On 10 July 2026, the Council of the European Union published a cover note for a Commission regulation amending Annex XVII to the REACH Regulation (EC No 1907/2006), updating restrictions on carcinogens, germ cell mutagens, and reproductive toxicants. The regulation adds numerous new substances to the restricted list, corrects existing CAS numbers, and introduces specific derogations for lead in fishing sinkers and dinitrogen oxide in food and motorsports.
The document, issued as a cover note by the Council, transmits the Commission regulation that will amend entries 28, 29, and 30 of Annex XVII, as well as Appendix 11 on derogations. The changes affect all EU suppliers and users of these substances, imposing new compliance obligations for manufacturers, importers, and downstream users.
Under entry 28 (carcinogens, Category 1A), the regulation corrects the CAS number for 'Hydrocarbons, C4; Petroleum gas' to 87741-01-3 and adds fluoroethylene (CAS 75-02-5). For Category 1B carcinogens, it corrects CAS numbers for two existing entries and adds eight new substances, including multi-walled carbon tubes with specific dimensions (diameter ≥30 nm to <3 μm, length ≥5 μm, aspect ratio >3:1), acetone oxime (CAS 127-06-0), benthiavalicarb-isopropyl (CAS 177406-68-7), 1,4-dichloro-2-nitrobenzene (CAS 89-61-2), trimethyl phosphate (CAS 512-56-1), barium chromate (CAS 10294-40-3), and 1,1-dichloroethylene (CAS 75-35-4).
Entry 29 (germ cell mutagens, Category 1B) gains two new substances: N,N'-methylenediacrylamide (CAS 110-26-9) and trimethyl phosphate (CAS 512-56-1). Entry 30 (reproductive toxicants, Category 1B) adds 14 new substances, including trimethyl borate (CAS 121-43-7), multiple perborate salts, dinitrogen oxide (CAS 10024-97-2), 2-bromo-3,3,3-trifluoroprop-1-ene (CAS 1514-82-5), and 2-ethylhexanoic acid monoester with propane-1,2-diol (CAS 85114-00-7). Six entries are deleted from entry 30, corresponding to Index Numbers 005-017-00-7, 005-017-01-4, 005-018-00-2, 005-018-01-X, 005-019-00-8, and 005-019-01-5.
Appendix 11, which lists derogations from restrictions, sees the deletion of entry 1 and the addition of two new derogations. Lead (CAS 7439-92-1) is granted a derogation for use in fishing sinkers. Dinitrogen oxide (CAS 10024-97-2) receives derogations for use in food cartridges (maximum 18 g per cartridge, 90 g total per supply, age 18+), aerosol food dispensers, and as a performance-enhancing oxidiser in motorsports (requiring a personal license). The Commission is required to review the dinitrogen oxide derogation within three years after the regulation enters into force. National anti-drug laws remain unaffected.
Stakeholder impact The regulation imposes direct compliance costs on chemical manufacturers, importers, and downstream users who must now ensure that the newly restricted substances are not placed on the market or used without authorisation. The addition of multi-walled carbon tubes targets the nanotechnology sector, potentially affecting innovation and production costs. The derogation for lead in fishing sinkers provides relief for the fishing industry and anglers, while the dinitrogen oxide derogation benefits the food industry (whipped cream cartridges) and motorsports, though with strict limits and licensing requirements. EU regulatory bodies gain an expanded scope for enforcement, while national authorities must align their monitoring and anti-drug laws remain unaffected.
Institutional follow-up The regulation, once formally adopted by the Commission, will enter into force 20 days after publication in the Official Journal. The Commission must review the dinitrogen oxide derogation within three years. The European Parliament and Council have the right to scrutinise the regulation under the comitology procedure.