decades ago, when
the government regarded regulations as top
secret. This attitude undermines the ideas of
better regulation and open access to informa-
tion – two concepts that the EU has attempted
to defend.
Taking the official on her word, we called her
colleague next door in charge of major-acci-
dent hazard facilities, and got the surprising
answer he was not aware of any change.
Most significantly, harmonized classifications
no longer include the generic concentration
limits. Generic concentration limits (25%,
2.5% and 0.25%) were introduced by Direc-
tive 1999/45/EC to define the classification
of the preparation based on the quantity of
the component substances and their environ-
mental classification. Also, in the transfer to
the CLP Regulation, the specific concentra-
tion limits that corresponded to the generic
ones were cancelled.
There has been little explanation of these
changes. The changes, and their consequenc-
es, are not mentioned in the Regulation, the
explanatory documents or the websites of the
European Commission. Moreover the chang-
es are not mentioned in the interim report
from the Technical Working Group on Seveso
and GHS, which was established in order to
Sdu Uitgevers
actualities
review the potential impact of GHS classifica-
tion rules in a Seveso context.
Only the Q&A document issued by the Euro-
pean Chemicals Agency (ECHA) in May 2009
makes mention of the change. The ECHA
states that the primary idea be-hind inclusion
of the generic concentration limits in Annex I
to Directive 67/548/EEC was to provide clas-
sifiers with an “all in one” table. As the CLP
Regulation contains the classifications (in Ta-
ble 3.1 of Annex VI) in accordance with the
CLP criteria which no longer provide for any
generic concentration limits, it was decided
to delete them from Table 3.2 (classifications
in accor-dance with 67/548/EEC) as well, to
avoid confusion and improve readability be-
tween the tables. Thus, according to ECHA,
the elimination of generic concentration lim-
its was only a cleaning up exercise and no con-
sequence is mentioned.
Despite the silence of the European Commis-
sion on the omission of the generic concen-
tration limits, the changes do have important
consequences. The modification affects many
substances, but it is not immediately obvi-
ous how many nor which ones are affected.
In order to seek clarification, Enhesa experts
called the competent EU official in charge
of classification, but the surprising response
was that the change was known to everyone
and that one could contact the industry asso-
ciations to figure it out. We used to get this
type of response several decades ago, when
the government regarded regulations as top
secret. This attitude undermines the ideas of
better regulation and open access to informa-
tion two concepts that the EU has attempted
to defend.
Taking the official on her word, we called her
colleague next door in charge of major-acci-
dent hazard facilities, and got the surprising
answer he was not aware of any change.
The EU adopts the Regulation, and the Mem-
ber States have to enforce it. So we called the
competent enforcement agencies in a dozen
member states and most of them were not
Sdu Uitgevers
aware of any change. Only three Member
States seem to have understood what has hap-
pened and have attempted to clarify the situ-
ation. But surprise again, their analysis differs
greatly 222 chemicals are affected according to
the Italian Ministry of Health; 98 have been
identified by the Hungarian authorities; while
the French authorities have identified 86 af-
fected chemicals. The Italian and French au-
thorities have issued circulars on the issue to
help clarify the situation.
For most of these substances, the changes
have no consequences. But about 20 to 40
substances are affected in terms of classifi-
cation of mixtures that contain them. Sub-
stances that are assigned the risk phrase R50
or R50/53 (very toxic to the aquatic environ-
ment) are, in the absence of a specific limit,
subject to Directive 2006/8/EC. According to
this Directive, for these substances the spe-
cific limit to be adopted has to be identified
in function of the effective value of CL50 or
EC50. This way, the 25% limit may remain the
same, but it can also be divided by 10 or 100
and thus become 2.5% or 0.25% through the
identification of an M-factor. An M-factor is
a multiplying factor. The concept of M-fac-
tors has been established to give an increased
weight to substances that are very toxic for the
aquatic environment when classifying mix-
tures containing these substances.
Particularly striking is the classification of So-
dium hypochlorite, commonly used as bleach.
The specific concentration limit has been de-
leted in the new CLP Regulation and replaced
by a general provision with the M-factor.
Where there is no harmonised M-factor listed
in Annex VI to CLP for a specific substance,
manufacturers, importers and downstream
users should set an M-factor themselves when
classifying substances for acute aquatic toxic-
ity category 1 or chronic aquatic toxicity cat-
egory 1. Tests reveal an M-factor of 10 should
be assigned to sodium hypochlorite which
means that solutions of 2.5% active chlorine
Journaal Stoffen en Preparaten november 2009, Nr. 9 243

will need to be classified as “Dangerous to the
Environment” (N; R50).
This means that there are immediate conse-
quences for some companies. From 20 Janu-
ary 2009, when the CLP Regulation entered
into force, mixtures containing substances for
which the generic or specific concentration
value was cancelled had to be reclassified and
relabelled according to Annex VI Table 3.2 of
the CLP Regulation. There is no grace or tran-
sition period included in the CLP Regulation,
probably because when this “clean-up” was
carried out, these consequences were not fore-
seen and communicated to the enforcement
agencies in the EU member states. Companies
placing mixtures on the market that should
be labelled differently, as a consequence of the
changed concentration limits, must immedi-
ately change the labels of all mixtures placed
on the market. Failure to do this exposes the
company to substantial liability.
In addition, the introduced change affects the
classification of installations under Directive
96/82/EC on the control of major-accident
hazards involving dangerous substances (the
Seveso II Directive). Concerned substances
classified as dangerous for the environment
and assigned R-phrase R50 (very toxic to
aquatic organisms) contained in certain con-
centrations in mixtures manufactured or used
by companies could now, due to stricter con-
centration limits, be caught up by the Seveso
II Directive. A facility will fall under the Seveso
II Directive if dangerous substances exceeding
the thresholds as listed in Annex I Part 1 or 2
to Directive 96/82/EC are present on site. For
substances classified as dangerous for the en-
vironment and assigned R-phrase R50 (very
toxic to aquatic organisms), the qualifying
quantities to become a Seveso II site are 100
tons (for facilities subject to Article 6 and 7
of Directive 96/82/EC) or 200 tons (for facili-
ties falling under Article 9 of Directive 96/82/
EC).
Due to this accident in the transposition of the
harmonized classification from Annex I of Di-
244 Journal Chemicals Management November 2009, No. 9
actualities
rective 67/548/EEC, many industrial facilities
are at risk of operating illegally without the
proper permit. Enhesa recommends that fa-
cilities check their chemical inventory against
Annex VI Part III of the CLP Regulation. If
there are consequences in terms of the facil-
ity’s Seveso classification, the facility should
check the transition period granted by the
transposition of the Seveso II Directive. De-
pending on the Member State concerned, this
transition period will often be 6 months (20
July 2009) or 12 months (20 January 2010).
Neither the intent of the regulators or the fi-
nal outcome is the problem. However, the lack
of communication on the issue and the lack
of transition periods are deplorable, and put
both industrial operators and enforcement
agencies in a difficult position.
REACH for non-Europeans
[2009/0187]
Companies that import substances and prep-
arations (mixtures) within the EU/EEA and
wish to inform their non-European suppli-
ers on the REACH legislation, some countries
may refer to the following web sites explain-
ing their suppliers in their own language this
complex regulation.
PR of China: www.reach-helpdesk.cn
Japan: www.nikkakyo.org
Korea: www.korea helpdesk.eu
www.reach.or.kr
www.coreach.net
Turkey: reach.immib.org.tr
Reference: http://www.essenscia.be/NL/essenscia/
REACH-portal-essenscia/page.aspx/1950
Sdu Uitgevers
international
international
Turkey adopts a REACH-like
Chemicals Legislation
[2009/0188] the possibility for the Ministry to require ad-
On 26 December 2008 Turkey adopted the
‘Regulation on inventory and control of chem-
icals’, which entered into force on 1  January
2009. This law is inspired by the EU regulation
of chemicals and in particular by the REACH
Regulation (EC) No. 1907/2006 which notably
imposes the obligation to notify all existing
and new substances, either on their own or in
preparation, manufactured or imported in the
EU in quantities above 1 tonne per year.
The main principles set out by the Turkish
Chemical Regulation are twofold:
– First, this Regulation aims at setting up a
chemical inventory comprising informa-
tion relating to new and existing substanc-
es manufactured or imported in Turkey.
– Secondly, this Regulation aims at con-
trolling and eventually reducing the risks
posed by existing and new substances
manufactured or imported in Turkey.
The Regulation imposes the obligation to no-
tify information to the inventory of the Min-
istry of Environment and Forestry on all exist-
ing and new substances, either on their own or
in preparation(s), imported or manufactured
in Turkey in quantities above 1 tonne per year.
Similar to what is provided under the REACH
Regulation, the data requirements differ de-
pending on the tonnages. For substances im-
ported or manufactured in quantities between
1 tonne to 1000 tonne per year, only basic in-
formation needs to be provided. More specifi-
cally, the notifier must provide the following
Sdu Uitgevers
information to the Ministry of Environment
and Forestry:
– Name, EC number and CAS number of
the substance
– Quantity of the substance manufactured
or imported
– Classification and Labelling for hazardous
substances
– Information on the uses of the substance
Note, that the Regulation also provides for
ditional information regarding the physico-
chemical, toxicological and eco-toxicological
characteristics of substances in relation with
the risk assessment of substances.
For substances imported or manufactured in
quantities above 1000 tonne per year, the in-
formation requirements are more substantial.
In that case, the notifier must provide the fol-
lowing information to the Ministry of Envi-
ronment and Forestry:
– Name, EC number and CAS number of
the substance
– Quantity of the substance manufactured
or imported
– Classification and Labelling for hazardous
substances
– Information on the uses of the substance
– Physicochemical data on the substance
– Data on the behaviour and attitude of the
substance among environmental media
– Eco-toxicity data on the of the substance
– Data on acute and subacute toxicity of the
substance,
– Data on the carcinogenic, mutagenic ef-
fect of the substance and/or toxic effect on
the reproductive system thereof
– Other related information that may be
used in risk assessment of the substance.
In addition, the notifier has an obligation to
update the information submitted in case of a
change in the use, in the characteristics of the
substance in relation to risk assessment, in the
classification of the substance, or in the quan-
tities imported or manufactured.
Journaal Stoffen en Preparaten november 2009, Nr. 9 245

Similar to the REACH Candidate list, the
Turkish Regulation also establishes a prior-
ity list for substances or substance groups
which require specific attention due to their
potential effects on human health and the en-
vironment. In addition, substances with car-
cinogenic and/or mutagenic effect and toxic
effect on reproduction will be under specific
scrutiny. The substances listed in the prior-
ity list will undergo a risk assessment under
which the notifier may be required to provide
further information.
Reference: http://www.khlaw.com/showpublication.
aspx?Show=3109
USA: OSHA issues proposed rule
to adopt the GHS System
[2009/0189] health, physical and environmental hazards,
A proposed rule to align the Occupational
Safety and Health Administration’s Hazard
Communication Standard (HCS) with provi-
sions of the United Nations Globally Harmo-
nized System of Classification and Labelling
of Chemicals (GHS) has been published in
the 30 September 2009 Federal Register. The
current HCS requires chemical manufactur-
ers and importers to evaluate the hazards of
the chemicals they produce or import and
provide information to subsequent users. The
current standard requires all employers to
have a hazard communication program for
workers exposed to hazardous chemicals. The
program includes materials such as container
labels, safety data sheets, and employee train-
ing.
A number of countries, including the United
States, international organizations and stake-
holders participated in developing the GHS
to address inconsistencies in hazard classifi-
cation and communications. The GHS was
developed to provide a single, harmonized
system to classify chemicals, labels and safety
data sheets with the primary benefit of in-
246 Journal Chemicals Management November 2009, No. 9
international
creasing the quality and consistency of infor-
mation provided to workers, employers and
chemical users. Under the GHS, labels would
include signal words, pictograms, and hazard
and precautionary statements. Additionally,
information on safety data sheets would be
presented in a designated order.
Under the Occupational Safety and Health
Act of 1970, OSHA’s role is to promote safe
and healthful working conditions for Ameri-
ca’s men and women by setting and enforcing
standards and providing training, outreach,
and education.
Background
In 2003, the United Nations (UN) adopted the
Globally Harmonized System of Classifica-
tion and Labelling of Chemicals (GHS). The
GHS includes criteria for the classification of
as well as specifying what information should
be included on labels of hazardous chemicals
as well as safety data sheets. The United States
was an active participant in the development
of the GHS, and is a member of the UN bod-
ies established to maintain and coordinate
implementation of the system.
OSHA GHS Proposal
OSHA published a proposed rulemaking on
30 September 2009 to align OSHA’s Hazard
Communication standard (HCS) with the
GHS. This is a significant step in the rule-
making process. OSHA has provided a 90-
day comment period ending on December
29, 2009. To aide in the understanding of the
HCS proposal OSHA is providing additional
information:
– Proposed HCS regulatory text
– Proposal HCS regulatory text (redline
strikeout)
– Proposal side-by-side comparison to the
current HCS and the Proposal
– Facts on Aligning the Hazard Communi-
cation Standard to the GHS
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international
OSHA GHS Advance Notice of Proposed
Rulemaking
In May 2005, the Agency added to its regula-
tory agenda consideration of rulemaking to
revise the HCS to align its requirements with
the GHS. As the first step in that rulemaking
process, OSHA published an advance notice
of proposed rulemaking (ANPR) on 12 Sep-
tember 2006. The ANPR explains the history
of the development of the GHS, including
OSHA’s involvement in the process. It also
indicates how alignment with the GHS would
affect the requirements of the HCS, and asks a
series of questions to allow the public an op-
portunity to provide input
In addition to the ANPR, OSHA has prepared
a Guide to the GHS to provide interested
stakeholders a substantive discussion of the
system’s requirements. OSHA has also com-
pleted a detailed comparison of the provi-
sions of the GHS to the requirements of the
HCS. This document indicates the changes
that would have to be made to be consistent
with the GHS.
Other Federal Agency Activities
– Globally Harmonized System (GHS) for
Classification and Labelling of Chemicals.
Environmental Protection Agency (EPA).
– Global Harmonization of Hazard Classifi-
cation and Labelling Systems. US Depart-
ment of Transportation (DOT).
– Policy of the U.S. Consumer Product
Safety Commission on the Globally Har-
monized System of Classification and La-
belling of Chemicals (GHS). Consumer
Product Safety Commission (CPSC).
Implementation in Other Countries
The Globally Harmonized System of Classi-
fication and Labelling of Chemicals (GHS).
Health Canada.
REACH and GHS Overview. European Com-
mission, European Union. Streamlines and
improves the former legislative framework
on chemicals of the European Union (EU)
Sdu Uitgevers
through Regulation, Evaluation, Authorisa-
tion, and Restriction of Chemicals (REACH)
which entered in force on June 1, 2007.
Workplace Hazardous Chemicals Public
Comment. Australian Safety and Compensa-
tion Council (ASCC). Draft National Stand-
ard for the Control of Workplace Hazardous
Chemicals. (2006, September), Proposed re-
visions to the workplace chemicals regulatory
framework. Australian Safety and Compensa-
tion Council (ASCC).
References: http://www.osha.gov/SLTC/hazardcom-
munications/global.html
http://edocket.access.gpo.gov/2009/
E9-22483.htm
Australia: Hazardous Substances
Information System Updated
April 2009
[2009/0190]
The Hazardous Substances Information Sys-
tem (HSIS) is an internet resource that allows
you to find information on substances that
have been classified in accordance with the
‘Approved Criteria for Classifying Hazardous
Substances’ [NOHSC:1008(2004] 3rd Edition
and/or have National Exposure Standards
declared under the NOHSC Adopted Na-
tional Exposure Standards for Atmospheric
Contaminants in the Occupational Environ-
ment [NOHSC:1003(1995)]. In addition to
providing powerful search features, HSIS also
provides direct access to a consolidated list of
all the classified substances contained in the
HSIS database.
Safe Work Australia has updated the Hazard-
ous Substances Information System (HSIS)
online database to reflect changes in Europe’s
30th Adaptation to Technical Progress to Di-
rective 67/548/EEC.
The update comprised of a total of 958 entries
of which there are 564 amendments to exist-
ing entries, 391 new entries and 3 deletions.
Journaal Stoffen en Preparaten november 2009, Nr. 9 247

