Commission Implementing Directive 2012/21/EU of 2 August 2012 amending, for the purpose of adaptation to technical progress, Annexes II and III to Council Directive 76/768/EEC relating to cosmetic products Text with EEA relevance
Commission Implementing Directive 2012/21/EUof 2 August 2012amending, for the purpose of adaptation to technical progress, Annexes II and III to Council Directive 76/768/EEC relating to cosmetic products(Text with EEA relevance) THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic productsOJ L 262, 27.9.1976, p. 169., and in particular Article 8(2) thereof,After consulting the Scientific Committee on Consumer Safety,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, subsequently replaced by the Scientific Committee on Consumer Products ("SCCP"), pursuant to Commission Decision 2004/210/ECOJ L 66, 4.3.2004, p. 45., concluded that the potential risks were of concern. The SCCP 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 or mutagenicity.(3)Following the opinions of the SCCP, the Commission agreed with Member States and stakeholders on an overall strategy to regulate substances used in hair dye products according to which the industry was required to submit files, containing updated scientific data on the safety of hair dye substances, for a risk assessment by the SCCP.(4)The SCCP, subsequently replaced by the Scientific Committee on Consumer Safety ("SCCS") pursuant to Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/ECOJ L 241, 10.9.2008, p. 21., assessed the safety of individual substances for which updated files had been submitted by industry.(5)The last step of the safety assessment strategy was to evaluate possible consumer health risk by reaction products formed by oxidative hair dye substances during the hair dyeing process. Based on the data yet available, the SCCS raised in its opinion of 21 September 2010 no major concern regarding genotoxicity and carcinogenicity of hair dyes and their reaction products currently used in the EU.(6)In the light of the risk assessment of the submitted safety data and the final opinions given by the SCCS on the safety of individual substances and of the reaction products, it is appropriate to include in Part 1 of Annex III to Directive 76/768/EEC 24 assessed hair dyes which are not regulated within Directive 76/768/EEC.(7)The substances Hydroxyethyl-2-Nitro-p-Toluidine and HC Red No 10 + HC Red No 11 were provisionally authorised for use in hair dye products until 31 December 2011 under the restrictions and conditions laid down in entries 10 and 50 in Part 2 of Annex III to Directive 76/768/EEC. Based on the final opinions given by the SCCS on their safety, Hydroxyethyl-2-Nitro-p-Toluidine and HC Red No 10 + HC Red No 11 can be considered safe in hair dye products and listed in Part 1 of Annex III to Directive 76/768/EEC.(8)Following the assessment by the SCCS concerning the substances 1-Naphthol and Resorcinol, listed in Part 1 of Annex III to Directive 76/768/EEC, their maximum authorised concentrations in the finished cosmetic product should be changed.(9)Concerning the substance HC Red No 16, the SCCS stated in its opinion of 14 December 2010 that based on the low margin of safety for the use in both oxidative and non-oxidative hair dye formulations, HC Red No 16 poses a risk to the health of the consumer. Therefore, HC Red No 16 should be listed in Annex II to Directive 76/768/EEC.(10)Directive 76/768/EEC should therefore be amended accordingly.(11)The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,HAS ADOPTED THIS DIRECTIVE:
Article 1Annexes II and III to Directive 76/768/EEC are amended in accordance with the Annex to this Directive.
Article 21.Member States shall adopt and publish, by 1 March 2013 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 those provisions from 1 September 2013.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.
