
COMMISSION DECISION of 23 August 2005 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2005 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council (notified under document number C(2005) 333) (Only the Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Italian, Slovenian, Spanish and Swedish texts are authentic) (Text with EEA relevance) (2005/626/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 is required 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 Twelfth Meeting of the Parties to the Montreal Protocol on measures to facilitate the transition to chlorofluorocarbon-free Metered-Dose Inhalers (MDIs), Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, Poland, Norway, Portugal, The Netherlands, Slovak Republic, Slovenia, Spain, Sweden and the United Kingdom have notified the United Nations Environment Programme that chlorofluorocarbons (CFCs) are no longer essential for the manufacture of CFC-MDIs that contain active ingredients belonging to the therapeutic categories of ‘short-acting beta agonist bronchiodilators’, ‘inhaled steroids’ and ‘anticholinergic bronchiodilators’. 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) 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 on the 22 July 2004 to those companies in the Community of 25 Member States that request consideration by the Commission for the use of controlled substances for essential uses in the Community in 2005 and has received declarations on intended essential uses of controlled substances in 2005.

(7) For the purpose of ensuring that interested companies and operators may continue to benefit in due time from the licensing system, it is appropriate that the present decision shall apply from 1 January 2005.

(8) 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 2005 shall be 1 029 770,0 ODP 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 2005 shall be 63 081,71 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 2005 shall be 70,705 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 2005 shall be 145 240,293 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 2005 shall be 815,30 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 2005 shall be 3,04 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 2005 shall be 12,048 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 2005 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 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 LynnPE30 2JJ — NorfolkUnited Kingdom
 Boehringer Ingelheim GmbHBinger Straße 173D-55216 Ingelheim am Rhein
 Chiesi Farmaceutici SpAVia Palermo 26/AI-43100 Parma
 GlaxoSmithKlineSpeke BoulevardSpekeL24 9JD — LiverpoolUnited Kingdom
 IG Sprühtechnik GmbHIm Hemmet 1D-79664 Wehr
 Inyx Pharmaceuticals LtdAstmoor Industrial Estate9 Arkwright Road RUNCORNCheshire WA7 1NUUnited Kingdom
 GlaxoSmithKline Pharmaceuticals SASiedziba w Poznaniuul. Grunwaldzka 18960-322 PoznańPoland
 IVAX LtdUnit 301 Industrial ParkWaterfordIreland
 Laboratorio Aldo Union SABaronesa de Maldá, 73Espluges de LlobregatE-08950 Barcelona
 SICOR S.p.AVia Terrazzano 77I-20017 Rho (MI)
 Valeas SpA PharmaceuticalsVia Vallisneri, 10I-20133 Milano
 Valois SA50, avenue de l'EuropeF-78160 Marly Le Roi
 Valvole Aerosol Research Italiana (VARI)Spa — LINDAL Group ItaliaVia del Pino, 10Olginate (LC)I-23854
 Acros Organics bvbaJanssen Pharmaceuticalaan 3aB-2440 Geel
 Agfa-Gevaert NVSeptestraat 27B-2640 Mortsel
 Bie & BerntsenSandbækvej 7DK-2610 Rødovre
 Biosolove BVWaalreseweg 175554 HA ValkenswaardNederland
 Carl Roth GmbHSchoemperlenstraße 3—5D-76185 Karlsruhe
 Elcom GroupOkružní 988CZ-735 14 Orlová-Lutyně
 Health Protection Inspectorate-LaboratoriesPaldiski mnt 81EE-10617 Tallinn
 Honeywell Specialty ChemicalsWunstorfer Straße 40Postfach 100262D-30918 Seelze
 Ineos Fluor LtdPO Box 13, The HeathRuncorn Cheshire WA7 4QFUnited Kingdom
 Institut scientifique de service public (ISSeP)Rue du Chéra, 200B-4000 Liège
 Katholieke Universiteit LeuvenKrakenstraat 3B-3000 Leuven
 LGC Promochem GmbHMercatorstraße 51D-46485 Wesel
 Mallinckrodt Baker BVTeugseweg 207418 AM DeventerNederland
 Merck KGaAFrankfurter Straße 250D-64293 Darmstadt
 Mikro+Polo d.o.o.Zagrebška cesta 22SI-2000 Maribor
 Ministry of DefenseDirectorate Material RNLNavyPO Box 20702500 ES The HagueNederland
 Panreac Quimica SARiera de Sant Cugat, 1E-08110 Montcada I Reixac (Barcelona)
 Rohs Chemie GmbHBerliner Str. 54D-53819 Neunkirchen-Seelscheid
 Sanolabor d.d.Leskovškova 4SI-1000 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 ChesneF-38297 Saint-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
 YA-Kemia Oy — Sigma-Aldrich FinlandTeerisuonkuja 4FI-00700 Helsinki
Article 5 
This Decision shall apply from 1 January 2005 and shall expire on 31 December 2005.
Done at Brussels, 23 August 2005.
For the Commission
Stavros DIMAS
Member of the Commission
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 countries 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 active ingredients:

Country Salbutamol Terbutaline Fenoterol Orciprenaline Reproterol Carbuterol Hexoprenaline Pirbuterol Clenbuterol Bitolterol Procaterol Beclamethasone Dexamethasone Flunisolide Fluticasone Budesonide Triamcinolone Ipratropium bromide Oxitropium bromide
Austria                   
Belgium                   
Cyprus                   
Czech Republic                   
Denmark                   
Estonia                   
Finland                   
France                   
Germany                   
Greece                   
Hungary                   
Ireland                   
Latvia                   
Lithuania                   
Luxembourg                   
Poland                   
Portugal                   
The Netherlands                   
Norway                   
Slovak Republic                   
Slovenia                   
Spain                   
Sweden                   
UK                   
Source: www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp
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 Health Care (UK)
 Aventis (UK)
 Bespak (UK)
 Boehringer Ingelheim (DE)
 Chiesi (IT)
 Glaxo Smith Kline (ES, FR, PL, UK)
 IG Sprühtechnik (DE)
 Inyx Pharmaceuticals (UK)
 IVAX (IE)
 Laboratorio Aldo-Unión (ES)
 Sicor (IT)
 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)
 Biosolve (NL)
 Carl Roth (DE)
 Elcom Group (CZ)
 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)

ANNEX IV
ESSENTIAL LABORATORY USES

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

 Ineos Fluor (UK)
 Ministry of Defense (NL)
 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)
 Health Protection Inspectorate-Laboratories (EE)
 Institut Scientifique de Service Public (ISSeP) (BE)
 Katholieke Universiteit Leuven (BE)
 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)
 Bie & Berntsen (DK)
 Katholieke Universiteit Leuven (BE)
 Mallinckrodt Baker (NL)
 Merck KGaA (DE)
 Mikro + Polo (SI)
 Panreac Química (ES)
 Sanolabor d.d. (SI)
 Sigma Aldrich Chemie (DE)
 Sigma Aldrich Chimie (FR)
 Sigma Aldrich Company (UK)
 VWR I.S.A.S. (FR)
 YA-Kemia Oy (FI)

ANNEX VII
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 (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)

ANNEX IX

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