The European Commission has taken a decisive step towards enhancing consumer safety with the latest proposed amendments to Annex XVII of the REACH regulation. This update tightens restrictions on carcinogenic, mutagenic, or reproductive toxicant (CMR) substances to reflect new scientific findings and harmonised classifications.
The proposed changes aim to ensure that hazardous substances no longer pose undue risks to public health. The draft regulation is open for public feedback until 2 January 2025 before its anticipated adoption by the European Commission in the fourth quarter of 2023.
Key Additions to CMR Restrictions
The updates to Annex XVII introduce several substances newly classified as CMR Category 1B, based on amendments to Regulation (EC) No 1272/2008. These substances are subject to strict market and usage limitations to prevent consumer exposure. Among the most notable additions are:
- Diuron (CAS 330-54-1): Commonly used in agriculture as a herbicide, diuron is associated with risks of reproductive toxicity and carcinogenicity.
- Tetrabromobisphenol-A (CAS 79-94-7): This chemical, widely used as a flame retardant in electronics and construction materials, is flagged for its mutagenic potential.
- 4-Methylimidazole (CAS 822-36-6): Frequently utilised in industrial processes, this substance is included due to its carcinogenic properties.
Additional substances listed in the updated annex include several phosphine derivatives and chemical compounds found in adhesives, resins, and industrial manufacturing processes. These substances are now subject to stringent market controls, ensuring they are either restricted entirely or limited to concentrations below hazardous thresholds when available for consumer use.
Industry-Specific Exemptions
Acknowledging the complexity of industrial applications, the Commission has carefully considered exemptions where practical alternatives may be limited. One such exemption involves cumene (CAS 98-82-8), a chemical used in aviation fuels for small aircraft.
Cumene had previously been restricted under Annex XVII as part of Commission Regulation (EU) 2023/1132 due to its inclusion in CMR Category 1B. However, this update allows its use in specific aviation fuels to accommodate the unique needs of non-professional small aircraft pilots. The exemption reflects the limited scope of such usage compared to the general public's use of automotive fuels, which remain subject to strict controls.
Implementation Timeline
The updated restrictions are slated to come into effect on 1 September 2025, in line with the application date for the revised CMR classifications under Regulation (EC) No 1272/2008. This synchronisation ensures a smooth transition for industries and regulatory bodies alike.
Notably, businesses are encouraged to comply with the new restrictions ahead of the official deadline to mitigate risks and align with consumer safety priorities.
Importance of Public Feedback
The Commission has opened a public consultation period from 5 December 2024 to 2 January 2025, allowing stakeholders—including businesses, industry associations, and non-governmental organisations—to provide feedback on the draft regulation. This participatory process is vital for refining the proposed measures and addressing any concerns about their practical implications.
Stakeholders can submit their feedback via the European Commission's official platform, where all contributions will be reviewed and published in adherence to feedback rules.
Implications for Businesses and Consumers
The updated Annex XVII represents a critical step in the EU’s broader strategy to protect public health while promoting sustainable industrial practices. For businesses, these restrictions necessitate a shift towards safer chemical alternatives and enhanced compliance measures.
Consumers, on the other hand, stand to benefit from reduced exposure to harmful substances in everyday products such as paints, adhesives, and electronic devices. The inclusion of new substances underscores the EU's commitment to keeping regulatory standards in line with the latest scientific evidence.
