Regulation 2017/1413 of 3 August 2017, published in Official Journal of the European Union on 4 August, amends Annex IV (colorant) of Cosmetics Regulation 1223/2009, to limit the use of non-nano zinc oxide to products which may not lead to exposure of the end-user’s lungs by inhalation. This provision will apply from 24 February 2018 and will be fully implemented from 24 May 2018.
The whereas of regulation 2017/1413
(1) Zinc oxide is authorised as a colorant in cosmetic products under entry 144 of Annex IV to Regulation (EC) No 1223/2009.
(2) In its opinion of 18 September 2012, which was revised in 23 September 2014, the Scientific Committee on Consumer Safety (SCCS) concluded that the use of zinc oxide is safe when used as colorant, in its uncoated non-nano form, in cosmetics for dermal application. However, the SCCS also considered that in view of the lung inflammation induced by zinc oxide particles after inhalation, the use of zinc oxide in cosmetic products that may result in exposure of the consumer’s lungs to zinc oxide by inhalation was of concern.
(3) In light of the SCCS opinions, the use of zinc oxide as a colorant, in its uncoated non-nano form, in cosmetic products should be restricted to those applications which may not lead to exposure of the end-user’s lungs by inhalation.
(4) Annex IV to Regulation (EC) No 1223/2009 should therefore be amended accordingly.
(5) The industry should be allowed a reasonable period of time to make the necessary adjustments to product formulations in view of their placing on the market and …
