Consumer Safety SCCS OPINION ON Colloidal Silver (nano)

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SCCS/1596/18 Final Opinion on Colloidal Silver (nano) __________________________________________________________________________________________ SCCS comment: Inhalation exposure is not expected during the use of the submitted products, so information on droplet size is not relevant. 3.1.14. Homogeneity and stability The Applicants did not provide data on homogeneity and stability of the nanomaterial in relevant formulation (colloidal silver dispersions). Rather, they stated that the cosmetic product is stable in prescribed conditions of application or at usual storage conditions and for foreseeable usage until the declared expiry period. Ref.: 1, 2 (4, 5, 7, 8, 10, 11), 25, 26, 43 Additional information Under normal conditions of use and storage, colloidal silver dispersion A is stable (and shows no reactivity). Ref.: 40 SCCS comment: The Applicants did not provide any data. Data on stability/dissociation constant of the nanomaterial in relevant formulation/media must be provided for all colloidal silver dispersions. 3.1.15. Other parameters of characterisation Additional information The photocatalytic activity of colloidal silver dispersion I has been studied by degradation of methylene blue under sunlight irradiation measured by UV/VIS. It was concluded from the measurements that dispersion I does not exhibit photocatalytic activity. Ref.: 51 SCCS comment: Data on photo-catalytic activity should be provided for all applications intended for use on the skin. 3.1.16. Summary on supplementary physicochemical characterisation SCCS comments to physicochemical characterisation Overall, the information provided on the physicochemical characterisation of the colloidal silver suspensions is minimal and patchy. The physicochemical characterisation of the colloidal silver dispersions under evaluation is insufficient for assessment of its dermal and oral applications. According to the SCCS Guidance on the safety assessment of nanomaterials in cosmetics (SCCS 1484/12), the following information on the physicochemical characteristics of colloidal silver should be provided:  Information on concentration in terms of particle mass (dry powder) and particle number per volume (dispersions) for all colloidal silver dispersions  Content of ionic silver for each material when dispersed in aqueous media  Full chemical composition of the nanomaterial including purity (total silver, any impurities) and concentration (colloidal particles in ppm and ionic silver in ppm), 18

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