Commission Regulation (EU) 2017/238 of 10 February 2017 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products

Commission Regulation (EU) 2017/238 of 10 February 2017 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products OJ L 342, 22.12.2009, p. 59. , and in particular Article 31(1) thereof, Whereas: (1) The Scientific Committee on Consumer Safety (SCCS), concluded in its opinion of 16 December 2008 SCCP 1201/08. that the use of Benzophenone-3 as a UV-filter at a concentration of up to 6 % w/w in cosmetic sunscreen products and up to 0,5 % w/w in all types of cosmetic products to protect the formulation does not pose a risk to human health, apart from its contact allergenic and photoallergenic potential. (2) Consequently, the current maximum concentration of 10 % w/w for Benzophenone-3 used as a UV-filter in cosmetic products should be decreased to 6 % w/w. (3) Regulation (EC) No 1223/2009 should therefore be amended accordingly. (4) The application of the new maximum concentration should be deferred to allow the industry to make the necessary adjustments to product formulations. In particular, undertakings should be granted six months from the entry into force of this Regulation to take the necessary measures to place on the market compliant products and to stop making available products already placed on the market that do not comply with the new maximum concentration. (5) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products, HAS ADOPTED THIS REGULATION:

Article 1

Annex VI to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall apply from 3 September 2017.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 10 February 2017. For the Commission The President Jean-Claude Juncker

Annex

ANNEX In Annex VI to Regulation (EC) No 1223/2009, entry 4 is replaced by the following: Reference numberSubstance identificationConditionsWordings of conditions of use and warningsChemical name/INN/XANName of Common Ingredients GlossaryCAS numberEC numberProduct type, body partsMaximum concentration in ready for use preparationOtherabcdefghi42-Hydroxy-4-methoxybenzophenone/OxybenzoneBenzophenone-3131-57-7205-031-56 %Not more than 0,5 % to protect product formulationContains Benzophenone-3 (1)