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COUNCIL REGULATION (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances
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RAADETS FORORDNING (EOEF) nr. 793/93 af 23. marts 1993 om vurdering af og kontrol med risikoen ved eksisterende stoffer
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THE COUNCIL OF THE EUROPEAN COMMUNITIES,
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RAADET FOR DE EUROPAEISKE FAELLESSKABER HAR -
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Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
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under henvisning til Traktaten om Oprettelse af Det Europaeiske OEkonomiske Faellesskab, saerlig artikel 100 A,
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Having regard to the proposal from the Commission(1) ,
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under henvisning til forslag fra Kommissionen(1) ,
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In cooperation with the European Parliament(2) ,
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i samarbejde med Europa-Parlamentet(2) ,
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Having regard to the opinion of the Economic and Social Committee(3) ,
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under henvisning til udtalelse fra Det OEkonomiske og Sociale Udvalg(3) ,
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Whereas disparities between the laws, regulations and administrative provisions relating to the risk evaluation of existing substances which are in effect or in preparation in the Member States are liable to hinder trade between Member States and create unequal conditions of competition;
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ud fra foelgende betragtninger:
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Whereas measures for the approximation of the provisions of the Member States which have as their object the establishment and functioning of the internal market must, in so far as they concern health, safety, environmental and consumer protection, take a high level of protection as a basis;
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Forskelle mellem medlemsstaternes gaeldende eller planlagte love og administrative bestemmelser om vurdering af risikoen ved eksisterende stoffer kan foere til handelshindringer mellem medlemsstaterne og skabe ulige konkurrencevilkaar;
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Whereas, in order to ensure the protection of man, including workers and consumers, and of the environment, it is necessary to carry out at Community level a systematic evaluation of the risks involving existing substances appearing in the Einecs (European Inventory of Existing Commercial Substances)(4) ;
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foranstaltninger til indbyrdes tilnaermelse af medlemsstaternes bestemmelser vedroerende det indre markeds oprettelse og funktion skal bygge paa et hoejt beskyttelsesniveau, for saa vidt de beroerer sundhed, sikkerhed, forbrugerbeskyttelse og miljoebeskyttelse;
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Whereas, in the interests of efficiency and economy, it is necessary to establish a Community policy which will ensure a sharing and coordination of responsibilities between Member States, the Commission and industrialists;
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for at beskytte mennesker, herunder arbejdstagere og forbrugere, og miljoe boer der paa faellesskabsplan foretages en systematisk risikovurdering af eksisterende stoffer, der er opfoert i EINECS (European Inventory of Existing Commercial Substances)(4) ;
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Whereas a Regulation is the appropriate legal instrument as it imposes directly on manufacturers and importers precise requirements to be implemented at the same time and in the same manner throughout the Community;
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der skal af effektivitets- og besparelseshensyn gennemfoeres en faellesskabspolitik, saaledes at der sker en fordeling og samordning af de opgaver, der udfoeres af medlemsstaterne, Kommissionen og industrien;
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Whereas, in order to undertake a preliminary risk evaluation of existing substances and to identify priority substances requiring immediate attention, it is necessary to collect certain information and test data on existing substances;
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en forordning er et passende juridisk instrument, da den direkte paalaegger producenter og importoerer praecise forpligtelser, der skal gennemfoeres samtidig og ensartet i hele Faellesskabet;
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Whereas the requirement to provide such information should not apply to certain substances which, on the basis of their intrinsic properties, involve only risks generally recognized as minimal;
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til foreloebig risikovurdering af eksisterende stoffer og indkredsning af, hvilke stoffer der i foerste raekke kraever opmaerksomhed, er det noedvendigt at indsamle oplysninger og data vedroerende undersoegelser af eksisterende stoffer;
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Whereas the information should be submitted by manufacturers and importers to the Commission, which will send copies to all Member States; whereas, however, it should be possible for a Member State to ask manufacturers and importers established in its territory to submit the same information at the same time to its competent authorities;
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stoffer, som paa grundlag af deres iboende egenskaber normalt anses for at udgoere en minimal risiko, boer undtages fra disse krav om indsamling af oplysninger;
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Whereas, for the purpose of the risk evaluation of certain existing substances, it is necessary, in certain cases, to require manufacturers or importers to submit further data or to carry out further testing on given existing substances;
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producenter og importoerer boer indgive disse oplysninger til Kommissionen, der sender alle medlemsstaterne genpart heraf; det boer dog vaere muligt for en medlemsstat at anmode producenter og importoerer paa dens omraade om samtidig at indgive de samme oplysninger til medlemsstatens kompetente myndigheder;
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Whereas it is necessary to draw up, at Community level, lists of priority substances which require special attention; whereas the Commission should submit not later than one year after the entry into force of this Regulation an initial priority list;
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for at kunne vurdere den potentielle risiko ved bestemte eksisterende stoffer er det i visse tilfaelde noedvendigt at anmode producenter og importoerer om at fremlaegge nye oplysninger eller udfoere yderligere undersoegelser af bestemte eksisterende stoffer;
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Whereas the risk evaluation of substances on the priority lists should be carried out by the Member States; whereas the latter should be designated at Community level on the basis of a distribution of responsibilities taking account of the situation of the Member States; whereas risk evaluation principles should also be established at Community level;
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der boer paa EF-plan udarbejdes lister over prioriterede stoffer, der kraever saerlig opmaerksomhed; Kommissionen boer senest ét aar efter denne forordnings ikrafttraeden fremlaegge en foreloebig prioriteringsliste;
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Whereas, in the priority-setting process and risk evaluation of existing substances, it is necessary to take into account, in particular, the lack of data on the effects of the substance, the work already carried out in other international organizations, such as the Organization for Economic Cooperation and Development, and other legislation and/or Community programmes concerning dangerous substances;
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risikovurderingen af de stoffer, der er opfoert paa prioriteringslisterne, boer foretages af medlemsstaterne; det er hensigtsmaessigt at udpege disse medlemsstater paa faellesskabsplan paa grundlag af en fordeling af opgaverne under hensyn til situationen i medlemsstaterne; der boer ligeledes paa faellesskabsplan opstilles principper for risikovurdering;
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Whereas it is necessary to adopt at Community level the results of the risk evaluation and the recommended strategy for limiting risks in respect of substances on the priority lists;
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der maa under prioriteringen og risikovurderingen af eksisterende stoffer navnlig tages hensyn til manglende oplysninger om stoffets virkninger, til det arbejde, der allerede er gjort i andre internationale organisationer saasom Organisationen for OEkonomisk Samarbejde og Udvikling (OECD), samt til oevrige faellesskabsregler og/eller faellesskabsprogrammer vedroerende farlige stoffer;
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Whereas it is appropriate to reduce to a minimum the number of animals used for experimental purposes in accordance with the provisions of 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) ; whereas, wherever possible and in consultation, in particular, with the European Centre for Alternative Testing Methods, the use of animals must be avoided by recourse to validated alternative procedures;
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det er noedvendigt paa faellesskabsplan at vedtage opfoelgningen af risikovurderingen samt den anbefalede strategi for begraensning af risikoen ved de stoffer, der er opfoert paa prioritetslisterne;
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Whereas for tests on chemical substances to be carried out in the context of this Regulation it is necessary to follow the good laboratory practices set out in Council Directive 87/18/EEC of 18 December 1986 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances(6) ;
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antallet af dyr, der anvendes til forsoegsformaal, boer begraenses mest muligt i overensstemmelse med Raadets direktiv 86/609/EOEF af 24. november 1986 om indbyrdes tilnaermelse af medlemsstaternes love og administrative bestemmelser om beskyttelse af dyr, der anvendes til forsoeg og andre videnskabelige formaal(5) ; i samraad navnlig med Det Europaeiske Center for Validering af Alternative Metoder skal anvendelse af forsoegsdyr undgaas, naar det overhovedet er muligt, idet der benyttes alternative godkendte metoder;
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Whereas the Commission, assisted by a committee made up of representatives of the Member States, should be given the necessary powers to adapt certain Annexes to technical progress and to adopt certain implementing measures in respect of the Regulation;
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den gode laboratoriepraksis, der er beskrevet i Raadets direktiv 87/18/EOEF af 18. december 1986 om indbyrdes tilnaermelse af lovgivningen om anvendelsen af principper for god laboratoriepraksis og om kontrol med deres anvendelse ved forsoeg med kemiske stoffer(6) , boer foelges ved undersoegelser af kemiske stoffer i forbindelse med denne forordning;
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Whereas the confidential nature of certain information covered by industrial or commercial secrecy should be guaranteed,
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der boer tillaegges Kommissionen, som bistaas af et udvalg bestaaende af medlemsstaternes repraesentanter, de noedvendige befoejelser, saaledes at den kan tilpasse nogle af bilagene til de tekniske fremskridt og traeffe visse foranstaltninger til gennemfoerelse af forordningen;
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HAS ADOPTED THIS REGULATION:
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der boer sikres fuld fortrolighed for visse data, der er hemmelige af industrielle eller kommercielle grunde -
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UDSTEDT FOELGENDE FORORDNING:
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Article 1
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Aims and scope
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Artikel 1
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1. This Regulation shall apply to:
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Maalsaetninger og anvendelsesomraade
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(a) the collection, circulation and accessibility of information on existing substances;
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1. Denne forordning finder anvendelse paa:
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(b) the evaluation of the risks of existing substances to man, including workers and consumers, and to the environment, in order to ensure better management of those risks within the framework of Community provisions.
