Scientific and Regulatory
- The purpose of food supplements which are foodstuffs is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect. They are marketed in dose form designed to be taken in measured small unit quantities.
- Directive 2002/46/EC establishes the specific provisions on the labelling of food supplements and lists vitamins and minerals (and their forms) authorized in food supplements. However, maximum amounts of those vitamins and minerals and the use of substances with a nutritional or physiological effect of which botanicals are not harmonized at European level. For formulation of a food supplement, the national specific legislations as amended on authorized ingredients and possible maximal daily doses have to be checked.
- General food law (food safety, information to consumers, novel foods, nutrition and health claims,…) also applies to food supplements.
- For placing a food supplement on the market, each of the 28 Member States has established its own notification or registration procedure.