COMMISSION DECISION of 20 December 1995 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 1996 under Council Regulation (EC) No 3093/94 on substances that deplete the ozone layer (95/555/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 (1), and in particular Articles 3, 4 and 7 thereof,

Whereas, because of concerns for the ozone layer, the Community has decided to phase out certain controlled substances earlier than provided for in the Montreal Protocol commencing on 1 January 1995;

Whereas Article 3 (1), (2), (3), (4), (5) and (7) of Regulation (EC) No 3093/94 states that the Commission shall determine every year any essential uses which may be permitted in the Community and any quantities of controlled substances which may be produced, placed on the market or used for these purposes;

Whereas, pursuant to the abovementioned Regulation, those 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:

(a) that a use of a controlled substance should qualify as 'essential` only if:

(i) it is a necessary for health or safety, or is critical for the functioning of society (including cultural and intellectual aspects); and (ii) there are no technically and economically feasible alternatives or substitutes that are acceptable environmentally or from the health point of view;

(b) that production and consumption, if any, of a controlled substance for essential uses should be permitted only if:

(i) all economically feasible steps have been taken to minimize the essential use and associated emission of the controlled substance; and (ii) the controlled substance is not available in sufficient quantity and quality from existing stocks of banked or recycled controlled substances, account also being taken of the needs of developing countries for controlled substances;

Whereas Decision VI/9 of the Parties to the Montreal Protocol authorizes the levels of production or consumption necessary to satisfy essential uses of controlled substances for (i) metered dose inhalers (MDIs) for the treatment of asthma and chronic obstructive pulmonary diseases (COPD) and for (ii) laboratory and analytical uses as specified in Annex I to this Decision;

Whereas the same Decision VI/9 also commits Parties to endeavouring to minimize use and emissions by all possible means; whereas in the case of MDIs, these means include educating physicians and patients about other treatment options and making real efforts to eliminate or recapture emissions from filling and testing consistent with national laws and regulations;

Whereas after receiving a certain number of applications from Member States, the Commission published Decision 95/324/EC (1) which recognizes the production of MDIs for the treatment of asthma and other COPDs and laboratory uses as essential uses and specifies quantities for the European Community on behalf of the Member States for 1996, in line with the Montreal Protocol Decisions IV/25 and VI/9 mentioned above;

Whereas the quantity of 1,1,1-trichloroethane authorized in Decision 95/324/EC is not sufficient for the essential laboratory and analytical uses;

Whereas, in order to increase the quantities of 1,1,1-trichloroethane to meet the essential laboratory uses identified in Decision 95/324/EC, the Commission shall identify the distributors who may supply the controlled substances for that purpose;

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 1996 pursuant to Regulation (EC) No 3093/94, and has thereby revealed applications for quantities of controlled substances for essential uses for 1996;

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 1996;

Whereas the Commission issues licences to the users identified pursuant to Articles 3, 4 and 7 and in accordance with the procedure set out in Article 16 of Regulation (EC) No 3093/94;

Whereas, consequently, within this framework a producer may be authorized by the competent authority of the Member State in which its relevant production is situated to produce the controlled substances for the purpose 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 authorization;

Whereas Article 16 of Regulation (EC) No 3093/94 sets out the procedure according to which decisions can be taken concerning the implementation of the Regulation;

Whereas the measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 16 of Regulation (EC) No 3093/94;

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,

HAS ADOPTED THIS DECISION:

Article 1

Companies which may take advantage of essential uses for their own account or which put the controlled substances in free circulation with a view to exemptions being granted for essential laboratory uses are listed in Annex I.

Article 2

Further to Article 1 (1) of Decision 95/324/EC, the quantities of 1,1,1-trichloroethane for essential laboratory uses shall be increased by 300 tonnes.

Article 3

The allocation of quantities for essential uses is specified in Annex II.

Article 4

This Decision is addressed to the companies listed in Annex I.

Article 5

This Decision shall apply from 1 January to 31 December 1996.

Done at Brussels, 20 December 1995.

