Commission Implementing Directive 2012/21/EUDangos y teitl llawn

Commission Implementing Directive 2012/21/EU of 2 August 2012 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)

ANNEXU.K.

Directive 76/768/EEC is amended as follows:

(1)

in Annex II, the following entry is added:

Ref. NoChemical nameCAS No / EC No
‘1373N-(2-Nitro-4-aminophenyl)-allylamine (HC Red No 16) and its saltsCAS No 160219-76-1’
(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
abcdef
‘253

2,2′-[(4-Aminophenyl))imino]bis(ethanol) sulphate

N,N-bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate

CAS No 54381-16-7

EC No 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

As mentioned in reference number 205, column f (a)
254

1,3-Benzenediol, 4-chloro-

4-Chlororesorcinol

CAS No 95-88-5

EC No 202-462-0

Hair dye substance in oxidative hair dye productsAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 %As mentioned in reference number 205, column f (a)
255

2,4,5,6-Tetraaminopyrimidine sulphate

Tetraaminopyrimidine Sulfate

CAS No 5392-28-9

EC No 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)As mentioned in reference number 205, column f (a)

(b)Hair dye substance in non-oxidative hair dye products

(b)3,4 % (calculated as sulphate)

256

3-(2-Hydroxyethyl)-p-phenylenediammonium sulphate

Hydroxyethyl-p-Phenylenediamine Sulfate

CAS No 93841-25-9

EC No 298-995-1

Hair dye substance in oxidative hair dye productsAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (calculated as sulphate)As mentioned in reference number 205, column f (a)
257

1H-Indole-5,6-diol

Dihydroxyindole

CAS No 3131-52-0

EC No 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)As mentioned in reference number 205, column f (a)

(b)Hair dye substance in non-oxidative hair dye products

(b)0,5 %

(b)As mentioned in reference number 208, column f

258

5-Amino-4-chloro-2-methylphenol hydrochloride

5-Amino-4-Chloro-o-Cresol HCl

CAS No 110102-85-7

Hair dye substance in oxidative hair dye productsAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % (calculated as hydrochloride)As mentioned in reference number 205, column f (a)
259

1H-Indol-6-ol

6-Hydroxyindole

CAS No 2380-86-1

EC No 417-020-4

Hair dye substance in oxidative hair dye productsAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 %As mentioned in reference number 205, column f (a)
260

1H-Indole-2,3-Dione

Isatin

CAS No 91-56-5

EC No 202-077-8

Hair dye substance in non-oxidative hair dye products1,6 %As mentioned in reference number 208, column f
261

2-Aminopyridin-3-ol

2-Amino-3-Hydroxypyridine

CAS No 16867-03-1

EC No 240-886-8

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)
262

2-Methyl-1-naphthyl acetate

1-Acetoxy-2-Methylnaphthalene

CAS No 5697-02-9

EC No 454-690-7

Hair dye substance in oxidative hair dye productsAfter 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 %.)As mentioned in reference number 205, column f (a)
263

1-Hydroxy-2-methylnaphthalene

2-Methyl-1-Naphthol

CAS No 7469-77-4

EC No 231-265-2

Hair dye substance in oxidative hair dye productsAfter 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 %.)As mentioned in reference number 205, column f (a)
264

Disodium 5,7-dinitro-8-oxido-2-naphthalenesulfonate

Acid Yellow 1

CAS No 846-70-8

EC No 212-690-2

CI 10316

(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)0,2 %

(b)As mentioned in reference number 208, column f

265

4-Nitro-1,2-phenylenediamine

4-Nitro-o-Phenylenediamine

CAS No 99-56-9

EC No 202-766-3

Hair dye substance in oxidative hair dye productsAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 %As mentioned in reference number 205, column f (a)
266

2-(4-Amino-3-nitroanilino)ethanol

HC Red No 7

CAS No 24905-87-1

EC No 246-521-9

Hair dye substance in non-oxidative hair dye products1,0 %

  • Do not use with nitrosating agents

  • Maximum nitrosamine content: 50 μg/kg

  • Keep in nitrite-free containers

As mentioned in reference number 208, column f
267

2-[bis(2-Hydroxyethyl)amino]-5-nitrophenol

HC Yellow No 4

CAS No 59820-43-8

EC No 428-840-7

Hair dye substance in non-oxidative hair dye products1,5 %

  • Do not use with nitrosating agents

  • Maximum nitrosamine content: 50 μg/kg

  • Keep in nitrite-free containers

268

2-[(2-Nitrophenyl)amino]ethanol

HC Yellow No 2

CAS No 4926-55-0

EC No 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)As mentioned in reference number 205, column f (a)

