CELEX: 32013R0658
Language: en
Date: 2013-07-10 00:00:00
Title: Commission Regulation (EU) No 658/2013 of 10 July 2013 amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products  Text with EEA relevance

11.7.2013   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 190/38
            
         
      COMMISSION REGULATION (EU) No 658/2013
   of 10 July 2013
   amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (1), and in particular Article 31(1) thereof,
   Whereas:
   
               (1)
            
            
               Regulation (EC) No 1223/2009 replacing Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (2) will apply from 11 July 2013.
            
         
               (2)
            
            
               Annexes II and III to Directive 76/768/EEC were amended by Commission Implementing Directive 2012/21/EU (3) after the adoption of the Regulation, by including one hair dye substance into Annex II, 26 hair dye substances into Part 1 of Annex III and by changing the maximum authorised concentrations in the finished cosmetic product for two hair dye substances in Part 1 of Annex III. Those amendments should now be reflected in Regulation (EC) No 1223/2009.
            
         
               (3)
            
            
               In accordance with Implementing Directive 2012/21/EU, Member States are to apply the laws, regulations and administrative provisions adopted in order to comply with that Directive from 1 September 2013. Therefore, this Regulation should apply from that date.
            
         
               (4)
            
            
               Regulation (EC) No 1223/2009 should therefore be amended accordingly.
            
         
               (5)
            
            
               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,
            
         HAS ADOPTED THIS REGULATION:
   Article 1
   Annexes II and III to Regulation (EC) No 1223/2009 are amended in accordance with the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 September 2013.
   
      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 10 July 2013.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
         
      
   
   
      (1)  OJ L 342, 22.12.2009, p. 59.
   
      (2)  OJ L 262, 27.9.1976, p. 169.
   
      (3)  OJ L 208, 3.8.2012, p. 8.
   
      ANNEX
      Annexes II and III to Regulation (EC) No 1223/2009 are amended as follows:
      
                  (1)
               
               
                  In Annex II, the following entry is added:
                  
                              Reference number
                           
                           
                              Substance identification
                           
                        
                              Chemical name/INN
                           
                           
                              CAS number
                           
                           
                              EC number
                           
                        
                              ‘1373
                           
                           
                              N-(2-Nitro-4-aminophenyl)-allylamine (HC Red No 16) and its salts
                           
                           
                              160219-76-1’
                           
                           
                               
                           
                        
            
                  (2)
               
               
                  Annex III is amended as follows:
                  
                              (a)
                           
                           
                              The following entries concerning reference numbers 198 to 200 are added:
                              
                                          Reference number
                                       
                                       
                                          Substance identification
                                       
                                       
                                          Restrictions
                                       
                                       
                                          Wording of conditions of use and warnings
                                       
                                    
                                          Chemical name/INN
                                       
                                       
                                          Name of Common Ingredients Glossary
                                       
                                       
                                          CAS number
                                       
                                       
                                          EC number
                                       
                                       
                                          Product type, body parts
                                       
                                       
                                          Maximum concentration in ready use preparation
                                       
                                       
                                          Other
                                       
                                    
                                          ‘198
                                       
                                       
                                          2,2'-[(4-Aminophenyl)imino]bis(ethanol) sulphate
                                       
                                       
                                          N,N-bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate
                                       
                                       
                                          54381-16-7
                                       
                                       
                                          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
                                                   
                                                
                                       
                                          To be printed on the label:
                                          The mixing ratio.
                                          ‘ Hair colorants can cause severe allergic reactions.
                                          Read and follow instructions.
                                          This product is not intended for use on persons under the age of 16.
                                          Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                          Do not colour your hair if:
                                          
                                                      —
                                                   
                                                   
                                                      you have a rash on your face or sensitive, irritated and damaged scalp,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have ever experienced any reaction after colouring your hair,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
                                                   
                                                
                                    