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a) indsamling og udbredelse af samt adgang til oplysninger om eksisterende stoffer
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2. The provisions of this Regulation shall apply without prejudice to Community legislation on the protection of workers and consumers.
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b) vurdering af risikoen ved eksisterende stoffer for mennesker, herunder arbejdstagere og forbrugere, og for miljoeet med sigte paa at muliggoere en bedre styring af denne risiko inden for rammerne af gaeldende faellesskabsbestemmelser.
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2. Bestemmelserne i denne forordning finder anvendelse med forbehold af andre faellesskabsforskrifter om beskyttelse af arbejdstagere og forbrugere.
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Article 2
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Definitions
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Artikel 2
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For the purpose of this Regulation:
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Definitioner
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(a) substances means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;
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I denne forordning forstaas ved:
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(b) preparations means mixtures or solutions composed of two or more substances;
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a) stoffer: grundstoffer og forbindelser heraf, naturlige eller industrielt fremstillede, indeholdende saadanne tilsaetningsstoffer, som er noedvendige til bevarelse af stoffets stabilitet, og saadanne urenheder, som foelger af fremstillingsprocessen, bortset fra oploesningsmidler, som kan udskilles, uden at det paavirker stoffets stabilitet eller aendrer dets sammensaetning
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(c) importing means bringing into the customs territory of the Community;
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b) praeparater: blandinger eller oploesninger, der er sammensat af to eller flere stoffer
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(d) producing means the production of substances which are isolated in a solid, liquid or gaseous form;
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c) import: indfoersel i Faellesskabs toldomraade
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(e) existing substances means substances listed in Einecs.
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d) produktion: produktion af stoffer, saa de isoleret forefindes i fast form, flydende form eller gasform
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PART 1 SYSTEMATIC DATA REPORTING AND ESTABLISHMENT OF LISTS OF PRIORITY SUBSTANCES
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e) eksisterende stoffer: stoffer, der er optaget i EINECS-fortegnelsen
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Article 3
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DEL 1 SYSTEMATISK INDBERETNING AF DATA OG UDARBEJDELSE AF LISTER OVER PRIORITEREDE STOFFER
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Data reporting on high volume production or import of existing substances
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Artikel 3
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Without prejudice to Article 6 (1), any manufacturer who has produced or any importer who has imported an existing substance, as such or in a preparation, in quantities exceeding 1 000 tonnes per year, at least once in the three years preceding the adoption of this Regulation and/or the year following its adoption, must submit to the Commission, in accordance with the procedure laid down in Article 6 (2) and (3), the following information, as specified in Annex III, within 12 months of entry into force of this Regulation in the case of a substance appearing in Annex I and within 24 months in the case of a substance appearing in Einecs but not in Annex I:
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Indberetning af data om eksisterende stoffer, der fremstilles eller importeres i store maengder
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(a) the name and the Einecs number of the substance;
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Producenter, som har fremstillet, eller importoerer, som har importeret et eksisterende stof som saadant eller indeholdt i et praeparat, i en maengde paa over 1 000 tons pr. aar, ogsaa selv om dette kun er sket en gang i loebet af de sidste tre aar inden og/eller aaret efter vedtagelsen af denne forordning, skal i overensstemmelse med fremgangsmaaden i artikel 6, stk. 2 og 3, senest tolv maaneder efter forordningens ikrafttraeden, hvis det drejer sig om et stof, som er opfoert i bilag I, og senest 24 maaneder efter forordningens ikrafttraeden, hvis det drejer sig om et stof, som er optaget i EINECS-fortegnelsen, men som ikke er opfoert i bilag I, forelaegge Kommissionen foelgende oplysninger, som er specificeret i bilag III, jf. dog bestemmelserne i artikel 6, stk. 1:
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(b) the quantity of the substance produced or imported;
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a) stoffets navn og dets nummer i EINECS-fortegnelsen
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(c) the classification of the substance according to Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous substances(7) or the provisional classification according to the said Directive, including the class of danger, the danger symbol, the risk phrases and the safety phrases;
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b) den producerede eller importerede maengde af stoffet
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(d) information on the reasonably foreseeable uses of the substance;
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c) stoffets klassificering i henhold til bilag I til direktiv 67/548/EOEF af 27. juni 1967 om tilnaermelse af lovgivning om klassificering, emballering og etikettering af farlige stoffer(7) eller dets foreloebige klassificering i henhold til naevnte direktiv, herunder fareklasse, faresymbol, standardpaaskrifter for risici og forsigtighedsregler
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(e) data on the physico-chemical properties of the substance;
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d) oplysninger om de maader for anvendelse af stoffet, som med rimelighed kan forudses
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(f) data on pathways and environmental fate;
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e) data om stoffets fysisk-kemiske egenskaber
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(g) data on the ecotoxicity of the substance;
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f) data om stoffets nedbrydningsvej i miljoeet
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(h) data on the acute and subacute toxicity of the substance;
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g) data om stoffets oekotoksicitet
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(i) data on carcinogenicity, mutagenicity and/or toxicity for reproduction of the substance;
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h) data om stoffets akutte og subakutte toksicitet
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(j) any other indication relevant to the risk evaluation of the substance.
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i) data om stoffets kraeftfremkaldende, mutationsfremkaldende og/eller reproduktionstoksiske egenskaber
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Manufacturers and importers must make all reasonable efforts to obtain existing data regarding points (e) to (j). However, in the absence of information, manufacturers and importers are not bound to carry out further tests on animals in order to submit such data.
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j) andre oplysninger af betydning for risikovurdering af stoffet.
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Producenter og importoerer skal goere enhver rimelig indsats for at indhente de tilgaengelige oplysninger for saa vidt angaar litra e) til j). Findes saadanne oplysninger ikke, er producenter og importoerer dog ikke forpligtet til et foretage supplerende dyreforsoeg for at fremskaffe dem.
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Article 4
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Data reporting on lower volume production or import of existing substances
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Artikel 4
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1. Without prejudice to Article 6 (1), any manufacturer who has produced, or any importer who has imported, an existing substance, as such or in a preparation, in quantities exceeding 10 tonnes per year but no greater than 1 000 tonnes per year, at least once in the three years preceding the adoption of this Regulation and/or the year following its adoption, shall submit to the Commission, in accordance with the procedure laid down in Article 6 (2) and (3), the following information, as specified in Annex IV, within a period of 24 months, to start once the Regulation has been in force for three years:
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Indberetning af data om eksisterende stoffer, der fremstilles eller importeres i begraensede maengder
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(a) the name of the substance and the Einecs number;
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1. Producenter, som har fremstillet, eller importoerer, som har importeret et eksisterende stof som saadant eller indeholdt i et praeparat, i en maengde paa over 10 tons, men ikke over 1 000 tons pr. aar, ogsaa selv om dette kun er sket en gang i loebet af de sidste tre aar inden og/eller aaret efter vedtagelsen af denne forordning, skal i overensstemmelse med fremgangsmaaden i artikel 6, stk. 2 og 3, inden for en frist paa 24 maaneder efter, at forordningen har vaeret i kraft i tre aar, forelaegge Kommissionen foelgende oplysninger, som er specificeret i bilag IV, jf. dog artikel 6, stk. 1:
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(b) the quantity of the substance produced or imported;
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a) stoffets navn og dets nummer i EINECS-fortegnelsen
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(c) the classification of the substance according to Annex I to Directive 67/548/EEC or the provisional classification according to the said Directive, including the class of danger, the danger symbol, the risk phrases and the safety phrases;
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b) den producerede eller importerede maengde af stoffet
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(d) information on the reasonably foreseeable uses of the substance.
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c) stoffets klassificering i henhold til bilag I til direktiv 67/548/EOEF eller dets foreloebige klassificering i henhold til naevnte direktiv, herunder fareklasse, faresymbol, standardpaaskrifter for risici og forsigtighedsregler
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2. The Commission, in consultation with the Member States, shall determine the cases in which it is necessary to request the manufacturers and importers of the substances declared in pursuance of paragraph 1 to submit additional information, in the framework of Annex III, on the physico-chemical properties, toxicity, and ecotoxicity of such substances, exposure and any other aspect relevant to the risk evaluation of the substances. However, without prejudice to Article 12 (2), manufacturers and importers are not bound to carry out further tests on animals for that purpose.
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d) oplysninger om de maader for anvendelse af stoffet, som med rimelighed kan forudses.
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The specific information to be submitted and the procedure to be followed for this submission shall be determined in accordance with the procedure laid down in Article 15.
