Revision of the Addendum to the opinion SCCS/1489/12 on Zinc oxide (nano form) (S76)

WG on Nano-materials
SCCS members: U. Bernauer, Q. Chaudhry (chairman), M. Dusinska, W. Lilienblum, Th. Platzek, S. Ch. Rastogi, J. van Benthem
SCENIHR members: P. H. M. Hoet, K. Rydzynski
External experts: O. Bussolati, W. H. de Jong (rapporteur), S. H. Doak, Th. Jung, T. Sanner, N. von Götz
Contact:SANTE-C2-SCCSec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1518/13
Doi: 10.2772/70325
Adopted on: 22 April 2014

Conclusion of the opinion:

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: (i) 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; (ii) 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; (iii) ZnO nanoparticles that are either uncoated or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane. Other cosmetic ingredients can be used as coatings as long as they are demonstrated to the SCCS to be safe and do not affect the particle properties related to behaviour and/or effects, compared to the nanomaterials covered in the current opinion; (iv) 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 0.3 mg/m3. However these new data do not address the concerns relating to the lung exposure and the potential manifestation of harmful effects.

Keywords:

SCCS, scientific opinion, UV filter, S76, Zinc oxide (nano form), directive 76/768/ECC, CAS 1314-13-2, EC 215-222-5

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), ADDENDUM to the Opinion SCCS/1489/12 on Zinc oxide (nano form), 23 July 2013, revision of 22 April 2014.