Regulation 2019/1858 of 6 November 2019, published in the Official Journal of the European Union on 7 November 2019, amends Annex V (Preservatives) of Cosmetics Regulation 1223/2009 to add Hydroxyethoxyphenyl Butanone (HEPB). The provision is effective immediately (20 days after the publication of the text).
The whereas of Regulation 2019/1858
The substance 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one (CAS Number: 569646-79-3), which has been assigned the name Hydroxyethoxyphenyl Butanone (HEPB) under the International Nomenclature of Cosmetic Ingredients, has the function of preservative and skin conditioning. It is currently not listed in Regulation (EC) No.1223/2009.
The Scientific Committee on Consumer Safety (SCCS) concluded in its opinion of 7 April 2017 that, under an aggregate exposure scenario, HEPB can be considered safe when used as a preservative in rinse off, oral care and leave-on cosmetic products at a maximum concentration of 0.7%. The SCCS also concluded that more evidence would be needed to exclude eye irritation.
Following concerns raised by several Member States on HEPB as a potential eye irritant and additional scientific data submitted to it by the applicant, the SCCS concluded in its opinion of 5 March 2019 that, under an aggregate exposure scenario, the use of HEPB as a preservative in rinse-off, oral care and leave-on cosmetic products at a maximum concentration of 0.7% is safe with regard to eye irritation.
In light of the opinions mentioned above and in order to take into account technical and scientific progress, HEPB should be allowed for use as a preservative in …
