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Pôle Cosmétique Cosmetic regulation Product Information File
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Is regulation an innovation-inhibiting factor?

Thrusday, April 12th 2014

Every year, we can find in big box stores more and more brands, new products with original textures and advertising claims ever more promising. In this area where competition is fierce, we must create innovation. However, cosmetic regulation is more and more severe, especially since the European regulation’s modification has been in effect on July 11, 2013, but that’s not all. Indeed, due to their (many) exigencies, REACH and CLP regulations,  restrictions for using CMR and nanomaterials in cosmetic products and the IFRA Amendment in particular, delay suppliers, manufacturers and service providers in their race for novelty.  They must do a lot of toxicological tests before put a new product or a new substance on the market, but they also have to perform an assessment of the effectiveness of the product to claim particulars pertaining to benefits among consumers. All that leads to a significant loss of time and money for suppliers and manufacturers. Marketing teams must then tweak it for not having a more significant increase in the cost of launching new products due to regulatory costs.

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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.