                                          199
                                       
                                       
                                          1,3-Benzenediol, 4-chloro-
                                       
                                       
                                          4-Chlororesorcinol
                                       
                                       
                                          95-88-5
                                       
                                       
                                          202-462-0
                                       
                                       
                                          Hair dye substance in oxidative hair dye products
                                       
                                       
                                           
                                       
                                       
                                          After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 %
                                       
                                       
                                          To be printed on the label:
                                          The mixing ratio.
                                          ‘ Hair colorants can cause severe allergic reactions.
                                          Read and follow instructions.
                                          This product is not intended for use on persons under the age of 16.
                                          Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                          Do not colour your hair if:
                                          
                                                      —
                                                   
                                                   
                                                      you have a rash on your face or sensitive, irritated and damaged scalp,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have ever experienced any reaction after colouring your hair,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
                                                   
                                                
                                    
                                          200
                                       
                                       
                                          2,4,5,6-Tetraaminopyrimidine sulphate
                                       
                                       
                                          Tetraaminopyrimidine Sulfate
                                       
                                       
                                          5392-28-9
                                       
                                       
                                          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)
                                                   
                                                   
                                                      To be printed on the label:
                                                      The mixing ratio.
                                                      ‘ Hair colorants can cause severe allergic reactions.
                                                      Read and follow instructions.
                                                      This product is not intended for use on persons under the age of 16.
                                                      Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                                      Do not colour your hair if:
                                                      
                                                                  —
                                                               
                                                               
                                                                  you have a rash on your face or sensitive, irritated and damaged scalp,
                                                               
                                                            
                                                                  —
                                                               
                                                               
                                                                  you have ever experienced any reaction after colouring your hair,
                                                               
                                                            
                                                                  —
                                                               
                                                               
                                                                  you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ ’
                                                               
                                                            
                                                
                                    
                                          
                                                      (b)
                                                   
                                                   
                                                      Hair dye substance in non-oxidative hair dye products
                                                   
                                                
                                       
                                          
                                                      (b)
                                                   
                                                   
                                                      3,4 % (calculated as sulphate)
                                                   
                                                
                                    
                        
                              (b)
                           
                           
                              The following entries concerning reference numbers 206 to 214 are added:
                              
                                          ‘206
                                       
                                       
                                          3-(2-Hydroxyethyl)-p-phenylenediammonium sulphate
                                       
                                       
                                          Hydroxyethyl-p-Phenylenediamine Sulfate
                                       
                                       
                                          93841-25-9
                                       
                                       
                                          298-995-1
                                       
                                       
                                          Hair dye substance in oxidative hair dye products
                                       
                                       
                                           
                                       
                                       
                                          After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (calculated as sulphate)
                                       
                                       
                                          To be printed on the label:
                                          The mixing ratio.
                                          ‘ Hair colorants can cause severe allergic reactions.
                                          Read and follow instructions.
                                          This product is not intended for use on persons under the age of 16.
                                          Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                          Do not colour your hair if:
                                          
                                                      —
                                                   
                                                   
                                                      you have a rash on your face or sensitive, irritated and damaged scalp,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have ever experienced any reaction after colouring your hair,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
                                                   
                                                
                                    
                                          207
                                       
                                       
                                          1H-Indole-5,6-diol
                                       
                                       
                                          Dihydroxyindole
                                       
                                       
                                          3131-52-0
                                       
                                       
                                          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)
                                                   
                                                   
                                                      To be printed on the label:
                                                      The mixing ratio.
                                                      For (a) and (b):
                                                      ‘ Hair colorants can cause severe allergic reactions.
                                                      Read and follow instructions.
                                                      This product is not intended for use on persons under the age of 16.
                                                      Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                                      Do not colour your hair if:
                                                      
                                                                  —
                                                               
                                                               
                                                                  you have a rash on your face or sensitive, irritated and damaged scalp,
                                                               
                                                            
                                                                  —
                                                               
                                                               
                                                                  you have ever experienced any reaction after colouring your hair,
                                                               
                                                            
                                                                  —
                                                               
                                                               
                                                                  you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
                                                               
                                                            
                                                
