Consumer Safety SCCS OPINION ON Colloidal Silver (nano)

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SCCS/1596/18 Final Opinion on Colloidal Silver (nano) __________________________________________________________________________________________ 3. OPINION Preamble: Initial assessment of all data submitted showed that the provided data by the Applicants appeared to be very minimal. No complete dossiers for all colloidal silver dispersions were submitted and there were hardly any data on physical chemical characterisation and experimental toxicity studies. Clarification on a number of aspects and missing safety data were needed before the SCCS could form an Opinion on the safety of the material. To facilitate the evaluation process, the Applicants were asked to provide additional data, revise the information submitted in the dossier, and provide clarifications. In response, some Applicants provided additional data and information. Much of this information related to antimicrobial activity of nano silver, which was not relevant to this evaluation. All the relevant information on colloidal silver dispersions, including additional data, has been described and assessed in the current Opinion. In addition, the Commission gave out a Call for information in regard to the safety of the nano silver. The information received from various sources has also been considered in this Opinion. 3.1. CHEMICAL AND PHYSICAL SPECIFICATIONS An overview on data on material characterisation is provided in the Table 1 of the Annex. 3.1.1. Chemical identity 3.1.1.1. Primary name and/or INCI name Colloidal silver 3.1.1.2. Chemical names Colloidal silver Silver particles suspended in liquid Non-ionic silver SCCS comment: The term colloidal silver implies that particles are in aqueous suspension. However, some proportion will also be in the form of ionic silver. Information is needed on the proportion of colloidal particles and ionic silver in a typical material. 3.1.1.3. Trade names and abbreviations Silver Water nano-TECH/ aXonnite silver (A, B, C, D, J, K, L) Premium Heritage Colloidal Silver (E) Nanosrebro (F, G) Nanocolloidal Silver (H2O Ag) Non-Chemical (H) Ag100 Koloidne Striebro (colloidal silver Ag 100) (I) 7

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