CosmeticOBS - L'Observatoire des cosmétiques
July 8, 2019SCCS

Solubility of the SAS: Final Opinion of the SCCS pro Add to my portfolio
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Solubility of the SAS: Final Opinion of the SCCS

The SCCS has published its Opinion on the solubility of Synthetic amorphous silica (SAS). It has been adopted during its plenary meeting of 26 February 2019. The issue was to determine whether or not these cosmetic ingredients meet the definition of a nanomaterial. This Opinion is opened to comments until 13 May 2019.
Update of 3 July 2019: this Opinion was finalised at the plenary meeting of the SCCS on 20 and 21 June 2019, without any change in the conclusion.

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Background

Article 2(1)(k) of Regulation 1223/2009 (the Cosmetics Regulation) establishes that “nanomaterial” means an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.
The Commission received several notifications under Article 16 of the Cosmetics Regulation on four types of nano silica.
In January 2018 the Association of Synthetic Amorphous Silica Producers (ASASP), a Cefic Sector Group, submitted a dossier with the purpose to demonstrate that SAS does not fall under the nanomaterial definition of the Cosmetic Regulation. Therefore, according to the applicant no further actions required for nanomaterials as defined in the Cosmetics Regulation would apply to SAS.

For an exhaustive background information, see the article
Solubility of SAS, TiO2 coatings: 2 requests for Opinion to SCCS of March 26, 2018.

Opinion

1. Does the SCCS consider that Synthetic Amorphous Silica (SAS) are soluble (100 mg/L or higher) or degradable/non-persistent in biological systems, in light of the nanomaterial definition of the Cosmetic Regulation?

Having considered the data provided in this dossier and that available in published literature, the SCCS concludes that:
i) the solubility values for hydrophilic SAS materials have been reported to range from 22 mg/L to 225 mg/L for the solubility tests performed in aqueous media, or following the enhanced OECD TG 105 (0.5% ...