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2. Kommissionen fastlaegger i samraad med medlemsstaterne, i hvilke tilfaelde det er noedvendigt at anmode producenter og importoerer af stoffer, der er anmeldt i henhold til stk. 1, om at forelaegge yderligere oplysninger som angivet i bilag III om stoffernes fysisk-kemiske egenskaber, toksicitet og oekotoksicitet samt eksponering og alle andre aspekter af betydning for risikovurderingen af stofferne. Dog er producenterne og importoererne ikke forpligtet til at foretage yderligere dyreforsoeg i dette oejemed, jf. dog artikel 12, stk. 2.
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Hvilke specifikke oplysninger der skal meddeles, og hvorledes det skal ske, fastlaegges efter fremgangsmaaden i artikel 15.
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Article 5
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Exemptions
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Artikel 5
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The substances listed in Annex II shall be exempt from the provisions of Articles 3 and 4. However, information on the substances listed in Annex II may be requested by a procedure laid down in accordance with the procedure referred to in Article 15.
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Undtagelser
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De stoffer, som er opfoert i bilag II, er undtaget fra bestemmelserne i artikel 3 og 4. Dog kan der efter en fremgangsmaade, som fastlaegges efter fremgangsmaaden i artikel 15, anmodes om oplysninger om stoffer, som er opfoert i bilag II.
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Article 6
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Procedure for data reporting
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Artikel 6
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1. In the case of a substance produced or imported by several manufacturers or importers, the information referred to in Article 3 and Article 4 (2) may be submitted by one manufacturer or importer acting, with their agreement, on behalf of other manufacturers or importers concerned. The latter shall nevertheless submit to the Commission the information specified in points 1.1 to 1.19 of the data set laid down in Annex III and, in doing so, shall make reference to the data set submitted by the manufacturer or importer.
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Procedure for meddelelse af data
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2. In submitting the information referred to in Article 3 and in Article 4 (1), the manufacturers and importers shall use only the special software package on diskette made available free of charge by the Commission.
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1. Hvis et stof fremstilles eller importeres af flere producenter eller importoerer, kan de i artikel 3 og artikel 4, stk. 2, omhandlede oplysninger indgives af en producent eller importoer, der, med disses samtykke, handler paa vegne af flere beroerte producenter eller importoerer. Disse skal dog forelaegge Kommissionen de oplysninger, der er omhandlet i punkt 1.1 til 1.19 i formularen i bilag III, og skal i denne forbindelse henvise til den formular, der er indgivet af naevnte producent eller importoer.
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3. Member States may provide that manufacturers and importers established in their territory shall be required to submit simultaneously to their competent authorities the same information as that forwarded to the Commission pursuant to Articles 3 and 4.
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2. Ved indberetningen af de i artikel 3 og i artikel 4, stk. 1, omhandlede oplysninger maa producenterne og importoererne kun anvende de standardprogrammer, der findes paa edb-disketter, som faas gratis hos Kommissionen.
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4. On receipt of the data referred to in Articles 3 and 4 respectively, the Commission shall forward copies to all the Member States.
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3. Medlemsstaterne kan fastsaette, at producenter og importoerer, som er etableret paa deres omraade, samtidig skal forelaegge deres kompetente myndigheder de oplysninger, der sendes til Kommissionen i henhold til artikel 3 og 4.
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4. Naar Kommissionen modtager de i artikel 3 og 4 omhandlede oplysninger, sender den alle medlemsstaterne kopier heraf.
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Article 7
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Updating of the reported information and obligation to submit certain information spontaneously
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Artikel 7
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1. Manufacturers and importers who have submitted information on a substance in accordance with Articles 3 and 4 shall update the information forwarded to the Commission.
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Ajourfoering af indberettede oplysninger og pligt til uopfordret at indberette bestemte oplysninger
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In particular, they shall submit, where appropriate:
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1. Producenter og importoerer, der har meddelt oplysninger om et stof i overensstemmelse med artikel 3 og 4, ajourfoerer de til Kommissionen fremsendte oplysninger.
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(a) new uses of the substance which substantially change the type, form, magnitude or duration of exposure of man or the environment to the substance;
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Isaer indberetter de efter omstaendighederne:
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(b) new data obtained on the physico-chemical properties, toxicological or ecotoxicological effects where this is likely to be relevant to the evaluation of the potential risk presented by the substance;
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a) nye maader for anvendelse af stoffet, hvorved type, form, omfang eller varighed af menneskers eller miljoeets eksponering for stoffet aendres i vaesentlig grad
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(c) any change in the provisional classification under Directive 67/548/EEC.
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b) nye oplysninger om stoffets fysisk-kemiske egenskaber og toksikologiske eller oekotoksikologiske virkninger, naar disse oplysninger kan vaere af betydning for risikovurderingen af stoffet
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They shall also be required to update the information regarding the production and import volumes referred to in Articles 3 and 4 every three years, if there is a change in relation to the volumes specified in Annex III or Annex IV.
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c) aendring af den foreloebige klassificering i henhold til direktiv 67/548/EOEF.
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2. Any manufacturer or importer of an existing substance who acquires knowledge which supports the conclusion that the substance in question may present a serious risk to man or the environment shall immediately report such information to the Commission and to the Member State in which he is located.
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De skal endvidere hvert tredje aar ajourfoere oplysningerne om de i artikel 3 og 4 omhandlede produktions- og importmaengder, hvis der er sket aendringer i de maengder, som er specificeret i bilag III eller IV.
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3. Upon receipt of the data referred to in paragraphs 1 and 2, the Commission shall submit copies thereof to all the Member States.
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2. Hvis en producent eller importoer af et eksisterende stof har kendskab til oplysninger, der underbygger antagelser om, at det paagaeldende stof kan indebaere alvorlig fare for mennesker eller miljoe, indgiver vedkommende oejeblikkelig disse oplysninger til Kommissionen og til den medlemsstat, hvor vedkommende er etableret.
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3. Naar Kommissionen modtager de i stk. 1 og 2 omhandlede oplysninger, sender den samtlige medlemsstater kopier heraf.
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Article 8
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Priority lists
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Artikel 8
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1. On the basis of the information submitted by manufacturers and importers in accordance with Articles 3 and 4, and on the basis of the national lists of priority substances, the Commission, in consultation with Member States, shall regularly draw up lists of priority substances or groups of substances (hereinafter referred to as priority lists) requiring immediate attention because of their potential effects on man or the environment. These lists shall be adopted in accordance with the procedure laid down in Article 15 and shall be published by the Commission for the first time in the course of the year following the entry into force of the Regulation.
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Prioriteringslister
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2. The factors to be taken into account in drawing up the priority lists shall be:
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1. Paa grundlag af de oplysninger, producenter og importoerer meddeler i henhold til artikel 3 og 4, og paa grundlag af medlemsstaternes lister over prioriterede stoffer, udarbejder Kommissionen i samarbejde med medlemsstaterne regelmaessigt lister over prioriterede stoffer eller grupper af stoffer, der paa grund af de virkninger, de kan have paa mennesker og miljoe, kraever saerlig opmaerksomhed, i det foelgende benaevnt prioriteringslister. Disse lister vedtages efter fremgangsmaaden i artikel 15 og offentliggoeres af Kommissionen foerste gang aaret efter forordningens ikrafttraeden.
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- the effects of the substance on man or the environment,
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2. Ved udarbejdelsen af prioriteringslister tages der hensyn til foelgende faktorer:
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- the exposure of man or the environment to the substance,
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- stoffets virkninger paa mennesker og miljoe
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- the lack of data on the effects of the substance on man and the environment,
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- menneskers og miljoeets eksponering for stoffet
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- work already carried out in other international fora,
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- manglende viden om stoffets virkning paa mennesker og miljoe
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- other Community legislation and/or programmes relating to dangerous substances.
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- det arbejde, som allerede er udfoert i andre internationale fora
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A substance subject to evaluation under other Community legislation should be placed on a priority list only if that evaluation fails to cover risk to the environment or risk to man, including workers and consumers, or if those risks have not been adequately evaluated. An equivalent evaluation carried out under other Community legislation should not be repeated under this Regulation.
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- andre faellesskabsforskrifter og/eller -programmer vedroerende farlige stoffer.
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Special attention shall be given to substances which may have chronic effects, in particular substances known or suspected to be carcinogenic, toxic to reproduction and/or mutagenic or known or suspected to increase the incidence of these effects.
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Et stof, der er underkastet vurdering i henhold til en anden faellesskabsforskrift, kan kun medtages paa en prioriteringsliste, hvis den paagaeldende vurdering ikke har omfattet risikoen for miljoeet eller for mennesket, herunder arbejdstagere og forbrugere, eller hvis disse risici ikke har vaeret underkastet den noedvendige vurdering. En tilsvarende vurdering, der er foretaget i medfoer af en anden faellesskabsforskrift, skal ikke foretages paa ny i henhold til denne forordning.
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Der laegges saerlig vaegt paa stoffer, der kan have kroniske virkninger, navnlig stoffer, der vides eller mistaenkes for at vaere kraeftfremkaldende, reproduktionstoksiske og/eller mutagene, eller som vides eller mistaenkes for at oege hyppigheden af disse virkninger.
