Which obligations must be met before and after putting a cosmetic product on the market?

Cosmetic products must comply with the provisions of the Cosmetics Regulation and the Public Health Code.

Before market placement

No authorisation is needed before placing a cosmetic product on the market. However, the Responsible Person must comply with certain rules before market launch:

Declaration that a facility has opened or is operating

All facilities with manufacturing or packaging operations must declare themselves to the National Agency for the Safety of Medicines and Health Products (ANSM).
Note: facilities that do not declare themselves to the ANSM are liable to two years imprisonment and a €30,000 fine.

Product Notification

Before it can be placed on the market, the Responsible Person must file a notification for each marketed cosmetic product on the Cosmetic Products Notification Portal (CPNP). This notification must indicate:

• The product name
• Its category
• Country of origin
• The Presence of nanomaterials and substances classified as CMR (carcinogenic, mutagenic or reprotoxic)
• The Member State where it will be marketed
• The name and address of the Responsible Person
• An emergency contact person

Its composition

Cosmetic products must be completely safe for human health when used under normal or reasonably foreseeable conditions of use. In other words, they must comply with product composition rules, including restrictions and bans on certain substances set out in Annexes II to VI of the Cosmetics Regulation:

• Prohibited substances (Annex II)
• Restricted substances (Annex III)

Substances authorised if used as:

• Colourants (Annex IV)
• Preservatives (Annex V)
• UV- filters (Annex VI)

Article 15 of the Cosmetics Regulation prohibits the presence of substances classified as carcinogenic, mutagenic or reprotoxic from categories IA, IB, or II (subject to certain exemptions).

Cosmetic products may contain nanomaterials but these must be clearly identified and assessable (see Article 16 of the Cosmetics Regulation concerning European level notification of cosmetic products containing nanomaterials placed on the EU market).

Labelling and presentation

Pursuant to Article 19 of the Cosmetics Regulation, the packaging and container of any cosmetic product must bear certain mandatory information such as:

• Manufacturers’ name and address
• The list of ingredients
• The minimal durability date, or the period of use after opening, for products that can be kept for at least 30 months
• Nominal content
• Batch number
• Precautions for use
• Country of origin for imported products

All this information must be written in French, in accordance with paragraph III of Article R.5131-4 of the Public Health Code.

Moreover, unfair commercial practices are prohibited: the Consumer Code (Article L. 121-1 et seq.) prohibits the use of misleading claims concerning the nature, composition or properties of a product to induce the consumer to buy a product whose specific claims do not correspond to the product’s actual merits.

After market placement

There are a number of obligations set out in the Consumer Code that must be met by the various actors in the cosmetics market.

Obligations of the Responsible Person

The Responsible Person must hold, at the address indicated on the packaging, a Product Information File (PIF) containing the information mentioned in Article 11 of the Cosmetic Regulation and Annex I, namely:

• Product description
• The product safety report
• A description of manufacturing methods used, and a declaration of conformity to the Good Manufacturing Practices (GMP)
• Proof of claimed effects

The PIF must be kept for a period of ten years from the date on which the last batch of the cosmetic product was placed on the market.
For more information on the PIF, see question 5.

Obligations of manufacturers and importers

Manufacturers and importers must be able to provide market authorities with proof of product claims when the latter are carrying out controls. These assessments should result in the creation of a product safety report which should be updated based on any additional relevant information that becomes available after the product is placed on the market.

Obligations for distributors

Distributors must ensure that product label information complies with article 19 of the cosmetic regulation. (For more information, see question 4.)

Obligations for manufacturers, importers and distributors

Manufacturers, importers and distributors must ensure that any cosmetic products placed on the market comply with the safety obligation set out in Article 3 of the Cosmetics Regulation and with the commercial practices obligations set out in Article L.221-1 of the Consumer Code.