Food Supplements

Definition of a Food Supplement

A food supplement is defined in Section 2, paragraph 1, subparagraph g) of Act No. 110/1997 Coll., on Food and Tobacco Products, as a foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities.

Legislative Requirements for Food Supplements

From a legislative perspective, a food supplement is classified as food. Therefore, a food business operator who manufactures, imports, or places food supplements on the market is required to comply with all applicable food law requirements. These include both European Union legislation (regulations) and national legislation (laws and decrees).

A list of the most important European and national legislation relating to food is available on the website of the Czech Agriculture and Food Inspection Authority (CAFIA): Státní zemědělská a potravinářská inspekce | Informace nejen pro začínající podnikatele.

The food business operator bears full responsibility for ensuring compliance with all relevant food law requirements.

Decree No. 58/2018 Coll., on Food Supplements and Food Composition

In the Czech Republic, food supplements are distinct category of food. This category is specifically regulated at the national level by Decree No. 58/2018 Coll., on Food Supplements and Food Composition, as amended by Decree No. 368/2024 Coll. (effective from 1. July 2025). Decree No. 58/2018 Coll. transposes Directive 2002/46/EC of the European Parliament and of the Council.

Decree No. 58/2018 Coll. sets out, for example, the obligation to include mandatory warnings on the label of food supplements (“Not a substitute for a varied diet,” “Keep out of reach of children,” “Do not exceed the recommended daily dose”), and the requirement to include the words “food supplement” in the name of the foodstuff etc.

It also lays down, in its annexes, the conditions for the use of certain plants and substances whose addition to food is regulated or restricted by the food law:

Annex 1 lists certain plants and other substances that may be used in the manufacture of food supplements, along with the conditions under which they may be used.
Annex 2 lists certain plants and other substances that may not be used in the manufacture of food.

These Annexes are not exhaustive, and all other applicable provisions of food law must also be respected.