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 15 (1) thereof, 
After consulting the Scientific Committee on Consumer Safety, Whereas: (1) Article 15 (1) of Regulation (EC) No 1223/2009  prohibits the use in  cosmetic products 
of substances classified as  carcinogenic, mutagenic or toxic for reproduction (CMR), 
of category 2, under Part 3 of Annex VI  to Regulation (EC) No 1272/2008 of the 
European Parliament and of the Council
2 unless that substance has been evaluated by 
the Scientific Committee on Consumer Sa fety (SCCS) and found safe for use in 
cosmetic products. 
(2) The substance Diphenyl(2,4,6-trimethyl benzoyl)phosphine oxide, with the 
International Nomenclature of Cosmetic Ingredients (INCI) name Trimethylbenzoyl 
diphenylphosphine oxide (TPO) is currently not included in  the Annexes to Regulation 
(EC) No 1223/2009. 
(3) TPO has been classified as toxic for re production category 2 under Regulation (EC) 
No 1272/2008 as amended by Commission Regulation (EU) No 618/20123. Pursuant 
to Article 2 of Regulation (EU)  No 618/2012 this cl assification started to apply as of 1 
December 2013. The use of that substance in cosmetic products was therefore 
automatically banned as of that date. 
(4) On 27 March 2014, the SCCS issued a scientific opinion on TPO4, which concluded 
that TPO is safe when used as a nail mode lling product at a concen tration of up to 5,0 
% w/w and that it is a moderate skin sensitizer. 
                                                 
1 OJ L 342, 22.12.2009, p. 59. 
2 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, 
p.1). 
3 Commission Regulation (EU) No 618/2012 of 10 July 2012 amending, for the purposes of its 
adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labe lling and packaging of substances and mixtures (OJ 
L 179, 11.7.2012, p. 3). 
4 SCCS/1528/14, http://ec.europa.eu/ health/scientific_committees/consum er_safety/docs/sccs_o_149.pdf.  
EN 3   EN (5) Following the scientific opinion of the SCCS, the Commission considers that TPO 
should be considered safe when  used in artificial nail systems at a use concentration of 
up to 5,0 % w/w. However, considering the sk in sensitising propert ies of TPO and the 
high risk of exposure through sk in contact in case of self -application of nail products, 
the Commission considers that the use of TP O should be restricted to professionals 
only.  
(6) Regulation (EC) No 1223/2009 should therefore be amended accordingly. 
(7) 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 
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