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On November 28th, 2019, the European Commission (EC) has published Commission Regulation (EU) 20191966 which amends and corrects Annexes II, III, and V of Regulation (EC) No 12232009 on cosmetic products.

The Regulation adds 12 new carcinogenic, mutagenic, or reproductive toxicants (CMRs) to Annex II – the list of prohibited substances in cosmetic products. It also makes corrections and amendments to some entries on this Annex.

The Regulation also amends Annex III by setting new concentration limits for use of salicylic acid as a preservative and non-preservative. The use of salicylic acid as a preservative in cosmetic products remains authorized at 0.5 % maximum concentration. After evaluation by the Scientific Committee on Consumer Safety (SCCS), the use of salicylic acid in oral products and applications that may lead to exposure of the end-user’s lungs by inhalation is prohibited. It is also not to be used in products for children under 3 years old except for shampoos.

The prohibition of the 12 new CMRs in cosmetic products and the new concentration limits for salicylic acid shall apply from May 1st, 2020. On the other hand, the Annex II entry for ‘hydroxy-8-quinoline and its sulphate bis(8-hydroxyquinolinium) sulphate except for the uses of the sulphate provided for in entry 51 of Annex III and the new limits for bis(8-hydroxyquinolium) sulphate shall apply retroactively from June 11th 2019.

The Regulation will be enforced beginning December 18th, 2019.