Commission Regulation (EU) 2016/314

of 4 March 2016

amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products

(Text with EEA relevance)

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 products1, and in particular Article 31(1) thereof,

Whereas:

(1)

The substance Diethylene Glycol Monoethyl Ether (DEGEE) with the INCI name Ethoxydiglycol which is used in cosmetic products is not yet regulated under Regulation (EC) No 1223/2009.

(2)

DEGEE was the subject of a risk assessment done by France on the basis of which France decided2 that it is safe for consumers, when used in a concentration up to 1,5 % in all cosmetics products except products for oral hygiene. This decision was notified to the Commission and the Member States in accordance with Article 12 of Council Directive 76/768/EEC3. As a result, the Commission gave a mandate to the Scientific Committee on Consumer Products (SCCP) to issue an opinion on the safety of each of the glycolethers restricted by the French decision.

(3)

The SCCP, subsequently replaced by the Scientific Committee on Consumer Safety (SCCS) pursuant to Commission Decision 2008/721/EC4, adopted scientific opinions on DEGEE, on 19 December 20065, 16 December 20086, 21 September 20107 and 26 February 20138.

(4)

The SCCS concluded that the use of DEGEE in oxidative hair dye formulations at a maximum concentration of 7 % w/w, in non-oxidative hair dye formulations at a maximum concentration of 5 % w/w and in other rinse-off products at a maximum concentration of 10 % w/w does not pose a risk to the health of consumers. The SCCS also concluded that the use of DEGEE does not pose a risk to the health of consumers at a maximum concentration of 2,6 % w/w in other non-spray cosmetic products and in the following spray products: fine fragrances, hair sprays, antiperspirants and deodorants. However, the use of DEGEE in oral hygiene products and eye products has not been assessed by the SCCS and thus cannot be considered safe for consumers.

(5)

In light of those SCCS opinions, the Commission considers that the non-regulation of DEGEE raises a potential risk to human health.

(6)

Regulation (EC) No 1223/2009 should therefore be amended accordingly.

(7)

The application of the abovementioned restrictions should be deferred to allow industry to make the necessary adjustments to product formulations. In particular, undertakings should be granted 12 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.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,

HAS ADOPTED THIS REGULATION: