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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(1), and in particular Article 31(1) thereof,
After consulting the Scientific Committee on Consumer Safety,
Whereas:
(1) 3-Benzylidene Camphor is currently authorised for use in cosmetic products as a UV filter in a concentration up to maximum 2,0 %. It is listed under reference number 19 of Annex VI to Regulation (EC) No 1223/2009.
(2) The Scientific Committee on Consumer Safety (SCCS)(2) concluded in its opinion of 18 June 2013 that, due to a margin of safety below 100, the use of 3-Benzylidene Camphor as a UV filter in cosmetic products in a concentration up to 2,0 % is considered unsafe.
(3) In order to ensure the safety of sunscreen products for human health it is necessary to remove 3-Benzylidene Camphor from the list of UV filters allowed in cosmetic products as laid down in Annex VI to Regulation (EC) No 1223/2009.
(4) Considering that 3-Benzylidene Camphor is known not only as a UV filter but also as a UV absorber, its use should be banned in cosmetic products.
(5) Annexes II and VI to Regulation (EC) No 1223/2009 should therefore be amended accordingly.
(6) The application of that restriction should be deferred to allow the industry to make the necessary adjustments to product formulations. In particular, undertakings should be granted 6 months to place on the market compliant products and to withdraw from the market non-compliant products after the entry into force of this Regulation.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,
HAS ADOPTED THIS REGULATION:
Annexes II and VI to Regulation (EC) No 1223/2009 are amended in accordance with the Annex to this Regulation.
From 18 February 2016 only cosmetic products which comply with this Regulation shall be placed and made available on the Union market.
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, 28 July 2015.
For the Commission
The President
Jean-Claude Juncker
Regulation (EC) No 1223/2009 is amended as follows:
in Annex II, the following entry is added:
| Reference number | Chemical name/INN | CAS number | EC number |
|---|---|---|---|
| ‘1379 | 3-Benzylidene Camphor | 15087-24-8 | 239-139-9’ |
in Annex VI the entry concerning reference number 19 is deleted.
Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC, OJ L 241, 10.9.2008, p. 21.