How to implement harmonisation of market entry for food supplements in the EU

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Information memo: How to implement harmonisation of market entry for food supplements in the EU

Practical information

  1. Composition of the study group
  2. Administrator / Assistant in charge: Conrad Ganslandt, Martine Delanoy / Luca Pitrone
  3. Contact

Background

The Portuguese presidency in 2021 has requested the European Economic and Social Committee (EESC) to provide an exploratory opinion on solutions and best practices for implementing a harmonisation of food safety requirements for food supplements marketing in the EU.

Food supplements are concentrated sources of nutrients (i.e. mineral and vitamins) or other substances with a nutritional or physiological effect that are marketed in “dose” form (e.g. pills, tablets, capsules, liquids in measured doses) and are intended to complement and/or supplement the normal diet. In the EU, food supplements are regulated as foods. This means that the substances used in food supplements are covered by various Community legislative texts, including the General food law (food safety), the regulation on Novel Foods (authorization procedure for ingredients which had not been used for human consumption to a significant degree within the Community prior to 1997), the rules on the use of nutrition and health claims on food packaging and the rules on the addition of vitamins and minerals and of certain other substances to foods ("Fortified Foods Regulation"). 

However, due to their composition or to their publicity, some products presented as food supplements may fall under the status of medicinal products (so-called borderline products), with potential food safety issues and misleading consumer information.

The specific EU legislation in the area of food supplements (Directive 2002/46/EC) provides for general requirements (e.g. purity criteria, labelling information) applying to all food supplements. However, this legislation only partially harmonises the rules applicable to the placing of food supplements on the market as only the rules applicable to the use of vitamins and minerals in the manufacture of food supplements are laid down. The use of other substances is subjected to national legislations: a large majority of the Member States have drawn up positive or negative lists of substances other than vitamins and minerals which can be used in food supplements.

While the market for food supplements containing vitamins and minerals appears relatively homogeneous, the European market for food supplements containing other substances is characterised by its variety with mutual recognition rules (recently modified) sometimes used to place food supplements on the market of different Member States.

This lack of harmonisation leads to complexity for companies marketing these foodstuffs in different EU member states as well as for Member States in performing official controls at all stages of the food chain, and may put the consumers at risk.