French labelling requirement for leave-on products containing Phenoxyethanol repealed
Ingredients: PHENOXYETHANOL

The EU Court of Justice repealed the French requirement for the labelling of the precautionary measurement “Not to be used on the nappy-skin area of children under 3 years of age” on leave-on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. Therefore, the labelling restriction related to Phenoxyethanol is officially not mandatory for products imported into France.

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

further
reading

cosmetic products

P-Cymene may soon be banned from cosmetics

Ingredient: P-CYMENE

Date of publication: 10/1/2025

P-cymene may be banned from cosmetics as its proposed classification as Reprotoxic 1B is under review and is expected to be approved.

Read More »
cosmetic products

SCCS Preliminary Opinion on Benzophenone-1 (BP-1)

Ingredient: BENZOPHENONE-1

Date of publication: 25/10/2024

On October 25 2024, the Scientific Committee on Consumer Safety (SCCS) could not conclude on the safety of UV absorber Benzophenone-1 (BP-1) due to insufficient data. The deadline for comments is set to January 13, 2025.

Read More »
cosmetic products

UK – OPSS Releases Statuatory Instrument on CMR Substances and Kojic Acid

Ingredients: CMR SUBSTANCES AND KOJIC ACID

Date of publication: 17/12/2024

On December 17, 2024, UK’s Office for Product Safety and Standards (OPSS) published the Cosmetic Products (Restriction of Chemical Substances) (No.2) Regulations 2024′ adding 64 substances classified as Carcinogenic, Mutagenic, or Reprotoxic (CMR) to Annex II of the UK Cosmetics Regulation (UKCR) and Kojic Acid to Annex III of the UKCR.

Read More »
cosmetic products

SCCS Preliminary Opinion on Ethylhexyl Methoxycinnamate (EHMC)

Ingredient: ETHYLHEXYL METHOXYCINNAMATE (EHMC)

Date of publication: 25/10/2024

On October 25 2024, the Scientific Committee on Consumer Safety (SCCS) could not conclude on the safety of UV-filter Ethylhexyl Methocycinnamate (EHMC) due to insufficient data. The deadline for comments is set to January 17, 2025.

Read More »