EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2015) XXX  draft 
  
COMMISSION REGULATION (EU) …/… 
of XXX  
amending Annex V 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 V 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, 
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 these substances  have been evaluated 
by the Scientific Committee on Consumer Sa fety (SCCS) and found safe for use in 
cosmetic products. 
(2) The substance Methenamine 3-chloroally lochloride, with the International 
Nomenclature of Cosmetic Ingredients (I NCI) name Quaternium-15, is currently 
authorised as a preservative in entry 31 of Annex V to Regulation 1223/2009 at a use 
concentration of up to 0,2 % w/w in a ready for use preparation. 
(3) Quaternium-15 is a mixture of isomers, where the cis form is the dominant isomer 
component and the trans form is the minor one present as an impurity. The cis-isomer 
of 1-(3-chloroallyl)-3,5,7-tr iaza-1-azoniaadamantane chloride (CTAC) has been 
classified as a substance toxic for repr oduction of category 2 under Regulation (EC) 
No 1272/2008 on classification, labelling and pack aging of substances and mixtures as 
amended by Commission Re gulation (EC) No 790/20093. Pursuant to Article 2 of 
Regulation (EC) No 790/2009 this classifica tion started to apply on 1 December 2010, 
the date on which Article 15 (1) of Regula tion (EC) No 1223/2009 started to apply as 
well. The use of this substance in cosm etic products was therefore automatically 
banned as of that date. 
(4) In December 2011, the SCCS issued a scientific opinion on Quaternium-15 
(cis-isomer)4, which concluded that the safety of  cis-1-(3-chloroally l)-3,5,7-triaza-1-
azoniaadamantane chloride could not be assessed because the available dermal absorption values were not su fficiently reliable to calcul ate the dermal uptake of 
cis-CTAC and because the appropriate toxicity studies to establish a reliable No Observed Adverse Effect Level (NOAEL) we re unavailable. Therefore, a margin of 
                                                
 
1 OJ L 342, 22.12.2009, p. 59. 
2 OJ L 353, 31.12.2008, p. 1. 
3 OJ L 235, 05.09.2009, p. 1 
4 SCCS/1344/10, http://ec.europa.eu/ health/scientific_committees/consum er_safety/docs/sccs_o_077.pdf.  
EN 3   EN safety (MoS) could not be calculated. Gi ven the CMR classification of cis-1-(3-
chloroallyl)-3,5,7-triaza-1-azoniaadamantane  chloride and taking into account the 
absence of relevant toxicological data, it wa s considered that the use of this substance 
in cosmetic products might not be safe for the consumers.  
(5) Since the scientific opinion of the SCCS provi ded no basis to consider the substance as 
safe for use in cosmetics, the Commission considers that Quaternium-15 represents a 
potential risk to human health when used in cosmetic products. As a result and aiming 
to ensure legal clarity regarding the prohi bition of this substance, Quaternium-15 
should be deleted from Annex V to Regulation (EC) No 1223/2009. 
(6) Regulation (EC) No 1223/2009 should therefore be amended accordingly. 
(7) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Cosmetic Products, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Annex V to Regulation (EC) No 1223/2009 is 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 . 
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