A Commission regulation amending Annex XVII of the REACH Regulation to update restrictions on carcinogens, mutagens, and reproductive toxicants (CMRs) has been published by the Council of the European Union in a cover note dated 10 July 2026. The regulation tightens market restrictions for substances newly classified as CMRs and introduces targeted derogations for lead fishing sinkers and dinitrogen oxide (nitrous oxide), while aligning mixture classification rules with the CLP Regulation.
The regulation updates Appendices 1, 2, 4, and 6 of Annex XVII to include newly harmonised CMR 1A/1B substances from two earlier delegated regulations: Delegated Regulation (EU) 2024/2564 and Delegated Regulation (EU) 2025/1222. Restrictions for substances classified under the 2024 delegated regulation apply from the date of entry into force of this regulation (the twentieth day after publication in the Official Journal). For substances classified under the 2025 delegated regulation, restrictions apply from 1 February 2027, though operators may comply earlier. The regulation also updates CAS numbers for three substances in Appendices 1 and 2.
A derogation from entry 30 is granted for lead fishing sinkers, which will be regulated separately under entry 63. A more detailed derogation is provided for dinitrogen oxide (E 942) when used as a food additive or in food packaging, subject to a review clause linked to the European Food Safety Authority's re-evaluation. For dinitrogen oxide in cartridges sold to the general public, the derogation includes a maximum content limit and age restrictions; aerosol dispensers are excluded from misuse conditions. A separate derogation allows dinitrogen oxide use in motorsports only for competitors in Member States that issue or recognise personal licences. Member States may maintain stricter measures on dinitrogen oxide to address recreational drug abuse.
The regulation deletes the expired derogation in Appendix 11, which ended on 1 June 2013. It also amends entries 28, 29, and 30 to apply additivity rules from Regulation (EC) No 1272/2008 (CLP) for mixture classification, ensuring consistency across EU chemicals legislation.
Stakeholder impact
The regulation imposes new compliance obligations on EU manufacturers, importers, and downstream users of CMR substances, requiring them to update product formulations, labelling, and market authorisations to reflect the newly restricted substances. For the food industry, the derogation for dinitrogen oxide as a food additive provides continued access, but the review clause creates uncertainty pending EFSA's re-evaluation. The nitrous oxide supply chain faces stricter conditions on cartridge sales, including age limits and content caps, aimed at curbing recreational misuse. EU consumers benefit from reduced exposure to newly classified CMRs in products for the general public, though the derogation for lead fishing sinkers maintains a limited exemption for anglers.
Institutional follow-up
The regulation will enter into force on the twentieth day after its publication in the Official Journal of the European Union. The European Commission is expected to monitor implementation and may propose further amendments based on EFSA's re-evaluation of dinitrogen oxide. Member States retain the right to maintain or introduce stricter national measures on nitrous oxide to combat recreational drug abuse.