CosmeticOBS - L'Observatoire des cosmétiques
April 1, 2019European Commission

Ethanol included in the Omnibus Regulation on CMRs… and soon to be banned in cosmetics! Add to my portfolio
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CosmeticOBS' April Fool's Day

On 29 June 2017, the European Union notified the WTO of a draft Regulation to prohibit or limit the use in cosmetic products of all substances classified as CMR. In an addendum dated 27 March 2019, it announced the addition of ethanol to the list of substances soon to be banned in all cosmetic products, including perfumes.

Reading time : ~ 4 minutes

Notification Date

27 March 2019

Products covered

Cosmetics

Title of the notified document

Draft Commission Regulation amending Annexes II, III and V to Regulation (EC) No.1223/2009 of the European Parliament and of the Council on cosmetic products – Addendum

Content

This draft Commission Regulation aims at adding Ethanol to substances which have been classified as carcinogenic, mutagenic or toxic for reproduction (CMR) during the period from the adoption of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures to the adoption of Commission Regulation (EU) 2015/1221 on classification, labelling and packaging of substances and mixtures, for the purposes of its adaptation to technical and scientific progress, to prohibit or limit their use in cosmetic products.

Objective

Protection of human health and safety

The text of the notification

The European Commission intends to notify the following proposed changes to the draft of Commission Regulation amending Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, notified on 29 June 2017:
1. Insertion of Recital 18bis
2. Addition of entry 1590 in Annex II of Regulation (EC) No.1223/2009

The text of Recital 18bis

The substance Ethanol, with the INCI name Alcohol, is currently not included in the Annexes to Regulation (EC) No 1223/2009. Ethanol is currently not classified as a CMR substance, but has been the subject of two classification proposals: Carcinogen Cat. 3 and Toxic for Reproduction Cat. 1. It is also classified as a Carcinogen Cat. 1 by the IARC. On 10 December 2018, the Standing Committee on Cosmetic Products considered that in view of the proven CMR potential of Ethanol, the substance should be banned in all cosmetic products, including perfumes, and adopted this resolution by 22 votes against 6. Therefore, the substance Ethanol should be added to the list of substances prohibited in cosmetic products in Annex II to Regulation (EC) No.1223/2009.

Entry 1590 of Annex II to Regulation 1223/2009

• Chemical name/INN: Ethanol
• CAS number: 64-17-5
• EC number: 200-578-6

Proposed date of adoption

2nd Quarter 2019

Proposed date of entry into force

20 days from publication in the Official Journal of the EU

Final date for comments

30 days from notification

For further information
• See the full text of the notification, on the WTO website

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