CELEX: 31998D0067
Language: en
Date: 1997-12-16 00:00:00
Title: 98/67/EC: Commission Decision of 16 December 1997 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 1998 under Council Regulation (EC) No 3093/94 on substances that deplete the ozone layer (Only the Dutch, English, Finnish, French, German, Italian and Spanish texts are authentic) (Text with EEA relevance)

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31998D0067

98/67/EC: Commission Decision of 16 December 1997 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 1998 under Council Regulation (EC) No 3093/94 on substances that deplete the ozone layer (Only the Dutch, English, Finnish, French, German, Italian and Spanish texts are authentic) (Text with EEA relevance)  

Official Journal L 010 , 16/01/1998 P. 0031 - 0035

COMMISSION DECISION of 16 December 1997 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 1998 under Council Regulation (EC) No 3093/94 on substances that deplete the ozone layer (Only the Dutch, English, Finnish, French, German, Italian and Spanish texts are authentic) (Text with EEA relevance) (98/67/EC) THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Regulation (EC) No 3093/94 of 15 December 1994 on substances that deplete the ozone layer (1), and in particular to Articles 3, 4 and 7 thereof,Whereas, because of concerns for the ozone layer, the Community has already phased out the production and consumption of certain controlled substances;Whereas essential uses have to be decided for chlorofluorocarbons (Articles 3.1 and 4.1); other fully halogenated chlorofluorocarbons (Articles 3.2 and 4.2); halons (Articles 3.3 and 4.3); carbon tetrachloride (Articles 3.4 and 4.4); 1,1,1 trichloroethane (Articles 3.5 and 4.5); and HBFCs (Articles 3.7 and 4.7);Whereas the criteria used for assessing essential uses are in line with Decision IV/25 of the Parties to the Montreal Protocol and are:1. that a use of a controlled substance should qualify as 'essential` only if:(a) it is necessary for the health, safety, or is critical for the functioning of society (encompassing cultural and intellectual aspects); and(b) there are no technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health;2. that production and consumption, if any, of a controlled substance for essential uses should be permitted only if:(a) all economically feasible steps have been taken to minimise the essential use and any associated emission of the controlled substance; and(b) the controlled substance is not available in sufficient quantity and quality from existing stocks of banked or recycled controlled substances, also bearing in mind the needs of developing countries for controlled substances;Whereas Decision VII/9 of the Parties to the Montreal Protocol authorises the levels of production and consumption necessary to satisfy essential uses of controlled substances for metered dose inhalers (MDIs) for the treatment of asthma and chronic obstructive pulmonary disease (COPD);Whereas Decisions VIII/10, VIII/11, VIII/12 and IX/19 set out further actions and measures to be taken by Parties to the Montreal Protocol to promote and facilitate a smooth and efficient transition away from CFC-based MDIs and request each Party to develop and submit to the Ozone Secretariat its agreed transition strategy, if possible by 1998;Whereas Decision VIII/9 of the Parties to the Montreal Protocol authorises the production and consumption necessary to satisfy essential uses of controlled substances for laboratory and analytical uses as listed in Annex IV to the report of the seventh meeting of the Parties, subject to the conditions set out in Annex II to the report of the sixth meeting of the Parties and in Decision VII/11;Whereas the Commission has published a notice (2) to those companies in the European Community which use controlled substances that may be allowed for essential uses in the Community in 1998 pursuant to Council Regulation (EC) No 3093/94, and has thereby received applications for quantities of controlled substances for essential uses in 1998;Whereas, in the framework of the Montreal Protocol nomination and assessment procedures for essential uses, Parties are requested to identify the users who may take advantage of essential uses in 1998;Whereas the Commission issues licenses to the users identified pursuant to Articles 3, 4 and 7 and in accordance with the