1999/59/EC: Commission Decision of 11 January 1999 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 1999 under Council Regulation (EC) No 3093/94 on substances that deplete the ozone layer (notified under document number C(1998) 4564) (Only the Spanish, German, English, French, Italian, Dutch and Finnish texts are authentic) (Text with EEA relevance)
L 19/18 EN Official Journal of the European Communities 26. 1. 1999 COMMISSION DECISION of 11 January 1999 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 1999 under Council Regulation (EC) No 3093/94 on substances that deplete the ozone layer (notified under document number C(1998) 4564) (Only the Spanish, German, English, French, Italian, Dutch and Finnish texts are authentic) (Text with EEA relevance) (1999/59/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 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 chloroflu- orocarbons (Articles 3(1) and 4(1)); other fully halogenated chlorofluorocarbons and 4(2)); halons (Articles 3(2) (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 as follows: 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 controlled substance for essential uses permitted only if: any, of a should be (b) the controlled substance is not available in suffi- cient quantity and quality from existing stocks of recycled controlled substances, also banked or bearing in mind the needs of developing countries for controlled substances; the authorises Whereas Decision IX/18 of the Parties to the Montreal Protocol 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 Decision IX/17 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 1999 pursuant to Council Regulation (EC) No 3093/94, and has thereby received applications for quantities of controlled substances for essential uses in 1999; in the framework of Whereas, 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 1999; (a) all economically feasible steps have been taken to minimise the essential use and any associated emission of the controlled substance; and 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; (1) OJ L 333, 22. 12. 1994, p. 1. (2) OJ C 242, 1. 8. 1998, p. 11. 26. 1. 1999 EN Official Journal of the European Communities L 19/19 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 IX/17 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 1999; 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, ture of metered dose inhalers and for the coating of cardiovascular surgical material are listed in Annex I. Article 2 The total quantities of controlled substances permitted for essential uses during 1999 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 1999 to 31 2. December 1999. HAS ADOPTED THIS DECISION: Done at Brussels, 11 January 1999. Article 1 Companies which may take advantage of the essential uses for their own account during 1999 for the manufac- For the Commission Ritt BJERREGAARD Member of the Commission L 19/20 EN Official Journal of the European Communities 26. 1. 1999 ANEXO I — BILAG I — ANHANG I — PAQAQTGLA I — 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 Maldá 73 Espluges de Llobregat E-08950 Barcelona Laboratorio Astra España SA Dr. E. Cabré Matas Mestre Joan Corrales, 95-105 Esplugues de Llobregat E-08950 Barcelona Baxter BV Dr. T. Bronkhorst Energielaan 3 P. O. Box 169 NL-5400 AD Uden 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 Cheshire WA7 1NU United Kingdom Chiesi Farmaceutici SpA Dott. P. Chiesi Via Palermo, 26 A I-43100 Parma Glaxo Wellcome Mr Barry Rosenthal Speke 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 Orion Corporation Mr Pasi Salokangas Orionintie 1 FIN-02200 Espoo Rhône-Poulenc Rorer Mr Bob Netrefa 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 — Societ 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 26. 1. 1999 EN Official Journal of the European Communities L 19/21 ANNEX II A. MEDICAL USES Production of metered dose inhalers (MDIs) for the treatment of asthma and other chronic obstructive pulmonary diseases (COPDs). Company 1999 quota allocation in tonnes (CFCs) 3M (UK) Bespak (UK) Boehringer (D) CCL Pharmaceuticals (UK) Chiesi (I) Glaxo Wellcome (UK) IG Sprühtechnik (D) Lab. Aldo-Unión (E) Lab. Astra (E) Lab. Lesvi (E) Lab. Vita (E) Leiras (FIN) Norton (IRL) Otsuka (E) Orion (FIN) Rhône-Poulenc Rorer (UK) Schering-Plough (B) Sicor (I) Valeas (I) Valois (F) Total 4 429 L 19/22 EN Official Journal of the European Communities 26. 1. 1999 B. LABORATORY USES Total quantities of controlled substances which may be produced or imported during 1999 for laboratory and analytical uses. Controlled substance Quantitative limit (in tonnes) CFCs Carbon tetrachloride 1,1,1-trichloroethane Other ODS 150 150 35 0,005 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 1999 for laboratory and analytical purposes shall not exceed the quantities listed above. C. CARDIOVASCULAR SURGICAL MATERIALS Controlled substance CFC 113 Quantity (in tonnes) 0,100