Professional Documents
Culture Documents
May , 2016
Wei(William) Zhou
Regulatory Consultant
REACH24H Consulting Group
--Value in Compliance
Purpose of webinar
To help comprehensively understanding on the obligations and
special registration types under K-REACH
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Content
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Part 1 overview main obligations under K-REACH/OSHA/CCA
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Legislation background
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Chemical substance management process
Chemical
substance
Priority evaluation
Existing substances authorization
existing substances
Note
3 year grace period for PEC substancesjoint registration for same PEC
Even less than 1 ton/year, registration is required for substances with high hazard to human health and
the environment as designated by MOE through the discussion of relevant ministries
Supply chain communication
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Chemical product management process
Chemical
product
Products contain hazardous
substances Product notification
(above 0.1%&1t/a)
yes Manufacture or
import approval
no Sale
prohibition/withdraw
Note
Risk concerned product designated by MOE such as products for daily use and use for biocides
Product safety and labeling standard (draft) is still under review by chemical safety evaluation
committee(CSEC)
Application of exemption from product notification when meet the exception conditions
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K-REACH scope
substancenew substance and existing substance
existing substance
chemical substances distributed in the market and announced by the MOE in consulting with the
MOEL before 2 Feb, 1991
chemical substances finished hazard review under TCCA and announced by MOE after 2 Feb,
1991
new substancemeans all chemical substances excluding existing chemical substances
NCIS(National Chemical Information System)
NCIS website http://ncis.nier.go.kr/main/Main.jsp
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K-REACH exemption scope
Radioactive substances
Pharmaceuticals and quasi-pharmaceutical drugs
Narcotics
Cosmetics and its raw materials
Agrochemicals and its raw ingredients
agrochemicals Fertilizers
Food, food additives, tools, containers and package
Livestock and fish feeds
Ammunitions
Military supplies
Health functional food
Medical devices
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K-REACH Authority
K-REACH obligation Exemption Simplified General registration and Annual report and
registration enquiry notification of
product
Relevant authority KCMA NIER NIER REO
Official process and Review and Review and issue of Enquiry (within 14d) Annual report
period exemption approval registration no. and Before Jun 30
issued within 3d date or further Completeness check and
requirement within Issue of Registration no. Product notification
In case of further 3 ~7days and date or further Review and issue of
consultation with requirement within 30 confirmation notice
NIER, the exemption days from the or further
approval is issued submission date requirement within 7
within 10 days days
Hazard assessment and
issue of assessment
result
within 6 months for new
chemical,
within 1 year for existing
substance subject to
registration
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Obligation and penalty
Article under k-reach Related obligation Penalty
Article 37 and 38 Safety and label standard Imprisonment not exceeding 7 years
- Fine up to 200,000,000 WON.
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Annual report
Reporting of manufacture (Article 8)
A person who manufacture, import or sell all new chemical and existing chemical
exceeding 1 ton/year shall report its amount and use etc. to the MOE (the local
Environmental agency) annually
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Annual report
Exemption from annual report
Directly exemption
Chemical substance imported as incorporated in machines
Chemical substance imported along with machines or devices for commissioning test
Chemical substances in products in solid form, preforming certain
Functions and does not release during normal condition of use
Other chemical substances as listed in the presidential decree that are manufactured or imported for
uses in research, studies, etc.
In case of any changes made by manufacturer, importer or seller, the change shall be reported within
1 month after the change takes place
In case of any changes made in use category, the change shall be reported within 1 month after the
noticed the change
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Registration
Registration (Article 10)
Existing chemicals subject to registration 1 ton/year and new chemicals required to be
registered prior to their manufacture or import
Even less than 1 ton/year, registration is required for substances with high concerns to human
health and the environment as designated by MOE through the discussion of relevant
ministries
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Registration
Transition period for registration
existing chemical is subject to registration has 3 years from the publication of the priority list
The first PEC list (final) issued in July.1, 2015, containing 510 substances
New substance has no transition period
Public notice of
existing chemical subject to registration
First batch & registration Second batch & registration Third batch & registration
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Registration
Data requirement for general registration
Chemical identity information Chemical name, molecular formula, chemical structure, CAS No, Purity
(%), etc.
