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Nutrivigilance
In France the adverse events likely to be related to the consumption of food supplements should be reported to ANSES:
What are food supplements?
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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
- Regulation 1924/2006 on nutrition and health claims made on food on nutrition and health
- Regulation 432/2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health
- Regulation 1047/2012 on the list of nutrition claims
- Decision 2013/63/EU adopting guidelines for the implementation of specific conditions for health 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.
- Commission Regulation No 353/2008 of 18 April 2008 establishing implementing rules for applications for authorization of health claims
- Commission Regulation No 1169/2009 of 30 November 2009 amending Regulation (EC) No 353/2008
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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:
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
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