
COMMISSION DECISION of 11 April 2006 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2006 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council (notified under document number C(2006) 1483) (Only the Danish, Dutch, English, Estonian, Finnish, French, German, Italian, Slovenian, Spanish and Swedish texts are authentic) (Text with EEA relevance) (2006/540/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 bromochloromethane.

(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, as well as Decisions VII/11, XI/15 and XV/5 of the Parties to the Montreal Protocol.Decision XVII/10 of the Parties to the Montreal Protocol authorises the production and consumption of the controlled substance listed in Annex E of the Montreal Protocol necessary to satisfy laboratory and analytical uses of methyl bromide.

(5) Pursuant to paragraph 3 of Decision XII/2 of the Parties to the Montreal Protocol on measures to facilitate the transition to chlorofluorocarbon-free Metered-Dose Inhalers (MDIs), all Member States have notified the United Nations Environment Programme that chlorofluorocarbons (CFCs) are no longer essential for the manufacture of salbutamol CFC-MDIs for placing on the market of the European Community. 

Austria, Belgium, Czech Republic, Denmark, Estonia, Germany, Greece, Hungary, Latvia, Lithuania, Norway, Portugal, The Netherlands, the Slovak Republic and Slovenia have notified UNEP that the use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of ‘short-acting beta agonist bronchiodilators’, specifically terbutaline, fenoterol, orciprenaline, reproterol, carbuterol, hexoprenaline, pirbuterol, clenbuterol, bitolterol and procaterol.

Belgium, the Czech Republic, Estonia, Germany, Hungary, Latvia, the Netherlands, the Slovak Republic, Slovenia and Sweden have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of ‘inhaled steroids’, specifically beclomethasone, dexamethasone, flunisolide, fluticasone, budesonide and triamcinolone.

Denmark (beclomethasone, fluticasone), Ireland (beclomethasone, fluticasone), Finland (beclomethasone, fluticasone), France (beclomethasone, fluticasone), Italy (beclomethasone, fluticasone, budesonide), Malta (fluticasone, budesonide), Portugal (fluticasone, budesonide), Slovenia (beclomethasone, fluticasone, budesonide), Spain (beclomethasone, fluticasone) and the United Kingdom (fluticasone) have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of ‘inhaled steroids’ shown in parentheses after each Member State.

Belgium, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Latvia, the Netherlands, the Slovak Republic and Slovenia have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of ‘non-steroidal anti-inflammatories’, specifically cromoglicic acid and nedrocromil.

Portugal has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contains the active ingredient cromoglicic acid. Spain has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contains the active ingredient nedrocromil.

Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Latvia, Malta, the Netherlands, the Slovak Republic, Spain, Sweden and the United Kingdom have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of ‘anticholinergic bronchodilators’, specifically ipatropium bromide and oxitropium bromide.

Portugal has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contains the active ingredient ipatropium bromide.

Germany has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of ‘long-acting beta agonist bronchiodilators’, specifically formoterol and salmeterol.

Italy has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contains the active ingredient formoterol.

Germany and the Netherlands have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain combinations of active ingredients.

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 therefore reduced the demand for CFCs used in MDIs that are placed on the market of the European 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 8 July 2005 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 2006 and has received declarations on intended essential uses of controlled substances for 2006.

(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 2006.

(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 2006 shall be 539 000,0 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 2006 shall be 256 761,86 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 2006 shall be 482,70 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 2006 shall be 149 641,536 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 2006 shall be 754,00 ODP kilograms.
6. The quantity of controlled substances of Group VI (methyl bromide) subject to Regulation (EC) No 2037/2000 that may be used for laboratory and analytical uses in the Community in 2006 shall be 300,00 ODP kilograms.
7. 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 2006 shall be 4,49 ODP kilograms.
8. 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 2006 shall be 13,308 ODP kilograms.
Article 2 
The chlorofluorocarbon metered-dose inhalers listed in Annex I shall not be placed on markets where the Competent Authority has determined chlorofluorocarbonsfor metered-dose inhalers on those markets to be non-essential.
Article 3 
During the period 1 January to 31 December 2006 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 laboratory and analytical critical use quotas for methyl bromide shall be to the companies indicated in Annex VII.
7.. The allocation of essential laboratory use quotas for hydrobromofluorocarbons shall be to the companies indicated in Annex VIII.
8.. The allocation of essential laboratory use quotas for bromochloromethane shall be to the companies indicated in Annex IX.
9.. 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 X.
Article 4 
This Decision shall apply from 1 January 2006 and shall expire on 31 December 2006.
Article 5 
This Decision is addressed to the following undertakings:

