Chemical compliance

What’s happening? Here is an update for May 2025:

EU: REACH revision draft proposal and timeline for 2025
USA: Federal measures to phase out artificial food dyes

EU: REACH revision draft proposal and timeline for 2025

In April’s Competent Authorities meeting, the European Commission circulated a set of draft REACH revision ‘simplification’ documents, marking the final phase of internal discussions on the long-awaited legislative update.

Part of the European Commission’s Clean Industrial Package, a final legislative proposal is expected by the end of this year.

Key proposals concerning registration and evaluation:

• Revoke registration numbers from non-compliant companies and limit registration validity to 10 years
• Require registration dossier updates for Substances of Very High Concern (SVHCs)
• Delete Annex III (criteria for substances registered in 1 – 10 tonnage band) and XIII (standard information requirements for substances at above 10 tonnes), and modify several others
• Streamline dossier evaluations and strengthen the impact of compliance checks, and
• Introduce a registry for coordinating substance evaluation, including justifications for substance grouping

Plans for Authorisation and Restriction:

• Inclusion of a substance on the Candidate List would not only lead it to the authorisation pathway, it could also be considered for restrictions
• Prioritise authorisation for high-volume substances with fewer users and uses
• Introduce upfront analysis and discussion of regulatory options for authorisation and restriction, and enable them in parallel for different uses, and
• Require data on use, exposure and alternatives earlier in the processes

The Commission has also suggested expanding the Generic Risk Management (GRA) approach and shared plans for digitalisation, supply chain communication, simplification and enforcement.

Next steps and timelines

• April 2025: Consultations with competent authorities, other key stakeholders
• By July 2025: Commission impact assessment is expected
• By November 2025: Commission legislative procedure and adoption, followed by submission of comitology proposal, and
• November-December 2025: Final eight-week consultation

USA: Federal measures to phase out artificial food dyes

On 22 April 2025, the US Health Secretary announced that the Food and Drug Administration (FDA) will start phasing out all petroleum-based synthetic dyes from the US food supply.

Although no formal legislation has been passed to officially ban the substances, the FDA has a “mutual understanding” with the food industry that the dyes will be progressively removed.

As part of this voluntary agreement, the FDA is asking food manufacturers to use natural ingredients like those used in the EU and Canada.

Make America Healthy Again

This action is part of the current administration’s Make America Healthy Again initiative and is based on reports that artificial dyes in food are associated with adverse effects in adults and children.

The multi-step phase out process will include the following activities by the FDA:

1. Establishing a national standard and timeline for the food industry to move from petrochemical-based dyes to natural alternatives
2. Immediate start of revocation of authorisation for two synthetic food colourings with the final ban to be effective in the coming months: Citrus Red No. 2 and Orange B
3. Cooperation with the food industry to eliminate six additional synthetic dyes from the food supply by the end of 2026: FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2
4. Authorisation for four new natural colour additives is expected in the coming weeks. The FDA is also accelerating the review and approval of further natural colour additives: Calcium phosphate, Galdieria extract blue, gardenia blue, and butterfly pea flower extract
5. Comprehensive research on how food additives impact children’s health and development to better inform regulatory decisions
6. A request to food and pharmaceutical companies to remove FD&C Red No. 3 sooner than the 2027-2028 deadline previously required, and
7. Guidance and regulatory flexibilities for affected industries