EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2013) XXX  draft 
ANNEX 1 
  
ANNEX 
to  
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 
  
EN 2   EN ANNEX 
to  
Commission Regulation (EU) No .../... of XXX 
amending Annexes III, V and VI to Regulati on (EC) No 1223/2009 of the European Parlia ment and the Council on cosmetic products 
The annexes to Regulation (EC) No 1223/2009 are amended as follows: 
(1) In Annex III, the following entr ies [x and y] are added: 
  Substance Identification Conditions   
Reference 
number Chemical name/INN Name of 
Common 
Ingredients 
Glossary CAS 
number EC number Product 
type, 
Body 
parts Maximum 
concentration in 
ready for use 
preparation Other Wording 
of 
conditions 
of use and 
warnings 
a b c d e f g h i 
'x1 C16-
alkyltrimethylammonium chloride   
 
 Cetrimonium 
chloride2 3  
   
 
 112-02-7 
    
 
 203-928-6 
    
 
 (a) Rinse-
off hair products   
 
  (a) 2,5% for the 
individual concentrations or the sum of the individual 
concentrations of 
cetrimonium For purposes other 
than inhibiting the development of micro-organisms in the product. 
The purpose has to 
be apparent from   
                                                 
1 For OPOCE: please insert numbering based on next available entry in Annex III. 
2 For use as a preservative, see Annex V, entry No 44. 
3 For translators: please do not translat e the INCI names highlighted in yellow!  
EN 3   EN                                                                                                                                                                                                                                                     
4 For use as a preservative, see Annex V, entry No 44. C18-
alkyltrimethylammonium chloride   Steartrimonium 
chloride4  
 112-03-8 203-929-1  
    (b) Leave-on hair products         (c) Leave-on face products chloride and 
steartrimonium chloride   (b) 1,0 % for the individual concentrations or the sum of the individual concentrations of cetrimonium chloride and steartrimonium chloride  (c) 0,5 % for the sum of cetrimonium chloride and steartrimonium chloride the presentation of 
the product.  
EN 4   EN y5 C22-
alkyltrimethylammonium chloride   Behentrimoniu
m chloride6  17301-
53-0 241-327-0 (a) Rinse-
off hair products                
 
       (b) Leave-on hair products (a) 5,0 % for the 
individual concentration of  behentrimonium chloride or the sum of  the individual concentrations of cetrimonium chloride, steartrimonium chloride and behentrimonium chloride, taking into account the relevant maximum concentration for 
the sum of 
cetrimonium chloride and steartrimonium chloride set out in entry x. 
  (b) 3,0 % for the individual concentration of  For purposes other 
than inhibiting the development of micro-organisms in the product. The purpose has to be apparent from the presentation of the product.  
                                                 
5 For OPOCE: please insert numbering based on next available entry in Annex III. 
6 For use as a preservative, see Annex V, entry No 44.  
EN 5   EN  
                 
 
    (c) Leave-on face products behentrimonium 
chloride or the sum of  the individual concentrations of cetrimonium chloride, steartrimonium chloride and behentrimonium chloride, while at the same time respecting the relevant maximum concentration for the sum of cetrimonium 
chloride and 
steartrimonium chloride set out in entry x. 
  (c) 3,0 % for the individual concentration of  behentrimonium chloride or the sum of  the individual concentrations of  
EN 6   EN cetrimonium 
chloride, steartrimonium chloride and behentrimonium chloride, while at the same time respecting the relevant maximum concentration for the sum of cetrimonium chloride and steartrimonium chloride set out in entry x.' 
 
  
EN 7   EN (2) Annex V is amended as follows: 
(a) entry 44 is replaced by the following: 
  Substance Identification Conditions   
Reference 
number Chemical name/INN Name of Common 
Ingredients 
Glossary CAS number EC 
number Product 
type, 
Body 
parts Maximum 
concentration 
in ready for 
use 
preparation Other Wording 
of 
conditions 
of use and 
warnings 
a b c d e f g h i 
'44 Alkyl (C 12-22) 
trimethyl ammonium bromide and chloride Behentrimonium 
chloride7,  
cetrimonium 
bromide,  
cetrimonium 
chloride8,  
laurtrimonium 
bromide,  
laurtrimonium 
chloride,  
steartrimonium 
bromide, 
steartrimonium 
chloride9 17301-53-0,  
 57-09-0,   112-02-7,   1119-94-4,   112-00-5,  
 
1120-02-1,   112-03-8 241-327-0,  
 200-311-3,  203-928-6,   214-290-3,   203-927-0,  
 
214-294-5,   203-929-1  0,1 %’   
 
                                                 
7 For use other than as a preservative, see Annex III, No.  y. 
8 For use other than as a preservative, see Annex III, No. x. 
9 For use other than as a preservative, see Annex III, No. x.  
EN 8   EN (b) entry 59 is added: 
  Substance Identification Conditions   
Reference 
number Chemical name/INN Name of Common 
Ingredients 
Glossary CAS number EC 
number Product 
type, 
Body 
parts Maximum 
concentration 
in ready for 
use 
preparation Other Wording 
of 
conditions 
of use and 
warnings 
a b c d e f g h i 
'59 1,2,3-
Propanetricarboxylic acid, 2-hydroxy-, monohydrate  and 1,2,3- Propanetricarboxylic acid, 2-hydroxy-, silver(1+) salt, monohydrate Citric acid (and) 
Silver citrate - 460-890-5  0,2 %, 
corresponding to 0,0024% of silver Not to be used 
in oral products and eye products'  
  
EN 9   EN  
(3) In Annex VI entry 29 is added: 
    Substance Identification Conditions   
Referenc
e number Chemical name/INN Name of 
Common 
Ingredients 
Glossary CAS number EC 
number Product 
type, Body 
parts Maximum 
concentration 
in ready for 
use 
preparation Other Wording 
of 
condition
s of use 
and 
warnings 
a b c d e f g h i 
'29 1,3,5-Triazine, 2,4,6-
tris[1,1'-biphenyl]-4-yl-, including as nanomaterial Tris-biphenyl 
triazine  
Tris-biphenyl 
triazine (nano) 31274-51-8 ---  10 % Not to be used 
in aerosol dispensers (sprays). Only nanomaterials having the following characteristics are allowed: - median primary particle size > 80 nm; - Purity ≥ 98 %; 
- Uncoated'