                                    
                                          
                                                      (b)
                                                   
                                                   
                                                      Hair dye substance in non-oxidative hair dye products
                                                   
                                                
                                       
                                          
                                                      (b)
                                                   
                                                   
                                                      0,5 %
                                                   
                                                
                                    
                                          208
                                       
                                       
                                          5-Amino-4-chloro-2-methylphenol hydrochloride
                                       
                                       
                                          5-Amino-4-Chloro-o-Cresol HCl
                                       
                                       
                                          110102-85-7
                                       
                                       
                                           
                                       
                                       
                                          Hair dye substance in oxidative hair dye products
                                       
                                       
                                           
                                       
                                       
                                          After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % (calculated as hydrochloride)
                                       
                                       
                                          To be printed on the label:
                                          The mixing ratio.
                                          ‘ Hair colorants can cause severe allergic reactions.
                                          Read and follow instructions.
                                          This product is not intended for use on persons under the age of 16.
                                          Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                          Do not colour your hair if:
                                          
                                                      —
                                                   
                                                   
                                                      you have a rash on your face or sensitive, irritated and damaged scalp,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have ever experienced any reaction after colouring your hair,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
                                                   
                                                
                                    
                                          209
                                       
                                       
                                          1H-Indol-6-ol
                                       
                                       
                                          6-Hydroxyindole
                                       
                                       
                                          2380-86-1
                                       
                                       
                                          417-020-4
                                       
                                       
                                          Hair dye substance in oxidative hair dye products
                                       
                                       
                                           
                                       
                                       
                                          After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 %
                                       
                                       
                                          To be printed on the label:
                                          The mixing ratio.
                                          ‘ Hair colorants can cause severe allergic reactions.
                                          Read and follow instructions.
                                          This product is not intended for use on persons under the age of 16.
                                          Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                          Do not colour your hair if:
                                          
                                                      —
                                                   
                                                   
                                                      you have a rash on your face or sensitive, irritated and damaged scalp,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have ever experienced any reaction after colouring your hair,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
                                                   
                                                
                                    
                                          210
                                       
                                       
                                          1H-Indole-2,3-Dione
                                       
                                       
                                          Isatin
                                       
                                       
                                          91-56-5
                                       
                                       
                                          202-077-8
                                       
                                       
                                          Hair dye substance in non-oxidative hair dye products
                                       
                                       
                                          1,6 %
                                       
                                       
                                           
                                       
                                       
                                          ‘ Hair colorants can cause severe allergic reactions.
                                          Read and follow instructions.
                                          This product is not intended for use on persons under the age of 16.
                                          Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                          Do not colour your hair if:
                                          
                                                      —
                                                   
                                                   
                                                      you have a rash on your face or sensitive, irritated and damaged scalp,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have ever experienced any reaction after colouring your hair,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
                                                   
                                                
                                    
                                          211
                                       
                                       
                                          2-Aminopyridin-3-ol
                                       
                                       
                                          2-Amino-3-Hydroxypyridine
                                       
                                       
                                          16867-03-1
                                       
                                       
                                          240-886-8
                                       
                                       
                                          Hair dye substance in oxidative hair dye products
                                       
                                       
                                           
                                       
                                       
                                          After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %
                                       
                                       
                                          To be printed on the label:
                                          The mixing ratio.
                                          ‘ Hair colorants can cause severe allergic reactions.
                                          Read and follow instructions.
                                          This product is not intended for use on persons under the age of 16.
                                          Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                          Do not colour your hair if:
                                          
                                                      —
                                                   
                                                   
                                                      you have a rash on your face or sensitive, irritated and damaged scalp,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have ever experienced any reaction after colouring your hair,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
                                                   
                                                
                                    
