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)
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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