CELEX: 32005L0080
Language: en
Date: 2005-11-21 00:00:00
Title: Commission Directive 2005/80/EC of 21 November 2005 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes II and III thereto to technical progress   (Text with EEA relevance)

22.11.2005   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 303/32
            
         
      COMMISSION DIRECTIVE 2005/80/EC
   of 21 November 2005
   amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes II and III thereto to technical progress
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), and in particular Article 4b and Article 8(2) thereof,
   After consulting the Scientific Committee on Consumer Products,
   Whereas:
   
               (1)
            
            
               Directive 76/768/EEC, as amended by Directive 2003/15/EC of the European Parliament and of the Council (2), prohibits the use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1, 2 and 3, under Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (3), but allows the use of substances classified in category 3 pursuant to Directive 67/548/EEC subject to evaluation and approval by the Scientific Committee on Cosmetic products and Non-Food Products intended for consumers SCCNFP, replaced by the Scientific Committee on Consumer Products (SCCP) by Commission Decision 2004/210 (4).
            
         
               (2)
            
            
               Directive 67/548/EEC has been amended by Directive 2004/73/EC, and it is therefore necessary to adopt measures so as to bring Directive 76/768/EEC in line with the provisions of Directive 67/548/EEC.
            
         
               (3)
            
            
               In so far as some of the substances classified as CMR of category 1 and 2 under Annex I to Directive 67/548/EEC are not yet listed in Annex II to Directive 76/768/EEC, it is necessary to include them in that Annex. Substances classified as CMR of category 3 under Annex I to Directive 67/548/EEC should also be included in Annex II to Directive 76/768/EEC, except if they have been evaluated by the SCCP and found acceptable for use in cosmetic products.
            
         
               (4)
            
            
               Substances classified as CMR of category 1 and 2 listed in Annex III, Part 1 to Directive 76/768/EEC should be deleted, since these substances are now listed in Annex II to Directive 76/768/EEC and therefore must not form part of the composition of cosmetic products.
            
         
               (5)
            
            
               Commission Directive 2004/93/EC (5) provided for the insertion in Annex II to Directive 76/768/EEC of certain substances which were already listed there. That Annex should therefore be amended for the sake of clarity.
            
         
               (6)
            
            
               Directive 76/768/EEC should therefore be amended accordingly.
            
         
               (7)
            
            
               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,
            
         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes II and III to Directive 76/768/EEC are amended in accordance with the text set out in the Annex to this Directive.
   Article 2
   Member States shall take all necessary measures to ensure that from 22 August 2006 cosmetic products which fail to comply with this Directive are not placed on the market by Community manufacturers or by importers established within the Community.
   Member States shall take all necessary measures to ensure that those products are not sold or disposed of to the final consumer after 22 November 2006.
   Article 3
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 22 May 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 4
   This Directive shall enter into force on the third day following its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.
   
      Done at Brussels, 21 November 2005.
      
         
            For the Commission
         
         Günter VERHEUGEN
         
         
            Vice-President
         
      
   
   
      (1)  OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2005/52/EC (OJ L 234, 10.9.2005, p. 9).
   
      (2)  OJ L 66, 11.3.2003, p. 26.
   
      (3)  OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2004/73/EC (OJ L 152, 30.4.2004, p. 1).
   
      (4)  OJ L 66, 4.3.2004, p. 45.
   
      (5)  OJ L 300, 25.9.2004, p. 13.
   
      ANNEX
      Annexes II and III to Directive 76/768/EEC are amended as follows:
      
                  1.
               