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Registration
Data requirement for general registration
Toxicity 2 4 8 11 15
Eco-environment 2 2 5 13 19
In total 9 11 20 33 46
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Registration
Risk assessment -CSR
tonnage Submission time for CSR
100t/a Jan.1.2015
70t/a Jan.1.2017
50t/a Jan.1.2018
20t/a Jan.1.2019
10t/a Jan.1.2020
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Registration
Exemption for registration
Direct exemption
Chemical substance imported as incorporated in machines
Chemical substance imported along with machines or devices for commissioning test
Chemical substances in products in solid form, preforming certain
Functions and does not release during normal condition of use
Low volume exemption (less than 1 ton/year) for existing substance subject to registration
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Registration
Data requirement for exemption confirmation of registration
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Registration
Registration exemption for PLC
1. Subject of exemption a) When average molecular weight of polymers is not less
from registration/definition of low than10,000 daltons, molecules with molecular weight less than
concern polymer 500 daltons have less than 2% content, and molecules with
molecularweight less than 1000 daltons have less than 5%
content;
b) When average molecular weight of polymers is 1,000-
10,000daltons, molecules with molecular weight less than 500
daltonshave less than 10% content, and molecules with
molecular weightless than 1000 daltons have less than 25%
content
2. Exception of polymer a) Cationic polymer (exception: polymer which is used only
subject to exemption in solid state, and insoluble or not dispersible)
from registration b) Polymer whose number-average molecular weight is less
than10,000 daltons and which contains more than 2% of
monomersthat are new chemical substance, hazardous
chemical substance and specific chemical substance prescribed
by Presidential Decree due to its hazard or risk
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Registration
Simplified registration only for new chemical
Risk assessment no no
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Registration
Polymer(non PLC) registration-registration for polymer , not monomer
100-1000t/a
>1000t/a
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Registration
Biocides registration
>100t/a
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Registration
Isolated intermediate registration
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Registration
Joint registration-mandatory
Jonint registration
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Registration
Data sharing and inquiry
Step 4 Submission of dossier to NIER with approval document showing permission from data
owner
Data sharing Physico-chemical data
Hazards data
Data submitted with registration can be used freely after 15 years
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Notification of products
Notification of products containing hazardous chemical substances
Notification conditions (1) Total amount of each hazardous chemical contained in a manufactured or imported
(both 1 and 2) product yearly 1 ton/year
(2) Content of the hazardous chemical contained in a product 0.1%(w/w)
Notification legal entity Manufacture, importer or only representative(OR)
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Management of products of risk concern
Assessment and safe labeling of products of risk concern
Scope of risk products Product with risk to human health and environment and published by MOE through
consultation with relevant Ministries, belong but not limited to:
Household product for general consumer use such as cleansing agent, air freshener,
adhesive, polish, deodorizer, detergent, whitener and softener
Biocidal products such as insecticide, disinfectant, and preservative
15 kind of consumer products has been published in 2015-86 guidance
Risk assessment of risk Minister of Environment will perform Risk Assessments on product
products when categories containing hazardous chemical substances which may
necessary cause harmful damages to human health and environment
Safety labeling for risk MOE have designate and announce safety standards and lebelling standards for risks for
products each product of risk concern after product risk assessment completed
Products management Products not satisfying safety and labelling criteria can not be sold, even withdraw;
Substances in risk concerned products with no safety and labelling criteria can be
requested for registration
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supply chain Communication
Information communication for annual report, registered substances and notified products
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Only representative
Only representative appointed by overseas manufactures (Article 38, 49-54)
A foreign manufacturer who intends to fulfill obligations is required to appoint OR to fulfill the obligation of the
importer;
Annual reporting, reporting update
Application of registration, etc. Registration update , exemption application, inquiry,
Product notification, exemption application, information communication of hazardous substance in product
Supply chain communication
CBI application
OR notification OR shall notify the nomination or dismissal of Only representative to the local
environmental office with relevant documents
OR legal responsibility Penalty will be imposed to OR for offense, heavy fine and imprison
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Legal entity to comply obligation under K-REACH
Outside of Korea
Non Korea
manufacturer A Foreign
formulator B
Foreign exporter C
Note:
(1)Article 38 of K-REACH states that Only manufacture and producer can appoint OR for K-REACH.