Also, the HSIS Guidance Material for Hazard
Classifications has been updated to reflect
amendments to Notes H, J and P in the label-
ling column.
Reference: http://hsis.ascc.gov.au/TheList.aspx
Australian Code for the Transport
of Explosives by Road and Rail
[2009/0191] Global Update on New Chemicals
The third edition of the Australian Code for
the Transport of Explosives by Road and Rail
(AE Code) of 2009 replaces the second edi-
tion that was endorsed by the Standing Com-
mittee on Transport (SCOT) in March 2000.
This code has been prepared by the Austral-
ian Forum of Explosives Regulators (AFER)
and was endorsed by the Workplace Relations
Minister’s Council in April 2009. Since 2005,
the Workplace Relations Minister’s Coun-
cil (WRMC) has assumed responsibility for
coordinating national uniform explosives
laws in Australia. Its objective is to provide a
uniform basis for Commonwealth, State and
Territory legislation governing the transport
of explosives and it is designed to apply to
all road and rail transport in Australia. This
Code is applicable to civilian and military ex-
plosives transport. This Code does not apply
to the transport of explosives by air or by sea.
The International Civil Aviation Organisation
– Technical Instructions for the Safe Transport
of Dangerous Goods by Air Doc. 9284 (ICAO
TI), including the ICAO TI-Supplement, and
the International Air Transport Authority –
Dangerous Goods Regulations (IATA DGR)
apply for air transport. The International
Maritime Dangerous Goods Code (IMDG
Code) applies to transport by sea.
It is envisaged that this Code will be adopted
in the explosives legislation of the Common-
wealth and all States and Territories.
This Code is the primary reference for explo-
sives and has been designed to complement
248 Journal Chemicals Management November 2009, No. 9
international
and be consistent with the 7th Edition of the
Australian Code for the Transport of Danger-
ous Goods by Road and Rail (ADG Code),
which currently includes limited and/or advi-
sory provisions regarding explosives (danger-
ous goods of Class 1).
References: ISBN 978 0 642 32747 5 (online PDF)
ISBN 978 0 642 32753 6 (print)
Regulations (Period July-
September 2009)
[2009/0192]
In July-September 2009 approximately 200
new regulations relating to chemicals ma-
nagement were adopted or published world-
wide. These involve implementation of GHS,
updates to chemical inventories, new priority
chemicals, several changes to the require-
ments on transport and handling, and last but
not least restrictions on the marketing and use
of chemicals.
The following overview provides the indica-
tive title in English and the date of adoption.
Further information on any of these new re-
gulations and what they require from industry
can be found in the Enhesa Update published
by ENHESA (www.enhesa.com). (Selection
only).
Australia
Regulations on ozone depleting substances
are amended to reduce some fees and record
keeping requirements 11-Jul-2009
Ban on import of asbestos in ships clarified
14-Aug-2009
NSW: Pesticides Regulation, 2009 published
21-Aug-2009
Austria
Chemicals legislation amended to implement
REACH-Regulation 19-Aug-2009
Sdu Uitgevers
international
Belgium
Federal: Royal Order on the prevention of ha-
zardous substances in electrical and electronic
equipment 02-Jul-2009
Brazil
Use of products containing asbestos prohibi-
ted to the Ministry of Health 21-Jul-2009
Bulgaria
Norms for admissible emissions of VOC re-
leased into the ambient air as a result of use of
solvents by particular installations amended
21-Aug-2009
Canada
An Act to amend the Transportation of Dan-
gerous Goods Act adopted 21-Jul-2009
Final screening assessment documents publis-
hed on Batch 4 Challenge substances specified
on the Domestic Substances List 01-Aug-
2009
Volatile Organic Compound (VOC) Con-
centration Limits for Automotive Refinishing
Products Regulations 08-Jul-2009
Ministerial Condition No. 15543 published
regarding poly[oxy(methyl-1,2-ethanediyl)],
a-sulfo-w-hydroxy-, branched alkyl ethers,
sodium salts 18-Jul-2009
Orders amending the Domestic Substances
List and the Non-domestic Substances List
adopted 08-Jul-2009
Ontario: Legislation adopted to revoke Onta-
rio Regulations regarding sewage systems 11-
Jul-2009
Alberta: Adopted amendments prohibiting
the use of certain pesticides 21-Jul-2009
Significant New Activity Notice No. 15414
adopted regarding oleic acid, compound with
alkaneamine 22-Aug-2009
Significant New Activity Notice No. EAU-455a
adopted to amend Significant New Activity
Notice No. EAU-455 regarding benzoic acid,
CAS No. 190085-41-7 22-Aug-2009
Chile
Activities involving the use of asbestos require
prior authorization 08-Aug-2009
Sdu Uitgevers
China, PR of
Shanghai: List of WEEE disposers updated
05-Jul-2009
Identification of serious hazard source of ha-
zardous chemicals amended 31-Mar-2009
Beijing: Certain chemicals subject to stricter
control for the 60th anniversary of Chinese
National Day 23-Jul-2009
Methyl chloroform (TCA) banned for use and
manufacture from 2010 20-Jul-2009
Colombia
Decree No. 2350 regulating controlled chemi-
cal substances issued 07-Jul-2009
Costa Rica
Decree for a registration fee and sanitary sur-
veillance of cosmetics adopted 03-Jul-2009
Czech Republic
Regulation on emission of ozone depleting
substances and fluorinated greenhouse gases
detailing Regulation (EC) No. 842/2006 adop-
ted 15-Aug-2009
Denmark
Directive on certain paints and varnishes and
vehicle refinishing transposed and entered
into force. 29-Aug-2009
Estonia
Terms and conditions of classification, pac-
kaging and labelling of hazardous chemicals
amended 28-May-2009
Finland
Decree amending the Decree on the safety ad-
visor for the transport of dangerous goods by
road adopted 23-Apr-2009
France
Order relating to the procedures of registra-
tion and declaration to the electrical and elec-
tronic equipment national register adopted
30-Jun-2009
Circular on the implementation of the first
applicable measures of the CLP Regulation
with respect to classified installations 23-Jun-
2009
Order relating to the terrestrial transport of
dangerous goods adopted 29-May-2009
Directive on marketing and use of certain
dangerous substances and preparations in-
Journaal Stoffen en Preparaten november 2009, Nr. 9 249

corporated into REACH with amendments
01-Jun-2009
Germany
Act on the Transport of Dangerous Goods
amended and published as consolidated ver-
sion 15-Jul-2009
Revised Water Act adopted 06-Aug-2009
Act amending several Federal environmental
pieces of legislation published 17-Aug-2009
Hong Kong
Air Pollution Control (Specified Processes)
(Amendment) Regulation published 29-May-
2009
Hungary
Decree on the national implementation of
Annexes A and B to the ADR adopted 07-Aug-
2009
Decree on Environmental Impact Assessment
and on Integrated Pollution Prevention and
Control (IPPC) permitting procedures amen-
ded 23-Jul-2009
Amendment to several environmental and
health and safety legislation adopted 01-Oct-
2009
India
MoEF issues new Hazardous Waste Rule for
transboundary movement of paper and me-
tallic waste, and proposes State registration
for recycling facilities 21-Jul-2009
The Ministry of Environment and Forests re-
quires publishing of environmental clearance
information online 30-Jun-2009
Indonesia
Traffic and Road Transportation Act is rene-
wed. 22-Jun-2009
Ministry Regulation to control goods and ser-
vices is renewed 26-May-2009
International
IMO adopts amendments to MARPOL to pre-
vent pollution during ship-to-ship oil transfer
operations 17-Jul-2009
Italy
Community Act for year 2008 foresees new
regulations on waste, air quality and noise 14-
Jul-2009
250 Journal Chemicals Management November 2009, No. 9
international
New document required for the transport of
any kind of goods 15-Jan-2009
Health and Safety Code amendments publis-
hed 05-Aug-2009
Latvia
Requirements for Use and Marking of Listed
Equipment and Products Containing Dange-
rous Chemical Substances and List of Harm-
ful Goods amended 21-Jul-2009
Regulations Regarding the Management of
Electrical and Electronic Equipment Waste
amended 04-Aug-2009
Luxembourg
Transposition of 30th and 31st Adaptation
to Technical Progress of the list of dangerous
substances in Annex I to Directive 67/548/
EEC 22-Jul-2009
Malaysia
Poisons (Amendment of Poisons List) (No. 2)
Order 2009 is adopted 16-Jul-2009
Safety standards for toys are adopted 28-Jul-
2009
Regulations on certificate of approval and
conformity mark of safety standards 28-Jul-
2009
[On 28 July 2009 the Minister of Domestic Trade, Co-
operatives and Consumerism issued the Consumer Pro-
tection (Certificate of Approval and Conformity Mark of
Safety Standards) Regulations 2009. The conformity as-
sessment report aimed at facilities supplying, offering or
advertising to supply or import any products specified in
the First Schedule of the Regulations. At this point in time,
the First Schedule lists only toys as products that require
a conformity assessment report and that conformity as-
sessment will be carried out by SIRIM QAS International
Sdn. Bhd.]
Panama
Resolution 210 prohibiting commercial pur-
poses, use and consumption of products con-
taining lindane adopted 21-Jul-2009
Philippines
Joint Administrative Order on Implemen-
tation of the Globally Harmonized System
(GHS) for Hazard Classification and Label-
ling of Chemicals Adopted 29-May-2009
Sdu Uitgevers
international
Proposed Allergen Regulatory Act of 2009 10-
Jun-2009
Poland
New detailed requirements for the marking of
packaged goods adopted 20-Jul-2009
New Ordinance on certification of waste elec-
trical and electronic equipment by treatment
facilities issued 16-Jul-2009
New Ordinance on a database of waste electri-
cal and electronic equipment issued 10-Aug-
2009
Ordinance on occupational health and safety
during municipal waste management issued
16-Jun-2009
Ordinance on the Method of Maintenance of
the Registry of Installations and Equipment
Including PCB by the authorities issued 23-
Jul-2009
Ordinance on submission to Voivodship Mar-
shal information on substances particularly
dangerous for the environment issued 23-Jul-
2009
Romania
Conditions for preparation of environmental
protection studies adopted 27-Jul-2009
Russia
Law on Technical Regulation Amended 18-
Jul-2009
Adopted Decree on Regulating Import and
Export of Ozone Depleting Substances 20-
Aug-2009
Slovakia
Act on Fluorinated Greenhouse Gases adop-
ted 19-Jun-2009
Decree Implementing the Act on Fluorinated
Greenhouse Gases adopted 15-Jul-2009
Act on Ambient Air proposed 28-Aug-2009
Decree Implementing Certain Provisions of
the Air Protection Act issued 23-Jul-2009
South Africa
Leaded paint declared as Group 1 hazardous
substance under the Hazardous Substances
Act (Act No. 15 of 1973) 31-Jul-2009
South Korea
Dimethylsulfamoyl chloride, triphenylsulfo-
nium 4-oxo-1-adamantyloxycarbonyldiflu-
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oromethane sulfonate designated as toxic
substances 20-Aug-2009
Scope of waste containing dioxin clarified and
reduced 25-Aug-2009
Sweden
Stricter rule on the safety of toys will be adop-
ted 10-Sep-2009
Ordinance on producers responsibility for
batteries amended 28-Jul-2009
Switzerland
Ordinance on the safety of toys amended 13-
Jul-2009
Taiwan
Liability insurance required to handle Class 1,
Class 2 and Class 3 toxic chemical substances
29-Jul-2009
[On 29 July 2009, the Management Measures on Third
Party Liability Insurance for the Handling of Toxic Che-
mical Substances (毒性化學物質運作責任保險辦法) were amended by the En-
vironmental Protection Administration. Compared to
the Management Measures of 26 July 2007, Section 1 of
Article 3 has now been revised by deleting the phrase of
“due to intentional act, gross negligence, or force majeure”
(故意，過失或者不可抗力).]
Fewer types of goods under the Sensitive
Commodities List to North Korea and Iran
are subject for export control 24-Jul-2009
Measures on the control of hydrochloroflu-
orocarbon consumption levels amended 28-
Apr-2009
Restriction on the handling of toxic chemical
substances amended 31-Jul-2009
Turkey
Regulation on Transport of Dangerous Sub-
stances on Roads will enter into force in 2011
10-Jul-2009
Circular on Import of Controlled Substances
2009/3 published 09-Jan-2009
Regulation on Control of Air Pollution Cau-
sed by Industry published repealing the Regu-
lation on the same issue 03-Jul-2009
Adopted procedure for the issue of import
and export licences for ozone depleting sub-
stances 23-Jun-2009
Journaal Stoffen en Preparaten november 2009, Nr. 9 251

United Kingdom
ENG: The Planning (Hazardous Substances)
(Amendment) (England) Regulations 2009
adopted 21-Jul-2009
NI: Manufacture and Storage of Explosives
Regulations amended 07-Aug-2009
NI: The consolidated Explosives (Hazard In-
formation and Packaging for Supply) Regula-
tions adopted 23-Jun-2009
United States of America
California: Adopted revisions to VOC consu-
mer product regulations 03-Jul-2009
Final significant new use rules issued for two
chemical substances 08-Jul-2009
California: Adopted amendments to give Safe
Use Determinations greater effect under Pro-
position 65 regulations 07-Aug-2009
Adoption of revision to Phase 2 implementa-
tion rule for the 1997 8-hour ozone national
ambient air quality standard 11-Aug-2009
Massachusetts: DEP issues final rule for mer-
cury-added product regulations 01-Aug-2009
California: 19 substances added to Propositi-
on 65 List as a result of court order; 11 remain
under consideration 07-Aug-2009
EPA withdraws 2 significant new use rules for
carbon nanotubes from the recently adopted
significant new use rules for 23 substances 24-
Aug-2009
CPSC adopts exemptions for classes of materi-
als used as components in children’s products
from lead testing requirement 19-Aug-2009
CPSC issues final rule designating tests to
determine when a lead-containing part in
a children’s product is inaccessible 07-Aug-
2009
EPA updates TSCA master file to include 530
chemicals as non-confidential that were pre-
viously confidential 28-Jul-2009
Delaware: Final amendment of Air Regula-
tions to align definition of Volatile Organic
Compound (VOC) with federal EPA 14-Aug-
2009
252 Journal Chemicals Management November 2009, No. 9
international
Uruguay
Decree 307/2009 on health and safety measu-
res to protect workers from risks related with
chemical agents adopted 09-Jul-2009
[Decree 307/2009 was adopted on 9 July 2009 by the Mini-
stry of Labour and Social Security (Ministerio de Trabajo
y Seguridad Social). It aims to establish health and safety
provisions to protect workers from risks related to che-
mical agents. Decree 307/2009 is applicable to every acti-
vity involving the manufacture, handling, transport and
storage of chemical agents. The main provisions of the
Decree relate to risk communication mechanisms; pro-
visions for risk evaluation and prevention plans; general
principles for risk prevention, safety prevention and pro-
tection measures; and provisions for health monitoring;
measures to adopt in order to face accidents, incidents
and emergencies; and hazards communication. Decree
307/2009 also introduces the Globally Harmonized Sy-
stem of Classification and Labelling of Chemicals (GHS)
into Uruguay’s legislation. GHS addresses classification of
chemicals by types of hazard and proposes harmonized
hazard communication elements, including labels and
safety data sheets.]
Venezuela
Regulation of the Administrative Law against
illegal traffic and consumption of drugs adop-
ted 01-Jul-2009
Norms and procedures to control companies
manufacturing storing, importing, exporting
marketing or using explosives or chemical
substances adopted 27-Aug-2009
Norms and procedures to control storage of
explosive materials adopted 27-Aug-2009
Vietnam
Decree on industrial explosive materials
adopted 23-Apr-2009
Circular on the quality inspection of impor-
ted goods adopted 18-Jun-2009
Decree determining the applicable admini-
strative penalties in the field of standards,
metrology and products and goods quality
adopted 05-Jun-2009
Sdu Uitgevers
official publications
official
publications
The Netherlands (Period August-
October 2009)
[2009/0193] Regeling van de Minister van Volkshuisves-
21-09-2009, Tractatenblad 2009, 129: Pro-
tocol betreffende registers inzake emissie en
verplaatsing van verontreinigde stoffen; Kiev,
21 mei 2003
28-08-2009, Staatsblad 2009, 363: Besluit van
10 augustus 2009, houdende wijziging van het
Warenwetbesluit cosmetische producten
[Artikel 2 van het Warenwetbesluit cosmetische producten
wordt als volgt gewijzigd: (5). Het is verboden cosmetische
producten te verhandelen indien met betrekking tot de
ingrediënten, combinaties van ingrediënten of de eindsa-
menstelling van deze producten dierproeven zijn verricht,
voorzover die dierproeven zijn verricht in het belang van
de eisen gesteld bij of krachtens dit besluit. (6). In afwij-
king van het vijfde lid is het toegestaan cosmetische pro-
ducten te verhandelen ten behoeve waarvan ingrediënten,
combinaties van ingrediënten of de eindsamenstelling van
deze producten in verband met toxiciteit bij herhaalde
toediening, toxiciteit met betrekking tot de voortplanting
en toxicokinetiek, zijn beproefd voor zover geen andere
methode wordt gebruikt dan een door Onze Minister voor
die beproeving aangewezen alternatieve methode, vanaf
het tijdstip dat deze alternatieve methode is aangewezen.]
28-08-2009, Staatscourant 2009,12819: (Ont-
werp-)Besluit van ......, houdende milieukwa-
liteitseisen externe veiligheid voor het vervoer
van gevaarlijke stoffen door buisleidingen
16-09-2009, Staatscourant 2009,13735:
Besluit van de Minister van Sociale Zaken
en Werkgelegenheid van 17 augustus 2009,
nr. G&VW/AA/2009/18091, tot wijziging van
de Beleidsregel arbocatalogi in verband met
de toevoeging van enkele nieuwe arbocatalogi
Sdu Uitgevers
17-09-2009, Staatscourant 2009,13925:
Regeling van de Minister van Volksgezond-
heid, Welzijn en Sport van 26 augustus 2009,
nr. VGP/PSL 2950476 houdende wijziging van
de Warenwetregeling nadere eisen cosmeti-
sche producten
29-09-2009, Staatscourant 2009,14498:
Voorschrift intern vervoer gevaarlijke stoffen
Defensie 2009 Nr. DMO/DB/2009010598
30-09-2009, Staatscourant 2009,14412:
ting, Ruimtelijke Ordening en Milieube-
heer van 17  september 2009, nr. DGM/K&L
2009054964, houdende vaststelling van regels
inzake de examinering en diplomering van
personen en de certificering van bedrijven die
werkzaamheden verrichten aan koelinstal-
laties waarbij gefluoreerde broeikasgassen of
gereguleerde stoffen vrij kunnen komen (Re-
geling gefluoreerde broeikasgassen en geregu-
leerde stoffen koelinstallaties)
01-10-2009, Staatscourant 2009,14712: Aan-
wijzing Bemonstering en Analyse Milieudelic-
ten
[In deze aanwijzing bemonstering en analyse milieudelic-
ten (hierna: de aanwijzing) wordt de procedure aangege-
ven, die gevolgd dient te worden bij het nemen en analy-
seren van monsters bij de opsporing van milieudelicten en
wordt aanbevolen voor bemonstering en analyse in het ka-
der van toezicht. Het betreft die gevallen waarin door be-
monstering en analyse wordt vastgesteld of een bepaalde
grens- en/of concentratiewaarde wordt overschreden die is
neergelegd in een wettelijke bepaling danwel (vergunning-
c.q. ontheffing-) voorschrift. Tevens geldt de aanwijzing
voor die situaties waarin de aard of de identiteit van een
bepaalde stof, die niet mag worden geloosd of geëmitteerd
of niet op of in de bodem mag worden gebracht, wordt
vastgesteld.]
13-10-2009, Staatscourant 2009,15331: Be-
sluit van de Minister van Volkshuisvesting,
Ruimtelijke Ordening en Milieubeheer van
1 oktober 2009, nr. K&L 2009056527, tot het
verlenen van mandaat, volmacht en machti-
ging voor de uitvoering van de Regeling geflu-
oreerde broeikasgassen hoogspanningsscha-
kelaars (Mandaatbesluit Dienst Uitvoering
Journaal Stoffen en Preparaten november 2009, Nr. 9 253

