On 28 March 201p, the European Union transmitted to WTO a draft Regulation aimed to authorise the use of a new preservative - Hydroxyethoxyphenyl Butanone (HEPB) - in cosmetic products. Modification of Annex V (authorised preservatives) is expected to be adopted during the 4th quarter of 2019.
Notification Date
28 March 2019
Products covered
Cosmetics
Title of the notified document
Draft Commission Regulation amending Annex V to Regulation (EC) No.1223/2009 of the European Parliament and of the Council on cosmetic products
Content
This draft Commission Regulation proposes the authorisation of a new preservative ingredient - Hydroxyethoxyphenyl Butanone (HEPB) – in rinse off, oral care and leave-on cosmetic products at a maximum concentration of 0.7%.
Objective
Protection of human health and safety
The text of the future regulation
Whereas
1. 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, is used as a cosmetic preservative and as a skin conditioning agent. It is currently not listed in Regulation (EC) No.1223/2009.
2. 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.
3. Following concerns raised by several Member States on HEPB as a potential eye …
