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Tuesday, April 7, 2020News

Europe notifies WTO of forthcoming restrictions for HEMA / di-HEMA TMHDC

L'Europe notifie à l'OMC de prochaines restrictions pour les HEMA / di-HEMA TMHDC

On March 27, 2020, the European Union transmitted to the WTO a draft Regulation intended to limit the use of nail products containing HEMA and di-HEMA ingredients to professional uses only, and to impose a statement warning of the risks of allergic reactions for which they may be responsible. The amendment to Annex III (restricted substances) of Cosmetics Regulation 1223/2009 is expected to be adopted in the 4th quarter of 2020.

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Notification Date

27 March 2020

Products covered

Cosmetic products

Title of the notified document

Draft Commission Regulation amending Annex III to Regulation (EC) No.1223/2009 of the European Parliament and of the Council on cosmetic products


This draft Commission Regulation would restrict nail products containing HEMA/Di-HEMA to professional use only and the following warnings “for professional use only” and “Can cause an allergic reaction” should be added on the package.


Protection of human health or safety

The text of the future regulation


  1. The substances 2-hydroxyethyl methacrylate (HEMA) and 11,14-Dioxa-2,9-diazaheptadec-16-enoic Acid, 4,4,6,16-tetramethyl-10,15-dioxo,2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl ester (Di-HEMA Trimethylhexyl Dicarbamate or Di-HEMA TMHDC) are currently not subject to prohibition or restriction pursuant to Regulation (EC) No.1223/2009.

  2. On 2 July 2014, the Swedish Medical Products Agency, which is the Swedish competent authority for the purposes of Regulation (EC) No.1223/2009, adopted and communicated a decision under Article 27 of Regulation (EC) No.1223/2009 introducing provisional restrictive measures on a nail cosmetic product that had caused a high number of undesirable effects. The substances identified as likely to cause those undesirable effects were HEMA and Di-HEMA TMHDC.

  3. According to Article 27(2) of Regulation (EC) No.1223/2009, the Swedish Medical Products Agency communicated immediately to the Commission and the …

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