EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2013) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annexe s III, V and VI to Regulation (EC) No 1223/2009 of  the European 
Parliament and the Council on cosmetic products 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annexes III, V and VI to Regula tion (EC) No 1223/2009 of the European 
Parliament and 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 Article 31(2) thereof, 
Whereas: (1) The  substances identified by the denominations alkyl (C
12-22) trimethyl ammonium 
bromide and chloride are regulated as pr eservatives under entry 44 of Annex V to 
Regulation (EC) No 1223/2009 with a maximum concentration of 0,1%. 
(2) The Scientific Committee on Consumer Produc ts ("SCCP"), subsequently replaced 
by the Scientific Committee on Consumer Sa fety ("SCCS") pursuant to Commission 
Decision 2008/721/EC2, evaluated the safety of alkyl (C 16, C 18, C 22) 
trimethylammonium chloride (cetrimonium chloride, steartrimonium chloride and 
behentrimonium chloride)3 for other uses than as preservatives in 2005, 2007 and 
2009. 
(3) The SCCS concluded in its opinion of 8 December 20094 that, apart from the fact 
that quaternary ammonium de rivative formulations have the potential to be skin 
irritants, especially when combinations  of the concerned compounds are used, the 
use of cetrimonium chloride, steartrimonium chloride and behentrimonium chloride 
does not pose a risk to the health of the consumer in concentrations below certain 
limits, which are explicitly se t out in the SCCS opinion.  
(4) In order to take into account the skin irr itation potential of the combinations of the 
quaternary ammonium deriva tives mentioned above, the Commission considers that, 
while allowing the use of these substances for other uses than as preservatives at 
higher concentrations, the sums of these s ubstances should be restricted to the 
maximum concentration indicated by th e SCCS for the individual substances. 
(5) The maximum concentrations indicated by the SCCS as safe for leave-on facial 
cream products should apply to  all leave-on face products, as  there is no reason to 
limit authorization of those substa nces to leave-on face creams only. 
(6) New entries in Annex III to Regulatio n (EC) No 1223/2009 s hould therefore be 
added to reflect the above-mentioned considerations, and entry 44 in Annex V should  
                                                 
1 OJ L 342, 22.12.2009, p. 59. 
2 OJ L 241, 10.9.2008, p. 21. 
3 For translators : please do not translat e the INCI names highlighted in yellow! 
4 SCCS/1246/09, http://ec.europa.eu/ health/scientific_committees/consum er_safety/docs/sccs_o_012.pdf.  
EN 3   EN cross-refer to the new entries in Annex II I, so that those Annexes are adapted to 
technical and scie ntific progress. 
(7) The SCCS evaluated the safety of the mixture citric acid (and) silv er citrate. In its 
opinion of 13 October 20095, it stated that, on the basis of the data submitted, the use 
of that mixture as a preservative in cosm etic products, at a concentration up to 0.2% 
(corresponding to a silver concentration of 0.0024%), does not pose a risk to the 
health of the consumer. The Committee spec ified that the substance was safe when 
used at the same maximum concentration in deodorants and anti -perspirants, as a 
preservative and/or an active ingredient . Its use in oral and eye products was, 
however, explicitly excluded given that  only dermal exposure was assessed. 
(8) A new entry in Annex V to Regulation (EC) No 1223/2009 should be added to 
reflect the above-mentioned considerations and to adapt it to tech nical and scientific 
progress. 
(9) The SCCS assessed tris-biphenyl triazine, wh ich is a UV-filter and a nanomaterial. In 
its opinion of 20 September 20116, it concluded that dermal exposure to formulations 
containing tris-biphenyl triazi ne with a mean particle size of 81 nm results in low 
absorption of that substance. Also after oral exposure, absorption of tris-biphenyl 
triazine is low. No systemic  effects are observed after or al or dermal exposure up to 
500 mg/kg bw/day. The data analysed by the SCCS leads to the conclusion that the 
use of 10% tris-biphenyl triazine, including as nanomaterial, as a UV-filter in 
cosmetic products can be considered safe for dermal application. 
(10) However, the SCCS clarified that, at the time of the risk assessment, there was too 
much uncertainty to conclude about safe us e of 10% tris-biphenyl triazine in spray 
applications, because of concerns over po ssible inhalation exposure. Therefore, the 
SCCS concluded that spray products cont aining tris-biphenyl triazine cannot be 
recommended until additional information on safety after repeated inhalation is 
provided. 
(11) In light of the SCCS opinion and taking in to account that the use of nanomaterials 
can improve the efficiency of UV-filters, Annex VI to Regulation (EC) No 1223/2009 should be amended for the purpose  of adapting it to technical and 
scientific progress. 
(12) The measures provided for in this Regulat ion are in accordance with the opinion of 
the Standing Committee on Cosmetic Products, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Annexes III, V and VI to Regulation (EC) No  1223/2009 are amended in accordance 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 . 
                                                
 
5 SCCS/1274/09, http://ec.europa.eu/ health/scientific_committees/consum er_safety/docs/sccs_o_004.pdf. 
6 SCCS/1429/11, Revision of 13/14 December 2011, 
http://ec.europa.eu/health/scientific_committ ees/consumer_safety/docs/sccs_o_070.pdf.  
EN 4   EN This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  José Manuel BARROSO