EU Amends CMR Substances under REACH

SafeGuardSHardgoods, Toys and Juvenile Products, Automotive, Cosmetics & Personal Care, Electrical & Electronics, Personal and Protective Equipment, SoftlinesAug 20, 2025

SG 121/25

The European Union (EU) has revised its lists of carcinogenic, mutagenic or reprotoxic category 1A or 1B (CMR) substances under Annex XVII of REACH. The new law will enter into force on August 31, 2025.

Entries 28 to 30 of Annex XVII of Regulation (EC) No 1907/2006 ‘Registration, Evaluation, Authorization and Restriction of Chemicals (Annex XVII of REACH)’ prohibit the use of CMR category 1A or 1B substances as standalone 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 no SCL exists, their generic concentration limits (GCL), under Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP Regulation, current consolidated version to February 2025). The GCL is 0.1% for carcinogenic category 1A or 1B substances, 0.1% for mutagenic category 1A or 1B substances and 0.3% for reprotoxic category 1A or 1B substances.

On August 11, 2025, the EU issued Commission Regulation (EU) 2025/1731 (the Regulation) revising the lists of CMR substances under entries 28 to 30 of Annex XVII of REACH.

Key highlights of the latest amendment include:

Adding five entries to Appendix 2 (Category 1B carcinogenic substances), including the flame retardant tetrabromobisphenol A (TBBPA)
Incorporating one substance into Appendix 4 (Category 1B mutagenic)
Introducing 12 substances to Appendix 6 (Category 1B reprotoxic), including bisphenol AF (BPAF) and two dibutyltin compounds
Exempting cumene when present as a substance on its own or as a constituent of other substances in kerosene or gasoline aviation fuel under certain conditions.

The first three points above will apply from September 1, 2025.

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