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Tuesday, August 27, 2019Regulation

Coatings for Zinc Oxide (nano): Request for the SCCS Opinion

Enrobages de Zinc oxide (nano) : demande d'Opinion au CSSC

The safety of three coatings for Zinc Oxide in its nano form will be assessed by the SCCS. The request was made by the European Commission and published on 19 August 2019. The Scientific Committee accepted this mandate by written procedure on 29 July 2019.

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This mandate to SCCS was withdrawn on 7 September 2020

Background

Zinc oxide, ZnO, (CAS/EC numbers 1314-13-2/215-222-5) is authorized both as colorant under entry 144 of Annex IV and as UV-filter under entry 30 and 30a (nano) of Annex VI to the Cosmetics Regulation (EC) No.1223/2009.

The Scientific Committee on Consumer Safety (SCCS) has delivered an Opinion on Zinc oxide (nano) (SCCS/1489/12) and an Addendum (SCCS/1518/13) concerning the safety of the nano form of ZnO and its coating (triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer and octyl triethoxy silane). The SCCS committee concluded that the use of ZnO (nano) as UV filter in sunscreens, with the characteristics laid out in this Opinion, and at a concentration of up to 25 %, can be considered to “pose no or limited risk for use on the skin as UV filter in sunscreen formulations.”

Regarding the use of other coatings, not covered in the Opinion, the SCCS concluded that: “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.” (SCCS/1518/13)

The SCCS conclusion clarifies that …

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