EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION REGULATION (EU) .../...  
amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and 
of the Council on cosmetic products    
EN 1  EN ANNEX  
 
Regulation (EC) No 1223/2009 is amended as follows:   
(1) In Annex II, in the table, the following entries are  added:  
Reference number  
 Substance identificatio n 
Chemical name/INN  CAS number  EC number  
‘X 1,2,4 -Trihydroxybenzene  (*) when used as a 
substance in hair dye products  533-73-3  208-575-1 
 4-Amino -3-hydroxytoluene  (*) when used as a 
substance in hair dye products  2835 -98-5  220-620-7 
Y 2-[(4-Amino -2-nitrophenyl) -amino] -benzoic acid  
(*) when used as a substance in hair dye products  117907 -43-4  411-260-3  
(*) From [date = 9 months after the date of entry into force] hair dye products containing those substances shall not be placed on the Union market. 
From [date = 18 months after the date of entry into force] hair dye products containing those substances shall not be made av ailable on the Union 
market. ’ 
(2) In Annex III, the table is amended as follows:  
(a) entry 292 is repla ced by the following:  
Referen
ce 
number  
 Substance identificatio n Restrictions  Wordings of conditions of use 
and warnings  
Chemical name/INN  Name of Common 
Ingredients Glossary  CAS number  EC number  Product type, body 
parts  Maximum 
concentration 
in ready use 
preparation  Other  
a b c d e f g h i 
`292 1,4-Benzenediamine, 2 - 2-Methoxy -methyl -p- 337906 -36-2 679-526-3     (a) Hair dye  (a) (b) After mixing (a) To be printed on the label:   
EN 2  EN (methoxymethyl)  
 
1,4-Benzenediamine, 2 -
(methoxymethyl) -, 
sulfate  Phenylenediamine  
 
2-Methoxy -methyl -p-
Phenylenediamine 
Sulfate   
337906 -37-3 
  
638-749-6    substance in 
oxidative hair dye 
products  
 
 
 
 
 
(b) Products 
intended for 
colouring 
eyelashes  under oxidative 
conditions the maximum 
concentration applied to  
hair or  eyelashes  must 
not exceed 1,8% 
(calculated as free base)  The mixing ratio.  
 
‘ Hair colorants can cause 
severe allergic reactions.  
Read and follow instructions.  
This product is not intended 
for use on persons under the 
age of 16.  
Temporary "black h enna" 
tattoos may increase your risk 
of allergy.  
Do not colour your hair if:  
- you have a rash on your face 
or sensitive, irritated and 
damaged scalp,  
- you have ever experienced 
any reaction after colouring 
your hair,  
- you have experienced a 
reaction  to a temporary "black 
henna" tattoo in the past.’  
 
((b) As from [date = 12 
months after the date of entry 
into force of this Regulation ], 
to be printed on the label: The 
mixing ratio.  
 
‘ This product can cause 
severe allergic reactions. 
Read and follow in structions . 
This product is not intended 
for use on persons under the 
age of 16. Temporary “black 
henna” tattoos may increase 
the risk of allergy.  
Eyelashes shall not  be 
coloured if the consumer:  
 - has a rash on the face or 
 
EN 3  EN sensitive, irritated and 
damaged scalp,  
- has experienced any 
reaction after colouring hair 
or eyelashes,  
- has experienced a reaction 
to a temporary “black henna” 
tattoo in the past.  
 
For professional use only.  
 
Rinse eyes immediately if 
product comes into contact 
with them. ’; 
 
(b) the following entries are added : 
Referen
ce 
number  
 Substance identificatio n Restrictions  Wordings of conditions of use 
and warnings  
Chemical name/INN  Name of Common 
Ingredients Glossary  CAS number  EC number  Product type, body 
parts  Maximum 
concentration 
in ready use 
preparation  Other  
a b c d e f g h i 
‘X 4-(3-aminopyrazolo[1,5 -
A]pyridin -2-yl)-1,1-
dimethylpiperazin -1-ium 
chloride hydrochloride  Dimethylpiperazinium 
Aminopyrazolopyridine 
HCl 1256553 -33-9 813-255-5 Hair dye substance 
in oxidative hair 
dye products  
 
 
 
 
 
 
 
 
  
 
 As from [date = 6 
months after the date of 
entry into force of this 
Regulation ], after 
mixing under oxidative 
conditions the maximum 
concentration applied to 
hair must not exceed 2% 
(calculated as free base)  
 As from [date = 12 months 
after the date of entry into 
force of this Regulation], t o 
be printed on the label: The 
mixing ratio.  
 
