EN    EN EN  
EN 1   EN Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending, for the purpose of adaptation to technical progress, Annex III to Council 
Directive 76/768/EEC concern ing cosmetic products 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  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 products
1, 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,  replaced by the Scientific Committee on 
Consumer Products ("SCCP"), by Commission Decision 2004/210
2, concluded that the 
potential risks were of concern. It reco mmended 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 strate gy to regulate substances used in hair dye 
products according to which the industry wa s required to submit files, containing 
updated scientific data on the safety of hair dye substances, for a risk assessment by 
the SCCP.  
(4) The SCCP, subsequently replaced by the Scientific Committee on Consumer Safety 
(SCCS) by Commission Decision 2008/721/EC3, assessed the safety of individual 
substances for which updated files had been submitted by industry.  
                                                 
1 OJ L 262, 27.9.1976, p. 169. 
2 OJ L66, 04.03.2004, p. 45. 
3 OJ L 241, 10.9.2008, p. 21.  
EN 2   EN (5) The last step of the safety assessment st rategy was to evaluate possible consumer 
health risk by reaction products formed by oxidative hair dye substances during the 
hair dyeing process. In its  opinion of 21 September 2010 the SCCS concluded that 
"Based on the data yet available, the SCCS raises no major concern regarding 
genotoxicity and carcinogenicity of hair dy es and their reaction products currently 
used in the EU."  
(6) Presently, some hair dye substances are prov isionally authorized for use in hair dye 
products until 31 December 2010 under the restrictions an d conditions laid down in 
Part 2 of Annex III to Directive 76/768/EEC. 
(7) The risk assessment of the submitted safety data and the final opinions given by the 
SCCS on the safety of individual substan ces and of the reaction products allow for 
including provisionally au thorized hair dye substances, cu rrently listed in Part 2, into 
Part 1 of Annex III to Directive 76/768/EEC. 
(8) Concerning the substances hydroxyethyl-2-nit ro-p-toluidine and HC Red No 10 + HC 
Red No 11, listed under reference number s 10 and 50 in Part 2 of Annex III to 
Directive 76/768/EEC, their safety assessment by the SCCS can not be finalized before 31 December 2010. Therefore, the provi sional use of the substances should be 
prolonged until 31 December 2011.  
(9) Concerning the substance o-aminophenol the SCCS gave an opini on on 22 June 2010 
in which it states that based on the available data no final conclusion on the safety of this substance can be drawn. Based on this opinion o-aminophenol can not be 
considered safe when used in hair dye pr oducts and shall be li sted in Annex II to 
Directive 76/768/EEC.  
(10) Directive 76/768/EEC should therefore be amended accordingly. 
(11) 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  
Annexes II and III to Directive 76/768/EEC are ame nded in accordance with the Annex to this 
Directive. 
Article 2 
1. Member States shall adopt and publish, by [Day, Month, Year = Six months after 
the entry into force 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 the provisions from [Day, Month, Year = Six months after the 
entry into force of the Directive] .   
EN 3   EN 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 . 
Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, […] 
For the Commission 
The President 
EN 4   EN ANNEX  
 
1. Part 1 of Annex III to Directive 76/768/EEC is amended as follows: 
(a) The following entries are added:  
Restrictions  
Ref. 
No. 
  
Substance Field of 
application and/or 
use Max. authorized 
concentration in 
the finished 
cosmetic product Other limitations and 
requirements  
Conditions of use 
and warnings which 
must be printed on 
the label 
215 4-amino-3-nitrophenol 
(CAS No 610-81-1) (EC No 210-236-8)  
 (a) Hair dye 
substance in oxidative hair dye 
products  
(b) Hair dye 
substance in non-oxidative hair dye products  
  
(b) 1.0% 
 (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) 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  
(b) Hair dye 
substance in non-oxidative hair dye products  
  (b) 1.0% 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) 
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 sulfate 
(CAS No 68239-81-6) (EC No 269-475-1) 
m-Aminophenol sodium 
(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)  
EN 5   EN 222 2-Hydroxyethyl picramic 
acid (CAS No 99610-72-7) (EC No 412-520-9)  
 (a) Hair dye 
substance in oxidative hair dye products  
(b) Hair dye 
substance in non-oxidative hair dye products  
  (b) 2.0% (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) 
 
  
223 p-Methylaminophenol (CAS No 150-75-4) (EC No 205-768-2) and its sulphate salt 
p-Methylaminophenol 
sulfate (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 salt   
HC Blue No 12 (CAS No 
132885-85-9) (EC No 407-
020-2) (a) Hair dye 
substance in oxidative hair dye products  
(b) Hair dye 
substance in non-oxidative hair dye 
products  
  (b) 1.5% (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) 
 
