In its announcement the Commission says it proposes to amend entry 144 of Annex IV to Regulation, to restrict the use of ZnO as a colorant to the applications that do not result in exposure of the end-user's lungs by inhalation.
As for Chloroacetamide, which is often used as a preservative, the Commission proposes to prohibit its use in cosmetic products and delete the corresponding entry from Annex V, adding Chloroacetamide to the list of substances prohibited in Annex II.
In both cases, the Commission invites any interested parties, including authorities of Member States, manufacturers of cosmetic products, producers of the substances concerned and relevant industry and consumers associations, to submit their comments on the proposed measures and on their possible economic impact.
A nine-month transitional period for withdrawing non-compliant products from the market, has also been proposed, with comments open on the proposal until 24 December this year.
Ban for one?
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.
However, the ingredient has been classified as a substance toxic for reproduction and its use in cosmetic products was assessed by the Scientific Committee on Consumer Safety (SCCS) which stated that it “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)"
Restriction for the other?
As for Zinc Oxide, the Commission says it is authorized as a colorant in cosmetic products through Annex IV/144 of the Regulation.
The SCCS adopted an opinion on ZnO (nano form) for use as a UV-filter three years ago, which was amended by a further opinion for clarification of the meaning of the term ‘sprayable applications/products’ for the nano forms of Carbon Black CI 77266, Titanium Dioxide and ZnO, adopted on 23 September 2014.
In the terms of reference on ZnO (nano) as a UV-filter, the SCCS was asked if it had any further scientific concern regarding the use of ZnO in cosmetic products, replying: "ZnO is also used as a colorant in cosmetic products. In view of the similar toxicity of both nano-sized and fine ZnO, it is considered that ZnO is safe when used as colorant in cosmetics for dermal application."
However, the Committee concluded that “[i]n view of the lung inflammation induced by ZnO particles after inhalation, the use of ZnO in cosmetic products that may result in exposure of the consumer’s lungs by inhalation is of concern.”