               
                  Annex II is amended as follows:
                  
                              (a)
                           
                           
                              the entries under reference numbers 615 and 616 are deleted;
                           
                        
                              (b)
                           
                           
                              the entry under reference number 687 is replaced by the following:
                              
                                          ‘687.
                                       
                                       
                                          dinitrotoluene, technical grade (Cas No 121-14-2)’;
                                       
                                    
                        
                              (c)
                           
                           
                              the following reference numbers 1137 and 1211 are added:
                              
                                          Ref. No
                                       
                                       
                                          Chemical name
                                       
                                       
                                          CAS No
                                          EC No
                                       
                                    
                                          ‘1137
                                       
                                       
                                          isobutyl nitrite
                                       
                                       
                                          542-56-3
                                       
                                    
                                          1138
                                       
                                       
                                          isoprene (stabilized)
                                          (2-methyl-1,3-butadiene)
                                       
                                       
                                          78-79-5
                                       
                                    
                                          1139
                                       
                                       
                                          1-bromopropane
                                          n-propyl bromide
                                       
                                       
                                          106-94-5
                                       
                                    
                                          1140
                                       
                                       
                                          chloroprene (stabilized)
                                          (2-chlorobuta-1,3-diene)
                                       
                                       
                                          126-99-8
                                       
                                    
                                          1141
                                       
                                       
                                          1,2,3-trichloropropane
                                       
                                       
                                          96-18-4
                                       
                                    
                                          1142
                                       
                                       
                                          ethylene glycol dimethyl ether
                                          (EGDME)
                                       
                                       
                                          110-71-4
                                       
                                    
                                          1143
                                       
                                       
                                          dinocap (ISO)
                                       
                                       
                                          39300-45-3
                                       
                                    
                                          1144
                                       
                                       
                                          diaminotoluene, technical product -mixture of [4-methyl-m-phenylene diamine] (1) and [2-methyl-m-phenylene diamine] (2)
                                          
                                          methyl-phenylenediamine
                                       
                                       
                                          25376-45-8
                                       
                                    
                                          1145
                                       
                                       
                                          
                                             p-chlorobenzotrichloride
                                       
                                       
                                          5216-25-1
                                       
                                    
                                          1146
                                       
                                       
                                          diphenylether; octabromo derivate
                                       
                                       
                                          32536-52-0
                                       
                                    
                                          1147
                                       
                                       
                                          1,2-bis(2-methoxyethoxy)ethane
                                          triethylene glycol dimethyl ether (TEGDME)
                                       
                                       
                                          112-49-2
                                       
                                    
                                          1148
                                       
                                       
                                          tetrahydrothiopyran-3-carboxaldehyde
                                       
                                       
                                          61571-06-0
                                       
                                    
                                          1149
                                       
                                       
                                          4,4′-bis(dimethylamino)benzophenone
                                          (Michler's ketone)
                                       
                                       
                                          90-94-8
                                       
                                    
                                          1150
                                       
                                       
                                          oxiranemethanol, 4-methylbenzene-sulfonate, (S)-
                                       
                                       
                                          70987-78-9
                                       
                                    
                                          1151
                                       
                                       
                                          1,2-benzenedicarboxylic acid, dipentylester, branched and linear [1]
                                       
                                       
                                          84777-06-0 [1]
                                       
                                    
                                          n-pentyl-isopentylphthalate [2]
                                       
                                       
                                          -[2]
                                       
                                    
                                          di-n-pentyl phthalate [3]
                                       
                                       
                                          131-18-0 [3]
                                       
                                    
                                          diisopentylphthalate [4]
                                       
                                       
                                          605-50-5 [4]
                                       
                                    
                                          1152
                                       
                                       
                                          benzyl butyl phthalate
                                          (BBP)
                                       
                                       
                                          85-68-7
                                       
                                    
                                          1153
                                       
                                       
                                          1,2-benzenedicarboxylic acid di-C 7-11, branched and linear alkylesters
                                       
                                       
                                          68515-42-4
                                       
                                    
                                          1154
                                       
                                       
                                          a mixture of: disodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-hydroxy-1-(4-sulfonatophenyl) pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate and trisodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-oxido-1-(4-sulfonatophenyl)pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate
                                       
                                       
                                          EC No 402-660-9
                                       
                                    
                                          1155
                                       
                                       
                                          (methylenebis(4,1-phenylenazo(1-(3-(dimethylamino)propyl)-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl)))-1,1′-dipyridinium dichloride dihydrochloride
                                       
