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Wednesday, April 1, 2015Regulation

European Commission: Call for data on nano Colloidal Silver

© CosmeticOBS-L'Observatoire des Cosmétiques

In the framework of Regulation 1223/2009 on cosmetic products, the European Commission calls for data on the ingredient Colloidal Silver [nano]. The period of consultation starts from 25 March and ends on 30 June 2015.

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Background

Article 2(1)(k) of Regulation (EC) No 1223/2009 establishes that ‘nanomaterial’ means an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.

That definition covers only materials in the nano-scale that are intentionally made, and are insoluble/partially-soluble or biopersistent (e.g. metals, metal oxides, carbon materials, etc.), and it does not cover those that are soluble or degradable/non-persistent in biological systems (e.g. liposomes, emulsions, etc.). Article 16 of Regulation (EC) No 1223/2009 (Cosmetics Regulation) requires any cosmetic product other than colorants, preservatives and UV-filters, containing nanomaterials to be notified to the Commission six months prior to being placed on the market. If there are concerns over the safety of a nanomaterial, the Commission shall refer it to the Scientific Committee on Consumer Safety (SCCS) for a full risk assessment.

The Commission has received the notification of several cosmetics products containing the ingredient ‘Colloidal silver [nano]’ (CAS No 7440-22-4, EC No 231-131-3). This ingredient ‘Colloidal silver’ as such is not regulated in Cosmetics Regulation, but it is reported in the CosIng database with antimicrobial functions. According to the applicants, the ingredient is used as antimicrobial in …

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