Monday, February 26, 2018Cosmetic regulations

Reminder: Zinc oxide banned in sprays as from February 24

© CosmeticOBS-L'Observatoire des Cosmétiques

If it was authorized as a colourant until recently, without any restrictions, the use of non-coated, non-nano zinc oxide is now banned in the applications likely to result in the final user’s lung exposure by inhalation. This ban results from the publication of Regulation 2017/1413 of last 3 August. It has taken effect on 24 February.

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This measure is the consequence of the SCCS Opinion of  18 September 2012 reviewed on 23 September 2014 . The Scientific Committee on Consumer Safety (SCCS) concluded that the use of zinc oxide is harmless if it is used as a colourant in its non-coated, non-nano form in cosmetic products intended for skin application. However, the SCCS also deemed that, given the lung inflammation triggered by zinc oxide particles after inhalation, the use of zinc oxide in cosmetic products likely to expose the consumer’s lungs to zinc oxide by inhalation is a cause for concern.

Regulation 2017/1413 was published par the European Commission on 3 August 2017 to amend Annex IV (colourants) of Cosmetics Regulation 1223/2009.

As a result, as from February 24, 2018, not a single new cosmetic product in the form of a spray or likely to result in consumer lung exposure may be placed on the market. The industry should have withdrawn all non-compliant products from the market by 24 May 2018.

It is the responsibility of manufacturers and Responsible Persons to take all the appropriate measures to comply with these dates, including by informing distributors of the ban and organizing the withdrawal from the market of …

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