(b)Hair dye substance in non-oxidative hair dye products

(b)1,0 %

269

4-[(2-Nitrophenyl)amino]phenol

HC Orange No 1

CAS No 54381-08-7

EC No 259-132-4

Hair dye substance in non-oxidative hair dye products1,0 %
270

2-Nitro-N1-phenyl-benzene-1,4-diamine

HC Red No 1

CAS No 2784-89-6

EC No 220-494-3

Hair dye substance in non-oxidative hair dye products1,0 %As mentioned in reference number 208, column f
271

1-Methoxy-3-(β-aminoethyl)amino-4-nitrobenzene, hydrochloride

HC Yellow No 9

CAS No 86419-69-4

EC No 415-480-1

Hair dye substance in non-oxidative hair dye products0,5 % (calculated as hydrochloride)

  • Do not use with nitrosating agents

  • Maximum nitrosamine content: 50 μg/kg

  • Keep in nitrite-free containers

272

1-(4’-Aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl) aminobenzene

HC Yellow No 7

CAS No 104226-21-3

EC No 146-420-6

Hair dye substance in non-oxidative hair dye products0,25 %
273

N-(2-Hydroxyethyl)-2-nitro-4-trifluormethyl-aniline

HC Yellow No 13

CAS No 10442-83-8

EC No 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)As mentioned in reference number 205, column f (a)

(b)Hair dye substance in non-oxidative hair dye products

(b)2,5 %

274

Benzenaminium, 3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-N,N,Ntrimethyl-, chloride

Basic Yellow 57

CAS No 68391-31-1

EC No 269-943-5

Hair dye substance in non-oxidative hair dye products2,0 %
275

Ethanol, 2,2′-[[4-[(4-aminophenyl)azo]phenyl]imino]bis-

Disperse Black 9

CAS No 20721-50-0

EC No 243-987-5

Hair dye substance in non-oxidative hair dye products0,3 % (of the mixture in the ratio 1:1 of 2,2’-[4-(4-aminophenylazo)phenylimino]diethanol and lignosulfate)
276

9,10-Anthracenedione, 1,4-bis[(2,3-dihydroxypropyl)amino]-

HC Blue No 14

CAS No 99788-75-7

EC No 421-470-7

Hair dye substance in non-oxidative hair dye products0,3 %

  • Do not use with nitrosating agents

  • Maximum nitrosamine content: 50 μg/kg

  • Keep in nitrite-free containers

277

2-(4-Methyl-2-nitroanilino)ethanol

Hydroxyethyl-2-Nitro-p-Toluidine

CAS No 100418-33-5

EC No 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)As mentioned in reference number 205, column f (a)

(b)Hair dye substance in non-oxidative hair dye products

(b)1,0 %

278

1-Amino-2-nitro-4-(2′,3′-dihydroxypropyl)amino-5-chlorobenzene + 1,4-bis-(2′,3′-dihydroxypropyl)amino-2-nitro-5-chlorobenzene

HC Red No 10 + HC Red No 11

CAS No 95576-89-9 + 95576-92-4

(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 %

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 %

(ii)

the entries with reference numbers 16 and 22 are replaced by the following:

Ref. NoSubstanceRestrictionsConditions of use and warnings which must be printed on the label
Field of application and/or useMax. authorized concentration in the finished cosmetic productOther limitations and requirements
abcdef
‘16

1-Naphthalenol

1-Naphthol

CAS No 90-15-3

EC No 201-969-4

Hair dye substance in oxidative hair dye productsAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 %As mentioned in reference number 205, column f (a)
22

1,3-benzenediol

Resorcinol

CAS No 108-46-3

EC No 203-585-2

(a)Hair dye substance in oxidative hair dye products

1.

general use

2.

professional use

(a)After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,25 %

(a)

1.

Contains resorcinol

Rinse hair well after application.

Do not use to dye eyelashes or eyebrows.

Rinse eyes immediately if product comes into contact with them.

As mentioned in reference number 205, column f (a).

2.

For professional use only

Contains resorcinol.

Rinse eyes immediately if product comes into contact with them.

As mentioned in reference number 205, column f (a)

(b)Hair lotions and shampoos

(b)0,5 %

(b)Contains resorcinol.’

(b)

in Part 2 the entries with reference numbers 10 and 50 are deleted.