                                          212
                                       
                                       
                                          2-Methyl-1-naphthyl acetate
                                       
                                       
                                          1-Acetoxy-2-Methylnaphthalene
                                       
                                       
                                          5697-02-9
                                       
                                       
                                          454-690-7
                                       
                                       
                                          Hair dye substance in oxidative hair dye products
                                       
                                       
                                           
                                       
                                       
                                          After 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 %).
                                       
                                       
                                          To be printed on the label:
                                          The mixing ratio.
                                          ‘ Hair colorants can cause severe allergic reactions.
                                          Read and follow instructions.
                                          This product is not intended for use on persons under the age of 16.
                                          Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                          Do not colour your hair if:
                                          
                                                      —
                                                   
                                                   
                                                      you have a rash on your face or sensitive, irritated and damaged scalp,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have ever experienced any reaction after colouring your hair,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
                                                   
                                                
                                    
                                          213
                                       
                                       
                                          1-Hydroxy-2-methylnaphthalene
                                       
                                       
                                          2-Methyl-1-Naphthol
                                       
                                       
                                          7469-77-4
                                       
                                       
                                          231-265-2
                                       
                                       
                                          Hair dye substance in oxidative hair dye products
                                       
                                       
                                           
                                       
                                       
                                          After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (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 %.)
                                       
                                       
                                          To be printed on the label:
                                          The mixing ratio.
                                          ‘ Hair colorants can cause severe allergic reactions.
                                          Read and follow instructions.
                                          This product is not intended for use on persons under the age of 16.
                                          Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                          Do not colour your hair if:
                                          
                                                      —
                                                   
                                                   
                                                      you have a rash on your face or sensitive, irritated and damaged scalp,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have ever experienced any reaction after colouring your hair,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
                                                   
                                                
                                    
                                          214
                                       
                                       
                                          Disodium 5,7-dinitro-8-oxido-2-naphthalenesulfonate CI 10316
                                       
                                       
                                          Acid Yellow 1
                                       
                                       
                                          846-70-8
                                       
                                       
                                          212-690-2
                                       
                                       
                                          
                                                      (a)
                                                   
                                                   
                                                      Hair dye substance in oxidative hair dye products
                                                   
                                                
                                       
                                           
                                       
                                       
                                          
                                                      (a)
                                                   
                                                   
                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %
                                                   
                                                
                                       
                                          
                                                      (a)
                                                   
                                                   
                                                      To be printed on the label:
                                                      The mixing ratio.
                                                      For (a) and (b):
                                                      ‘ Hair colorants can cause severe allergic reactions.
                                                      Read and follow instructions.
                                                      This product is not intended for use on persons under the age of 16.
                                                      Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                                      Do not colour your hair if:
                                                      
                                                                  —
                                                               
                                                               
                                                                  you have a rash on your face or sensitive, irritated and damaged scalp,
                                                               
                                                            
                                                                  —
                                                               
                                                               
                                                                  you have ever experienced any reaction after colouring your hair,
                                                               
                                                            
                                                                  —
                                                               
                                                               
                                                                  you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ ’
                                                               
                                                            
                                                
                                    
                                          
                                                      (b)
                                                   
                                                   
                                                      Hair dye substance in non-oxidative hair dye products
                                                   
                                                
                                       
                                          
                                                      (b)
                                                   
                                                   
                                                      0,2 %
                                                   
                                                
                                    
                        
                              (c)
                           
                           
                              The entry with reference number 240 is replaced by the following:
                              
                                          ‘240
                                       
                                       
                                          4-Nitro-1,2-phenylenediamine
                                       
                                       
                                          4-Nitro-o-Phenylenediamine
                                       
                                       
                                          99-56-9
                                       
                                       
                                          202-766-3
                                       
                                       
                                          Hair dye substance in oxidative hair dye products
                                       
                                       
                                           
                                       
                                       
                                          After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 %
                                       
                                       
                                          To be printed on the label:
                                          The mixing ratio.
                                          ‘ Hair colorants can cause severe allergic reactions.
                                          Read and follow instructions.
                                          This product is not intended for use on persons under the age of 16.
                                          Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                          Do not colour your hair if:
                                          
