AxeRegel

Regulatory and pharmaceutical consulting services for the life sciences industry through the lifecycle of their products

Nutrivigilance

In France the adverse events likely to be related to the consumption of food supplements should be reported to ANSES:

on-line declaration

Regulatory and pharmaceutical consulting services for the life sciences industry through the lifecycle of their products.

Learn more about our services

Food supplements regulation

Food supplements are:

  • concentrated source of nutrients (vitamines, minerals or other substances)
  • with a nutritional or physiological effect
  • marketed in “dose” form
  • intended to supplement the normal dietary regimen.

Compliance with EU food obligations

Food supplements are regulated under food law as well as under their specific legislation. Food supplements companies main obligations include food safety and traceability, compliance with the legislation, cooperation, loyalty in transactions and information to the consumers (information on the label or other information).

European Union legislation of food supplements

In the European Union food supplements are dictated by:

Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002, on the approximation of the laws of the Member States relating to food supplements.

This directive defines food supplements as 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.

Food supplements labelling

The labelling of food supplements must comply with the food legislation, namely with

Regulation (UE) n°1169/2011 of the European Parliament and of the Council of 25 October 2011 (commonly referred to as INCO (Information to Consumers)), as well as with their specific legislation .

The nutritional and health claims must comply with the dispositions of Regulation (EC) n° 1924/2006 of the European Parliament and of the Council of 20 December 2006.

Authorised food supplements claims

The EU Register of nutrition and health claims made on foods is updated regularly.

If a health claim or a nutrition claim is not listed, a health or nutrition claim application can be submitted to the European Union.


In the EU the labelling of food supplements must not contain

  • false or misleading statements
  • any non authorized nutritionnel or health claim
  • any statement attributing to the product properties of preventing, treating or curing a human disease
  • any reference to the rate or the importance of weight loss
  • any mention to the recommandations of a doctor or health professional
  • any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general or that the consumer is in danger if he does not take the food supplement

Mandatory mentions on the packaging of food supplements

  • name of the food supplement
  • information stating that the product is a food supplement
  • list of ingredients
  • major allergens
  • quantity of certain ingredients or categories of ingredients put in advance
  • net quantity
  • date of minimum durability or limit date for consuming
  • special storage or conditions of use
  • name or business name and the adress of the company commercialising the product or the responsible for the information mentioned on the package
  • country of origin or provenance, if applicable
  • instruction for use, if need for an appropriate use of the product
  • the acquired alcoholic strength of beverages, for beverages contain more than 1.2 % by volume of alcohol
  • nutrional declaration

To learn more about food supplements:

  • EFSA (European Food Safety Authority)
  • ANSES (French Agency for Food, Environmental and Occupational Health & Safety) 

French legislation on food supplements

Food supplements in France must comply with Decree n° 2006-352 of 20 March 2006 regarding food supplements, which transposed Directive 2002/46/CE, and with its implementing orders (arrêté).

Implementing orders of Décret n° 2006-352 :

  • Arrêté of 9 Mai 2006 regarding the nutrients that can be used in the manufacture of food supplements
  • Arrêté of 24 June 2014 establishing the list of plants, other than mushrooms, authorized for food supplements and their conditions of use
  • Arrêté of 26 September 2016 establishing the list of substances, with a nutritionnel purpose, authorized in food supplements and their conditions of use

In France, food supplements must be previously notified to DGCCRF (General Directorate for Competition Policy, Consumer Affairs and Fraud Control).

The notification is done on-line: TéléIcare

Since the beginning of the year 2017, the list of electronically declared products is available online to the consumer: télédéclarés

What are food supplements?

Click on the image to learn the brief definition.

Recent posts