Avis juridique important

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31986L0431

Seventh Commission Directive 86/431/EEC of 24 June 1986 adapting to technical progress Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances

Official Journal L 247 , 01/09/1986 P. 0001 - 0041 Finnish special edition: Chapter 13 Volume 16 P. 0003  Swedish special edition: Chapter 13 Volume 16 P. 0003

SEVENTH COMMISSION DIRECTIVE of 24 June 1986 adapting to technical progress Council Directive  67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (86/431/EEC)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Economic Community,Having regard 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(1), as last amended by Directive 79/831/EEC(2), and in particular Article 19 thereof,(1)OJ N  196, 16. 8. 1967, p. 1.(2)OJ N  L 259, 15. 10. 1979, p. 10.Whereas Annex I to Directive /548/EEC contains a list of dangerous substances, together with particulars of the classification and labelling procedures in respect of each substance; whereas examination of the list of dangerous substances has shown that this list needs to be adapted in the light of present scientific and technical knowledge or, more precisely, that it is necessary to change the classification and labelling of certain substances, to clarify certain names, to correct certain CAS-numbers (Chemical Abstract Service) and to enter other substances in the list;Whereas Annex II to Directive 67/548/EEC illustrates the symbols and indications of danger; whereas, in view of the advances in knowledge, a certain indication of danger can be better formulated in the German language;Whereas Annexes III and IV to Directive 67/548/EEC define the indications of special risks (R-phrases) and safety advice (S-phrases); whereas certain R- and S-phrases can be better formulated in the Danish language; whereas in view of the advances in knowledge it is necessary to introduce new safety advice;Whereas Annex VI, D, to Directive 67/548/EEC contains a guide to the classification and labelling of dangerous substances and preparations; whereas it is necessary to correct in this Annex some criteria for the choice of phrases indicating the special risks (R phrases) and to define the criteria for the choice of a new safety advice phrase (S phrase);Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for the Elimination of Technical Barriers to Trade in Dangerous Substances and Preparations,HAS ADOPTED THIS DIRECTIVE:Article 1Directive 67/548/EEC is hereby amended as follows:1. Annex I (list of dangerous substances):1. The following Note E is added after Note D in the foreword to Annex I:'Note EFor substances ascribed Note E the risk phrases R 20, R 21, R 22, R 23, R 24, R 25, R 26, R 27 and R 28 and all combinations of these risk phrases shall be preceded by the word "also".Examples:R 23: 'Also toxic by inhalation.'R 27 / R 28: 'Also very toxic in contact with skin and if swallowed.'2. The designation, CAS-number, classification and labelling of the substances of Annex I detailed below are replaced by those listed in Annex I to this Directive.No 016-023-00-4No 016-027-00-6No 048-008-00-3No 601-020-00-8No 602-010-00-6No 602-021-00-6No 603-026-00-6No 603-046-00-5No 603-070-00-6No 608-003-00-4No 609-002-00-1No 612-022-00-3No 612-042-00-23. The substances listed in Annex II to this Directive are added to Annex I.2. Annex II (Symbols and indications of danger):In the German language the term 'Gesundheitsschädlich' next to the symbol 'Xn' of Annex II is replaced by the term 'Mindergiftig (Gesundheitsschädlich)'.3. Annex III (Nature of special risks attaching to dangerous substances):1. In the Danish language the following R-phases replace those listed in Annex III:'R 21 Farlig ved hudkontakt R 24 Giftig ved hudkontakt R 27 Meget giftig ved hudkontakt R 33 Kan ophobes i kroppen efter gentagen brug R 39 Fare for varig skade på helbred R 40 Mulighed for varig skade på helbred R 42 Kan give allergi ved indånding R 43 Kan give allergi ved kontakt med huden'.2. In the Danish language the following combinations of R-phrases replace those listed in Annex III:'R 20 / 21 Farlig ved indånding og ved hudkontakt R 21 / 22 Farlig ved hudkontakt og ved indtagelse R 20 / 21 / 22 Farlig ved indånding, ved hudkontakt og ved indtagelse R 23 / 24 Giftig ved indånding og ved hudkontakt R 24 / 25 Giftig ved hudkontakt og ved indtagelse R 23 / 24 / 25 Giftig ved indånding, ved hudkontakt og ved indtagelse R 26 / 27 Meget giftig ved indånding og ved hudkontakt R 27 / 28 Meget giftig ved hudkontakt og ved indtagelse R 26 / 27 / 28 Meget giftig ved indånding, ved hudkontakt og ved indtagelse R 42 / 43 Kan give allergi ved indånding og ved kontakt med huden.'4. Annex IV (Safety advice concerning dangerous chemical substances):1. The following phrase is added to Annex IV:'S 53:ES: Evitese la exposición - recábense instrucciones especiales antes del usoDA: Undgå enhver kontakt - indhent særlige anvisninger før brugDE: Exposition vermeiden - vor Gebrauch besondere Anweisungen einholenGR: Áðïöåýãåôå ôçí Ýêèåóç - åöïäéáóôåßôå ìå åéäéêÝò ïäçãßåò ðñéí ôçí ÷ñçóéìïðïßçóçEN: Avoid exposure - obtain special instruction before useFR: Éviter l'exposition - se procurer des instructions spéciales avant l'utilisationIT: Evitare l'esposizione - procurarsi speciali istruzioni prima dell'usoNL: Blootstelling vermijden - vóór gebruik speciale aanwijzingen raadplegenPT: Evitar a exposição - obter instruções especiais antes da utilização'.2. In the Danish language the following S-phrases replace those listed in Annex IV:'S 26 Kommer stoffet i øjnene, skylles straks grundigt med vand og læge kontaktes S 28 Kommer stof på huden vaskes straks med store mængder...(angives af producenten eller importøren) S 30 Hæld aldrig vand på eller i produktet S 36 Brug særligt arbejdstøj S 37 Brug egnede beskyttelseshandsker under arbejdet S 38 Brug egnet åndedrætsværn, his effektiv ventilation ikke er mulig S 39 Brug beskyttelsesbriller/ansigtsskærm under arbejdet S 41 Undgå at indånde røgen ved brand eller eksplosion S 43 Brug...ved brandslukning (Den nøjagtige type brandslukningsudstyr angives af producenten eller importøren. Såfremt vand ikke må bruges tilføjes:'Brug ikke vand')S 45 Ved ulykkestilfælde eller ved ildebefindende er omgående lægebehandling nødvendig; vis etiketten, hvis det er muligt'.3. In the Danish language the following combinations of S-phrases replace those listed in Annex IV: 'S 20 / 21 Der må ikke spises, drikkes eller ryges under brugen S 36 / 37 Brug særligt arbejdstøj og egnede beskyttelses-handsker S 36 / 39 Brug særligt arbejdstøj og egnede beskyttelses-briller/ensigtsskærm  S 37 / 39 Brug egnede beskyttelseshandsker og -briller/ansigtsskærm under arbejdet S 36 / 37 / 39 Brug særligt arbejdstøj, egnede beskyttelses-handsker og -briller/ansigtsskærm'.5. Annex VI, D (Guide to the classification and labelling of dangerous substances and preparations): 1. In chapter 2.4.10 (irritant), second indent (criteria for use of R 36 Irritating to eyes) the last seven words of the final sentence 'the value should be equal to three' are replaced by the words 'the value should be 2,5 or more'.2. The following general criteria for the choice of safety advice phrase S 53 are added after the general criteria for S 52 at the end of chapter 4: 'S 53: Avoid exposure - obtain special instructions before use- Applicability- Carci genic, mutagenic and/or teratogenic substances and preparations- Criteria for use- Obligatory for substances and preparations mentioned above to which R 45, R 46 and/or R 47 have been ascribed'.Article 2Member States shall adopt and publish before 1 july 1987 the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.They shall apply these provisions by 31 December 1987.Article 3This Directive is addressed to the Member States.Done at Brussels, 24 June 1986.For the CommissionStanley CLINTON DAVISMember of the CommissionANEXO I - BILAG I - ANHANG I - ÐÁÑÁÑÔÇÌÁ É - ANNEX I - ANNEXE I - ALLEGATO I - BIJLAGE I - ANEXO I>START OF GRAPHIC>ES: sulfato de dimetiloDA: dimethylsulfatDE: DimethylsulfatEL: Èåééêüò äéìåèõëåóôÝñáòEN: dimethyl sulphateFR: sulfate de diméthyleIT: dimetilsolfatoNL: dimethylsulfaatPT: sulfato de dimetilo>END OF GRAPHIC>>START OF GRAPHIC>ES: sulfato de dietiloDA: diethylsulfatDE: DiethylsulfatEL: Èåééêüò äéáéèõëåóôÝñáòEN: diethyl sulphateFR: sulfate de diéthyleIT: dietilsolfatoNL: diëthylsulfaatPT: sulfato de dietilo>END OF GRAPHIC>>START OF GRAPHIC>ES: cloruro de cadmioDA: cadmiumchloridDE: CadmiumchloridEL: ×ëùñéïý÷ï êÜäìéïEN: cadmium chlorideFR: chlorure de cadmiumIT: cadmio cloruroNL: cadmiumchloridePT: cloreto de cádmio>END OF GRAPHIC>>START OF GRAPHIC>ES: bencenoDA: benzenDE: BenzolEL: ÂåíæüëéïEN: benzeneFR: benzèneIT: benzeneNL: benzeenPT: benzeno>END OF GRAPHIC>>START OF GRAPHIC>ES: 1,2-dibromoetano; dibromuro de etilenoDA: 1,2-dibromethan; ethylendibromidDE: 1,2-Dibromethan; EthylendibromidEL: 1,2-äéâñùìïáéèÜíéï áéèõëåíïäéâñùìßäéïEN: 1,2-dibromoethane; ethylene dibromideFR: 1,2-dibromoéthane; dibromure d'éthylèneIT: 1,2-dibromoetano; etilene dibromuroNL: 1,2-dibroomethaan; ethyleendibromidePT: 1,2-dibromoetano; dibrometo de etileno>END OF GRAPHIC>>START OF GRAPHIC>ES: 1,2-dibromo-3-cloropropanoDA: 1,2-dibrom-3-chlorpropanDE: 1,2-Dibrom-3-chlorpropanEL: 1,2-äéâñùìï-3-÷ëùñïðñïðÜíéïEN: 1,2-dibromo-3-chloropropaneFR: 1,2-dibromo-3-chloropropaneIT: 1,2-dibromo-3-chloropropanoNL: 1,2-dibroom-3-chloorpropaanPT: 1,2-dibromo-3-chloropropano>END OF GRAPHIC>>START OF GRAPHIC>ES: 1-cloro-2,3-epoxipropano; epiclorohidrinaDA: 1-chlor-2,3-epoxypropan; epichlorhydrinDE: 1-Chlor-2,3-epoxypropan; EpichlorhydrinEL: 1-÷ëùñï-2,3-åðïîõðñïðÜíéï* åðé÷ëùñõäñßíçEN: 1-chloro-2,3-epoxypropane; epichlorohydrinFR: 1-chloro-2,3-époxypropane; épichlorhydrineIT: 1-cloro-2,3-epossipropano; epicloridrinaNL: 1-chloor-2,3-epoxypropaan; epichloorhydrinePT: 1-cloro-2,3-epoxipropano; epicloridrina>END OF GRAPHIC>>START OF GRAPHIC>ES: eter diclorometílico; eter bisclorometílicoDA: bis(chlormethyl)ether; dichlordimethyletherDE: Bis(chlormethyl)etherEL: Äéó(÷ëùñïìåèõë)áéèÝñáòEN: bis (chloromethyl) etherFR: oxyde de bis(chlorométhyle); éther bis (chlorométhylique)IT: ossido di bis (clorometile); bis (clorometil) etereNL: bis(chloormethyl)ether; dichloordimethyletherPT: éter bis(clorometilico); óxido de bis (clorometilo)>END OF GRAPHIC>>START OF GRAPHIC>ES: 2-amino-2-metil-1-propanolDA: 2-amino-2-methylpropanolDE: 2-Amino-2-methylpropanolEL: 2-áìéíï-2-ìåèõëïðñïðáíüëçEN: 2-amino-2-methylpropanolFR: 2-amino-2-méthylpropanolIT: 2-amino-2-metilpropanoloNL: 2-amino-2-methylpropanolPT: 2-amino-2-metilpropanol>END OF GRAPHIC>>START OF GRAPHIC>ES: acrilonitriloDA: acrylonitrilDE: AcrylnitrilEL: ÁêñõëïíéôñßëéïEN: acrylonitrileFR: acrylonitrileIT: acrilonitrileNL: acrylnitrilPT: acrilonitrilo>END OF GRAPHIC>>START OF GRAPHIC>ES: 2-nitropropanoDA: 2-nitropropanDE: 2-NitropropanEL: 2-íéôñïðñïðÜíéïEN: 2-nitropropaneFR: 2-nitropropaneIT: 2-nitropropanoNL: 2-nitropropaanPT: 2-nitropropano>END OF GRAPHIC>>START OF GRAPHIC>ES: 2-naftilaminaDA: 2-naphthylaminDE: 2-NaphthylaminEL: 2-íáöèõëáìßíçEN: 2-naphthylamineFR: 2-naphtylamineIT: 2-naftilaminaNL: 2-naftylaminePT: 2-naftilamina>END OF GRAPHIC>>START OF GRAPHIC>ES: bencidina; 4,4'-diaminobifeniloDA: benzidin; 4,4'-diaminobiphenylDE: Benzidin; 4,4'-DiaminobiphenylEL: Âåíæéäßíç* 4,4¢-äéáìéíïäéöáéíýëéïEN: benzidine; 4,4'-diaminobiphenyl; biphenyl-4,4'-ylenediamineFR: benzidine; 4,4'-diaminobiphényleIT: benzidina; 4,4'-diaminobifenileNL: benzidine; 4,4'-diaminobifenylPT: benzidina; 4,4'-diaminobifenilo>END OF GRAPHIC>ANEXO II - BILAG II - ANHANG II - ÐÁÑÁÑÔÇÌÁ II - ANNEX II - ANNEXE II - ALLEGATO II - BIJLAGE II - ANEXO II >START OF GRAPHIC> ES: trialquilboranosDA: trialkylboranerDE: TrialkylboraneEL: ÔñéáëêõëïâïñÜíéáEN: trialkylboranesFR: trialkylboranesIT: trialchilboraniNL: trialkylboranenPT: trialquilboranos>END OF GRAPHIC>>START OF GRAPHIC>ES: borato de trimetiloDA: trimethylboratDE: TrimethylboratEL: âïñéêüò ôñéìåèõëåóôÝñáòEN: trimethyl borateFR: borate de triméthyleIT: trimetil boratoNL: trimethylboraatPT: borato de trimetilo>END OF GRAPHIC>>START OF GRAPHIC>ES: carbonato de sodioDA: natriumcarbonatDE: NatriumcarbonatEL: áíèñáêéêü íÜôñéïEN: sodium carbonateFR: carbonate de sodiumIT: sodio carbonatoNL: natriumcarbonaatPT: carbonato de sódio>END OF GRAPHIC>>START OF GRAPHIC>ES: cloruro de calcioDA: calciumchloridDE: CalciumchloridEL: ÷ëùñéïý÷ï áóâÝóôéïEN: calcium chlorideFR: chlorure de calciumIT: calcio cloruroNL: calciumchloridePT: cloreto de cálcio>END OF GRAPHIC>>START OF GRAPHIC>ES: cloruro de amonioDA: ammoniumchloridDE: AmmoniumchloridEL: ÷ëùñéïý÷ï áììþíéïEN: ammonium chlorideFR: chlorure d'ammoniumIT: ammonio cloruroNL: ammoniumchloridePT: cloreto de amónio>END OF GRAPHIC>>START OF GRAPHIC>Nota EES: cromatos de cinc, incluido el cromato de cinc y de potasioDA: zinkchromater, herunder zinkkaliumchromatDE: Zinkchromate einschließlich ZinkkaliumchromatEL: ÷ñùìéêÜ øåõäáñãýñïõ, ðåñéëáìâáíïìÝíïõ ôïõ ÷ñùìéêïý ôïõ øåõäáñãýñïõ êáé êáëßïõEN: zinc chromates including zinc potassium chromateFR: chromates de zinc y compris le chromate de zinc et potassiumIT: zinco cromati, compresi il cromato di zinco e potassioNL: zinkchromaat met inbegrip van zinkkaliumchromaatPT: cromatos de zinco, incluindo o cromato de zinco e potássio>END OF GRAPHIC>>START OF GRAPHIC>ES: cromato de calcioDA: calciumchromatDE: CalciumchromatEL: ÷ñùìéêü áóâÝóôéïEN: calcium chromateFR: chromate de calciumIT: calcio cromatoNL: calciumchromaatPT: cromato de cálcio>END OF GRAPHIC>>START OF GRAPHIC>ES: cromato de estroncioDA: strontiumchromatDE: StrontiumchromatEL: ÷ñùìéêü óôñüíôéïEN: strontium chromateFR: chromate de strontiumIT: stronzio cromatoNL: strontiumchromaatPT: cromato de estrôncio>END OF GRAPHIC>>START OF GRAPHIC>ES: cloruro de cobre (I)DA: kobber (I) chlorid; cuprochloridDE: Kupfer (I)-chloridEL: ÷ëùñéïý÷ïò ÷áëêüò (I)EN: copper (I) chloride; copper chlorideFR: chlorure de cuivre (I); chlorure cuivreuxIT: cloruro di rame (I); cloruro rameosoNL: koper(I)chloride; cuprochloridePT: cloreto de cobre (I)>END OF GRAPHIC>>START OF GRAPHIC>ES: óxido de cobre (I); óxido cuprosoDA: dikobberoxid; kobber (I) oxid; cuprooxidDE: Dikupferoxid; Kupfer (I)-oxidEL: ïîåßäéï ôïõ ÷áëêïý (I)EN: dicopper oxide; copper (I) oxideFR: oxyde de cuivre (I); oxyde cuivreuxIT: ossido di rame (I); ossido rameosoNL: dikoperoxide; koper(I)oxidePT: óxido de cobre (I); óxido cuproso>END OF GRAPHIC>>START OF GRAPHIC>ES: naftenato de cobreDA: kobbernaphthenatDE: KupfernaphthenatEL: íáöèåíéêüò ÷áëêüòEN: copper naphthenateFR: naphténate de cuivreIT: rame naftenatoNL: kopernaftenaatPT: naftenato de cobre>END OF GRAPHIC>>START OF GRAPHIC>ES: éter clorometil-metiloDA: chlormethylmethylether; chlordimethyletherDE: Chlormethyl-methylether; ChlordimethyletherEL: ÷ëùñïìåèõëï-ìåèõëéêüò áéèÝñáò* ÷ëùñïäéìåèõëéêüò áéèÝñáòEN: chlormethyl methyl ether; chlorodimethyl etherFR: oxyde de chlorométhyle et de méthyle; éther chlorodiméthyliqueIT: clorometil (metil) ossido; clorometil (metil) etereNL: chloormethyl-methylether; chloordimethyletherPT: éter clorodimetilico; óxido de clorometilo e de metilo>END OF GRAPHIC>>START OF GRAPHIC>ES: but-2-ino-1,4-diol; 2-butino-1,4-diolDA: but-2-yn-1,4-diol; 2-butyn-1,4-diolDE: But-2-in-1,4-diol; 2-Butin-1,4-diolEL: 2-âïõôéíï-1,4-äéüëçEN: but-2-yne-1,4-diol; 2-butyne-1,4-diolFR: but-2-yne-1,4-diol; 2-butyne-1,4-diolIT: but-2-in-1,4-diolo; 2-butin-1,4-dioloNL: but-2-yn-1,4-diol; 2-butyn-1,4-diolPT: but-2-ino-1,4-diol; 2-butino-1,4-diol>END OF GRAPHIC>>START OF GRAPHIC>ES: 1-dimetilaminopropan-2-ol; dimepranol (DCI)DA: 1-dimethylaminopropan-2-ol; dimepranol (INN)DE: 1-Dimethylaminopropan-2-ol; Dimepranol (INN)EL: 1-äéìåèõëáìéíïðñïðáíüëç-2* äéìåðñáíüëç (INN)EN: 1-dimethylaminopropan-2-ol; dimepranol (INN)FR: 1-diméthylaminopropane-2-ol; 1-diméthylamino-2-propanol; dimépranol (DCI)IT: 1-dimetilaminopropan-2-olo; dimepranol (DCI)NL: 1-dimethylaminopropan-2-ol; dimepranol (INN)PT: 1-dimetilaminopropano-2-ol; dimepranol (DCI)>END OF GRAPHIC>>START OF GRAPHIC>ES: prop-2-ino-1-ol; 2-propino-1-ol; alcohol propargílicoDA: prop-2-yn-1-ol; propargylalkoholDE: Prop-2-in-1-ol; PropargylalkoholEL: 2-ðñïðéí-1-üëç* ðñïðáñãõëéêÞ áëêïüëçEN: prop-2-yn-1-ol; propargyl alcoholFR: prop-2-yne-1-ol; 2-propyne-1-ol; alcool propargyliqueIT: prop-2-in-1-olo; alcole propargilicoNL: prop-2-yn-1-ol; propargylalcoholPT: prop-2-ino-1-ol; álcool propargílico>END OF GRAPHIC>>START OF GRAPHIC>ES: 2,2'-metiliminodietanol; N-metildietanolaminaDA: 2,2'-methyliminodiethanol; N-methyldiethanolaminDE: 2,2'-Methyliminodiethanol; N-MethyldiethanolaminEL: 2,2'-ìåèõëéìéíïäéáéèáíüëç* Í-ìåèõëïäéáéèáíïëáìßíçEN: 2,2'-(methylimino)diethanol; N-methyldiethanolamineFR: 2,2'-méthyliminodiéthanol; N-méthyldiéthanolamineIT: 2,2'-metiliminodietanolo; N-metildietanolaminaNL: 2,2'-methyliminodiëthanol; N-methyldiëthanolaminePT: 2,2'-metiliminodietanol; N-metildietanolamina>END OF GRAPHIC>>START OF GRAPHIC>ES: 2-metilaminoetanol; N-metil-2-etanolaminaDA: 2-methylaminoethanol; N-methyl-2-aminoethanol; N-methyl-2-ethanolaminDE: 2-Methylamino-ethanol; N-MethylethanolaminEL: 2-ìåèõëáìéíïáéèáíüëç* Í-ìåèõëáéèáíïëáìßíçEN: 2-methylaminoethanol; N-methyl-2-ethanolamine; N-methyl-2-amino ethanolFR: 2-méthylaminoéthanol; N-méthyléthanolamineIT: 2-metilaminoetanolo; N-metiletanolaminaNL: 2-methylaminoëthanol; N-methyl-2-aminoëthanol; N-methyl-2-ethanolaminePT: 2-metilaminoetanol; N-metiletanolamina>END OF GRAPHIC>>START OF GRAPHIC>ES: 2,2'-tiodietanol; tiodiglicolDA: 2,2'-thiodiethanol; thiodiglycolDE: 2,2'-Thiodiethanol; ThiodiglykolEL: 2,2'-èåéïäéáéèáíüëç* èåéïäéãëõêüëçEN: 2,2'-thiodiethanol; thiodiglycolFR: 2,2'-thiodiéthanol; thiodiglycolIT: tiodiglicol; 2,2'-tiodietanoloNL: 2,2'-thiodiëthanol; thiodiglycolPT: 2,2'-tiodietanol; tiodiglicol>END OF GRAPHIC>>START OF GRAPHIC>ES: 1-aminopropan-2-ol; isopropanolaminaDA: 1-aminopropan-2-ol; isopropanolaminDE: 1-Aminopropan-2-ol; IsopropanolaminEL: 1-áìéíï-ðñïðáíüëç-2* éóïðñïðáíïëáìßíçEN: 1-aminopropan-2-ol; isopropanolamineFR: 1-amino-2-propanol; isopropanolamineIT: 1-aminopropan-2-olo; isopropanolaminaNL: 1-aminopropan-2-ol; isopropanolaminePT: 1-amino-2-propanol; isopropanolamina>END OF GRAPHIC>>START OF GRAPHIC>ES: 1,1'-iminodipropan-2-ol; diisopropanolaminaDA: 1,1'-iminodipropan-2-ol; diisopropanolaminDE: 1,1'-Iminodipropan-2-ol; DiisopropanolaminEL: 1,1'-éìéíïäé-ðñïðáíüëç-2* äé-éóïðñïðõëáìßíçEN: 1,1'-iminodipropan-2-ol; di-isopropanolamineFR: 1,1'-iminodi-2-propanol; diisopropanolamineIT: 1,1'-iminodi-2-propanolo; diisopropanolaminaNL: 1,1'-iminodipropan-2-ol; diisopropanolaminePT: 1,1'-iminodipropano-2-ol; diisopropanolamina>END OF GRAPHIC>>START OF GRAPHIC>ES: 1,2-dihidroxibenceno; pirocatecolDA: dihydroxybenzen; pyrocatecholDE: 1,2-Dihydroxybenzol; BrenzcatechinEL: ðõñïêáôå÷üëçEN: 1,2-dihydroxybenzene; pyrocatecholFR: 1,2-dihydroxybenzène; pyrocatécholIT: 1,2-diidrossibenzene; pirocatecoloNL: 1,2-dihydroxybenzeen; pyrocatecholPT: 1,2-diidroxibenzeno; pirocatecol>END OF GRAPHIC>>START OF GRAPHIC>ES: ácido butíricoDA: butansyre, smørsyreDE: ButtersäureEL: âïõôõñéêü ïîýEN: butyric acidFR: acide butyriqueIT: acido butirricoNL: boterzuurPT: ácido butírico>END OF GRAPHIC>>START OF GRAPHIC>ES: cloruro de butiriloDA: butyroylchloridDE: ButyrylchloridEL: âïõôõñï÷ëùñßäéïEN: butyryl chlorideFR: chlorure de butyryleIT: butirrile cloruroNL: butyrylchloridePT: cloreto de butirilo>END OF GRAPHIC>>START OF GRAPHIC>ES: acetoacetato de metiloDA: methylacetoacetat; aceteddikesyremethylesterDE: Methylacetoacetat; AcetessigsäuremethylesterEL: áêåôïîåéêüò ìåèõëåóôÝñáòEN: methyl acetoacetateFR: acétoacétate de méthyleIT: metile acetoacetatoNL: methylacetoacetaatPT: acetoacetato de metilo>END OF GRAPHIC>>START OF GRAPHIC>ES: cloroformiato de butilo; ester butílico del ácido clorofórmicoDA: butylchlorformiat; chlormyresyrebutylesterDE: Butylchlorformiat; ChlorameisensäurebutylesterEL: ÷ëùñïìõñìçêéêüò âïõôõëåóôÝñáòEN: butyl chloroformate; chloroformic acid butyl esterFR: chloroformiate de butyle; chloroformiate de n-butyleIT: butile cloroformiatoNL: n-butylchloorformiaatPT: cloroformato de butilo; cloroformato de n-butilo>END OF GRAPHIC>>START OF GRAPHIC>ES: ácido 2-cloropropiónicoDA: 2-chlorpropionsyreDE: 2-ChlorpropionsäureEL: 2-÷ëùñïðñïðéïíéêü ïîýEN: 2-chloropropionic acidFR: acide 2-chloropropioniqueIT: acido 2-cloropropionicoNL: 2-chloorpropionzuurPT: ácido 2-cloropropiónico>END OF GRAPHIC>>START OF GRAPHIC>ES: cloruro de isobutiriloDA: isobutyroylchloridDE: IsobutyrylchloridEL: éóïâïõôõñõëï÷ëùñßäéïEN: isobutyryl chlorideFR: chlorure d'isobutyryleIT: isobutirile cloruroNL: isobutyrylchloridePT: cloreto de isobutirilo>END OF GRAPHIC>>START OF GRAPHIC>ES: bis (cloroformiato) de oxidietilenoDA: oxydiethylenbis(chlorformiat)DE: Oxydiethylenbis(chlorformiat)EL: äéó(÷ëùñïìõñìçêéêü) ïîõäéáéèõëÝíéïEN: oxydiethylene bis(chloroformate)FR: bis(chloroformiate) d'oxydiéthylène; bis(chloroformiate) de diéthylène-glycolIT: ossidietilen bis (cloroformiato)NL: oxydiëthyleenbis(chloorformiaat)PT: bis(cloroformato) de oxidietileno; bis(cloroformato) de dietílenoglicol>END OF GRAPHIC>>START OF GRAPHIC>ES: cloroformiato de n-propiloDA: n-propylchlorformiat; chlormyresyrepropylesterDE: n-Propylchlorformiat; ChlorameisensäurepropylesterEL: ÷ëùñïìõñìçêéêüò ðñïðõëåóôÝñáòEN: propyl chloroformate; chloroformic acid propylester; n-propyl chloroformateFR: chloroformiate de propyle; chloroformiate de n-propyleIT: n-propil cloroformiatoNL: n-propylchloorformiaatPT: cloroformato de propilo; cloroformato de n-propílo>END OF GRAPHIC>>START OF GRAPHIC>ES: ácido valéricoDA: pentansyre; valerianesyreDE: ValeriansäureEL: âáëåñéáíéêü ïîýEN: valeric acidFR: acide valériqueIT: acido valerianicoNL: valeriaanzuurPT: ácido valérico>END OF GRAPHIC>>START OF GRAPHIC>ES: ácido adípicoDA: adipinsyreDE: AdipinsäureEL: áäéðéêü ïîýEN: adipic acidFR: acide adipiqueIT: acido adipicoNL: adipinezuurPT: ácido adípico>END OF GRAPHIC>>START OF GRAPHIC>ES: ácido metanosulfónicoDA: methansulfonsyreDE: MethansulfonsäureEL: ìåèáíïóïõëöïíéêü ïîýEN: methanesulphonic acidFR: acide méthanesulfoniqueIT: acido metansolfonicoNL: methaansulfonzuurPT: ácido metanossulfónico>END OF GRAPHIC>>START OF GRAPHIC>ES: ácido fumáricoDA: fumarsyreDE: FumarsäureEL: öïõìáñéêü ïîýEN: fumaric acidFR: acide fumariqueIT: acido fumaricoNL: fumaarzuurPT: ácido fumárico>END OF GRAPHIC>>START OF GRAPHIC>ES: oxalato de dietilo; éster dietílico del ácido oxálicoDA: diethyloxalat; ethyloxalatDE: Diethyloxalat; OxalsäurediethylesterEL: ïîáëéêüò äéáéèõëåóôÝñáòEN: oxalic acid diethylester; diethyl oxalateFR: oxalate de diéthyle; oxalate d'éthyleIT: dietile ossalato; etile ossalatoNL: diëthyloxalaatPT: oxalato de dietilo; oxalato de etilo>END OF GRAPHIC>>START OF GRAPHIC>ES: cloruro de guanidinioDA: guanidinhydrochlorid; guanidiniumchloridDE: Guanidiniumchlorid; GuanidinhydrochloridEL: õäñï÷ëùñéêÞ ãïõáíéäßíçEN: guanidinium chloride; guanadine hydrochlorideFR: chlorure de guanidiniumIT: guanidinio cloruroNL: guanidiniumchloridePT: cloreto de guanidinio>END OF GRAPHIC>>START OF GRAPHIC>ES: benzonitriloDA: benzonitrilDE: BenzonitrilEL: âåíæïíéôñßëéïEN: benzonitrileFR: benzonitrileIT: benzonitrileNL: benzonitrilPT: benzonitrilo>END OF GRAPHIC>>START OF GRAPHIC>ES: 2-clorobenzonitriloDA: 2-chlorbenzonitrilDE: 2-ChlorbenzonitrilEL: 2-÷ëùñïâåíæïíéôñßëéïEN: 2-chlorobenzonitrileFR: 2-chlorobenzonitrileIT: 2-clorobenzonitrileNL: 2-chloorbenzonitrilPT: 2-clorobenzonitrilo>END OF GRAPHIC>>START OF GRAPHIC>ES: 5-nitroacenaftenoDA: 5-nitroacenaphthenDE: 5-NitroacenaphthenEL: 5-íéôñïáêåíáöèÝíéïEN: 5-nitroacenaphtheneFR: 5-nitroacénaphtèneIT: 5-nitroacenafteneNL: 5-nitroacenafteenPT: 5-nitroacenafteno>END OF GRAPHIC>>START OF GRAPHIC>ES: 3,3'-diclorobencidinaDA: 3,3'-dichlorbenzidinDE: 3,3'-DichlorbenzidinEL: 3,3'-äé÷ëùñïâåíæéäßíçEN: 3,3'-dichlorobenzidine; 3,3'-dichlorobiphenyl-4,4'-ylenediamineFR: 3,3'-dichlorobenzidineIT: 3,3'-diclorobenzidinaNL: 