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Monday, March 11, 2019Regulation

Final opinion of the SCCS: the HEPB validated as a new preservative

Le HEPB validé en tant que nouveau conservateur

On March 5, 2019, the SCCS adopted its Final Opinion on HEPB eye irritation. Technically, the document was adopted during the CSSC plenary meeting on 26 February 2019 and formally endorsed on 5 March, at the end of the commenting period. As none were received, the conclusions of the SCCS remained unchanged. The HEPB should therefore soon incorporate Annex V of Cosmetics Regulation 1223/2009 as an authorised preservative in cosmetics.

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With this text, Ethylzingerone - Hydroxyethoxyphenyl butanone (HEPB) is now the subject of two Final Opinions of the SCCS.

Opinion on HEPB as a conservative

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.

For the full background, see the article
HEPB as a preservative: request for Opinion to SCCS of January 6, 2016

Conclusion of SCCS

Based on the information provided by the applicant, a maximum concentration of 0.7% of Hydroxyethoxyphenyl Butanone (HEPB) as a cosmetic preservative in rinse-off, oral care and leave-on cosmetic products can be considered safe.

The SCCS is aware that Hydroxyethoxyphenyl Butanone (HEPB) is also used as skin conditioning agent. According to the Cosmetics Regulation 1223/2009 a substance authorised as preservative at specific conditions of use (e.g. maximum concentration) can only be used for other purposes at the same conditions of use set up for the preservative …

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