Cosmetics law

The cosmetics and beauty industry is a highly competitive and constantly evolving sector, with a dynamic of innovation. It is evolving under the dual prism of compliance with strict and restrictive sanitary standards and a highly competitive environment, placing cosmetics law at the heart of these issues.

A SECTORAL APPROACH TO COSMETIC PRODUCTS

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.

cosmetics law, Our main areas of practice

Regulatory
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  • Product qualification / borderline products
  • Regulatory support to national and European authorities (ANSM, DDPP, inspection, injunction, health policy decisions (DPS), financial sanctions, etc.)
  • Setting up and monitoring clinical trials
  • Cosmetovigilance, vigilance of tattoo products
Contract & commercial policy (Drafting, proofreading, follow-up and advice)
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  • Contracts related to marketing: pharmaceutical operation, licence, distribution, distribution networks, single agreement, commercial agency, sales commission, mandate, promotion, co-promotion, co-marketing
  • Other commercial contracts: services, partnership agreements, cooperation agreements, market research, confidentiality agreements (NDA), general terms and conditions of sale (GTC) and use (GTU)
  • Unfair competition: free-riding, denigration, violation of advertising rules
Litigation and liability
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  • Product liability: French non-judicial procedure and litigation procedure
  • Negotiation & transaction
  • Appeals against decisions of health authorities
  • Commercial litigation
Health data
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  • Identification of personal data
  • GDPR compliance
  • Personal data policy
  • Securing contracts
  • Support for digital projects

Regulatory constraints and competitive dynamics DRIVE THE COSMETICS SECTOR

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.

Discover our other expertise

regulatory affairs

Marketing, advertising, health police, establishments, anti-gift & transparency

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Business law

Contract law, commercial, advertising, distribution, restrictive practices, anti-competitive practices

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Litigation and liability disputes

Commercial litigation, defective products, appeals against authorities' decisions, communication & crisis management

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Personal data - Health data

GDPR, CNIL methodology, health data hosting
securing contracts, support for digital projects

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trainings

Legal and regulatory updates, skills upgrading, find out about all our tailor-made offers

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Anti-gift & transparency

Our outsourcing offer, the subcontracting of your anti-gift activities & health transparency

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SUBSCRIPTIONS consulting & subcontracting

Subscriptions to regulatory advice, audit packages, find out about all our subscription and subcontracting offers

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interim management

Transformation, temporary surge, implementation of new processes, crisis management

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