European Commission Seeks SCCS Evaluation on Safety of Micron-sized Particulate Silver in Cosmetics

The European Commission has formally reached out to the Scientific Committee on Consumer Safety (SCCS) to conduct a comprehensive safety assessment on micron-sized particulate Silver (CAS/EC No. 7440-22-4/231-131-3), a commonly used ingredient in cosmetics. The request comes against the backdrop of the European Risk Assessment Committee's (RAC) opinion in February 2023, suggesting a classification of Silver as 'Toxic for Reproduction Category 2.'

The Directorate-General for Internal Market, Industry, Entrepreneurship, and SMEs oversees the Commission Department making this request, emphasizing the significance of evaluating Silver's safety in cosmetic formulations.

Silver, identified as a colorant (CI 77820) in cosmetics, is a permitted ingredient listed in entry 142 of Annex IV to the Cosmetics Regulation. Widely employed for its metallic or shimmery effect, Silver features prominently in makeup products like eyeshadows, highlighters, nail polishes, and body powders. The dossier submitted to the Commission in October 2023 specifically highlights its use as a conditioning agent in both rinse-off and leave-on cosmetic products.

The RAC's opinion recommending a 'Toxic for Reproduction Category 2' classification for Silver prompts regulatory considerations. According to Article 15(1) of the Cosmetics Regulation, the use of substances classified as CMR substances, specifically in Category 2, necessitates evaluation by the SCCS to determine their safety in cosmetic products. This evaluation becomes imperative within 15 months of classification as CMR 1A or 1B.

Given these regulatory provisions, the Commission seeks SCCS's expertise to assess the safety of micron-sized particulate Silver in cosmetic products. The terms of reference provided by the Commission outline specific queries for the SCCS to address:

1. Considering the classification as toxic for reproduction Category 2, does the SCCS deem micron-sized particulate Silver safe at concentrations up to 0.2% in rinse-off and 0.3% in leave-on cosmetic products?

2. Alternatively, what is the maximum concentration of micron-sized particulate Silver that the SCCS considers safe for use in cosmetic products?

3. Does the SCCS have additional scientific concerns regarding the use of micron-sized particulate Silver in cosmetic products?

The SCCS is expected to provide its evaluation within a 6-month timeframe, with the deadline set for the completion of this safety assessment.

The supporting documents for this evaluation include the Microsilver BG-Dossier, providing essential information for the SCCS to conduct a thorough and informed assessment. The SCCS has approved this mandate through a written procedure on November 21, 2023, signaling a pivotal step in ensuring the safety of cosmetics containing micron-sized particulate Silver.