For the Commission Ritt BJERREGAARD Member of the Commission

ANEXO I - BILAG I - ANHANG I - ÐÁÑÁÑÔÇÌÁ É - ANNEX I - ANNEXE I - ALLEGATO I - BIJLAGE I - ANEXO I - LIITE I - BILAGA I

USOS MÉDICOS / MEDICINSKE ANVENDELSESFORMAAL / MEDIZINISCHE VERWENDUNGEN / ÉÁÔÑÉÊAAÓ ×ÑÇÓAAÉÓ / MEDICAL USES / UTILISATIONS MÉDICALES / USO MEDICO / MEDISCHE TOEPASSING / UTILIZAÇÕES MÉDICAS / LAEAEKETIETEELLINEN KAEYTTOE / MEDICINSK ANVAENDNING

3M Health Care Ltd Mr A. J. Maynard 3M House Morley Street Loughborough GB-Leicestershire LE11 1EP Ankerpharm GmbH Fr. Elzer-Vetter Hansa-Allee 177 D D-Duesseldorf Laboratorio Astra España SA Dr. E. Cabré Matas Mestre Joan Corrales, 95-105 Esplugues de Llobregat E-08950 Esplugues de Llobregat Bespak PLC Mr M. A. Talbot Bergen Way King's Lynn GB-Norfolk PE30 2JJ Boehringer Ingelheim GmbH J. Pink D-55216 Ingelheim/Rhein CCL Industries Ltd Mrs C. King Astmoor Industrial Estate 9 Arkwright Road GB-Runcorn WA7 1NU Chiesi Farmaceutici SpA Dr P. Chiesi Via Palermo, 26/A I-43100 Parma Fisher Pharmaceuticals Mr K. Gould 12 Derby Road Loughborough Leicesterhire GB-LE11 0BB Glaxo Manufacturing Services Ltd Mr Jan Piskaldo Priory Street GB-Ware, Hertfordshire SG12 0DJ IGS Spruehtechnik GmbH F. Guck Im Hemmet 1 D-79664 Wehr Baden Jaba Farmacêutica Ana Maria Baptista de Almeida Apartado 165 Abrunheira P-2710 Sintra Leiras Oy Pansiontie 47 PL 415 FIN-20101 Turku Lesvi Pol. Ind. Can Pelegrí E-08740 Sant Andreu de la Barca (Barcelona) Laboratorio Aldo-Unión SA Dr. José Sabater Sanmartí Àngel Guimerà, 123-125 E-08950 Esplugues de Llobregat Norton Ltd Mr Peter Earps IDA Industrial Estate Cork Road IRL-Waterford Orion-Farmos Pasi Salokangas Orionintie 1 PL 65 FIN-02101 Espoo Pharmasol Ltd Mr N. J. Ball North Way Walworth Industrial Estate, Andover GB-Hampshire SP10 5AZ Resolution Chemicals Dr Chris Homan Wodgewood Way GB-Stevenage, Hertfordshire SG1 4QT Rexam Dispenser SpA Via del Pino, 10 I-22057 Olginate (Lecco) Schering-Plough Labo N.V.

Ms Ingrid Van de Poel Industriepark 30 B-2220 Heist op den berg Sicor Società Italiana Corticosteroidi SpA Dr Roberto Giani Via Terrazzano, 77 I-20017 Rho (MI) Valeas SpA Pharmaceuticals Dr Virgilo Bernareggi 10, Via Vallisneri I-20133 Milan Société Valois M. O. Fourment 50, avenue de l'Europe F-78160 Marly-le-Roi Vita Mr Enric Vallès Av. Barcelona, 69 E-08970 Sant Joan Despí

USOS DE LABORATORIO / LABORATORIEFORMAAL / VERWENDUNG ZU LABORZWECKEN / AAÑÃÁÓÔÇÑÉÁÊAAÓ ×ÑÇÓAAÉÓ / LABORATORY USES / UTILISATIONS EN LABORATOIRE / USO PER SCOPI DI LABORATORIO / LABORATORIUMTOEPASSINGEN / UTILIZAÇÕES LABORATORIAIS / LABORATORIOKAEYTTOE / LABORATORIE ANVAENDNING

