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Registration tration, and substances not registered by the
to such comprehensive testing regulations. until the relevant transitional period expires.
In the absence of pre-registration, the sub-
These old substances were taken up in the
stance will be regarded as a new substance
EINECS list (European Inventory of Exist-
and must be registered immediately.
ing Commercial Chemical Substances)
4. Registration, evaluation and Evaluation of the submitted material data is
approval performed by the European Chemicals Agen-
cy. Where the data suggests an increased
The following transitional periods apply for hazard to humans or the environment, the
the registration of „old substances“: agency can arrange for further studies.
1 December • Substances
2010 > 1,000 t.p.a
(three-and-a- The mandatory authoriza-
• Carcinogenic, mutagenic or repro toxic
half years after tion requirement applies to
substances of category 1 and 2
coming into substances whose proper-
(so-called „CMR substances“)
force) ties give particular cause
> 1 t.p.a
for concern: carcinogenic,
• Substances with the classification R 50/53 mutagenic, repro toxic/
(„very poisonous for aquatic organisms“)
embryotoxic and/or par-
> 100 t.p.a
ticularly environmentally
hazardous substances will
1 June 2013 • Substances
be subject to an approval
(six years after > 100 t.p.a
process by the new EU
coming into
authority;
force)
Objective: To ensure the
substance is only utilized
1 June 2018 • Substances
> 1 t.p.a in applications with a mini-
(eleven years
mal or reasonable risk to
after coming
humans / the environment
into force)
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