CosmeticOBS - L'Observatoire des cosmétiques
April 2, 2019European Commission

A new preservative (HEPB) authorized at the end of 2019 pro Add to my portfolio
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Hydroxyethoxyphenyl Butanone, a new cosmetic preservative

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.

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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 irritant and additional scientific data submitted by the applicant, the ...