TAGS: Skin Care Decorative Cosmetic Toiletries
European Commission requests SCCS for a scientific opinion on Silver (CAS/EC No. 7440-22-4/231-131-3) used in cosmetic products.
Commission Department requesting the Opinion: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs.
Background
Silver (CAS/EC No. 7440-22-4/231-131-3) is an ingredient primarily used as a colorant (
CI 77820) in cosmetics, providing a silver hue to various cosmetic formulations. It is an authorized colorant and, therefore, listed in entry 142 of Annex IV to the Cosmetics Regulation. Silver is frequently found in
makeup products such as
eyeshadows, highlighters,
nail polishes, and
body powders, where it provides a metallic/shimmery effect. In addition, in the current dossier submission, silver is reported as
conditioning agent in rinse-off and leave on cosmetic products.
The European Risk Assessment Committee (RAC) of ECHA issued in February 2023 an opinion recommending among others a ‘Toxic for Reproduction Category 2’ classification for Silver. Following the RAC opinion, the European Commission may propose a classification for silver as a ‘Toxic for Reproduction Category 2’ (CLP Regulation Annex VI entry).
According to Article 15(1) of the Cosmetics Regulation ‘the use in cosmetic products of substances classified as CMR substances, of category 2, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited. However, a substance classified in category 2 may be used in cosmetic products where the substance has been evaluated by the SCCS and found safe for use in cosmetic products’. In view of these provisions, regulatory measures must be adopted by the Commission services within 15 months of the classification as CMR 1A or 1B of the substance(s) concerned in Part 3 of Annex VI to Regulation (EC) No 1272/2008.
In October 2023, the Commission services received a dossier to defend the safe use of micronsized particulate Silver (CAS/EC No. 7440-22-4/231-131-3) as a conditioning agent in cosmetic products according to Article 15(1) of the Cosmetics Regulation 1223/2009. The Commission, therefore, requests the SCCS to carry out a safety assessment on this ingredient in view of the information provided.
Terms of Reference
(1) In light of the data provided and taking under consideration the classification as toxic for reproduction Cat. 2, does the SCCS consider micron-sized particulate Silver safe when used up to a maximum concentration of 0.2 % in rinse-off and 0.3 % in leave-on cosmetic products?
(2) Alternatively, what is according to the SCCS, the maximum concentration considered safe for use of micron-sized particulate Silver in cosmetic products?
(3) Does the SCCS have any further scientific concerns with regard to the use of micron-sized particulate Silver in cosmetic products?
Deadline: 6 months
Supporting documents: Microsilver BG-Dossier
The SCCS approved this mandate by written procedure on 21 November 2023.
Source: European Commission
