CosmeticOBS - L'Observatoire des cosmétiques
Jan. 6, 2016SCCS

HEPB as a preservative: request for Opinion to SCCS pro Add to my portfolio
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CosmeticOBS - Observatoire des Cosmétiques

The safety of Hydroxyethoxyphenyl Butanone, currently listed as a skin conditioning agent, will be evaluated regarding its use as a preservative by the SCCS. The request from the European Commission was published on January 4, 2016.

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Background

Ethylzingerone with INCI name ‘Hydroxyethoxyphenyl Butanone’ (HEPB) Cosmetics Europe No P98 - CAS No 569646-79-3 is a cosmetic ingredient not regulated under Cosmetic Regulation No 1223/2009 with the function as skin conditioning agent.

In September 2015, the Commission' services received a dossier from industry to support the safe use of Hydroxyethoxyphenyl Butanone (HEPB) when used as preservative in rinse-off, oral care and leave-on cosmetic products.

According to the above-mentioned dossier the safety profile of HEPB has been studied in preclinical studies conducted according to Good Laboratory Practices and following OECD guidelines whenever available. They were conducted using HEPB from batches which were well characterized analytically with a minimum purity of 95.9%.

Questions to SCCS

 1. In light of the data provided, does the SCCS consider safe the use of Hydroxyethoxyphenyl Butanone (HEPB) as a cosmetic preservative in rinse-off, oral care and leave-on cosmetic products with a maximum concentration of 2.0 % under an aggregate exposure scenario for cosmetics?

 2. Alternatively, what is according to the SCCS, the maximum target concentration considered safe for use of Hydroxyethoxyphenyl Butanone (HEPB) as a cosmetic preservative in rinse-off, oral care and leave-on cosmetic products under an aggregate exposure scenario for cosmetics?

 3. Does the SCCS have any further scientific concerns regarding ...