After SCCS mandate on HEPB (Submission II) related to eye irritation was adopted on 24-25 October, a Preliminary Opinion has been released on 21st December 2018

On the occasion of its plenary meeting on the 24th and 25th of October, the Scientific Committee on Consumer Safety (SCCS) approved  the mandate for a scientific Opinion on Ethylzingerone with INCI name  ‘Hydroxyethoxyphenyl Butanone’ (HEPB) and the possibility of this  substance to cause eye irritation. This Opinion on HEPB was requested by  the European Commission.

After a first submission of a dossier from the industry to support  the safe use of Hydroxyethoxyphenyl Butanone as a cosmetic preservative  in rinse off, oral care and leave-on cosmetic products, which was  adopted by the SCCS in its Opinion SCCS/1582/16, concerns were raised,  and more evidence was requested “to exclude eye irritation”.

As a result of the examination of the second dossier submitted to the SCCS, an Opinion was adopted on this question on the 21st of December 2018 (SCCS/1604/18) and after a thorough analysis of the data provided, the conclusion is that “Based   on  the  new  information  provided  by  the  Applicant,  the  SCCS   considers  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 0.7% safe with regard to eye irritation.”

This preliminary Opinion is still open for clarifications and comments until the 5th of March 2019.

With more than 25 years of regulatory experience, it will be our pleasure to help and advise you on EU cosmetics regulatory updates,  SCCS opinions and restricted or banned cosmetic ingredients in the EU.  If you would like to know more on cosmetics products regulatory  compliance, please contact us.

Manon Prado

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