Capitalizing on the experience of its partners in health authorities, laboratories and law firms dedicated to the health industries, ELSI has developed a sharp expertise and a recognized practice on regulatory issues and problems, in their economic, commercial and competitive context.
Thanks to its strong sectorial experience dedicated to the health industries, ELSI also intervenes on behalf of its clients in the elaboration, negotiation, implementation and protection of their commercial policy and their economic activities
This is why our law firm, specialised in the law of health products and foodstuffs and food supplements, has developed a global and transversal vision of the food supplements sector and assists its clients in all of their projects and in securing the legal aspects of the marketing and distribution of their food supplements, both in terms of advice and litigation
European regulations consider food supplements to be products and foodstuffs, subject to all the general provisions of food law set out in Regulation No. 178/2002 of 28 January 2002, as well as to the specific rules defined by Directive No. 2002/46/EC of 10 June 2002 on food supplements, known as the "Food Supplements Framework Directive". This text, which gives them a real status and a specific regulatory framework, is transposed into French law by decree n°2006-352.
Defined by national and European texts, food supplements are foodstuffs containing active ingredients, alone or in combination, used for their nutritional or physiological role, the purpose of which is to supplement the normal diet, marketed in pre-dosed form , such as capsules, pastilles, tablets, powder sachets or ampoules.
The qualification of food supplements requires compliance with strict regulations concerning composition, manufacture, compliance with strict safety and quality standards,labelling in accordance with the requirements of Regulation No. 1169/2011 (INCO) and Regulation No. 1924/2006 on nutrition claims, presentation so as not to confer any preventive, treatment or curative properties on a human disease, and marketing. The latter is in fact conditional on a notification to the DGCCRF, by teleprocedure, accompanied by the labelling and the list of plants and other substances used.
The essential question for any operator placing a food supplement on the market is therefore to know whether his product qualifies as a food supplement by ensuring that both its composition and its presentation (claim, labelling, etc.) do not give it the status of another health product (such as medicines or medical devices) and thus to determine the legal regime applicable to his product and the resulting obligations; questions for which recourse to a lawyer specialising in food supplement law may be necessary.
Organic food supplements are subject to specific directives and regulations, in addition to general regulations such as Regulation (EC) No. 834/2007 on organic production and labelling of organic products, Regulation (EC) No. 889/2008 on organic production, labelling and controls of organic products, Regulation (EC) No. 1235/2008 on the import regime for organic products from third countries.
