To protect consumers against potential health risks arising from the consumption of food supplements and to ensure that they are not provided with misleading information, food supplements are covered by European and national laws and regulations on food safety.


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). Food supplements are intended to correct nutritional deficiencies, maintain an adequate intake of certain nutrients, or to support specific physiological functions. They are not medicinal products and as such cannot exert a pharmacological, immunological or metabolic effect.

Food supplements are only intended to ‘supplement’ people’s diets and not replace healthy foods.  The regulation of food supplements makes clear that food supplements are not intended to replace a varied and balanced diet and food supplements packaging is required to state this information.

Because food supplements are considered as food, it is the responsibility of the manufacturer, importer, supplier or distributor to ensure that a food supplement placed on the market is safe.

EU Member States may, for monitoring purposes, request notification of the placing on the market in their territory of a food supplement. Once the product is on the market, the competent authority of the Member State may monitor its use and safety in that territory.

Following an assessment by the European Food Safety Authority (EFSA), the European Commission may take a decision to include a certain substance in a list of substances whose use in foods is prohibited, restricted or under scrutiny. This may happen when the addition of a substance in food products increases its exposure to levels greatly exceeding the normal consumption and/or poses a potential risk to consumers.

Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 partially harmonizes the rules for placing food supplements on the European market. The scope of the Directive includes all food supplements with certain requirements, in particular those relating to labeling particulars, which apply to all food supplements, whatever their composition.


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