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)
16. 1. 98 ‹ EN ‹ Official Journal of the European Communities L 10/31 II (Acts whose publication is not obligatory) COMMISSION 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, 1. that a use of a controlled substance should qualify as ‘essential’ only if: Having regard to the Treaty establishing the European Community, (a) it is necessary for the health, safety, or is critical for the functioning of society (encompassing cultural and intellectual aspects); and 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, (b) there are no technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health; Whereas, because of concerns for the ozone layer, the Community has already phased out the production and consumption of certain controlled substances; 2. that production and consumption, if controlled substance for essential uses permitted only if: any, of a should be Whereas essential uses have to be decided for chloro- fluorocarbons (Articles 3. 1 and 4. 1); other fully halo- genated 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); (a) all economically feasible steps have been taken to minimise the essential use and any associated emis- sion of the controlled substance; and (b) the controlled substance is not available in suffi- cient 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 the criteria used for assessing essential uses are in line with Decision IV/25 of the Parties to the Montreal Protocol and are: (1) OJ L 333, 22. 12. 1994, p. 1. Whereas Decision VII/9 of the Parties to the Montreal Protocol authorises the levels of production and con- sumption necessary to satisfy essential uses of controlled L 10/32 ‹ EN ‹ Official Journal of the European Communities 16. 1. 98 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 limits set out the Within the overall Commission shall issue licenses to acquire controlled substances from producers in the Community or by import for essential laboratory and analytical uses. in Annex IIB, Article 4 This Decision is addressed to the companies listed 1. in Annex I. This Decision shall apply from 1 January 1998 to 31 2. December 1998. Done at Brussels, 16 December 1997. For the Commission Ritt BJERREGAARD Member of the Commission substances for metered dose inhalers (MDIs) for the treat- ment 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 if possible by 1998; its agreed transition strategy, Whereas Decision VIII/9 of the Parties to the Montreal the production and consumption Protocol authorises 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 (1) 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; in the framework of the Montreal Protocol Whereas, 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 accord- ance 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 (1) OJ C 285, 20. 9. 1997, p. 7. 16. 1. 98 ‹ EN ‹ Official Journal of the European Communities L 10/33 ANEXO I — BILAG I — ANHANG I — ΠΑΡΑΡΤΗΜΑ Ι — ANNEX I — ANNEXE I — ALLEGATO I — BIJLAGE I — ANEXO I — LIITE I — BILAGA I 3M Health Care Ltd Mrs L. Humphreys 3M House Morley Street Loughborough Leicestershire LE11 1EP United Kingdom Laboratorio Aldo Unión SA Dr. J. Sabater Sanmarti Baronese de Imald ´a 73 E-08950 Espluges de Llobregat Laboratorio Astra Espa ˜na SA Dr. E. Cabré Matas Mestre Joan Corrales, 95-105 E-08950 Esplugues de Llobregat Bespak plc Mr T. Clutterbuck North Lynn Industrial Estate King’s Lynn Norfolk PE30 2JJ United Kingdom Boehringer Ingelheim GmbH Herrn J. Pink D-55216 Ingelheim am Rhein CCL Pharmaceuticals Ltd Mrs C. King Astmoor Industrial Estate 9 Arkwright Road Runcorn WA7 1NU United Kingdom Chauvin Ankerpharm GmbH Fr. Elzer-Vetter Hansaallee 177 D D-40549 Düsseldorf Chiesi Farmaceutici SpA Dott. P. Chiesi Via Palermo, 26 A I-43100 Parma Glaxo Wellcome Mr Barry Rosenthal Liverpool L24 9JD United Kingdom IG Sprühtechnik GmbH Herrn F. Guck Im Hemmet 1 D-79664 Wehr Leiras Oy Mr Kai Buri, Pansiontie 47 P. O. Box 415 FIN-20101 Turku Laboratorios Lesvi SA Sr. Alejandro Biel Andrés Poligono Industrial Can Pelegrí E-08740 Sant Andreu de la Barca Laboratorios Miquel, SA Sr. A. Costa Espelleta Santanyí, 16 E-08016 Barcelona Norton Waterford Ltd Mr Jim Kennedy Unit 301 Industrial Park Waterford Ireland Nycomed Austria GmbH Dr. Vorreither St. -Peter-Straße 25 A-4020 Linz Orion Corporation Mr Pasi Salokangas Orionintie 1 FIN-02200 Espoo Rhône-Poulenc Rorer Mr K. J. Bradley London Road Holmes Chapel Cheshire CW4 8BE United Kingdom Schering-Plough Labo NV Mr P. Gyselinck Industriepark 30 B-2220 Heist op den Berg SICOR — Società italiana corticosteroidi SpA Dott. Roberto Giani Via Terrazzano, 77 I-20017 RHO (Milano) Valeas SpA Pharmaceuticals Dott. Virgilio Bernareggi Via Vallisneri, 10 I-20133 Milano Valois SA M. Chris Hall 50, avenue de l’Europe F-78160 Marly-le-Roi Laboratorios Vita, SA Sr. Alejandro Biel Andrés Av. Barcelona, 69 E-08970 Sant Joan Despí L 10/34 ‹ EN ‹ Official Journal of the European Communities 16. 1. 98 ANNEX II A. MEDICAL USES Production of metered dose inhalers (MDIs) for the treatment of asthma and other chronic obstructive pulmonary diseases (COPDs). Company 1998 quota allocation in tonnes (CFCs) 3M (UK) Bespak (UK) Boehringer (D) CCL Pharm (UK) Chauvin Ankerpharm (D) Chiesi (I) Glaxo Wellcome (UK) IG Sprühtechnik (D) Lab. Aldo-Unión (E) Lab. Astra (E) Lab. Lesvi (E) Lab. Miquel (E) Lab. Vita (E) Leiras (FI) Norton (Irl) Nycomed (A) Orion (F) Rhône-Poulenc Rorer (UK) Schering-Plough (B) Sicor (I) Valeas (I) Valois (F) Total 5 462,5 16. 1. 98 ‹ EN ‹ Official Journal of the European Communities L 10/35 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. Controlled substance Quantitative limit (in tonnes) CFCs Carbon tetrachloride 1,1,1 trichloroethane Other ODS 150 100 35 0,035 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