(2) Either Foreign manufacturer of the substance or Foreign down-steam producer(formulator) can appoint OR for K-
REACH compliance on behalf of the Korean importers of ones own.
(3) Foreign manufacturer can appoint OR and apply for registration on behalf of Korea importers of his foreign down-
steam formulator.
(4) MoE has clearly stated that trade corporations which not involved in manufacture or produce(formulate) of the
substance cannot be entitled to appoint OR for their K-REACH compliance.
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Obligation of substance registration under K-OSHA
Since K-REACH enforcement, all dossier including hazard test studies for KREACH
registration can be used to cover OSHA registration, without the further data
development.
But there is still conflict in required data between two regulations, only regarding
registration of tonnage band 0.1 to 1 t/y.
prior confirmation of exemption from OSHA registration is required for new chemicals with
less than 100kg.
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Conflict K-REACH vs K-OSHA: Registration with 0.1 to 1 t/y
New chemicals is required to be registered according to both K-REACH and Korea OSHA.
Dossier for Registration over 1 t/y under K-REACH can be used to cover Registration under
OSHA
: No further data development
Registration 0.1~1 t/y is critical: need the additional action to comply with OSHA until 2020
Note: Micronucleus test can be exempted at present, but MOEL might ask for
additional test according to hazard of new chemical.
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How Can Non-Korea exporter comply with K-OSHA?
K-OSHA
When Exporting can be done only after getting the registration notices both from MOE and MOEL.
Who the registration obligators are Korea importers and Korea manufacturers.
TPR is necessary to proceed with new chemical registration, without disclosing the substance information
(such as chemical name, CAS No, structural formulae, etc.) to the Korea importer.
Penalty (1) A person violates new substance registration under Article 40 shall be published by a fine not exceeding
ten million won;
(2) A person fails to keep and post the Material safety data sheet under Article 41 shall be published by a
fine not exceeding five million won.
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Obligation of written confirmation under CCA
Article 9: Manufacturer or Importer of chemicals shall submit a Witten Confirmation of Details for
Chemical Product to the KCMA prior to manufacture or import after careful self-evaluation whether it
contains any regulated chemical.
Regulated chemicals
Subject to submission
Procedure
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Regulated chemicals under CCA
Toxic substance(s)
Restricted Substance(s)
Prohibited Substance(s)
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Part 2 Compliance instructions and Experience sharing
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Substance/ Product information collection and identification
Firstly, Substance/ Product information Collection
Chemical name and each components in the product
CAS no. (if any)
Expected tonnage
Use information in Korea
In this case, Impurities and by-products are not subject to registration and can be directly exemption
from K-REACH.
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Registration exemption confirmation-PLC
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Joint Registration for PEC under K-REACH
General work flow for Joint registration Cautions when take part in the consortiums
Step 1 Conclusion of agreement The method for identifying the SIP (Substance
Identification Profile) will be decided by each consortium
group of the substances.
Step 2 Select a lead registrant
there is no pre-registration system under K-REACH. So, it
Step 3 Confirm substance sameness is need to spontaneously find consortiums for the
substances and join through SIEF-like IT system.
Step 4 Data sharing
SIEF-like IT system designed by MoE is still under
construction. It is expected to release in early next month.
Step 5 Survey on data availability
Step 6 Analysis data gap Data in EU-REACH could be used for K-REACH registration
if the data quality is high (OECD GLP standard), but
copyright should be clarified first.
Step 7 Generate the additionally required data
Some endpoints could be waived according to the rules
Step 8 Discussion on cost-sharing under K-REACH, after data gap analysis and expert
assessment.
Step 9 Preparation on the submission dossier
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Roadmap on K-REACH Join registration
2015 2016 2017 2018
Contents
9 10 11 12 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q
Prior review carried out for the test report (check for
testing institute, schedule, cost, testing institute capacity)
Test request
Uses survey
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Case Study 2- new chemical registration under K-REACH and OSHA(0.1-1)
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Consulting services of K-REACH
Our services
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Thanks for your listening!
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