No labeling restriction required for phenoxyethanol in France, EC elaborates

31 Oct 2022 --- The French requirement to label leave-on cosmetic products containing phenoxyethanol with the precautionary measure, “not to be used on the nappy-skin area of children under three years of age” has been repealed. As a result, the phenoxyethanol labeling restriction is not officially required for products imported into France.

Phenoxyethanol is frequently used as a preservative or stabilizer for other ingredients within cosmetics. The ingredient is listed as a preservative in Annex V/29 of Regulation (EC) No 1223/2009, with a maximum concentration of 1%.

Given the requirement established by the French National Agency for the Safety of Medicines and Health Products, the Fédération des Entreprises de la beauté petitioned the French Council of State to overturn the French labeling precaution measure. Following that, the French Council of State requested a preliminary ruling from the European Union Court of Justice on the interpretation of Article 27 of Regulation (EC) No 1223/2009 on cosmetic products.

“The Court case ruling repeals the unilateral decision of the French authorities to impose additional restrictions (via labeling) on a substance that has been assessed and found safe for use in cosmetic products,” Sonya Gospodinova, spokesperson for the internal market, defense industry and space at EC, tells PersonalCareInsights.

Phenoxyethanol is listed as a preservative in Annex V/29 of Regulation (EC) No 1223/2009, with a maximum concentration of 1%.“The French decision was based on the wrong application of Article 27 of the European Cosmetics Regulation. There could be positive impacts for businesses, given the disproportionate burden stemming from the measures taken by the French Authorities. At the same time, there is no impact on consumer safety since the current concentration of use is based on thorough safety assessment by the Scientific Committee on Consumer Safety (SCCS).”

Safe for health?
In 2019, the French National Agency for the Safety of Medicines and Health Products published a new requirement for phenoxyethanol-containing leave-on cosmetic products (excluding deodorants, hair and makeup).

The French authorities, in particular, mandated the labeling of the precautionary measure “Not to be used on the nappy-skin area of children under three years of age.” Many cosmetic products were harmed, regardless of their intended use.

Regarding its impact on health, Gospodinova explains that: “Phenoxyethanol is an authorized preservative listed in entry 29 in Annex V to the Cosmetics Regulation with restrictions for use. As is the case for all preservatives allowed for use in cosmetic products, before its authorization, phenoxyethanol was assessed – including the safety to infants – and found safe for use in cosmetics.”

According to the assessment, the EC’s SCCS “considers 2-phenoxyethanol safe for use as a preservative with a maximum concentration of 1.0%, taking into account the information provided.”

PersonalCareInsights previously reported on products that contain phenoxyethanol, such as Japan-based MyKirei’s Easy-Spray Laundry Detergent. In contrast, Johnson & Johnson’s Vivvi & Bloom – a brand for babies and toddlers – does not contain phenoxyethanol. The latter is also not present in Precime’s Cica Perfect Radiant Fit Cushion foundation.

Industry’s labeling and ingredient moves
The EC recently consulted the public on changes to the current list of potentially carcinogenic, mutagenic and reprotoxic chemicals under the Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation 1907/2006. The list includes many hazardous chemicals that should not be used in cosmetic or personal care formulations.

The UK-based Cosmetic Toiletry and Perfumery Association (CTPA) explained its stance on using “free from” claims, releasing a paper stating companies should not mislead customers with these claims.

Regarding ingredient bans, the CTPA warned the industry of the impending prohibition of cosmetics containing butylphenyl methylpropional. It implies that by December 15th, products containing the ingredient must be removed from Great Britain shelves.

By Nicole Kerr