Regeling gefluoreerde broeikasgassen hoog-
spanningsschakelaars)
13-10-2009, Staatscourant 2009,15337: Be-
sluit van de Minister van Volkshuisvesting,
Ruimtelijke Ordening en Milieubeheer van
1 oktober 2009, nr. K&L 2009053180, tot het
verlenen van mandaat, volmacht en machti-
ging ter uitvoering van de Regeling gefluo-
reerde broeikasgassen en gereguleerde stoffen
koelinstallaties (Mandaatbesluit Dienst Uit-
voering Regeling gefluoreerde broeikasgassen
en gereguleerde stoffen koelinstallaties)
13-10-2009, Staatscourant 2009,15332:
Besluit van de Minister van Sociale Zaken
en Werkgelegenheid van 5 oktober 2009,
nr. G&VW/AA/2009/22315, tot wijziging van
de Beleidsregel arbocatalogi in verband met
de toevoeging van enkele nieuwe arbocatalogi
15-10-2009, Staatscourant 2009,15507: Re-
geling van de Minister van Volksgezond­
heid, Welzijn en Sport van 8 oktober 2009,
nr. VGP/PSL2959817, houdende vaststelling
van de Warenwetregeling elektronische pro-
ductnotificatie.
[De Minister van Volksgezondheid,Welzijn en Sport,
Gelet op artikel17 van richtlijn nr.1999/45/EG van het
Europees Parlement en de Raad van 31mei 1999 betref-
fende de onderlinge aanpassing van de wettelijke en be-
stuursrechtelijke bepalingen van de lidstaten inzake de
indeling, de verpakking en het kenmerken van gevaar-
lijke preparaten (PbEGL200) ,alsmede op artikel3, twee-
delid, van het Warenwetbesluit deponering informatie
preparaten; Besluit: Artikel1: De gegevens bedoeld in
artikel3, eerste lid,van het Warenwetbesluit deponering
informatie preparaten, alsmede de concentratie van de
ingrediënten van het mengsel,worden op elektronische
wijze door middel van een door het Nationaal Vergifti-
gingen Informatie Centrum in stand gehouden website
aan het Nationaal Vergiftigingen Informatie Centrum
verstrekt. Artikel 2: Deze regeling treedt in werking
met ingang van de dag na de datum van uitgifte van de
Staatscourant waarin zij wordt geplaatst. Artikel 3: De
Warenwetregeling preparaatinformatieformulier wordt
ingetrokken. ….]
254 Journal Chemicals Management November 2009, No. 9
official publications
Belgium (Period August-
September 2009)
[2009/0194]
Belgisch Staatsblad 27 augustus 2009, editie
N.287: Koninklijk besluit van 31 juli 2009 be-
treffende het vervoer van gevaarlijke goederen
over de binnenwateren
Belgisch Staatsblad 28 augustus 2009, editie
N.291: Besluit van de Vlaamse Regering van
19 juni 2009 tot wijziging van het besluit van
de Vlaamse Regering van 1 juni 1995 houden-
de algemene en sectorale bepalingen inzake
milieuhygiëne
Belgisch Staatsblad 01 september 2009, edi-
tie N.295: Koninklijk besluit van 31 juli 2009
betreffende aerosols
Belgisch Staatsblad 29 september 2009, edi-
tie N.330: Koninklijk besluit van 29 augustus
2009 tot wijziging van het koninklijk besluit
van 15 oktober 1997 betreffende cosmetica
Belgisch Staatsblad 2 oktober 2009, editie
N.335: Wet van 28 januari 1999 betreffende
de waarborgen die de stoffen en preparaten
inzake de veiligheid en de gezondheid van
de werknemers met het oog op hun welzijn
moeten bieden. – Officieuze coördinatie in
het Duits
United Kingdom (Period
September 2009)
[2009/0195]
by Dr Ross Fielding
UK Guidance Free to Download
In the July edition of this Journal (Vol 6,No 6)
it was reported that the UK Competent Au-
thority for most UK chemical legislation (the
Health and Safety Executive) was to make
it’s previously priced advice and guidance
documents available for free download. That
Sdu Uitgevers
official publications
policy is now been implemented and over 250
previously priced documents (mostly in the
HSG and L series) are now available for free
download.
For example, the following documents that
may be relevant to readers:
HSG 61 Health surveillance at work
HSG 71 Chemical warehousing – The stor-
age of packaged dangerous sub-
stances
HSG53 Respiratory protective equipment
at work – A practical guide
HSG167 Biological Monitoring in the
Workplace a Guide to its Practical
Application to Chemical Exposure
L131 Approved Classification and La-
belling Guide (Sixth edition)
Chemicals (Hazard Information
and Packaging for Supply) Regula-
tions 2009 (CHIP 4)
are now available for free download. Some ti-
tles are not yet converted. The complete con-
version of all documents to pdf format is ex-
pected to be complete by 31 March 2010.
To find documents, search either the main
HSE web site or it’s publications outlet: http://
www.hse.gov.uk/ ; http://books.hse.gov.uk
Printed hard copy documents are still obtain-
able (to purchase) but a wide and authorita-
tive series of guidance documents are now
available for free.
Other Sources of UK Chemical Regulatory
Information
Although the HSE is the main source of UK
Government information on Chemicals, the
HSE is not the only Competent Authority in
this field and sometimes the Government ap-
points the Department for Environment Food
and Rural Affairs (Defra) for the lead role. The
main Defra web site has been reorganised. The
chemical related content has been moved to:
http://www.defra.gov.uk/environment/qual-
ity/chemicals/index.htm
Sdu Uitgevers
Consultation on UK Implementation of
Enforcement Obligations on Mercury
Compounds
Defra is engaged in consultation on UK im-
plementation of enforcement obligations on
ban of exports of metallic mercury and cer-
tain metallic mercury compounds and mix-
tures, and the safe storage of metallic mercu-
ry. This consultation concerns EC regulation
No. 11102/2008. The regulation requires com-
panies that produce or gain mercury to for-
ward all relevant data related to the decom-
missioning of mercury cells in their plants to
the Commission and competent authorities of
the Member States concerned to facilitate the
enforcement of the regulation. Defra’s consul-
tation seeks views on how the UK proposes to
implement within the UK the enforcement
obligations as laid down by this EC regulation.
The storage obligations of this regulation will
be dealt with in a later consultation.
The closing date for responses is 14 October
2009.
Reference: http://www.defra.gov.uk/corporate/con-
sult/mercury/index.htm
The Chemicals Regulation Directorate
The Chemicals Regulation Directorate (CRD)
is a Directorate of the Health & Safety Ex-
ecutive (HSE). The Directorate contributes
jointly and specifically to HSE and Defra’s ob-
jectives. The primary aim of the Directorate
is to ensure the safe use of biocides, industrial
chemicals, pesticides and detergents to protect
the health of people and the environment.
The Directorate is responsible for the regu-
lation of biocides, pesticides, detergents,
chemicals as they are regulated by REACH,
and duties under the Classification and La-
belling regime. The Directorate also delivers
a number of other responsibilities including
Prior Informed Consent (imports/exports
legislation), specialist expertise to other parts
of HSE (e.g. toxicology expertise) and inter-
national representation of UK interests in
chemicals regulation.
Journaal Stoffen en Preparaten november 2009, Nr. 9 255

The major role is to deliver Competent Au-
thority functions within EU legislation regu-
lating chemicals, pesticides, biocides and de-
tergents where HSE is the appointed authority
for the UK.
Reference: http://www.pesticides.gov.uk/home.asp
Plant Protection Products
A table has been added showing the imple-
mentation of various directives amending the
Placing of Plant Protection Products on the
Market Directive 91/414/EC Commission Di-
rective 2009/25/EC of 02 April 2009 amending
Council Directive 91/414/EEC extending the
use of pyraclostrobin as an active substance
http://www.hse.gov.uk/aboutus/furtherinfo/
policy/transposition/tn91414ec.htm
Pesticide Residues
The Pesticide Residues Committee (PRC) has
published their 2008 annual report, the first
quarterly report in 2009 and findings from the
Department of Health’s School Fruit and Veg-
etable Scheme (fruit and vegetables tested for
pesticide residues) for Spring 2009
http://www.hse.gov.uk/press/2009/e09084.
htm
http://www.hse.gov.uk/press/2009/e09083.
htm
http://www.hse.gov.uk/press/2009/e09085.
htm
The list of new products and amendments to
existing products that have gained approval
via the HSE during August 2009 has been
published.
http://www.hse.gov.uk/biocides/copr/approv-
als/approvals0809.pdf
Biocidal Products
The HSE has published details of the EU
Commission proposals to derogate some
foodstuffs from the requirements of the re-
view programme with the aim to eventually
amend the Directive itself to take such prod-
ucts out of scope.
256 Journal Chemicals Management November 2009, No. 9
official publications
http://www.hse.gov.uk/biocides/derogation.
htm
HSE is also aiming to make some simple
changes to the Biocidal Product Regulations
2001. HSE is asking current duty holders to
view the draft proposal of changes and give
their opinions via an online questionnaire.
http://www.hse.gov.uk/press/2009/e09072.
htm
Regulation (EC) no. 1272/2008 (CLP)
It is planned that HSE will act as UK Com-
petent Authority for the Regulation on the
classification, labelling and packaging of sub-
stances and mixtures (Regulation (EC) no.
1272/2008). The Regulation, known as the
‘CLP Regulation’, was published in the Official
Journal of the European Union on 31Decem-
ber 2008, and entered into force on 20 Janu-
ary 2009. The Regulation adopts in the EU the
Globally Harmonised System of the classifica-
tion and labelling of chemicals or ‘GHS’, which
aims to provide world-wide harmonised cri-
teria for classifying substances and mixtures
according to their health, environmental and
physical hazards; and world-wide harmonised
hazard communication elements.
The HSE has developed a web page for further
information;
http://www.hse.gov.uk/ghs/eureg.htm
There is also some information (mainly re-
lating to the implementation time scales) for
both the 1st and 2nd ATPs to this regulation:
http://www.hse.gov.uk/legislation/sectionc.
htm
European Union (Period August-
October 2009)
[2009/0196]
O.J. L237, 2009: Council Directive 2009/116/
EC of 25  June 2009 amending Directive
91/414/EEC (plant protection products ) to
include paraffin oils CAS No 64742-46-7, CAS
Sdu Uitgevers
official publications
No 72623-86-0 and CAS No 97862-82-3 as ac-
tive substances
O.J. L237, 2009: Council Directive 2009/117/
EC of 25  June 2009 amending Directive
91/414/EEC to include paraffin oil CAS
No 8042-47-5 as an active substance  […Substances p-phenylenediamine (PPD) and tolu-
O.J. L240, 2009: Commission Decision
2009/700/EC of 10  September 2009 recog-
nising in principle the completeness of the
dossier submitted for detailed examination
in view of the possible inclusion of bixafen
[N-(3′,4′-dichloro-5-fluorobiphenyl-2-yl)-
3-(difluoromethyl)-1-methylpyrazole-4-
carboxamide; CAS 581809-46-3] in Annex I
to Council Directive 91/414/EEC
O.J. L251, 2009: Commission Decision
2009/715/EC of 23 September 2009 concern-
ing the non-inclusion of chlorthal-dimethyl
[dimethyl tetrachloroterephthalate ; CAS
1861-32-1] in Annex I to Council Directive
91/414/EEC and the withdrawal of authorisa-
tions for plant protection products containing
that substance
O.J. L262, 2009: Directive 2009/107/EC of the
European Parliament and of the Council of
16 September 2009 amending Directive 98/8/
EC concerning the placing of biocidal prod-
ucts on the market as regards the extension of
certain time periods
O.J. L267, 2009: Commission Directive
2009/129/EC of 9  October 2009 amending
Council Directive 76/768/EEC concerning
cosmetic products for the purposes of adapt-
ing Annex III thereto to technical progress
[In column ‘f ’ corresponding to reference numbers 26 to
43, 47 and 56 of Part 1 of Annex III to Directive 6/768/
EEC, the text after the first sentence is replaced by the fol-
lowing sentences:
‘For any toothpaste with compounds containing fluorine
in a concentration of 0,1 to 0,15 % calculated as F unless
it is already labelled as contra-indicated for children (e.g.
“for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount
for supervised brushing to minimise swallowing. In case
of intake of fluoride from other sources consult a dentist
or doctor”.]
Sdu Uitgevers
O.J. L268, 2009: Commission Directive
2009/130/EC of 12  October 2009 amending
Council Directive 76/768/EEC, concerning
cosmetic products, for the purpose of adapt-
ing Annex III thereto to technical progress
ene-2,5- diamine (PTD)…]
USA (Period September-October
2009)
[2009/0197]
Federal Register, Vol. 74, No. 146, 31 July
2009, 38878: Nanoscale Titanium Dioxide in
Water Treatment and Topical Sunscreen. En-
vironmental Protection Agency (EPA). Notice
of Public Comment Period.
Federal Register, Vol. 74, No. 148, 4 August
2009, 38878: Sixty-Fourth Report of the
TSCA Interagency Testing Committee to the
Administrator of the Environmental Protec-
tion Agency; Receipt of Report and Request
for Comments. Environmental Protection
Agency (EPA). Notice.
Federal Register, Vol. 74, No. 161, 21 Au-
gust 2009, 42217: Schedules of Controlled
Substances: Placement of 5-Methoxy-N,N-
Dimethyltryptamine [5-MeO-DMT, CAS
1019-45-0] into Schedule I of the Controlled
Substances Act. Drug Enforcement Adminis-
tration (DEA), Department of Justice. Notice
of Proposed Rulemaking.
Federal Register, Vol. 74, No. 163, 25 August
2009, 42896: Toxic Chemical Release Report-
ing; Community Right-To-Know; Request for
Comment on Change of Contractor Handling
Trade Secret Claims. Environmental Protec-
tion Agency (EPA). Notice.
Federal Register, Vol. 74, No. 164, 26 August
2009, 43031: Acrylamide in Food; Request for
Comments and for Scientific Data and In-
formation. Food and Drug Administration,
HHS. Notice; request for comments and sci-
entific data and information.
Journaal Stoffen en Preparaten november 2009, Nr. 9 257

