Draft Regulation amending Annex XVII, entries 28–29–30
Revisions to Annex XVII of the REACH Regulation aim to align restrictions on placing substances on the market with newly harmonised CMR classifications and to clearly define the application of the additivity rule for specific substance groups
02 Feb 2026Entries 28, 29 and 30, set out in the Table of Annex XVII to Regulation (EC) No 1907/2006, prohibit the placing on the market and use, for supply to the general public, of substances that are classified as carcinogen, germ cell mutagen or reproductive toxicant (CMR) category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council2, and that are listed in Appendices 1 to 6 of Annex XVII to Regulation (EC) No 1907/2006, and of mixtures containing such substances in specified concentrations
The first significant amendment concerns the integration of paragraph 1. The draft text introduces the additivity rules set out in the notes to section 1.1.3 of Annex VI to the CLP Regulation.
This rule is particularly relevant for certain substances, such as boron compound covered by Note 11. The note provides that mixtures are classified as toxic for reproduction where the sum of the concentrations of individual boron compounds classified as such is present at a concentration ≥ 0.3%.
This new approach could therefore lead to a re-evaluation of the classification of mixtures that are currently not considered hazardous for this hazard class.
The second amendment reflects the need to update Appendix 1, 2, 4, 6 and 11 following recent amendments to the CLP Regulation introduced by Commission Delegated Regulations (EU) 2024/2564 and (EU) 2025/1222 (22nd and 23rd ATPs).
It should be noted that this is currently a draft regulation, therefore the provisions described may be subject to further changes and clarifications prior to formal adoption.