EN    EN EN  
EN 1   EN Draft 
COMMISSION DIRECTIVE ../…/EC 
of […] 
amending Council Directive 76/768/EEC, concern ing cosmetic products, for the purpose 
of adapting Annex III thereto to technical progress 
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the 
laws of the Member States relating to cosmetic products1, and in particular Article 8(2) 
thereof, 
After consulting the Scientific Committee on Consumer Products, Whereas: (1) Following the publication of a scientific st udy in 2001, entitled “Use of permanent hair 
dyes and bladder cancer risk”, the Scient ific Committee on Cosmetic Products and 
Non-Food Products intended for Consumers, currently the Scientific Committee on 
Consumer Products (hereinafter "SCCP")
2, concluded that the pot ential risks were of 
concern. It recommended that the Commission take further steps to  control the use of 
hair dye substances. 
(2) The SCCP further recommended an overall safe ty assessment strategy for hair dye 
substances including the requirements for tes ting substances used in hair dye products 
for their potential genotoxicity/mutagenicity. 
(3) Following the opinions of the SCCP, the Co mmission, together with Member States 
and stakeholders, agreed on an overall strategy to regulate substances  used in hair dye 
products, according to which the industry wa s required to submit files containing the 
scientific data on hair dye substanc es to be evaluated by the SCCP.  
(4) Substances for which updated safety files were submitted are currently being evaluated 
by the SCCP. For 17 hair dye substances fina l opinions have already been given by the 
SCCP. Therefore, definitive re gulation of these hair dye su bstances, on the basis of 
such evaluations, can take place.  
                                                 
1 OJ L 262, 27.9.1976, p. 169.  
2 The name of the committee was changed by Commission Decision 2004/210 (OJ L 66, 04.03.2004, p. 
45)  
EN 2   EN (5) Substances p-Phenylenediamine (PPD) a nd toluene-2,5-diamine (PTD) are currently 
regulated under entries 8 and 9 in part  1 of Annex III to Council Directive 
76/768/EEC. The SCCP classified these substa nces as extreme sens itizers contributing 
to a great extent to the incidence of sk in allergies among consumers to hair dye 
products. The risk assessment of the submitted additional data on PPD and PTD, and final decisions made by the SCCP on the safety  of these substances might still require 
a considerable amount of time. As a precautionary measure to reduce the risk of allergies to hair dye products among consumers, the maximum authorized 
concentrations of PPD and PTD should be immediately decreased to the levels for 
which the industry submitted the safety files.  
(6) Directive 76/768/EEC should therefore be amended accordingly. 
(7) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on Cosmetic Products, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1  
Annex III to Directive 76/768/EEC is amende d in accordance with the Annex to this 
Directive. 
Article 2 
1. Member States shall adopt and publish, by [insert concrete date = Six months after 
the entry into forc e of the Directive]  at the latest, the la ws, regulations and 
administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commissi on the text of those provisions. 
They shall apply points 1a) to 1d) of the Annex from [insert concrete date = Nine 
months after the entry in to force of the Directive] .  
They shall apply points 1e), 2 and 3 of the Annex from [insert concrete date = 
Twelve months after the entry into force of the Directive] .  
When Member States adopt those provisions,  they shall contain a reference to this 
Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determin e how such reference is to be made. 
2. Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 
Article 3 
This Directive shall enter into force on the tw entieth day following that of its publication in 
the Official Journal of  the European Union .  
EN 3   EN Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, […] 
 For the Commission 
 […] 
 Member of the Commission  
EN 4   EN ANNEX  
Directive 76/768/EEC is amended as follows: 
(1) Part 1 of Annex III is amended as follows: 
(a) The text in the column “d” of entries 8 and 9 is deleted. 
(b) The following text is added to column “e” of entry 8:  “After mixing under oxidative conditions the maximum concentration applied to hair 
must not exceed 2% calc ulated as free base.” 
(c) The following text is added to column “e” of entry 9:  “After mixing under oxidative conditions the maximum concentration applied to hair 
must not exceed 4% calc ulated as free base.” 
(d) The following text is added to column “f” of entries 8 and 9: 
“The mixing ratio must be printed on the label.” (e) The following reference numbers [X]
3 - [Y]4 are added: 
Restrictions Referen
ce 
number 
  
Substance Field of 
application and/or 
use Maximum 
authorized 
concentration in 
the finished 
cosmetic product Other limitations and 
requirements  
Conditions of use 
and warnings 
which must be 
printed on the 
label 
a b c d e f 
“[X]  Trisodium 5-hydroxy-1-(4-
sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate and aluminium lake (
5) 
Acid Yellow 23  CAS 1934-21-0 
EINECS 217-699-5 
Acid Yellow 23 Aluminum lake CAS 12225-21-7 Hair dye substance 
in non-oxidative hair dye products 0.5%   
                                                 