3,3'-dichloorbenzidinePT: 3,3'-diclorobenzidina>END OF GRAPHIC>>START OF GRAPHIC>ES: sales de 3,3'-diclorobencidinaDA: salte af 3,3'-dichlorbenzidinDE: Salze von 3,3'-DichlorbenzidinEL: Üëáôá ôçò 3,3'-äé÷ëùñïâåíæéäßíçòEN: salts of 3,3'-dichlorobenzidine; salts of 3,3'-dichlorobiphenyl-4,4'-ylenediamineFR: sels de 3,3'-dichlorobenzidineIT: 3,3'-diclorobenzidina saliNL: zouten van 3,3'-dichloorbenzidinePT: sais de 3,3'-diclorobenzidina>END OF GRAPHIC>>START OF GRAPHIC>ES: sales de bencidinaDA: salte af benzidinDE: Salze von BenzidinEL: Üëáôá ôçò âåíæéäßíçòEN: salts of benzidineFR: sels de benzidineIT: benzidina saliNL: zouten van benzidinePT: sais de benzidina>END OF GRAPHIC>>START OF GRAPHIC>ES: sales de 2-naftilaminaDA: salte af 2-naphthylaminDE: Salze von 2-NaphthylaminEL: Üëáôá ôçò 2-íáöèõëáìßíçòEN: salts of 2-naphthylamineFR: sels de 2-naphtylamineIT: 2-naftilamina saliNL: zouten van 2-naftylaminePT: sais de 2-naftilamina>END OF GRAPHIC>>START OF GRAPHIC>ES: 4-aminobifeniloDA: 4-aminobiphenylDE: 4-AminobiphenylEL: 4-áìéíïäéöáéíýëéïEN: biphenyl-4-ylamine; xenylamine; 4-aminobiphenylFR: 4-aminobiphényle; 4-biphénylylamineIT: 4-aminobifenileNL: 4-aminobifenylPT: 4-aminobifenilo; 4-bifenilamina>END OF GRAPHIC>>START OF GRAPHIC>ES: sales de 4-aminobifeniloDA: salte af 4-aminobiphenylDE: Salze von 4-AminobiphenylEL: Üëáôá ôïõ 4-áìéíïäéöáéíõëßïõEN: salts of biphenyl-4-ylamine; salts of xenylamine; salts of 4-aminobiphenylFR: sels de 4-aminobiphényle; sels de 4-biphénylylamineIT: 4-aminobifenile saliNL: zouten van 4-aminobifenylPT: sais de 4-aminobifenilo; sais de 4-bifenilamina>END OF GRAPHIC>>START OF GRAPHIC>ES: bencildimetilaminaDA: benzyldimethylaminDE: BenzyldimethylaminEL: âåíæõëïäéìåèõëáìßíçEN: benzyldimethylamineFR: benzyldiméthylamine; N,N-diméthylbenzylamineIT: benzildimetilaminaNL: benzyldimethylaminePT: benzildimetilamina>END OF GRAPHIC>>START OF GRAPHIC>ES: 2-aminoetildimetilamina; 2-dimetilaminoetilaminaDA: 2-aminoethyldimethylamin; 2-dimethylaminoethylaminDE: 2-Aminoethyldimethylamin; 2-DimethylaminoethylaminEL: 2-áìéíïáéèõëïäéìåèõëáìßíç* 2-äéìåèõëáìéíïáéèõëáìßíçEN: 2-aminoethyldimethylamine; 2-dimethylaminoethylamineFR: 2-aminoëthyldimëthylamine; 2-diméthylaminoëthylamineIT: 2-aminoetildimetilamina; 2-dimetilaminoetilaminaNL: 2-aminoëthyldimethylamine; 2-dimethylaminoëthylaminePT: 2-aminoetildimetilamina; 2-dimetilaminoetilamina>END OF GRAPHIC>>START OF GRAPHIC>ES: etildimetilaminaDA: ethyldimethylaminDE: EthyldimethylaminEL: áéèõëïäéìåèõëáìßíçEN: ethyldimethylamineFR: éthyldiméthylamine; N,N-diméthyléthylamineIT: etildimetilaminaNL: ethyldimethylaminePT: etildimetilamina>END OF GRAPHIC>>START OF GRAPHIC>ES: dimetilnitrosamina; N-nitrosodimetilaminaDA: dimethylnitrosamin; N-nitrosodimethylaminDE: Dimethylnitrosamin; N-NitrosodimethylaminEL: äéìåèõëïíéôñïäïáìßíç* N-íéôñïæïäéìåèõëáìßíçEN: N-nitrosodimethylamine; dimethylnitrosamineFR: diméthylnitrosamine; N-nitrosodiméthylamineIT: dimetilnitrosamina; N-nitrosodimetilaminaNL: dimethylnitrosamine; N-nitrosodimethylaminePT: dimetilnitrosamina; N-nitrosodimetilamina>END OF GRAPHIC>>START OF GRAPHIC>ES: 2,2'-dicloro-4,4'-metilendianilina; 4,4'-metilenbis (2-cloroanilina)DA: 2,2'-dichlor-4,4'-methylendianilin; 4,4'-methylenbis (2-chloranilin)DE: 2,2'-Dichlor-4,4'-methylendianilin; 4,4'-Methylen-bis (2-chloranilin)EL: 2,2'-äé÷ëùñï-4,4'-ìåèõëåíïäéáíéëßíç* 4,4'-ìåèõëåíïäéó(2-÷ëùñïáíéëßíç)EN: 2,2'-dichloro-4,4'-methylenedianiline; 4,4'-methylene bis (2-chloroaniline)FR: 2,2'-dichloro-4,4'-méthylènedianiline; 4,4'-méthylènebis (2-chloroaniline)IT: 2,2'-dicloro-4,4'-metilendianilina; 4,4'-metilenbis (2-cloroanilina)NL: 2,2'-dichloor-4,4'-methyleendianiline; 4,4'-methyleenbis(2-chlooraniline)PT: 2,2'-dicloro-4,4'-metilenodianilina; 4,4'-metileno-bis (2-cloroanilina)>END OF GRAPHIC>>START OF GRAPHIC>ES: sales de 2,2'-dicloro-4,4'-metilendianilina; sales de 4,4'-metilenbis (2-cloroanilina)DA: salte af 2,2'-dichlor-4,4'-methylendianilin; salte af 4,4'-methylenbis (2-chloranilin)DE: Salze von 2,2'-Dichlor-4,4'-methylendianilin; Salze von 4,4'-Methylen-bis (2-chlor-anilin)EL: ¶ëáôá ôçò 2,2'-äé÷ëùñï-4,4'-ìåèõëåíïäéáíéëßíçò* Üëáôá ôçò 4,4'-ìåèõëåíïäéó-(2-÷ëùñïáíéëßíçò)EN: salts of 2,2'-dichloro-4,4'-methylenedianiline; salts of 4,4'-methylenebis (2-chloro-aniline);FR: sels de 2,2'-dichloro-4,4'-méthylènedianiline; sels de 4,4'-méthylènebis (2-chloro-aniline)IT: 2,2'-dicloro-4,4'-metilendianilina sali; 4,4'-metilenbis (2-cloroanilina) saliNL: zouten van 2,2'-dichloor-4,4'-methyleendianiline; zouten van 4,4'-methyleenbis- (2-chlooraniline)PT: sais de 2,2'-dicloro-4,4'-metilenodianilina; sais de 4,4'-metileno-bis (2-cloroanilina)>END OF GRAPHIC>>START OF GRAPHIC>ES: 4-amino-N,N-dietilanilina; N,N-dietil-p-fenilenodiaminaDA: 4-amino-N,N-diethylanilin; N,N-diethyl-4-aminoanilinDE: 4-Amino-N,N-diethylanilin; N,N-Diethyl-p-phenylendiaminEL: 4-áìéíï-N-N'-äéáéèõëáíéëßíç* N,N-äéáéèõëï-ð-öáéíõëåíïäéáìßíçEN: 4-amino-N,N-diethylaniline; N,N-diethyl-p-phenylenediamineFR: 4-amino-N,N-diéthylaniline; N,N-diéthyl-p-phénylènediamineIT: 4-amino-N,N-dietilanilina; N,N-dietil-p-fenilendiaminaNL: 4-amino-N,N-diëthylaniline; N,N-diëthyl-p-fenyleendiaminePT: 4-amino-N,N-dietilanilina; N,N-dietil-p-fenilenodiamina>END OF GRAPHIC>>START OF GRAPHIC>ES: 2-metilaziridina; propileniminaDA: 2-methylaziridin; propyleniminDE: 2-Methylaziridin; PropyleniminEL: 2-ìåèõëáæéñéäßíçEN: 2-methylaziridine; propyleneimineFR: 2-méthylaziridine; propylènimineIT: 2-metilaziridina; propileniminaNL: 2-methylaziridine; propyleeniminePT: 2-metilaziridina; propilenimina>END OF GRAPHIC>>START OF GRAPHIC>ES: 1,2-dimetilimidazolDA: 1,2-dimethylimidazolDE: 1,2-DimethylimidazolEL: 1,2-äéìåèõëéìéäáæüëéïEN: 1,2-dimethylimidazoleFR: 1,2-diméthylimidazoleIT: 1,2-dimetilimidazoloNL: 1,2-dimethylimidazoolPT: 1,2-dimetilimidazole>END OF GRAPHIC>>START OF GRAPHIC>ES: 1-metilimidazolDA: 1-methylimidazolDE: 1-MethylimidazolEL: 1-ìåèõëéìéäáæüëéïEN: 1-methylimidazoleFR: 1-méthylimidazoleIT: 1-metilimidazoloNL: 1-methylimidazoolPT: 1-metilimidazole>END OF GRAPHIC>>START OF GRAPHIC>ES: 2-metilpiridina; 2-picolinaDA: 2-methylpyridin; 2-picolinDE: 2-Methylpyridin; 2-PicolinEL: 2-ìåèõëïðõñéäßíç, 2-ðéêïëßíçEN: 2-methylpyridine; 2-picolineFR: 2-méthylpyridine; 2-picolineIT: 2-metilpiridina; 2-picolinaNL: 2-methylpyridine; 2-picolinePT: 2-metïlpiridina; 2-picolina>END OF GRAPHIC>>START OF GRAPHIC>ES: 4-metilpiridina; 4-picolinaDA: 4-methylpyridin; 4-picolinDE: 4-Methylpyridin; 4-PicolinEL: 4-ìåèõëïðõñéäßíçEN: 4-methylpyridine; 4-picolineFR: 4-méthylpyridine; 4-picolineIT: 4-metilpiridina; 4-picolinaNL: 4-methylpyridine; 4-picolinePT: 4-metilpiridina; 4-picolina>END OF GRAPHIC>>START OF GRAPHIC>ES: 6-fenil-1,3,5-triazina-2,4-diamina; benzoguanaminaDA: 6-phenyl-1,3,5-triazin-2,4-diamin; benzoguanaminDE: 6-Phenyl-1,3,5-triazin-2,4-diamin; BenzoguanaminEL: 6-öáéíõëï-1,3,5-ôñéáæéíï-2,4-äéáìßíç* âåíæïãïõáíáìßíçEN: 6-phenyl-1,3,5-triazine-2,4-diamine; benzoguanamineFR: 6-phényl-1,3,5-triazine-2,4-diamine; benzoguanamineIT: 6-fenil-1,3,5-triazin-2,4-diamina; benzoguanaminaNL: 6-fenyl-1,3,5-triazine-2,4-diamine; benzoguanaminePT: 6-fenil-1,3,5-triazina-2,4-diamina; benzoguanamina>END OF GRAPHIC>>START OF GRAPHIC>ES: cianamida; carbamonitriloDA: cyanamidDE: CyanamidEL: ÊõáíáìßäéïEN: cyanamide; carbamonitrileFR: cyanamideIT: cianamideNL: cyaanamidePT: cianamida>END OF GRAPHIC>>START OF GRAPHIC>ES: butiraldehído-oximaDA: butyraldehydoximDE: ButyraldehydoximEL: âïõôõñáëäåûäïîßìçEN: butyraldehyde oximeFR: butyraldehyde-oximeIT: butirraldeideossimaNL: butyraldehydoximPT: butiraldeído-oxima>END OF GRAPHIC>>START OF GRAPHIC>ES: 2-butanona-oximaDA: 2-butanonoxim; ethylmethylketoximDE: 2-Butanonoxim; EthylmethylketoximEL: 2-âïõôáíïíïîßìç* áéèõëïìåèõëïêåôïîßìçEN: 2-butanone oxime; ethyl methyl ketoxime; ethyl methyl ketone oximeFR: 2-butanone-oxime; éthylméthylcétoximeIT: 2-butanonossima; etilmetilchetossimaNL: 2-butanonoxim; ethylmethylketoximPT: 2-butanona-oxima; etilmetilcetoxima>END OF GRAPHIC>


