Last June, the Direction générale de la concurrence, de la consommation et de la répression des fraudes (DGCCRF) published a guide entitled " Je lance mon entreprise de cosmétiques ". The aim of this guide is to provide entrepreneurs with the keys to a clearer understanding of the complex legal and regulatory landscape surrounding the marketing of cosmetic products.

The marketing of cosmetic products is subject to a number of regulatory requirements, laid down inRegulation (EC) no. 1223/2009 of the European Parliament and of the Council of November 30, 2009 on cosmetic products and the French Public Health Code ("CSP"), as well as the Consumer Code. We are reminded of this both by the recent sanctions imposed by the ANSM, suspending the marketing of non-compliant products, and by the various reports published by the DGCCRF on the non-compliant use of claims or substances.

Whatever your status (manufacturer, subcontractor, distributor, etc.), it's important to master the regulatory framework applicable to the marketing of cosmetics, but also to your commercial policy through the establishment of appropriate general sales conditions ("GSC"), and to the online sale of cosmetic products.

From product definition to the obligations of the person responsible: the keys to cosmetics regulations

The purpose of this guide is to remind entrepreneurs of the key definitions and concepts to bear in mind when launching a cosmetics business.

Is my product a cosmetic? The importance of qualification

Determining whether or not a product is a cosmetic is a crucial step, and one which determines the applicable regulations. Manufacturing and marketing conditions differ depending on whether the product is a medicine, a cosmetic, a medical device, a dietary supplement, a blend of essential oils or a biocide.

Cosmetics are defined as " any substance or mixture intended to be placed in contact with the superficial parts of the human body (epidermis, hair and capillary systems, nails, lips and external genital organs) or with the teeth and oral mucous membranes with a view, exclusively or mainly, to cleaning them, perfuming them, modifying their appearance, protecting them, maintaining them in good condition or correcting body odors" (Article 2 of the Regulation).

Three cumulative elements can be drawn from this definition for a product to be considered a cosmetic product: product form, area of application and purpose.

This definition includes the following product categories: oral care products (toothpaste, etc), fragrance products (aftershave, etc), hair care products (hair masks, etc), make-up products (lipstick and gloss, etc), body care products (face creams and milks, etc) and sun care products (oils, creams, etc).

On the other hand, cosmetic products do not include dietary supplements for aesthetic purposes (skin enhancement, etc.), which are foodstuffs, or medical devices for aesthetic purposes such as injectable fillers, laser devices, etc., which are foodstuffs.

Once a cosmetic has been qualified, a number of obligations must be met before it can be marketed, including the appointment of a responsible person.

Designating a responsible person

Any cosmetic product placed on the European market. The responsible person may be a natural or legal person. It guarantees the conformity of the cosmetic product placed on the market. By default, this person is :

• The manufacturer, if the products are manufactured in the European Union
• The importer if the products are imported from a third country
• The distributor when he places a cosmetic product on the market under his name or trademark, or modifies a product already on the market in such a way that its compliance with the applicable requirements may be affected.

Vigilance on this last point!

It should be noted that the role of responsible person can be delegated to a third party by means of a written mandate signed by both parties.

Reminder of the obligations and responsibilities of the person in charge :

Being designated as a responsible person entails a number of obligations and responsibilities:

• Technical documentation: Before marketing, the responsible person must draw up a Product Information File (PIF ) for each product, which must contain: a full description, a report on the safety of the cosmetic product, a description of the manufacturing method and a declaration of compliance with good manufacturing practice (GMP), and proof of the claimed effects.
• Safety: Responsible persons and distributors must report to the authorities any undesirable effects, whether serious or resulting from misuse of the product or other effects, observed on the product and the measures they have taken to remedy them (cosmetovigilance).
• Cosmetic product labeling includes mandatory information that must be written in French, in visible, legible and indelible characters (article 19 of the European regulation).
• The composition of the cosmetic must not contravene the list of prohibited and authorized substances for preservation, discoloration and UV filtering functions (article 14 and annexes II to VI of the European regulation).
• To avoid misleading the consumer, authorized claims must comply with the law, be true, verifiable, sincere, fair and non-denigrating, clear and understandable.
• Placing on the market: Every cosmetic product placed on the market must be notified to the European Commission via the European portal.

Obligations subject to penalties for non-compliance

Failure to comply with these obligations exposes the person responsible for placing the product on the market to penalties ranging from fines to imprisonment. For example, failure to notify the authorities of an establishment manufacturing or packaging cosmetic products is punishable by 2 years' imprisonment and a €30,000 fine. The DGCCRF also pays particular attention to misleading commercial practices , characterized by any claim that is ambiguous, exaggerated or false , or that fails to comply with cosmetics regulations. These are punishable by up to 2 years' imprisonment and a €300,000 fine, particularly in the case of online commercial practices, blogs and packaging information.

Point of vigilance on cosmetic product claims

The marketing presentation of a cosmetic product must also respect a strict general framework in order not to be considered misleading. The advertising message must be honest and not seek to mislead the consumer.

The DGCCRF guide stresses the importance of avoiding unjustified claims, and points out that for a claim to be authorized, it must meet the 6 criteria set out in the cosmetics regulation: comply with the law, be true, verifiable, sincere, fair and not disparaging, clear and understandable.

In this respect, the DGCCRF regularly publishes practical information sheets to help operators ensure that their products comply with the claims they make, particularly when they boast the absence of certain substances through the use of the term "free", a natural composition, substances from organic farming, and so on.

Regulated advertising and the use of influencers

In line with the control of misleading claims and commercial practices, particular vigilance is required with regard to advertising. This vigilance is all the more important given that while the June 9, 2023 law aims to regulate commercial influence and combat the abuses of influencers on social networks, it is particularly aimed at the beauty and cosmetics sector.

Operators also need to be careful when using influencers, as new rules apply to product placements.

(See our article: What are the new rules for influencers in the healthcare field?)

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Placing a cosmetic on the market therefore implies compliance with a number of regulatory obligations designed to guarantee the information and safety of the product and its users, which are subject to particular surveillance by national authorities.

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Controls by national authorities

Article 22 of Regulation (EC) n°1223/2009, known as the "Cosmetics" Regulation, stipulates that "Member States of the European Union shall monitor compliance with this Regulation by carrying out appropriate controls on cosmetic products placed on the market, but also by carrying out controls on economic operators ".

In France, since January¹, 2024, the control and market surveillance authorities have been the DGCCRF and ANSES.  

The monitoring of these cosmetic products focuses on three main areas:

• Product quality and safety;
• Compliance with good manufacturing practices;
• Fairness of consumer information and advertising.

In addition to initiating criminal proceedings, these authorities can establish non-compliance with the aforementioned regulations and require: product or operator compliance, or decide on product withdrawal or recall.

It should be noted that these measures can only be implemented after a prior adversarial procedure, and can still be challenged before the administrative courts.

Supervision of online cosmetics sales

Finally, the sale of cosmetics online is also subject to compliance with the provisions of the French law for confidence in the digital economy (LCEN) of June 21, 2004. This law specifies the mandatory information that must appear on the site.

All websites, regardless of the activity concerned, must include a legal notice that includes identity, contact details, intellectual property information (images, illustrations, photographs, texts that are not your own), hosting information (name of host, company name, address and telephone number), etc.

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