[….In 2002, scientists in Sweden announced the discovery
of the chemical acrylamide in a variety of heated foods.
Further research subsequently determined that acrylamide
can form in some Foods during certain types of high-
temperature cooking . Acrylamide in food is a concern
because it has been found to be carcinogenic in rodents
and is therefore considered a potential carcinogen for
humans…. Acrylamide forms in foods primarily from a
reaction between asparagine, an amino acid, and reducing
sugars such as glucose and fructose. This reaction is part
of the Maillard reaction, which leads to color, flavor, and
aroma changes in cooked foods. Acrylamide formation
usually occurs at elevated temperatures used when frying
or baking (above 120 °C) and in low moisture conditions,
although acrylamide has also been identified in some fruit
and vegetable products heated at lower temperatures or
higher moisture conditions. …]
Federal Register, Vol. 74, No. 164, 26 August
2009, 43031: Children’s Products Containing
Lead; Determinations Regarding Lead Con-
tent Limits on Certain Materials or Products;
Final Rule. Consumer Product Safety Com-
mission. Final rule.
[The Consumer Product Safety Commission (Commis-
sion) is issuing a final rule on determinations that certain
materials do not exceed the lead content limits specified
under section 101(a) of the Consumer Product Safety Im-
provement Act of 2008 (CPSIA). This regulation becomes
effective on August 26, 2009.]
Federal Register, Vol. 74, No. 167, 31 August
2009, 44845: National Toxicology Program
(NTP): Report on Carcinogens (RoC); Avail-
ability of the Draft Background Document
for Formaldehyde; Request for Comments on
the Draft Background Document; Announce-
ment of the Formaldehyde Expert Panel
Meeting. National Institute of Environmental
Health Sciences (NIEHS); National Institutes
of Health (NIH). Availability of background
document; request for comments; and an-
nouncement of a meeting
Federal Register, Vol. 74, No. 182, 22 Septem-
ber 2009, 48153: Implementation of the New
Source Review (NSR) Program for Particulate
Matter less than 2.5 micrometers (PM2.5); Fi-
nal Rule to Stay the Grandfathering Provision
258 Journal Chemicals Management November 2009, No. 9
official publications
for PM2.5. Environmental Protection Agency
(EPA). Final rule
Federal Register, Vol. 74, No. 188, 30 Septem-
ber 2009, 50280: Hazard Communication.
[OSHA is proposing to modify its existing Hazard Com-
munication Standard (HCS) to conform with the United
Nations’ (UN) Globally Harmonized System of Classifi-
cation and Labelling of Chemicals (GHS). OSHA has
made a preliminary determination that the proposed
modifications will improve the quality and consistency
of information provided to employers and employees
regarding chemical hazards and associated protective
measures. The Agency anticipates this improved in-
formation will enhance the effectiveness of the HCS in
ensuring that employees are apprised of the chemical
hazards to which they may be exposed, and in reducing
the incidence of chemical-related occupational illnesses
and injuries.
The proposed modifications to the standard include
revised criteria for classification of chemical hazards;
revised labeling provisions that include requirements
for use of standardized signal words, pictograms, haz-
ard statements, and precautionary statements; a speci-
fied format for safety data sheets; and related revisions
to definitions of terms used in the standard, require-
ments for employee training on labels and safety data
sheets. OSHA is also proposing to modify provisions of
a number of other standards, including standards for
flammable and combustible liquids, process safety man-
agement, and most substance-specific health standards,
to ensure consistency with the modified HCS require-
ments.]
Reference: http://www.osha.gov/SLTC/hazardcommu-
nications/global.html
Side-by-Side Comparison of Proposed
Hazard Communication Standard and Exi-
sting Rule:
http://www.osha.gov/SLTC/hazardcommu-
nications/hcs_side_by_side_draft_100109.
pdf]
Federal Register, Vol. 74, No. 192, 6 Octo-
ber 2009, 51234: Schedules of Controlled
Substances; Placement of Fospropofol [CAS
258516-89-1] into Schedule IV. Drug Enforce-
ment Administration, Department of Justice.
Final rule.
Sdu Uitgevers
official publications
Federal Register, Vol. 74, No. 193, 7 October
2009, 51592: Exposure Factors Handbook:
2009 Update. Environmental Protection
Agency (EPA). Notice of public comment pe-
riod.
[The Exposure Factors Handbook provides a summary
of the available statistical data on various factors used in
assessing human exposure. This Handbook is aimed at
exposure assessors inside the Agency as well as those out-
side who use data on standard factors to calculate human
exposure to toxic chemicals. These factors include: drink-
ing water consumption; mouthing behavior; soil ingestion
rates; inhalation rates; dermal factors, including skin area
and soil adherence factors; consumption of fruits and veg-
etables, fish, meats, dairy products, and homegrown foods;
breast milk intake; human activity factors; consumer prod-
uct use; and residential characteristics. Recommended
values are for the general population and also for various
segments of the population who may have characteristics
different from the general population.]
Reference: http://cfpub.epa.gov/ncea/cfm/recordis-
play.cfm?deid=209866 (1265 pages)]
Federal Register, Vol. 74, No. 193, 7 October
2009, 51643: Advisory Guidance; Transporta-
tion of Batteries and Battery-Powered Devic-
es. Pipeline and Hazardous Materials Safety
Administration (PHMSA), DOT. Safety advi-
sory.
Federal Register, Vol. 74, No. 194, 8 October
2009, 51850: Drinking Water Contaminant
Candidate List 3 – Final Environmental Pro-
tection Agency (EPA). Notice.
[The Environmental Protection Agency is publishing
the third Contaminant Candidate List (CCL 3) since the
Safe Drinking Water Act (SDWA) amendments of 1996.
The CCL 3 is a list of contaminants that are currently not
subject to any proposed or promulgated national primary
drinking water regulations, that are known or anticipated
to occur in public water systems, and which may require
regulation under SDWA. Today’s final CCL 3 includes 104
chemicals or chemical groups and 12 microbiological con-
taminants.]
Federal Register, Vol. 74, No. 198, 15 October
2009, 52896: Hazardous Materials: Chemical
Oxygen Generators. Pipeline and Hazardous
Sdu Uitgevers
Materials Safety Administration (PHMSA).
Direct final rule.
[This direct final rule amends the Hazardous Materials
Regulations to revise the quantity limitation from 25 kg
‘‘gross’’ to 25 kg ‘‘net’’ for packages of chemical oxygen
generators transported aboard cargo aircraft only.]
Federal Register, Vol. 74, No. 200, 19 October
2009, 53498: Review of the National Ambient
Air Quality Standards for Ozone. Environ-
mental Protection Agency (EPA). Availability
of draft document for public review and com-
ment.
Federal Register, Vol. 74, No. 202, 21 October
2009, 53982: Hazardous Materials: Harmoni-
zation with the United Nations Recommen-
dations on the Transport of Dangerous Goods
Model Regulations, International Maritime
Dangerous Goods Code, International Civil
Aviation Organization Technical Instructions
for the Safe Transport of Dangerous Goods
by Air, and Transport Canada’s Transport of
Dangerous Goods Regulations. Pipeline and
Hazardous Materials Safety Administration
(PHMSA), DOT. Advanced notice of pro-
posed rulemaking (ANPRM).
Federal Register, Vol. 74, No. 200, 19 October
2009, 54334: Combustible Dust. Occupation-
al Safety and Health Administration (OSHA),
Labor. Advance notice of proposed
rulemaking.
[In this advance notice of proposed rulemaking (ANPR),
OSHA is requesting comments, including data and other
information, on issues related to the hazards of combus-
tible dust in the workplace. For the purposes of this notice,
the term ‘‘combustible dust’’ includes all combustible par-
ticulate solids of any size, shape, or chemical composition
that could present a fire or deflagration hazard when sus-
pended in air or other oxidizing medium. OSHA plans to
use the information received in response to this notice in
developing a proposed standard for combustible dust.]
Journaal Stoffen en Preparaten november 2009, Nr. 9 259

INTERNET
The EU Interactive Terminology
database can help find EU-specific
terms
[2009/0198] the Downstream Users of chemical substances
It is the EU-interinstitutional multilingual
term database where you can find EU-specific
terminology and jargon, as well as terms from
all sorts of areas, such as law, agriculture,
information technology and many others.
IATE means interactive Terminology for Eu-
rope and brings together all the information
previously included in the European institu-
tions’ former terminology databases, such as
EURODICAUTOM from the Commission,
EUTERPE
from the European Parliament and TIS from
the Council.
IATE has 8.4 million terms, including approx-
imately 540 000 abbreviations and 130 000
phrases, and covers all 23 official EU languag-
es. New terms are added every day and the
contents are constantly updated.
References: http://iate.europa.eu/iatediff/switchLang.
do?success=mainPage&lang=en
Contact address: iate@cdt.europa.eu
Source: http://www.bcci.bg/een/en/bul-
letin/3_EUServicesBulletin_20081219.pdf
260 Journal Chemicals Management November 2009, No. 9
official publications
CALENDER OF EVENTS &
IMPORTANT DATA
[2009/0199]
30 November 2009:
REACH: There are less than a few weeks left for
to inform their suppliers of the use they make
of the substance. The deadline, 30 November
2009, applies only if the substance needs to be
registered before 1 December 2010.
Info: http://echa.europa.eu/doc/press/na_09_19_
du__communication_final_20091012.pdf
30 November 2009:
REACH: The final deadline for the pre-reg-
istration of certain chemical substances and
high volume manufacturers and importers.
This deadline applies to companies within the
first 6 months of manufacturing, importing
or using a phasein substance that needs to be
registered by 30 November 2010.
Info: http://echa.europa.eu/doc/press/na_09_21_
late_pre-reg_ends_final_20091014.pdf
11-14 January 2010
RIVM-IRAS course on Chemical Safety As-
sessment under REACH
Bilthoven, the Netherlands
Info: www.iras.uu.nl >> Education >> Short courses
Sdu Uitgevers
Sdu Uitgevers Journaal Stoffen en Preparaten november 2009, Nr. 9 261
Colofon
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Alle rechten voorbehouden. Niets uit deze uitgave mag worden verveel-
voudigd, opgeslagen in een geautomatiseerd gegevensbestand, of openbaar
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Voorzover het maken van kopieën uit deze uitgave is toegestaan op grond
van artikel 16b Auteurswet 1912 jo het Besluit van 20 juni 1974, Stb. 351,
zoals laatstelijk gewijzigd bij het Besluit van 22 december 1997, Stb. 764 en
artikel 17 Auteurswet 1912, dient men de daarvoor wettelijk verschuldigde
vergoedingen te voldoen aan de Stichting Reprorecht (Postbus 3060, 2130 KB
Hoofddorp). Voor het overnemen van gedeelten(n) uit deze uitgave in bloem-
lezingen, readers en andere compilatiewerken (artikel 16 Auteurswet 1912)
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Citeertitel
Journaal Stoffen en Preparaten jaartal/nummer
(voorbeeld: Journaal Stoffen en Preparaten 2009/1)

ISSN 1574-1079
Journal
Chemicals
Management
Journaal
Stoffen & Preparaten
Chief-editor:
Drs. A.C.H. van Peski
Editorial Board:
Dr. M.M. Kops-Werkhoven
Drs. H.A.F. van Well
Dr. J.A.S.J. Razenberg
Dr. L.J.M. Rodenburg
Drs. G.A. Schouten
Drs. J. Zawierko
Advisory Board:
K. E. Armstrong (U.S.A.)
Dr. R. Fielding (United Kingdom)
Drs. A. Gondová
G. Koh (Singapore)
Dr. C. van Lint (Australia)
Dan Liu (U.S.A.)
S. Park (S.-Korea)
H. Sano (Japan)
S. Savary (Canada)
Ir. C. Sieger (Germany)
J. Simpson (Australia)
Dr. U. Schumacher (China)
E. Snyman (South Africa)
P.G. Tse (New Zealand)
No. 10
December 2009
Volume 6
Part of Stoffennieuws.nl
CONTENT
ARTICLES
[2009/0200] P.R. of China: Notification of new
chemicals / 265
[2009/0201] P.R.of China: Revised regime for ‘new’
chemicals / 269
[2009/0202] Status of the Implementation of GHS in
China / 274
ACTUALITIES
European Union
[2009/0203] ECHA: New publications
November 2009) / 277
International
[2009/0204] Singapore: Occupational Safety and Health
Management Standards / 278
[2009/0205] Australia: Proposal for Regulatory Reform of
Industrial Nanomaterials / 279
[2009/0206] Australia: Disinfectants / 279
[2009/0207] Australia: Stevedoring information
booklets / 280
[2009/0208] Nanosilver and nanotechnology / 281
[2009/0209] Global Update on New Chemicals
Regulations (Period September-October
2009) / 282
OFFICIAL PUBLICATIONS
[2009/0210] The Netherlands
(Period November 2009) / 286
[2009/0211] United Kingdom (Period October 2009) / 286
[2009/0212] European Union (Period October-
November 2009) / 287
[2009/0213] USA Federal Register publications (Period
October-November 2009) / 287
[2009/0214] World Trade Organization
(Period November 2009) / 289
 inhoud

Internet
[2009/0215] Official Journal of the European Union / 289
[2009/0216] Thesis Dr. Theo Vermeire / 289

[2009/0217] CALENDER OF EVENTS & IMPORTANT DATA / 290

264 Journal Chemicals Management December 2009, No. 10 Sdu Uitgevers

articles
articles
P.R. of China:
Notification of new
chemicals
[2009/0200] requires manufacturers and importers of new
by Henk van Peski and Marja Kops-Werkhoven
Like many other countries (Canada, USA,
South-Korea, Japan, The Philippines, Austral-
ia, New Zealand, European Union and in the
near future also Taiwan) the Peoples Republic
of China uses a system of notification of new
industrial chemicals, i.e. substances not listed
on the Chinese Inventory. The Inventory of
Existing Chemical Substances in China 2009
(IECSC 2009) can be found on http://www.
crc-mep.org.cn/iecscweb/IECSC.aspx?La=1.
In September 2003, China’s State Environ-
mental Protection Agency (SEPA) issued its
new chemical notification law, ‘Provisions on
the Environmental Administration of New
Chemical Substances’, with an implementa-
tion date of 15 October 2003.
China has long required registration of
imported chemical products, and has peri-
odically reopened its Inventory of Existing
Chemical Substances, which is available on
SEPA’s website. China’s new chemical notifi-
cation law supersedes the product registration
requirements, which are no longer in effect.
Under China’s law, ‘new chemical substances’
are those which were not imported or man-
ufactured in China prior to effective date of
the law. Although it has not been widely pub-
licized, SEPA has opened the Chinese Inven-
Sdu Uitgevers
tory for nominations of additional existing
substances until 31 March 2004. Substances
eligible for addition to the Inventory are those
that were manufactured, used, or sold in Chi-
na between 01 January 2002 and 14 October
2003.
The National People’s Congress decided to
upgrade the former State Environmental Pro-
tection Administration (SEPA) to Ministry of
Environmental Protection (MEP) in March
2008.
– Registration Certificate: The new law
chemical substances to obtain a ‘registration
certificate’ for a new substance by submitting
to SEPA a notification package. SEPA authori-
ties have indicated that foreign companies
may directly submit notifications without the
use of an agent in China. Notification forms
are available on SEPA’s website, and must be
completed in Chinese. Studies and other sup-
porting documents do not need to be in Chi-
nese; however the results of testing must be
provided in Chinese.
Note: the Hong Kong Special Administrative
Region (SAR), the Macao SAR, and the Sepa-
rate Customs Territory of Taiwan, Penghu,
Jinmen, and Mazu are not a part of the cus-
toms territory of China
– Data Requirements: The new law requires
toxicity and ecotoxicity data to be submitted.
However, specific data requirements and noti-
fication thresholds have yet to be determined.
Article 12: In notifying a new chemical sub-
stance which has been included in the inven-
tories of existing chemical substances in at least
Drs. A.C.H. van Peski is an independent consultant with cli-
ents as ChemWatch, Caulfield, Vic., Australia, GBK Gefahr-
gut Büro GmbH,Ingelheim, Germany and TetraQ, Brisbane,
Australia. He is adjunct-professor at the CIPDD/School of
Pharmacy, University of Queensland, Australia.
Dr. Marja M. Kops-Werkhoven is Senior HSE Manager,
Corporate Scientific and Regulatory Analysis Group, Kodak
Nederland B.V., Bunschoten, The Netherland
Journaal Stoffen en Preparaten december 2009, Nr. 10 265

