October 06, 2022 – On September 15, 2022, the Court of Justice of the European Union (CJEU) issued a judgment on the interpretation of Article 27 of the EU Cosmetics Regulation. Article 27 is a safeguard clause which provides that the Member States, in the context of their post-market surveillance activities, can take all appropriate measures to remove from the market cosmetic products that present or could present a serious risk to human health.
At first, on March 13, 2019, the French authority for cosmetic products (Agence nationale de sécurité du médicament et des produits de santé, AFMPS) established an additional labelling requirement for the commercialisation in France of leave-on cosmetic products containing phenoxyethanol. In particular, products/labels had to bear the warning “not to be used on the nappy area of children under three years of age”. The French authority justified this decision in light of Article 27.
As a matter of fact, in the EU, phenoxyethanol (CAS number 122-99-6) can be used in cosmetic products as a preservative up to a maximum concentration of 1%. The list of preservatives allowed for use is Annex V to the EU Cosmetics Regulation, and among them is phenoxyethanol.
Considering the AFMPS measure, the Fédération des entreprises de la beauté (FEBEA), the trade union of French cosmetic companies, objected to it. Hence, it asked to the French Council of State to repeal the decision. During the proceeding, the latter requested the CJEU to issue a preliminary ruling on the interpretation of Article 27. Specifically, the Court must clarify whether EU Member States can unilaterally limit the marketing of a category of products containing a substance allowed for use in the EU Cosmetics Regulation
Firstly, the Court of Justice of the EU highlighted that the main purposes of the EU Cosmetics Regulation are to:
- Protect human health;
- Harmonise the rules at the EU level;
- Ensure the free movement of goods.
Moreover, Article 27 concerns post-market surveillance activities only.
Therefore, EU Member States cannot use Article 27 to adopt general provisions limiting the use of a category of products containing a specific and same substance. In conclusion, the safeguard clause applies only to one or more individually identified cosmetic products available on the market.
- InfoCuria. (2022). Judgment of the Court (Second Chamber). 15 September 2022. (Reference for a preliminary ruling. Approximation of laws. Cosmetic products. Regulation (EC) No 1223/2009. Article 27 – Safeguard clause. Article 27(1) – Scope. Provisional national safeguard measures. General measure. Application to a category of cosmetic products containing the same substance. Individual measure. Application to an identified cosmetic product. Provisional national measure imposing certain labelling requirements on a category of leave-on products containing phenoxyethanol). Retrieved on 04/10/2022
- European Commission. (2009). Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Retrieved on 04/10/2022