
COMMISSION DECISION of 23 February 2005 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2004 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council (notified under document number C(2005) 293) (Only the Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Italian, Portuguese, Slovenian and Spanish texts are authentic) (Text with EEA relevance) (2005/171/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, 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, hydrobromofluorocarbon and bromo-chloromethane.

(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 in each Party.

(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 (Group II and III substances) of 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 12th Meeting of the Parties to the Montreal Protocol on measures to facilitate the transition to chlorofluorocarbon-free metered-dose inhalers (MDIs), Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Luxembourg, Norway, Portugal, the Netherlands, Sweden and the United Kingdom have notified the United Nations Environment Programme that chlorofluorocarbons (CFCs) are no longer essential for the manufacture of specific short-acting beta agonist CFC-MDIs. Article 4(4)(i)(b) of Regulation (EC) No 2037/2000 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) 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 published a notice on 11 July 2003 to those companies in the Community (15) that request consideration by the Commission for the use of controlled substances for essential uses in the Community in 2004 and a further notification to companies in the 10 new Member States on 11 May 2004, and has received declarations on intended essential uses of controlled substances in 2004.

(7) Commission Decision 2004/209/EC 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 should be amended in order to take account of the inclusion of specific quantities of ozone depleting substances required for essential uses in the 10 new Member States from 1 May 2004.

(8) In the interests of legal clarity and transparency Decision 2004/209/EC should therefore be replaced.

(9) The measures provided for in this Decision are in accordance with the opinion of the Management Committee established by Article 18(1) 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 1 428 533,0 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 73 336,765 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 19 268,7 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 141 834,0 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 European Union in 2004 shall be 529,300 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 13,248 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 
Decision 2004/209/EC is repealed.
References to the repealed Decision shall be construed as references to this Decision.
Article 5 
This Decision is addressed to the following undertakings:

 3M Health Care Ltd3M House Morley StreetLoughboroughLeicestershire LE11 1EPUnited Kingdom
 AventisLondon Road, Holmes ChapelCheshire CW4 8BEUnited Kingdom
 Bespak PLCNorth Lynn Industrial EstateKing's LynnNorfolk PE30 2JJUnited Kingdom
 Boehringer Ingelheim GmbHBinger Strasse 173D-55216 Ingelheim am Rhein
 Chiesi Farmaceutici SpAVia Palermo 26/AI-43100 Parma
 GlaxoSmithKlineSpeke BoulevardSpekeLiverpool L24 9JDUnited Kingdom
 IG Sprühtechnik GmbHIm Hemmet 1D-79664 Wehr
 Inyx Pharmaceuticals LtdAstmoor Industrial Estate9 Arkwright Road RuncornCheshire WA7 1NUUnited Kingdom
 IVAX LtdUnit 301 Industrial ParkWaterfordIreland
 Jaba Farmaceutica SARua da Tapada Grande, 2P-2710-089, Abrunheira Sintra
 Laboratorio Aldo Union SABaronesa de Maldá 73Espluges de LlobregatE-08950 Barcelona
 Otsuka Pharmaceuticals (E)Provenca, 388E-08025 Barcelona
 SICOR SpAVia Terrazzano 77I-20017 RHO Milano
 Schering-Plough Labo NVIndustriepark 30B-2220 Heist Op Den Berg
 Valvole Aerosol Research Italiana(VARI) Spa — LINDAL Group ItaliaVia del Pino, 10Olginate (LC)I-23854 Italia
 Valeas SpA PharmaceuticalsVia Vallisneri, 10I-20133 Milano
 Valois SA50 avenue de l’EuropeF-78160 Marly-Le-Roi
 Acros Organics bvbaJanssen Pharmaceuticalaan 3aB-2440 Geel
 Airbus France316, route de BayonneF-31300 Toulouse
 Agfa-Gevaert NVSeptestraat 27B-2640 Mortsel
 Bie & BerntsenSandbækvej 7DK-2610 Rødovre
 Biosolove BVWaalreseweg 175554 HA ValkenswaardThe Netherlands
 Butterworth Laboratories Ltd54 Waldegrave Road, TeddingtonMiddlesex TW11 8NYUnited Kingdom
 Carl Roth GmbHSchoemperlenstr. 1—5D-76185 Karlsruhe
 Elcom GroupOkružní 988CZ-735 14 Orlová — Lutyně
 Environnement SA111, Bld RobespierreBP 4513F-78304 Poissy
 Fisher ScientificBishop Meadow RoadLoughborough LE11 5RGUnited Kingdom
 Health Protection Inspectorate-LaboratoriesPaldiski mnt 81EE-10617 Tallinn
 Honeywell Specialty ChemicalsWunstorfer Straße 40Postfach 100262D-30918 Seelze
 Institut scientifique de service public (ISSeP)Rue du Chéra 200B-4000 Liège
 Institut E. Malvoz (B)Quai du Barbou, 4B-4000 Liège
 Ineos Fluor LtdPO Box 13, The HeathRuncorn Cheshire WA7 4QFUnited Kingdom
 Katholieke Universiteit LeuvenKrakenstraat 3B-3000 Leuven
 Laboratoires sérobiologiques3, rue de SeichampsF-54425 Pulnoy
 LGC Promochem GmbHMercatorstr. 51D-46485 Wesel
 Mallinckrodt Baker BVTeugseweg 207418 AM DeventerThe Netherlands
 Merck KgaAFrankfurter Strasse 250D-64271 Darmstadt
 Mikro+Polo d.o.o.Lackova 78SLO-2000 Maribor
 Panreac Química SARiera de Sant Cugat 1E-08110 Montcada I Reixac (Barcelona)
 Rohs Chemie GmbHBerliner Str. 54D-53819 Neunkirchen-Seelsheid
 Sanolabor d.d.Leskoškova 4SLO-Ljubljana
 SDS Solvants, Documentation, Synthèses SAZ.I. de Valdonne, BP 4F-13124 Peypin
 Sigma Aldrich Chemie GmbHRiedstrasse 2D-89555 Steinheim
 Sigma Aldrich Chimie SARL80 rue de LuzaisL'Isle-d'Abeau ChesnesF-38297 St-Quentin-Fallavier
 Sigma Aldrich Company LtdThe Old BrickyardNew Road Gillingham SP8 4XTUnited Kingdom
 Sigma Aldrich LaborchemikalienWunstorfer Straße 40, Postfach 100262D-30918 Seelze
 VWR I.S.A.S.201, rue CarnotF-94126 Fontenay-sous-bois
 University Of Technology ViennaInstitut of Industrial Electronics and Material ScienceGusshausstrasse 27-29A-1040 Wien
 YA-Kemia Oy — Sigma-Aldrich FinlandTeerisuonkuja 4FI-00700 Helsinki
Done at Brussels, 23 February 2005.
For the Commission
Stavros DIMAS
Member of the Commission
ANNEX I

