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Wednesday, September 23, 2015Regulation

Chloroacetamide, Zinc Oxide: Consultations by European Commission

© CosmeticOBS-L'Observatoire des Cosmétiques

On September 21, the European Commission has launched two public consultations on its proposals to make regulations evolve as regards two cosmetic ingredients. This project aims to prohibit the preservative Chloroacetamide (already forbidden in France) in all cosmetic products, and to prohibit Zinc Oxide as a colorant in spray products. These consultations will remain open until December 24, 2015.

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These two consultations concern 'any interested parties, including authorities of the Member States, manufacturers of cosmetic products, producers of the substances concerned and relevant industry and consumers associations.'

Chloroacetamide

Background

Chloroacetamide is authorised as a preservative in cosmetics products in entry 41 of Annex V to Regulation (EC) No 1223/2009, at a concentration up to 0.3% w/w in ready for use preparations.

Chloroacetamide has been classified as a substance toxic for reproduction - category 3 under Directive 67/548/EEC (toxic for reproduction - category 2, based on the criteria of Regulation (EC) No 1272/2008). The use of Chloroacetamide in cosmetic products has been assessed by the Scientific Committee on Consumer Safety (SCCS) which concluded as follows:
'On the basis of the data available, the SCCS comes to the conclusion that 2- chloroacetamide is not safe for consumers when used under the current use conditions of 0.3% in cosmetic products.
Human data demonstrate that allergic reactions can be elicited at concentrations lower than 0.3% (use conditions in cosmetics products).'

Proposed modifications to Annex II and Annex V to the Cosmetics Regulation

On the basis of the information provided above, the Commission proposes to prohibit the use of Chloroacetamide in cosmetic products.

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