Food Supplements in Europe: Key Regulatory Changes in 2025 and What to Expect in 2026

The following summarises key regulatory topics affecting food supplements in the EU based on developments observed in 2025 and items expected to progress in 2026 and beyond.

· EU harmonisation of maximum permitted levels (MPLs) for vitamins and minerals: While harmonised MPLs are foreseen under Directive 2002/46/EC, they have not yet been established. In 2025, the topic regained visibility following indications of a draft proposal with low MPL values and related industry concerns. In December 2025, Germany (supported by 17 Member States) raised the issue at the AGRIFISH Council and called for the European Commission to set harmonised MPLs in 2026. The Commission has indicated it intends to resume preparatory work and launch a call for evidence, although no specific deadlines were provided.

· Article 8 proceedings under Regulation (EC) No 1925/2006: EU continues to assess “other substances” where potential consumer risk has been identified, with risk management options including prohibition, restriction, or Union scrutiny (Annex III Parts A/B/C). Several ongoing risk assessments have timelines extending into 2026 (including hydroxycitric acid, berberine, and fennel fruits). Additional preparatory work is ongoing for a set of substances identified in the HoA report, although EFSA has not yet been formally mandated to assess all of them. The webinar also noted expectations and timelines for specific substances, including alpha-lipoic acid (expected Union scrutiny listing) and the progression of regulatory discussions regarding green tea catechins and monacollins from red yeast rice.

· EU Biotech Act: The European Commission is preparing a new Biotech Act aimed at strengthening the competitiveness of the biotechnology sector in the EU and improving time-to-market through streamlined and potentially more harmonised regulatory approaches. Although the legislation is still under development (planned for adoption in 2026), it may have a future impact on the novel food framework by facilitating more efficient assessment pathways, particularly for biotech-derived ingredients such as precision fermentation, cell-based and other innovative technologies.

· Packaging and Packaging Waste Regulation (EU) 2025/40: The regulation entered into force in February 2025 and will apply generally from August 2026, with phased implementation deadlines thereafter. Key elements to monitor include upcoming harmonised packaging labelling requirements and restrictions on harmful substances, including the planned prohibition of food packaging containing certain PFAS levels.

· EU–UK SPS Agreement: The agreement aims to reduce the trade burdens through alignment of sanitary and phytosanitary rules. While the SPS scope is food safety-focused, discussions continue on areas of divergence relevant to food supplements, including substances and wider regulatory topics that may not be covered by SPS alignment.

Overall, regulatory activity in the EU during 2025 reflects parallel developments in harmonisation initiatives and ongoing risk-management actions targeting specific substances and product categories. Discussions on maximum permitted levels, continued Article 8 proceedings, and evolving positions on novel ingredients illustrate a regulatory environment focused on safety assessment, scientific review, and policy alignment. Developments expected in 2026 suggest further progression of harmonised frameworks, ingredient evaluations, and packaging-related obligations, reinforcing the importance of early regulatory assessment and proactive compliance strategies when developing or expanding food supplement products within the EU market.

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