As an addition to a normal diet, food business operators market food supplements, which are concentrated sources of nutrients (or other substances) with a nutritional or physiological effect. Such food supplements can be marketed in “dose” form, such as pills, tablets, capsules, liquids in measured doses, etc.
The objective of the harmonised rules on those products in Directive 2002/46/EC is to protect consumers against potential health risks from those products and to ensure that they are not provided with misleading information.
With respect to the safety of food supplements, the Directive lays down a harmonised list of vitamins and minerals that may be added for nutritional purposes in food supplements (in Annex I to the Directive). Annex II of the Directive contains a list of permitted sources (vitamin and mineral substances) from which those vitamins and minerals may be manufactured.
This list has been amended by the following Regulations and Directive to include additional substances:
- Commission Regulation (EU) 2015/414
The trade of products containing vitamins and minerals not listed in Annex II has been prohibited from the 1st of August 2005.
Directive 2002/46/EC has been aligned with the new Regulatory Procedure with scrutiny by Regulation (EC) 1137/2008.
Submission of requests for inclusion of vitamins and minerals and their sources in the Annexes
Guidance document for competent authorities, tolerances for the control of compliance of nutrient values declared on a label with EU legislation . (A simplified summary table gives an overview of the different tolerance values included in the guidance document. In case of doubt the guidance document text should be consulted as the official reference).
Levels of vitamins and minerals in food supplements
Directive 2002/46/EC on food supplements envisages the setting of maximum and minimum amounts of vitamins and minerals in supplements via the Standing Committee on Plants, Animals, Food and Feed ( PAFF Committee) procedure.
The Commission has issued a Discussion Paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs , which identified the main issues to be considered in this exercise and originated a set of Responses.
Although the Commission has consulted extensively with Member States and interested stakeholders on the issue, no proposal has not yet been presented due to the complex nature of the issue and the divergent views that were expressed. All the available data on the potential effects on economic operators and consumers of the setting of maximum amounts of vitamins and minerals in foods, including food supplements, will be taken into account. Every effort will be made to ensure that the maximum amounts set will take into account the concerns expressed by all interested parties.
Use of substances other than vitamins and minerals in food supplements
The EC commissioned a study on the use of substances with nutritional or physiological effects other than vitamins and minerals in food supplements.
Taking into account this study and other available information, the Commission - in accordance with the requirement set out in Article 4(8) of Directive 2002/46/EC on food supplements - has prepared a report to the Council and the European Parliament on the use of substances other than vitamins and minerals in food supplements.
The report is accompanied by two Commission staff working documents.
Monitoring of food supplement products
Member States may, for monitoring purposes, request notification to their competent authority of the placing on the market in their territory of a food supplement product in accordance with Article 10 of the Directive. The list of competent authorities may be found here: