A bit of history

The story begins in 1972 with the Morhange case, a case of poisoning of infants by talc in France during the 1970s, leading to the death of 36 children and the poisoning of 168. A handling error led to 38 kilos of hexa-chlorophene, a highly toxic product, being mixed with 600 kilos of baby powder.
Following this tragedy, in 1975, French law n°75-604 regulates cosmetic products, followed by European Directive 76/768/EEC in 1978 and its numerous amendments.

It was in 2009 that the European Commission decided to carry out a total recast by creating European Regulation No. 1223/2009, still in force today.

Did you know? A directive gives “objectives” to be achieved and must be transposed into the national law of member countries to apply. A regulation is of total and direct application, and must be followed by the entities concerned.

The definition of a cosmetic product decoded

When developing a cosmetic product, the first essential question to ask is: does the product that I wish to market meet the definition of a cosmetic product with regard to the regulation? Let’s decipher this definition together.

Part 1: what form?

“any substance or mixture”

Translation: just because a product only contains one ingredient does not mean it is not a cosmetic product

Part 2: on which body part is it used on?

“intended to be brought into contact with the superficial parts of the human body (epidermis, hair and capillary systems, nails, lips and external genitalia) or with the teeth and oral mucous membranes”

Translation: products for the internal genital mucous membranes, products to swallow, products to inject, do not meet this definition

Part 3: what is its purpose?

"with a view, exclusively or mainly, to cleaning them, perfuming them, modifying their appearance, protecting them, maintaining them in good condition or correcting body odors"

Translation: a product with any other objective (treating a medical condition, repelling an insect, etc.), does not meet this definition.

Ajouter des exemples de produits cosmétiques bordeline + ref au doc de la commission

Exemple d’un savon pour les mains : c’est un produit cosmétique, sauf s’il revendique des propriétés antibactériennes

Exemple des peelings pour la peaux : s’ils n’atteignent que les couches supérieures de l’épidermes, ce sont des cosmétiques, s’ils atteignent les couches plus profondes, ce sont des DM

Un produit cosmétique ne doit pas avoir d’effet thérapeutique, sous peine de tomber sous la régulation pharmaceutique (exemple d’une crème anti-démangeaison ou d’une huile de massage « anti-douleur »).

The requirements of the cosmetic regulation

Responsible person (article 4)

A company can place on the market cosmetic products in Europe on the condition of having designated a responsible person (natural or legal) established in Europe capable of ensuring that the requirements of Regulation (EC) No. 1223/2009 are respected.

Ban of animal testing (article 18)

Animal testing is strictly prohibited on finished products, materials and combinations of raw materials.

Safety report (article 10)

Expliquer

Restrictions / authorization of substances and ingredients (annexes II to VI)