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Commission Directive 2011/59/EUShow full title

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)

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ANNEX

Directive 76/768/EEC is amended as follows:

(1)

in Annex II, the following entry is added:

Ref. NoChemical nameCAS No/EC No
‘13722-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. NoSubstanceRestrictionsConditions of use and warnings which must be printed on the label
Field of application and/or useMax. authorised concentration in the finished cosmetic productOther limitations and requirements
‘2154-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

2162,7-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 productsAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,2 %As mentioned in reference number 205, column f (a)
2182,6-Dihydroxy-3,4-dimethylpyridine (CAS No 84540-47-6) (EC No 283-141-2)Hair dye substance in oxidative hair dye productsAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %As mentioned in reference number 205, column f (a)
2222-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)

230Phenyl methyl pyrazolone (CAS No 89-25-8) (EC No 201-891-0)Hair dye substance in oxidative hair dye productsAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 %As mentioned in reference number 205, column f (a)
2322-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)
234Hydroxybenzomorpholine (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 productsAfter 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)
239HC 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

2411,5-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 productsAfter 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)
2434-Amino-2-hydroxytoluene (CAS No 2835-95-2) (EC No 220-618-6)Hair dye substance in oxidative hair dye productsAfter 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 productsAfter 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)
2452-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 %

2464-Amino-m-cresol (CAS No 2835-99-6) (EC No 220-621-2)Hair dye substance in oxidative hair dye productsAfter 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)
2503-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

2514-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 %

2522-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:

‘2012-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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