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 for its clients in the elaboration, the negotiation, the implementation and the protection of their commercial policy and their economic activities.
This is why our law firm, specialised in the law of health products and cosmetics, has developed a global and transversal vision of the cosmetics sector and assists its clients in all their projects and in securing the legal aspects of the marketing and distribution of their cosmetic products, both as advisors and in litigation.
The marketing of cosmetic products is subject in France and in Europe to restrictive regulations set out in Regulation (EU) No. 1223/2009 on cosmetic products and in the Public Health Code (Articles L. 5131-1 et seq.).
At the borderline, sometimes tenuous, with other health products, such as drugs or medical devices, the qualification of cosmetic products is a preliminary and essential issue, which is imposed on any manufacturer, importer or person in charge of the marketing. Indeed, a cosmetic product cannot be presented as having curative or preventive properties with regard to human diseases, the product falling in this case under the definition of a medicinal product. In the same sense, products intended to be ingested, inhaled or implanted cannot be cosmetic products, despite the claim of such a purpose.
As soon as the product is qualified as a cosmetic product, it is therefore subject to the restrictive regulatory framework of the Cosmetic Regulation, which implies the respect of a certain number of obligations for operators such as the declaration of establishment, the designation of a responsible person, the conformity and safety of the product by respecting of good practices (in particular good manufacturing practices (GMP)), of the substances listed in the annexes of the Regulation (prohibited substances, restricted substances, preservatives, etc.), of the labelling rules and of the rules on the use of cosmetics.), labelling rules and possession of a product information file (PIF), as well as cosmetovigilance monitoring. Cosmetic products must also be notified to the European Commission and from 2023, a specific notification will have to be made for cosmetics containing nanomaterials.
Tattoo products are also subject to specific and restrictive regulations.
Beyond the mastery of this regulatory framework, the cosmetics and beauty industry must face market constraints in the implementation of their commercial and distribution policy, in a highly competitive environment. It is also a sector in full mutation, where the players must take up the challenges of digital technology and the new ethical stakes of sustainable and responsible consumption. This is why ELSI, a lawyer specialising in health and cosmetic products, assists its clients in the strategy and legal security of all aspects of the life cycle of their cosmetic products.
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An investigation by the DGCCRF in 2021 led to the penalization of 6.6 million euros for illegal practices by the URGO group.
Medical device law
An amendment to the WDR has just been proposed by the European Commission to postpone the entry into force of the WDR.