227 3-Amino-2,4-
dichlorophenol (CAS No 61693-42-3) (EC No 262-909-0) and its 
hydrochloride salt  
3-Amino-2,4-
dichlorophenol HCL (CAS No 61693-43-4) (a) Hair dye 
substance in oxidative hair dye products  
(b) Hair dye 
substance in non-oxidative hair dye products  
  (b) 1.5% (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) 
 
230 Phenyl methyl pyrazolone Hair dye  After mixing under oxidative As mentioned in  
EN 6   EN (CAS No 89-25-8) (EC No 
201-891-0)  substance in 
oxidative hair dye products conditions the maximum 
concentration applied to hair must not exceed 0.25% 
 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) 
 
238 2,6-Dimethoxy-3,5-
pyridinediamine (CAS No 85679-78-3 (free base)) and its hydrochloride salt  
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  
(b) Hair dye 
substance in non-oxidative hair dye products  
 
 
(b) 0.28 % (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) As mentioned in 
reference number 208, column f  
 
241 1,5-Naphthalenediol (CAS 
No 83-56-7) (EC No 201-(a) Hair dye 
substance in  After mixing under oxidative 
conditions the maximum (a) As mentioned in 
reference number  
EN 7   EN 487-4  oxidative hair dye 
products  
(b) Hair dye 
substance in non-oxidative hair dye products   
 (b) 1.0%  concentration applied to hair 
must not exceed 1.0% 
 205, column f (a) 
 
242 Hydroxypropyl bis(N-
hydroxyethyl-p-
phenylenediamine) (CAS 
No 128729-30-6) and its tetrahydrochloride salt 
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 salts 
2,4-
Diaminophenoxyethanol 
HCL (CAS No 66422-95-
5) (EC No 266-357-1) 
2,4-
Diaminophenoxyethanol sulfate (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  
(b) Hair dye 
substance in non-oxidative hair dye products  
  
(b) 1.8% (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) 
 
 
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- Hair dye  After mixing under oxidative As mentioned in  
EN 8   EN hydroxyethylaminoanisole 
(CAS No 83763-47-7) (EC No 280-733-2) and its sulphate salt 
2-Amino-4-
hydroxyethylaminoanisole sulfate (CAS No 83763-48-8) (EC No 280-734-8) substance in 
oxidative hair dye products  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 reference number 
205, column f (a) 
 
249 Hydroxyethyl-3,4-
methylenedioxyaniline and its hydrochloride salt 
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  
(b) Hair dye 
substance in non-oxidative hair dye products  
  (b) 1.85% (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) 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  
(b) Hair dye 
substance in non-oxidative hair dye products  
  (b) 0.5%  (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) 
  
EN 9   EN 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  
(b) Hair dye 
substance in non-oxidative hair dye products  
  (b) 2.0 % (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) As mentioned in 
reference number 208, column f  
 
237 2,2'-[(4-Amino-3-
nitrophenyl)imino]bisetha nol (CAS No 29705-39-3) and its hydrochloride salt 
HC Red No 13 (CAS No 
94158-13-1) (EC No 303-083-4  (a) Hair dye 
substance in oxidative hair dye products  
(b) Hair dye 
substance in non-oxidative hair dye products  
  (b) 2.5% (as 
hydrochloride) 
 (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) The reference number 201 is replaced as follows:  
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  
(b) Hair dye 
substance in non-oxidative hair dye products  
  
  (b) 3.0 % (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) 
 
 
2. In Part 2 of Annex III to Directive 76/768/EEC the reference numbers 3, 4, 5, 6, 11, 12, 16, 
19, 20, 21, 22, 25, 27, 31, 32, 33, 34, 35, 36, 37, 38, 39, 44, 48, 49, 55, and 56 are deleted.  
 
3. In Part 2 of Annex III to Directive 76/768/EE C, in reference numbers 10 and 50, in column 
g, the date ‘31.12.2010’ is replaced by ‘31.12.2011’.  
 
4. In Annex II to Directive 76/768/EEC the following entry is added:  
Ref. No  Chemical name CAS No / EC No 
X 2-Aminophenol (o-Aminophenol; CI CAS No 95-55-6 / 67845- 
EN 10   EN 76520) and its salts  79-8 / 51-19-4 
EC No 202-431-1 / 267-
335-4 / -