Document
Regulatory Compliance

Regulatory framework for active ingredients used in food supplements in Europe

EU regulations harmonize forms of vitamins and minerals in food supplements, but other active ingredients is only partially harmonized and it is necessary to follow national rules.

In the EU, while Directive 2002/46/CE standardizes the forms of vitamins and minerals used in food supplements, other active ingredients, like botanicals, are not fully harmonized and must follow national regulations.

Only certain ingredients, such as novel foods listed under Regulation (EU) 2017/2470 or those in Regulation (EC) 1925/2006, are controlled at the EU level. Regulation 1925/2006 prohibits, restricts, or place under community scrutiny specific substances in all foodstuffs, including supplements.

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