Does REACH provide sufficient information to regulate mutagenic and carcinogenic substances?
ABSTRACT - The
REACH (Registration, Evaluation, Authorisation and Restriction of
Chemicals) data requirements for mutagenicity and carcinogenicity have
been compared to the criteria for classification under Classification,
Labelling and Packaging (CLP) and the studies used as key evidence by
Committee for Risk Assessment (RAC) in drafting its opinions on the
appropriate classification. This comparison revealed that the REACH
information requirements will not provide sufficient information to
conclude a substance is a Cat 1B mutagen and/or carcinogen. In addition,
requiring such information via a substance evaluation under REACH
requires a large investment from the Member States and takes years.
Classification and labeling is essential in the communication of the
hazardous properties of substances and mixtures and is amongst others an
important first step in the identification of a substance as a
Substance of Very High Concern (SVHC). REACH will hardly generate
sufficient information for classification of substances as category 1B
for mutagenicity and carcinogenicity. Therefore, indications of very
severe hazards of substances are missed and health risks could occur.
There are various ways to deal with this problem, however as most of
these require adaptation of regulations this will cost considerable time
and political will. This study is a first step to raise awareness for
the problem and to start a discussion to search for a sustainable
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