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The European Commission has announced the timetable for one of the most significant regulatory initiatives affecting the food supplements and fortified foods sector in recent years—the harmonisation of maximum levels of vitamins and minerals across the European Union.
According to the Commission, the updated draft Regulation is expected to be published for public consultation in the third quarter of 2026, while the adoption of the final legal act is currently scheduled for the first quarter of 2028.
Based on the information released so far, the Commission intends to apply the “residual amount” concept. Under this approach, the maximum amount permitted for supplementation would be calculated by subtracting the intake from the habitual diet (at the 95th percentile of consumption) from the Tolerable Upper Intake Level (UL) established for each vitamin and mineral.
Only this remaining amount—the residual amount—would be available for use in food supplements and fortified foods. According to the Commission’s current approach, this residual amount would then be allocated between these two product categories.
The planned harmonisation has the potential to reshape the European food supplements market. In practice, the proposal may result in:
The public consultation planned for 2026 will be of fundamental importance to the food supplements and fortified foods sector. It will provide businesses, trade associations and other stakeholders with an opportunity to submit comments on the proposed methodology for establishing maximum levels and on its potential impact on the market.
Given the potentially far-reaching consequences of the proposed framework for product composition and the EU food supplements market, companies should already be monitoring the legislative process closely and assessing the possible regulatory implications for their product portfolios.
The food law experts at IGI FOOD LAW will continue to keep you informed about further developments and forthcoming draft legislation.
