Cosmetic products have been regulated by Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products since 11 July 2013, known as the "cosmetic regulation".
The annexes to this regulation are regularly updated by regulations of the European Commission.
The Cosmetics Regulation establishes rules that must be complied with by any cosmetic product made available on the market, in order to guarantee the functioning of the internal market and ensure a high level of protection of human health.
Definition of a cosmetic product:
A cosmetic product is defined using three cumulative criteria:
Its shape: it can only be one substance or a mixture of substances;
Its area of application: the product must be intended to come into 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
Its goal: the application of the product is carried out with a view, mainly or exclusively, to cleaning, perfuming, modifying the appearance, protecting or maintaining in good condition these parts of the human body, or to correct body odors.
It is also sometimes difficult in certain cases to know whether a product falls within the definition of a cosmetic product or into another product category (biocide, pharmaceutical, food, etc.).
The cosmetic regulation:
Its primary objective is to guarantee consumer safety. Rules exist to control the composition of products, the way they are manufactured and marketed, to ensure consumer information for proper use of the product, but also to list any adverse effects and quickly withdraw a defective or counterfeit product from the market.
This regulation applies equally to all 27 countries of the European Union and three countries of the European Free Trade Association (EFTA – Norway, Iceland, Liechtenstein), and also concerns all cosmetic products imported into the territory of the European Union. Thanks to this regulation and the commitment of manufacturers, a cosmetic product is necessarily safe for human health.
In addition to the designation of the responsible person, the requirements prior to placing a cosmetic product on the market concern in particular:
- The composition of cosmetic products
- The manufacturing
- The constitution of the cosmetic product information file (DIP)
- Labeling rules on the container and packaging
- Declaration of establishment to the ANSM
- Notification to the European Commission
Cosmetic product controls:
Cosmetic products are not subject to prior authorization before being placed on the market, but the responsible person must guarantee that the products placed on the market are safe for human health when used under normal or reasonably foreseeable conditions of use.
Member States monitor compliance with the Cosmetics Regulation by carrying out appropriate checks on cosmetic products placed on the market.
They can in particular:
- review the product information file (PIF).
- carry out physical checks.
- carry out laboratory checks based on relevant samples. They also monitor compliance with the principles of Good Manufacturing Practices (GMP).
In France, surveillance of the cosmetic products market is carried out by the DGCCRF.
Sources:
Document: REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products
https://www.febea.fr/article-ingredient/la-reglementation-cosmetique
https://ansm.sante.fr/documents/reference/reglementation-des-produits-cosmetiques