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Article 9
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Data to be supplied for substances appearing on the priority lists
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Artikel 9
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1. For the substances included in the priority lists referred to in Article 8 (1), manufacturers and importers who have submitted information on a substance in accordance with Articles 3 and 4 shall, within six months of publication of the list, submit to the rapporteur designated in accordance with Article 10 (1) all relevant available information and corresponding study reports for risk assessment of the substance concerned.
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Oplysninger om stofferne paa prioriteringslisterne
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2. In addition to the requirement specified in paragraph 1, and without prejudice to the testing which may be required under Article 10 (2), if any of the particulars listed in Annex VII A to Directive 67/548/EEC are not available for a given priority substance, the manufacturers and importers who have submitted information on a substance in accordance with Articles 3 and 4 shall be obliged to carry out the testing necessary to obtain the missing data and to provide the test results and test reports to the rapporteur within 12 months.
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1. For saa vidt angaar de stoffer, der er opfoert paa de prioriteringslister, der er omhandlet i artikel 8, stk. 1, skal producenter og importoerer, der i overensstemmelse med artikel 3 og 4 har indberettet oplysninger om et stof, inden for en frist paa seks maaneder efter listens offentliggoerelse forelaegge den referent, der er udpeget i overensstemmelse med artikel 10, stk. 1, samtlige tilgaengelige og relevante oplysninger samt hertil svarende undersoegelsesrapporter med henblik paa at vurdere risikoen ved det paagaeldende stof.
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3. By way of derogation from paragraph 2, manufacturers and importers may request of the rapporteur that they be exempted from some or all of the additional testing on the grounds that a given piece of information is either unnecessary for risk assessment or is impossible to obtain; they may also request a longer period where circumstances so require. Full justification must be provided to support such derogation and the rapporteur shall decide whether the request should be accepted. Where derogations are allowed in conformity with this Article, the rapporteur shall immediately inform the Commission of his decision. The Commission shall inform the other Member States. If the decision of the rapporteur is contested by one of the other Member States, a final decision shall be taken in conformity with the committee procedure laid down in Article 15.
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2. Ud over den i stk. 1 naevnte forpligtelse og uanset de undersoegelser, der kan vaere paakraevet i henhold til artikel 10, stk. 2, skal producenter og importoerer, der i overensstemmelse med artikel 3 og 4 har indberettet oplysninger om et stof, hvis en af de i bilag VII A til direktiv 67/548/EOEF fastsatte oplysninger mangler for et givet prioriteret stof, foretage de noedvendige undersoegelser for at fremskaffe de manglende data og meddele referenten resultaterne af undersoegelserne og rapporterne om undersoegelserne inden for en frist paa tolv maaneder.
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PART 2 RISK EVALUATION
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3. Uanset bestemmelserne i stk. 2, kan producenter og importoerer anmode referenten om helt eller delvis at blive fritaget for yderligere undersoegelser, enten fordi en given oplysning ikke er noedvendig for at vurdere risikoen, eller fordi den er umulig at skaffe; de kan ogsaa anmode om en laengere frist, naar omstaendighederne goer det paakraevet. Denne anmodning om fritagelse skal vaere behoerigt begrundet, og referenten beslutter, om den skal efterkommes. Naar der er indroemmet en undtagelse i henhold til denne artikel, underretter referenten straks Kommissionen om sin beslutning. Kommissionen underretter de oevrige medlemsstater. Hvis referentens beslutning anfaegtes af en af de oevrige medlemsstater, traeffes der endelig afgoerelse efter udvalgsproceduren i artikel 15.
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Article 10
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DEL 2 RISIKOVURDERING
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Risk evaluation of the substances on the priority lists at the level of the Member State designated as rapporteur
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Artikel 10
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1. For each substance on the priority lists a Member State shall be given responsibility for its evaluation in accordance with the procedure laid down in Article 15, whilst ensuring fair burden sharing between Member States.
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Risikovurdering af stofferne paa prioriteringslisterne i den medlemsstat, der er udpeget som referent
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The Member State shall designate a rapporteur for that substance from among the competent authorities referred to in Article 13.
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1. For hvert stof paa prioriteringslisterne udpeges der efter fremgangsmaaden i artikel 15 og under hensyn til en rimelig opgavefordeling mellem medlemsstaterne en medlemsstat som ansvarlig for vurdering af stoffet.
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The rapporteur shall be responsible for evaluating the information submitted by the manufacturer(s) or importer(s) in conformity with the requirements of Articles 3, 4, 7 and 9 and any other available information, and for identifying, after consultation of the producers or importers concerned, whether, for the purpose of the risk evaluation, it is necessary to require the above manufacturers or importers of priority substances to submit further information and/or to carry out further testing.
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Medlemsstaten udpeger blandt de i artikel 13 omhandlede kompetente myndigheder en referent for det paagaeldende stof.
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2. Where the rapporteur considers it necessary to request further information and/or testing, it shall inform the Commission accordingly. The decision to impose on the above importers or manufacturers a request for further information and/or testing and the time limits for responding to that request shall be taken in accordance with the procedure laid down in Article 15.
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Referenten har til opgave at vurdere de oplysninger, der meddeles af producenter og importoerer i medfoer af artikel 3, 4, 7 og 9, og al anden tilgaengelig information og efter at have raadfoert sig med de paagaeldende producenter og importoerer at vurdere, hvornaar det med henblik paa risikovurdering skal paalaegges ovennaevnte producenter og importoerer af prioriterede stoffer at indgive yderligere oplysninger og/eller udfoere yderligere undersoegelser.
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3. The rapporteur for a given priority substance shall evaluate the risk of that substance to man and the environment.
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2. Hvis referenten finder, at der er behov for yderligere oplysninger og/eller undersoegelser, underretter han Kommissionen derom. Beslutningen om at paalaegge ovennaevnte producenter eller importoerer at indgive yderligere oplysninger og/eller udfoere yderligere undersoegelser, herunder fristen for at efterkomme kravet, traeffes efter fremgangsmaaden i artikel 15.
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Where appropriate, it shall suggest a strategy for limiting these risks, including control measures and/or surveillance programmes. Where such control measures include recommendations for restrictions on the marketing or use of the substance in question, the rapporteur shall submit an analysis of the advantages and drawbacks of the substance and of the availability of replacement substances.
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3. Referenten for et givet prioriteret stof vurderer den risiko, det paagaeldende stof udgoer for mennesker og miljoe.
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The recommended risk evaluation and strategy shall be forwarded to the Commission by the rapporteur.
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Han foreslaar i givet fald en strategi for begraensning af disse risici, herunder kontrolforanstaltninger og/eller overvaagningsprogrammer. Omfatter de paagaeldende kontrolforanstaltninger henstillinger om begraensning af markedsfoeringen og anvendelsen af stoffet, forelaegger referenten en analyse vedroerende de fordele og ulemper, der er forbundet med stoffet, og vedroerende muligheden for erstatningsstoffer.
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4. The real or potential risk to man and the environment shall be assessed on the basis of principles adopted, by 4. June 1994, in accordance with the procedure laid down in Article 15. These pinciples shall be regularly reviewed and, where appropriate, revised in accordance with the same procedure.
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Referenten sender Kommissionen risikovurderingen og den anbefalede strategi.
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5. When manufacturers or importers are asked for further information and/or testing, they must also check, in view of the need to limit practical experiments on vertebrates, whether the information needed to evaluate the substance is not available from former manufacturers or importers of the declared substance and cannot be obtained, possibly against payment of costs. Where experiments are essential, it must be checked whether tests on animals cannot be replaced or limited by using other methods.
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4. Vurderingen af den faktiske eller mulige risiko for mennesker og miljoe foretages paa grundlag af principper, der vedtages inden den 4. juni 1994 efter fremgangsmaaden i artikel 15. Disse principper tages jaevnligt op til fornyet vurdering og revideres i givet fald efter samme fremgangsmaade.
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Necessary laboratory tests must be performed with due respect for the principles of 'good laboratory practice' as laid down in Directive 87/18/EEC and for the provisions of Directive 86/609/EEC.
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5. Anmodes producenterne eller importoererne om yderligere oplysninger og/eller undersoegelser, skal de, henset til noedvendigheden af at begraense forsoegene med hvirveldyr, ogsaa undersoege, om de oplysninger, der er noedvendige til vurdering af stoffet, er til raadighed hos tidligere producenter eller importoerer af det anmeldte stof, og om disse oplysninger kan erhverves, eventuelt mod betaling af udgifterne hertil. Saafremt forsoeg er absolut noedvendige, boer det undersoeges, om dyreforsoeg kan erstattes eller begraenses ved hjaelp af andre metoder.
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Noedvendige laboratorieundersoegelser skal gennemfoeres under overholdelse af principperne om »god laboratoriepraksis«, som fastlagt i direktiv 87/18/EOEF, samt bestemmelserne i direktiv 86/609/EOEF.
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Article 11
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Risk evaluation of the substances on the priority lists at Community level
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Artikel 11
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1. On the basis of the risk evaluation and measures recommended by the rapporteur, the Commission shall submit to the Committee referred to in Article 15 (1) a proposal concerning the results of the risk evaluation of the priority substances and, if necessary, a recommendation for an appropriate strategy for limiting those risks.