Avis juridique important

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32002L0095

Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment

Official Journal L 037 , 13/02/2003 P. 0019 - 0023

Directive 2002/95/EC of the European Parliament and of the Councilof 27 January 2003on the restriction of the use of certain hazardous substances in electrical and electronic equipmentTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Having regard to the opinion of the Committee of Regions(3),Acting in accordance with the procedure laid down in Article 251 of the Treaty in the light of the joint text approved by the Conciliation Committee on 8 November 2002(4),Whereas:(1) The disparities between the laws or administrative measures adopted by the Member States as regards the restriction of the use of hazardous substances in electrical and electronic equipment could create barriers to trade and distort competition in the Community and may thereby have a direct impact on the establishment and functioning of the internal market. It therefore appears necessary to approximate the laws of the Member States in this field and to contribute to the protection of human health and the environmentally sound recovery and disposal of waste electrical and electronic equipment.(2) The European Council at its meeting in Nice on 7, 8 and 9 December 2000 endorsed the Council Resolution of 4 December 2000 on the precautionary principle.(3) The Commission Communication of 30 July 1996 on the review of the Community strategy for waste management stresses the need to reduce the content of hazardous substances in waste and points out the potential benefits of Community-wide rules limiting the presence of such substances in products and in production processes.(4) The Council Resolution of 25 January 1988 on a Community action programme to combat environmental pollution by cadmium(5) invites the Commission to pursue without delay the development of specific measures for such a programme. Human health also has to be protected and an overall strategy that in particular restricts the use of cadmium and stimulates research into substitutes should therefore be implemented. The Resolution stresses that the use of cadmium should be limited to cases where suitable and safer alternatives do not exist.(5) The available evidence indicates that measures on the collection, treatment, recycling and disposal of waste electrical and electronic equipment (WEEE) as set out in Directive 2002/96/EC of 27 January 2003 of the European Parliament and of the Council on waste electrical and electronic equipment(6) are necessary to reduce the waste management problems linked to the heavy metals concerned and the flame retardants concerned. In spite of those measures, however, significant parts of WEEE will continue to be found in the current disposal routes. Even if WEEE were collected separately and submitted to recycling processes, its content of mercury, cadmium, lead, chromium VI, PBB and PBDE would be likely to pose risks to health or the environment.(6) Taking into account technical and economic feasibility, the most effective way of ensuring the significant reduction of risks to health and the environment relating to those substances which can achieve the chosen level of protection in the Community is the substitution of those substances in electrical and electronic equipment by safe or safer materials. Restricting the use of these hazardous substances is likely to enhance the possibilities and economic profitability of recycling of WEEE and decrease the negative health impact on workers in recycling plants.(7) The substances covered by this Directive are scientifically well researched and evaluated and have been subject to different measures both at Community and at national level.(8) The measures provided for in this Directive take into account existing international guidelines and recommendations and are based on an assessment of available scientific and technical information. The measures are necessary to achieve the chosen level of protection of human and animal health and the environment, having regard to the risks which the absence of measures would be likely to create in the Community. The measures should be kept under review and, if necessary, adjusted to take account of available technical and scientific information.(9) This Directive should apply without prejudice to Community legislation on safety and health requirements and specific Community waste management legislation, in particular Council Directive 91/157/EEC of 18 March 1991 on batteries and accumulators containing certain dangerous substances(7).(10) The technical development of electrical and electronic equipment without heavy metals, PBDE and PBB should be taken into account. As soon as scientific evidence is available and taking into account the precautionary principle, the prohibition of other hazardous substances and their substitution by more environmentally friendly alternatives which ensure at least the same level of protection of consumers should be examined.(11) Exemptions from the substitution requirement should be permitted if substitution is not possible from the scientific and technical point of view or if the negative environmental or health impacts caused by substitution are likely to outweigh the human and environmental benefits of the substitution. Substitution of the hazardous substances in electrical and electronic equipment should also be carried out in a way so as to be compatible with the health and safety of users of electrical and electronic equipment (EEE).(12) As product reuse, refurbishment and extension of lifetime are beneficial, spare parts need to be available.(13) The adaptation to scientific and technical progress of the exemptions from the requirements concerning phasing out and prohibition of hazardous substances should be effected by the Commission under a committee procedure.(14) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(8),HAVE ADOPTED THIS DIRECTIVE:Article 1ObjectivesThe purpose of this Directive is to approximate the laws of the Member States on the restrictions of the use of hazardous substances in electrical and electronic equipment and to contribute to the protection of human health and the environmentally sound recovery and disposal of waste electrical and electronic equipment.Article 2Scope1. Without prejudice to Article 6, this Directive shall apply to electrical and electronic equipment falling under the categories 1, 2, 3, 4, 5, 6, 7 and 10 set out in Annex IA to Directive No 2002/96/EC (WEEE) and to electric light bulbs, and luminaires in households.2. This Directive shall apply without prejudice to Community legislation on safety and health requirements and specific Community waste management legislation.3. This Directive does not apply to spare parts for the repair, or to the reuse, of electrical and electronic equipment put on the market before 1 July 2006.Article 3DefinitionsFor the purposes of this Directive, the following definitions shall apply:(a) "electrical and electronic equipment" or "EEE" means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields falling under the categories set out in Annex IA to Directive 2002/96/EC (WEEE) and designed for use with a voltage rating not exceeding 1000 volts for alternating current and 1500 volts for direct current;(b) "producer" means any person who, irrespective of the selling technique used, including by means of distance communication according to Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts(9):(i) manufactures and sells electrical and electronic equipment under his own brand;(ii) resells under his own brand equipment produced by other suppliers, a reseller not being regarded as the "producer" if the brand of the producer appears on the equipment, as provided for in subpoint (i); or(iii) imports or exports electrical and electronic equipment on a professional basis into a Member State.Whoever exclusively provides financing under or pursuant to any finance agreement shall not be deemed a "producer" unless he also acts as a producer within the meaning of subpoints (i) to (iii).Article 4Prevention1. Member States shall ensure that, from 1 July 2006, new electrical and electronic equipment put on the market does not contain lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) or polybrominated diphenyl ethers (PBDE). National measures restricting or prohibiting the use of these substances in electrical and electronic equipment which were adopted in line with Community legislation before the adoption of this Directive may be maintained until 1 July 2006.2. Paragraph 1 shall not apply to the applications listed in the Annex.3. On the basis of a proposal from the Commission, the European Parliament and the Council shall decide, as soon as scientific evidence is available, and in accordance with the principles on chemicals policy as laid down in the Sixth Community Environment Action Programme, on the prohibition of other hazardous substances and the substitution thereof by more environment-friendly alternatives which ensure at least the same level of protection for consumers.Article 5Adaptation to scientific and technical progress1. Any amendments which are necessary in order to adapt the Annex to scientific and technical progress for the following purposes shall be adopted in accordance with the procedure referred to in Article 7(2):(a) establishing, as necessary, maximum concentration values up to which the presence of the substances referred to in Article 4(1) in specific materials and components of electrical and electronic equipment shall be tolerated;(b) exempting materials and components of electrical and electronic equipment from Article 4(1) if their elimination or substitution via design changes or materials and components which do not require any of the materials or substances referred to therein is technically or scientifically impracticable, or where the negative environmental, health and/or consumer safety impacts caused by substitution are likely to outweigh the environmental, health and/or consumer safety benefits thereof;(c) carrying out a review of each exemption in the Annex at least every four years or four years after an item is added to the list with the aim of considering deletion of materials and components of electrical and electronic equipment from the Annex if their elimination or substitution via design changes or materials and components which do not require any of the materials or substances referred to in Article 4(1) is technically or scientifically possible, provided that the negative environmental, health and/or consumer safety impacts caused by substitution do not outweigh the possible environmental, health and/or consumer safety benefits thereof.2. Before the Annex is amended pursuant to paragraph 1, the Commission shall inter alia consult producers of electrical and electronic equipment, recyclers, treatment operators, environmental organisations and employee and consumer associations. Comments shall be forwarded to the Committee referred to in Article 7(1). The Commission shall provide an account of the information it receives.Article 6ReviewBefore 13 February 2005, the Commission shall review the measures provided for in this Directive to take into account, as necessary, new scientific evidence.In particular the Commission shall, by that date, present proposals for including in the scope of this Directive equipment which falls under categories 8 and 9 set out in Annex IA to Directive 2002/96/EC (WEEE).The Commission shall also study the need to adapt the list of substances of Article 4(1), on the basis of scientific facts and taking the precautionary principle into account, and present proposals to the European Parliament and Council for such adaptations, if appropriate.Particular attention shall be paid during the review to the impact on the environment and on human health of other hazardous substances and materials used in electrical and electronic equipment. The Commission shall examine the feasibility of replacing such substances and materials and shall present proposals to the European Parliament and to the Council in order to extend the scope of Article 4, as appropriate.Article 7Committee1. The Commission shall be assisted by the Committee set up by Article 18 of Council Directive 75/442/EEC(10).2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to Article 8 thereof.The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months.3. The Committee shall adopt its rules of procedure.Article 8PenaltiesMember States shall determine penalties applicable to breaches of the national provisions adopted pursuant to this Directive. The penalties thus provided for shall be effective, proportionate and dissuasive.Article 9Transposition1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 13 August 2004. They shall immediately inform the Commission thereof.When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.2. Member States shall communicate to the Commission the text of all laws, regulations and administrative provisions adopted in the field covered by this Directive.Article 10Entry into forceThis Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 11AddresseesThis Directive is addressed to the Member States.Done at Brussels, 27 January 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentG. Drys(1) OJ C 365 E, 19.12.2000, p. 195 and OJ C 240 E, 28.8.2001, p. 303.(2) OJ C 116, 20.4.2001, p. 38.(3) OJ C 148, 18.5.2001, p. 1.(4) Opinion of the European Parliament of 15 May 2001 (OJ C 34 E, 7.2.2002, p. 109), Council Common Position of 4 December 2001 (OJ C 90 E, 16.4.2002, p. 12) and Decision of the European Parliament of 10 April 2002 (not yet published in the Official Journal). Decision of the European Parliament of 18 December 2002 and Decision of the Council of 16 December 2002.(5) OJ C 30, 4.2.1988, p. 1.(6) See page 24 of this Official Journal.(7) OJ L 78, 26.3.1991, p. 38. Directive as amended by Commission Directive 98/101/EC (OJ L 1, 5.1.1999, p. 1).(8) OJ L 184, 17.7.1999, p. 23.(9) OJ L 144, 4.6.1997, p. 19. Directive as amended by Directive 2002/65/EC (L 271, 9.10.2002, p. 16).(10) OJ L 194, 25.7.1975, p. 39.ANNEXApplications of lead, mercury, cadmium and hexavalent chromium, which are exempted from the requirements of Article 4(1)1. Mercury in compact fluorescent lamps not exceeding 5 mg per lamp.2. Mercury in straight fluorescent lamps for general purposes not exceeding:>TABLE>.3. Mercury in straight fluorescent lamps for special purposes.4. Mercury in other lamps not specifically mentioned in this Annex.5. Lead in glass of cathode ray tubes, electronic components and fluorescent tubes.6. Lead as an alloying element in steel containing up to 0,35 % lead by weight, aluminium containing up to 0,4 % lead by weight and as a copper alloy containing up to 4 % lead by weight.7. - Lead in high melting temperature type solders (i.e. tin-lead solder alloys containing more than 85 % lead),- lead in solders for servers, storage and storage array systems (exemption granted until 2010),- lead in solders for network infrastructure equipment for switching, signalling, transmission as well as network management for telecommunication,- lead in electronic ceramic parts (e.g. piezoelectronic devices).8. Cadmium plating except for applications banned under Directive 91/338/EEC(1) amending Directive 76/769/EEC(2) relating to restrictions on the marketing and use of certain dangerous substances and preparations.9. Hexavalent chromium as an anti-corrosion of the carbon steel cooling system in absorption refrigerators.10. Within the procedure referred to in Article 7(2), the Commission shall evaluate the applications for:- Deca BDE,- mercury in straight fluorescent lamps for special purposes,- lead in solders for servers, storage and storage array systems, network infrastructure equipment for switching, signalling, transmission as well as network management for telecommunications (with a view to setting a specific time limit for this exemption), and- light bulbs,as a matter of priority in order to establish as soon as possible whether these items are to be amended accordingly.(1) OJ L 186, 12.7.1991, p. 59.(2) OJ L 262, 27.9.1976, p. 201.


