|
(2)
|
Annex III is amended as follows:
|
(a)
|
The following entries concerning reference numbers 198 to 200 are added:
|
Reference number
|
Substance identification
|
Restrictions
|
Wording 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
|
|
‘198
|
2,2'-[(4-Aminophenyl)imino]bis(ethanol) sulphate
|
N,N-bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate
|
54381-16-7
|
259-134-5
|
Hair dye substance in oxidative hair dye products
|
|
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 % (calculated as sulphate)
|
—
|
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.’
|
|
|
199
|
1,3-Benzenediol, 4-chloro-
|
4-Chlororesorcinol
|
95-88-5
|
202-462-0
|
Hair dye substance in oxidative hair dye products
|
|
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 %
|
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 experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
|
|
|
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)
|
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3,4 % (calculated as sulphate)
|
|
|
(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.
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)
|
3,4 % (calculated as sulphate)
|
|
|
|
(b)
|
The following entries concerning reference numbers 206 to 214 are added:
|
‘206
|
3-(2-Hydroxyethyl)-p-phenylenediammonium sulphate
|
Hydroxyethyl-p-Phenylenediamine Sulfate
|
93841-25-9
|
298-995-1
|
Hair dye substance in oxidative hair dye products
|
|
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (calculated as sulphate)
|
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.’
|
|
|
207
|
1H-Indole-5,6-diol
|
Dihydroxyindole
|
3131-52-0
|
412-130-9
|
|
(a)
|
Hair dye substance in oxidative hair dye products
|
|
|
|
(a)
|
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 %
|
|
|
(a)
|
To be printed on the label:
The mixing ratio.
For (a) and (b):
‘ 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.’
|
|
|
|
(b)
|
Hair dye substance in non-oxidative hair dye products
|
|
|
|
208
|
5-Amino-4-chloro-2-methylphenol hydrochloride
|
5-Amino-4-Chloro-o-Cresol HCl
|
110102-85-7
|
|
Hair dye substance in oxidative hair dye products
|
|
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % (calculated as hydrochloride)
|
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.’
|
|
|
209
|
1H-Indol-6-ol
|
6-Hydroxyindole
|
2380-86-1
|
417-020-4
|
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 experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
|
|
|
210
|
1H-Indole-2,3-Dione
|
Isatin
|
91-56-5
|
202-077-8
|
Hair dye substance in non-oxidative hair dye products
|
1,6 %
|
|
‘ 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.’
|
|
|
211
|
2-Aminopyridin-3-ol
|
2-Amino-3-Hydroxypyridine
|
16867-03-1
|
240-886-8
|
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 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.’
|
|
|
212
|
2-Methyl-1-naphthyl acetate
|
1-Acetoxy-2-Methylnaphthalene
|
5697-02-9
|
454-690-7
|
Hair dye substance in oxidative hair dye products
|
|
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (When both 2-Methyl-1-Naphthol and 1-Acetoxy-2-Methylnaphthalene are present in a hair dye formulation, the maximum concentration on the head of 2-Methyl-1-Naphthol should 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.’
|
|
|
213
|
1-Hydroxy-2-methylnaphthalene
|
2-Methyl-1-Naphthol
|
7469-77-4
|
231-265-2
|
Hair dye substance in oxidative hair dye products
|
|
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (When both 2-Methyl-1-Naphthol and 1-Acetoxy-2-Methylnaphthalene are present in a hair dye formulation, the maximum concentration on the head of 2-Methyl-1-Naphthol should 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.’
|
|
|
214
|
Disodium 5,7-dinitro-8-oxido-2-naphthalenesulfonate CI 10316
|
Acid Yellow 1
|
846-70-8
|
212-690-2
|
|
(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.
For (a) and (b):
‘ 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.’ ’
|
|
|
|
(b)
|
Hair dye substance in non-oxidative hair dye products
|
|
|
|
|
(c)
|
The entry with reference number 240 is replaced by the following:
|
‘240
|
4-Nitro-1,2-phenylenediamine
|
4-Nitro-o-Phenylenediamine
|
99-56-9
|
202-766-3
|
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 experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ ’
|
|
|
|
(d)
|
The entry with reference number 251 is replaced by the following:
|
‘251
|
2-(4-Amino-3-nitroanilino)ethanol
|
HC Red No 7
|
24905-87-1
|
246-521-9
|
Hair dye substance in non-oxidative hair dye products
|
1,0 %
|
|
—
|
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.’ ’
|
|
|
|
(e)
|
The entry with reference number 253 is replaced by the following:
|
‘253
|
2-[bis(2-Hydroxyethyl)amino]-5-nitrophenol
|
HC Yellow No 4
|
59820-43-8
|
428-840-7
|
Hair dye substance in non-oxidative hair dye products
|
1,5 %
|
|
—
|
Do not use with nitrosating agents
|
|
—
|
Maximum nitrosamine content: 50 μg/kg
|
|
—
|
Keep in nitrite-free containers’
|
|
|
|
|
(f)
|
The entries with reference numbers 255 and 256 are replaced by the following:
|
‘255
|
2-[(2-Nitrophenyl)amino]ethanol
|
HC Yellow No 2
|
4926-55-0
|
225-555-8
|
|
(a)
|
Hair dye substance in oxidative hair dye products
|
|
|
|
(a)
|
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,75 %
|
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.