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Risikovurdering af stofferne paa prioriteringslisterne paa faellesskabsplan
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2. The results of the risk evaluation of the priority substances, and the recommended strategy shall be adopted at Community level in accordance with the procedure laid down in Article 15, and shall be published by the Commission.
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1. Paa grundlag af referentens risikovurdering og anbefalede strategi forelaegger Kommissionen det i artikel 15, stk. 1, omhandlede udvalg forslag om opfoelgning af risikovurdering af de prioriterede stoffer og om noedvendigt en henstilling vedroerende en passende strategi med henblik paa at begraense risikoen.
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3. On the basis of the risk evaluation and the recommended strategy referred to in paragraph 2, the Commission shall decide, where necessary, to propose Community measures in the framework of Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (8) or in the framework of other relevant existing Community instruments.
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2. Opfoelgningen af risikovurdering af de prioriterede stoffer, herunder den anbefalede strategi, vedtages paa faellesskabsplan efter fremgangsmaaden i artikel 15 og offentliggoeres af Kommissionen.
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3. Paa grundlag af risikovurderingen og den i stk. 2 omhandlede strategihenstilling paahviler det Kommissionen om noedvendigt at foreslaa faellesskabsforanstaltninger inden for rammerne af Raadets direktiv 76/769/EOEF af 27. juli 1976 om indbyrdes tilnaermelse af medlemsstaternes administrativt eller ved lov fastsatte bestemmelser om begraensning af markedsfoering og anvendelse af visse farlige stoffer og praeparater(8) eller inden for rammerne af andre relevante eksisterende faellesskabsinstrumenter.
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Article 12
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Obligations relating to the provision of further information and to further testing
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Artikel 12
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1. Any manufacturer or importer of a substance appearing on the priority lists referred to in Article 8 (1) and who has submitted the information under Articles 3 and 4 must, within a given time limit, supply the rapporteur with the data and test results concerning that substance referred to in Article 9 (1) and (2) and those referred to in Article 10 (2).
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Forpligtelser med hensyn til tilvejebringelse af yderligere oplysninger og udfoerelse af yderligere undersoegelser
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2. Without prejudice to Article 7 (2), where there are valid reasons for believing that a substance appearing in Einecs may present a serious risk to man or the environment, a decision to ask the manufacturer(s) and importer(s) of the said substance to supply the information which they possess and/or to subject the existing substance to testing and provide a report thereon shall be taken in accordance with the procedure laid down in Article 15.
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1. Alle producenter og importoerer af stoffer, der er opfoert paa de i artikel 8, stk. 1, naevnte prioriteringslister, og som har indberettet de i artikel 3 og 4 naevnte oplysninger, skal inden for den fastsatte frist sende referenten de i artikel 9, stk. 1 og 2, og i artikel 10, stk. 2, omhandlede oplysninger og undersoegelsesresultater vedroerende det paagaeldende stof.
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3. In the case of a substance produced or imported as such or in a preparation by several manufacturers or importers, testing in pursuance of paragraphs 1 and 2 may be performed by one or more manufacturers or importers acting on behalf of other manufacturers or importers concerned. The other manufacturers or importers concerned shall make reference to the tests carried out by that or those manufacturers or importers and shall make a fair and equitable contribution to the cost.
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2. Er der gyldige grunde til at antage, at et eksisterende stof kan udgoere en alvorlig risiko for mennesker eller miljoe, traeffes der efter fremgangsmaaden i artikel 15 beslutning om at anmode producenten eller importoeren af stoffet om at meddele alle tilgaengelige oplysninger om stoffet og/eller udfoere undersoegelser af det og forelaegge en rapport herom, jf. dog bestemmelserne i artikel 7, stk. 2.
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3. Fremstilles eller importeres et stof som saadant eller indeholdt i et praeparat af flere producenter eller importoerer, kan undersoegelserne i henhold til stk. 1 og 2 udfoeres af en eller flere producenter eller importoerer, der handler paa vegne af andre beroerte producenter eller importoerer. Disse producenter eller importoerer henviser til de saaledes udfoerte undersoegelser og deltager i omkostningerne hertil paa et rimeligt grundlag.
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Article 13
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Collaboration between the Member States and the Commission
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Artikel 13
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Member States shall designate one or more competent authorities to participate in the implementation of this Regulation in collaboration with the Commission, in particular for the work referred to in Articles 8 and 10. The Member States shall also designate the authority or authorities to which the Commission shall send the copy of the data received.
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Samarbejde mellem medlemsstaterne og Kommissionen
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PART 3 MANAGEMENT, CONFIDENTIALITY, MISCELLANEOUS AND FINAL PROVISIONS
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Medlemsstaterne udpeger en eller flere myndigheder til at deltage i gennemfoerelsen af denne forordning i samarbejde med Kommissionen, saerlig med hensyn til det i artikel 8 og 10 omhandlede arbejde. Medlemsstaterne udpeger ligeledes den eller de myndigheder, Kommissionen skal sende en kopi af de modtagne oplysninger.
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Article 14
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DEL 3 FORVALTNING, FORTROLIGHED, DIVERSE OG AFSLUTTENDE BESTEMMELSER
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Amendment and adaptation of the Annexes
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Artikel 14
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1. The amendments necessary for adapting Annexes I, II, III and IV to technical progress shall be adopted in accordance with the procedure laid down in Article 15.
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AEndring og tilpasning af bilagene
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2. The amendments and adaptations to Annex V shall be adopted by the Commission.
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1. AEndringer, der er noedvendige for at tilpasse bilag I, II, III og IV til den tekniske udvikling, vedtages efter fremgangsmaaden i artikel 15.
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2. AEndringer og tilpasninger af bilag V vedtages af Kommissionen.
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Article 15
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Committee
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Artikel 15
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1. The Commission shall be assisted by a Committee composed of the representatives of the Member States and chaired by the representative of the Commission.
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Udvalget
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2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decision which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.
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1. Kommissionen bistaas af et udvalg, der bestaar af repraesentanter for medlemsstaterne, og som har Kommissionens repraesentant som formand.
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3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
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2. Kommissionens repraesentant forelaegger udvalget et udkast til de foranstaltninger, der skal traeffes. Udvalget afgiver en udtalelse om dette udkast inden for en frist, som formanden kan fastsaette under hensyn til, hvor meget spoergsmaalet haster. Det udtaler sig med det flertal, som er fastsat i Traktatens artikel 148, stk. 2, for vedtagelse af de afgoerelser, som Raadet skal traeffe paa forslag af Kommissionen. Under afstemninger i udvalget tildeles de stemmer, der afgives af repraesentanterne for medlemsstaterne, den vaegt, som er fastlagt i naevnte artikel. Formanden deltager ikke i afstemningen.
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If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
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3. Kommissionen vedtager de paataenkte foranstaltninger, naar de er i overensstemmelse med udvalgets udtalelse.
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4. (a) Except in the cases referred to in subparagraph (b) below, if, on the expiry of a period of two months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.
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Er de paataenkte foranstaltninger ikke i overensstemmelse med udvalgets udtalelse, eller er der ikke afgivet nogen udtalelse, forelaegger Kommissionen straks Raadet et forslag til de foranstaltninger, der skal traeffes. Raadet traeffer afgoerelse med kvalificeret flertal.
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(b) In the case of decisions referred to in Article 11 (2) and Article 14 (1) if, on the expiry of a period of two months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority.
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4. a) Med undtagelse af de tilfaelde, der er naevnt i litra b), vedtager Kommissionen de foreslaaede foranstaltninger, hvis Raadet ikke har truffet nogen afgoerelse ved udloebet af en frist paa to maaneder fra forslagets forelaeggelse for det.
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b) I forbindelse med de afgoerelser, der er omhandlet i artikel 11, stk. 2, og artikel 14, stk. 1, vedtager Kommissionen de foreslaaede foranstaltninger, hvis Raadet ikke har truffet nogen afgoerelse ved udloebet af en frist paa to maaneder fra forslagets forelaeggelse for det, medmindre Raadet med simpelt flertal har udtalt sig imod de naevnte foranstaltninger.
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Article 16
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Confidentiality of data
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Artikel 16
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1. If he considers that there is a confidentiality problem, the manufacturer or importer may indicate the information provided for in Articles 3, 4, 7 and 12, which he considers to be commercially sensitive and disclosure of which might harm him industrially or commercially, and which he therefore wishes to be kept secret from all persons other than Member States and the Commission. Full justification must be given in such cases.
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Oplysningernes fortrolighed
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Industrial and commercial secrecy shall not apply to:
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1. Med hensyn til oplysninger, der meddeles i henhold til artikel 3, 4, 7 og 12, kan producenten eller importoeren, saafremt han mener, at der foreligger et fortrolighedsproblem, anfoere, hvilke oplysninger han anser for kommercielt foelsomme, og hvis offentliggoerelse kunne skade ham industrielt eller kommercielt, og som han derfor oensker at hemmeligholde for alle andre end medlemsstaterne og Kommissionen. Der skal i saadanne tilfaelde forelaegges en fyldestgoerende begrundelse for oensket om hemmeligholdelse.
