The French Competent Authorities warns on the use of Phenoxyethanol in leave-on baby products and sets a new labelling requirement!
The substance Phenoxyethanol is a preservative frequently used in cosmetic products regulated in Annex V/28 of the Cosmetic Regulation (EC) n. 1223/2009. It corresponds to the CAS number 122-99-6 and is authorized in cosmetic products in a maximum concentration of 1.0%.
This substance has been on the radar of the French ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) since 2012. Back then, the French Authorities presented a risk assessment concluding that the maximum concentration of Phenoxyethanol in products meant to be used for children should be lowered to 0.4% and that the substance should not be present in products used on their nappy area.
Nevertheless, in its opinion from 6th October 2016, the SCCS concluded that Phenoxyethanol was considered safe at a maximum concentration of 1.0% even for specific age groups including children.
It is on 20th March 2019 that the ANSM published a Decision on its website setting special conditions of use for leave-on cosmetic products containing Phenoxyethanol by stating on their labels that they must not be used on the nappy area of children of 3 years of age and under.
In its Decision, the French Authorities concluded that as a precautionary measure, to place leave-on cosmetic products containing Phenoxyethanol on the market, manufacturers will have to state on the labels of these products that they are not to be used on the nappy area of children of 3 years of age and under.
The French Agency takes as an example the wipes which are being frequently used on this particularly sensitive area when changing babies and excludes leave-on products such as deodorants, hairstyling and makeup products from the scope of its decision.
This Decision was taken in anticipation of an action at the European level as some concerns were raised by toxicological studies suggesting that this substance would endanger animal development and reproduction when found in high concentrations. This is a safety measure as such effects have not been reported for human reproduction and development.
Responsible Persons for the marketing of such products will have to comply with this new labelling requirement from the French Competent Authorities at the latest 9 months after the publication of the Decision on the ANSM website i.e. at the latest on 20th December 2019.
If you wish to know more about labelling requirements in the EU market, do not hesitate to contact us! Obelis Expert Consultants, with 30 years of experience with EU regulatory affairs, will gladly answer your questions.
April 19, 2019