four countries or regional economic integration
organizations, the notifier is only required to
complete and submit the notification form and
the report of eco-toxicological testing performed
in China.
Ecotoxicity testing must be completed by an
approved laboratory in China. Other test-
ing completed outside of China is subject to
approval for use by MEP. On 23 March 2009,
the Notice on Issuing the List of Qualified
Testing Centres for New Chemical Substances
Registration was published by the Ministry of
Environmental Protection. This notice was
issued in accordance with the Notice on Car-
rying out Inspections on Testing Centres for
New Chemical Substances Registration and
Guidance on Qualified Chemical Testing Cen-
tres (HJ/T155-2004) and listed seven testing
centres which are qualified to carry out eco-
toxicological test for new chemical substances
registration.
‘Chinese creature for test ‘refer to creatures culti-
vated and bred in China complying with stand-
ard for designated test, including Gobiocypris
rarus (rare gudgeon), Xiphophorus helleri
(green swordtail), zebra fish, active sludge, etc.
Article 8: The notifiers shall, prior to the manu-
facture or import of new chemical substances,
complete and submit the notification forms and
the testing reports of new chemical substances,
together with a copy of the document on the qual-
ification of the testing entity(ies), to the Chemical
Registration Centre of SEPA (CRC-SEPA).
The contents of the notification form shall
include information of the new chemical sub-
stance notified: the name(s) and the molecular
structure; the method(s) applied in measuring;
the use(s) of the new chemical substance; the
scheduled annual amount of manufacture or
import; the physico-chemical properties, toxi-
cological and eco-toxicological characteristics;
the measures for accident prevention and emer-
gency responses; and the measures for pollution
prevention and elimination and for waste dis-
posal, etc..
266 Journal Chemicals Management December 2009, No. 10
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articles
In case that the testing data were completed out
of China, the testing entity(ies) involved shall
have been accredited by qualifications the com-
petent authorities of the country in which the
entity(ies) is(are) located.
The ecotoxicological data of new chemical sub-
stances shall include those obtained through
biological tests performed in China by the
application of China’s test organisms.
Article 10: The notifiers may make a serial noti-
fication on the new chemical substances with
similarities in molecular constitutions, simi-
larities or sameness in use(s) and testing data,
whereas the registration certificate shall be
applied for each new chemical substance.
The standard HJ/T 154-2004 contains the
schedule for the data requirements (evalu-
ation levels), as well as the requirements for
each level.
If the single quantity or the annual cumula-
tive quantity Q < 10.000kg, evaluate accord-
ing to the basic level; if 10.000 kg ≤ Q <
1.000.000 kg, evaluate according to the first
level; if Q ≥ 1.000.000 kg, evaluate according
to the second level.
Chapter 6 contains the minimum data require-
ments for the physical characteristics evalua-
tion: The evaluation shall explain the data that
reflect the physical characteristics of the notified
chemical substances, such as melting point,
boiling point relative density, vapour tension,
surface tension, water-solubility, grease-sol-
ubility, pH, n-octyl alcohol/water partition
coefficient, flash point, particle size, and so on.
Chapter 7 describes the data requirements for
the toxicology evaluation:
Basic level: acute toxicity: acute oral toxicity,
acute inhalation toxicity, acute dermal toxic-
ity, skin irritation, eye irritation, and skin sen-
sitization; short-term repeated dose toxicity:
oral toxicity, dermal toxicity, and inhalation
toxicity; mutagenicity: bacterial back muta-
tion test and mammalian extracellular chro-
mosome aberration test.
Sdu Uitgevers
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Level 1, additionally: structure/effect analy-
sis; mutagenicity; reproduction/development
toxicity; repeated dose toxicity (90 days).
Level 2 depends on the judgement of expertise
committee: acute and/or repeated dose toxic-
ity; reproduction/development toxicity (sec-
ond generation).
Chapter 8 deals with the evaluation of the
human exposure (risk assessment).
Chapter 9 is on the evaluation of the ecotoxi-
cological data:
Basic level: algal growth inhibition test; daph-
nia 24h acute immobilization test; fish acute
toxicity test; activated sludge respiration
inhibition test; biodegradation test (or abi-
otic degradation test); adsorption/desorption
screening test.
Level 1 & 2: as basic level. Bioconcentration
test is requested if non-biodegradable
More test data might be requested when the
Committee cannot make evaluation
– Assessment and Inventory Listing: The law
establishes a review period for notifications of
up to 140 days. (Chapter 3). However, this is
the maximum timeframe for review, and most
notifications will be processed more quickly.
After a substance has been approved, China’s
law requires that its production and distribu-
tion be closely monitored. Within five days of
each batch actually manufactured, imported
or transferred, a report must be submitted to
the county environmental protection admin-
istrative department. This information is
then distributed to the municipality and up
to SEPA. Reporting is required until the sub-
stance is listed on the Chinese Inventory. The
law does not specify the timeframe for listing
a substance on the Inventory once it has been
approved, or how this will be accomplished.
SEPA officials have indicated that approved
substances may be subject to a period of con-
tinued monitoring and review before they are
eligible for addition to the Inventory.
Article 19: Any holder of the registration certifi-
cates shall, within 5 days after each batch actu-
Sdu Uitgevers
ally manufactured, imported or transferred new
chemical substances to users, fill in and submit a
record form on manufacture, import or circula-
tion of new chemical substances to the environ-
mental protection administrative department of
the county where the manufacturer or importer
is located.
The environmental protection administrative
department at county level shall, within 5 days
after received the record form, report to the
municipal environmental protection admin-
istrative department; the latter shall, within 5
days after received the record form, report to
the environmental protection administrative
department at the province level; the provin-
cial environmental protection administrative
department shall, within 5 days after receiving
the record form, report to the SEPA.
– Confidentiality: Protection of confiden-
tial business information (CBI) under China’s
law remains a key industry concern. The law
permits notifiers to identify CBI included in
the notification package, and provides for
enforcement against authorities that disclose
such information. However, there have been
many industry complaints regarding SEPA’s
disclosure of CBI submitted during the devel-
opment of the Chinese Inventory. Industry
representatives are working with SEPA to
improve procedures for CBI protection.
Article 9: The notifiers who provide information
materials containing commercial and technical
secrets shall give confidential indications at the
relevant items in the materials. 
The notifiers who will uncover the secrets which
is mentioned in aforesaid item shall inform
CRC-SEPA in written form.
– Exemptions: China’s law provides for only
a handful of specific exemptions from the
notification requirements. These exemptions
are not self-executing. In order to claim one of
these exemptions, a manufacturer or importer
must make a formal application to SEPA and
be approved for the exemption. The follow-
Journaal Stoffen en Preparaten december 2009, Nr. 10 267

ing substances are exempt from notification
under China’s law:
Article 13: In one of the following cases, the
notifier may apply for exemption from the noti-
fication:
(a) The annual amount of manufacture or
import of the new chemical substance does
not exceed 100 kilograms and they are only
used for scientific research purpose;
(b) A polymer containing a new chemical sub-
stance monomer less than 2% (w/w);
(c) The total amount of the manufacture or
import of a new chemical substance does
not exceed 1000 kilograms and they are spe-
cifically used for technologies research and
development. In this case, the manufacturer
or importer may apply for one-year exemp-
tion from notification and no extension will
be granted;
(d) Samples of new chemical substances im-
ported for the purpose of performing the
eco-toxicological tests in China as required
by this Provisions.
Any notifier intending to apply for the exemp-
tion from notification shall submit the appli-
cation form for exemption from notification to
CRC-SEPA, provide the necessary documents
demonstrating the conformities to the afore-
said provision and is obliged to keep a record
of the information on the scientific research
of the substance, the research and develop-
ment of relevant technologies, the quantities
of the substance manufactured or imported,
the names of the customers, and others.
Chemicals Under the Management of Other
Existing Laws and Regulations: Radioactive
substances; Military industry products; Pyro-
technics; Biological substances; Pesticides;
Veterinary drugs; Pharmaceuticals; Cosmet-
ics; Foods; Food additives; Feed; Feed addi-
tives; Tobacco and tobacco products.
– Enforcement: The enforcement provi-
sions of China’s new law provide for fines of
up to 30 000 RMB (3625 USD) for each viola-
268 Journal Chemicals Management December 2009, No. 10
articles
tion of the new chemical notification require-
ments. SEPA is also authorized to record and
publicize violations and refuse approval of
future notifications for up to 3 years. SEPA has
issued guidelines for submitting new chemi-
cal substance notifications; however, these
guidelines are not readily available in English.
Many of the specifics for implementing this
law, such as required data protocols; the status
of impurities and articles; when notified sub-
stances will be added to the Inventory; and a
fee schedule for notification have not yet been
developed. However, SEPA officials stress that
the law is currently effective.
– Standards: On 13 April 2004 the Ministry
of Environmental Protection of The Peoples
Republic of China made an announcement
on the issuance of three industry standards
for environmental protection:
HJ/T 153-2004: The Guidelines for the Testing
of Chemicals
HJ/T 154-2004: The Guidelines for the Haz-
ard Evaluation of New Chemical Substances
HJ/T 155-2004: The Guidelines for Chemical
Testing Good Laboratory Practices
Address:
Branch of New Chemical Substance Manage-
ment
Chemical Registration Centre of MEP
No.115 Xizhimennei Nanxiaojie, Xicheng
District,
Beijing, P.R. of China (100035) 
http://english.mep.gov.cn/contact/200712/
t20071204_113785.htm
References: Provisions on the Environmental Admini-
stration of New Chemical substances
http://www.crc-mep.org.cn/newchem/ene-
wchem.htm
Keller and Heckman LLP: Notification of
New Chemical Substances in China (March
2004)
http://www.khlaw.com/showpublication.
aspx?Show=1118
Sdu Uitgevers
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HJ/ T 154 – 2004: The guidelines for the
hazard evaluation of new chemical sub-
stances (in Chinese)
http://www.sepa.gov.cn/
image20010518/4342.pdf
Guidance for New Chemical Substance
Notification (First version)
Chemical Registration Centre of
SEPA; October 2004 http://english.
mep.gov.cn/special_reports/chemi-
cal_regulation/newchemicals/200712/
P020071217518150802043.pdf
Gao Yingxin: Environmental Management
on Chemicals in China (2007)
http://www.env.go.jp/chemi/reach/second/
gao.pdf
Sdu Uitgevers
P.R.of China:
Revised regime for
‘new’ chemicals
[2009/0201]
by Freshfield Bruckhaus Deringer LLP
In June 2009 Freshfields Bruckhaus Der-
inger LLP published on Internet an interest-
ing briefing paper on the revised regime, that
should come into force in October 2010.
China is overhauling its existing regime for
the notification of new chemical substances to
make it more like the EU’s regime. The regime
only applies to novel substances – ie those not
already listed on China’s chemicals inventory –
so it will not immediately have a direct effect
on all companies in the sector. However, this
is unlikely to mark the end of China’s efforts
to strengthen its chemical safety regime and
regulatory trends in such an important mar-
ket will no doubt be watched with interest by
all chemical companies.
Key points
– China is consulting on new measures to
overhaul its existing regime for the noti-
fication of new chemical substances. If
adopted in the current form, the new rules
would come into force in October 2010.
– The new rules would apply only to ‘new’
chemical substances – ie chemicals other
than the approximately 45 000 substances
currently listed on the Inventory of Exist-
ing Chemical Substances Produced or
Imported in China (IECSC). Substances
listed on IECSC would continue to enjoy
lighter touch regulation.
– The proposed new regime draws on many
elements of the EU’s chemicals regulatory
framework, REACH, and has been dubbed
‘China REACH’. The similarities relate
Journaal Stoffen en Preparaten december 2009, Nr. 10 269

to risk assessment, risk management and
data submission. It would expand on Chi-
na’s existing registration regime for new
chemical substances by increasing the vol-
ume and complexity of data that must be
supplied to the authorities before import
or production. The manufacture, import
or use of a new chemical substance that
had not been properly registered would be
expressly prohibited.
– It appears from the current legislative draft
that data to support product registration
may be submitted only by Chinese-regis-
tered entities. If so, non-Chinese compa-
nies wishing to export innovative products
to China, or to have them manufactured
there, would have to rely on local agents
or affiliates. Moreover, it would be manda-
tory under the regime to use Chinese test-
ing laboratories to generate certain of this
data. As with any other sharing of product
data with a third party, steps will need to
be taken to protect confidentiality.
– Financial penalties for breach of the new
regime would not, on their face, be sig-
nificant. However, the practical costs of
non-compliance – e.g. an inability to pro-
duce, import or use a particular product
– might be more substantial, and the rel-
evant authorities can also require correc-
tive action to be taken in case of breach.
– Compliance with the new regime may be
challenging for those whose products fall
within its scope.
In detail: the new proposals
On 21 May 2009, China’s Ministry of Envi-
ronmental Protection launched an internal,
inter-ministries consultation on a proposal
(the 2009 Measures) to replace its existing
Measures on Environmental Management of
New Chemical Substances, which date from
2003 (the 2003 Measures).
The 2009 Measures would, like the 2003 Meas-
ures, apply only to substances that are not list-
ed on IECSC. There were 45 290 substances
270 Journal Chemicals Management December 2009, No. 10
articles
listed on IECSC, as at December 2008, and
these are and would remain subject to piece-
meal regulation. (There are specific occupa-
tional health and safety rules governing the
marketing and use of hazardous and toxic
chemicals, but no generally applicable rules.
Managerial and enforcement responsibilities
are shared between a plethora of district, pro-
vincial and state entities).
Already, under the 2003 Measures, manufac-
turers and importers of new chemical sub-
stances must obtain a ‘registration certificate’
prior to manufacture/import. They do so by
notifying toxicological and other data to the
Chemical Registration Centre (the CRC)
of the Ministry of Environmental Protec-
tion. The 2009 Measures would not change
this basic structure, but would significantly
increase the burden on industry in terms of
data production and ongoing risk manage-
ment obligations.
The main features of the new regime are:
– Under the 2009 Measures, the CRC must
be notified, and a registration certificate
obtained, before a new chemical sub-
stance may be manufactured in China or
imported into China. The manufacture,
import or use of a new chemical substance
that has not been so registered is expressly
prohibited. For example, a valid registra-
tion certificate will need to be provided to
the General Administration of Customs
before any import is permitted (Article 5).
– On notification of a new chemical sub-
stance manufactured or imported at over
1 tonne per year, the manufacturer or
importer must provide:
– the appropriate notification form;
– a test report detailing the substance’s
physicochemical properties and its toxic-
ity and eco‑toxicity;
– an environmental risk assessment report
(covering a variety of areas, including
exposure scenarios, control measures,
pollution prevention control and waste
disposal);
Sdu Uitgevers
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– recommendations on classification and
labelling; and
– a chemical safety data sheet.
– The level of data required will increase
depending on the annual tonnage band of
the substance in question (1-10, 10-100,
100-1000 or 1000+ tonnes). This principle
is described as ‘the higher the volume, the
more information required’ (Article 8).
– Less onerous requirements apply in the
case of new chemical substances, which:
– are manufactured/imported at under 1
tonne a year;
– are low-volume intermediates for export;
– are polymers containing less than 2 per
cent monomers and which are ‘of low
concern’ (a term which is not defined in
the 2009 Measures); or
– fall into defined categories of low-volume
substances for scientific research or for
technical research and product develop-
ment.
However, while the contents of the notifica-
tion dossier may be reduced (in some cases,
substantially so) for new chemical substances
of this sort, notification is still required for all
such chemicals (Article 8).
– On the wording of the current draft, cer-
tain fast-track notifications may only be
made by an entity registered in China
(Article 10). However, it is unclear, based
on the current draft, whether this require-
ment in fact applies to all notifications -in
other words, whether only China-based
companies can notify. If so, this would
be similar to the situation under REACH,
except that REACH, unlike the 2009 Meas-
ures, expressly provides for the appoint-
ment of ‘only representatives’ by non-EU
manufacturers.
– However, it is clear on the wording of the
current draft that the eco-toxicological
test report included in the notification
dossier (where required) must ‘include
testing data using Chinese target organ-
Sdu Uitgevers
isms within the territory of the People’s
Republic of China’ (Article 8). (However,
data testing more generally may be carried
out by both accredited overseas and Chi-
nese laboratories (Article 11)). Use of Chi-
nese laboratories will therefore be manda-
tory in most cases.
– Notifications may be submitted jointly
with other applicants. Applicants may also
rely on data already submitted to support
the registration of the same new chemical
substance, but only with the agreement of
the prior applicant (Article 10).
– The CRC will consider any notification
submitted to it and will classify the sub-
stance in question in one of three ways:
as a general chemical substance, a hazard-
ous chemical substance or as a chemical
substance of environmental concern. If it
is satisfied that the information supplied
to it meets the statutory requirements, the
CRC will issue a registration certificate.
However, it is not permitted to register
a chemical substance of environmental
concern unless the application has been
accompanied by the appropriate risk con-
trol measures (Article 13).
– Registrants and end users of new chemical
substances are required to adopt various
risk management measures covering haz-
ard and exposure in the areas of labelling
and packaging, transportation and dispos-
al. Stricter risk management obligations
and supply chain information obligations
will apply in the case of substances clas-
sified as hazardous or of environmental
concern (Articles 7 and 19-21).
– There are also various post-registration
reporting and record-keeping require-
ments. For example, a ‘first‑time activ-
ity report’ must be submitted to the
CRC within 30 days of the first produc-
tion or transfer of a registered substance.
In the case of new chemical substances
of environmental concern, registrants
must file similar reports each time they
Journaal Stoffen en Preparaten december 2009, Nr. 10 271