 3M Health Care Ltd3M House Morley StreetLoughboroughLeicestershire LE11 1EPUnited Kingdom
 Bespak PLCNorth Lynn Industrial EstateKing's LynnPE30 2JJ — NorfolkUnited Kingdom
 Boehringer Ingelheim GmbHBinger Straße 173D-55216 Ingelheim am Rhein
on behalf of Boehringer Ingelheim (France)
 Chiesi Farmaceutici SpAVia Palermo, 26/AI-43100 Parma
 IVAX LtdUnit 301 Industrial ParkWaterfordIreland
 Laboratorio Aldo Union SABaronesa de Maldá, 73Espluges de LlobregatE-08950 Barcelona
 SICOR SpAVia Terrazzano, 77I-20017 Rho (MI)
 Valeas SpA PharmaceuticalsVia Vallisneri, 10I-20133 Milano
 Valvole Aerosol Research Italiana (VARI)Spa — LINDAL Group ItaliaVia del Pino, 10I-23854 Olginate (LC)
 Acros Organics bvbaJanssen Pharmaceuticalaan 3oB-2440 Geel
 Airbus Franceroute de Bayonne 316F-31300 Toulouse
 Biosolove B.V.Waalreseweg 175554 HA ValkenswaardNederland
 Bie & BerntsenSandbækvej 7DK-2610 Roedovre
 Carlo Erba Reactifs-SDSZ.I. de Valdonne, BP 4F-13124 Peypin
 CNRS — Groupe de Physique des SolidesUniversité Paris, 7 Denis Diderot & Paris6 Pierre et Marie CurieF-75251 Paris Cedex 5
 Health Protection Inspectorate-LaboratoriesPaldiski mnt 81EE-10617 Tallinn
 Honeywell Fluorine Products EuropeKempenweg 90P.O. Box 2646000 AG WeertNederland
 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-64271 Darmstadt
 Mikro+Polo d.o.o.Lackova 78SLO-2000 Maribor
 Ministry of DefenseDirectorate Material RNL NavyPO Box 20702500 ES The HagueNederland
 Panreac Química SARiera de Sant Cugat 1E-08110 Montcada I Reixac (Barcelona)
 Sanolabor d.d.Leskovškova 4SLO-1000 Ljubljana
 Sigma Aldrich Logistik GmbHRiedstraße 2D-89555 Steinheim
 Sigma Aldrich Chimie SARL80, rue de LuzaisL'isle-d'abeau ChesnesF-38297 Saint-Quentin-Fallavier
 Sigma Aldrich Company LtdThe Old BrickyardNew Road Gillingham SP8 4XTUnited Kingdom
 Sigma Aldrich LaborchemikalienWunstorfer Straße 40Postfach 100262D-30918 Seelze
 Sigma Aldrich Chemie GmbHRiedstraße 2D-89555 Steinheim
 Tazzetti Fluids S.r.l.Corso Europa, 600/aI-10088 Volpiano (TO)
 University of Technology ViennaInstitut of Industrial Electronics&Material ScienceGusshausstraße 27-29A-1040 Wien
 VWR I.S.A.S.201, rue CarnotF-94126 Fontenay-sous-Bois
 YA-Kemia Oy — Sigma Aldrich FinlandTeerisuonkuja 4FI-00700 Helsinki
Done at Brussels, 11 April 2006.
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:


Table 1Country Short-acting Beta Agonist Bronchodilators
Salbutamol Terbutaline Fenoterol Orciprenaline Reproterol Carbuterol Hexoprenaline Pirbuterol Clenbuterol Bitolterol Procaterol
Austria X X X X X X X X X X X
Belgium X X X X X X X X X X X
Cyprus 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
Estonia 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
Greece X X X X X X X X X X X
Hungary X X X X X X X X X X X
Ireland X          
Italy X          
Latvia X X X X X X X X X X X
Lithuania X X X X X X X X X X X
Luxembourg X          
Malta X          
Netherlands X X X X X X X X X X X
Poland X          
Portugal X X X X X X X X X X X
Norway X X X X X X X X X X X
Slovak Republic X X X X X X X X X X X
Slovenia X X X X X X X X X X X
Spain X          
Sweden X          
United Kingdom X          
Source: www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp

Table 2Country Inhaled steroids
Beclomethasone Dexamethasone Flunisolide Fluticasone Budesonide Triamcinolone
Austria      
Belgium X X X X X X
Cyprus      
Czech Republic X X X X X X
Denmark X   X  
Estonia X X X X X X
Finland X   X  
France X   X  
Germany X X X X X X
Greece      
Hungary X X X X X X
Ireland X   X  
Italy X   X X 
Latvia X X X X X X
Lithuania      
Luxembourg      
Malta    X X 
Poland      
Portugal    X X 
Netherlands X X X X X X
Norway      
Slovak Republic X X X X X X
Slovenia X X X X X X
Spain X   X  
Sweden X X X X  X
United Kingdom    X  
Source: www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp

Table 3Country Non-steroidal anti-inflammatories
Cromoglicic acid Nedrocromil    
Austria      
Belgium X X    
Cyprus      
Czech Republic X X    
Denmark X X    
Estonia X X    
Finland X X    
France X X    
Germany X X    
Greece X X    
Hungary      
Ireland      
Italy      
Latvia X X    
Lithuania      
Luxembourg      
Malta      
Poland      
Portugal X     
Netherlands X X    
Norway      
Slovak Republic X X    
Slovenia X X    
Spain  X    
Sweden      
United Kingdom      
Source: www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp

Table 4Country Anticholinergic Bronchodilators
Ipratropium bromide Oxitropium Bromide    
Austria      
Belgium X X    
Cyprus X X    
Czech Republic X X    
Denmark X X    
Estonia X X    
Finland X X    
France      
Germany X X    
Greece X X    
Hungary X X    
Ireland X X    
Italy      
Latvia      
Lithuania      
Luxembourg      
Malta X X    
Netherlands X X    
Poland      
Portugal X     
Norway      
Slovak Republic X X    
Slovenia      
Spain X X    
Sweden X X    
United Kingdom X X    
Source: www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp

Table 5Country Long-acting Beta Agonist Bronchodilators
Formoterol Salmeterol    
Austria      
Belgium      
Cyprus      
Czech Republic      
Denmark      
Estonia      
Finland      
France      
Germany X X    
Greece      
Hungary      
Ireland      
Italy X     
Latvia      
Lithuania      
Luxembourg      
Malta      
Netherlands      
Poland      
Portugal      
Norway      
Slovak Republic      
Slovenia      
Spain      
Sweden      
United Kingdom      
Source: www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp

Table 6Country Combinations of active ingredients in a single MDI
Austria      
Belgium      
Cyprus      
Czech Republic      
Denmark      
Estonia      
Finland      
France      
Germany X     
Greece      
Hungary      
Ireland      
Italy      
Latvia      
Lithuania      
Luxembourg      
Malta      
Netherlands      
Poland      
Portugal      
Norway      
Slovak Republic      
Slovenia      
Spain      
Sweden      
United Kingdom      
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)
 Bespak (UK)
 Boehringer Ingelheim (DE) on behalf of Boehringer Ingelheim France
 Chiesi (IT)
 IVAX (IE)
 Lab Aldo-Union (ES)
 Sicor (IT)
 Valeas (IT)
 V.A.R.I. (IT)

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:

 Acros organics bvba (BE)
 Bie & Berntsen (DK)
 Biosolve (NL)
 Carlo Erba Reactifs-SDS (FR)
 CNRS — Groupe de Physique des Solides (FR)
 Honeywell Fluorine Products Europe (NL)
 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)
 Sanolabor (SI)
 Sigma Aldrich Chimie (FR)
 Sigma Aldrich Company (UK)
 Sigma Aldrich Logistik (DE)
 Tazzetti Fluids (IT)
 University of Technology Vienna (AT)

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)
 Ineos Fluor (UK)
 Ministry of Defense (NL)
 Sigma Aldrich Chimie (FR)

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)
 Bie & Berntsen (DK)
 Biosolve (NL)
 Carlo Erba Reactifs-SDS (FR)
 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)
 Sanolabor d.d. (SI)
 Sigma Aldrich Chimie (FR)
 Sigma Aldrich Company (UK)
 Sigma Aldrich Laborchemikalien (DE)
 Sigma Aldrich Logistik (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 Chimie (FR)
 Sigma Aldrich Company (UK)
 Sigma Aldrich Logistik (DE)
 YA-Kemia Oy (FI)

ANNEX VII
LABORATORY AND ANALYTICAL CRITICAL USES

Quota of controlled substances of Group VI that may be used for laboratory and analytical critical uses are allocated to:
Sigma-Aldrich Chemie GmbH (DE)

ANNEX VIII
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)
 Katholieke Universiteit Leuven (BE)
 Sigma Aldrich Logistik (FR)
 Sigma Aldrich Company (UK)

ANNEX IX
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)
 Katholieke Universiteit Leuven (BE)
 Sigma Aldrich Logistik (FR)
 YA-Kemia Oy (FI)

ANNEX X

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