Food Supplements - Legislation

Food Supplements - Legislation

Food Supplement are regulated in Europe as foodstuff, falling under the EU General Food Law (Regulation (EC)No 178/2002) for safety requirements and Regulation (EU) No 1169/2011, on the provision of food information to consumers (FIC). In addition to these general rules, specific requirements are set out by the Food Supplements Directive 2002/46/EC. which establishes harmonised lists of the vitamins and minerals-substances used in the manufacture of food supplements- and the labelling requirements for these products.

Besides harmonized rules, national legislation may apply, including additional restrictions and requirements for the use of substances other than vitamins or minerals, and the maximum and minimum level of vitamins and minerals allowed.  Food supplement may be subject to national registration as a pre-market authorization.

Applicable harmonized regulatory framework for food supplements in Europe:

*D. = Directive | R. = Regulation

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