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31989L0117

Council Directive 89/117/EEC of 13 February 1989 on the obligations of branches established in a Member State of credit institutions and financial institutions having their head offices outside that Member State regarding the publication of annual accounting documents

Official Journal L 044 , 16/02/1989 P. 0040 - 0042 Finnish special edition: Chapter 6 Volume 2 P. 0200  Swedish special edition: Chapter 6 Volume 2 P. 0200

*****COUNCIL  DIRECTIVE  of 13 February 1989  on the obligations of branches established in a Member State of credit institutions and financial institutions having their head offices outside that Member State regarding the publication of annual accounting documents  (89/117/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 54 thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3)  Whereas the establishment of a European internal market presupposes that the branches of credit institutions and financial institutions having their head offices in other Member States should be treated in the same way as branches of credit institutions and financial institutions having their head offices in the same Member State; whereas this means that, with regard to the publication of annual accounting documents, it is sufficient for the branches of such institutions having their head offices in other Member States to publish the annual accounting documents of their institution as a whole;  Whereas, as part of a further instrument of coordination of the disclosure requirements in respect of branches, provision is made for certain documents and particulars relating to branches established in a Member State which certain types of companies governed by the law of another Member State, including banks and other financial institutions, have to publish; whereas, as regards disclosure of accounting documents, reference is made to specific provisions to be laid down for banks and other financial institutions;  Whereas the present practice of some Member States of requiring the branches of credit institutions and financial institutions having their head offices outside these Member States to publish annual accounts relating to their own activities is no longer justified following the adoption of Council Directive 86/635/EEC of 8 December 1986 on the annual accounts and consolidated accounts of banks and other financial institutions (4); whereas the publication of annual branch accounts cannot in any case provide the public, and in particular creditors, with an adequate view of the financial situation of the undertaking, since part of a whole cannot be viewed in isolation;  Whereas, on the other hand, in view of the present level of integration, the need for certain information on the activities of branches established in a Member State by credit institutions and financial institutions having their head offices outside that Member State cannot be disregarded; whereas, nevertheless, he extent of such information should be limited so as to prevent distortions of competition;  Whereas, however, this Directive affects only disclosure requirements concerning annual accounts, and does not in any way affect the obligations of branches of credit institutions and financial institutions to provide information pursuant to other requirements, deriving, for  example, from social legislation, with regard to employees' rights to information, host countries' rights of supervision over credit institutions or financial institutions and fiscal legislation and also for statistical purposes;  Whereas equality of competition means, with regard to the branches of credit institutions and financial institutions having their head offices in non-member countries, that such branches must, on the one hand, in publishing annual accounting documents, adhere to a standard which is the same as, or equivalent to, that of the Community, but, on the other hand, that such branches should not have to publish annual accounts relating to their own activities if they fulfil the abovementioned condition;  Whereas the equivalence, required under this Directive, of annual accounting documents of credit institutions and financial institutions having their head offices in non-member countries may lead to problems of assessment; whereas it is therefore necessary for this and other problems in the area covered by the Directive, and in particular in its implementation, to be dealt with by representatives of the Member States and of the Commission jointly in a Contact Committee; whereas, in order to keep the number of such committees within limits, such cooperation should be carried out within the framework of the Committee set up under Article 52 of Council Directive 78/660/EEC of 25 July 1978 on the annual accounts of certain types of companies (1), as last amended by Directive 84/569/EEC (2); whereas, however, where problems relating to credit institutions are to be dealt with, the Committee should be appropriately constituted,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Scope  1. The coordination measures prescribed by this Directive shall apply to branches established in a Member State by credit institutions and financial institutions within the meaning of Article 2 (1) (a) and (b) of Directive 86/635/EEC having their head offices outside that Member State. Where a credit institution or financial institution has its head office in a non-member country, this Directive shall apply in so far as the credit institution or financial institution has a legal form which is comparable to the legal forms specified in the abovementioned Article 2 (1) (a) and (b).  2. The third indent of Article 1 of Directive 77/780/EEC (3) shall apply mutatis mutandis to branches of credit institutions and financial institutions covered by this Directive.  Article 2  Provisions relating to branches of credit institutions and financial institutions having their head offices in other Member States  1. Member States shall require branches of credit institutions and financial institutions having their head offices in other Member States to publish, in accordance with Article 44 of Directive 86/635/EEC, the credit institution or financial institution documents referred to therein (annual accounts, consolidated accounts, annual report, consolidated annual report, opinions of the person responsible for auditing the annual accounts and consolidated accounts).  2. Such documents must be drawn up and audited in the manner required by the law of the Member State in which the credit institution or financial institution has its head office in accordance with Directive 86/635/EEC.  3. Branches may not be required to publish annual accounts relating to their own activities.  4. Member States may, pending further coordination, require branches to publish the following additional information:  - the income and costs of the branch deriving from items 1, 3, 4, 6, 7, 8 and 15 of Article 27 or from items A.4, A.9, B.1 to B.4 and B.7 of Article 28 of Directive 86/635/EEC,  - the average number of staff employed by the branch,  - the total claims and liabilities attributable to the branch, broken down into those in respect of credit institutions and those in respect of customers, together with the overall amount of such claims and liabilities expressed in the currency of the Member State in which the branch is established,  - the total assets and the amounts corresponding to items 2, 3, 4, 5 and 6 of the assets, 1, 2 and 3 of the liabilities and 1 and 2 of the off-balance sheet items defined in Article 4 and parallel Articles of Directive 86/635/EEC, and, in the case of items 2, 5 and 6 of the assets, a breakdown of securities according to whether they have or have not been regarded as financial fixed assets pursuant to Article 35 of Directive 86/635/EEC.  Where such information is required, its accuracy and its accordance with the annual accounts must be checked by one or more persons authorized to audit accounts under the law of the Member State in which the branch is established.  Article 3  Provisions relating to branches of credit institutions and financial institutions having their head offices in non-members countries  1. Member States shall require branches of credit institutions and financial institutions having their head offices in non-member countries to publish the documents specified in Article 2 (1), drawn up and audited in the manner required by the law of the country of the head office, in accordance with the provisions set out therein.  2. Where such documents are in conformity with, or equivalent to, documents drawn up in accordance with Directive 86/635/EEC and the condition of reciprocity, for Community credit institutions and financial institutions, is fulfilled in the non-member country in which the head office is situated, Article 2 (3) shall apply.  3. In cases other than those referred to in paragraph 2, Member States may require the branches to publish annual accounts relating to their own activities.  4. In the cases specified in paragraphs 2 and 3, Member States may require branches to publish the information referred to in Article 2 (4) and the amount of the endowment capital.  5. Article 9 (1) and (3) of Directive 77/780/EEC shall apply by analogy to branches of credit institutions and financial institutions covered by this Directive.  Article 4  Language of publication  Member States may require that the documents provided for in this Directive be published in their official national language or languages and that translations thereof be certified.  Article 5  Work of the Contact Committee  The Contact Committee set up pursuant to Article 52 of Directive 78/660/EEC shall, when constituted appropriately, also:  (a) facilitate, without prejudice to Articles 169 and 170 of the Treaty, harmonized application of this Directive through regular meetings dealing, in particular, with practical problems arising in connection with its application, such as assessment of equivalence of documents, and facilitate decisions concerning the comparability and equivalence of the legal forms referred to in Article 1 (1);  (b) advise the Commission, if necessary, on additions or amendments to this Directive.  Final provisions  Article 6  1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1991. They shall forthwith inform the Commission thereof.  2. A Member State may provide that the provisions referred to in paragraph 1 shall apply for the first time to annual accounts for the financial year beginning on 1 January 1993 or during the calendar year 1993.  3. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.  Article 7  Five years after the date referred to in Article 6 (2), the Council, acting on a proposal from the Commission, shall examine and, upon a Commission proposal and in cooperation with the European Parliament, if need be, revise Article 2 (4), in the light of the experience acquired in applying this Directive and of the aim of eliminating the additional information referred to in Article 2 (4), taking account of the progress made in striving towards the harmonization of the accounts of banks and other financial institutions.  Article 8  This Directive is addressed to the Member States.  Done at Brussels, 13 February 1989.  For the Council  The President  C. SOLCHAGA CATALAN  (1) OJ No C 230, 11. 9. 1986, p. 4.  (2) OJ No C 319, 30. 11. 1987, p. 64 and OJ C 290, 14. 11. 1988, p. 66.  (3) OJ No C 345, 21. 12. 1987, p. 73.  (4) OJ No L 372, 31. 12. 1986, p. 1.  (1) OJ No L 222, 14. 8. 1978, p. 11.  (2) OJ No L 314, 4. 12. 1984, p. 28.  (3) OJ No L 322, 17. 12. 1977, p. 30.


