EC Committee Accepting Comment on Preliminary Opinion on Solubility of Synthetic Amorphous Silica

On March 15, 2019, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published its preliminary opinion on the solubility of synthetic amorphous silica (SAS).  The EC asked whether the SCCS considers that SAS are soluble (100 milligram per liter (mg/L) or higher) or degradable/non-persistent in biological systems in light of the nanomaterial definition of the Cosmetics Regulation.  Having considered the data provided in this dossier and that available in published literature, the SCCS concluded that: 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 Organization for Economic Cooperation and Development (OECD) Test Guideline (TG) 105 (0.5 percent ethanol). The latter protocol has been noted to increase the solubility by a factor of ten for some hydrophilic SAS materials. The solubility values of…

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