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Pôle Cosmétique Cosmetic regulation Product Information File
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International regulation

Thrusday, April 25th 2014

Nowadays, cosmetic products became daily consumption products. In most countries, they represent an appreciable share of the market. So it should be appropriate to create a “standard cosmetic product range”, that is to say products sold internationally.

However, if it was so easy, we already would know many of these standard ranges. Indeed, the regulation pole imposes many constraints on this project. Firstly, from one country to another, the definition of a “cosmetic product” is often different. For instance, in the USA, soaps are not considered as a cosmetic product, while in Europe they meet the requirements.

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postheadericon Cosmetic Product Information File (PIF)

The responsible person must keep a Product Information File (PIF) at their address indicated on the label and make it available to supervisory authorities. For cosmetics manufactured in the European Union, the person who sells the product under their brand is the responsible person. For imported products, the importer is the responsible person. The file contains all the necessary elements relative to the identity, quality and safety for human health as well as the effects claimed by the cosmetic product.

The product information file contains the following informations:

  • A description of the cosmetic product, allowing a clear link between the file and the cosmetic product
  • The safety assessment which contains:
    • The qualitative and quantitative formula of the product (specifying the chemical identity of substances)
    • The physical and chemical characteristics and the stability test
    • The microbiological quality of the product justified by the results of the Challenge Test
    • Information on the packaging material
    • Data relative to the exposure to the cosmetic product and to the substances according to diverse parameters, considering the possible toxicological effect
    • Toxicological profile of ingredients
    • Results of safety testing
    • Possible adverse effects of the cosmetic product on human health
  • A description of the manufacturing process and a statement of compliance with good manufacturing practice
  • Proof of the effect claimed for the cosmetic product
  • The data relating to the development or to the safety assessment of the cosmetic product and its ingredients

The Product Information File can be checked at any time.

The Product Information File must be permanently updated and made at all time available to the sanitary authorities. It can, at any time and without advance notice be audited by the Sanitary Authorities.

Three competent inspection organisations:

  • Inspectors of the ANSM (formerly AFSSAPS, French Office for the safety of health products)
  • Doctor and pharmacists inspectors of Public health for the Head office of Health (Ministry of Health)
  • Inspectors of the DDPP (Departmental Direction of Protection of the Populations)

According to the public health code, sanctions could be a market withdrawal, fees, even imprisonment.