                                                      —
                                                   
                                                   
                                                      you have a rash on your face or sensitive, irritated and damaged scalp,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have ever experienced any reaction after colouring your hair,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ ’
                                                   
                                                
                                    
                        
                              (d)
                           
                           
                              The entry with reference number 251 is replaced by the following:
                              
                                          ‘251
                                       
                                       
                                          2-(4-Amino-3-nitroanilino)ethanol
                                       
                                       
                                          HC Red No 7
                                       
                                       
                                          24905-87-1
                                       
                                       
                                          246-521-9
                                       
                                       
                                          Hair dye substance in non-oxidative hair dye products
                                       
                                       
                                          1,0 %
                                       
                                       
                                          
                                                      —
                                                   
                                                   
                                                      Do not use with nitrosating agents
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      Maximum nitrosamine content: 50 μg/kg
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      Keep in nitrite-free containers
                                                   
                                                
                                       
                                          ‘ Hair colorants can cause severe allergic reactions.
                                          Read and follow instructions.
                                          This product is not intended for use on persons under the age of 16.
                                          Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                          Do not colour your hair if:
                                          
                                                      —
                                                   
                                                   
                                                      you have a rash on your face or sensitive, irritated and damaged scalp,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have ever experienced any reaction after colouring your hair,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ ’
                                                   
                                                
                                    
                        
                              (e)
                           
                           
                              The entry with reference number 253 is replaced by the following:
                              
                                          ‘253
                                       
                                       
                                          2-[bis(2-Hydroxyethyl)amino]-5-nitrophenol
                                       
                                       
                                          HC Yellow No 4
                                       
                                       
                                          59820-43-8
                                       
                                       
                                          428-840-7
                                       
                                       
                                          Hair dye substance in non-oxidative hair dye products
                                       
                                       
                                          1,5 %
                                       
                                       
                                          
                                                      —
                                                   
                                                   
                                                      Do not use with nitrosating agents
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      Maximum nitrosamine content: 50 μg/kg
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      Keep in nitrite-free containers’
                                                   
                                                
                                       
                                           
                                       
                                    
                        
                              (f)
                           
                           
                              The entries with reference numbers 255 and 256 are replaced by the following:
                              
                                          ‘255
                                       
                                       
                                          2-[(2-Nitrophenyl)amino]ethanol
                                       
                                       
                                          HC Yellow No 2
                                       
                                       
                                          4926-55-0
                                       
                                       
                                          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)
                                                   
                                                   
                                                      To be printed on the label:
                                                      The mixing ratio.
                                                      ‘ Hair colorants can cause severe allergic reactions.
                                                      Read and follow instructions.
                                                      This product is not intended for use on persons under the age of 16.
                                                      Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                                      Do not colour your hair if:
                                                      
                                                                  —
                                                               
                                                               
                                                                  you have a rash on your face or sensitive, irritated and damaged scalp,
                                                               
                                                            
                                                                  —
                                                               
                                                               
                                                                  you have ever experienced any reaction after colouring your hair,
                                                               
                                                            
                                                                  —
                                                               
                                                               
                                                                  you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
                                                               
                                                            
                                                
                                    
                                          
                                                      (b)
                                                   
                                                   
                                                      Hair dye substance in non-oxidative hair dye products
                                                   
                                                
                                       
                                          
                                                      b)
                                                   
                                                   
                                                      1,0 %
                                                   
                                                
                                    
                                          256
                                       
                                       
                                          4-[(2-Nitrophenyl)amino]phenol
                                       
                                       
                                          HC Orange No 1
                                       
                                       
                                          54381-08-7
                                       
                                       
                                          259-132-4
                                       
                                       
                                          Hair dye substance in non-oxidative hair dye products
                                       
                                       
                                          1,0 %’
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                        
                              (g)
                           
