EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2016) XXX  draft  
ANNEX 1  
  
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 2   EN ANNEX  
Annex III to Regulation (EC) No 1223/2009  is amended as follows:   
(1) The following entry is added as reference number 8c:  
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 
'8c Ethanol, 2,2' -[(2-nitro -
1,4-
phenylene)diimino]bis -
(9CI)  N,N’ -bis-(2-
hydroxyethyl) -2-nitro -p-
phenylenediamine  84041 -77-0 281-856-4 (a) Hair dye 
substance in 
oxidative hair dye 
products  
 
(b) H air dye 
substance in non -
oxidative hair dye 
products   
 
  
 
 
 
 
(b) 1.5%  (a) After mixing under 
oxidative conditions the 
maximum concentration 
applied to hair must not 
exceed 0.5% 
 
 
For (a) and (b):  
- Do not use with 
nitrosating agents  
- Maximum nitrosamine 
content: 50 µg/kg  
- Keep in nitrite -free 
containers  
 (a) 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.  
Tempor ary "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 ever experienced 
any reaction after colouring 
your hair,  
- you have experienced a 
reaction to a temporary "black 
henna" tattoo in the past. '' 
(2) the text in entry  9, column b,  is replaced by the following:  
 
EN 3   EN ‘Methylphenylenediamines, their N -substituted derivatives and their salts (1) with the exception of the substance s under reference number s 9a and 9b of 
this Annex and substances under reference numbers 364, 1310 and 1313 in Annex II’ ;  
 
(3) the entry 9a is replaced 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 
9a 1,4-Benzenediamine, 2 -
methyl - 
2,5-Diaminotoluene 
sulphate  Toluene -2,5-Diamine  
Toluene -2,5-Diamine 
sulfate  (1)  95-70-5 
615-50-9 202-442-1 
210-431-8 (a) Hair dye 
substance in 
oxidative hair dye 
products  
 
 
 
 
 
 
 
 
 
 
 
(b) Products 
intended for 
colouring 
eyelashes   
 
 (a) 
 
(i)  General use  
 
(ii) Professional use  
 
 
 
 
 
 
 
 
 
 
(b) Professional use  
 
 
For (a) and (b): After 
mixing under oxidative 
conditions the maximum 
concentration applied to 
hair or eyelashes must 
not exceed 2 % (a) (i) (ii) (b) To be printed on 
the label: The mixing ratio.  
 
(a) (i) (ii)  
‘ Hair colorants can cause 
severe allergic reactions. 
Read and follow instructi ons. 
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 e ver experienced 
any reaction after colouring 
your hair,  
- you have experienced a 
reaction to a temporary 
“black henna” tattoo in the 
past. 
 
EN 4   EN (calculated as free base) 
or 3,6 % (calculated as 
sulfate salt)  
 
  
Do not use to dye eyelashes  
or eyebrows .’ 
 
(a) (ii) (b) Wear suitable 
gloves.  
For professional use only.  
 
(a) (b) Contains 
phenylenediamines 
(toluenediamines).  
 
(b) 
' This product 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 
the risk of allergy.  
Eyelashes shall not  be 
coloured if the consumer:  
 - has a rash on the face or 
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.  
 
Rinse eyes immediately if 
product comes into contact 
with them.’  
 
 
 
EN 5   EN (4) the following entry is added as a reference number 9b:  
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 
'9b 1-Methyl -2,6-bis-(2-
hydroxyethylamino) -
benzene  2,6-
Dihydroxyethylaminotol
uene  149330 -25-6 443-210-1 Hair dye substance 
in oxidative hair 
dye products  
  After mixing under 
oxidative conditions the 
maximum concentration 
applied to hair must not 
exceed 1.0%  
 
- Do not use with 
nitrosating agents  
- Maximum nitrosamine 
content: 50 µg/kg  
- Keep in nitrite -free 
containers  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 ever experienced 
any reaction after colouring 
your hair,  
- you have experienced a 
reaction to a temporary "black 
henna" tattoo in the past. '' 
 
 
 
 
 
EN 6   EN (5) the entries  200, 206, 211, 243 and 272 are replaced 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 
200 2,4,5,6 -
Tetraaminopyrimidine 
sulphate  Tetraaminopyrimidine 
Sulfate  5392 -28-9 226-393-0 (a) Hair dye 
substance in 
oxidative hair dye 
products  
 
(b) Hair dye 
substance in non-
oxidative hair dye 
products  
 
(c) Products 
intended for 
colouring 
eyelashes  
  
 
 
 
 
(b) 3,4 % 
(calculated as 
sulfate) 
 
 (a) (c) After mixing 
under oxidative 
conditions the maximum 
concentration applied to 
hair or eyelashes  must 
not exceed 3,4 % 
(calculated as sulfate ) 
 
(c) Professional use  (a) (c) To be printed on the 
label:  
The mixing ratio.  
 
