EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2015) XXX  draft 
  
COMMISSION REGULATION (EU) …/… 
of XXX  
amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and 
of the Council on cosmetic products 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) …/… 
of XXX  
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 products
1, and in particular Ar ticle 31 (1) thereof, 
After consulting the Scientific Committee on Consumer Safety, Whereas: (1) The substance Diethylene Glycol Monoethyl  Ether (DEGEE) with  the INCI name 
Ethoxydiglycol which is used in cosmetic  products is not ye t 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 decided
2 that it is safe for consumers, when used in a concentration up to 1,5% 
in all cosmetics products except products fo r 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 i ssue 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 ha ir dye formulations at a 
maximum concentration of 7 % w/w, in non-oxidative hair dye formulations at a 
                                                 
1 OJ L 342, 22.12.2009, p. 59. 
2 Ministère de la Santé et des Solidarités. Décision du 23 novembre 2005 soumettant à des conditions 
particulières et à des restrictions la fabrication, le  conditionnement, l'importation, la distribution en gros, 
la mise sur le marché à titre gratuit ou onéreux, la détention en vue de la vente ou de la distribution à titre gratuit ou onéreux et l'utilisation de produits cosmétiques contenant certains éthers de glycol, 
Journal officiel, n° 291 du 15 décembre 2005, http://www.journal -officiel.gouv.fr/frameset.html. 
3 Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States 
relating to cosmetic products (OJ L 262, 27.9.1976, p. 169). 
4 Commission Decision 2008/721/EC of 5 September 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). 
5 SCCP/1044/06, http://ec.europa.eu/health/ph_ risk/committees/04_sccp/docs/sccp_o_082.pdf. 
6 SCCP/1200/08, http://ec.europa.eu/health/ph_ risk/committees/04_sccp/docs/sccp_o_161.pdf. 
7 SCCS/1316/10, http://ec.europa.eu/ health/scientific_committees/consum er_safety/docs/sccs_o_039.pdf. 
8 SCCS/1507/13, http://ec.europa.eu/ health/scientific_committees/consum er_safety/docs/sccs_o_119.pdf.  
EN 3   EN 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 in  other non-spray cosmetic products at a 
maximum concentration of 2,6 % w/w an d in fine fragrances, hair sprays, 
antiperspirants and deodorants at a ma ximum concentration of 2,6 % w/w does not 
pose a risk to the health of consumers. Howe ver, the SCCS consider ed that the use of 
DEGEE in oral hygiene products and eye products is not safe for consumers. 
(5) In light of those SCCS opinions, the Commi ssion considers that the non-regulation of 
DEGEE raises a potential ri sk to human health.  
(6) Regulation (EC) No 1223/2009 should therefore be amended accordingly. 
(7) The application of the above mentioned re strictions should be  deferred to allow 
industry to make the necessary adjustment s to product formulations. In particular, 
undertakings should be granted twelve months to place on the market compliant products and to withdraw from the market non-compliant products af ter the entry into 
force of this Regulation. 
(8) The measures provided for in this Regula tion are in accordance with the opinion of 
the Standing Committee on Cosmetic Products, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Annex III to Regulation (EC) No  1223/2009 is amended in accordan ce with the Annex to this 
Regulation. 
Article 2 
From [date = 12 months after the date of en try into force] only cosmetic products which 
comply with this Regulation shall be placed  and made available on the Union market. 
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, 
 For the Commission 
 The President  Jean-Claude Juncker