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
|
|
|
|
256
|
4-[(2-Nitrophenyl)amino]phenol
|
HC Orange No 1
|
54381-08-7
|
259-132-4
|
Hair dye substance in non-oxidative hair dye products
|
1,0 %’
|
|
|
|
|
(g)
|
The following entries concerning reference numbers 258 to 264 are added:
|
‘258
|
2-Nitro-N1-phenyl-benzene-1,4-diamine
|
HC Red No 1
|
2784-89-6
|
220-494-3
|
Hair dye substance in non-oxidative hair dye products
|
1,0 %
|
|
‘ 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.’
|
|
|
259
|
1-Methoxy-3-(β-aminoethyl)amino-4-nitrobenzene, hydrochloride
|
HC Yellow No 9
|
86419-69-4
|
415-480-1
|
Hair dye substance in non-oxidative hair dye products
|
0,5 % (calculated as hydrochloride)
|
|
—
|
Do not use with nitrosating agents
|
|
—
|
Maximum nitrosamine content: 50 μg/kg
|
|
—
|
Keep in nitrite-free containers
|
|
|
|
260
|
1-(4’-Aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl) aminobenzene
|
HC Yellow No 7
|
104226-21-3
|
146-420-6
|
Hair dye substance in non-oxidative hair dye products
|
0,25 %
|
|
|
|
261
|
N-(2-Hydroxyethyl)-2-nitro-4-trifluormethyl-aniline
|
HC Yellow No 13
|
10442-83-8
|
443-760-2
|
|
(a)
|
Hair dye substance in oxidative hair dye products
|
|
|
|
(a)
|
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 %
|
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.
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
|
|
|
|
262
|
Benzenaminium, 3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-N,N,Ntrimethyl-, chloride
|
Basic Yellow 57
|
68391-31-1
|
269-943-5
|
Hair dye substance in non-oxidative hair dye products
|
2,0 %
|
|
|
|
263
|
Ethanol, 2,2’-[[4-[(4-aminophenyl)azo]phenyl]imino]bis-
|
Disperse Black 9
|
20721-50-0
|
243-987-5
|
Hair dye substance in non-oxidative hair dye products
|
0,3 % (of the mixture in the ratio 1:1 of 2,2’-[4-(4-aminophenylazo)phenylimino]diethanol and lignosulfate)
|
|
|
|
264
|
9,10-Anthracenedione, 1,4-bis[(2,3-dihydroxypropyl)amino]-
|
HC Blue No 14
|
99788-75-7
|
421-470-7
|
Hair dye substance in non-oxidative hair dye products
|
0,3 %
|
|
—
|
Do not use with nitrosating agents
|
|
—
|
Maximum nitrosamine content: 50 μg/kg
|
|
—
|
Keep in nitrite-free containers’
|
|
|
|
|
(h)
|
The entries with reference numbers 16, 22, 221, 250 are replaced by the following:
|
Reference number
|
Substance identification
|
Restrictions
|
Wording 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
|
|
‘16
|
1-Naphthalenol
|
1-Naphthol
|
90-15-3
|
201-969-4
|
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.’
|
|
|
22
|
1,3-benzenediol
|
Resorcinol
|
108-46-3
|
203-585-2
|
|
(a)
|
Hair dye substance in oxidative hair dye products
|
|
|
For 1 and 2:
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,25 %
|
|
(a)
|
|
1.
|
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.
|
Contains resorcinol.
Rinse hair well after application.
Rinse eyes immediately if product comes into contact with them.
Do not use to dye eyelashes or eyebrows.’
|
|
2.
|
To be printed on the label:
The mixing ratio.
‘For professional use only.
Contains resorcinol.
Rinse eyes immediately if product comes into contact with them.
 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.’
|
|
|
|
|
(b)
|
Hair lotions and shampoos
|
|
|
|
221
|
2-(4-Methyl-2-nitroanilino)ethanol
|
Hydroxyethyl-2-Nitro-p-Toluidine
|
100418-33-5
|
408-090-7
|
|
(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 %
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.
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
|
|
|
|
250
|
1-Amino-2-nitro-4-(2’,3’-dihydroxypropyl)amino-5-chlorobenzene + 1,4-bis-(2’,3’-dihydroxypropyl)amino-2-nitro-5-chlorobenzene
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HC Red No 10 + HC Red No 11
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95576-89-9 + 95576-92-4
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(a)
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Hair dye substance in oxidative hair dye products
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(a)
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After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %
For (a) and (b):
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—
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Do not use with nitrosating agents
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—
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Maximum nitrosamine content: 50 μg/kg
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—
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Keep in nitrite-free containers
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(a)
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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:
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—
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you have a rash on your face or sensitive, irritated and damaged scalp,
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—
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you have ever experienced any reaction after colouring your hair,
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—
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you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ ’
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(b)
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Hair dye substance in non-oxidative hair dye products
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In force