Call for data on ingredients: 'Di-HEMA Trimethylhexyl Dicarbamate', 'HEMA' and the class of compounds 'Urethane acrylates'

Policy fields

Enterprise and Industry, Internal Market, Consumer Affairs, Public Health.

Target

Any interested parties, including authorities of the Member States, manufacturers of cosmetic products, producers of the substances concerned and relevant industry and consumers associations.

Period of consultation: from 10 March to 31 July 2016

Background

The Commission was informed of a decision of the Swedish authorities to withdraw and prohibit the sale and delivery of a range of nail polishes, according to Article 27 of Regulation (EC) No 1223/2009 on cosmetic products ('Cosmetics Regulation'). These products were notified through the RAPEX system, pursuant to Article 12 of Directive 2001/95/EC on general product safety, as posing a serious risk to consumers (RAPEX notification of 5 August 2014, with the reference number A12/1226/14).

The Swedish authorities consider that the above-mentioned products, which after application are hardened with the use of a LED lamp, constitute a serious risk for consumers as they can result in damage to nails and / or hands.

Pursuant to Article 27(3) of the Cosmetics Regulation, in order to determine whether the provisional measures taken by Sweden are justified or not, the Commission shall consult the interested parties, the Member States and the Scientific Committee on Consumer Safety (SCCS), whenever possible.

Discussions took place with the Member States at the meetings of the Standing Committee on Cosmetic Products. In 2015 Sweden produced preliminary results regarding substances that caused positive reactions on several patients who had reported reactions to the products in question, thus enabling further enquiries by the Commission.

To determine which substances may cause safety concerns, relevant scientific information and data on the safety of the substances contained  in these products, in particular 'Di-HEMA Trimethylhexyl Dicarbamate' (CAS 41137-60-4), 'HEMA' (CAS 868-77-9) and on the class of compounds 'Urethane acrylates', would be required.

Letters have already been sent to the Member States and other interested parties asking for contributions.

Action proposed by the Commission

In order to prepare requests for scientific opinions to the SCCS, interested parties are invited to submit any relevant scientific information on the safety of 'Di-HEMA Trimethylhexyl Dicarbamate' (CAS 41137-60-4), 'HEMA' (CAS 868-77-9) and on the class of compounds 'Urethane acrylates' used in cosmetic products, in particular information on the types of cosmetic products in which they are used, the concentration levels at which they are used in specific products and their function(s), as well as data regarding all toxicological endpoints. The dossiers shall be in line with the SCCS's Notes of Guidance for the testing of cosmetic substances and their safety evaluation (8th revision).

Request

The Commission would like to invite any interested parties, including authorities of Member States, manufacturers of cosmetic products, producers of 'Di-HEMA Trimethylhexyl Dicarbamate', 'HEMA' and the class of compounds 'Urethane acrylates' and relevant industry and consumers associations, to submit their contribution.

How to submit your contribution

Any comments should be sent with the reference 'Di-HEMA Trimethylhexyl Dicarbamate, HEMA and Urethane acrylates' by post or e-mail by 31 July 2016 at the latest to:

European Commission
Directorate General Internal Market, Industry, Entrepreneurship and SMEs
Unit D/4, Health Technology and Cosmetics,
Av. d’Auderghem 45, BREY 12/10
1040 Brussels
Belgium

E-mail: GROW-D4@ec.europa.eu

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