                                       
                                          EC No 401-500-5
                                       
                                    
                                          1156
                                       
                                       
                                          2-[2-hydroxy-3-(2-chlorophenyl) carbamoyl-1-naphthylazo]-7-[2-hydroxy-3-(3-methylphenyl)-2-[2-hydroxy-3-(3-methylphenyl)-carbamoyl-1-naphthylazo]-7-[2-hydroxy-3-(3-methylphenyl)-carbamoyl-1-naphthylazo]fluoren-9-one
                                       
                                       
                                          EC No 420-580-2
                                       
                                    
                                          1157
                                       
                                       
                                          azafenidin
                                       
                                       
                                          68049-83-2
                                       
                                    
                                          1158
                                       
                                       
                                          2,4,5-trimethylaniline [1]
                                       
                                       
                                          137-17-7 [1]
                                       
                                    
                                          2,4,5-trimethylaniline hydrochloride [2]
                                       
                                       
                                          21436-97-5 [2]
                                       
                                    
                                          1159
                                       
                                       
                                          4,4′-thiodianiline and its salts
                                       
                                       
                                          139-65-1
                                       
                                    
                                          1160
                                       
                                       
                                          4,4′-oxydianiline (p-aminophenyl ether) and its salts
                                       
                                       
                                          101-80-4
                                       
                                    
                                          1161
                                       
                                       
                                          
                                             N,N,N′,N′-tetramethyl-4,4′-methylendianiline
                                       
                                       
                                          101-61-1
                                       
                                    
                                          1162
                                       
                                       
                                          6-methoxy-m-toluidine
                                          (p-cresidine)
                                       
                                       
                                          120-71-8
                                       
                                    
                                          1163
                                       
                                       
                                          3-ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine
                                       
                                       
                                          143860-04-2
                                       
                                    
                                          1164
                                       
                                       
                                          a mixture of: 1,3,5-tris(3-aminomethylphenyl)-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione and a mixture of oligomers of 3,5-bis(3-aminomethylphenyl)-1-poly[3,5-bis(3-aminomethylphenyl)-2,4,6-trioxo-1,3,5-(1H,3H,5H)-triazin-1-yl]-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione
                                       
                                       
                                          EC No 421-550-1
                                       
                                    
                                          1165
                                       
                                       
                                          2-nitrotoluene
                                       
                                       
                                          88-72-2
                                       
                                    
                                          1166
                                       
                                       
                                          tributyl phosphate
                                       
                                       
                                          126-73-8
                                       
                                    
                                          1167
                                       
                                       
                                          naphthalene
                                       
                                       
                                          91-20-3
                                       
                                    
                                          1168
                                       
                                       
                                          nonylphenol [1]
                                       
                                       
                                          25154-52-3 [1]
                                       
                                    
                                          4-nonylphenol, branched [2]
                                       
                                       
                                          84852-15-3 [2]
                                       
                                    
                                          1169
                                       
                                       
                                          1,1,2-trichloroethane
                                       
                                       
                                          79-00-5
                                       
                                    
                                          1170
                                       
                                       
                                          pentachloroethane
                                       
                                       
                                          76-01-7
                                       
                                    
                                          1171
                                       
                                       
                                          vinylidene chloride
                                          (1,1-dichloroethylene)
                                       
                                       
                                          75-35-4
                                       
                                    
                                          1172
                                       
                                       
                                          allyl chloride
                                          (3-chloropropene)
                                       
                                       
                                          107-05-1
                                       
                                    
                                          1173
                                       
                                       
                                          1,4-dichlorobenzene
                                          (p-dichlorobenzene)
                                       
                                       
                                          106-46-7
                                       
                                    
                                          1174
                                       
                                       
                                          bis(2-chloroethyl) ether
                                       
                                       
                                          111-44-4
                                       
                                    
                                          1175
                                       
                                       
                                          phenol
                                       
                                       
                                          108-95-2
                                       
                                    
                                          1176
                                       
                                       
                                          bisphenol A
                                          (4,4′-isopropylidenediphenol)
                                       
                                       
                                          80-05-7
                                       
                                    
                                          1177
                                       
                                       
                                          trioxymethylene
                                          (1,3,5-trioxan)
                                       
                                       
                                          110-88-3
                                       
                                    
                                          1178
                                       
                                       
                                          propargite (ISO)
                                       