procedure set out in Article 16 of Council Regulation (EC) No 3093/94;Whereas, within this framework, a producer may be authorised by the competent authority of the Member State in which its relevant production is situated to produce the controlled substances for the purposes of meeting the licensed demands presented by the identified users; whereas the competent authority of the Member State concerned shall in turn notify the Commission well in advance of any such authorisation;Whereas, pursuant to Decision VIII/9 of the Parties to the Montreal Protocol, overall quantitative limits may be set for essential laboratory and analytical uses of controlled substances in the European Community during 1998;Whereas the list of essential uses and the quantities of the controlled substances are hereby given in Annex II as information for producer and user industries;Whereas the measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 16 of Council Regulation (EC) No 3093/94,HAS ADOPTED THIS DECISION:Article 1 Companies which may take advantage of the essential uses for their own account for the manufacture of metered dose inhalers are listed in Annex I.Article 2 The total quantities of controlled substances permitted for essential uses during 1998 shall be as specified in Annex II.Article 3 Within the overall limits set out in Annex IIB, the Commission shall issue licenses to acquire controlled substances from producers in the Community or by import for essential laboratory and analytical uses.Article 4 1. This Decision is addressed to the companies listed in Annex I.2. This Decision shall apply from 1 January 1998 to 31 December 1998.Done at Brussels, 16 December 1997.For the CommissionRitt BJERREGAARDMember of the Commission(1) OJ L 333, 22. 12. 1994, p. 1.(2) OJ C 285, 20. 9. 1997, p. 7.ANEXO I - BILAG I - ANHANG I - ÐÁÑÁÑÔÇÌÁ É - ANNEX I - ANNEXE I - ALLEGATO I - BIJLAGE I - ANEXO I - LIITE I - BILAGA I 3M Health Care LtdMrs L. Humphreys3M HouseMorley StreetLoughboroughLeicestershire LE11 1EPUnited KingdomLaboratorio Aldo Unión SADr. J. Sabater SanmartiBaronese de Imaldá 73E-08950 Espluges de LlobregatLaboratorio Astra España SADr. E. Cabré MatasMestre Joan Corrales, 95-105E-08950 Esplugues de LlobregatBespak plcMr T. ClutterbuckNorth Lynn Industrial EstateKing's LynnNorfolk PE30 2JJUnited KingdomBoehringer Ingelheim GmbHHerrn J. PinkD-55216 Ingelheim am RheinCCL Pharmaceuticals LtdMrs C. KingAstmoor Industrial Estate9 Arkwright RoadRuncorn WA7 1NUUnited KingdomChauvin Ankerpharm GmbHFr. Elzer-VetterHansaallee 177 DD-40549 DüsseldorfChiesi Farmaceutici SpADott. P. ChiesiVia Palermo, 26 AI-43100 ParmaGlaxo WellcomeMr Barry RosenthalLiverpool L24 9JDUnited KingdomIG Sprühtechnik GmbHHerrn F. GuckIm Hemmet 1D-79664 WehrLeiras OyMr Kai Buri,Pansiontie 47P.O. Box 415FIN-20101 TurkuLaboratorios Lesvi SASr. Alejandro Biel AndrésPoligono Industrial Can PelegríE-08740 Sant Andreu de la BarcaLaboratorios Miquel, SASr. A. Costa EspelletaSantanyí, 16E-08016 BarcelonaNorton Waterford LtdMr Jim KennedyUnit 301 Industrial ParkWaterfordIrelandNycomed Austria GmbHDr. VorreitherSt.-Peter-Straße 25A-4020 LinzOrion CorporationMr Pasi SalokangasOrionintie 1FIN-02200 EspooRhône-Poulenc RorerMr K. J. BradleyLondon RoadHolmes ChapelCheshire CW4 8BEUnited KingdomSchering-Plough Labo NVMr P. GyselinckIndustriepark 30B-2220 Heist op den BergSICOR - Società italiana corticosteroidi SpADott. Roberto GianiVia Terrazzano, 77I-20017 RHO (Milano)Valeas SpA PharmaceuticalsDott. Virgilio BernareggiVia Vallisneri, 10I-20133 MilanoValois SAM. Chris Hall50, avenue de l'EuropeF-78160 Marly-le-RoiLaboratorios Vita, SASr. Alejandro Biel AndrésAv. Barcelona, 69E-08970 Sant Joan DespíANNEX II A. MEDICAL USES Production of metered dose inhalers (MDIs) for the treatment of asthma and other chronic obstructive pulmonary diseases (COPDs).>TABLE>B. LABORATORY USES Total quantities of controlled substances which may be produced or imported and placed in the European Community during 1998 for laboratory and analytical uses.>TABLE>Laboratory users or suppliers of laboratory chemicals needing to obtain controlled substances from producers or importers under this essential use exemption should apply to the Commission for authorisation. The total quantity each controlled substance authorised during 1998 for laboratory and analytical purposes shall not exceed the quantities listed above.