Regulation of Cosmetics in France

France is one of the member states of the European Union, which must implement by their respective competent authorities the new EU regulation on cosmetics - EC No 1223/2009 - officially published on 22 December 2009, which became the first step towards the harmonization of cosmetic regulations in all EU countries.

In France, the competent authorities are the National Agency for the Safety of Drugs and Health Products (ANSM) and the Ministry of Economy of the Directorate General of Competition, Consumer Affairs and Fraud Control (DGCCRF). ANSM is responsible for the health and safety of cosmetics (substance assessment, cosmetics industry stakeholder inspection, laboratory control and vigilance), and its director general has the power of health police in this regard. DGCCRF is responsible for market supervision (inspection and control) and cooperates with ANSM according to the cooperation agreement made in December 2006.

The Ministry of Health, in cooperation with the ministries responsible for industrial and consumer affairs, participates in the formulation of European regulations and supervises national legislation on cosmetics.

Laws that France Enforces for Cosmetics:

• Public Health Act
• EC No 1223/2009 (EU)

Definition of Cosmetic Product

The definition of cosmetics is common to all EU member states (Article 2 of the Cosmetics Regulations). In France, it is transcribed in the Public Health Act (article L.5131-1). Cosmetics are "substances or mixtures intended to contact human surface parts (epidermis, hair and capillary system, nails, lips and external genitalia) or teeth and oral mucosa, with the sole or main purpose of cleaning, flavoring, changing appearance, protecting, maintaining good condition or correcting body odor".

Conditions for putting cosmetics on the market

• Apply to the National Drug and Health Product Safety Administration (ANSM) for the opening or operation of the institutions that produce or package cosmetics, even on an auxiliary basis. The manufacturer shall designate the responsible person for each cosmetic put on the market.
• Prepare and provide product information file (PIF) to the competent department. This document shall be kept for ten years from the date when the last batch of cosmetics is put on the market.
• Evaluate the safety of products according to the standards defined by cosmetics regulations. The assessment shall produce a product safety report, which shall be updated according to other relevant information available after the product is put on the market.
• Comply with the composition rules of the product, including regularly updating the restrictions and prohibitions of certain substances specified in the annex to the regulation.
• Inform the Committee of a group of product information (product category, responsible person, ingredients, labels, etc.) through the general portal of all Member States (CPNP).
• For any cosmetics containing nanomaterials, a further notice must be sent to the European Commission (except for the exceptions specified in Article 16 of this Regulation). Nanoparticle substances manufactured, imported or distributed in France must also be declared through the "R-Nano" nanoparticle state substance declaration application.

Responsible

For any cosmetic product placed on the European market, a responsible person must be appointed. The responsible person may be a manufacturer, importer, distributor or any other person established in the EU. It must ensure compliance with the regulatory provisions regarding the cosmetic products it places on the market.

The words "free from" and "hypoallergenic" are banned from most cosmetic product labels.

• First, ingredients that have been banned, such as "free from corticosteroid hormones"; second, ingredients that may be present or released, such as "free from formaldehyde" if a product contains a substance that releases formaldehyde; third, ingredients that are clearly not used in a certain type of product; and fourth, one or more ingredients for which the scope of the description is unclear, such as "free from allergens". Fourthly, an ingredient or ingredients the scope of which is unclear, e.g. "allergen-free" may not be used; fifthly, a product with multiple functions, including a function claimed not to be contained in the description, e.g. "preservative-free" if the product contains alcohol "Sixth, statements that may denigrate the safety of an ingredient, such as "triclosan free". However, products targeted at specific user groups may continue to use the word 'free'. For example, "alcohol-free" mouthwash for the whole family, "free from animal sources" for vegetarians, etc.
• It also says that cosmetic products should not contain any known allergenic substances or substances for which allergenicity data are missing. Therefore, the use of the word "hypoallergenic" is prohibited in product descriptions.

Notification system

The EU Cosmetics Regulation provides for a central notification system for cosmetic notifications through a central notification portal, the Cosmetic Notification Portal (CPNP).

For R&D and Further Manufacturing ONLY.