How to market a food supplement in France
Are you thinking of marketing a food supplement in France? In this post we will inform you about the procedure that supplement companies need to know about the declaration of food supplements before expanding their business to the French-speaking country.
Regulation
Food supplements are regulated by Directive 2002/46/EC of the European Parliament and of the Council of June 10, 2002 on the approximation of the laws of the Member States relating to food supplements and transposed into French law by Decree 2006-352.
In addition, based on this we find other important orders:
- Ordinance of May 9, 2006 modifying the nutrients that can be used in the manufacture of food supplements;
- Order of June 24, 2014 establishing the list of plants, other than mushrooms, authorized in food supplements and the conditions for their use;
- Order of September 26, 2016 for the establishment of the list of substances with nutritional or physiological fines authorized in food supplements and the conditions for their use.
The regulation of food supplements in France depends on the General Directorate of Competition, Consumption and Repression of Fraud (Direction générale de la Concurrence, de la Consommation et de la Répression des Fraudes, DGCCRF), so it is necessary to contact this body to make the registration declaration.
The declaration can be made by ordinary mail, but since 2016 it can also be made telematically through the Teleicare platform.
Required data
As stated in Article 16 of the French Decree No. 2006-352, the registration declaration must be accompanied by:
- Identification of the importing manufacturer
- A model of the product labeling
- Documents and information certifying that the substance, plant or plant preparation for nutritional or physiological purposes is legally manufactured or marketed in another Member State of the European Community or the European Economic Area.
- Useful data to assess the substance to be declared.
Obligations
Laboratories and manufacturers of food supplements are also subject to very strict regulations that must include certain mandatory information on their food supplement.
Thus, the regulation establishes that the following must be indicated in a mandatory manner:
- Sales denomination including the concept of “food supplement”.
- List of ingredients
- Any ingredient listed in Annex II of Regulation (EU) No 1169/2011 or derived from a substance or product listed in Annex II that causes allergies or intolerances, used in the manufacture or preparation of a foodstuff and still present in the finished product, even in modified form;
- Amount per daily serving of ingredients (plants, herbal preparations, vitamins and minerals) for nutritional or physiological purposes, as well as their percentage of the nutritional reference value;
- Net amount of food;
- Minimum shelf life or expiration date;
- Particular conditions of conservation and / or use;
- Number or business name and address of the food business operator referred to in Article 8(1);
- Country of origin or the place of origin when so provided in Article 26;
- Instructions for use, when their absence hinders the correct use of the food;
- Health claims.
Health claims
What is a health claim? A statement is any message or representation that is not mandatory under EU or national law. Thus, when we talk about health claims, we refer to those that relate a food or one of its components to health.
They are highly regulated and subject to a strict validation process established in Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foodstuffs.
This same regulation establishes that the control of declarations must be made prior to the commercial use of food supplements. For this reason, they must first have been evaluated by the European Food Safety Authority (EFSA). This body must issue a favorable opinion on the product in question.
Deadline
Once the DGCCRF receives this complete dossier, it will contact the company within a maximum period of two months to inform it whether it can market the product and under what conditions. If, on the other hand, no response is received within that period of time, it would be considered as a marketing authorization.
The refusal of authorization can be for two reasons: for the absence of documents or information referred to above, or for scientific evidence issued by the French Food Safety Agency showing that the food supplement in France poses a health risk. The DGCCRF will also invite the declarant to comment on such denial.
Product modifications
It should be noted that each claim refers to the first placing on the market of a food supplement. Therefore, any modification of the product will be considered as a new product that will have to be declared again.
It is also important to mention that products with the same composition/active ingredients, but available in two different forms, e.g. capsules and tablets, should be the subject of two separate declarations. On the other hand, if only the packaging changes – for example, one box of 60 capsules and another box of 120 capsules – a single statement is sufficient.
At LegaleGo Nutrition, as a food consultancy, we are experts in the management and legal procedures for the commercialization of food supplements in other countries, among them, the member countries of the European Community.