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SCCS/1596/18 Final Opinion on Colloidal Silver (nano) __________________________________________________________________________________________ 2. MANDATE FROM THE EUROPEAN COMMISSION 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.): it does not cover those that are soluble or degradable/non-persistent in biological systems (e.g. liposomes, emulsions, etc.). Article 16 of the Cosmetics Regulation requires the manufacturer to notify the Commission of any cosmetic product containing nanomaterials six months prior to being placed on the market, and Article 19 requires nano ingredients to be labelled (name of the ingredient, followed by ‘nano’ in brackets). 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 received 63 notifications of cosmetic products containing Colloidal Silver (CAS No 7440-22-4, EC No 231-131-3) in nano form, as reported in the attached list. This ingredient is reported in the CosIng database without any reference to the nano form with the function of abrasive, bulking and emulsion stabilising, but it is not regulated in Cosmetic Regulation (EC) No 1223/2009. According to the Applicants, the ingredient is used in nano uncoated form both in leave-on and rinse-off oral cosmetics products including toothpastes and skin care products with a maximum reported concentration limit of 1% and specifications as reported in the list attached to the mandate. The Commission has concerns over the safety of the use of Colloidal Silver in nano form in cosmetic products. The Commission published a 12-week call for data with the deadline of 30 June 2015, in which interested parties were invited to submit any relevant scientific information on the safety of Colloidal Silver (CAS No 7440-22-4, EC No 231-131-3) in nano form used in cosmetic products and in particular data regarding all toxicological end-points and an indication on the suggested concentration safe limits for this ingredient. The documentation received by Commission is annexed to the mandate. Therefore, the Commission is requesting the SCCS to produce a safety assessment of the nano form of Colloidal Silver covered in the notifications listed in the annex to this mandate, in the above-mentioned categories of products, taking into account the reasonably foreseeable exposure conditions. Terms of reference 1. In view of the above, and taking into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterial Colloidal Silver when used in cosmetics including toothpastes and skin care products with a maximum concentration limit of 1%, taking into account the reasonably foreseeable exposure conditions. 2. SCCS is requested to address any further scientific concerns with regard to the use of Colloidal Silver in nano form in cosmetic products. 6PDF Image | Consumer Safety SCCS OPINION ON Colloidal Silver (nano)
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