# Commission Directive 2011/59/EU of 13 May 2011 amending, for the purpose of adaptation to technical progress, Annexes II and III to Council Directive 76/768/EEC relating to cosmetic products (Text with EEA relevance), Annex

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

Directive 76/768/EEC is amended as follows:
(1) in Annex II, the following entry is added:
Ref. No
Chemical name
CAS No/EC No
‘1372
2-Aminophenol (o-Aminophenol; CI 76520) and its salts
CAS No 95-55-6/67845-79-8/51-19-4
EC No 202-431-1/267-335-4’
(2) Annex III is amended as follows:
(a) Part 1 is amended as follows:
(i) the following entries are added:
Ref. No
Substance
Restrictions
Conditions of use and warnings which must be printed on the label
Field of application and/or use
Max. authorised concentration in the finished cosmetic product
Other limitations and requirements
‘215
4-amino-3-nitrophenol (CAS No 610-81-1) (EC No 210-236-8)
(a)
Hair dye substance in oxidative hair dye products
(a)
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %
(a)
As mentioned in reference number 205, column f (a)
(b)
Hair dye substance in non-oxidative hair dye products
(b)
1,0 %
(b)
As mentioned in reference number 208, column f
216
2,7-Naphthalenediol (CAS No 582-17-2) (EC No 209-478-7)
(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 %
(a)
As mentioned in reference number 205, column f (a)
(b)
Hair dye substance in non-oxidative hair dye products
(b)
1,0 %
217
m-Aminophenol (CAS No 591-27-5) (EC No 209-711-2) and its salts
m-Aminophenol HCl (CAS No 51-81-0) (EC No 200-125-2)
m-Aminophenol sulphate (CAS No 68239-81-6) (EC No 269-475-1)
sodium m-Aminophenol (CAS No 38171-54-9)
Hair dye substance in oxidative hair dye products
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,2 %
As mentioned in reference number 205, column f (a)
218
2,6-Dihydroxy-3,4-dimethylpyridine (CAS No 84540-47-6) (EC No 283-141-2)
Hair dye substance in oxidative hair dye products
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %
As mentioned in reference number 205, column f (a)
222
2-Hydroxyethyl picramic acid (CAS No 99610-72-7) (EC No 412-520-9)
(a)
Hair dye substance in oxidative hair dye products
(a)
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %
For (a) and (b):
Do not use with nitrosating agents
Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers
(a)
As mentioned in reference number 205, column f (a)
(b)
Hair dye substance in non-oxidative hair dye products
(b)
2,0 %
223
p-Methylaminophenol (CAS No 150-75-4) (EC No 205-768-2) and its sulphate
p-Methylaminophenol sulphate (CAS No 55-55-0/1936-57-8) (EC No 200-237-1/217-706-1)
Hair dye substance in oxidative hair dye products
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,68 % (as sulphate)
Do not use with nitrosating agents
Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers
As mentioned in reference number 205, column f (a)
225
Ethanol, 2-[4-[Ethyl[(2-Hydroxyethyl)Amino]-2-Nitrophenyl]Amino]-, (CAS No 104516-93-0) and its hydrochloride
HC Blue No 12 (CAS No 132885-85-9) (EC No 407-020-2)
(a)
Hair dye substance in oxidative hair dye products
(a)
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,75 % (as hydrochloride)
For (a) and (b):
Do not use with nitrosating agents
Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers
(a)
As mentioned in reference number 205, column f (a)
(b)
Hair dye substance in non-oxidative hair dye products
(b)
1,5 % (as hydrochloride)
227
3-Amino-2,4-dichlorophenol (CAS No 61693-42-3) (EC No 262-909-0) and its hydrochloride
3-Amino-2,4-dichlorophenol HCl (CAS No 61693-43-4)
(a)
Hair dye substance in oxidative hair dye products
(a)
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % (as hydrochloride)
(a)
As mentioned in reference number 205, column f (a)
(b)
Hair dye substance in non-oxidative hair dye products
(b)
1,5 % (as hydrochloride)
230
Phenyl methyl pyrazolone (CAS No 89-25-8) (EC No 201-891-0)
Hair dye substance in oxidative hair dye products
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 %
As mentioned in reference number 205, column f (a)
232
2-Methyl-5-hydroxyethylaminophenol (CAS No 55302-96-0) (EC No 259-583-7)
Hair dye substance in oxidative hair dye products
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %
Do not use with nitrosating agents
Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers
As mentioned in reference number 205, column f (a)
234
Hydroxybenzomorpholine (CAS No 26021-57-8) (EC No 247-415-5)
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
As mentioned in reference number 205, column f (a)
237
2,2’-[(4-Amino-3-nitrophenyl)imino]bisethanol (CAS No 29705-39-3) and its hydrochloride
HC Red No 13 (CAS No 94158-13-1) (EC No 303-083-4
(a)
Hair dye substance in oxidative hair dye products
(a)
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,25 % (as hydrochloride)
(a)
As mentioned in reference number 205, column f (a)
(b)
Hair dye substance in non-oxidative hair dye products
(b)
2,5 % (as hydrochloride)
238
2,6-Dimethoxy-3,5-pyridinediamine (CAS No 85679-78-3 (free base)) and its hydrochloride
2,6-Dimethoxy-3,5-pyridinediamine HCl (CAS No 56216-28-5) (EC No 260-062-1)
Hair dye substance in oxidative hair dye products
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 % (as hydrochloride)
