MEP Barbara Bonte (PfE) has asked the European Commission to clarify the state of play on setting harmonised maximum levels for vitamins and minerals in food supplements and fortified foods, a process that has been pending for over two decades. In a written parliamentary question dated 8 June 2026, Bonte also questioned whether the Commission will account for varying consumption patterns across Member States and population groups, such as athletes, and which nutrients will be covered in the first batch of limits.
The question comes more than 20 years after Directive 2002/46/EC entered into force, which required the establishment of maximum levels but left them unset at EU level. Since 2023, the European Food Safety Authority (EFSA) has published revised scientific opinions on Tolerable Upper Intake Levels (ULs) for vitamin B6, vitamin D, folic acid, and selenium, and is currently reviewing ULs for vitamins A and E, beta-carotene, iron, and manganese. Industry organisations have raised concerns about a modelling approach made public in January 2025, warning it could lead to significantly stricter dosages than currently allowed in several Member States, forcing product reformulations or market withdrawals.
Bonte's question seeks concrete answers on the timeline for harmonisation, the flexibility to account for national dietary differences, and the scope of the first set of maximum levels. The Commission is expected to reply within approximately six weeks; its response will signal the direction of EU policy on food supplement regulation, balancing consumer safety against industry concerns over market disruption. The issue pits consumer protection — ensuring safe upper intake levels — against business competitiveness, as stricter limits could impose compliance costs on supplement manufacturers and reduce product availability for specific consumer groups such as athletes.
Stakeholder impact - EU consumers: potentially benefit from clearer safety standards, but may face reduced choice if products are withdrawn. - Food supplement industry: faces possible reformulation costs and market losses if maximum levels are set lower than current national allowances. - National authorities: would need to align existing national limits with harmonised EU levels, affecting regulatory consistency. - Athletes and specialised groups: may lose access to higher-dose supplements tailored to their needs if consumption patterns are not adequately considered.