The European Union (EU) has expanded its list of
carcinogenic, mutagenic or reprotoxic (CMR) category 1B substances in Annex
XVII of REACH.
Published on December 14, 2021, Regulation (EU)
2021/2204 expands the list of CMR category 1B substances in each of the three
CMR categories falling under entries 28 to 30 of Annex XVII. The total number
of new substances is 29, which is broken down as:
- Entry 28 Carcinogenic
1B: 10 substances, including dibenzo[def,p]chrysene (a polycyclic aromatic
hydrocarbon (PAH)) - Entry 29 Mutagenic 1B:
2 - Entry 30 Reprotoxic
1B: 17, including diisooctyl phthalate (DIOP)
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Chemicals listed in entries 28 to 30 are prohibited as
substances, constituents of other substances, or in mixtures for the general
public if their concentrations are equal to or greater than their specific
concentration limits (SCL) or, if there is no SCL, their general concentration
limit (GCL) under Regulation (EC) 1272/2008 ‘Classification, Labeling and
Packaging of Substances and Mixtures (CLP Regulation). The GCL is 0.1% for a
carcinogenic category 1A or 1B substance, 0.1% for mutagenic category 1A or 1B
and 0.3% for reprotoxic category 1A or 1B.
These changes reflect newly classified CMR substances
under Regulations (EU) 2020/1182 and (EU) 2021/849, both of which amended the
CLP Regulation.
The effective dates for the new legislation are:
- March 1, 2022 – reflect
CMR substances adopted from Regulation (EU) 2020/1182 - December 17, 2022 – reflect
CMR substances adopted from Regulation (EU) 2021/849
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