In 2019, the French National Agency for the Safety of Medicines and Health Products (ANSM), published a new national requirement (ANSM Decision March 13th, 2019) related to leave-on cosmetic products (excluding deodorants, hair, and make-up products) containing Phenoxyethanol as preservative (CAS number 122-99-6). Specifically, the French Authorities mandated the labelling of the precautionary measurement “Not to be used on the nappy-skin area of children under 3 years of age”.

Although in the EU, Phenoxyethanol is included on the list of allowed preservatives in cosmetic products, ANSM justified this decision in light of Article 27 to Regulation (EU) 1223/2009. 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.

Many cosmetic products were affected by this additional labelling requirement regardless of their foreseeable use.

This administrative decision led to a dispute between the Fédération des Entreprises de la Beauté (FEBEA), the trade union of French cosmetic companies and ANSM that escalated up to the EU Court of Justice, to clarify the interpretation of Article 27 of Regulation (EU) No. 1223/2009.

The EU Court of Justice judgment stated that “Article 27(1) cannot be interpreted as authorising Member States to adopt general provisional measures applying, not to one or more individually identified cosmetic products, but to a category of products containing the same substance. Moreover, the scope of Article 27(1) is necessarily limited, so that it does not authorize disproportionate infringements, even temporary, of the free movement of cosmetic products and can therefore relate only to specific cosmetic products covered individually.”

In conclusion, the requirement for the labelling of the precautionary measurement “Not to be used on the nappy-skin area of children under 3 years of age” on leave-on cosmetic products containing Phenoxyethanol has been repealed. Therefore, the labelling restriction related to Phenoxyethanol is officially not mandatory for products imported into France.

For more information feel free to contact us at info@criticalcatalyst.com.

References:

1. InfoCuria. (2022). Judgement of the Court (Second Chamber), 15 September 2022

2. Regulation (EU) No. 1223/2009 on cosmetic products