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31969L0466

Council Directive 69/466/EEC of 8 December 1969 on control of San José Scale

Official Journal L 323 , 24/12/1969 P. 0005 - 0006 Finnish special edition: Chapter 3 Volume 2 P. 0253  Danish special edition: Series I Chapter 1969(II) P. 0549  Swedish special edition: Chapter 3 Volume 2 P. 0253  English special edition: Series I Chapter 1969(II) P. 0565  Greek special edition: Chapter 03 Volume 5 P. 0023  Spanish special edition: Chapter 03 Volume 3 P. 0174  Portuguese special edition Chapter 03 Volume 3 P. 0174

COUNCIL DIRECTIVE  of 8 December 1969  on control of San José Scale  (69/466/EEC)THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof; Having regard to the proposal from the Commission; Having regard to the Opinion of the European Parliament (1); Having regard to the Opinion of the Economic and Social Committee; Whereas the production of woody dicotyledonous plants and their fruit occupies an important place in Community agriculture; Whereas the yield of that production is constantly threatened by harmful organisms; Whereas, through the protection of such plants against such harmful organisms, not only should productive capacity be maintained but also agricultural productivity increased; Whereas protective measures to prevent the introduction of harmful organisms into invididual Member States would have only a limited effect if such organisms were not controlled simultaneously and methodically throughout the Community and were not prevented from spreading; Whereas one of the organisms most harmful to woody dicotyledonous plants is San José Scale (Quadraspidiotus perniciosus Comst.); Whereas this pest has occurred in several Member States and there are contaminated areas within the Community; Whereas there is a permanent risk to the cultivation of woody dicotyledonous plants throughout the Community if effective measures are not taken to control this pest and prevent it from spreading; Whereas, to eradicate this pest, minimum provisions must be adopted for the Community ; whereas Member States must be able to adopt additional or stricter provisions where necessary; HAS ADOPTED THIS DIRECTIVE:Article 1This Directive concerns the minimum measures to be taken within the Member States to control San José Scale (Quadraspidiotus perniciosus Comst.) and to prevent it from spreading. Article 2For the purposes of this Directive: (a) "plants" means live plants and live parts of plants with the exception of fruit and seeds; (b) "contaminated plants or fruit" means plants or fruit on which one or more San José Scale insects are found, unless it is confirmed that they are dead; (c) "San José Scale host plants" means plants of the genera Acer L., Cotoneaster Ehrh., Crataegus L., Cydonia Mill., Euonymus L., Fagus L., Juglans L., Ligustrum L., Malus Mill., Populus L., Prunus L., Pyrus L., Ribes L., Rosa L., Salix L., Sorbus L., Syringa L., Tilia L., Ulmus L., Vitis L.; (d) "nurseries" means plantations in which plants intended for transplanting, multiplying or distributing as individually rooted plants are grown.  (1) OJ No 156, 15.7.1967, p. 31.  Article 3When an occurrence of San José Scale is recorded, Member States shall demarcate the contaminated area and a safety zone large enough to ensure the protection of the surrounding areas. Article 4The Member States shall provide that, in contaminated areas and safety zones, San José Scale host plants must be appropriately treated to control this pest and prevent it from spreading. Article 5The Member States shall provide that: (a) all contaminated plants in nurseries must be destroyed; (b) all other plants which are contaminated or suspected of being contaminated and which are growing in a contaminated area must be treated in such a way that those plants and the fresh fruit therefrom are no longer contaminated when moved; (c) all rooted San José Scale host plants growing within a contaminated area, and parts of such plants which are intended for multiplication and are produced within that area, may be replanted within the contaminated area or transported away from it only if they have not been found to be contaminated and if they have been treated in such a way that any San José Scale insects which might still be present are destroyed. Article 6The Member States shall ensure that in the safety zones San José Scale host plants are subjected to official supervision and are inspected at least once a year in order to detect any occurrence of San José Scale. Article 7The Member States shall provide that in any batch of plants (other than those that are rooted in the ground) and fresh fruit within which contamination has been found, the contaminated plants and fruit must be destroyed and the other plants and fruit in the batch treated or processed in such a way that any San José Scale insects which might still be present are destroyed. Article 8The Member States shall revoke the measures taken to control San José Scale or to prevent it from spreading only if San José Scale is no longer found to be present. Article 9The Member States shall prohibit the holding of San José Scale.    Article 10  1. Member States may authorise: (a) derogations from the measures referred to in Articles 4, 5, 7 and 9 for scientific and phytosanitary purposes, tests and selection work; (b) by way of derogation from Articles 5 (b) and 7, the immediate processing of contaminated fresh fruit; (c) by way of derogation from Articles 5 (b) and 7, the movement of contaminated fresh fruit within the contaminated area.   2. The Member States shall ensure that the authorisations referred to in paragraph 1 are granted only where adequate controls guarantee that they do not prejudice the control of San José Scale and create no risk of the spread of this pest.    Article 11Member States may adopt such additional or stricter provisions as may be required to control San José Scale or to prevent it from spreading. Article 12Member States shall bring into force the measures necessary to comply with this Directive within two years following its notification and shall forthwith inform the Commission thereof. Article 13This Directive is addressed to the Member States.Done at Brussels, 8 December 1969. For the Council The President J.M.A.H. LUNS


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32003L0015

Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance)

