Commission Decision

of 16 April 2002

on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2002 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council

(notified under document number C(2002) 1410)

(Only the Danish, Dutch, English, Finnish, French, German, Italian, Portuguese, Spanish and Swedish texts are authentic)

(Text with EEA relevance)

(2002/612/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 2037/2000 of the European Parliament and of the Council of 29 June 2000 on substances that deplete the ozone layer(1), as last amended by Regulation (EC) No 2039/2000(2), and in particular to Articles 3 and 7 thereof;

Whereas:

(1) The Community has already phased out the production and consumption of chlorofluorocarbons, other fully halogenated chlorofluorocarbons, halons, carbon tetrachloride, 1,1,1-trichloroethane and hydrobromofluorocarbons.

(2) Each year the Commission has to determine what the essential uses of these controlled substances are, the quantities that may be used and the companies that may use them.

(3) Decision IV/25 of the Parties to the Montreal Protocol on substances that deplete the ozone layer, hereinafter "Montreal Protocol", sets out the criteria used by the Commission for determining any essential uses.

(4) Decision XII/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).

(5) Decision X/19 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, Decision VII/11 and Decision XI/15 of the Parties to the Montreal Protocol.

(6) Decision VIII/9 of the Parties to the Montreal Protocol allows the Secretariat to authorise, in an emergency situation, consumption of quantities not exceeding 20 tonnes of ozone-depleting substances (ODS) for essential uses on application by a Party, and the Community applied for such an emergency use to be allowed for oil-in-water testing in 2002.

(7) The Commission has published a notice(3) to those companies in the Community that intend to use controlled substances for essential uses in the Community in 2002, and has received declarations on intended essential uses of controlled substances in 2002.

(8) To meet the need for controlled substances for essential uses, production may be authorised in accordance with Article 3(5) of Regulation (EC) No 2037/2000 or an import may be licensed in accordance with Article 6 of that Regulation.

(9) The measures provided for in this Decision are in accordance with the opinion of the Committee established pursuant to Article 18 of Regulation (EC) No 2037/2000,

HAS ADOPTED THIS DECISION:

Article 1

1. The quantity of controlled substances of group I (chlorofluorocarbons 11, 12, 113, 114 and 115) subject to Regulation (EC) No 2037/2000 which may be used for essential medical uses in the Community in 2002 shall be 2558948,00 ODP (ozone depletion potential) weighted kilograms.

2. The quantity of controlled substances of group I (chlorofluorocarbons 11, 12, 113, 114 and 115) and group II (other fully halogenated chlorofluorocarbons) subject to Regulation (EC) No 2037/2000 which may be used for essential laboratory uses in the Community in 2002 shall be 135971,59 ODP weighted kilograms.

3. The quantity of controlled substances of group III (halons) subject to Regulation (EC) No 2037/2000 that may be used for essential laboratory use in the Community in 2002 shall be 3758,70 ODP weighted kilograms.

4. The quantity of controlled substances of group IV (carbon tetrachloride) subject to Regulation (EC) No 2037/2000 that may be used for essential laboratory uses in the Community in 2002 shall be 151668,50 ODP weighted kilograms.

5. The quantity of controlled substances of group V (1,1,1-trichloroethane) subject to Regulation (EC) No 2037/2000 that may be used for essential laboratory uses in the Community in 2002 shall be 641,18 ODP weighted kilograms.

6. The quantity of controlled substances of group VII (hydrobromofluorocarbons) subject to Regulation (EC) No 2037/2000 that may be used for essential laboratory uses in the Community in 2002 shall be 4,53 ODP weighted kilograms.

7. The quantity of controlled substances of groups I and IV subject to Regulation (EC) No 2037/2000 that may be used for oil-in-water testing in the Community in 2002 shall be 11927,50 ODP weighted kilograms of CFC 113 and 4502,50 ODP weighted kilograms of carbon tetrachloride.

Article 2

During the period 1 January to 31 December 2002 the following rules shall apply:

1. the allocation of essential medical use quotas for chlorofluorocarbons 11, 12, 113, 114 and 115 shall be to the companies indicated in Annex I;

2. the allocation of essential laboratory use quotas for chlorofluorocarbons 11, 12, 113, 114 and 115 and other fully halogenated chlorofluorocarbons shall be to the companies indicated in Annex II;

3. the allocation of essential laboratory use quotas for halons shall be to the companies indicated in Annex III;

4. the allocation of essential laboratory use quotas for carbon tetrachloride shall be to the companies indicated in Annex IV;

5. the allocation of essential laboratory use quotas for 1,1,1-trichloroethane shall be to the companies indicated in Annex V;

6. the allocation of essential laboratory use quotas for hydrobromofluorocarbons shall be to the companies indicated in Annex VI;

7. the allocation of essential laboratory use quotas for CFC 113 and carbon tetrachloride for oil-in-water testing shall be to the companies indicated in Annex VII;

8. the essential use quotas for chlorofluorocarbons 11, 12, 113, 114 and 115, other fully halogenated chlorofluorocarbons, carbon tetrachloride, 1,1,1-trichloroethane and hydrobromofluorocarbons shall be as set out in Annex VIII.