                                       
                                          2312-35-8
                                       
                                    
                                          1179
                                       
                                       
                                          1-chloro-4-nitrobenzene
                                       
                                       
                                          100-00-5
                                       
                                    
                                          1180
                                       
                                       
                                          molinate (ISO)
                                       
                                       
                                          2212-67-1
                                       
                                    
                                          1181
                                       
                                       
                                          fenpropimorph
                                       
                                       
                                          67564-91-4
                                       
                                    
                                          1182
                                       
                                       
                                          epoxiconazole
                                       
                                       
                                          133855-98-8
                                       
                                    
                                          1183
                                       
                                       
                                          methyl isocyanate
                                       
                                       
                                          624-83-9
                                       
                                    
                                          1184
                                       
                                       
                                          N,N-dimethylanilinium tetrakis(pentafluorophenyl)borate
                                       
                                       
                                          118612-00-3
                                       
                                    
                                          1185
                                       
                                       
                                          O,O′-(ethenylmethylsilylene) di[(4-methylpentan-2-one) oxime]
                                       
                                       
                                          EC No 421-870-1
                                       
                                    
                                          1186
                                       
                                       
                                          a 2:1 mixture of: 4-(7-hydroxy-2,4,4-trimethyl-2-chromanyl)resorcinol-4-yl-tris(6-diazo-5,6-dihydro-5-oxonaphthalen-1-sulfonate) and 4-(7-hydroxy-2,4,4-trimethyl-2-chromanyl)resorcinolbis(6-diazo-5,6-dihydro-5-oxonaphthalen-1-sulfonate)
                                       
                                       
                                          140698-96-0
                                       
                                    
                                          1187
                                       
                                       
                                          a mixture of: reaction product of 4,4′-methylenebis[2-(4-hydroxybenzyl)-3,6-dimethylphenol] and 6-diazo-5,6-dihydro-5-oxo-naphthalenesulfonate (1:2) and reaction product of 4,4′-methylenebis[2-(4-hydroxybenzyl)-3,6-dimethylphenol] and 6-diazo-5,6-dihydro-5-oxonaphthalenesulfonate (1:3)
                                       
                                       
                                          EC No 417-980-4
                                       
                                    
                                          1188
                                       
                                       
                                          malachite green hydrochloride [1]
                                       
                                       
                                          569-64-2 [1]
                                       
                                    
                                          malachite green oxalate [2]
                                       
                                       
                                          18015-76-4 [2]
                                       
                                    
                                          1189
                                       
                                       
                                          1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol
                                       
                                       
                                          107534-96-3
                                       
                                    
                                          1190
                                       
                                       
                                          5-(3-butyryl-2,4,6-trimethylphenyl)-2-[1-(ethoxyimino)propyl]-3-hydroxycyclohex-2-en-1-one
                                       
                                       
                                          138164-12-2
                                       
                                    
                                          1191
                                       
                                       
                                          trans-4-phenyl-L-proline
                                       
                                       
                                          96314-26-0
                                       
                                    
                                          1192
                                       
                                       
                                          bromoxynil heptanoate (ISO)
                                       
                                       
                                          56634-95-8
                                       
                                    
                                          1193
                                       
                                       
                                          a mixture of: 5-[(4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl) azo]-2,5-diethoxyphenyl)azo]-2-[(3-phosphonophenyl)azo]benzoic acid and 5-[(4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)azo]-2,5-diethoxyphenyl)azo]-3-[(3-phosphonophenyl) azo]benzoic acid
                                       
                                       
                                          163879-69-4
                                       
                                    
                                          1194
                                       
                                       
                                          2-{4-(2-ammoniopropylamino)-6-[4-hydroxy-3-(5-methyl-2-methoxy-4-sulfamoylphenylazo)-2-sulfonatonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-2-aminopropyl formate
                                       
                                       
                                          EC No 424-260-3
                                       
                                    
                                          1195
                                       
                                       
                                          5-nitro-o-toluidine [1]
                                       
                                       
                                          99-55-8 [1]
                                       