transfer such substances to other market
actors, and processors and users must file
such reports within 30 days of their first
processing or use of such a substance
(Article 23).
This permits the Ministry of Environmental
Protection to issue ‘administrative control
notices’ to local Environmental Protection
Bureaus, which will set conditions for the
processing or use of substances classified as
hazardous and of environmental concern
(Article 26).
– Enforcement is by the Ministry of Envi-
ronmental Protection and local Bureaus
(Articles 35-37). All such regulators may
impose financial penalties of between
RMB10 000 (approx €1050) to RMB30
000 (approx €3150) and require corrective
measures be taken for violation of speci-
fied requirements under the 2009 Meas-
ures. These include failing to notify new
chemical substances before production/
import, failing to disclose relevant infor-
mation during the notification process,
providing false data to the CRC and failing
to comply with an administrative control
notice.
– Private prosecutions by companies and
members of the public are also foreseen
(Article 29). It is possible that this may
become a tool for competitive regulation
– ie taking legal action to sanction com-
petitors’ failure to comply with the law.
What does this mean for the international
chemicals industry?
Since the EU first began debating REACH,
there has been speculation that other coun-
tries would be forced by the globalised nature
of the chemicals industry to introduce similar
controls. In the US, the bill to introduce the
Kid-Safe Chemicals Act of 2008, which would
have required (among other things) manu-
facturers of existing chemical substances to
provide all reasonably available information
not previously submitted concerning those
272 Journal Chemicals Management December 2009, No. 10
articles
substances to the Environmental Protection
Agency, ran out of time. However, similar leg-
islation may well be introduced into the cur-
rent session of Congress. As regards the major
Asian economies, the authors of a recent study
noted that legislators were ‘trying to fill the
regulatory gap they see between REACH and
their own chemical regulatory systems’. They
predicted that ‘China may follow at a slower
pace. Not because China is not willing to do
so, but because its existing chemical control
system has a complex structure governed
by multiple Ministries’ and its scientific and
testing infrastructure might require develop-
ment.
Although to describe the 2009 Measures
as ‘China REACH’ is probably to overstate
the case, they do represent a significant step
towards introducing a REACH -style regime in
China. By this, we mean that they are intended
to bolster the 2003 Measures by introducing
REACH -style data submission requirements
and ongoing risk management obligations,
while continuing to apply only to non IECSC-
listed chemicals (REACH, by contrast, applies
to both existing and new substances, although
existing substances listed on the EU inventory
(EINECS) benefit from extended deadlines
for registration if duly pre-registered. They
are unlikely to mark the end of China’s efforts
to strengthen its chemical safety regime, par-
ticularly since they are administered by the
new Ministry of Environmental Protection
(MEP) – a powerful ‘super-ministry’ created
in 2008 from the State Environmental Pro-
tection Administration (SEPA). Regulatory
trends in such an important market will no
doubt be watched with interest by all chemical
companies.
The 2009 Measures will of course be of par-
ticular interest to businesses that export inno-
vative chemical substances, or preparations
containing such substances, to China or that
manufacture them there (either themselves
or under licence). This might include those
involved in nanotechnology development,
Sdu Uitgevers
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since, unlike REACH, a notification will still
need to be made in the case of new chemical
substances manufactured/imported at under
1 tonne per year (although, as noted, there
are reduced data submission requirements in
these cases).
As well as the practical challenges involved in
generating the datasets required to support
notification/registration, the proposed meas-
ures raise concerns from the perspective of
commercial confidentiality. If, ultimately, it
remains the case that notifications may only
be filed by Chinese-registered entities, foreign
exporters with no affiliates in the territory are
likely to have to appoint an agent in China for
these purposes. In addition, the need for eco-
toxicological test reports to include China-
generated test data means that sensitive prod-
uct information may also have to be shared
with testing houses there. As with any instance
in which sensitive information is shared with
a third party, businesses would be advised to
ensure that robust arrangements are in place
to protect confidentiality.
In the short to medium term, there may also
be questions as to the capacity of China’s
existing technical infrastructure to support
the services required of it by the measures.
Possibilities for influencing the legislative text
appear limited. The current consultation was
scheduled to close on 28 June 2009 and is in
any event only open to designated government
authorities and to certain trade associations
(the China Petroleum and Chemical Indus-
try Association, the Chinese Chemical Soci-
ety, the Association of International Chemical
Manufacturers and the European Chamber of
Commerce in China).
Since the 2009 Measures are currently sched-
uled to come into force on 15 October 2010,
businesses that may be affected should start
planning for compliance now.
Finally, it is currently unclear how a number
of elements of the proposed regime will func-
tion in practice. Key issues include how joint
notification or cost-sharing between a noti-
Sdu Uitgevers
fying party and a previous registrant of the
same substance will operate; how ‘adminis-
trative control notices’ served by the relevant
local regulators may affect a business’s ability
freely to market its products; and, more gen-
erally, the impact of the designation of a new
chemical substance as hazardous or of envi-
ronmental
concern. The Ministry of Environmental Pro-
tection is expected to update its existing Guid-
ance for New Substance Notification after the
draft measures come into effect, and other
elements of the regime should become more
certain with time.
Preparing for compliance
– Establish whether any products that you
are planning to bring to market in, say, the
next five years are likely to be caught by
the new regime. In other words: do you
plan to export any new product to China,
or produce any new product there, that
contains substances that are not listed on
IECSC? If so, are you planning to do so
after the 2009 Measures come into force?
– Consider whether it might be possible to
accelerate your plans, in order to be able
to notify under the less onerous current
regime.
– Consider whether your products might
fall within one of the categories for which
less onerous obligations will apply under
the 2009 Measures.
– For products that will require a full noti-
fication dossier, work out what the data
requirements are likely to be (on the basis
of the applicable guidance) and consider
your strategy for gathering the necessary
data and presenting it in due course. It
may be possible to repackage existing data
that is being or has been generated in the
context of, for example, REACH registra-
tion.
Previous experience suggests that managing
registration effectively will involve bringing
together a number of different perspectives
Journaal Stoffen en Preparaten december 2009, Nr. 10 273

from across the organisation – production,
quality/environmental/health and safety, legal
etc.
– Establish needs for testing by third party
laboratories, in China or elsewhere.
– Consider your current arrangements in
China. Do you have an existing affiliate
who could manage notification and regis-
tration for you, as required? If not, is there
a natural candidate who might act as an
agent for you?
– Formal contractual arrangements, com-
pliant with local legal requirements, ought
to be put in place with any Chinese test-
ing laboratory or third party importer, not
least to protect business sensitive informa-
tion.
References: http://www.freshfields.com/publications/
pdfs/2009/jun09/26185.pdf
See also: The New Chemical Substance Notification
Guideline.
http://www.hklaw.com/id24660/Publicatio-
nId2674/ReturnId31/contentid54215/
REACHing Asia: Recent Trends in Che-
mical Regulations of China, Japan and
Korea’, DaeYoung Park, Me-Young Song,
Kwi-Ho Lee, Duk-Chan Yoon, Xiong
Cong, Social Science Research Network
Working Paper Series, 18 April 2008 (last
revised 26 June 2008). An electronic copy
of this study is available at http://ssrn.com/
abstract=1121404
REACHing Asia Continued, DaeYoung
Park, 16 September 2009.
http://papers.ssrn.com/sol3/papers.
cfm?abstract_id=1474504
274 Journal Chemicals Management December 2009, No. 10
articles
Status of the
Implementation of
GHS in China
[2009/0202]
On 17 March 2009 Mr Gao Yingxin of the
Chemical Registration Centre of MEP pre-
sented a paper on the status of the GHS
implementation in the P.R. of China.
The China’s law and regulation system include
four levels: the first level is the laws approved
and promulgated by the People’s Congress;
the second level is the administrative laws
promulgated by State Council; the third level
is the regulations issued by each Ministry; the
fourth level is the national standards.
– Laws concerning Chemicals: Law of the
People’s Republic of China on Work Safe-
ty, promulgated in June 2002, taking effect
on 1 November 2002; Law of the People’s
Republic of China on Prevention and
Control of Occupational Diseases, prom-
ulgated in January 2001, taking effect on
1 May 2002.
– There are also several Administrative
Regulations: Regulations of the People’s
Republic of China on monitored and
controlled chemicals, promulgated by the
State Council in 1995; Regulations of the
People’s Republic of China on the control
of agricultural chemicals, promulgated
by the State Council in 1997, amended
in 2001; regulations on the control over
safety of dangerous chemicals, promul-
gated by the state council in January 2002,
taking effect on 15 March 2002, manufac-
turers are requested to make MSDS and
labelling for chemicals in certain lists;
Regulation on work safety licenses, prom-
ulgated by the State Council in January
2004; Regulations on labour protection
in workplaces where toxic substances are
used, promulgated by the State Council
Sdu Uitgevers
articles
in April 2002; Regulations for adminis-
tration of precursors and chemicals used
in production of narcotic drugs and psy-
chotropic substances, promulgated by the
State Council in May 2005.
– … and Ministerial Regulations: Measures
for the administration of operating licens-
es for hazardous chemicals, issued by the
former State Economy and Trade Com-
mission (SETC) in 2002; Measures for the
administration of registration of hazard-
ous chemicals, issued by SETC in 2002;
Measures for the administration of pack-
aging and container fixed-point produc-
tion, issued by SETC in 2002; Regulation
of environmental management on the first
import of chemicals and the import and
export of toxic chemicals, jointly issued
by the former SEPA, SETC and General
Administration of Customs (GAC) of in
1994; Measures for environmental man-
agement of new chemical substances,
issued by SEPA in 2003;
Management measure for pesticide label
and instruction, issued by Ministry of
Agriculture (MoA) in November 2007, to
specifically provide the label and introduc-
tion of pesticide, including the content,
symbol, production, usage and manage-
ment requirement which need to be noted
in the label and introduction.
– and National Standards for chemical
classification: Classification and code of
dangerous goods (GB6944-2005); List of
dangerous goods (GB12268-2005); Classi-
fication and labels of dangerous chemical
substances commonly used (GB13690-
1992); Levels, Classification and Code of
Hypertoxic Substance (GA57-93); Clas-
sification of health hazard levels from
occupational exposure to toxic substanc-
es (GB5044-85); Safety rules for clas-
sification, precautionary labelling and
precautionary statements of chemicals
(26 items) (note: the 26 items are fully
transferred from UN-GHS, no aspiration
Sdu Uitgevers
hazards currently); The guidelines for
the hazard evaluation of new chemical
substances（HJ/T 154-2004); 16 standards
on Chemical hazardous properties test
methods (GB 19458-04, GB 19452-04, GB
19455-04, GB 19456-04, GB 19521.1-04
up to GB 19521.10-04, GB 19521.13-04,
GB 19521.14-04);
The principle of classification of trans-
port Packaging groups of dangerous
goods (GB/T 15098-94); Rule for the
Storage of Common Dangerous Chemi-
cals (GB15603-1995); Symbols for the
Transport of Dangerous Goods (GB191-
2000); Material Safety Data Sheet (GB/T
17519.1-1998): Part 1 content and order
of sections (replaced by GB/T16483-
2008); Material Safety Data Sheet (GB/T
17519.2-2003): Part 2 detailed rules for
preparation; General rule for classification
and hazard communication of chemicals
(already sent to WTO according to TBT
Agreement and waiting for reply).
GHs implementation is a complex process in
China, several institutions play a role: Joint
promotion by ministries and committees:
Lead Department: National Development
and Reform Commission (NDRC); Partici-
pating departments: MEP, Ministry of Health
(MoH), Ministry of Commerce (MoC), Min-
istry of Public Security (MPS), Ministry of
Transport (MoT), General Administration of
Quality Supervision, Inspection and Quar-
antine (AQSIQ), the State Administration of
Work Safety (SAWS), etc.
The problems and challenges for implement-
ing GHS are: Multi-departments involved,
not yet formed AN inter-ministerial coordi-
nation mechanism; Lack of uniform plan for
GHS implementation; Distempered system of
chemical management laws; Technically dif-
ficult for China to ensure the timeliness of
GHS, due to quick update of GHS; Lack of
experts and experiences of GHS classification;
Authoritative data information of the sub-
Journaal Stoffen en Preparaten december 2009, Nr. 10 275
 articles

Difference between UN GHS and China’s GB

HEALTH UN GHS National Standards of China
HAZARDS (Second revised edition, 2007) (GB…-2006)

Acute toxicity (gases) Category 1 Category 1

Category 2 Category 2
Category 3 Category 3
Category 4: (ATE values is 20 mL/L) Category 4: (ATE values is 5mL/L)
Category 5 Category 5

Reproductive Classification criteria for mixtures： Classification criteria for mixtures:

toxicity Category 1 Category 1
Category 2 Category 2
Additional category for effects on or —
via lactation

Specific target Category 1 Category 1

organ toxicity - Category 2 Category 2
single exposure Category 3 —

Aspiration hazard Category 1 —

Category 2 —

stances is severely in short; Lack of domestic
propaganda.
So the recommendations by Mr.Yingxin are:
Establish and perfect chemical management
law and regulation system; Revise the existing
national standards such as chemical classifi-
cation, label according to GHS classification
requirements; Enhance international coop-
eration and GHS information communion;
Strengthen personnel and technical training
about chemical identification and classifica-
tion; Promote the propaganda of GHS, etc.
National Standards based on GHS
– Safety data sheet for chemical products
– Content and Order of sections (GB/T
16483-2008)
Revised according to GHS requirement of
safety data sheet for chemical products, replac-
es GB/T17519.1-1998 and GB16483-2000;
Stipulates the content and general format of
SDS; Appendix provides the requirements for
the preparation of the 16 items information,
also the requirements for toxicological and
ecological data are revised according to GHS.
– Labelling of Chemicals Based on GHS
(GB/T 22234-2008); Adopts the contents
of JIS Z 7251:2006 (Labelling of Chemi-
cals Based on GHS, Japanese version;
Stipulates the GHS hazards categories
and their label elements (symbol, warning
statements, hazard instruction, etc.).
– General rules for preparation of Chemical
Safety Label (GB15258-1999); Made par-
ticular provisions on the definition, con-
tents, compiling requirements, produc-
tion and usage of chemical safety label. (at
present, the revision has already been done
and sent to WTO, but not issued yet).
– Labels for packages of dangerous
goods(GB190-1990); Stipulates the clas-
sification symbol, size, colour, methods
of usage and so on of the package label of
dangerous goods. (at present, the revision
has already been done and sent to WTO,
but not issued yet).

276 Journal Chemicals Management December 2009, No. 10 Sdu Uitgevers

actualities

Reference: Gao Yingxin (Chemical Registration Centre

of MEP): Status of the Implementation of
GHS in China (17 March 2009) actualities
http://www.chemical-net.info/pdf/GHS_
StatusinChina.pdf

European Union

ECHA: New publications

(November 2009)

[2009/0203]

Guidance on registration (Update 9 Novem-

ber 2009)
This document describes when and how to
register a substance under REACH. It consists
of two parts: one on Registration tasks and
obligations and the other on the preparation
of the Registration Dossier.
Reference: http://guidance.echa.europa.eu/docs/gui-
dance_document/registration_en.pdf

Website subsection restrictions

The European Chemicals Agency has pub-
lished on its website a new subsection con-
cerning restrictions. The web pages describe
existing restrictions as well as the procedure
for new restrictions.
If a substance poses an unacceptable risk
to health or to the environment, it can be
restricted under the Restriction process
described in Title VIII of the Reach Regula-
tion. The Restriction will operate as a ‘safety
net’ to manage risks that are not addressed
by the other REACH processes. Proposals
for Restrictions can be prepared by Member
States or by ECHA on request of the European
Commission.
This new Restriction subsection on ECHA’s
website has been created to give an easy
access to core information on restrictions to
Member States Competent Authorities and
stakeholders. It also facilitates access to the

Sdu Uitgevers Journaal Stoffen en Preparaten december 2009, Nr. 10 277


relevant guidance documents and the submis-
sion format to be used by authorities when a
Restriction proposal is being prepared. It also
explains the main actors and steps to be taken
to arrive of a new or modified restriction.
References: http://echa.europa.eu/doc/press/na_09_27_
restrictions_web_section_20091105.pdf
http://echa.europa.eu/restrictions
Harmonised Classification and Labelling of
Chemical Substances
The European Chemicals Agency has pub-
lished on its website a public consultation on
the proposal to harmonise the classification
and labelling of two chemical substances.
The substances in this consultation, proposed
by Sweden and Germany, are:
– Hexabromocyclododecane (HBCDD)
(Sweden) (CAS 25637-99-4 ), which is
used as a flame retardant (eg in polysty-
rene, then further processed for the pro-
duction of insulation panels/boards or
packaging products, and in textile appli-
cations). Hexabromocyclododecane is
proposed to be classified in category 3 for
reproductive toxicity for possible risk of
both impaired fertility and harm to the
unborn child, and to be labelled with ‘May
cause harm to breastfed babies’.
– Cryolite (Germany) (CAS 15096-52-3),
which is the main constituent of the elec-
trolytic bath in the production of alu-
minium. Germany proposes to change the
current classification by adding classifica-
tion in category 3 for reproductive toxic-
ity as ‘Possible risk of harm to the unborn
child’; and classification as ‘Irritating to
eyes’. It is also proposed to withdraw the
current classification as ‘Harmful if swal-
lowed’.
The Swedish and German authorities have
submitted to ECHA comprehensive dossiers
on these substances and asked for their classi-
fication and labelling to be harmonised across
the European Union.
278 Journal Chemicals Management December 2009, No. 10
actualities
Reference: http://echa.europa.eu/doc/press/
na_09_26_consultations_clp_20091104.
pdf
International
Singapore: Occupational
Safety and Health Management
Standards
[2009/0204]
Singapore has recently published the newly
revised SS 506 Part 1 : 2009 & SS 506 Part
2 : 2009, which are full adoption of OHSAS
18001 : 2007 and OHSAS 18002 : 2008 respec-
tively. The revisions were carried out by an
industry-led Occupational Safety and Health
Management Technical Committee under the
guidance of the Management Systems Stand-
ards Committee, managed by SPRING.
SS 506 : Part 1 : 2009 Occupational safety and
health (OSH) management system – Require-
ments is the result of the revision of SS 506 :
Part 1 : 2004 to align with the new edition of
the OHSAS 18001 : 2007. This part of SS 506
specifies requirements for an OSH manage-
ment system that enables an organisation to
control its OSH risks and improve the OSH
performance. The changes in this revision
include the alignment of the standard more
closely with ISO 14001 : 2004 and ISO 9001
: 2000. New and revised definitions have also
been included to improve the clarity of the
OSH management system.
SS 506 : Part 2 : 2009 Occupational safety and
health (OSH) management system – Guide-
lines for the implementation of SS 506 : Part 1
: 2009 is the result of the revision of SS 506 :
Part 2 : 2004 to align with the new edition of
the OHSAS 18002 : 2008. It provides advice
on the application of SS 506 : Part 1 : 2009 and
explains the underlying principles as well as
Sdu Uitgevers
actualities
describes the intent, typical inputs, processes
and typical outputs, against each require-
ment of SS 506 : Part 1. This will aid in the
understanding and implementation of SS 506
: Part 1.
SS 506 Part 1 and SS 506 Part 2 can be pur-
chased online at http://www.singaporestand-
ardseshop.sg or via E-mail: singaporestand-
ardseshop@toppanleefung.com
Australia: Proposal for
Regulatory Reform of Industrial
Nanomaterials
[2009/0205] the expectations of the community to
This public discussion paper provides NIC-
NAS’s stakeholders (the community, indus-
try and government) with the opportunity to
comment to NICNAS on a reform initiative
to introduce new approaches to the regulation
of industrial nanomaterials. The proposal uti-
lises the existing NICNAS framework, and
proposes some adjustments to address uncer-
tainties in potential risks posed by these novel
materials to health, safety and the environ-
ment. NICNAS has a specific role in the over-
all regulatory framework for industrial chem-
icals in Australia, under legislation provided
by the ‘Industrial Chemical (Notification and
Assessment) Act 1989’. Other government
agencies are responsible for regulation of
nanomaterials in medicines, food, pesticides
and veterinary medicines.
The proposal addresses three elements:
– Regulation of nanoforms of new chemi-
cals;
– Regulation of nanoforms of existing
chemicals;
– The principle of an integrated approach
for industrial nanomaterials within the
NICNAS framework as a longer term
strategy.
Sdu Uitgevers
In particular, noting the NICNAS’s guiding
principles for managing risks posed by new
Technologies it is seeking input as to whe­
ther:
– this strategy provides for the sound man-
agement of industrial nanomaterials;
– the options meet the needs of all stake-
holders to have confidence in the regula-
tory system through protecting human
health and the environment and by pro-
viding a clear regulatory path for indus-
try;
– there are other options which could be
considered; and
– any imposts on industry are balanced
against the objectives of government and
ensure public health, worker safety and
environmental standards are maintained.
Attachment 2 contains an Indicative List of
Nanomaterials, attachment 4 an Overview of
international activities addressing regulation
of industrial nanomaterials.
Reference: http://www.nicnas.gov.au/Current_Issues/
Nanotechnology/Stakeholder_Consulta-
tion.asp
Australia: Disinfectants
[2009/0206]
NICNAS and the TGA have finalised details of
the upcoming Public Consultation to deter-
mine impact of proposed changes to the regu-
lation of disinfectants on business, the com-
munity and government.
Currently disinfectants are regulated by the
Therapeutic Goods Administration (TGA) as
therapeutic goods:
– hospital, household and commercial
grade disinfectants (with ‘specific claims)
undergo a pre-market evaluation for qual-
ity, safety and effectiveness prior to entry
on the Australian Register of Therapeutic
Goods (ARTG):
Journaal Stoffen en Preparaten december 2009, Nr. 10 279

