Commission Decision

of 28 January 2004

on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2004 pursuant to Regulation (EC) No 2037/2000 of the European Parliament and of the Council

(notified under document number C(2004) 103)

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

(2004/209/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), and in particular Article 3(1) 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, hydrobromofluorocarbons and bromochloromethane.

(2) Each year the Commission has to determine essential uses for these controlled substances, 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 "the Montreal Protocol"), sets out the criteria used by the Commission for determining any essential uses and authorises the production and consumption necessary to satisfy essential uses of controlled substances.

(4) Decision XV/8 of the Parties to the Montreal Protocol authorises the production and consumption necessary to satisfy essential uses of controlled substances listed in Annexes A, B and C (groups II and III substances) to the Montreal Protocol 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.

(5) Pursuant to paragraph 3 of Decision XII/2 of the twelfth meeting of the Parties to the Montreal Protocol on measures to facilitate the transition to chlorofluorocarbon-free metered-dose inhalers (MDIs), Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Luxembourg, Norway, Portugal, the Netherlands and the United Kingdom have recently determined that chlorofluorocarbons (CFCs) are no longer essential for the manufacture of specific short-acting beta agonist CFC-MDIs(2). Article 4(4)(i)(b) of Regulation (EC) No 2037/2000 in effect prevents CFCs from being used and placed on the market unless they are considered essential under the conditions described in Article 3(1) of that Regulation. These non-essentiality determinations have reduced the demand for CFCs in the Community. In addition, Article 4(6) of Regulation (EC) No 2037/2000 prevents CFC-MDI products being imported and placed on the market unless the CFCs in these products are considered essential under the conditions described in Article 3(1).

(6) The Commission has published a Notice(3) to those companies in the Community that request consideration by the Commission for the use of controlled substances for essential uses in the Community in 2004, and has received declarations on intended essential uses of controlled substances in 2004.

(7) The measures provided for in this Decision are in accordance with the opinion of the Management 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 2004 shall be 1428553,000 ODP (ozone depletion potential) 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 2004 shall be 63198,365 ODP 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 2004 shall be 19268,700 ODP 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 2004 shall be 141694,630 ODP 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 2004 shall be 525,800 ODP 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 2004 shall be 3,070 ODP kilograms.

7. The quantity of controlled substances of group IX (bromochloromethane) subject to Regulation (EC) No 2037/2000 that may be used for essential laboratory uses in the Community in 2004 shall be 13248 ODP kilograms.

Article 2

The chlorofluorocarbon metered-dose inhalers (CFC-MDIs) listed in Annex I shall not be placed on markets that have determined CFCs for these products to be non-essential.

Article 3

During the period 1 January to 31 December 2004 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 II.

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 III.

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

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

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

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

7. The allocation of essential laboratory use quotas for bromochloromethane shall be to the companies indicated in Annex VIII.

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

Article 4

This Decision is addressed to:

3M Health Care Ltd 3M House Morley Street Loughborough Leicestershire LE11 1EP United Kingdom

Bespak PLC North Lynn Industrial Estate King's Lynn Norfolk PE30 2JJ United Kingdom

Chiesi Farmaceutici SpA Via Palermo 26/A I - 43100 Parma

IG Sprühtechnik GmbH Im Hemmet 1 D - 79664 Wehr

Jaba Farmaceutica SA Rua da Tapada Grande n.o 2 P - 2710-089 Abrunheira, Sintra

Inyx Pharmaceuticals Ltd Astmoor Industrial Estate

9 Arkwright Road

Runcorn Cheshire WA7 1NU United Kingdom

Schering-Plough Labo NV Industriepark 30 B - 2220 Heist Op Den Berg

Valeas SpA Pharmaceuticals Via Vallisneri, 10 I - 20133 Milano

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

Biosolove BV Waalreseweg 17 5554 HA Valkenswaard Nederland

Carl Roth GmbH Schoemperlenstr. 1-5 D - 76185 Karlsruhe

Fisher Scientific Bishop Meadow Road LE11 5RG Loughborough United Kingdom

Honeywell Specialty Chemicals Wunstorfer Straße 40 Postfach 100262 D - 30918 Seelze

Katholieke Universiteit Leuven Krakenstraat 3 B - 3000 Leuven

LGC Promochem GmbH Mercatorstr. 51 D - 46485 Wesel

Panreac Quimica SA Riera de Sant Cugat 1 E - 08110 Montcada I Reixac ( Barcelona )

Rohs Chemie GmbH Berliner Str. 54 D - 53819 Neunkirchen-Seelsheid

Sigma Aldrich Chemie GmbH Riedstraße 2 D - 89555 Steinheim

Sigma Aldrich Company Ltd The Old Brickyard

New Road

Gillingham SP8 4XT United Kingdom

VWR ISAS 201 rue Carnot F - 94126 Fontenay-sous-Bois

Airbus France route de Bayonne 316 F - 31300 Toulouse

University of Technology Vienna Institute of Industrial Electronics and Material Science Gusshausstraße 27-29 A - 1040 Wien

