SCCS Opinion on Silica (nanoform)

On 29th of September, the EC Scientific Committee on Consumer Safety (SCCS) has published the finalized version of the opinion on silica, hydrated silica, and silica surface modified with alkyl silylates (nano form). Synthetic amorphous silica (SAS) materials are used in cosmetics and other consumer products including pharmaceuticals and foods. In cosmetics, typically leave-on and rinse-off products use these ingredients in nano form. This includes hair, skin, lip, face, and nail products at different concentrations and with different specifications.

 

The submitted 28 SAS materials were categorized into four categories, however showing large differences in the experimental data for some physico-chemical properties even within an SAS category. Therefore, the SCCS used a case-by-case approach to assess each material safety. The SCCS did not draw any firm decision either for or against the safety of any of the individual SAS materials – as well as any of the SAS categories that are intended for use in cosmetic products – due to the inadequate and insufficient evidence provided in the submission and the available scientific literature.

Applicants are therefore advised to follow the SCCS Notes of Guidance (SCCS/1501/12), the SCCS Guidance on Risk Assessment of Nanomaterials (SCCS/1484/12), and the SCCS Memorandum on Data Quality (SCCS/1524/13) for any future evaluation of the SAS materials.

The Committee clearly stated that data from appropriately designed studies are needed to exclude the toxicity of the SAS materials, in particular the mutagenic/ genotoxic potential, considering the different possible exposure routes, the SAS concentration, and actual use conditions of the final Products. Further studies are also needed to exclude the possibility of dermal penetration of SAS materials, especially the surface modified hydrophobic types, in the media/formulations that are relevant to the final product.

 

The complete document can be accessed via the following link:

SCCS (Scientific Committee on Consumer Safety), Opinion on Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form) 20 March 2015, SCCS/1545/15, revision of 29 September 2015. (PDF; 2.9 MB)

 

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