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Public Health
Expert opinion

Ethylzingerone – ‘Hydroxyethoxyphenyl Butanone’ (HEPB) (Cosmetics Europe No P98)

Final Opinion

Details

Publication date
7 April 2017
Author
Scientific Committee on Consumer Safety (SCCS)

Description

WG on Cosmetic ingredients
SCCS members: U. Bernauer (Rapporteur), L. Bodin, L. Celleno, Q. Chaudhry, P. Coenraads (Chairperson), M. Dusinska, J. Duus-Johansen, J. Ezendam, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, C. Rousselle, M. Stępnik, T. Vanhaecke, S. Wijnhoven
Former SCCS members: J. van Benthem, G.H. Degen
Contact:SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1582/16
Adopted on: 7 April 2017

Conclusion of the opinion:

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?

Based on the information provided by the applicant, 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 is not considered safe.
It is of note that a maximum concentration of 2.0 % under an aggregate exposure scenario for cosmetics could be considered safe if more reliable and supporting data on in vitro dermal penetration was provided.

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?

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.

3. Does the SCCS have any further scientific concerns regarding the use of Hydroxyethoxyphenyl Butanone (HEPB) in cosmetic products?

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 function. In the specific case of Ethylzingerone, this substance cannot be used as conditioning agent at concentrations higher than that one authorised for the preservative function.

Keywords:

SCCS, scientific opinion, Ethylzingerone - ‘Hydroxyethoxyphenyl Butanone’ (HEPB) - Cosmetics Europe No P98, Regulation 1223/2009, CAS 569646-79-3

Opinion to be cited as:

Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Ethylzingerone - ‘Hydroxyethoxyphenyl Butanone’ (HEPB) - Cosmetics Europe No P98, SCCS/1582/16, 7 April 2017.

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