Pursuant to paragraph 3 of Decision XII/2 of the 12th 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 that, due to the presence of suitable non-CFC MDIs, CFCs no longer qualify as ‘essential’ under the Protocol when combined with following products:

ProductCountry Salbutamol Terbutaline Fenoterol Orciprenaline Reproterol Carbuterol Hexoprenaline Pirbuterol Clenbuterol Bitolterol Procaterol Beclomethasone Dexamethasone Fluinisolide Fluiticasone Budesonide Triamcinolone Ipratropium bromide Oxitropium Bromide
Austria X X X X X X X X X X X        
Belgium X X X X X X X X X X X        
Czech Republic X X X X X X X X X X X        
Denmark X X X X X X X X X X X        
Finland X                  
France X                  
Germany X X X X X X X X X X X X X X X X X X X
Greece X X X X X X X X X X X        
Ireland X                  
Luxembourg X                  
Portugal X X X X X X X X X X X        
The Netherlands X X X X X X X X X X X        
Norway X X X X X X X X X X X        
Sweden X                  
UK X                  
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 (DE)
 Chiesi (IT)
 Glaxo Smith Kline (UK)
 IG Sprühtechnik (DE)
 Inyx Pharmaceuticals (UK)
 IVAX (IE)
 Jaba Farmaceutica (PT)
 Lab. Aldo-Union (ES)
 Otsuka Pharmaceuticals (ES)
 Sicor (IT)
 Schering-Plough (BE)
 V.A.R.I. (IT)
 Valeas (IT)
 Valois (FR)

ANNEX III
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 (BE)
 Bie & Berntsen (DK)
 Butterworth Laboratories (UK)
 Biosolve (NL)
 Carl Roth (DE)
 Elcom Group (CZ)
 Environnement SA (FR)
 Honeywell Specialty Chemicals (DE)
 Ineos Fluor (UK)
 Katholieke Universiteit Leuven (BE)
 LGC Promochem (DE)
 Mallinckrodt Baker (NL)
 Merck KGaA (DE)
 Mikro + Polo (SI)
 Panreac Química (ES)
 SDS Solvants (FR)
 Sanolabor (SI)
 Sigma Aldrich Chemie (DE)
 Sigma Aldrich Chimie (FR)
 Sigma Aldrich Company (UK)
 University Of Technology Vienna (AT)
 Ya Kemia Oy — Sigma Aldrich (FI)

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 (BE)
 Agfa-Gevaert (BE)
 Bie & Berntsen (DK)
 Biosolve (NL)
 Butterworth Laboratories (UK)
 Fisher Scientific (UK)
 Health Protection Inspectorate-Laboratories (EE)
 Institut E. Malvoz (BE)
 Institut Scientifique de Service Public (ISSeP) (BE)
 Katholieke Universiteit Leuven (BE)
 Laboratoires Sérologiques (FR)
 Mallinckrodt Baker (NL)
 Merck KGaA (DE)
 Mikro + Polo (SI)
 Panreac Química (ES)
 Rohs Chemie (DE)
 SDS Solvants (FR)
 Sanolabor d.d. (SI)
 Sigma Aldrich Chemie (DE)
 Sigma Aldrich Chimie (FR)
 Sigma Aldrich Company (UK)
 Sigma Aldrich Laborchemikalien (DE)
 VWR I.S.A.S. (FR)
 YA-Kemia Oy (FI)

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 (BE)
 Agfa-Gevaert (BE)
 Bie & Berntsen (DK)
 Katholieke Universiteit Leuven (BE)
 Mallinckrodt Baker (NL)
 Mikro + Polo (SI)
 Panreac Química (ES)
 Sanolabor d.d. (SI)
 Sigma Aldrich Chemie (DE)
 Sigma Aldrich Chimie (FR)
 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 (BE)
 Ineos Fluor (UK)
 Sigma Aldrich Chimie (FR)
 Sigma Aldrich Company (UK)

ANNEX VIII
ESSENTIAL LABORATORY USES

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

 Ineos Fluor (UK)
 Sigma Aldrich Chemie (DE)
 Sigma Aldrich Chimie (FR)

ANNEX IX

(This Annex is not published because it contains confidential commercial information.)