                                    
                                          5-nitro-o-toluidine hydrochloride [2]
                                       
                                       
                                          51085-52-0 [2]
                                       
                                    
                                          1196
                                       
                                       
                                          1-(1-naphthylmethyl)quinolinium
                                       
                                       
                                          65322-65-8
                                       
                                    
                                          1197
                                       
                                       
                                          (R)-5-bromo-3-(1-methyl-2-pyrrolidinyl
                                          methyl)-1H-indole
                                       
                                       
                                          143322-57-0
                                       
                                    
                                          1198
                                       
                                       
                                          pymetrozine (ISO)
                                       
                                       
                                          123312-89-0
                                       
                                    
                                          1199
                                       
                                       
                                          oxadiargyl (ISO)
                                       
                                       
                                          39807-15-3
                                       
                                    
                                          1200
                                       
                                       
                                          chlorotoluron
                                          (3-(3-chloro-p-tolyl)-1,1-dimethylurea)
                                       
                                       
                                          15545-48-9
                                       
                                    
                                          1201
                                       
                                       
                                          N-[2-(3-acetyl-5-nitrothiophen-2-ylazo)-5-diethylaminophenyl] acetamide
                                       
                                       
                                          EC No 416-860-9
                                       
                                    
                                          1202
                                       
                                       
                                          1,3-bis(vinylsulfonylacetamido)-propane
                                       
                                       
                                          93629-90-4
                                       
                                    
                                          1203
                                       
                                       
                                          
                                             p-phenetidine (4-ethoxyaniline)
                                       
                                       
                                          156-43-4
                                       
                                    
                                          1204
                                       
                                       
                                          
                                             m-phenylenediamine and its salts
                                       
                                       
                                          108-45-2
                                       
                                    
                                          1205
                                       
                                       
                                          residues (coal tar), creosote oil distn., if it contains > 0,005 % w/w benzo[a]pyrene
                                       
                                       
                                          92061-93-3
                                       
                                    
                                          1206
                                       
                                       
                                          creosote oil, acenaphthene fraction, wash oil, if it contains > 0,005 % w/w benzo[a]pyrene
                                       
                                       
                                          90640-84-9
                                       
                                    
                                          1207
                                       
                                       
                                          creosote oil, if it contains > 0,005 % w/w benzo[a]pyrene
                                       
                                       
                                          61789-28-4
                                       
                                    
                                          1208
                                       
                                       
                                          creosote, if it contains > 0,005 % w/w benzo[a]pyrene
                                       
                                       
                                          8001-58-9
                                       
                                    
                                          1209
                                       
                                       
                                          creosote oil, high-boiling distillate, wash oil, if it contains > 0,005 % w/w benzo[a]pyrene
                                       
                                       
                                          70321-79-8
                                       
                                    
                                          1210
                                       
                                       
                                          extract residues (coal), creosote oil acid, wash oil extract residue, if it contains > 0,005 % w/w benzo[a]pyrene
                                       
                                       
                                          122384-77-4
                                       
                                    
                                          1211
                                       
                                       
                                          creosote oil, low-boiling distillate, wash oil, if it contains > 0,005 % w/w benzo[a]pyrene
                                       
                                       
                                          70321-80-1
                                       
                                    
                        
            
                  2.
               
               
                  Annex III, part one, is amended as follows:
                  
                              (a)
                           
                           
                              the entry under reference number 19 is deleted;
                           
                        
                              (b)
                           
                           
                              under reference number 1a, column b the words ‘Boric acid, borates and tetraborates’ are replaced by ‘Boric acid, borates and tetraborates with the exception of substance No in Annex II’;
                           
                        
                              (c)
                           
                           
                              under reference number 8, column b the words ‘m-and p-Phenylenediamine, their N-substituted derivatives and their salts; N-substituted derivatives of o-Phenylenediamine (5), with exception of those derivatives listed elsewhere in this Annex’ are replaced by ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine (5), with exception of those derivatives listed elsewhere in this Annex’.
                           
                        
            
         (1)  for the individual ingredient see reference number 364 in Annex II.
      
         (2)  for the individual ingredient see reference number 413 in Annex II.’