Definition

According to the Article 2.1.a of the Regulation (EC) No 1223/2009, a Cosmetic product is defined as: "any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours".

 

Regulatory obligations for my cosmetic product

Cosmetic products on the market are required to be safe for human health. They are not subjected to prior marketing authorisation but have to be notified on an online platform: the CPNP portal – for the sake of traceability and information. Nonetheless, Article 3 of the regulation stipulates that “A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use”.

Thus, before placing their products in the market, every manufacturer has to be able to guarantee that:

  • the composition of their products complies with the requirements of the cosmetic regulation (and its annexes) as well as with the legislative and regulatory requirements;
  • their products respected, during their manufacturing process, the good practices enumerated in Article 8 of the regulation;
  • the Product Information File (PIF) gathers all the adequate information in order for the security of the product to be evaluated and safety report to be established, according to Annex I of the cosmetic regulation.