Done at Brussels, 2 August 2012.For the CommissionThe PresidentJosé Manuel BarrosoANNEXDirective 76/768/EEC is amended as follows:(1)in Annex II, the following entry is added:
Ref. NoChemical nameCAS No / EC No
"1373N-(2-Nitro-4-aminophenyl)-allylamine (HC Red No 16) and its saltsCAS No 160219-76-1"
(2)Annex III is amended as follows:(a)Part 1 is amended as follows:(i)the following entries are added:
Ref. NoSubstanceRestrictionsConditions of use and warnings which must be printed on the label
Field of application and/or useMax. authorised concentration in the finished cosmetic productOther limitations and requirements
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"2532,2′-[(4-Aminophenyl))imino]bis(ethanol) sulphateN,N-bis(2-Hydroxyethyl)-p-Phenylenediamine SulfateCAS No 54381-16-7EC No 259-134-5Hair dye substance in oxidative hair dye productsAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 % (calculated as sulphate)Do not use with nitrosating agentsMaximum nitrosamine content: 50 μg/kgKeep in nitrite-free containersAs mentioned in reference number 205, column f (a)
2541,3-Benzenediol, 4-chloro-4-ChlororesorcinolCAS No 95-88-5EC No 202-462-0Hair dye substance in oxidative hair dye productsAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 %As mentioned in reference number 205, column f (a)
2552,4,5,6-Tetraaminopyrimidine sulphateTetraaminopyrimidine SulfateCAS No 5392-28-9EC No 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)As mentioned in reference number 205, column f (a)
(b)Hair dye substance in non-oxidative hair dye products(b)3,4 % (calculated as sulphate)
2563-(2-Hydroxyethyl)-p-phenylenediammonium sulphateHydroxyethyl-p-Phenylenediamine SulfateCAS No 93841-25-9EC No 298-995-1Hair dye substance in oxidative hair dye productsAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (calculated as sulphate)As mentioned in reference number 205, column f (a)
2571H-Indole-5,6-diolDihydroxyindoleCAS No 3131-52-0EC No 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)As mentioned in reference number 205, column f (a)
(b)Hair dye substance in non-oxidative hair dye products(b)0,5 %(b)As mentioned in reference number 208, column f
2585-Amino-4-chloro-2-methylphenol hydrochloride5-Amino-4-Chloro-o-Cresol HClCAS No 110102-85-7Hair dye substance in oxidative hair dye productsAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % (calculated as hydrochloride)As mentioned in reference number 205, column f (a)
2591H-Indol-6-ol6-HydroxyindoleCAS No 2380-86-1EC No 417-020-4Hair dye substance in oxidative hair dye productsAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 %As mentioned in reference number 205, column f (a)
2601H-Indole-2,3-DioneIsatinCAS No 91-56-5EC No 202-077-8Hair dye substance in non-oxidative hair dye products1,6 %As mentioned in reference number 208, column f
2612-Aminopyridin-3-ol2-Amino-3-HydroxypyridineCAS No 16867-03-1EC No 240-886-8Hair dye substance in oxidative hair dye productsAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %As mentioned in reference number 205, column f (a)
2622-Methyl-1-naphthyl acetate1-Acetoxy-2-MethylnaphthaleneCAS No 5697-02-9EC No 454-690-7Hair dye substance in oxidative hair dye productsAfter 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 %.)As mentioned in reference number 205, column f (a)
2631-Hydroxy-2-methylnaphthalene2-Methyl-1-NaphtholCAS No 7469-77-4EC No 231-265-2Hair dye substance in oxidative hair dye productsAfter 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 %.)As mentioned in reference number 205, column f (a)
264Disodium 5,7-dinitro-8-oxido-2-naphthalenesulfonateAcid Yellow 1CAS No 846-70-8EC No 212-690-2CI 10316(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)As mentioned in reference number 205, column f (a)
(b)Hair dye substance in non-oxidative hair dye products(b)0,2 %(b)As mentioned in reference number 208, column f
2654-Nitro-1,2-phenylenediamine4-Nitro-o-PhenylenediamineCAS No 99-56-9EC No 202-766-3Hair dye substance in oxidative hair dye productsAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 %As mentioned in reference number 205, column f (a)
2662-(4-Amino-3-nitroanilino)ethanolHC Red No 7CAS No 24905-87-1EC No 246-521-9Hair dye substance in non-oxidative hair dye products1,0 %Do not use with nitrosating agentsMaximum nitrosamine content: 50 μg/kgKeep in nitrite-free containersAs mentioned in reference number 208, column f
