EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2015) XXX  draft  
ANNEX 1  
  
ANNEX  
to the  
Commission Regulation (EU) .../...  
amending Annexes IV and VI to Regulation (EC) No 1223/2009 of the European 
Parliament and of the Council on cosmetic products    
EN 2   EN ANNEX  
 
(a) Annex IV to Regulation (EC) No 1223/2009 is amended as follows:  
 
Reference 
number  Substance identification  Conditions  
Wording of 
conditions of 
use and 
warnings  Chemical 
Name  Colour 
index 
Number/Na
me of 
Common 
Ingredients 
Glossary  CAS 
number  EC number  Colour  Product 
type, 
Body 
parts  Maximum 
concentration 
in ready for 
use 
preparation  Other  
a b c d e f g h i j 
'126 Carbon 
black  CI 77266  1333 -86-4, 
7440 -44-0 215-609-9, 
231-153-3, 
931-328-0,          
931-334-3 Black    Purity >97%, with 
the following 
impurity profile: 
Ash content ≤ 
0,15%, total 
sulphur ≤ 0,65%, 
total PAH ≤ 500 
ppb and 
benzo(a)pyrene ≤5 
ppb, 
dibenz(a,h)anthrace
ne ≤ 5 ppb, total As 
≤ 3 ppm, total Pb ≤ 
10 ppm, and total   
EN 3   EN Hg ≤ 1 ppm  
126a  Carbon 
black  CI 77266 
(nano)  
 
 
Carbon 
black 
(nano)  1333 -86-4, 
7440 -44-0 215-609-9, 
231-153-3, 
931-328-0,          
931-334-3 Black    10 %  Not to be used in 
applications that 
may lead to 
exposure of the end 
user’s lungs by 
inhalation.  
Only nanomaterials 
having the 
following 
characteristics are 
allowed:  
- Purity >97%, 
with the following 
impurity profile: 
Ash content ≤ 
0,15%, total 
sulphur ≤ 0,65%, 
total PAH ≤ 500 
ppb and 
benzo(a)pyrene ≤5 
ppb, 
dibenz(a,h)anthrace
ne ≤ 5 ppb, total As 
≤ 3 ppm, total Pb ≤ 
10 ppm, and total 
Hg ≤ 1 ppm;  
- Primary particle For eye 
products:  
'May cause  eye 
irritation'1' 
                                                 
1 The sentence 'May cause eye irritation'  is still subject to discussion.   
EN 4   EN size ≥ 20 nm.  
 
 
(b) The following entries are added  to Annex VI to Regulation (EC) No 1223/2009 as reference numbers 30 and 30a:  
 
    Substance Identification  Conditions    
Reference 
number  Chemical 
name/INN  Name of 
Common 
Ingredients 
Glossary  CAS 
number  EC number  Product 
type, Body 
parts  Maximum 
concentratio
n in ready 
for use 
preparation  Other  Wording of 
conditions of 
use and 
warnings  
a b c d E f g h i  
EN 5   EN '30 Zinc oxide  Zinc Oxide  
 1314 -13-2 215-222-5  25% Not to be used in applications 
that may lead to exposure of the 
end user’s lungs by inhalation.   
30a Zinc oxide  Zinc Oxide 
(nano)  1314 -13-2 
 215-222-5  25% Not to be used in applications 
that may lead to exposure of the 
end user’s lungs by inhalation.  
Only nanomaterials having the 
following characteristics are 
allowed:  
- Purity ≥96%, with wurtzite 
crystalline structure and 
physical appearance as clusters 
that are rod -like, star -like and/or 
isometric shapes, with 
impurities consisting only of 
carbon dioxide and water, whilst 
any other impurities are less 
than 1% in total.  
- Median diameter of  the 
particle number size distribution 
D50 (50% of the number below    
EN 6   EN this diameter)>30nm and  
D1(1% below  this size)>20nm  
- Water solubility <50 mg/L  
- Uncoated, or coated with 
triethoxycaprylylsilane, 
dimethicone, 
dimethoxydiphenyl silanetrietho
xycaprylylsilane cross -polymer, 
or octyl triethoxy silane. '