– Such products must comply with Thera-
peutic Goods Order (TGO) 54 which
describes requirements in relation to
composition, packaging labelling and per-
formance;
– hospital grade disinfectants (without ‘spe-
cific claims’) are regulated as listed thera-
peutic devices. This means that they are
not subject to formal pre-market evalu-
ation by the TGA, however information
that reasonably demonstrates the safety
and quality of these goods is required and
they must still be entered on the ARTG
and comply with TGO 54; and
– household and commercial grade disin-
fectants (without specific claims) as well
as sanitizers, sanitary fluids and antibacte-
rial surface wipes are exempt from entry
on the ARTG but are expected to comply
with TGO 54.
Sterilants and instrument grade disinfectants
have been regulated since October 2002 under
the regulatory system for medical devices.
These products are outside of the scope of
this review.
Government seeks to address the following
problems identified with the current regula-
tion of disinfectants:
– An absence of adequate regulation, com-
mensurate with potential risk, for house-
hold and commercial grade disinfectants
(without specific claims), sanitizers, sani-
tary fluids and antibacterial surface wipes
(referred to in this RIS as ‘other prod-
ucts’).
– Currently, listable or registrable disinfect-
ants that contain a new chemical entity
undergo a toxicological evaluation by the
TGA. In the case of other chemical prod-
ucts (not regulated by the TGA), NICNAS
applies a legislated risk framework and,
where necessary, undertakes toxicologi-
cal evaluation of new chemical entities.
However, there is a regulatory anomaly
for household and commercial grade dis-
280 Journal Chemicals Management December 2009, No. 10
actualities
infectants (without specific claims) and
other products. These products fall within
the TGA regulatory framework but are
exempt from entry on the ARTG.
– There is no provision under the Thera-
peutic Goods Act 1989 for the TGA to
undertake a pre-market risk assessment
or toxicological evaluation for new chem-
ical entities contained in these products.
Equally, NICNAS has no jurisdiction to
undertake such assessments because the
products do not fall within the regulatory
remit of NICNAS.
– This poses potential public health and
safety risks and is inconsistent with public
expectations that such products are ade-
quately regulated. The likelihood or extent
of the potential public health and safety
risks is not currently known, particularly
as the identity of the chemicals within dis-
infectant products that are exempt under
the TGA regulatory system is not known.
– Household and commercial disinfectants
(without specific claims) and other prod-
ucts do not comfortably fit within the
TGA regulatory system (even as exempt
products) because the products have less
connection to a therapeutic purpose,
such as the prevention of disease. This is
by contrast to hospital grade disinfect-
ants or disinfectants with specific claims,
where there is a clear expectation that the
products serve to minimise or prevent the
spread of disease.
Reference:  http://www.nicnas.gov.au/Current_Issues/
Disinfectants/Consultation_Disinfectants.
asp.
Australia: Stevedoring
information booklets
[2009/0207]
Safe Work Australia has announced the
release of three guidance publications for the
Sdu Uitgevers
actualities
stevedoring industry: Working Safely on the
Waterfront, Working Safely with General Car-
go – Steel products, and Working Safely with
Containers.
The booklets have been developed by Safe
Work Australia in consultation with a range
of key stakeholders including state and terri-
tory OHS regulators, unions, the Australian
Maritime Safety Authority and the stevedor-
ing industry.
The booklets aim to offer a national approach
to improving safety in the Australian steve-
doring industry by providing guidance on the
best occupational health and safety (OHS)
practice for the industry. The booklets are a
reference tool for employers and employees in
the transport and storage industry, including
shipping agents and stevedoring companies.
The transport and storage industry is listed as
a priority industry under the National OHS
Strategy 2002-2012. There were 45 fatalities
in the industry in 2006-07 and an average of
11000 serious injury claims each year.
The booklets are based on materials originally
developed by WorkSafe Victoria, which have
been adapted for use nationally.
Reference: To download the booklets visit www.safe-
workaustralia.gov.au
Nanosilver and nanotechnology
[2009/0208] EPA is seeking recommendations from the
In early November 2009, a Scientific Advisory
Panel (SAP) has met to evaluate nanosilver
and other nanometal pesticides. Later that
month, Environmental Protection Agency
(EPA) hold a meeting on the latest nanotech
research sponsored by a host of federal agen-
cies. Both meetings have drawn considerable
attention from industry, as companies are
eager for greater clarity on the regulatory sta-
tus of nanomaterials.
Sdu Uitgevers
Scientific Advisory Panel and
Nano-pesticides
The SAP, established under the Federal Insecti-
cide, Fungicide, and Rodenticide Act (FIFRA),
has met in Arlington, Virginia on November
3-6 to ‘consider and review a set of scientific
issues related to the assessment of hazard and
exposure associated with nanosilver and other
nanometal pesticide products.’ As the primary
scientific peer review mechanism for EPA’s
Office of Prevention, Pesticides and Toxic
Substances, the SAP provides scientific infor-
mation, guidance, and recommendations on
pesticide issues, especially the effect of regula-
tory actions on health and the environment.
EPA has used the November meeting to
gather guidance and recommendations from
the SAP on several issues. First, the Agency is
seeking information on how size and other
properties affect the behaviour of nanopar-
ticles in pesticides compared to convention-
ally-sized particles in pesticides. Second, EPA
wants information on the types of data that
would demonstrate that pesticides containing
nanomaterials pose no unreasonable risk of
harm. This is a key question, as registration
of a pesticide under FIFRA requires submis-
sion of data showing that the product will
not have unreasonable adverse effects on the
environment. Specifically, EPA is concerned
about the potential leaching of free nanosilver
and nanometals or nanometal oxides. Finally,
SAP on whether traditional methods of risk
assessment will be effective in the context of
nano-pesticides. For example, EPA predicts
that lower limits of detection will be needed in
order to measure exposure to nanoparticles.
As nano-pesticides are currently in some-
what of a regulatory holding pattern at EPA
pending further progress on these issues, the
meeting is likely to attract substantial indus-
try attention in the hope that EPA will clarify
the Agency’s position on nano-pesticides and
identify the types of data necessary to obtain
registration under FIFRA for such products.
Journaal Stoffen en Preparaten december 2009, Nr. 10 281

EPA Spearheads Nanotech Research
In an effort to better understand “how manu-
factured nanomaterials may harm human
health and the environment,” EPA recently
announced that it will pursue a new research
strategy on nanotechnology. The Agency
seeks to generate data on the use of nanotech-
nology and products containing nanomateri-
als in order to identify potential hazards and
minimize risks. The research will focus on
several manufactured nanomaterials, includ-
ing silver.
EPA’s new strategy will likely build on existing
research sponsored by the Agency. Industry
and other members of the public had a chance
to learn more about research currently being
conducted at the Interagency Nanotechnol-
ogy Implications Grantees Workshop held in
Las Vegas, Nevada on 9-10 November 2009.
The workshop featured the latest research on
nanotechnology sponsored by EPA, National
Science Foundation, National Institutes of
Health, National Institute of Environmental
Health Sciences, National Institute for Occu-
pational Safety and Health, and Department of
Energy. The meeting has been a prime oppor-
tunity to understand the most recent findings
on nanotechnology and gather insight on how
the new information will impact EPA’s regula-
tion of nanomaterials.
State, Federal, and Foreign Agencies Focus
on Nano
EPA is not the only agency focusing on nano-
materials. Nanotechnology is getting attention
from state agencies, as well as foreign bodies.
For more information, see the following arti-
cles: Nanomaterials and REACH: “No Data, No
Market” Rule to Apply to Nanomaterials,; EPA
Issues Significant New Use Rules (SNURs) for
Certain Carbon Nanotubes; California’s Data
Call-ins on Nanomaterials Raise Legal Issues.
References: http://edocket.access.gpo.gov/2009/pdf/
E9-22165.pdf
http://www.epa.gov/nanoscience/files/
nanotech_research_strategy_final.pdf
282 Journal Chemicals Management December 2009, No. 10
actualities
Nanomaterials and REACH: http://
www.khlaw.com/showpublication.
aspx?Show=2805
Carbon nanotubes: http://www.khlaw.com/
showpublication.aspx?Show=3085
California and nanomaterials: http://
www.khlaw.com/showpublication.
aspx?Show=2806
http://www.khlaw.com/showpublication.
aspx?Show=3233
Global Update on New Chemicals
Regulations (Period September-
October 2009)
[2009/0209]
In September and October 2009, approxi-
mately 200 new regulations relating to chemi-
cals management were adopted or published
worldwide. These involve implementation of
GHS, updates to chemical inventories, new
priority chemicals, several changes to the
requirements on transport and handling, and
last but not least restrictions on the marketing
and use of chemicals.
The following overview provides the indica-
tive title in English and the date of adoption.
Further information on any of these new reg-
ulations and what they require from industry
can be found in the Enhesa Update published
by ENHESA (www.enhesa.com). (Selection
only).
Argentina
Restrictions on the transport of goods and
hazardous waste adopted 09-Oct-2009
Guidance on the application of Resolution
(MS) 7/09 establishing limits on the con-
tent of lead in paints, lacquers and varnishes
14-Oct-2009
Resolution 456/2009 banning the manufac-
ture, import, marketing, donation and/or
use of certain chemicals compounds adopted
07-Oct-2009
Sdu Uitgevers
actualities
Australia
Measures to control the use of lead in surface
coatings and inks implemented 05-Feb-2008
NICNAS publishes guidance and application
forms for introduction of low regulatory con-
cern chemicals
South Australia: Amendments impose great-
er controls on drug precursors and related
equipment 10-Oct-2009
Austria
Ordinance on aerosol dispensers 2009 adopt-
ed 29-Sep-2009
Act on fluorinated greenhouse gases adopted
22-Sep-2009
Bahrain
Decree on Implementation of Law No. 33 of
2006 on Wastewater and Surface Water Issued
01-Oct-2009
Brazil
Standard partially implementing the Harmo-
nized System of Classification and Labelling
of Chemicals (GHS) in Brazil entered into
force 26-Aug-2009
Bulgaria
Consolidated version of the Act on the Protec-
tion of Environment issued 10-Jun-2009
Canada
Orders amending the Domestic Substances
List and the Non-domestic Substances List
adopted 16-Sep-2009
Notices published with respect to chemicals
and micro-organisms on the Domestic Sub-
stances List 03-Oct-2009
Significant New Activity Notice No. 15513
adopted regarding tungsten carbide (W2C),
CAS 12070-13-2, 05-Sep-2009
Notice with respect to Batch 11 Challenge
substances published 26-Sep-2009
Orders Amending the Domestic and Non-
domestic Substances List published 14-Oct-
2009
Significant New Activity Notice No. EAU-461
adopted regarding fatty acids, CAS 519050-
73-8, 24-Oct-2009
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Chile
Text of the Sanitary Code adopted 09-Jun-
2009
Toys regulation modified 22-Oct-2009
China
List of eco-label products subject to govern-
ment procurement updated 31-Aug-2009
Inspection and quarantine system for the
imports of solid waste which can be used as
raw material adopted 21-Aug-2009
National Standards containing technical cri-
teria on several environmental and health and
safety in September 2009 01-Sep-2009
Procedures for importing and exporting toxic
chemicals specified 18-Sep-2009
Distilled residue of DMF (N,N’-Dimethyl-
formamide) classified as hazardous waste
22-Sep-2009
Registration rules for consignees importing
solid waste that can be used as raw materials
put on trial 25-Sep-2009
The use of HCFCs (hydrochlorofluorocar-
bons) in 5 types of newly established facilities
is prohibited 13-Oct-2009
Standards on general specifications for trans-
port packages of dangerous goods amended
21-Jun-2009
Costa Rica
Guidance for the transport of dangerous
goods in case of emergencies adopted 23-Sep-
2009
Croatia
Act on Air Quality Protection amended
Czech Republic
Battery Directive transposed by amendment
of the Waste Act 22-Jul-2009
Regulation on aerosol dispensers harmonized
with the EU legislation 17-Aug-2009
Estonia
List of chemicals banned in products of con-
cern and restrictions concerning products of
concern amended 22-Oct-2009
Journaal Stoffen en Preparaten december 2009, Nr. 10 283

Finland
Adopted a Decree amending the Annex to
Decree 853/2004 on the restriction of haz-
ardous substances in electrical and electronic
equipment 03-Sep-2009
Adopted a Decree amending the Decree on
batteries and accumulators 27-Aug-2009
France
Decree relating to batteries and accumulators
and waste batteries and accumulators adopted
15-Jan-2009
Order on the ban on the use of certain bio-
cidal products adopted 09-Sep-2009
Germany
Guidance to perform the Ordinance on
Transport of Dangerous Goods by Road, Rail
and Internal Waterways (GGVSEB) published
24-Jun-2009
Hungary
Amendment to the Decree containing restric-
tions on the use of certain dangerous sub-
stances in electrical and electronic equipment
adopted 22-Oct-2009
Indonesia
Ministry Regulations on distribution, import
and monitoring of hazardous substances are
repealed 15-Sep-2009
Regulation on the Globally Harmonized Sys-
tem of Classification and Labelling of Chemi-
cals (GHS) implementation is published
24-Sep-2009
Indonesia ratifies Stockholm Convention on
Persistent Organic Pollutants 11-Jun-2009
International
Amendments to MARPOL implementing
GHS to go into force as of 1 January 2010
13-Oct-2006
Italy
Manufacturers must communicate the quan-
tities of EEE placed on the market in 2008 and
2009 by the end of the year 29-Jul-2005
Japan
Japanese REACH: Twelve additional sub-
stances prohibited and reporting threshold
for General and Priority Assessment Chemi-
cal Substances established 27-Oct-2009
284 Journal Chemicals Management December 2009, No. 10
actualities
[On 27 October 2009, the amendments to the Order for
Enforcement of the Act on the Evaluation of Chemical
Substances and Regulation of Their Manufacture, etc were
adopted at the Cabinet Meeting, and they were promulgat-
ed on 30 October 2009. By the amendments to the Order
for Enforcement, 9 types of chemical substances (12 sub-
stances including PFOS and its salt) will be added to Class 1
Specified Chemical Substances under the Japanese REACH
(20 May 2009 amendment of the Act on the Evaluation
of Chemical Substances and Regulation of Their Manu-
facture, etc which will come into effect on 1 April 2010).
Use, manufacture and import of those 12 substances will
become prohibited in principle except use of PFOS or its
salt in 3 products after 1 April 2010. Widely used 1 product
including PFOS or its salt in addition to those exempted 3
products will be required to comply with set standards and
to be labelled after 1 October 2010. Additionally, import
of 14 products which include PFOS or its salt, tetrabro-
modiphenyl ether, or pentabromodiphenyl ether to Japan
will be prohibited after 1 May 2010. The amendments of
the Order for Enforcement also include that the technical
guidelines for 11 products which include Class 2 Specified
Chemical Substances will need to be published and label-
ling requirements will apply to handlers of such products
after 1 April 2010. Additionally, the amendments deter-
mine that the threshold for reporting General Chemical
Substances and Priority Assessment Chemical Substances
manufactured or imported is 1 ton. This reporting require-
ment will come into effect on 1 April 2011.]
Latvia
Amendments to Regulations regarding the
Management of Electrical and Electronic
Equipment Waste adopted 04-Aug-2009
Lithuania
Competent authority for the export and
import of dangerous chemicals appointed
09-Oct-2009
Hygiene Norm on prohibited and restricted
substances amended to reflect exemptions
from RoHS Directive prohibitions 22-Oct-
2009
Mexico
NOM-010-SCT2/2009 establishing provi-
sions for the storage and transport of hazard-
ous substances, materials and waste adopted
01-Sep-2009
Sdu Uitgevers
actualities
New Zealand
Regulatory group standard for toxic corrosive
organic peroxides published 16-Oct-2009
Norway
Regulations amending the Regulations on
Classification, Labelling, etc. of Dangerous
Chemicals adopted 22-Apr-2009
Poland
New Ordinance on the format for reporting to
the National PRTR issued 14-Aug-2009
Ordinance on the registry number of entities
putting batteries or accumulators on the mar-
ket or processing their waste issued 21-Aug-
2009
Ordinance on the application for registration
of entities putting batteries or accumulators
on the market or processing their waste issued
20-Aug-2009
Ordinance on the Form of a Report on the
Kind, Quantity and the Mass of Batteries and
Accumulators Placed on the Market issued
24-Sep-2009
Ordinance on the format for reporting on
collection targets for waste batteries and accu-
mulators issued 10-Jun-2009
Consolidated text of the Act on Chemical Sub-
stances and Mixtures published 27-Aug-2009
New Ordinance on declarations on recov-
ery and recycling of electrical and electronic
equipment issued 30-Sep-2009
Portugal
Decree Law on batteries and accumulators
and waste batteries and accumulators amend-
ed 29-Sep-2009
Kiev Protocol of Aarhus Convention on PRTR
approved 15-Sep-2009
Decree Law implementing the REACH Regu-
lation adopted 13-Oct-2009
Rules on the control of drug precursors man-
ufacture and trade reviewed 12-Oct-2009
Singapore
Adopted Biological Agents and Toxins
(Exemption) Regulations 2009 01-Oct-2009
South Korea
Triclosan classified as toxic substance 05-Nov-
2009
Sdu Uitgevers
Two toxic substances and four observational
substances newly designated 24-Sep-2009
List of severely restricted or banned substanc-
es further clarified 05-Oct-2009
Spain
Royal Decree regulating aerosol dispenser
safety manufacturing, labelling and marking
requirements 23-Sep-2009
Switzerland
Ordinance on the transport of dangerous
goods by road amended 01-Sep-2009
Taiwan
Labelling requirements for small toxic chemi-
cal substance containers to be loosened
07-Sep-2009
Risk prevention and response plan notifica-
tion required for transport of toxic chemical
substances 28-Sep-2009
List of countries where controlled substances
or products under the Montreal Protocol can
be imported from or exported to published
10-Sep-2009
Ukraine
Occupational Safety Rules for Processing
and Storage of Ammonium Nitrate in Heaps
Adopted 01-Sep-2009
United Arab Emirates
Fuel Storage Tank Regulations Issued 01-Oct-
2009
United States
Revision to requirements for emergency
response telephone numbers for hazardous
materials transport adopted 19-Oct-2009
EPA adopts significant new use rules for 12
chemical substances 02-Oct-2009
Expanded list of acceptable substitutes for
ozone-depleting substances issued 30-Sep-
2009
Maine: List of chemicals hazardous to human
health issued 19-Jul-2009
Venezuela
New occupational illnesses discussed 06-Oct-
2009
Journaal Stoffen en Preparaten december 2009, Nr. 10 285