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- the name of the substance, as given in Einecs,
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Foelgende kan ikke betragtes som drifts- eller forretningshemmeligheder:
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- the name of the manufacturer or importer,
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- stoffets navn som anfoert i EINECS
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- data on physico-chemical properties of the substance and on pathways and environmental fate,
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- producentens eller importoerens navn
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- the summary results of the toxicological and ecotoxicological tests, in particular data on carcinogenity, mutagenicity and/or the substance's toxicity for reproduction,
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- de fysisk-kemiske data om stoffet samt data om stoffets nedbrydningsvej i miljoeet
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- any information relating to the methods and precautions relating to the substance and the emergency measures,
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- resuméet af resultaterne af de toksikologiske og oekotoksikologiske undersoegelser, bl.a. data om stoffets kraeftfremkaldende, mutagene og/eller reproduktionstoksiske egenskaber
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- any information which, if withheld, might lead to animal experiments being carried out or repeated needlessly,
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- oplysninger om metoder og sikkerhedsforanstaltninger vedroerende stoffet og om noedforholdsregler
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- analytical methods that make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans to the substance.
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- oplysninger, som, hvis de blev tilbageholdt, kunne medfoere dyreforsoeg eller unoedig gentagelse af dyreforsoeg
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If the manufacturer or importer should himself later disclose previously confidential information, he shall inform the competent authority accordingly.
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- analysemetoder, som goer det muligt at foelge et farligt stof efter dets indfoerelse i miljoeet og at bestemme menneskets direkte eksponering for stoffet.
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2. The authority receiving the information shall decide on its own responsibility which information is covered by industrial and commercial secrecy in accordance with paragraph 1.
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Hvis producenten eller importoeren paa et senere tidspunkt selv offentliggoer oplysninger, der tidligere har vaeret fortrolige, skal han give den ansvarlige myndighed meddelelse herom.
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Information accepted as being confidential by the authority receiving the information shall be treated as being confidential by the other authorities.
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2. Den myndighed, der modtager oplysningerne, afgoer paa eget ansvar, hvilke oplysninger der skal betragtes som drifts- og forretningshemmeligheder efter stk. 1.
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Oplysninger til den myndighed, som modtager oplysningerne, skal, hvis denne myndighed accepterer dem som fortrolige, behandles som saadanne af de andre myndigheder.
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Article 17
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Not later than one year following adoption of this Regulation, Member States shall establish appropriate legal or administrative measures in order to deal with non-compliance with the provisions of this Regulation.
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Artikel 17
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Senest et aar efter vedtagelsen af denne forordning traeffer medlemsstaterne passende retlige eller administrative foranstaltninger med henblik paa behandling af overtraedelser af denne forordnings bestemmelser.
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Article 18
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This Regulation shall enter into force on the 60th day following its publication in the Official Journal of the European Communities.
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Artikel 18
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This Regulation shall be binding in its entirety and directly applicable in all Member States.
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Denne forordning traeder i kraft paa tresindstyvendedagen efter offentliggoerelsen i De Europaeiske Faellesskabers Tidende.
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Done at Brussels, 23 March 1993.
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Denne forordning er bindende i alle enkeltheder og gaelder umiddelbart i hver medlemsstat.
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For the Council The President S. AUKEN
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Udfaerdiget i Bruxelles, den 23. marts 1993.
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Paa Raadets vegne S. AUKEN Formand
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(1) OJ No C 276, 5. 11. 1990, p. 1.
|
|
|
(2) OJ No C 280, 28. 10. 1991, p. 65 and OJ No C 337, 21. 12. 1992.
|
(1) EFT nr. C 276 af 5. 11. 1990, s. 1.
|
|
(3) OJ No C 102, 18. 4. 1991, p. 42.
|
(2) EFT nr. C 280 af 28. 10. 1991, s. 65, og EFT nr. C 337 af 21. 12. 1992.
|
|
(4) OJ No C 146, 15. 6. 1990, p. 1.
|
(3) EFT nr. C 102 af 18. 4. 1991, s. 42.
|
|
(5) OJ No L 358, 18. 12. 1986, p. 1.
|
(4) EFT nr. C 146 af 15. 6. 1990, s. 1.
|
|
(6) OJ No L 15, 17. 1. 1987, p. 29.
|
(5) EFT nr. L 358 af 18. 12. 1986, s. 1.
|
|
(7) OJ 196, 16. 8. 1967, p. 1. Directive as last amended by Commission Directive 91/632/EEC (OJ No L 338, 10. 12. 1991, p. 23).
|
(6) EFT nr. L 15 af 17. 1. 1987, s. 29.
|
|
(8) OJ No L 262, 27. 9. 1976, p. 201. Directive as last amended by Directive 91/659/EEC (OJ No L 363, 31. 12. 1991, p. 36).
|
(7) EFT nr. 196 af 16. 8. 1967, s. 1. Direktivet er senest aendret ved Kommissionens direktiv 91/632/EOEF (EFT nr. L 338 af 10. 12. 1991, s. 23).
|
|
|
(8) EFT nr. L 262 af 27. 9. 1976, s. 201. Direktivet er senest aendret ved Kommissionens direktiv 91/659/EOEF (EFT nr. L 363 af 31. 12. 1991, s. 36).
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ANNEX I
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LIST OF EXISTING SUBSTANCES PRODUCED OR IMPORTED WITHIN THE COMMUNITY IN QUANTITIES EXCEEDING 1 000 TONNES PER YEAR (*) (*) The petroleum products are grouped into 31 groups identified by a number or a number and a letter (group 1, group 2, group 3A, group 3B, group 3C, group 4A, group 4B, etc.), see pages 35 to 68.
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BILAG I
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For any one particular group of substances, manufacturers or importers may decide to submit only one set of information, but only in so far as points 2 to 6 inclusive of the information as laid down in Annex III are concerned; this information will then be taken as applying to all substances contained within that particular group.
|
LISTE OVER EKSISTERENDE STOFFER FREMSTILLET I ELLER IMPORTERET TIL FAELLESSKABET I EN MAENGDE PAA OVER 1 000 TONS PR. AAR (*) (*) Olieprodukterne er opdelt i 31 grupper, der er identificeret ved et nummer eller et nummer og et bogstav (gruppe 1, gruppe 2, gruppe 3 A, gruppe 3 B osv.), se nedenfor s. 35-68.
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For enhver gruppe af stoffer kan producenter eller importoerer beslutte kun at meddele et saet oplysninger, men kun for saa vidt angaar de oplysninger, der er anfoert i punkt 2 til 6 i bilag III. Disse oplysninger anses derefter for at angaa alle stoffer inden for den paagaeldende gruppe.
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ANNEX II
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LIST OF SUBSTANCES EXEMPT FROM THE PROVISIONS OF ARTICLES 3 AND 4
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BILAG II
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LISTE OVER STOFFER, SOM ER UNDTAGET FRA BESTEMMELSERNE I ARTIKEL 3 OG 4
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ANNEX III
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INFORMATION REFERRED TO IN ARTICLE 3 1. General information
|
BILAG III
|
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1.1. Name of substance
|
OPLYSNINGER, DER ER OMHANDLET I ARTIKEL 3 OPLYSNINGER, DER KRAEVES TIL DEN I ARTIKEL 3 OMHANDLEDE FORMULAR 1. Generelle oplysninger
|
|
1.2. Einecs No
|
1.1. Stoffets navn
|
|
1.3. CAS No
|
1.2. EINECS-nr.
|
|
1.4. Synonyms
|
1.3. CAS-nr.
|
|
1.5. Purity
|
1.4. Synonymer
|
|
1.6. Impurities
|
1.5. Renhed
|
|
1.7. Molecular formula
|
1.6. Urenheder
|
|
1.8. Structural formula
|
1.7. Bruttoformel
|
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1.9. Type of substance
|
1.8. Strukturformel
|
|
1.10. Physical state
|
1.9. Stoftype
|
|
1.11. Please indicate who is submitting the data set
|
1.10. Fysisk form
|
|
1.12. Quantity produced or imported, greater than 1 000 tonnes per year
|
1.11. Navnet paa indsenderen af formularen
|
|
1.13. Indicate if the substance has been produced during the last 12 months
|
1.12. Produceret og importeret maengde over 1 000 tons pr. aar
|
|
1.14. Indicate if the substance has been imported during the last 12 months
|
1.13. Har stoffet vaeret produceret inden for de foregaaende tolv maaneder?
|
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1.15. Classification and labelling