                           
                              The following entries concerning reference numbers 258 to 264 are added:
                              
                                          ‘258
                                       
                                       
                                          2-Nitro-N1-phenyl-benzene-1,4-diamine
                                       
                                       
                                          HC Red No 1
                                       
                                       
                                          2784-89-6
                                       
                                       
                                          220-494-3
                                       
                                       
                                          Hair dye substance in non-oxidative hair dye products
                                       
                                       
                                          1,0 %
                                       
                                       
                                           
                                       
                                       
                                          ‘ Hair colorants can cause severe allergic reactions.
                                          Read and follow instructions.
                                          This product is not intended for use on persons under the age of 16.
                                          Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                          Do not colour your hair if:
                                          
                                                      —
                                                   
                                                   
                                                      you have a rash on your face or sensitive, irritated and damaged scalp,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have ever experienced any reaction after colouring your hair,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
                                                   
                                                
                                    
                                          259
                                       
                                       
                                          1-Methoxy-3-(β-aminoethyl)amino-4-nitrobenzene, hydrochloride
                                       
                                       
                                          HC Yellow No 9
                                       
                                       
                                          86419-69-4
                                       
                                       
                                          415-480-1
                                       
                                       
                                          Hair dye substance in non-oxidative hair dye products
                                       
                                       
                                          0,5 % (calculated as hydrochloride)
                                       
                                       
                                          
                                                      —
                                                   
                                                   
                                                      Do not use with nitrosating agents
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      Maximum nitrosamine content: 50 μg/kg
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      Keep in nitrite-free containers
                                                   
                                                
                                       
                                           
                                       
                                    
                                          260
                                       
                                       
                                          1-(4’-Aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl) aminobenzene
                                       
                                       
                                          HC Yellow No 7
                                       
                                       
                                          104226-21-3
                                       
                                       
                                          146-420-6
                                       
                                       
                                          Hair dye substance in non-oxidative hair dye products
                                       
                                       
                                          0,25 %
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          261
                                       
                                       
                                          N-(2-Hydroxyethyl)-2-nitro-4-trifluormethyl-aniline
                                       
                                       
                                          HC Yellow No 13
                                       
                                       
                                          10442-83-8
                                       
                                       
                                          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)
                                                   
                                                   
                                                      To be printed on the label:
                                                      The mixing ratio.
                                                      ‘ Hair colorants can cause severe allergic reactions.
                                                      Read and follow instructions.
                                                      This product is not intended for use on persons under the age of 16.
                                                      Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                                      Do not colour your hair if:
                                                      
                                                                  —
                                                               
                                                               
                                                                  you have a rash on your face or sensitive, irritated and damaged scalp,
                                                               
                                                            
                                                                  —
                                                               
                                                               
                                                                  you have ever experienced any reaction after colouring your hair,
                                                               
                                                            
                                                                  —
                                                               
                                                               
                                                                  you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
                                                               
                                                            
                                                
                                    
                                          
                                                      (b)
                                                   
                                                   
                                                      Hair dye substance in non-oxidative hair dye products
                                                   
                                                
                                       
                                          
                                                      (b)
                                                   
                                                   
                                                      2,5 %
                                                   
                                                
                                    
                                          262
                                       
                                       
                                          Benzenaminium, 3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-N,N,Ntrimethyl-, chloride
                                       
                                       
                                          Basic Yellow 57
                                       
                                       
                                          68391-31-1
                                       
                                       
                                          269-943-5
                                       
                                       
                                          Hair dye substance in non-oxidative hair dye products
                                       
                                       
                                          2,0 %
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          263
                                       
                                       
                                          Ethanol, 2,2’-[[4-[(4-aminophenyl)azo]phenyl]imino]bis-
                                       
                                       
                                          Disperse Black 9
                                       
                                       
                                          20721-50-0
                                       
                                       
                                          243-987-5
                                       
                                       
                                          Hair dye substance in non-oxidative hair dye products
                                       
                                       
                                          0,3 % (of the mixture in the ratio 1:1 of 2,2’-[4-(4-aminophenylazo)phenylimino]diethanol and lignosulfate)
                                       
