Updates on the EU Food Contact Material regulation revision proposal.

The revision of the FCM Regulation has been long-awaited, with the Regulation not having been reviewed since its entry into force in 2004. In May 2020, the Commission announced that it would adopt a proposal for the revision in the fourth quarter of 2022. However, due to the Regulation being “complex” the revision was postponed to 2023.

Recently the Commission's Department on Health & Food Safety (DG Sante) revealed that work on the revision would not begin until 2025. The Commission's numerous proposals announced under the REACH and CLP revisions have added to the challenges, with questions arising over the extent to which these policy options, including essential use criteria, should be factored into the work on updating the FCM Regulation.

Despite the delay in legislative work, DG Sante has outlined plans for 2023 to refine solutions and define more detailed policy options for the revision of the FCM Regulation. The focus will be on policy pillar A: 'shifting the focus onto the final material' and pillar B: 'prioritisation of substances'. Together, these pillars will form the core of the future risk management approach, with new material categories being applied.

The goals for pillar A are for producers of final FCMs to have full knowledge of 'migratables' and to become solely accountable for their release above the permitted safe levels. DG Sante's objective is also for all migratables to be risk assessed by national authorities or potentially businesses, as outlined in pillar B.

Under pillar B, the directorate will also create three tiers. The first is generic rules that will apply to the use of the most hazardous substances. Tier two will see public authorities conducting risk assessments, while the final tier envisages business operators assessing "more benign" chemicals.

In addition to these pillars, DG Sante plans to work on a study to assess the impact and options of pillar C – 'supporting safer and more sustainable alternatives'. The study is expected to be submitted to the Commission's regulatory scrutiny board by Q1 2024.

It has furthermore been pointed out that the drafting of the proposal is likely to clash with the European elections in May 2024 and the appointment of a new college of commissioners six months later. This could further delay the proposal, depending on other priorities such as dealing with the cost-of-living crisis and energy security.

If the proposal comes out in 2025, a revised regulation might not come into place until 2026 or 2027.