(a) ' 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 ever experienced 
any reaction after colouring 
your hair,  
- you have  experienced a 
reaction to a temporary "black 
henna" tattoo in the past.'  
 
(c) ' This product can 
cause severe allergic 
 
EN 7   EN 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 
the risk of allergy.  
Eyelashes shall not  be 
coloured if the consumer:  
 - has a rash on the face or 
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.’  
206 3-(2-Hydroxye thyl) - p-
phenylenediammonium 
sulphate  Hydroxyethyl -p- 
Phenylenediamine 
Sulfate  93841 -25-9 298-995-1 (a) Hair dye 
substance in 
oxidative hair dye 
products  
 
 
 
(b) Products 
intended for 
colouring 
eyelashes   
 
 
 (a) After mixing under 
oxidative conditions the 
maximum concentration 
applied to hair must not 
exceed 2,0 %  (calculated 
as sulphate)  
 
(b) After mixing under 
oxidative conditions the 
maximum concentration 
applied to eyelashes  
must not exceed 1,75%    
 
(b) Professional use  (a) (b) To be printed on the 
label: The mixing ratio.  
(a) ' 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 
 
EN 8   EN 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) ' This product 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 
the risk o f allergy.  
Eyelashes shall not  be 
coloured if the consumer:  
 - has a rash on the face or 
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.’  
211 2-Aminopyridin -3-ol 2-Amino -3- 
Hydroxypyridine  16867 -03-1 240-886-8 (a) Hair dye 
substance in 
oxidative hair dye 
products  
  (a) After mixing under 
oxidative conditions the 
maximum concentration 
applied to hair must not 
exceed 1,0 %  (a) (b) To be printed on the 
label: The mixing ratio.  
(a) ' Hair colorants can 
cause severe allergic 
reactions.  
 
EN 9   EN  
 
(b) Products 
intended for 
colouring 
eyelashes   
(b) After mixing under 
oxidative conditions the 
maximum concentration 
applied to eyelashes  
must not exceed 0,5 %  
 
(b) Professional use  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 ever experienced 
any reaction after colouring 
your hair,  
- you have expe rienced a 
reaction to a temporary "black 
henna" tattoo in the past.'  
 
(b) ' This product 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 
the risk of allergy.  
Eyelashes shall not  be 
coloured if the consumer:  
 - has a rash on the face or 
sensitive, irritated and 
damaged scalp,  
- has experienced any 
reaction after colouring hair 
or eyelashes,  
- has experienced a reaction 
to a t emporary “black henna” 
tattoo in the past.  
 
 
EN 10   EN For professional use only.  
 
Rinse eyes immediately if 
product comes into contact 
with them.’  
243 1,3-benzenediol, 2 - 
methyl  2-Methylresorcinol  608-25-3 210-155-8 (a) Hair dye 
substance in 
oxidative hair dye 
products  
 
(b) Hair dye 
substance in non -
oxidative hair dye 
products  
 
(c) Products 
intended for 
colouring 
eyelashes  
  
 
 
 
 
(b) 1,8 %  (a) After mixing under 
oxidative conditions the 
maximum concentration 
applied to hair must not 
exceed 1,8 %  
 
 
 
 
 
(c) After mixing under 
oxidative conditions the 
maximum concentration 
applied to eyelashes  
must not exceed 1.25%   
 
(c) Professional use  (a) (c) To be printed on the 
label:  
The mixing ratio.  
 
(a) ' Hair colorants can 
cause severe allergic 
reactions.  
Read and f ollow 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 s calp,  
- you have ever experienced 
any reaction after colouring 
your hair,  
- you have experienced a 
reaction to a temporary "black 
henna" tattoo in the past.'  
 
(c) ' This product can 
cause severe allergic 
reactions. Read and follow 
instructions . 
This prod uct is not intended 
for use on persons under the 
age of 16. Temporary “black 
henna” tattoos may increase 
the risk of allergy.  
 