Article 3

This Decision is addressed to: 3M Health Care Ltd 3M House

Morley Street

LE11 1EP Loughborough United Kingdom Bespak plc North Lynn Industrial Estate

King's Lynn

Norfolk PE30 2JJ United Kingdom Boehringer Ingelheim GmbH Binger Straße 173 D - 55216 Ingelheim am Rhein Chiesi Farmaceutici SpA Via Palermo, 26/A I - 43100 Parma GlaxoSmithKline Speke Boulevard

Speke

Liverpool L24 9JD United Kingdom IG Sprühtechnik GmbH Im Hemmet 1 D - 79664 Wehr IVAX Ltd Unit 301 Industrial Park Waterford Ireland Jaba Farmacêutica SA Rua da Tapada Grande n.o 2 P - Abrunheira, 2710-089, Sintra Laboratorio Aldo Unión SA Baronessa de Maldá 73

Esplugues de Llobregat

E - 08950 Barcelona Laboratorios Lesvi SA Apartado de Correos, 65 E - 08740 Sant Andreu de la Barca (Barcelona) Laboratorios Vita SA Avinguda Barcelona 69 E - 08970 Sant Joan Despí MIZA Pharmaceuticals Ltd

Astmoor Industrial Estate

9 Arkwright Road Runcorn WA7 1NU United Kingdom Schering-Plough Labo NV Industriepark 30 B - 2220 Heist-op-den-Berg SICOR SpA Via Terrazzano, 77 I - 20017 Rho ( MI ) Valeas SpA Pharmaceuticals Via Vallisneri, 10 I - 20133 Milano Valois SA 50, avenue de l'Europe F - 78160 Marly Le Roi Valvole Aerosol Research Italiana (VARI) SpA LINDAL Group Italia Via del Pino, 10 I - 23854 Olginate ( LC ) Acros Organics bvba Janssen Pharmaceuticalaan 3a B - 2440 Geel Agfa-Gevaert NV Septestraat 27 B - 2640 Mortsel Atofina SA Cours Michelet - La Défense 10 F - 92091 Paris La Défense Airbus France 316, route de Bayonne F - 31300 Toulouse Bie & Bertsen Sanbækvej 7 DK - 2610 Rødovre Biosolove BV Waalreseweg 17 5554 HA Valkenswaard Nederland Butterworth Laboratories Ltd 54 Waldegrave Road, Teddington TW11 8NY United Kingdom Carl Roth GmbH Schoemperlenstraße 1-5 D - 76231 Karlsruhe Carlo Erba Réactifs Parc d'Activités des Portes

Ch. du Vexin,

BP 616 F - 27106 Val de Reuil Cedex Codif International 61, rue du Commandant-l'Herminier

Rothéneuf

F - 35404 Saint-Malo Cedex Dow Benelux BV Herbert H. Dowweg 4530 AA Terneuzen Nederland Fisher Scientific GmbH Im Heiligen Feld 17 D - 58239 Schwerte Fisher Scientific Bishop Meadow Road Loughborough LE11 5RG United Kingdom Honeywell Specialty Chemicals Wunstorfer Straße 40 Postfach 100262 D - 30918 Seelze Ineos Fluor Ltd PO Box 13, The Heath WA7 4QF Runcorn United Kingdom Katholieke Universiteit Leuven Krakenstraat 3 B - 3000 Leuven Laboratoires sérobiologiques 3, rue de Seichamps F - 54425 Pulnoy Mallinckrodt Baker BV Rijsterborgherweg 20 7412 VA Deventer Nederland Merck Eurolab 201, rue Carnot F - 94126 Fontenay-sous-bois Merck KgaA Frankfurter Straße 250 D - 64271 Darmstadt Panreac Quimica SA Riera de Sant Cugat 1 E - 08110 Montcada i Reixac (Barcelona) Promochem GmbH Mercatorstraße 51 D - 46485 Wesel Rathburn Chemicals Mfg Ltd Caberston Road Walkerburn EH43 6AS United Kingdom SDS Solvants, Documentation, Synthèses SA Z.I. de Valdonn, BP 4 F - 13124 Peypin Sigma Aldrich Chemie GmbH Riedstraße 2 D - 89555 Steinheim Sigma Aldrich Chimie SARL 80, rue de Luzais, L'isle d'abeau Chesnes F - 38297 Saint-Quentin-Fallavier Sigma Aldrich Company Ltd The Old Brickyard

New Road

Gillingham SP8 4XT United Kingdom Sigma Aldrich Laborchemikalien Wunstorfer Straße 40 Postfach 100262 D - 30918 Seelze YA Kemia Oy Teerisuonkuja 4 FIN - 00700 Helsinki

Done at Brussels, 16 April 2002.