|
1.14. Har stoffet vaeret importeret inden for de foregaaende tolv maaneder?
|
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1.16. Use pattern
|
1.15. Klassificering og maerkning
|
|
1.17. Has the complete data set already been submitted by another manufacturer or importer?
|
1.16. Anvendelsesmoenster
|
|
1.18. Specify if you are acting on behalf of another concerned manufacturer or importer
|
1.17. Er den komplette formular allerede indsendt af en anden producent eller importoer?
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1.19. Other remarks: (e. g. options for disposal)
|
1.18. Handler De paa vegne af en anden beroert producent eller importoer?
|
|
2. Physical-chemical data
|
1.19. Andre bemaerkninger (f.eks. bortskaffelsesmuligheder)
|
|
2.1. Melting point
|
2. Fysisk-kemiske data
|
|
2.2. Boiling point
|
2.1. Smeltepunkt
|
|
2.3. Density
|
2.2. Kogepunkt
|
|
2.4. Vapour pressure
|
2.3. Densitet
|
|
2.5. Partition coefficient (log10 POW)
|
2.4. Damptryk
|
|
2.6. Water solubility
|
2.5. Fordelingskoefficient (log10 POW)
|
|
2.7. Flash point
|
2.6. Vandoploeselighed
|
|
2.8. Auto flammability
|
2.7. Flammepunkt
|
|
2.9. Flammability
|
2.8. Selvantaendelighed
|
|
2.10. Explosive properties
|
2.9. Antaendelighed
|
|
2.11. Oxidizing properties
|
2.10. Eksplosive egenskaber
|
|
2.12. Other data and remarks
|
2.11. Oxiderende egenskaber
|
|
3. Environmental fate and pathways
|
2.12. Andre data og bemaerkninger
|
|
3.1. Stability
|
3. Skaebne og veje i miljoeet
|
|
3.1.1. Photodegradation
|
3.1. Stabilitet
|
|
3.1.2. Stability in water
|
3.1.1. Photodegradering
|
|
3.1.3. Stability in soil
|
3.1.2. Stabilitet i vand
|
|
3.2. Monitoring data (environment)
|
3.1.3. Stabilitet i jord
|
|
3.3. Transport and distribution between environmental compartments including estimated environmental concentrations and distribution pathways
|
3.2. Overvaagningsdata (miljoe)
|
|
3.3.1. Transport
|
3.3. Transport og spredning til forskellige miljoeer, herunder anslaaede koncentrationer og spredningsveje i miljoeet
|
|
3.3.2. Distribution among environmental compartments
|
3.3.1. Transport
|
|
3.4. Biodegradation
|
3.3.2. Spredning til forskellige miljoeer
|
|
3.5. Bioaccumulation
|
3.4. Bionedbrydning
|
|
3.6. Other remarks
|
3.5. Bioakkumulation
|
|
4. Ecotoxicity
|
3.6. Andre bemaerkninger
|
|
4.1. Toxicity to fish
|
4. OEkotoksicitet
|
|
4.2. Toxicity to daphnia and other aquatic invertebrates
|
4.1. Toksicitet for fisk
|
|
4.3. Toxicity to algae
|
4.2. Toksicitet for dafnier og andre hvirvelloese vanddyr
|
|
4.4. Toxicity to bacteria
|
4.3. Toksicitet for alger
|
|
4.5. Toxicity to terrestrial organisms
|
4.4. Toksicitet for bakterier
|
|
4.6. Toxicity to soil dwelling organisms
|
4.5. Toksicitet for landorganismer
|
|
4.7. Other remarks
|
4.6. Toksicitet for jordbundsorganismer
|
|
5. Toxicity
|
4.7. Andre bemaerkninger
|
|
5.1. Acute toxicity
|
5. Toksicitet
|
|
5.1.1. Acute oral toxicity
|
5.1. Akut toksicitet
|
|
5.1.2. Acute inhalation toxicity
|
5.1.1. Akut toksicitet ved indtagelse
|
|
5.1.3. Acute dermal toxicity
|
5.1.2. Akut toksicitet ved indaanding
|
|
5.1.4. Acute toxicity (other routes of administration)
|
5.1.3. Akut toksicitet ved hudkontakt
|
|
5.2. Corrosiveness and irritation
|
5.1.4. Akut toksicitet (andre former for indgivelse)
|
|
5.2.1. Skin irritation
|
5.2. AEtsende og irriterende egenskaber
|
|
5.2.2. Eye irritation
|
5.2.1. Irriterer huden
|
|
5.3. Sensitization
|
5.2.2. Irriterer oejnene
|
|
5.4. Repeated dose toxicity
|
5.3. Sensibilisering
|
|
5.5. Genetic toxicity in vitro
|
5.4. Toksicitet ved gentagne paavirkninger
|
|
5.6. Genetic toxicity in vivo
|
5.5. Genetisk toksicitet in vitro
|
|
5.7. Carcinogenicity
|
5.6. Genetisk toksicitet in vivo
|
|
5.8. Toxicity to reproduction
|
5.7. Carcinogenicitet
|
|
5.9. Other relevant information
|
5.8. Reproduktionstoksicitet
|
|
5.10. Experience with human exposure
|
5.9. Andre relevante oplysninger
|
|
6. List of references
|
5.10. Erfaringer med human eksponering
|
|
|
6. Referencer
|
|
|
|
|
|
|
|
ANNEX IV
|
|
|
INFORMATION REFERRED TO IN ARTICLE 4 (1) 1. General information
|
BILAG IV
|
|
1.1. Name of substance
|
OPLYSNINGER, DER ER OMHANDLET I ARTIKEL 4, STK. 1 OPLYSNINGER, DER KRAEVES TIL DEN I ARTIKEL 4, STK. 1, OMHANDLEDE FORMULAR 1. Generelle oplysninger
|
|
1.2. Einecs No
|
1.1. Stoffets navn
|
|
1.3. CAS No
|
1.2. EINECS-nr.
|
|
1.4. Synonyms
|
1.3. CAS-nr.
|
|
1.5. Purity
|
1.4. Synonymer
|
|
1.6. Impurities
|
1.5. Renhed
|
|
1.7. Molecular formula
|
1.6. Urenheder
|
|
1.8. Structural formula
|
1.7. Bruttoformel
|
|
1.9. Type of substance
|
1.8. Strukturformel
|
|
1.10. Physical state
|
1.9. Stoftype
|
|
1.11. Please indicate who is submitting the data set
|
1.10. Fysisk form
|
|
1.12. Quantity produced or imported exceeding 10 tonnes per year but not greater than 1 000 tonnes
|
1.11. Navnet paa indsenderen af formularen
|
|
1.13. Indicate if the substance has been produced during the last 12 months
|
1.12. Produceret og importeret maengde over 10, men ikke over 1 000 tons pr. aar
|
|
1.14. Indicate if the substance has been imported during the last 12 months
|
1.13. Har stoffet vaeret produceret inden for de foregaaende tolv maaneder?
|
|
1.15. Classification and labelling
|
1.14. Har stoffet vaeret importeret inden for de foregaaende tolv maaneder?
|
|
1.16. Use pattern
|
1.15. Klassificering og maerkning
|
|
1.17. Other remarks
|
1.16. Anvendelsesmoenster
|
|
|
1.17. Andre bemaerkninger
|
|
|
|
|
|
|
|
ANNEX V
|
|
|
COMMUNITY INFORMATION OFFICES The special software packages are available, on diskette, at the following information offices in the Community
|
BILAG V
|
|
Germany
|
PRESSE OG INFORMATIONSKONTORER I FAELLESSKABET Standardprogrammer paa edb-disketter kan faas paa foelgende presse- og informationskontorer i Faellesskabet:
|
|
Bonn
|
Belgien
|
|
Kommission der Europaeischen Gemeinschaften
|
Bruxelles
|
|
Vertretung in der Bundesrepublik Deutschland
|
a) Commission des Communautés européennes
|
|
Zitelmannstrasse 22
|
Bureau en Belgique
|
|
D-5300 Bonn
|
b) Commissie van de Europese Gemeenschappen
|
|
Telex 88 66 48 EUROP D
|
Bureau in België
|
|
Telefax 5 30 09 50
|
Rue Archimède 73, 1040 Bruxelles
|
|
Berlin
|
Archimedesstraat 73, 1040 Brussel
|
|
Kommission der Europaeischen Gemeinschaften
|
Telex 26 657 COMTNF B
|
|
Vertretung in der Bundesrepublik Deutschland
|
Telefax 235 01 66
|
|
Aussenstelle Berlin
|
Danmark
|
|
Kurfuerstendamm 102
|
Koebenhavn
|
|
D-1000 Berlin 31
|
Kommissionen for De Europaeiske Faellesskaber
|
|
Telex 18 40 15 EUROP D
|
Kontor i Danmark
|
|
Telefax 8 92 20 59
|
Hoejbrohus
|
|
Munich
|
OEstergade 61
|
|
Kommission der Europaeischen Gemeinschaften
|
Postbox 144
|
|
Vertretung in der Bundesrepublik Deutschland
|
1004 Koebenhavn K
|
|
Vertretung in Muenchen
|
Telex 16 402 COMEUR DK
|
|
Erhardtstrasse 27
|
Telefax 33 11 12 03/33 14 12 44
|
|
D-8000 Muenchen 2
|
Tyskland
|
|
Telex 5 21 81 35
|
Bonn
|
|
Telefax 2 02 10 15
|
Kommission der Europaeischen Gemeinschaften
|
|
Belgium
|
Vertretung in der Bundesrepublik Deutschland
|
|
Brussels
|
Zitelmannstrasse 22
|
|
(a) Commission des Communautés européennes
|
5300 Bonn
|
|
Bureau en Belgique
|
Telex 886648 EUROP D
|
|
(b) Commissie van de Europese Gemeenschappen
|
Telefax 530 09 50
|
|
Bureau in België
|
Berlin
|
|
Rue Archimede 73, B-1040 Bruxelles
|
Kommission der Europaeischen Gemeinschaften
|
|
Archimedesstraat 73, B-1040 Brussel
|
Vertretung in der Bundesrepublik Deutschland
|
|
Telex 26657 COMTNF B
|
Aussenstelle Berlin
|
|
Telefax 2 35 01 66
|
Kurfuerstendamm 102
|
|
Denmark
|
1000 Berlin 31
|
|
Copenhagen
|
Telex 184 015 EUROP D
|
|
Kommissionen for De Europaeiske Faellesskaber
|
Telefax 892 20 59
|
|
Kontor in Danmark
|
Muenchen
|
|
Hoejbrohus
|
Kommission der Europaeischen Gemeinschaften
|
|
OEstergade 61
|
Vertretung in der Bundesrepublik Deutschland
|
|