Aventis London Road, Holmes Chapel Cheshire CW4 8BE United Kingdom

Boehringer Ingelheim GmbH Binger Straße 173 D - 55216 Ingelheim am Rhein

GlaxoSmithKline Speke Boulevard

Speke

Liverpool L24 9JD United Kingdom

IVAX Ltd Unit 301 Industrial Park Waterford Ireland

Laboratorio Aldo Unión SA Baronesa de Maldá 73

Espluges de Llobregat

E - 08950 Barcelona

Otsuka Pharmaceuticals(E) Provenca, 388 E - 08025 Barcelona

SICOR SpA Via Terrazzano, 77 I - 20017 RHO Milano

Valois SA 50, avenue de l'Europe F - 78160 Marly Le Roi

Mallinckrodt Baker BV Teugseweg 20 7418 AM Deventer Nederland

Agfa-Gevaert NV Septestraat 27 B - 2640 Mortsel

Bie & Berntsen Sandbækvej 7 DK - 2610 Rødovre

Butterworth Laboratories Ltd 54 Waldegrave Road, Teddington Middlesex TW11 8NY United Kingdom

Environnement SA 111 Bd Robespierre, BP 4513 F - 78304 Poissy

Ineos Fluor Ltd PO Box 13, The Heath Runcorn Cheshire WA7 4QF United Kingdom

Laboratoires Sérobiologiques 3 rue de Seichamps F - 54425 Pulnoy

Merck KgaA Frankfurter Straße 250 D - 64271 Darmstadt

Institut Scientifique de Service Public (ISSeP) Rue du Chéra 200 B - 4000 Liège

SDS Solvants, Documentation, Synthèses SA ZI de Valdonne, BP 4 F - 13124 Peypin

Sigma Aldrich Chimie SARL 80 rue de Luzais

L'isle d'abeau Chesnes

F - 38297 St Quentin Fallavier

Sigma Aldrich Laborchemikalien Wunstorfer Straße 40 Postfach 100262 D - 30918 Seelze

YA-Kemia Oy - Sigma Aldrich Finland Teerisuonkuja 4 FIN - 00700 Helsinki

Institut E. Malvoz (B) Quai du Barbou, 4 B - 4000 Liège

Done at Brussels, 28 January 2004.

For the Commission

Margot Wallström

Member of the Commission

(1) OJ L 244, 29.9.2000, p. 1. Regulation as last amended by Regulation (EC) No 1804/2003 (OJ L 265, 16.10.2003, p. 1).

(2) www.unep.org/ozone/dec12-2-3.shtml

(3) OJ C 162, 11.7.2003, p. 19.

ANNEX I

Pursuant to paragraph 3 of Decision XII/2 of the twelfth meeting of the Parties to the Montreal Protocol on measures to facilitate the transition to chlorofluorocarbon-free metered-dose inhalers (MDIs), the following Parties have determined in December 2002 that, due to the presence of suitable non-CFC MDIs, CFCs no longer qualify as "essential" according to the Protocol when combined with following products:

List of non-essential substances

>TABLE>

Source:

www.unep.org/ozone/dec12-2-3.pdf

ANNEX II

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)

Aventis (UK)

Bespak (UK)

Boehringer Ingelheim (D)

Chiesi (I)

Glaxo Smith Kline (UK)

IG Sprühtechnik (D)

IVAX (IRL)

Jaba Farmaceutica (P)

Lab. Aldo-Union (E)

Inyx Pharmaceuticals (UK)

Otsuka Pharmaceuticals (E)

Schering-Plough (B)

Sicor (I)

Valeas (I)

Valois (F)

VARI (I)

ANNEX III

ESSENTIAL LABORATORY USES

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

Agfa-Gevaert (B)

Bie & Berntsen (DK)

Biosolve (NL)

Butterworth Laboratories (UK)

Carl Roth (D)

Environnement SA (F)

Honeywell Specialty Chemicals (D)

Ineos Fluor (UK)

Katholieke Universiteit Leuven (B)

LGC Promochem (D)

Merck KGaA (D)

Mallinckrodt Baker (NL)

Panreac Quimica (E)

SDS Solvants (F)

Sigma Aldrich Chemie (D)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

University of Technology Vienna (AUT)

Ya Kemia Oy - Sigma Aldrich (FIN)

ANNEX IV

ESSENTIAL LABORATORY USES

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

Airbus France (FR)

Butterworth Laboratories (UK)

Ineos Fluor (UK)

Sigma Aldrich Chimie (FR)

Sigma Aldrich Company (UK)

ANNEX V

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)

Butterworth Laboratories (UK)

Fisher Scientific (UK)

Institut E. Malvoz (B)

Institut Scientifique de Service Public (ISSeP) (B)

Katholieke Universiteit Leuven (B)

Laboratoires Sérologiques (F)

Mallinckrodt Baker (NL)

Merck KGaA (D)

Panreac Quimica (E)

Rohs Chemie (D)

SDS Solvants (F)

Sigma Aldrich Chemie (D)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

Sigma Aldrich Laborchemikalien (D)

VWR ISAS (F)

YA-Kemia Oy (FIN)

ANNEX VI

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)

Katholieke Universiteit Leuven (B)

Mallinckrodt Baker (NL)

Panreac Quimica (E)

Sigma Aldrich Chemie (D)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

ANNEX VII

ESSENTIAL LABORATORY USES

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

Acros Organics (B)

Ineos Fluor (UK)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

ANNEX VIII

ESSENTIAL LABORATORY USES

Quota for bromochloromethane that may be used for laboratory and analytical uses are allocated to:

Ineos Fluor (UK)

Sigma Aldrich Chemie (D)

Sigma Aldrich Chimie (F)

ANNEX IX

[This Annex is not published because it contains confidential commercial information.]