Official Journal L 066 , 11/03/2003 P. 0026 - 0035

Directive 2003/15/EC of the European Parliament and of the Councilof 27 February 2003amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products(Text with EEA relevance)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article 251 of the Treaty in the light of the joint text approved by the Conciliation Committee on 3 December 2002(3),Whereas:(1) Council Directive 76/768/EEC(4) has comprehensively harmonised the national laws relating to cosmetic products and has as its main objective the protection of public health. To this end, it continues to be indispensable to carry out certain toxicological tests to evaluate the safety of cosmetic products.(2) The Protocol on protection and welfare of animals annexed by the Treaty of Amsterdam to the Treaty establishing the European Community provides that the Community and the Member States are to pay full regard to the welfare requirements of animals in the implementation of Community policies, in particular with regard to the internal market.(3) Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(5) has established common rules for the use of animals for experimental purposes within the Community and laid down the conditions under which such experiments must be carried out in the territory of the Member States. In particular, Article 7 of that Directive requires that animal experiments be replaced by alternative methods, when such methods exist and are scientifically satisfactory. In order to facilitate the development and use of alternative methods in the cosmetic sector which do not use live animals, specific provisions have been introduced by Council Directive 93/35/EEC of 14 June 1993 amending for the sixth time Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products(6).However, these provisions concern only alternative methods which do not use animals and they do not take account of alternative methods developed in order to reduce the number of animals used for experiments or to reduce their suffering. Therefore, in order to afford optimal protection to animals used for testing cosmetic products pending implementation of the prohibition of animal tests for cosmetic products and the marketing of animal-tested cosmetic products in the Community, these provisions should be amended in order to provide for the systematic use of alternative methods, which reduce the number of animals used or reduce the suffering caused, in those cases where full replacement alternatives are not yet available, as provided by Article 7(2) and (3) of Directive 86/609/EEC, when these methods offer consumers a level of protection equivalent to that of the conventional methods which they are intended to replace.(4) In accordance with Directive 86/609/EEC and with Directive 93/35/EEC, it is essential that the aim of abolishing animal experiments for testing cosmetic products be pursued and that the prohibition of such experiments becomes effective in the territory of the Member States. In order to ensure that this prohibition is fully implemented, it may be necessary for the Commission to bring forward further proposals to amend Directive 86/609/EEC.(5) Currently, only alternative methods which are scientifically validated by the European Centre for the Validation of Alternative Methods (ECVAM) or the Organisation for Economic Cooperation and Development (OECD) and applicable to the whole chemical sector are systematically adopted at Community level. However, the safety of cosmetic products and their ingredients may be ensured through the use of alternative methods which are not necessarily applicable to all uses of chemical ingredients. Therefore, the use of such methods by the whole cosmetic industry should be promoted and their adoption at Community level ensured, when such methods offer an equivalent level of protection to consumers.(6) The safety of finished cosmetic products can already be ensured on the basis of knowledge of the safety of the ingredients that they contain. Provisions prohibiting animal testing of finished cosmetic products can therefore be incorporated into Directive 76/768/EEC. The Commission should establish guidelines in order to facilitate the application, in particular by small and medium-sized enterprises, of methods which do not involve the use of animals for assessing the safety of finished cosmetic products.(7) It will gradually become possible to ensure the safety of ingredients used in cosmetic products by using non-animal alternative methods validated at Community level, or approved as being scientifically validated, by ECVAM and with due regard to the development of validation within the OECD. After consulting the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) as regards the applicability of the validated alternative methods to the field of cosmetic products, the Commission should immediately publish the validated or approved methods recognised as being applicable to such ingredients. In order to achieve the highest possible degree of animal protection, a deadline must be set for the introduction of a definitive prohibition.(8) The Commission should establish timetables of deadlines for the prohibition of the marketing of cosmetic products, the final formulation, ingredients or combinations of ingredients which have been tested on animals, and for the prohibition of each test currently carried out using animals, up to a maximum of six years from the date of entry into force of this Directive. In view, however, of the fact that there are no alternatives yet under consideration for tests concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, it is appropriate for the maximum deadline for the prohibition of the marketing of cosmetic products for which those tests are used to be 10 years from the date of entry into force of this Directive. On the basis of annual reports, the Commission should be authorised to adapt the timetables within the respective abovementioned maximum time limits.(9) Better coordination of resources at Community level will contribute to increasing the scientific knowledge indispensable for the development of alternative methods. It is essential, for this purpose, that the Community continue and increase its efforts and take the measures necessary for the promotion of research and the development of new non-animal alternative methods, in particular within its Sixth Framework Programme as set out in Decision No 1513/EC/2002 of the European Parliament and of the Council(7).(10) The recognition by non-member countries of alternative methods developed in the Community should be encouraged. In order to achieve this objective, the Commission and the Member States should take all appropriate steps to facilitate acceptance of such methods by the OECD. The Commission should also endeavour, within the framework of European Community cooperation agreements, to obtain recognition of the results of safety tests carried out in the Community using alternative methods so as to ensure that the export of cosmetic products for which such methods have been used is not hindered and to prevent or avoid non-member countries requiring the repetition of such tests using animals.(11) It should be possible to claim on a cosmetic product that no animal testing was carried out in relation to its development. The Commission, in consultation with the Member States, should develop guidelines to ensure that common criteria are applied in the use of claims and that an aligned understanding of the claims is reached, and in particular that such claims do not mislead the consumer. In developing such guidelines, the Commission must also take into account the views of the many small and medium-sized enterprises which make up the majority of the "non-animal testing" producers, relevant non-governmental organisations, and the need of consumers to be able to make practical distinctions between products on the basis of animal testing criteria.(12) The SCCNFP stated in its opinion of 25 September 2001 that substances classified pursuant 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(8) as carcinogenic (except substances only carcinogenic by inhalation), mutagenic or toxic for reproduction, of category 1 or 2, and substances with similar potential, must not be intentionally added to cosmetic products, and that substances classified pursuant to Directive 67/548/EEC as carcinogenic, mutagenic or toxic for reproduction, of category 3, and substances with similar potential, must not be intentionally added to cosmetic products unless it can be demonstrated that their levels do not pose a threat to the health of the consumer.(13) Given the special risks that substances classified as carcinogenic, mutagenic or toxic for reproduction, category 1, 2 and 3, pursuant to Directive 67/548/EEC may entail for human health, their use in cosmetic products should be prohibited. A substance classified in category 3 may be used in cosmetics if the substance has been evaluated by the SCCNFP and found acceptable for use in cosmetic products.(14) In order to improve the information provided to consumers, cosmetic products should bear more precise indications concerning their durability for use.(15) Certain substances have been identified as an important cause of contact-allergy reactions in fragrance-sensitive consumers. In order to ensure that such consumers are adequately informed, it is therefore necessary to amend the provisions of Directive 76/768/EEC to require that the presence of these substances be mentioned in the list of ingredients. This information will improve the diagnosis of contact allergies among such consumers and will enable them to avoid the use of cosmetic products which they do not tolerate.(16) A number of substances have been identified by the SCCNFP as likely to cause allergenic reactions and it will be necessary to restrict their use and/or impose certain conditions concerning them.(17) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(9).(18) The provisions of Directive 93/35/EEC banning the marketing of cosmetic products containing ingredients or combinations of ingredients tested on animals should be superseded by the provisions of this Directive. In the interests of legal certainty therefore it is appropriate to apply Article 1(1) of this Directive with effect from 1 July 2002, whilst fully respecting the principle of legitimate expectations,HAVE ADOPTED THIS DIRECTIVE:Article 1Directive 76/768/EEC is hereby amended as follows:1. Article 4(1)(i) shall be deleted;2. the following Articles shall be inserted:"Article 4a1. Without prejudice to the general obligations deriving from Article 2, Member States shall prohibit:(a) the marketing of cosmetic products where the final formulation, in order to meet the requirements of this Directive, has been the subject of animal testing using a method other than an alternative method after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD;(b) the marketing of cosmetic products containing ingredients or combinations of ingredients which, in order to meet the requirements of this Directive, have been the subject of animal testing using a method other than an alternative method after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD;(c) the performance on their territory of animal testing of finished cosmetic products in order to meet the requirements of this Directive;(d) the performance on their territory of animal testing of ingredients or combinations of ingredients in order to meet the requirements of this Directive, no later than the date on which such tests are required to be replaced by one or more validated alternative methods listed in Annex V 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(10)or in Annex IX to this Directive.No later than 11 September 2004 the Commission shall, in accordance with the procedure referred to in Article 10(2) and after consultation of the Scientific Committee on Cosmetic Products and Non-Food Products intended for consumers (SCCNFP) establish the contents of Annex IX.2. The Commission, after consultation of the SCCNFP and of the European Centre for the Validation of Alternative Methods (ECVAM) and with due regard to the development of validation within the OECD, shall establish timetables for the implementation of the provisions under paragraph 1(a), (b) and (d), including deadlines for the phasing-out of the various tests. The timetables shall be made available to the public not later than 11 September 2004 and be sent to the European Parliament and the Council. The period for implementation shall be limited to a maximum of six years after the entry into force of Directive 2003/15/EC in relation to paragraph 1(a), (b) and (d).(2.1) In relation to the tests concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, for which there are no alternatives yet under consideration, the period for implementation of paragraph 1(a) and (b) shall be limited to a maximum of 10 years after the entry into force of Directive 2003/15/EC.(2.2) The Commission shall study possible technical difficulties in complying with the ban in relation to tests, in particular those concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, for which there are no alternatives yet under consideration. Information about the provisional and final results of these studies should form part of the yearly reports presented pursuant to Article 9.On the basis of these annual reports, the timetables established in accordance with paragraph 2 may be adapted within a maximum time limit of six years as referred to in paragraph 2 or 10 years as referred to in paragraph 2.1 and after consultation of the entities referred to in paragraph 2.(2.3) The Commission shall study progress and compliance with the deadlines as well as possible technical difficulties in complying with the ban. Information about the provisional and final results of the Commission studies should form part of the yearly reports presented pursuant to Article 9. If these studies conclude, at the latest two years prior to the end of the maximum period referred to in paragraph 2.1, that for technical reasons one or more tests referred to in paragraph 2.1 will not be developed and validated before the expiry of the period referred to in paragraph 2.1 it shall inform the European Parliament and the Council and shall put forward a legislative proposal in accordance with Article 251 of the Treaty.(2.4) In exceptional circumstances where serious concerns arise as regards the safety of an existing cosmetic ingredient a Member State may request the Commission to grant a derogation from paragraph 1. The request shall contain an evaluation of the situation and indicate the measures necessary. On this basis, the Commission may, after consultation of the SCCNFP and by means of a reasoned decision, authorise the derogation in accordance with the procedure referred to in Article 10(2). This authorisation shall lay down the conditions associated with this derogation in terms of specific objectives, duration and reporting of the results.A derogation shall only be granted if:(a) the ingredient is in wide use and cannot be replaced by another ingredient able to perform a similar function;(b) the specific human health problem is substantiated and the need to conduct animal tests is justified and is supported by a detailed research Protocol proposed as the basis for the evaluation.The decision on the authorisation, the conditions associated with it and the final result achieved shall be part of the annual report to be presented by the Commission in accordance with Article 9.3. For the purposes of this Article:(a) 'finished cosmetic product' means the cosmetic product in its final formulation, as placed on the market and made available to the final consumer, or its prototype.(b) 'prototype' means a first model or design that has not been produced in batches, and from which the finished cosmetic product is copied or finally developed.Article 4bThe use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction, of category 1, 2 and 3, under Annex I to Directive 67/548/EEC shall be prohibited. To that end the Commission shall adopt the necessary measures in accordance with the procedure referred to in Article 10(2). A substance classified in category 3 may be used in cosmetics if the substance has been evaluated by the SCCNFP and found acceptable for use in cosmetic products."3. Article 6(1)(c) shall be replaced by the following:"(c) The date of minimum durability shall be indicated by the words: 'best used before the end of' followed by either:- the date itself, or- details of where it appears on the packaging.The date shall be clearly expressed and shall consist of either the month and year or the day, month and year in that order. If necessary, this information shall be supplemented by an indication of the conditions which must be satisfied to guarantee the stated durability.Indication of the date of durability shall not be mandatory for cosmetic products with a minimum durability of more than 30 months. For such products, there shall be an indication of the period of time after opening for which the product can be used without any harm to the consumer. This information shall be indicated by the symbol given in Annex VIIIa followed by the period (in months and/or years).";4. Article 6(1)(g) shall be replaced by the following:"(g) a list of ingredients in descending order of weight at the time they are added. That list shall be preceded by the word 'ingredients'. Where that is impossible for practical reasons, an enclosed leaflet, label, tape or card must contain the ingredients to which the consumer is referred either by abbreviated information or the symbol given in Annex VIII, which must appear on the packaging.The following shall not, however, be regarded as ingredients:- impurities in the raw materials used,- subsidiary technical materials used in the preparation but not present in the final product,- materials used in strictly necessary quantities as solvents or as carriers for perfume and aromatic compositions.Perfume and aromatic compositions and their raw materials shall be referred to by the word 'perfume' or 'aroma'. However, the presence of substances, the mention of which is required under the column 'other limitations and requirements' in Annex III, shall be indicated in the list irrespective of their function in the product.Ingredients in concentrations of less than 1 % may be listed in any order after those in concentrations of more than 1 %.Colouring agents may be listed in any order after the other ingredients, in accordance with the colour index number or denomination adopted in Annex IV. For decorative cosmetic products marketed in several colour shades, all colouring agents used in the range may be listed, provided that the words 'may contain' or the symbol '+/-' are added.An ingredient must be identified by the common name referred to in Article 7(2) or, failing that, by one of the names referred to in Article 5a(2), first indent.In accordance with the procedure referred to in Article 10(2), the Commission may adapt the criteria and conditions set out in Commission Directive 95/17/EC of 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non-inclusion of one or more ingredients on the list used for the labelling of cosmetic products(11) under which a manufacturer may, for reasons of trade secrecy, apply not to include one or more ingredients on the abovementioned list."5. the last sentence of Article 6(3) shall be deleted and the following subparagraph shall be added:"Furthermore, the manufacturer or the person responsible for placing the product on the Community market may take advantage, on the product packaging or in any document, notice, label, ring or collar accompanying or referring to the product, of the fact that no animal tests have been carried out only if the manufacturer and his suppliers have not carried out or commissioned any animal tests on the finished product, or its prototype, or any of the ingredients contained in it, or used any ingredients that have been tested on animals by others for the purpose of developing new cosmetic products. Guidelines shall be adopted in accordance with the procedure referred to in Article 10(2) and published in the Official Journal of the European Union. The European Parliament shall receive copies of the draft measures submitted to the Committee."6. Article 7a(1)(d) shall be replaced by the following:"(d) assessment of the safety for human health of the finished product. To that end the manufacturer shall take into consideration the general toxicological profile of the ingredients, their chemical structure and their level of exposure. It shall take particular account of the specific exposure characteristics of the areas on which the product will be applied or of the population for which it is intended. There shall be inter alia a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene.Should the same product be manufactured at several places within Community territory, the manufacturer may choose a single place of manufacture where that information will be available. In this connection, and when so requested for monitoring purposes, it shall be obliged to indicate the place so chosen to the monitoring authority or authorities concerned. In this case this information shall be easily accessible;"7. the following point shall be added to Article 7a(1):"(h) data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety evaluation of the product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of non-member countries.Without prejudice to the protection, in particular, of commercial secrecy and of intellectual property rights, Member States shall ensure that the information required under (a) and (f) shall be made easily accessible to the public by any appropriate means, including electronic means. The quantitative information required under (a) to be made publicly accessible shall be limited to dangerous substances covered by Directive 67/548/EEC."8. in Article 8(2) and Article 8a(3), the title "Scientific Committee on Cosmetology" shall be replaced by "Scientific Committee for Cosmetic Products and Non-Food Products intended for Consumers";9. Articles 9 and 10 shall be replaced by the following:"Article 9Every year the Commission shall present a report to the European Parliament and the Council on:(a) progress made in the development, validation and legal acceptance of alternative methods. The report shall contain precise data on the number and type of experiments relating to cosmetic products carried out on animals. The Member States shall be obliged to collect that information in addition to collecting statistics as laid down by Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(12). The Commission shall in particular ensure the development, validation and legal acceptance of alternative test methods which do not use live animals;(b) progress made by the Commission in its efforts to obtain acceptance by the OECD of alternative methods validated at Community level and recognition by non-member countries of the results of the safety tests carried out in the Community using alternative methods, in particular within the framework of cooperation agreements between the Community and these countries;(c) the manner in which the specific needs of small and medium-sized enterprises have been taken into account.Article 101. The Commission shall be assisted by the Standing Committee on Cosmetic Products.2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.3. The Committee shall adopt its rules of procedure."10. the following shall be added to Annex III, Part I:">TABLE>"11. an Annex VIIIa shall be added, consisting of a symbol representing an open cream jar. The Commission shall, in accordance with the procedure referred to in Article 10(2) establish this symbol by 11 September 2003 at the latest.Article 2For the application of Article 1, point 3 as regards Article 6(1)(c), third subparagraph of Directive 76/768/EEC as well as of Article 1, point 4 as regards Article 6(1)(g), third subparagraph of Directive 76/768/EEC:Member States shall take all necessary measures to ensure that from 11 March 2005 neither manufacturers nor importers established within the Community place on the market cosmetic products which fail to comply with this Directive.Article 31. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 11 September 2004. They shall forthwith inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive.Article 4This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.By way of derogation from Article 3, Article 1, point (1) shall apply from 1 July 2002.Article 5This Directive is addressed to the Member States.Done at Brussels, 27 February 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentM. Chrisochoïdis(1) OJ C 311 E, 31.10.2000, p. 134 and OJ C 51 E, 26.2.2002, p. 385.(2) OJ C 367, 20.12.2000, p. 1.(3) Opinion of the European Parliament of 3 April 2001 (OJ C 21 E, 24.1.2002, p. 24), Council Common Position of 14 February 2002 (OJ C 113 E, 14.5.2002, p. 109) and Decision of the European Parliament of 11 June 2002 (not yet published in the Official Journal). Decision of the European Parliament of 15 January 2003 and Decision of the Council of 27 February 2003.(4) OJ L 262, 27.7.1976, p. 169. Directive as last amended by Commission Directive 2002/34/EC (OJ L 102, 18.4.2002, p. 19).(5) OJ L 358, 18.12.1986, p. 1.(6) OJ L 151, 23.6.1993, p. 32.(7) OJ L 232, 29.8.2002, p. 1.(8) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2001/59/EC (OJ L 225, 21.8.2001, p. 1).(9) OJ L 184, 17.7.1999, p. 23.(10) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2001/59/EC (OJ L 225, 21.8.2001, p. 1).(11) OJ L 140, 23.6.1995, p. 26.(12) OJ L 358, 18.12.1986, p. 1.