Information Letter 058 – March 2019

Subject: – FRANCE – New Labeling Requirements for Leave-on Products Containing Phenoxyethanol

Dear All,

The French Authorities will shortly publish a new legal requirement related to Phenoxyethanol-containing leave-on products (ANSM Decision of March 13th, 2019). This is an administrative decision triggering Article 27 of the European Cosmetics Regulation, the safeguard clause. This requirement will remain in place until a formal decision is taken at the European level.

The product labels of all leave-on cosmetic products (at the exception of deodorants, hair-styling and make-up products) shall contain the warning “Not to be used on the nappy-skin area of children under 3 years of age”, which can be translated in French as “Ne pas utiliser sur le siège des enfants de 3 ans et moins”. All products categories that are not explicitly exempted are impacted, whatever the intended usage (e.g. anti-wrinkle face creams will bear the new warning).

The transition period is 9 months from the publication date on the ANSM website (https://www.ansm.sante.fr/Decisions/Injonctions-decisions-de-police-sanitaire-sanctions-financieres-interdictions-de-publicite-Decisions-de-police-sanitaire). The publication should take place in the next few days. At the end of this transition period (~ mid December 2019), all impacted products available on the French market will have to bear the new warning.

We hope that this letter will provide you with helpful information and invite you to contact your account manager in case of questions.

Best regards,
Dr. Fred Lebreux