Scientific Committee on Consumer Safety: addendum to the opinion SCCS/1489/12 on Zinc oxide (nano form)

Text extracted from the conclusions of the SCCS report:

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The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for use on the skin as UV filter in sunscreen formulations:

1. ZnO nanoparticles of purity >= 96%, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1% in total.
2. ZnO nanoparticles with a median diameter (D50: 50% of the number below this diameter) of the particle number size distribution above 30 nm, and the D1 (1% below this size) above 20nm.
3. ZnO nanoparticles that are either uncoated or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane, and/or coated with other cosmetic ingredients as long as these cosmetic ingredients are accepted by the regulatory authorities and/or have been demonstrated to be safe for use as cosmetic ingredient.
4. ZnO nanoparticles that have a comparable solubility to that reported in the dossier, i.e. below 50 mg/L (approximately the maximum solubility of the ZnO nanomaterials for which data are provided in the dossier).

The submitted 90 days inhalation study resulted in a NOAEL of 0.3mg/m3.
However these new data do not address the concerns relating to the lung exposure and the potential manifestation of harmful effects.

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Source internet document: SCCS report