Commissioner Olivér Várhelyi, in a written answer on 22 July 2026, outlined the European Commission's ongoing work to set harmonised maximum levels for vitamins and minerals in food supplements and fortified foods, with a public consultation planned for the second half of 2026. The move aims to resolve a two-decade-old regulatory gap and will impact food supplement and fortified food producers across the EU, who face potential reformulation costs and product withdrawals if limits are set significantly lower than current national allowances.
The answer responds to a question from Barbara Bonte (PfE), who noted that more than 20 years after Directive 2002/46/EC entered into force, maximum levels have still not been set at EU level. Bonte highlighted industry concerns that a modelling approach published in January 2025 could lead to stricter dosages than currently permitted in several Member States.
Várhelyi stated that preparatory work has been based on scientific advice from the European Food Safety Authority (EFSA), which has updated safe consumption levels for over ten vitamins and minerals. Member States' technical experts have contributed, and all Member States have engaged in ongoing preparatory discussions, allowing national experience and existing rules to be taken into account. The general approach will follow the legal requirements of Article 6 of Regulation (EC) No 1925/2006 on fortified foods and Article 5 of Directive 2002/46/EC on food supplements, which require considering upper safe levels, scientific risk assessment, and varying consumer sensitivities. All authorised vitamins and minerals are being examined for the first set of maximum levels.
The announcement signals a concrete step toward EU-wide harmonisation, but the timeline remains open-ended. The Call for Evidence in late 2026 will gather initial public and stakeholder feedback, with formal legislative proposals expected to follow. The outcome will directly affect producers who must adapt formulations and consumers who may see changes in product availability and dosage limits.