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Commission Directive 2009/36/EC (repealed)Show full title

Commission Directive 2009/36/EC of 16 April 2009 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress (Text with EEA relevance) (repealed)

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ANNEX

Directive 76/768/EEC is amended as follows:

1.

In Part 1 of Annex III the following reference numbers 189 - 205 are added:

a

The free base and salts of this hair colouring ingredient, unless prohibited under Annex II, are permitted for use.’

Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the label
Field of application and/or useMaximum authorized concentration in the finished cosmetic productOther limitations and requirements
abcdef
‘189

Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate and aluminium lakea

Acid Yellow 23

CAS 1934-21-0

EINECS 217-699-5

Acid Yellow 23 Aluminum lake

CAS 12225-21-7

EINECS 235-428-9

CI 19140

Hair dye substance in non-oxidative hair dye products0,5 %
190

Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl-[(3-sulfophenyl)-methyl]-amino]-phenyl] [2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo, inner salt, disodium salt and its ammonium and aluminium saltsa

Acid Blue 9

CAS 3844-45-9

EINECS 223-339-8

Acid Blue 9 Ammonium salt

CAS 2650-18-2

EINECS 220-168-0

Acid Blue 9 Aluminum lake

CAS 68921-42-6

EINECS 272-939-6

CI 42090

Hair dye substance in non-oxidative hair dye products0,5 %
191

Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonatea

Curry Red

CAS 25956-17-6

EINECS 247-368-0

CI 16035

Hair dye substance in non-oxidative hair dye products0,4 %
192

Trisodium 1-(1-naphthylazo)-2-hydroxynaphthalene-4′,6,8-trisulphonate and aluminium lakea

Acid Red 18

CAS 2611-82-7

EINECS 220-036-2

Acid Red 18 Aluminum lake

CAS 12227-64-4

EINECS 235-438-3

CI 16255

Hair dye substance in non-oxidative hair dye products0,5 %
193

Hydrogen 3,6-bis(diethylamino)-9-(2,4-disulphonatophenyl)xanthylium, sodium salta

Acid Red 52

CAS 3520-42-1

EINECS 222-529-8

CI 45100

(a)Hair dye substance in oxidative hair dye products

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

(b)0,6 %

(a)After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %.

(a)The mixing ratio must be printed on the label.

194

Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonatea

Acid Red 33

CAS 3567-66-6

EINECS 222-656-9

CI 17200

Hair dye substance in non-oxidative hair dye products0,5 %
195

Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonatea

Acid Blue 62

CAS 4368-56-3

EINECS 224-460-9

CI 62045

Hair dye substance in non-oxidative hair dye products0,5 %
  • Do not use with nitrosating systems

  • Maximum nitrosamine content: 50 μg/kg

  • Keep in nitrite-free containers

196

1-[(2′-Methoxyethyl)amino]-2-nitro-4-[di-(2′-hydroxyethyl)amino]benzenea

HC Blue No 11

CAS 23920-15-2

EINECS 459-980-7

Hair dye substance in non-oxidative hair dye products2,0 %
  • Do not use with nitrosating systems

  • Maximum nitrosamine content: 50 μg/kg

  • Keep in nitrite-free containers

197

1,5-Di-(ß-hydroxyethylamino)-2-nitro-4-chlorobenzenea

HC Yellow No 10

CAS 109023-83-8

EINECS 416-940-3

Hair dye substance in non-oxidative hair dye products0,1 %
  • Do not use with nitrosating systems

  • Maximum nitrosamine content: 50 μg/kg

  • Keep in nitrite-free containers

198

3-Methylamino-4-nitrophenoxyethanola

3-Methylamino-4-nitrophenoxyethanol (INCI)

CAS 59820-63-2

EINECS 261-940-7

Hair dye substance in non-oxidative hair dye products0,15 %
  • Do not use with nitrosating systems

  • Maximum nitrosamine content: 50 μg/kg

  • Keep in nitrite-free containers

199

2,2′-[[4-[(2-hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanola

HC Blue No 2

CAS 33229-34-4

EINECS 251-410-3

Hair dye substance in non-oxidative hair dye products2,8 %
  • Do not use with nitrosating systems

  • Maximum nitrosamine content: 50 μg/kg

  • Keep in nitrite-free containers

Can cause allergic reaction
200

1-Propanol, 3-[[4-[bis(2-hydroxyethyl)amino]-2-nitrophenyl]amino]a

HC Violet No 2

CAS 104226-19-9

EINECS 410-910-3

Hair dye substance in non-oxidative hair dye products2,0 %
  • Do not use with nitrosating systems

  • Maximum nitrosamine content: 50 μg/kg

  • Keep in nitrite-free containers

Can cause allergic reaction
201

Phenol, 2-chloro-6-(ethylamino)-4-nitro-a

2-Chloro-6-ethylamino-4-nitrophenol

CAS 131657-78-8

EINECS 411-440-1

Hair dye substance in non-oxidative hair dye products3,0 %
  • Do not use with nitrosating systems

  • Maximum nitrosamine content: 50 μg/kg

  • Keep in nitrite-free containers

Can cause allergic reaction
202

4,4′-[1,3-Propanediylbis(oxy)]bisbenzene-1,3-diamine and its tetrahydrochloride salta

1,3-bis-(2,4-Diaminophenoxy)propane

CAS 81892-72-0

EINECS 279-845-4

1,3-bis-(2,4-Diaminophenoxy)propane HCl

CAS 74918-21-1

EINECS 278-022-7

(a)Hair dye substance in oxidative hair dye products

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

(b)1,2 % as free base (1,8 % as tetrahydrochloride salt)

(a)After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,2 % calculated as free base (1,8 % as tetrahydrochloride salt).

(a)The mixing ratio must be printed on the label.

For (a) and (b):

Can cause allergic reaction

203

6-Methoxy-N2-methyl-2,3-pyridinediamine hydrochloride and dihydrochloride salta

6-Methoxy-2-methylamino-3-aminopyridine HCl

CAS 90817-34-8 (HCl)

CAS 83732-72-3 (2HCl)

EINECS 280-622-9 (2HCl)

(a)Hair dye substance in oxidative hair dye products

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

(b)0,68 % as free base (1,0 % as dihydrochloride)

(a)After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,68 % calculated as free base (1,0 % as dihydrochloride).

For a) and b):

  • Do not use with nitrosating systems

  • Maximum nitrosamine content: 50 μg/kg

  • Keep in nitrite-free containers

(a)The mixing ratio must be printed on the label.

For (a) and (b):

Can cause allergic reaction

204

2,3-Dihydro-1H-indole-5,6-diol and its hydrobromide salta

Dihydroxyindoline

CAS 29539-03-5

Dihydroxyindoline HBr

CAS 138937-28-7

EINECS 421-170-6

Hair dye substance in non-oxidative hair dye products2,0 %Can cause allergic reaction
205

4-Hydroxypropylamino-3-nitrophenola

4-Hydroxypropylamino-3-nitrophenol (INCI)

CAS 92952-81-3

EINECS 406-305-9

(a)Hair dye substance in oxidative hair dye products

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

(b)2,6 %

(a)After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,6 % calculated as free base.

For (a) and (b):

  • Do not use with nitrosating systems

  • Maximum nitrosamine content: 50 μg/kg

  • Keep in nitrite-free containers

(a)The mixing ratio must be printed on the label.

2.

In columns ‘c’ and ‘d’ of entry 55 of Part 2 of Annex III section b is deleted.

3.

In Part 2 of Annex III reference numbers 7, 9, 14, 24, 28, 47, and 58 are deleted.

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