3 [the relevant reference numbers will be introduced at the time of the publication] 
4 [the relevant reference numbers will be introduced at the time of the publication] 
5 The free base and salts of this hair colouring in gredient, unless prohibited under Annex II, are permitted 
for use.  
EN 5   EN EINECS 235-428-9  
CI 19140 
 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 salts (
5) 
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 products 0.5%   
 Disodium 6-hydroxy-5-[(2-
methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate (
5)  
Curry Red  CAS 25956-17-6 EINECS 247-368-0 CI 16035 Hair dye substance 
in non-oxidative hair dye products 0.4%   
 Trisodium 1-(1-naphthylazo)-2-
hydroxynaphthalene-4',6,8-trisulphonate and aluminium lake (
5) 
Acid Red 18 CAS 2611-82-7 EINECS 220-036-2 Acid Red 18 Aluminum lake Hair dye substance 
in non-oxidative hair dye products 0.5%    
EN 6   EN CAS 12227-64-4  
EINECS 235-438-3  CI 16255 
 Hydrogen 3,6-bis(diethylamino)-
9-(2,4-disulphonatophenyl)xanthylium, 
sodium salt (
5) 
Acid Red 52  CAS 3520-42-1 EINECS 222-529-8 CI 45100 Hair dye substance 
in non-oxidative hair dye products 0.6%   
 Disodium 5-amino-4-hydroxy-3-
(phenylazo)naphthalene-2,7-disulphonate (
5) 
Acid Red 33 CAS 3567-66-6 
EINECS 222-656-9 
CI 17200 Hair dye substance 
in non-oxidative hair dye products 
0.5%    
 Sodium 1-amino-4-
(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate (
5)  
Acid Blue 62 CAS 4368-56-3 EINECS 224-460-9 
CI 62045 Hair dye substance 
in non-oxidative hair dye products  0.5% - Do not use with 
nitrosating systems - Maximum nitrosamine content: 50 µg/kg - Keep in nitrite-free containers  
 1-[(2’-Methoxyethyl)amino]-2-
nitro-4-[di-(2’-hydroxyethyl)amino]benzene (
5)  
HC Blue No 11 CAS 23920-15-2 EINECS 459-980-7  Hair dye substance 
in non-oxidative hair dye products 2.0% - Do not use with 
nitrosating systems - Maximum nitrosamine content: 50 µg/kg - Keep in nitrite-free containers  
 1,5-Di-(ß-hydroxyethylamino)-2-
nitro-4-chlorobenzene (5)  
HC Yellow No 10 CAS 109023-83-8 Hair dye substance 
in non-oxidative hair dye products 0.1% - Do not use with 
nitrosating systems - Maximum nitrosamine content: 50 µg/kg - Keep in nitrite-free containers   
EN 7   EN EINECS 416-940-3 
 3-Methylamino-4-
nitrophenoxyethanol (5)  
3-Methylamino-4-
nitrophenoxyethanol (INCI) 
CAS 59820-63-2 
EINECS 261-940-7 Hair dye substance 
in non-oxidative hair dye products 0.15% - Do not use with 
nitrosating systems - Maximum nitrosamine content: 50 µg/kg - Keep in nitrite-free 
containers  
 N1,N4,N4 -Tris-(2-
hydroxyethyl)-1,4-diamino-2-nitrobenzene (
5) 
HC Blue No 2 CAS 33229-34-4 EINECS 251-410-3 Hair dye substance 
in non-oxidative hair dye products 2.8% - Do not use with 
nitrosating systems - Maximum nitrosamine content: 50 µg/kg - Keep in nitrite-free containers Can cause allergic 
reaction  
 1-Propanol, 3-[[4-[bis(2-hydroxyethyl)amino]-2-nitrophenyl]amino] (
5) 
HC Violet No 2 CAS 104226-19-9 EINECS 410-910-3 Hair dye substance 
in non-oxidative hair dye products 2.0% - Do not use with 
nitrosating systems - Maximum nitrosamine content: 50 µg/kg - Keep in nitrite-free containers Can cause allergic 
reaction 
 Phenol, 2-chloro-6-(ethylamino)-
4-nitro- (5)  
2-Chloro-6-ethylamino-4-
nitrophenol  
CAS 131657-78-8  EINECS 411-440-1 Hair dye substance 
in non-oxidative 
hair dye products 3.0% 
 - Do not use with 
nitrosating systems 
- Maximum nitrosamine content: 50 µg/kg - Keep in nitrite-free containers Can cause allergic 
reaction 
 
 1,3-Benzenediamine, 4,4’-[1,3-propanediylbis(oxy)]bis- (9CI) and tetrahydrochloride salt (
5) 
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 Hair dye substance 
in non-oxidative hair dye products 1.2 % as free base 
(1.8 % as tetrahydrochloride salt)  Can cause allergic 
reaction  
EN 8   EN  2,3-Pyridinediamine, 6-methoxy-
N2-methyl- , hydrochloride and its dihydrochloride salt (
5) 
CAS 90817-34-8  6-Methoxy-2-methylamino-3-
aminopyridine HCl 
CAS 83732-72-3  EINECS 280-622-9  Hair dye substance 
in non-oxidative hair dye 0.68% as free base 
(1.0% as dihydrochloride) - Do not use with 
nitrosating systems - Maximum nitrosamine content: 50 µg/kg - Keep in nitrite-free containers Can cause allergic 
reaction 
 2,3-Dihydro-1H-indole-5,6-diol and its hydrobromide salt (
5) 
Dihydroxyindoline CAS 29539-03-5 Dihydroxyindoline HBr CAS 138937-28-7 EINECS 421-170-6 Hair dye substance 
in non-oxidative hair dye products 2.0%  Can cause allergic 
reaction 
 
 4-Hydroxypropylamino-3-
nitrophenol (5) 
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 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.