2672-[bis(2-Hydroxyethyl)amino]-5-nitrophenolHC Yellow No 4CAS No 59820-43-8EC No 428-840-7Hair dye substance in non-oxidative hair dye products1,5 %Do not use with nitrosating agentsMaximum nitrosamine content: 50 μg/kgKeep in nitrite-free containers
2682-[(2-Nitrophenyl)amino]ethanolHC Yellow No 2CAS No 4926-55-0EC No 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 agentsMaximum nitrosamine content: 50 μg/kgKeep in nitrite-free containers(a)As mentioned in reference number 205, column f (a)
(b)Hair dye substance in non-oxidative hair dye products(b)1,0 %
2694-[(2-Nitrophenyl)amino]phenolHC Orange No 1CAS No 54381-08-7EC No 259-132-4Hair dye substance in non-oxidative hair dye products1,0 %
2702-Nitro-N1-phenyl-benzene-1,4-diamineHC Red No 1CAS No 2784-89-6EC No 220-494-3Hair dye substance in non-oxidative hair dye products1,0 %As mentioned in reference number 208, column f
2711-Methoxy-3-(β-aminoethyl)amino-4-nitrobenzene, hydrochlorideHC Yellow No 9CAS No 86419-69-4EC No 415-480-1Hair dye substance in non-oxidative hair dye products0,5 % (calculated as hydrochloride)Do not use with nitrosating agentsMaximum nitrosamine content: 50 μg/kgKeep in nitrite-free containers
2721-(4’-Aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl) aminobenzeneHC Yellow No 7CAS No 104226-21-3EC No 146-420-6Hair dye substance in non-oxidative hair dye products0,25 %
273N-(2-Hydroxyethyl)-2-nitro-4-trifluormethyl-anilineHC Yellow No 13CAS No 10442-83-8EC No 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 agentsMaximum nitrosamine content: 50 μg/kgKeep in nitrite-free containers(a)As mentioned in reference number 205, column f (a)
(b)Hair dye substance in non-oxidative hair dye products(b)2,5 %
274Benzenaminium, 3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-N,N,Ntrimethyl-, chlorideBasic Yellow 57CAS No 68391-31-1EC No 269-943-5Hair dye substance in non-oxidative hair dye products2,0 %
275Ethanol, 2,2′-[[4-[(4-aminophenyl)azo]phenyl]imino]bis-Disperse Black 9CAS No 20721-50-0EC No 243-987-5Hair dye substance in non-oxidative hair dye products0,3 % (of the mixture in the ratio 1:1 of 2,2’-[4-(4-aminophenylazo)phenylimino]diethanol and lignosulfate)
2769,10-Anthracenedione, 1,4-bis[(2,3-dihydroxypropyl)amino]-HC Blue No 14CAS No 99788-75-7EC No 421-470-7Hair dye substance in non-oxidative hair dye products0,3 %Do not use with nitrosating agentsMaximum nitrosamine content: 50 μg/kgKeep in nitrite-free containers
2772-(4-Methyl-2-nitroanilino)ethanolHydroxyethyl-2-Nitro-p-ToluidineCAS No 100418-33-5EC No 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 agentsMaximum nitrosamine content: 50 μg/kgKeep in nitrite-free containers(a)As mentioned in reference number 205, column f (a)
(b)Hair dye substance in non-oxidative hair dye products(b)1,0 %
2781-Amino-2-nitro-4-(2′,3′-dihydroxypropyl)amino-5-chlorobenzene + 1,4-bis-(2′,3′-dihydroxypropyl)amino-2-nitro-5-chlorobenzeneHC Red No 10 + HC Red No 11CAS No 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 agentsMaximum nitrosamine content: 50 μg/kgKeep in nitrite-free containers(a)As mentioned in reference number 205, column f (a)"
(b)Hair dye substance in non-oxidative hair dye products(b)2,0 %
(ii)the entries with reference numbers 16 and 22 are replaced by the following:
Ref. NoSubstanceRestrictionsConditions of use and warnings which must be printed on the label
Field of application and/or useMax. authorized concentration in the finished cosmetic productOther limitations and requirements
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"161-Naphthalenol1-NaphtholCAS No 90-15-3EC No 201-969-4Hair dye substance in oxidative hair dye productsAfter mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 %As mentioned in reference number 205, column f (a)
221,3-benzenediolResorcinolCAS No 108-46-3EC No 203-585-2(a)Hair dye substance in oxidative hair dye products1.general use2.professional use(a)After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,25 %(a)1.Contains resorcinolRinse hair well after application.Do not use to dye eyelashes or eyebrows.Rinse eyes immediately if product comes into contact with them.As mentioned in reference number 205, column f (a).2.For professional use onlyContains resorcinol.Rinse eyes immediately if product comes into contact with them.As mentioned in reference number 205, column f (a)
(b)Hair lotions and shampoos(b)0,5 %(b)Contains resorcinol."
(b)in Part 2 the entries with reference numbers 10 and 50 are deleted.