With a European market valued at 77 billion euros in 2016, the cosmetics industry remains a dynamic economic sector subject to strict regulations. The marketing of cosmetic products in the European Economic Area is in fact closely supervised, the primary goal being consumer safety.

I. What is meant by “cosmetic product”?

According to article 2 of regulation no. 1223/2009/EC, 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”.

Cosmetic products can in no case be presented as having curative or preventive properties with regard to human diseases, such characteristics corresponding to the definition of a medicinal product according to article L.5111-1 of the French Public Health Code of Law (CSP).

Likewise, a product requiring ingestion, injection, inhalation or implantation in the body is not a cosmetic product even if it is claimed to act on the skin, teeth, oral mucosa and/or appendages.

II. Cosmetics Regulation

Although not subject to marketing authorization like medicinal products, cosmetic products are subject to strict supervision to guarantee their safety with regard to human health under normal or reasonably foreseeable conditions of use. For this reason, cosmetic products placed on the market meet the obligations described

• by the provisions of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 relating to cosmetic products, known as the “Cosmetics regulation” in force since 11 July 2013;

• by the provisions of the French Public Health Code of Law (CSP) and in particular the Articles L.5131-1 to L.5131-8 and L.5431-1 to L.5431-9 from law no. 2014-201 of 24 February 2014 laying down provisions for adaptation to European Union law in the field of health as well as articles R.5131-1 to R.5131-15 from decree no. 2015-1417 of 4 November 2015 relating to cosmetic products and tattoo products.

The provisions of the Cosmetics regulation are identical throughout the European Union and directly applicable in all the Member States of the European Union.

III. Marketing of a cosmetic product

While the placing on the market of a cosmetic product is not dependent on a Prior authorisation of placing on the market (AMM) based on the assessment of the benefit/risk ratio as for medicinal products, it must nevertheless comply with the requirements dictated by the “cosmetics regulation”. Five steps are crucial and define the procedure for placing a cosmetic product on the market:

• Designate a physical or legal “Responsible Person” (RP) within the European community

• Ensure the composition of the cosmetic product and its manufacturing compliance with Good Manufacturing Practices

• Produce the Product Information File (PIF)

• Ensure the labelling of the cosmetic product is compliant

• Notify the cosmetic product to the European Commission via the European online portal CPNP (Cosmetics Products Notification Portal)

The establishment which manufactures or packages cosmetic products must first be declared to the ANSM in accordance with articles L.5131-2 and R.5131-1 of the French Public Health Code of Law (CSP).

IV. Post-marketing obligations

A. Reporting of serious adverse effects

In accordance with article 23 of the Cosmetics regulation, the person responsible or the distributor must immediately declare to the competent authority of the Member State where the undesirable effect has been notified, all serious adverse effects (SAEs) of which they have become aware concerning a cosmetic product as well than the other adverse effects (article 2 of the Cosmetics regulation) or effects likely to result from misuse of the product (articles L.5131-5, R.5131-7 and R.5131-9 of the French Public Health Code of Law [CSP]).

In France, this declaration is made to the ANSM via a specific declaration form available on its website. If applicable, the corrective measures put in place must also be described. Consumers as well as professional users can also report to the agency any adverse effect following the use of a cosmetic product, as well as the effects likely to result from misuse (articles L.5131-5 and R.5131-11 of the French Public Health Code of Law [CSP]).

In addition, health professionals must immediately report serious adverse effects to the ANSM following the use of a cosmetic product. They can report other adverse effects of which they are aware as well as the effects likely to result from misuse (articles L.5131-5 and R.5131-10 of the French Public Health Code of Law [CSP]). These declarations are made via a specific form available on the ANSM website.

Information relating to SAEs is immediately transmitted by the ANSM to the competent authorities of the Member States and to the responsible person when the latter is not the rapporteur. All of this information can be used by the competent authorities for surveillance, market analysis, assessment and consumer information.

B. Minimisation des risques pour la santé humaine

In accordance with Articles 5 and 6 of the Cosmetics Regulation and with article L.221-1-3 of the French Consumer Code of Law, the person responsible is under an obligation to inform the competent authorities without delay of the risks involving cosmetic products placed on the market and to detail the corrective or preventive measures put in place to guarantee consumer safety. In France, the competent authorities to alert if necessary are the ANSM (cosmetovigilance@ansm.santé) and the General Directorate for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF).