EU Proposes Restrictions on CMR Substances under REACH

The European Union has notified the World Trade Organization (WTO) of a draft Commission Regulation proposing amendments to the REACH Regulation (Regulation (EC) No 1907/2006). The amendment aims to include recently classified carcinogens, germ cell mutagens, and reproductive toxicants (CMRs) in category 1A and 1B of the EU’s Classification, Labelling, and Packaging (CLP) Regulation (Regulation (EC) No 1272/2008). The amendments will extend the scope of Annex XVII of REACH and impose new restrictions on the placing on the market or use of these substances, in particular for supply to the general public. The amendments are in line with the recent harmonised classification of these substances under the CLP Regulation, ensuring stricter control of their use in consumer products.

Key Provisions of the Proposed Regulation

• Extended Restrictions for CMR Substances: The draft Regulation introduces new amendments to Entries 28, 29 and 30 of Annex XVII to REACH, which will impose restrictions on substances classified as CMR category 1A or 1B. These restrictions will apply to substances when sold as such, in mixtures or as constituents of other substances.

• Labelling Requirements: To further ensure safety, packaging containing these newly classified substances will have to be labelled with the warning "restricted to professional users", effectively restricting consumer access to products containing these substances.

• Derogation for Cumene in Aviation Fuels: An important derogation is introduced for cumene, allowing its presence in certain aviation fuels (kerosene and aviation gasoline) used in small aircraft flown by non-professional pilots. This derogation takes into account the limited use of aviation fuels by non-professional pilots compared to motor fuels used by non-professional car drivers.

Objectives and Rationale for the Regulation

The regulation is motivated by the recent harmonised classification of certain substances as CMR category 1A or 1B under the CLP Regulation. In response, the European Commission is using its powers under Article 68(2) of REACH to propose these restrictions which aim to protect human health and safety by reducing exposure to these dangerous substances.

Timeline and Next Steps

• Adoption Date: The Regulation is expected to be adopted in the second quarter of 2025.

• Effective Date: The restrictions on CMR substances classified as category 1B will apply from 1 September 2025. Operators will be able to apply the restrictions earlier if they wish.

• Entry into Force: The Regulation will enter into force 20 days after its publication in the Official Journal of the EU, with the derogation for cumene in aviation fuels applying immediately.

• Final Date for Comments: Stakeholders have 60 days from the date of notification to submit comments on the draft Regulation. The notification was sent to the WTO on 22 November 2024, so the final date for comments is 21 January 2025.

Conclusion

The EU’s proposed amendments to REACH aim to strengthen protection against hazardous CMR substances, particularly those newly classified as category 1A and 1B. The regulation introduces important restrictions, including enhanced labelling and an exemption for cumene in aviation fuels. Industry stakeholders are encouraged to review the draft regulation and participate in the public comment period to help shape the final text of the regulation.

The full text of the draft regulation can be accessed here.