Tuesday, June 5, 2012Ingredients news

Phenoxyethanol: the French ANSM questions its safety for young children

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In a new evaluation of the risk linked to using phenoxyethanol in cosmetics, the French ANSM surveys all the currently available data. Its report, release, beginning May 2012, concludes that there is a safe enough margin for adults, but not for children under three. Therefore, the Agency recommends more stringent restrictions for use in products designed for them.

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Phenoxyethanol is an aromatic ether, used in many products. In cosmetics, it is used as a preservative; thus, it is listed in the Annex VI of the Cosmetic Directive 76/768/CEE, which details the preservatives acceptable for use in cosmetics. Its maximum content is set at 1%.

Indeed, taking into account “the discrepancies between the data supplied by the FEBEA ( Editor’s note: the French Association of Beauty Companies) and the data available in literature (including the 2008 safety data sheet released by INRS [Editor’s note: the French National Institute of Research and Safety] ), the Commission of Cosmetology thinks it necessary to update the evaluation of the risk of this substance.”

Mildly irritant and sensitizing, but with systemic effects

In its May 2012 report, the ANSM (National Agency for the Safety of Medicines) bases its recommendations on the following points:
“The analysis of the available toxicological studies shows that phenoxyethanol:
• is absorbed by oral and dermal routes; it is metabolized, mainly by the liver, into phenoxyacetic acid, and is then eliminated through urine,
has a slight acute toxicity in animals ; it is neither irritant to skin neither sensitizing; it leads to a moderate to severe eye irritation,
is not potentially genotoxic,
• is not harmful to reproduction in many of the studies
used for writing the critical analysis in this report for evaluation; however, a study reports a lower fetal weight equivalent to 10%, and shows an increase of the mortality of the youngsters of the first generation exposed to doses from 2,000 mg/kg body weight/day,
induces systemic effects, such as blood-toxicity and liver-toxicity.

Insufficient safety for children

In its conclusion, the ANSM states that the evaluation of the risks it performed shows that the safety margins:
• may be considered as acceptable for adults,
•are not sufficient for children under three.

Therefore, the ANSM recommends, for children under three:
• no phenoxyethanol allowed for products designed to be used on the bottom,
•restricting the content of phenoxyethanol down to 0.4% in all the other kinds of products (instead of 1% currently).

From issuing a recommendation to its application

However, the ANSM points out the fact that any restriction and/or modification of the final content of phenoxyethanol in cosmetic products shall be compliant with the antimicrobial action looked for from a preservative.

The final point is that the agency thinks it necessary to have this report on the evaluation of the risk linked to the use of phenoxyethanol in cosmetic products sent to the European Commission for an evaluation on the Union level. It hopes that its conclusions could be taken as it and translated into the European regulation, which would, then, make them mandatory.

For further information
Read the full text (in French) of the Evaluation of the risk linked to using phenoxyethanol in cosmetic products (Évaluation du risque lié à l’utilisation du phénoxyéthanol dans les produits Cosmétiques), by ANSM 2012

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