Commission Directive 2009/36/EC of 16 April 2009 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress (Text with EEA relevance )
Modified by
  • Regulation (EC) No 1223/2009 of the European Parliament and of the Councilof 30 November 2009on cosmetic products(recast)(Text with EEA relevance), 32009R1223, December 22, 2009
Corrected by
  • Corrigendum to Commission Directive 2009/36/EC of 16 April 2009 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress, 32009L0036R(01), April 23, 2009
Commission Directive 2009/36/ECof 16 April 2009amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress(Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty 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 productsOJ L 262, 27.9.1976, p. 169., and in particular Article 8(2) thereof,After consulting the Scientific Committee on Consumer Products,Whereas:(1)Following the publication of a scientific study in 2001, entitled "Use of permanent hair dyes and bladder cancer risk", the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, currently the Scientific Committee on Consumer Products (hereinafter SCCP)The name of the committee was changed by Commission Decision 2004/210 (OJ L 66, 4.3.2004, p. 45)., concluded that the potential risks were of concern. It recommended that the Commission take further steps to control the use of hair dye substances.(2)The SCCP further recommended an overall safety assessment strategy for hair dye substances including the requirements for testing substances used in hair dye products for their potential genotoxicity/mutagenicity.(3)Following the opinions of the SCCP, the Commission, together with Member States and stakeholders, agreed on an overall strategy to regulate substances used in hair dye products, according to which the industry was required to submit files containing the scientific data on hair dye substances to be evaluated by the SCCP.(4)Substances for which updated safety files were submitted are currently being evaluated by the SCCP. For 17 hair dye substances final opinions have already been given by the SCCP. Therefore, definitive regulation of these hair dye substances, on the basis of such evaluations, can take place.(5)Directive 76/768/EEC should therefore be amended accordingly.(6)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 1Annex III to Directive 76/768/EEC is amended in accordance with the Annex to this Directive.
Article 21.Member States shall adopt and publish, by 15 November 2009 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.They shall apply the provisions set out in the Annex to this Directive from 15 May 2010.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 3This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 4This Directive is addressed to the Member States.
nullANNEXDirective 76/768/EEC is amended as follows:1.In Part 1 of Annex III the following reference numbers 189 - 205 are added:
The free base and salts of this hair colouring ingredient, unless prohibited under Annex II, are permitted for use."
Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the label
Field of application and/or useMaximum authorized concentration in the finished cosmetic productOther limitations and requirements
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"189Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate and aluminium lakeAcid Yellow 23CAS 1934-21-0EINECS 217-699-5Acid Yellow 23 Aluminum lakeCAS 12225-21-7EINECS 235-428-9CI 19140Hair dye substance in non-oxidative hair dye products0,5 %
190Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl-[(3-sulfophenyl)-methyl]-amino]-phenyl] [2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo, inner salt, disodium salt and its ammonium and aluminium saltsAcid Blue 9CAS 3844-45-9EINECS 223-339-8Acid Blue 9 Ammonium saltCAS 2650-18-2EINECS 220-168-0Acid Blue 9 Aluminum lakeCAS 68921-42-6EINECS 272-939-6CI 42090Hair dye substance in non-oxidative hair dye products0,5 %
191Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonateCurry RedCAS 25956-17-6EINECS 247-368-0CI 16035Hair dye substance in non-oxidative hair dye products0,4 %
192Trisodium 1-(1-naphthylazo)-2-hydroxynaphthalene-4′,6,8-trisulphonate and aluminium lakeAcid Red 18CAS 2611-82-7EINECS 220-036-2Acid Red 18 Aluminum lakeCAS 12227-64-4EINECS 235-438-3CI 16255Hair dye substance in non-oxidative hair dye products0,5 %
193Hydrogen 3,6-bis(diethylamino)-9-(2,4-disulphonatophenyl)xanthylium, sodium saltAcid Red 52CAS 3520-42-1EINECS 222-529-8CI 45100(a)Hair dye substance in oxidative hair dye products(b)Hair dye substance in non-oxidative hair dye products(b)0,6 %(a)After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %.(a)The mixing ratio must be printed on the label.
194Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonateAcid Red 33CAS 3567-66-6EINECS 222-656-9CI 17200Hair dye substance in non-oxidative hair dye products0,5 %
195Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonateAcid Blue 62CAS 4368-56-3EINECS 224-460-9CI 62045Hair dye substance in non-oxidative hair dye products0,5 %Do not use with nitrosating systemsMaximum nitrosamine content: 50 μg/kgKeep in nitrite-free containers
1961-[(2′-Methoxyethyl)amino]-2-nitro-4-[di-(2′-hydroxyethyl)amino]benzeneHC Blue No 11CAS 23920-15-2EINECS 459-980-7Hair dye substance in non-oxidative hair dye products2,0 %Do not use with nitrosating systemsMaximum nitrosamine content: 50 μg/kgKeep in nitrite-free containers
1971,5-Di-(ß-hydroxyethylamino)-2-nitro-4-chlorobenzeneHC Yellow No 10CAS 109023-83-8EINECS 416-940-3Hair dye substance in non-oxidative hair dye products0,1 %Do not use with nitrosating systemsMaximum nitrosamine content: 50 μg/kgKeep in nitrite-free containers
1983-Methylamino-4-nitrophenoxyethanol3-Methylamino-4-nitrophenoxyethanol (INCI)CAS 59820-63-2EINECS 261-940-7Hair dye substance in non-oxidative hair dye products0,15 %Do not use with nitrosating systemsMaximum nitrosamine content: 50 μg/kgKeep in nitrite-free containers
1992,2′-[[4-[(2-hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanolHC Blue No 2CAS 33229-34-4EINECS 251-410-3Hair dye substance in non-oxidative hair dye products2,8 %Do not use with nitrosating systemsMaximum nitrosamine content: 50 μg/kgKeep in nitrite-free containersCan cause allergic reaction
2001-Propanol, 3-[[4-[bis(2-hydroxyethyl)amino]-2-nitrophenyl]amino]HC Violet No 2CAS 104226-19-9EINECS 410-910-3Hair dye substance in non-oxidative hair dye products2,0 %Do not use with nitrosating systemsMaximum nitrosamine content: 50 μg/kgKeep in nitrite-free containersCan cause allergic reaction
201Phenol, 2-chloro-6-(ethylamino)-4-nitro-2-Chloro-6-ethylamino-4-nitrophenolCAS 131657-78-8EINECS 411-440-1Hair dye substance in non-oxidative hair dye products3,0 %Do not use with nitrosating systemsMaximum nitrosamine content: 50 μg/kgKeep in nitrite-free containersCan cause allergic reaction
2024,4′-[1,3-Propanediylbis(oxy)]bisbenzene-1,3-diamine and its tetrahydrochloride salt1,3-bis-(2,4-Diaminophenoxy)propaneCAS 81892-72-0EINECS 279-845-41,3-bis-(2,4-Diaminophenoxy)propane HClCAS 74918-21-1EINECS 278-022-7(a)Hair dye substance in oxidative hair dye products(b)Hair dye substance in non-oxidative hair dye products(b)1,2 % as free base (1,8 % as tetrahydrochloride salt)(a)After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,2 % calculated as free base (1,8 % as tetrahydrochloride salt).(a)The mixing ratio must be printed on the label.For (a) and (b):Can cause allergic reaction
2036-Methoxy-N2-methyl-2,3-pyridinediamine hydrochloride and dihydrochloride salt6-Methoxy-2-methylamino-3-aminopyridine HClCAS 90817-34-8 (HCl)CAS 83732-72-3 (2HCl)EINECS 280-622-9 (2HCl)(a)Hair dye substance in oxidative hair dye products(b)Hair dye substance in non-oxidative hair dye(b)0,68 % as free base (1,0 % as dihydrochloride)(a)After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,68 % calculated as free base (1,0 % as dihydrochloride).For a) and b):Do not use with nitrosating systemsMaximum nitrosamine content: 50 μg/kgKeep in nitrite-free containers(a)The mixing ratio must be printed on the label.For (a) and (b):Can cause allergic reaction
2042,3-Dihydro-1H-indole-5,6-diol and its hydrobromide saltDihydroxyindolineCAS 29539-03-5Dihydroxyindoline HBrCAS 138937-28-7EINECS 421-170-6Hair dye substance in non-oxidative hair dye products2,0 %Can cause allergic reaction
2054-Hydroxypropylamino-3-nitrophenol4-Hydroxypropylamino-3-nitrophenol (INCI)CAS 92952-81-3EINECS 406-305-9(a)Hair dye substance in oxidative hair dye products(b)Hair dye substance in non-oxidative hair dye products(b)2,6 %(a)After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,6 % calculated as free base.For (a) and (b):Do not use with nitrosating systemsMaximum nitrosamine content: 50 μg/kgKeep in nitrite-free containers(a)The mixing ratio must be printed on the label.
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The free base and salts of this hair colouring ingredient, unless prohibited under Annex II, are permitted for use."2.In columns "c" and "d" of entry 55 of Part 2 of Annex III section b is deleted.3.In Part 2 of Annex III reference numbers 7, 9, 14, 18, 24, 28, 47 and 58 are deleted.