                                       
                                           
                                       
                                       
                                           
                                       
                                    
                                          264
                                       
                                       
                                          9,10-Anthracenedione, 1,4-bis[(2,3-dihydroxypropyl)amino]-
                                       
                                       
                                          HC Blue No 14
                                       
                                       
                                          99788-75-7
                                       
                                       
                                          421-470-7
                                       
                                       
                                          Hair dye substance in non-oxidative hair dye products
                                       
                                       
                                          0,3 %
                                       
                                       
                                          
                                                      —
                                                   
                                                   
                                                      Do not use with nitrosating agents
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      Maximum nitrosamine content: 50 μg/kg
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      Keep in nitrite-free containers’
                                                   
                                                
                                       
                                           
                                       
                                    
                        
                              (h)
                           
                           
                              The entries with reference numbers 16, 22, 221, 250 are replaced by the following:
                              
                                          Reference number
                                       
                                       
                                          Substance identification
                                       
                                       
                                          Restrictions
                                       
                                       
                                          Wording of conditions of use and warnings
                                       
                                    
                                          Chemical name/INN
                                       
                                       
                                          Name of Common Ingredients Glossary
                                       
                                       
                                          CAS number
                                       
                                       
                                          EC number
                                       
                                       
                                          Product type, body parts
                                       
                                       
                                          Maximum concentration in ready use preparation
                                       
                                       
                                          Other
                                       
                                    
                                          ‘16
                                       
                                       
                                          1-Naphthalenol
                                       
                                       
                                          1-Naphthol
                                       
                                       
                                          90-15-3
                                       
                                       
                                          201-969-4
                                       
                                       
                                          Hair dye substance in oxidative hair dye products
                                       
                                       
                                           
                                       
                                       
                                          After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 %
                                       
                                       
                                          To be printed on the label:
                                          The mixing ratio.
                                          ‘ Hair colorants can cause severe allergic reactions.
                                          Read and follow instructions.
                                          This product is not intended for use on persons under the age of 16.
                                          Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                          Do not colour your hair if:
                                          
                                                      —
                                                   
                                                   
                                                      you have a rash on your face or sensitive, irritated and damaged scalp,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have ever experienced any reaction after colouring your hair,
                                                   
                                                
                                                      —
                                                   
                                                   
                                                      you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
                                                   
                                                
                                    
                                          22
                                       
                                       
                                          1,3-benzenediol
                                       
                                       
                                          Resorcinol
                                       
                                       
                                          108-46-3
                                       
                                       
                                          203-585-2
                                       
                                       
                                          
                                                      (a)
                                                   
                                                   
                                                      Hair dye substance in oxidative hair dye products
                                                   
                                                
                                       
                                           
                                       
                                       
                                          
                                                      (a)
                                                   
                                                   
                                                      
                                                                  1.
                                                               
                                                               
                                                                  general use
                                                               
                                                            
                                                                  2.
                                                               
                                                               
                                                                  professional use
                                                               
                                                            
                                                For 1 and 2:
                                          After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,25 %
                                       
                                       
                                          
                                                      (a)
                                                   
                                                   
                                                      
                                                                  1.
                                                               
                                                               
                                                                  To be printed on the label:
                                                                  The mixing ratio.
                                                                  ‘ Hair colorants can cause severe allergic reactions.
                                                                  Read and follow instructions.
                                                                  This product is not intended for use on persons under the age of 16.
                                                                  Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                                                  Do not colour your hair if:
                                                                  
                                                                              —
                                                                           
                                                                           
                                                                              you have a rash on your face or sensitive, irritated and damaged scalp,
                                                                           
                                                                        
                                                                              —
                                                                           
                                                                           
                                                                              you have ever experienced any reaction after colouring your hair,
                                                                           
                                                                        
                                                                              —
                                                                           
                                                                           
                                                                              you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.
                                                                           