EN 11   EN Eyelashes shall not  be 
coloured if the consumer:  
 - has a rash on the face or 
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.’  
272 4-Aminophenol  p-Aminophenol  123-30-8 204-616-2 (a) Hair dye 
substance in 
oxidative hair dye 
products  
 
 
 
(b) Products 
intended for 
colouring 
eyelashes   
 
 
 (a) (b) After mixing 
under oxidative 
conditions the maximum 
concentration applied to 
hair or eyelashes  must 
not exce ed 0,9 %  
 
 
(b) P rofessional use  (a) (b) To be printed on the 
label: The mixing ratio.  
(a) ' 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 ever experienced 
any reaction after colouring 
your hair,  
- you have experienced a 
reaction to a temporary "black 
henna" tattoo in the past.'  
 
EN 12   EN  
(b) ' This product 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 incre ase 
the risk of allergy.  
Eyelashes shall not  be 
coloured if the consumer:  
 - has a rash on the face or 
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.’  
(6) the following entries 289 to 296 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 
 
EN 13   EN '289 Di-[2-[4-[(E)-2-[4-
[bis(2 -
hydroxyethyl)aminophen
yl]vinyl]pyridin -1-ium] - 
butanoyl]aminoethyl]dis
ulfanyl dichloride  HC Red No. 17 1449471 -67-3  Hair dye substance 
in non -oxidative 
hair dye products   
 
 
 0.5%  - Do not use with 
nitrosating agents  
- Maximum nitrosamine 
content: 50 µg/kg  
- Keep in nitrite -free 
containers   
 
290 Di-[2-[4-[(E)-2-[2,4,5 -
trimethoxyphenyl]vinyl]
pyridinin -1- 
ium]butanoyl]aminoethyl
]disulfanyl dichloride  HC Yellow  No. 17 1450801 -55-4  Hair dye substance 
in non -oxidative 
hair dye products   
 
 
 0.5%   
' 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 ever experienced 
any reaction after colouring 
your hair,  
- you have experienced a 
reaction to a temporary "black 
henna" tattoo in the past. ' 
291 1H-Pyrazole -4,5-
diamine, 1 -hexyl -, 
sulfate (2:1)  1-Hexyl 4,5 -diamino 
pyrazole sulfate  1361000 -03-4  Hair dye substance 
in oxidative hair 
dye products  
  After mixing under 
oxidative conditions the 
maximum concentration 
applied to hair must not 
exceed  1.0%  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 you r risk 
of allergy.  
Do not colour your hair if:  
- you have a rash on your face 
 
EN 14   EN 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. ' 
292 4-Hydroxy -2,5,6 -
triaminopyrimidine 
sulfate  2,5,6 -Triamino -4-
pyrimidinol sulfate  1603 -02-7 216-500-9 Hair dye substance 
in oxidative hair 
dye products  
  After mixing under 
oxidative conditions the 
maximum concentration 
applied to hair must not 
exceed 0.5% 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 ever experienced 
any reaction after colouring 
your hair,  
- you have expe rienced a 
reaction to a temporary "black 
henna" tattoo in the past. ' 
293 2-[(3-
aminopyrazolo[1,5 -
a]pyridin -2-
yl)oxy]ethanol 
hydrochloride  Hydroxyethoxy 
aminopyrazolopyridine 
HCl 1079221 -49-0 695-745-7 Hair dye substance 
in oxidative hair 
dye products  
  After mixing under 
oxidative conditions the 
maximum concentration 
applied to hair must not 
exceed 2 .0% 
 
 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" 
 
EN 15   EN 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. ' 
294 Phenol, 3 -amino -2,6-
dimethyl  3-amino -2,6-
dimethylphenol  6994 -64-5 230-268-6 Hair dye substance 
in oxidative hair 
dye products  
  After mixing under 
oxidative conditions the 
maximum concentration 
applied to hair must not 
exceed 2 .0% 
 
 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 ever experienced 
any reaction after colouring 
your hair,  
- you have experienced a 
reaction to a temporary "black 
henna" tattoo in the past. ' 
295 2-Naphthalenaminium, 
8-[(4-amino -3-
nitrophenyl)azo] -7-
hydroxy -N,N,N -
trimethyl -, 
chloride  Basic Brown 17  68391 -32-2  269-944-0  Hair dye substance 
in non -oxidative 
hair dye products   
 
 
 2.0%    
 
EN 16   EN 296 3-Amino -7-
(dimethylamino) -2-
methoxyphenoxazin -5-
ium chloride  Basic Blue 124  67846 -56-4 
 267-370-5 Hair dye substance 
in non -oxidative 
hair dye products   
 0.5%  - Do not use with 
nitrosating agents  
- Maximum nitrosamine 
content: 50 µg/kg  
- Keep in nitrite -free 
containers  ' 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 ever experienced 
any reaction after colouring 
your hair,  
- you have experienced a 
reaction to a temporary "black 
henna" tattoo in the past. ''