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Evaluation by the Authorities
An important instrument of quality assurance is the evaluation. Here, the
relevant authorities of the member states will evaluate the registration
dossiers (compliance check) and examine substances which cause concern.
Furthermore, they will study any proposal for animal testing with great
care to limit this practice to an absolute minimum. If suspicious facts
are identified, the authorities themselves may propose measures targeted
at closing the information gap. Resulting from the evaluation, a testing
strategy will be defined and companies will have to put this into practice
within a given period of time. The evaluation of the registered information
will be carried out for all substances exceeding a production volume of
100 tons per year. The role of companies/the industry in the evaluation
is limited; it mainly consists of filling information gaps or commenting
on decision drafts of the chemicals agency.
The Authorisation Process
Substances known or expected to be seriously hazardous require authorisation.
They are labelled "of special concern" and, under REACH regulation,
divided into three groups: Substances that may cause cancer, alter the
genetic information, or result in impaired reproduction (carcinogenic,
mutagenic and toxic to reproduction: CMRs), are authorised only if the
safety of their applications is demonstrated by the industry. Substances
that do not degrade naturally, accumulate in organisms, and are generally
toxic (persistent, bio-accumulative and toxic: PBTs) and substances that
are very persistent and very bio-accumulative (vPvBs) will be identified
through further research. The EU Commission will identify at a later stage
how such substances should be treated – particularly whether they
should be subject to the authorisation procedure. |
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