                                                                        Contains resorcinol.
                                                                  Rinse hair well after application.
                                                                  Rinse eyes immediately if product comes into contact with them.
                                                                  Do not use to dye eyelashes or eyebrows.’
                                                               
                                                            
                                                                  2.
                                                               
                                                               
                                                                  To be printed on the label:
                                                                  The mixing ratio.
                                                                  ‘For professional use only.
                                                                  Contains resorcinol.
                                                                  Rinse eyes immediately if product comes into contact with them.
                                                                  
                                                                      Hair colorants can cause severe allergic reactions.
                                                                  Read and follow instructions.
                                                                  This product is not intended for use on persons under the age of 16.
                                                                  Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                                                  Do not colour your hair if:
                                                                  
                                                                              —
                                                                           
                                                                           
                                                                              you have a rash on your face or sensitive, irritated and damaged scalp,
                                                                           
                                                                        
                                                                              —
                                                                           
                                                                           
                                                                              you have ever experienced any reaction after colouring your hair,
                                                                           
                                                                        
                                                                              —
                                                                           
                                                                           
                                                                              you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
                                                                           
                                                                        
                                                            
                                                
                                                      (b)
                                                   
                                                   
                                                      Contains resorcinol.
                                                   
                                                
                                    
                                          
                                                      (b)
                                                   
                                                   
                                                      Hair lotions and shampoos
                                                   
                                                
                                       
                                          
                                                      (b)
                                                   
                                                   
                                                      0,5 %
                                                   
                                                
                                    
                                          221
                                       
                                       
                                          2-(4-Methyl-2-nitroanilino)ethanol
                                       
                                       
                                          Hydroxyethyl-2-Nitro-p-Toluidine
                                       
                                       
                                          100418-33-5
                                       
                                       
                                          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)
                                                   
                                                   
                                                      To be printed on the label:
                                                      The mixing ratio.
                                                      ‘ Hair colorants can cause severe allergic reactions.
                                                      Read and follow instructions.
                                                      This product is not intended for use on persons under the age of 16.
                                                      Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                                      Do not colour your hair if:
                                                      
                                                                  —
                                                               
                                                               
                                                                  you have a rash on your face or sensitive, irritated and damaged scalp,
                                                               
                                                            
                                                                  —
                                                               
                                                               
                                                                  you have ever experienced any reaction after colouring your hair,
                                                               
                                                            
                                                                  —
                                                               
                                                               
                                                                  you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
                                                               
                                                            
                                                
                                    
                                          
                                                      (b)
                                                   
                                                   
                                                      Hair dye substance in non-oxidative hair dye products
                                                   
                                                
                                       
                                          
                                                      (b)
                                                   
                                                   
                                                      1,0 %
                                                   
                                                
                                    
                                          250
                                       
                                       
                                          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
                                       
                                       
                                          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)
                                                   
                                                   
                                                      To be printed on the label:
                                                      The mixing ratio.
                                                      ‘ Hair colorants can cause severe allergic reactions.
                                                      Read and follow instructions.
                                                      This product is not intended for use on persons under the age of 16.
                                                      Temporary ‘black henna’ tattoos may increase your risk of allergy.
                                                      Do not colour your hair if:
                                                      
                                                                  —
                                                               
                                                               
                                                                  you have a rash on your face or sensitive, irritated and damaged scalp,
                                                               
                                                            
                                                                  —
                                                               
                                                               
                                                                  you have ever experienced any reaction after colouring your hair,
                                                               
                                                            
                                                                  —
                                                               
                                                               
                                                                  you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ ’
                                                               
                                                            
                                                
                                    
                                          
                                                      (b)
                                                   
                                                   
                                                      Hair dye substance in non-oxidative hair dye products
                                                   
                                                
                                       
                                          
                                                      (b)
                                                   
                                                   
                                                      2,0 %