Postbox 144
|
Vertretung in Muenchen
|
|
DK-1004 Koebenhavn K 33
|
Erhardtstrasse 27
|
|
Telex 1 64 02 COMEUR DK
|
8000 Muenchen 2
|
|
Telefax 33 11 12 03/33 14 12 44
|
Telex 52 18 135
|
|
Spain
|
Telefax 202 10 15
|
|
Madrid
|
Graekenland
|
|
Comisión de las Comunidades Europeas
|
Athen
|
|
Oficina en España
|
Epitropi ton Evropaikon Koinotiton
|
|
Calle de Serrano 41
|
Grafeio stin Ellada
|
|
5a planta
|
2 Vassilissis Sofias
|
|
E-28001 Madrid
|
T.K. 11002
|
|
Telex 4 68 18 OIPE E
|
10674 Athina
|
|
Telefax 2 76 03 87
|
Telex 219324 ECAT GR
|
|
Barcelona
|
Telefax 724 46 20
|
|
Edificio Atlantico
|
Spanien
|
|
Av. Diagonal, 407 bis, Planta 18
|
Madrid
|
|
08008 Barcelona
|
Comisión de las Comunidades Europeas
|
|
Telefax 415 63 11
|
Oficina en España
|
|
France
|
Calle de Serrano, 41
|
|
Paris
|
Planta 5
|
|
Commission des Communautés européennes
|
28001 Madrid
|
|
Bureau de représentation en France
|
Telex 46 818 OIPE
|
|
288, Bld. St. Germain
|
Telefax 276 03 87
|
|
F-75007 Paris
|
Barcelona
|
|
Telex Paris 611019 COMEUR
|
Edificio Atlántico
|
|
Telefax 1 45 56 94 19/7
|
Av. Diagonal, 407bis, Planta 18
|
|
Marseilles
|
08008 Barcelona
|
|
Commission des Communautés européennes
|
Telefax 415 63 11
|
|
Bureau á Marseille
|
Frankrig
|
|
CMCI
|
Bureaux de représentation en France
|
|
2, rue Henri-Barbusse
|
Paris
|
|
F-13241 Marseille Cedex 01
|
Commission des Communautés européennes
|
|
Telex 40 25 38 EURMA
|
Bureau à Paris
|
|
Telefax 91 90 98 07
|
288, bld St. Germain
|
|
Greece
|
75007 Paris
|
|
Athens
|
Telex Paris 611 019 COMEUR
|
|
Epitropi ton Evropaikon Koinotiton
|
Telefax 45 56 94 19/7
|
|
Grafeio stin Ellada
|
Marseille
|
|
2 Vassilissis Sofias
|
Commission des Communautés européennes
|
|
Case postale 1 10 02
|
Bureau à Marseille
|
|
GR-Athina 10674
|
CMCI
|
|
Telex 21 93 24 ECAT GR
|
2, rue Henri-Barbusse
|
|
Telefax 7 24 46 20
|
13241 Marseille Cedex 01
|
|
Ireland
|
Telex 402 538 EURMA
|
|
Dublin
|
Telefax 91 90 98 07
|
|
Commission of the European Communities
|
Irland
|
|
Office in Ireland
|
Dublin
|
|
39 Molesworth Street
|
Commission of the European Communities
|
|
IRL-Dublin 2
|
Office in Ireland
|
|
Telex 9 38 27 EUCO EI
|
39 Molesworth Street
|
|
Telefax 71 26 57
|
Dublin 2
|
|
Italy
|
Telex 93827 EUCO EI
|
|
Roma
|
Telefax 71 26 57
|
|
Commissione delle Comunità europee
|
Italien
|
|
Ufficio in Italia
|
Rom
|
|
Via Poli 29
|
Commissione delle Comunità europee
|
|
I-00187 Roma
|
Ufficio in Italia
|
|
Telex 61 01 84 EUROMA I
|
Via Poli 29
|
|
Telefax 6 79 16 58
|
00187 Roma
|
|
Milan
|
Telex 610184 EUROMA I
|
|
Commissione delle Comunità europee
|
Telefax 679 16 58
|
|
Ufficio a Milano
|
Milano
|
|
Corso Magenta 59
|
Commissione delle Comunità europee
|
|
I-20123 Milano
|
Ufficio in Milano
|
|
Telex 31 62 00 EURMIL I
|
Corso Magenta 59
|
|
Telefax 4 81 85 43
|
20123 Milano
|
|
Luxembourg
|
Telex 316200 EUROMIL I
|
|
Luxembourg
|
Telefax 481 85 43
|
|
Commission des Communautés européennes
|
Luxembourg
|
|
Bureau au Luxembourg
|
Luxembourg
|
|
Bâtiment Jean Monnet B/0
|
Commission des Communautés européennes
|
|
Rue Alcide De Gasperi
|
Bureau au Luxembourg
|
|
L-2920 Luxembourg
|
Bâtiment Jean Monnet B/O
|
|
Telex 34 23/34 46/34 76 COMEUR LU
|
2920 Luxembourg
|
|
Telefax 43 01 44 33
|
Telex 3423/3446/3476 COMEUR LU
|
|
Netherlands
|
Telefax 43 01 44 33
|
|
The Hague
|
Nederlandene
|
|
Commissie van de Europese Gemeenschappen
|
Haag
|
|
Bureau in Nederland
|
Commissie van de Europese Gemeenschappen
|
|
Korte Vijverberg 5
|
Bureau in Nederland
|
|
NL-2513 AB Den Haag
|
Korte Vijverberg 5
|
|
Telex 3 10 94 EURCO NL
|
2513 AB Den Haag
|
|
Telefax 364 66 19
|
Telex 31094 EURCO NL
|
|
Portugal
|
Telefax 364 66 19
|
|
Lisbon
|
Portugal
|
|
Comissao das Comunidades Europeias
|
Lissabon
|
|
Gabinete em Portugal
|
Comissao das Comunidades Europeias
|
|
Centro Europeu Jean Monnet
|
Gabinete em Portugal
|
|
Largo Jean Monnet 1-10o
|
Centro Europeu Jean Monnet
|
|
P-1200 Lisboa
|
Largo Jean Monnet 1-10o
|
|
Telex 18810 COMEUR P
|
1200 Lisboa
|
|
Telefax 1 55 43 97
|
Telex 18 810 COMEUP P
|
|
United Kingdom
|
Telefax 155 43 97
|
|
London
|
Det Forenede Kongerige
|
|
Commission of the European Communities
|
London
|
|
Office in the United Kingdom
|
Commission of the European Communities
|
|
Jean Monnet House
|
Office in the United Kingdom
|
|
8 Storey's Gate
|
Jean Monnet House
|
|
UK-London SW1P 3AT
|
8 Storey's Gate
|
|
Telex 2 32 08 EURUK G
|
London SW1 P 3 AT
|
|
Telefax 7 19 73 19 00/19 20
|
Telex 23208 EURUK G
|
|
Belfast
|
Telefax 71 973 1900/1920
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Commission of the European Communities
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Belfast
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Office in Northern Ireland
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Commission of the European Communities
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Windsor House
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Office in Northern Ireland
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9/15 Bedford Street
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Windsor House
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UK-Belfast BT2 7EG
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9/15 Bedford Street
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Telex 7 41 17 CECBEL G
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Belfast BT2 7EG
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Telefax 24 82 41
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Telex 74117 CECBEL G
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Cardiff
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Telefax 24 82 41
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Commission of the European Communities
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Cardiff
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Office in Wales
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Commission of the European Communities
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4 Cathedral Road
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Office in Wales
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PO Box 15
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4 Cathedral Road
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UK-Cardiff CF1 9SG
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PO Box 15
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Telex 49 77 27 EUROPA G
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Cardiff CF1 9SG
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Telefax 39 54 89
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Telex 497727 EUROPA G
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Edinburgh
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Telefax 395489
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Commission of the European Communities
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Edinburgh
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Office in Scotland
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Commission of the European Communities
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7 Alva Street
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Office in Scotland
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UK-Edinburgh EH2 4PH
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7 Alva Street
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Telex 72 74 20 EUEDING
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Edinburgh EH2 4PH
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Telefax 2 26 41 05
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Telex 727420 EUEDING
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Telefax 226 41 05
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