Ausimont SpA Dr Enzo Giannetti Viale Lombardia, 20 I-20021 Bollate Bie & Berntsen AS Mona Slothuus Sandbaekvej 7 DK-2610 Roedovre Carlo Erba Reactifs M. J.M. Ervay Chaussée du Vexin Parc d'Affaires des Portes Boîte postale 616 F-27106 Val-de-Reuil Carlo Erba Reagenti Srl Dr Roberto Baschieri Via Winckelmann, 1 I-Milano Dehon Service M. Claude Brian 26, avenue du Petit-Parc F-94683 Vincennes Cedex Dideco SpA Mr Giorgio Sgarbi Via Statale 12 Nord 86 I-41037 Mirandola Laboratoires Domilens Mme Christine Jacquemier 321, avenue Jean-Jaurès Boîte postale 7254 F-69354 Lyon Cedex 07 Elf Atochem (Centre de recherche Rhône-Alpes) M. Paul Kiener Rue Henri-Moissan F-Pierre-Bénite Cedex Elf Atochem (Centre d'application de Levallois) M. J.-P. Alais 95, rue Danton Boîte postale 108 F-92303 Levallois-Perret Fisia SpA Strada Torino, 50 I-10043 Orbassano Fisher Scientific Ltd Mr G. Smith Bishop Meadow Road Loughborough GB-Leicestershire LE11 0RG Distillerie Haugel M. Ferin 37, route de Saint-Laurent Hameau de Gournay F-76700 Gonfreville-l'Orcher Ismar Chimica Srl Dr Fabio de Paz Via Isocorte, 16 I-16164 Genova Lactan Ges.mbH & Co. KG Walter Posch Zinzendorfgasse 10-12 A-8011 Graz Linna-Ryhmae Oy Hannu Pesonen Savilahdentie 6 FIN-70260 Kuopio Mallinckrodt Baker B.V.

Mr Fleurink Rijsterborgherweg 20 Postbus 1 NL-7400 AA Deventer Merck Ltd Mr P. E. Wall Merck House Poole GB-Dorset BH15 1TD Merck KGaA K.-H. Mocikat D-64271 Darmstadt Mikrolab Aarhus Axel Kiers 34 DK-8270 Hoejbjerg OSI M. J.-P. Frocot Chemin de Montchevillon F-02210 Oulchy-le-Château Prolabo M. H. Doucerain 54, rue Roger Salengro F-94126 Fontenay-sous-Bois Cedex Promochem GmbH T. Karrer Mercatorstr. 51 D-46485 Wesel Renault VI Mlle Claire Adenis 402, avenue Charles-de-Gaulle F-69635 Vénissieux Cedex Riedel-de-Haen Dr. Creutzburg Wunstorfer Str. 40 D-30926 Seelze Romil Ltd Dr R. Lenk The Source Convent Drive Waterbeach GB-Cambridgeshire CB5 9QT SDS M. Philippe Coste ZI Valdonne Boîte postale 4 F-13124 Peypin Sigma-Aldrich Chimie s.a.r.l.

Me Karine Duval L'Isle-d'Abeau-Chesnes Boîte postale 701 F-38297 Saint-Quentin-Fallavier Sigma-Aldrich Company Ltd Dr Chris Hewitt The Old Brickyard New Road Gillingham GB-Dorset SP8 4JL Sigma-Aldrich Chemie GmbH Geschaeftsbereich Aldrich Dr. Gerd Backes Riedstrasse 2 D-89555 Steinheim Sigma-Aldrich Chemie GmbH Dr. Christoph Zimmermann Geschaeftsbereich Fluka Messerschmittstr. 17 D-89231 Neu-Ulm Vel N.V.

Dr Ronny Kennis Geldenaaksebaan 464 B-3001 Leuven Ya-Kemia Oy Timo Posti Kalliolanrinne 6 FIN-00510 Helsinki

ANNEX II

A. MEDICAL USES

Production of metered dose inhalers (MDIs) for the treatment of asthma and other chronic obstructive pulmonary diseases (CFCs) >TABLE>

B. LABORATORY USES

B.1. CFCs

>TABLE>

B.2. Carbon tetrachloride

>TABLE>

B.3. 1,1,1-Trichloroetane

>TABLE>