United States Mission to the European Union
Foreign Agricultural Service
United States Department Of Agriculture
Last modified: April 4, 2017

Food Supplements

In the EU, Directive 2002/46/EC on “the approximation of the laws of the Member States relating to food supplements” defines food supplements as “food”.  This means that all exports of food supplements to the EU must comply with horizontal rules applicable to all foods (including laws on additives, labeling, claims, hygiene, contaminants, GMOs) in addition to the specific rules applying exclusively to food supplements.

Marketing food supplements in the EU is a complex issue which requires careful consideration.  Food Supplements Directive 2002/46/EC only contains harmonized rules on labeling and authorized vitamins and minerals and their forms.  Key aspects in the marketing of food supplements such as maximum and minimum levels of vitamins and minerals or the use of other substances such as botanical extracts, remains the competence of the Member States.  Given the different traditions and approaches, exporters should be aware that having a single product formula which can be used in all 28 EU Member States is rather exceptional and adjustments for different national markets may be needed.  To complicate things even further, exporters may encounter divergent interpretations of EU-harmonized rules among the Member States’ authorities.

GAIN report “Exporting Food Supplements to the European Union” provides a detailed overview of the main EU legislation applicable to food supplements.