Assessing the Safety of Micron-sized Particulate Silver in Cosmetic Products: A Scientific Opinion Requested by the European Commission

The European Commission's Directorate-General for Internal Market, Industry, Entrepreneurship, and SMEs has requested a scientific opinion from the Scientific Committee on Consumer Safety (SCCS) regarding the use of Silver (CAS/EC No. 7440-22-4/231-131-3) in cosmetic products. Silver is employed as a colorant in cosmetics, authorized under entry 142 of Annex IV to the Cosmetics Regulation. The European Risk Assessment Committee (RAC) has recommended a 'Toxic for Reproduction Category 2' classification for Silver, and the Commission may propose this classification.

Article 15(1) of the Cosmetics Regulation stipulates that the use of substances classified as CMR (Carcinogenic, Mutagenic, or Toxic for Reproduction) Category 2 shall be prohibited in cosmetic products, unless evaluated and found safe by the SCCS. In response to the RAC opinion, the Commission received a dossier defending the safe use of micron-sized particulate Silver as a conditioning agent in cosmetic products. The Commission has asked the SCCS to assess the safety of using micron-sized particulate Silver up to certain concentrations in rinse-off and leave-on cosmetic products.

The terms of reference for the SCCS include evaluating the safety of micron-sized particulate Silver at specified concentrations, determining alternative safe concentrations, and addressing any additional scientific concerns. The deadline for the SCCS to provide its opinion is six months, and supporting documents include the Microsilver BG-Dossier. The SCCS approved this mandate on 21 November 2023 through a written procedure.