Draft EU REACH CMR Restrictions Update For Annex XVII

The European Commission has published a draft regulation to amend EU REACH Annex XVII restrictions for carcinogens, germ cell mutagens, and reproductive toxicants, commonly referred to as CMR category 1A or 1B substances. The draft would update restricted substance lists and align mixture threshold rules with CLP. The proposal targets restrictions that apply when CMR substances, or mixtures containing them above specified limits, are supplied to the general public. For consumer-facing supply chains, the immediate task is to identify whether any ingredients become newly restricted as CLP classifications are updated.

What The Draft Would Change

The Commission explains that entries 28, 29, and 30 of Annex XVII prohibit placing on the market and use, for supply to the general public, of listed CMR category 1A and 1B substances and mixtures containing them above specified concentrations. To keep restrictions aligned with CLP, the draft would update Appendices 1, 2, 4 and 6 to include substances with new harmonised CMR classifications under Commission Delegated Regulations (EU) 2024/2564 and (EU) 2025/1222. It also notes that some CAS numbers should be updated for clarity. The draft also proposes changes so mixture thresholds follow CLP additivity rules where applicable.

When The Changes Would Apply

The draft notes that CLP amendments in Delegated Regulation (EU) 2024/2564 apply from 1 May 2026, while Delegated Regulation (EU) 2025/1222 applies from 1 February 2027. The draft regulation would enter into force 20 days after publication in the Official Journal, with restrictions linked to 2024/2564 applying from entry into force and restrictions linked to 2025/1222 applying from 1 February 2027. It also states that operators may apply earlier, and that certain points of its Annex would apply from 1 February 2027.

Practical Implications For Consumer Supply Chains

If you supply consumer products or mixtures, screening needs to cover both ingredient identity and mixture classification logic. In practice, that means mapping formulations to CLP harmonised classifications and validating any additivity calculations used to classify mixtures.

Nitrous Oxide Food Additive Derogation

The draft highlights dinitrogen oxide (nitrous oxide), included in Appendix 6 due to classification as a reproductive toxicant category 1B. It notes that nitrous oxide is authorised as food additive E 942 under Regulation (EC) No 1333/2008 at quantum satis and is subject to EFSA re-evaluation, and proposes a derogation so food use by the general public can continue.

Summary

The Commission’s draft would update EU REACH Annex XVII CMR restrictions by refreshing appendices for newly harmonised CLP classifications, updating some CAS identifiers, and clarifying mixture thresholds where additivity rules apply. For consumer-facing supply chains, the next step is impact screening against the entry-into-force timing and the 1 February 2027 application date.