# Commission Regulation (EU) 2017/237 of 10 February 2017 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance), Annex

Extent: E+W+S+N.I.

Annex III to Regulation (EC) No 1223/2009 is amended as follows:
(1) The following entry is inserted as reference number 8c:
Reference number
Substance identification
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
(a)
As from 3 September 2017, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %
For (a) and (b), as from 3 September 2017:
Do not use with nitrosating agents
Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers
(a)
As from 3 March 2018, to be printed on the label:
The mixing ratio.
Hair colourants 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’
(b)
Hair dye substance in non-oxidative hair dye products
(b)
As from 3 September 2017: 1,5 %
(2) the text in entry 9, column b, is replaced by the following:
‘Methylphenylenediamines, their N-substituted derivatives and their salts (1) with the exception of the substances under reference numbers 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:
Reference number
Substance identification
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
(a) (i)
General use
(a) (ii)
Professional use
(a)
To be printed on the label: The mixing ratio.
‘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.
Contains phenylenediamines (toluenediamines)
(a) (i)
Do not use to dye eyelashes.
(a) (ii)
Wear suitable gloves.
For professional use only.
(b)
As from 3 March 2018, to be printed on the label: The mixing ratio.
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.
Contains phenylenediamines (toluenediamines).
Wear suitable gloves.
For professional use only’
(b)
Products intended for colouring eyelashes
(b)
Professional use
For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair or eyelashes must not exceed 2,0 % (calculated as free base) or 3,6 % (calculated as sulfate salt)
(4) the following entry is inserted as a reference number 9b:
Reference number
Substance identification
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-Dihydroxyethylaminotoluene
149330-25-6
443-210-1
Hair dye substance in oxidative hair dye products
As from 3 September 2017, 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
As from 3 March 2018, to be printed on the label:
The mixing ratio.
Hair colourants 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’
(5) the entries 200, 206, 211, 243 and 272 are replaced by the following:
Reference number
Substance identification
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
(a) (c)
After mixing under oxidative conditions the maximum concentration applied to hair or eyelashes must not exceed 3,4 % (calculated as sulfate)
(a)
To be printed on the label:
The mixing ratio.
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)
As from 3 March 2018, to be printed on the label:
The mixing ratio.
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.
For professional use only.
Rinse eyes immediately if product comes into contact with them’
(b)
Hair dye substance in non-oxidative hair dye products
(b)
3,4 % (calculated as sulfate)
(c)
Products intended for colouring eyelashes
(c)
Professional use
‘206
3-(2-Hydroxyethyl)- p-phenylenediammonium sulphate
Hydroxyethyl-p- Phenylenediamine Sulfate
93841-25-9
298-995-1
(a)
Hair dye substance in oxidative hair dye products
(a)
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (calculated as sulphate)
(a)
To be printed on the label: The mixing ratio.
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.
(b)
As from 3 March 2018, to be printed on the label: The mixing ratio.
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.
For professional use only.
Rinse eyes immediately if product comes into contact with them’
(b)
Products intended for colouring eyelashes
(b)
After mixing under oxidative conditions the maximum concentration applied to eyelashes must not exceed 1,75 % (calculated as free base)
(b)
Professional use
‘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)
To be printed on the label: The mixing ratio.
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 b‘lack henna’ tattoo in the past.
(b)
As from 3 March 2018, to be printed on the label: The mixing ratio.
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.
For professional use only.
Rinse eyes immediately if product comes into contact with them’
(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
‘243
1,3-Benzenediol, 2- methyl
2-Methylresorcinol
608-25-3
210-155-8
(a)
Hair dye substance in oxidative hair dye products
(a)
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,8 %
(a)
To be printed on the label:
The mixing ratio.
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)
As from 3 March 2018, to be printed on the label:
The mixing ratio.
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.
For professional use only.
Rinse eyes immediately if product comes into contact with them’
(b)
Hair dye substance in non-oxidative hair dye products
(b)
1,8 %
(c)
Products intended for colouring eyelashes
(c)
After mixing under oxidative conditions the maximum concentration applied to eyelashes must not exceed 1,25 %
(c)
Professional use
‘272
4-Aminophenol
p-Aminophenol
123-30-8
204-616-2
(a)
Hair dye substance in oxidative hair dye products
(a) (b)
After mixing under oxidative conditions the maximum concentration applied to hair or eyelashes must not exceed 0,9 %
(a)
To be printed on the label: The mixing ratio.
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.
(b)
As from 3 March 2018, to be printed on the label: The mixing ratio.
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.
For professional use only.
Rinse eyes immediately if product comes into contact with them’
(b)
Products intended for colouring eyelashes
(b)
Professional use
(6) the following entries 298 to 305 are added:
Reference number
Substance identification
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
‘298
Di[2-[4-[(E)-2-[4-[bis(2-hydroxyethyl)aminophenyl]vinyl]pyridin-1-ium] butanoyl]aminoethyl]di-sulfanyl dichloride
HC Red No 17
1449471-67-3
Hair dye substance in non-oxidative hair dye products
As from 3 September 2017: 0,5 %
As from 3 September 2017:
Do not use with nitrosating agents
Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers
299
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
As from 3 September 2017: 0,5 %
As from 3 March 2018:
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.
300
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
As from 3 September 2017, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %
As from 3 March 2018, to be printed on the label:
The mixing ratio.
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.
301
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
As from 3 September 2017, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 %
As from 3 March 2018, to be printed on the label:
The mixing ratio.
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.
302
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
As from 3 September 2017, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 %
As from 3 March 2018, to be printed on the label:
The mixing ratio.
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.
303
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
As from 3 September 2017, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 %
As from 3 March 2018, to be printed on the label:
The mixing ratio.
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.
304
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
As from 3 September 2017: 2,0 %
305
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
As from 3 September 2017: 0,5 %
As from 3 September 2017:
Do not use with nitrosating agents
Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers
As from 3 March 2018:
Hair colourants 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’

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Source: https://www.legislation.gov.uk/eur/2017/237/annex (the official version)
Page: https://openlegislation.uk/eu-regulation-2017-237/annex
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.