‘ Hair colorants can cause 
severe allergic reactions. 
Read and follow instructions. 
This product is not intended 
for use on perso ns under the 
age of 16. Temporary “black 
 
EN 4  EN  
 henna” tattoos may increase 
your risk of allergy.  
Do not colour your hair if:  
- you hav e a rash on your face 
or sensitive, irritated and 
damaged scalp,  
- you have ever experienced 
any reaction after colouring 
your hair, 
- you have experienced a 
reaction to a temporary 
“black henna” tattoo in the 
past.’  
 
 1-(3-((4-
Aminophenyl)amino)pro
pyl)-3-methyl -1H-
imidazol -3-ium chloride 
hydrochloride  Methylimidazoliumprop
yl p-phenylenediamine 
HCl 220158 -86-1  Hair dye substance  
in oxidative hair 
dye products  
 
  
 
 
 
 
 
 As from [date = 6 
months after the date of 
entry into force of this 
Regulation ], after 
mixing under oxidative 
conditions the maximum 
concentration applied to 
hair must not exceed 2% 
(calculated as free base)  
 
 As from [date = 12 months 
after the date of entry into 
force of this Regulation], t o 
be printed on the label:  
The mixing ratio.  
 
‘ Hair colorants can cause 
severe allergic reactions.  
Read and follow instructions.  
This product is not intended 
for use on persons under the 
age of 16.  
Temporary "black henna" 
tattoos may increase your risk 
of allergy.  
Do not colour your hair if:  
- you have a rash on your face 
or sensitive, irritated and 
damaged scalp,  
- you have eve r experienced 
any reaction after colouring 
your hair,  
- you have experienced a 
reaction to a temporary "black 
henna" tattoo in the past.’  
 
EN 5  EN  
 Di-[2-[(E)-2-[4-[bis(2 -
hydroxyethyl)aminophen
yl]vinyl]pyridin -1-ium] -
ethyl]disulphide 
dimethanesulfonate  HC Orange  No. 6  1449653 -83-1  Hair dye substance 
in non -oxidative 
hair dye products  
 As from [date 
= 6 months 
after the date 
of entry into 
force of this 
Regulation ]: 
0,5%  Methanesulfonates 
impurities, in particular 
ethyl methanesulfonate  
shall not be present .  
 Sodium 4 -[(2-hydroxy -1-
naphthyl)azo]benzene 
sulfonate   Acid Orange 7  633-96-5 211-199-0 Hair dye substance 
in non -oxidative 
hair dye products  
 As from [date 
= 6 months 
after the date 
of entry into 
force of this 
Regulation ]: 
0,5%    
 Phenol, 4,4'-(4,5,6,7 -
tetrabromo -1,1-dioxido -
3H-2,1-benzoxathiol -3-
ylidene)bis[2,6 -20 
dibromo - Tetrabromophenol Blue  4430 -25-5 224-622-9 (a) Hair dye 
substance in 
oxidative hair dye 
products  
 
(b) Hair dye 
substance in non -
oxidative hair dye 
products  
 
 (b) As from 
[date = 6 
months after 
the date of 
entry into 
force of this 
Regulation ]:  
0,2%  (a) As from [date = 6 
months after the date of 
entry into force of this 
Regulation ], after 
mixing under oxidative 
conditions the maximum 
concentration applied to  
hair must not e xceed 
0,2% (calculated as free 
base)  (a) As from [date = 12 
months after the date of 
entry into force of this 
Regulation],  to be printed on 
the label:  
The mixing ratio.  
 
‘ Hair colorants can cause 
severe allergic reactions.  
Read and follow instructions.  
This product is not intended 
for use on persons under the 
age of 16.  
Temporary "black henna" 
tattoos may increase your risk 
of allergy.  
Do not colour your hair if:  
- you have a rash on your face 
or sensitive, irritated and 
damaged scalp,  
- you have eve r experienced 
any reaction after colouring 
your hair,  
 
EN 6  EN - you have experienced a 
reaction to a temporary "black 
henna" tattoo in the past.’  
 
Y Indigofera tinctoria , 
dried and pulverised 
leaves of Indigofera 
tinctoria L  Indigofera tinctoria  leaf 
Indigofera tinctoria  leaf 
powder  
Indigofera tinctoria  leaf 
extract  
Indigofera tinctoria  
extract  84775 -63-3 283-892-6 Hair dye substance 
in non -oxidative 
hair dye products  
 As from [date 
= 6 months 
after the date 
of entry into 
force of this 
Regulation ]:  
25%’