For the Commission

Margot Wallström

Member of the Commission

(1) OJ L 244, 29.9.2000, p. 1.

(2) OJ L 244, 29.9.2000, p. 26.

(3) OJ C 205, 21.7.2001, p. 2.

ANNEX I

ESSENTIAL MEDICAL USES

Quota of controlled substances of Group I that may be used in the production of metered dose inhalers (MDIs) for the treatment of asthma and other chronic obstructive pulmonary diseases (COPDs) are allocated to:

3M (UK)

Bespak (UK)

Boehringer Ingelheim (D)

Chiesi (I)

Glaxo Smith Kline (UK)

IG Sprühtechnik (D)

IVAX (IRL)

Jaba Farmacêutica (P)

Laboratorios Lesvi (E)

Laboratorios Vita (E)

Laboratorio Aldo-Unión (E)

Miza Pharmaceuticals (UK)

Schering-Plough (B)

Sicor (I)

V.A.R.I. (I)

Valeas (I)

Valois (F)

ANNEX II

ESSENTIAL LABORATORY USES

Quota of controlled substances of Group I and II that may be used for laboratory and analytical uses are allocated to:

Agfa-Gevaert (B)

Atofina (F)

Bie & Berntsen (DK)

Biosolve (NL)

Carl Roth (D)

Carlo Erba Réactifs (F)

Dow Benelux (NL)

Fisher Scientific (D)

Fisher Scientific (UK)

Honeywell Specialty Chemicals (D)

Ineos Fluor (UK)

Katholieke Universiteit Leuven (B)

Merck Eurolab (F)

Merck (D)

Panreac Química (E)

Promochem (D)

Rathburn Chemicals (UK)

SDS Solvants (F)

Sigma Aldrich Chemie (D)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

YA Kemia Oy (FIN)

ANNEX III

ESSENTIAL LABORATORY USES

Quota of controlled substances of Group III that may be used for laboratory and analytical uses are allocated to:

Airbus (F)

Butterworth Laboratories (UK)

Ineos Fluor (UK)

Sigma Aldrich Company (UK)

ANNEX IV

ESSENTIAL LABORATORY USES

Quota of controlled substances of Group IV that may be used for laboratory and analytical uses are allocated to:

Acros Organics (B)

Agfa-Gevaert (B)

Bie & Berntsen (DK)

Biosolve (NL)

Carlo Erba Réactifs (F)

Codif International (F)

Dow Benelux (NL)

Fisher Scientific (UK)

Katholieke Universiteit Leuven (B)

Laboratoires Sérologiques (F)

Mallinckrodt Baker (NL)

Merck Eurolab (F)

Merck (D)

Panreac Química (E)

Rathburn Chemicals (UK)

SDS Solvants (F)

Sigma Aldrich Chemie (D)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

Sigma Aldrich Laborchemikalien (D)

YA Kemia Oy (FIN)

ANNEX V

ESSENTIAL LABORATORY USES

Quota of controlled substances of Group V that may be used for laboratory and analytical uses are allocated to:

Acros Organics (B)

Agfa-Gevaert (B)

Bie & Berntsen (DK)

Dow Benelux (NL)

Katholieke Universiteit Leuven (B)

Mallinckrodt Baker (NL)

Merck (D)

Panreac Química (E)

Rathburn Chemicals (UK)

Sigma Aldrich Chemie (D)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

ANNEX VI

ESSENTIAL LABORATORY USES

Quota of controlled substances of Group VII that may be used for laboratory and analytical uses are allocated to:

Ineos Fluor (UK)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

ANNEX VII

EMERGENCY ESSENTIAL LABORATORY USE

Quota of controlled substances CFC 113 and carbon tetrachloride that may be imported for the temporarily exempted use of oil-in-water testing are allocated to:

Bie & Berntsen (DK)

Biosolve (NL)

Carlo Erba Réactifs (F)

Carl Roth (D)

Fisher Scientific (D)

Honeywell Specialty Chemicals (D)

Mallinckrodt Baker (NL)

Merck (D)

Promochem (D)

Rathburn Chemicals (UK)

16430 ODP weighted kilograms of controlled substances may be imported for oil-in-water testing for use by laboratories in Denmark, Finland, the Netherlands, Spain and Sweden. No Member State may authorise production of ozone depleting substances for oil-in-water testing. Laboratories and suppliers cannot supply ozone depleting substances from stocks for oil-in-water testing.

The importers listed in Annex VII shall not supply the controlled substances imported for the exempted use to users in Austria, Belgium, France, Germany, Greece, Ireland, Italy, Luxembourg, Portugal and the United Kingdom from 1 January 2002.

Enterprises using ozone depleting substances for oil-in-water testing in Austria, Belgium, France, Germany, Greece, Ireland, Italy, Luxembourg, Portugal and the United Kingdom from 1 January 2002 will be in non-compliance with Regulation No (EC) 2037/00.