As mentioned in reference number 205, column f (a)
239
HC Violet No 1 (CAS No 82576-75-8) (EC No 417-600-7)
(a)
Hair dye substance in oxidative hair dye products
(a)
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 %
For (a) and (b):
Do not use with nitrosating agents
Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers
(a)
As mentioned in reference number 205, column f (a)
(b)
Hair dye substance in non-oxidative hair dye products
(b)
0,28 %
(b)
As mentioned in reference number 208, column f
241
1,5-Naphthalenediol (CAS No 83-56-7) (EC No 201-487-4
(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)
As mentioned in reference number 205, column f (a)
(b)
Hair dye substance in non-oxidative hair dye products
(b)
1,0 %
242
Hydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) (CAS No 128729-30-6) and its tetrahydrochloride
Hydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) HCl (CAS No 128729-28-2) (EC No 416-320-2)
Hair dye substance in oxidative hair dye products
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,4 % (as tetrahydrochloride)
As mentioned in reference number 205, column f (a)
243
4-Amino-2-hydroxytoluene (CAS No 2835-95-2) (EC No 220-618-6)
Hair dye substance in oxidative hair dye products
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %
As mentioned in reference number 205, column f (a)
244
2,4-Diaminophenoxyethanol (CAS No 70643-19-5), its hydrochloride and its sulphate
2,4-Diaminophenoxyethanol HCl (CAS No 66422-95-5) (EC No 266-357-1)
2,4-Diaminophenoxyethanol sulphate (CAS No 70643-20-8) (EC No 274-713-2)
Hair dye substance in oxidative hair dye products
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (as hydrochloride)
As mentioned in reference number 205, column f (a)
245
2-Methylresorcinol (CAS No 608-25-3) (EC No 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)
As mentioned in reference number 205, column f (a)
(b)
Hair dye substance in non-oxidative hair dye products
(b)
1,8 %
246
4-Amino-m-cresol (CAS No 2835-99-6) (EC No 220-621-2)
Hair dye substance in oxidative hair dye products
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %
As mentioned in reference number 205, column f (a)
248
2-Amino-4-hydroxyethylaminoanisole (CAS No 83763-47-7) (EC No 280-733-2) and its sulphate
2-Amino-4-hydroxyethylaminoanisole sulphate (CAS No 83763-48-8) (EC No 280-734-8)
Hair dye substance in oxidative hair dye products
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % (as sulphate)
Do not use with nitrosating agents
Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers
As mentioned in reference number 205, column f (a)
249
Hydroxyethyl-3,4-methylenedioxyaniline and its hydrochloride
Hydroxyethyl-3,4-methylenedioxyaniline HCl (CAS No 94158-14-2) (EC No 303-085-5)
Hair dye substance in oxidative hair dye products
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %
Do not use with nitrosating agents
Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers
As mentioned in reference number 205, column f (a)
250
3-Nitro-p-hydroxyethylaminophenol (CAS No 65235-31-6) (EC No 265-648-0)
(a)
Hair dye substance in oxidative hair dye products
(a)
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3,0 %
For (a) and (b):
Do not use with nitrosating systems
Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers
(a)
As mentioned in reference number 205, column f (a)
(b)
Hair dye substance in non-oxidative hair dye products
(b)
1,85 %
(b)
As mentioned in reference number 208, column f
251
4-Nitrophenyl aminoethylurea (CAS No 27080-42-8) (EC No 410-700-1)
(a)
Hair dye substance in oxidative hair dye products
(a)
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 %
For (a) and (b):
Do not use with nitrosating agents
Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers
(a)
As mentioned in reference number 205, column f (a)
(b)
Hair dye substance in non-oxidative hair dye products
(b)
0,5 %
252
2-Amino-6-chloro-4-nitrophenol (CAS No 6358-09-4) (EC No 228-762-1)
(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 %
(a)
As mentioned in reference number 205, column f (a)
(b)
Hair dye substance in non-oxidative hair dye products
(b)
2,0 %
(b)
As mentioned in reference number 208, column f’
(ii) the entry with reference number 201 is replaced by the following:
‘
201
2-Chloro-6-ethylamino-4-nitrophenol (CAS No 131657-78-8) (EC No 411-440-1)
(a)
Hair dye substance in oxidative hair dye products
(a)
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %
(a) and (b):
Do not use with nitrosating agents
Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers
(a)
As mentioned in reference number 205, column f (a)
(b)
Hair dye substance in non-oxidative hair dye products
(b)
3,0 %
’
(b) Part 2 is amended as follows:
(i) the entries with reference numbers 3 to 6, 11, 12, 16, 19 to 22, 25, 27, 31 to 39, 44, 48, 49, 55 and 56 are deleted;
(ii) in the entries with reference numbers 10 and 50, in column g, the date ‘31.12.2010’ is replaced by ‘31.12.2011’.

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Source: https://www.legislation.gov.uk/eudr/2011/59/annex (the official version)
Page: https://openlegislation.uk/eu-directive-2011-59/annex
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.