official
publications
The Netherlands
(Period November 2009)
[2009/0210] has been recently revised (INDG136 Rev4).
Staatsblad 2009, 440: Wet van 24 september
2009 tot uitbreiding en wijziging van de Wet
milieubeheer in verband met de uitvoering
van de verordening (EG) nr. 1272/2008 van
het Europees Parlement en de Raad van de
Europese Unie van 16 december 2008 betref-
fende de indeling, etikettering en verpakking
van stoffen en mengsels en tot wijziging en
intrekking van de Richtlijnen 67/548/EEG
en 1999/45/EEG en tot wijziging van Veror-
dening (EG) nr. 1907/2006 alsmede daarmee
samenhangende wijzigingen van andere wet-
ten (Uitvoeringswet EG-verordening inde-
ling, etikettering en verpakking van stoffen en
mengsels)
13-11-2009, Staatscourant 2009,14412: Rec-
tificatie Regeling gefluoreerde broeikasgassen
en gereguleerde stoffen koelinstallaties
[In de Staatscourant van 30september 2009,
nr.14412, is gepubliceerd de Regeling gefluo-
reerde broeikasgassen en gereguleerde stoffen
koelinstallaties. Helaas is de tabel in bijlage II
bij de regeling niet geheel correct weergege-
ven.]
286 Journal Chemicals Management December 2009, No. 10
official publications
United Kingdom
(Period October 2009)
[2009/0211]
by Dr Ross Fielding
COSHH and current practice
HSE Guidance on the Control of Substances
Hazardous to Health Regulations (COSHH)
Before publication, HSE wished to test wheth-
er this new format would properly engage
and inform the target audience of Small and
Medium-sized Enterprises (SME’s) and, espe-
cially, micro-businesses. The overall aim of
this project was, therefore, to gather indicative
feedback from this intended user group about
the utility and usability of the draft version of
the new COSHH guidance, and suggestions
for improvements.
The new draft guidance document was con-
sidered to be broadly acceptable, comprehen-
sible, and usable by the end-user community
of SMEs and micro-businesses. Evidence from
the three focus groups points to a number of
key areas within the guidance that address the
main issues of COSHH risk management.
The HSE report (RR737: COSHH and current
practice) on the research behind the revised
guidance is available.
References: http://www.hse.gov.uk/pubns/indg136.pdf
http://www.hse.gov.uk/research/rrpdf/
rr737.pdf
Pesticide approvals for September 2009
New products and amendments to existing
products that have gained approval via the
HSE during September 2009 can be found at:
Reference: http://www.hse.gov.uk/biocides/copr/
approvals/approvals0909.pdf
Biocides law – Consultation has Ended
Consultation on the proposal for a European
Regulation concerning the placing on the
market and use of biocidal products (sched-
Sdu Uitgevers
official publications
uled for January 2013), has ended (5 October
2009).
European Union
(Period October-November 2009)
[2009/0212] information about the hazardous material as needed.
O.J. L274, 2009: Commission Regulation (EC)
No  975/2009 of 19  October 2009 amending
Directive 2002/72/EC relating to plastic ma-
terials and articles intended to come into con-
tact with foodstuffs
O.J. L282, 2009: Commission Directive
2009/134/EC of 28  October 2009 amending
Council Directive 76/768/EEC concerning
cosmetic products for the purposes of adapt-
ing Annex III thereto to technical progress  tification and Listing of Hazardous Waste:
O.J. L286, 2009: Regulation (EC) No 1005/2009
of the European Parliament and of the Coun-
cil of 16  September 2009 on substances that
deplete the ozone layer (recast)
O.J. L292, 2009: Commission Recommenda-
tion 2009/824/EC of 29 October 2009 on the
use of the International Standard Classifica-
tion of Occupations (ISCO-08)
USA Federal Register publications
(Period October-November 2009)
[2009/0213] FR, Vol. 74, No. 207, 28 October 2009, 55502:
FR, Vol. 74, No. 200, 19 October 2009, 53413:
Hazardous Materials: Revision of Require-
ments for Emergency Response Telephone
Numbers. Pipeline and Hazardous Materials
Safety Administration (PHMSA), DOT. Final
rule.
[In this final rule, PHMSA is amending the Hazardous
Materials Regulations to clarify requirements governing
emergency response information services provided by
arrangement with hazardous materials offerors (shippers).
In order to preserve the effectiveness of these arrangements
for providing accurate and timely emergency response
Sdu Uitgevers
information, PHMSA is requiring basic identifying infor-
mation (offeror name or contract number) to be included
on shipping papers. This information will enable the
emergency response information provider to identify the
offeror on whose behalf it is accepting responsibility for
providing emergency response information in the event
of a hazardous materials incident and obtain additional
This new rule also clarified that emergency telephone
numbers outside of the United States, the international
access code or the + (plus) sign, country code, and city
code must also be included, as appropriate.
Effective Date: The effective date of this final rule is
1  October 2010. Voluntary Compliance Date: PHMSA is
authorizing immediate voluntary compliance beginning
18 November 2009.]
FR, Vol. 74, No. 206, 27 October 2009, 55163:
Hazardous Waste Management System: Iden-
Conditional Exclusion From Hazardous
Waste and Solid Waste for Solvent-Contam-
inated Industrial Wipes. Environmental Pro-
tection Agency. Data availability, management
approaches, and request for comment.
FR, Vol. 74, No. 207, 28 October 2009, 55502:
Schedules of Controlled Substances: Place-
ment of 5-Methoxy-N,NDimethyltryptamine
Into Schedule I of the Controlled Substanc-
es Act. Drug Enforcement Administration
(DEA), Department of
Justice. Notice of proposed rulemaking; reo-
pening of comment period.
Lead; Amendment to the Opt-out and Record-
keeping Provisions in the Renovation, Repair,
and Painting Program. Environmental Pro-
tection Agency (EPA). Proposed rule.
FR, Vol. 74, No. 208, 29 October 2009, 55843:
Release of Draft Document Related to the
Review of the National Ambient Air Quality
Standards for Carbon Monoxide. Environ-
mental Protection Agency (EPA). Availability
of draft document for public comment.
FR, Vol. 74, No. 211, 03 November 2009,
56834: Draft Toxicological Review of Trichlo-
roethylene: In Support of the Summary Infor-
Journaal Stoffen en Preparaten december 2009, Nr. 10 287

mation in the Integrated Risk Information
System (IRIS). Environmental Protection
Agency (EPA). Notice of public comment
period.
FR, Vol. 74, No. 211, 03 November 2009,
56842: Draft Guidance for Industry on List-
ing of Ingredients in Tobacco Products; Avail-
ability. Food and Drug Administration,
HHS. Notice.
FR, Vol. 74, No. 213, 05 November 2009,
57278: Hazard Communication; Correction.
Occupational Safety and Health Administra-
tion (OSHA), DOL. Proposed rule: correc-
tion.
[This document corrects the OSHA Hazard Communi-
cation standard proposed rule and request for comment,
published in the Federal Register of 30 September 2009.
This notice corrects eight errors, four in the preamble and
four that appear in Appendix A: Table A.1.1, Table A.1.2,
Table A.2.3, and Table A7.1.]
FR, Vol. 74, No. 213, 05 November 2009,
57313: Draft Toxicological Review of Chloro-
prene: In Support of the Summary Informa-
tion in the Integrated Risk Information Sys-
tem (IRIS). Environmental Protection Agency
(EPA). Notice of listening session.
FR, Vol. 74, No. 214, 06 November 2009,
57424: Significant New Use Rules on Certain
Chemical Substances; Technical Amendment.
Environmental Protection Agency (EPA).
Final rule; technical amendment.
[In the Federal Register of 5 November 2008 EPA issued
direct final significant new use rules (SNURs) for 56
chemical substances which were the subject of preman-
ufacture notices (PMNs). For the chemical substance
identified as Oxetane, 3,3′-[oxybis(methylene)] bis[3-
ethyl- (PMN P–03–471; CAS 18934–00–4), the citation at
§ 721.10095(a)(2)(ii) incorrectly identified one of the haz-
ard communication program requirements. This action
corrects the final regulation.]
FR, Vol. 74, No. 216, 10 November 2009,
57883: Revising Standards Referenced in the
Acetylene Standard. Occupational Safety and
Health Administration (OSHA), Department
of Labor. Final rule; confirmation of effective
date.
288 Journal Chemicals Management December 2009, No. 10
official publications
FR, Vol. 74, No. 216, 10 November 2009,
57974: Combustible Dust. Occupational Safe-
ty and Health Administration (OSHA), Labor.
Notice of stakeholder meetings.
FR, Vol. 74, No. 216, 10 November 2009,
58003: Impact of Implementation of the
Chemical Weapons Convention on Commer-
cial Activities Involving ‘Schedule 1’ Chemi-
cals Through Calendar Year 2009. Bureau of
Industry and Security, Commerce. Notice of
inquiry.
FR, Vol. 74, No. 216, 10 November 2009,
58014: Draft Toxicological Review of cis- and
trans-1,2-Dichloroethylene: In Support of the
Summary Information in the Integrated Risk
Information System (IRIS). Environmental
Protection Agency (EPA). Notice of peer-
review workshop.
FR, Vol. 74, No. 216, 10 November 2009,
58015: Draft Toxicological Review of Hydro-
gen Cyanide and Cyanide Salts: In Support of
the Summary Information on the Integrated
Risk Information System (IRIS). Environ-
mental Protection Agency (EPA). Notice of
peer-review workshop.
FR, Vol. 74, No. 216, 10 November 2009,
58015: Draft Toxicological Review of Trichlo-
roacetic Acid: In Support of the Summary
Information in the Integrated Risk Informa-
tion System (IRIS). Environmental Protection
Agency (EPA). Notice of peer-review work-
shop.
FR, Vol. 74, No. 217, 12 November 2009,
58278: Dimethyldithiocarbamate Salts;
Amendment to Terminate Uses. Environmen-
tal Protection Agency (EPA). Notice.
FR, Vol. 74, No. 217, 12 November 2009,
58279: Certain New Chemicals; Receipt and
Status Information. Environmental Protec-
tion Agency (EPA). Notice.
FR, Vol. 74, No. 218, 13 November 2009,
58688: Air Quality Designations for the 2006
24-Hour Fine Particle (PM2.5) National
Ambient Air Quality Standards. Environmen-
tal Protection Agency (EPA). Final rule.
Sdu Uitgevers
official publications
FR, Vol. 74, No. 220, 17 November 2009,
59112: Schedules of Controlled Substances:
Placement of Carisoprodol Into Schedule IV.
Drug Enforcement Administration, Depart-
ment of Justice. Notice of proposed rulemak-
ing.
FR, Vol. 74, No. 220, 17 November 2009,
59183: Office of Environmental Information;
Announcement of Availability and Comment
Period for Revised Environmental Sampling,
Analysis and Results Data Standards (ESAR).
Environmental Protection
Agency (EPA). Notice of data availability and
request for comment.
World Trade Organization
(Period November 2009)
[2009/0214] official languages of the European Union. One
- USA: Proposed Significant New Use Rules
on Certain Chemical Substances.
EPA is proposing significant new use rules
(SNURs) under section 5(a)(2) of the Tox-
ic Substances Control Act (TSCA) for two
chemical substances which were the subject of
premanufacture notices. The two substances
are identified generically as multi-walled car-
bon nanotubes and single-walled carbon nan-
otubes. These substances are subject to TSCA
section 5(e) consent orders issued by EPA.
The consent orders require protective meas-
ures to limit exposures or otherwise mitigate
the potential unreasonable risk. The proposed
SNURs on these substances are based on and
consistent with the provisions in the underly-
ing consent orders. The proposed SNURs des-
ignate as a ‘significant new use’’ the absence of
the protective measures required in the cor-
responding consent orders. This action would
require persons who intend to manufacture,
import, or process either of these two sub-
stances for an activity that is designated as a
significant new use by this proposed rule to
notify EPA at least 90 days before commencing
Sdu Uitgevers
that activity. The required notification would
provide EPA with the opportunity to evaluate
the intended use and, if necessary, to prohibit
or limit that activity before it occurs.
References: G/TBT/N/USA/499 of 10 November 2009
http://edocket.access.gpo.gov/2009/pdf/
E9-26818.pdf
INTERNET
Official Journal of the European
Union
[2009/0215]
EUR-Lex provides free access to European
Union law and other documents considered
to be public. The website is available in 23
of the publications is the Official Journal of
the European Union. The url has been modi-
fied slightly.
References: http://eur-lex.europa.eu/en/index.htm
Online version of OJ: http://eur-lex.europa.
eu/JOIndex.do?ihmlang=en
Thesis Dr. Theo Vermeire
[2009/0216]
An abstract of the dissertation of Dr. T.G. Ver-
meire on the topic ‘Evaluating uncertainties
in an integrated approach for risk assessment
under REACH: more certain decisions?’ has
been published in Journal Chemicals Man-
agement, No. 07 of September 2009 (pages
181-185).
The complete text of the thesis can now be
downloaded from Internet:
Reference: http://igitur-archive.library.uu.nl/disserta-
tions/2009-0602-201023/vermeire.pdf
Journaal Stoffen en Preparaten december 2009, Nr. 10 289
 Colofon
Redactiesecretariaat
Sdu Uitgevers Tel. (070) 378 92 31
CALENDER OF EVENTS & Postbus 20025 www.sdu.nl/service
IMPORTANT DATA 2500 EA Den Haag

[2009/0217] Hoofdredactie:
Drs. A.C.H. van Peski
27-28 January 2010 Redactie:
Managing SVHCs under REACH and Mw. dr. M.M. Kops-Werkhoven
Understanding CLP Drs. H.A.F. van Well
Brussels, Belgium Dr. J.A.S.J. Razenberg
Info: http://www.ismithers.net/confer- Drs. J. Zawierko
ences/XDAN10/ Uitgever:
Dhr. B. Pijfers
13-14 April 2010
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Info: http://www.ismithers.net/down- site, een e-mail nieuwsbrief en een tijdschrift. Op de site vindt u artikelen
loads/conferences/REACH%20USA%20 over recente wijzigingen in wet- en regelgeving rond chemische stoffen. De
e-mail nieuwsbrief attendeert u op de laatste berichten. Daarnaast ontvangt u
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van artikel 16b Auteurswet 1912 jo het Besluit van 20 juni 1974, Stb. 351,
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Citeertitel
Journaal Stoffen en Preparaten jaartal/nummer
(voorbeeld: Journaal Stoffen en Preparaten 2009/1)

ISSN 1574-1079