SG 83/23
The European Union has amended its lists of CMR substances under Annex XVII of REACH. The provisions for newly added substances will become effective on December 1, 2023.
Entries 28 to 30 of Annex XVII of REACH prohibit the use of carcinogenic, mutagenic or reprotoxic category 1A or 1B substances (CMR category 1A or 1B substances) 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, in the absence of an SCL, their generic concentration limits (GCL), under Regulation (EC) 1272/2008 ‘Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation, consolidated version to April 2023). 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.
On June 9, 2023, the EU issued Regulation (EU) 2023/1132 to amend the list of CMR substances in Appendices 1 (Category 1A carcinogenic substances), 2 (Category 1B carcinogenic), 5 (Category 1A reprotoxic) and 6 (Category 1B reprotoxic). This latest revision:
- Revises one entry in each of Appendices 1 (arsenic and its salts, index no. 033-005-00-1), 2 (refractory ceramic fibers (index no. 650-017-00-8) and 5 (lead compounds (index no. 082-001-00-6) and two entries under Appendix 6
- Adds four new entries to Appendix 2
- Inserts 20 new entries to Appendix 6, including two dibutyltin analogs, bisphenol S (BPS) and perfluoroheptanoic acid.
The latest amendment contains two important dates:
- June 29, 2023 – date of entry into force
- December 1, 2023 – date of applicability for the aforementioned 24 newly added entries
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