
COMMISSION DECISION of 17 April 2008 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2008 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council (notified under document number C(2008) 1403) (Only the Danish, Dutch, English, Estonian, French, German, Italian, Slovenian and Spanish texts are authentic) (Text with EEA relevance) (2008/409/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 XIX/13 of the Parties to the Montreal Protocol authorises the production in the European Community of 200 tonnes of chlorofluorocarbons (CFCs) in 2008 for the manufacturing and use of Metered-Dose Inhalers (MDIs) qualifying for essential uses of CFCs as defined in Decision IV/25.

(5) Decision XIX/18 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.

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

(7) 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).

(8) The Commission has published a Notice on the 18 July 2007 to those companies in the Community of 27 Member States that request consideration by the Commission for the use of controlled substances for essential uses in the Community in 2008 and has received declarations on intended essential uses of controlled substances for 2008.

(9) 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 2008.

(10) 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 2008 shall be 155 460,0 ozone-depleting potential (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 2008 shall be 56 213,6 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 2008 shall be 418,7 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 2008 shall be 150 832,836 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 2008 shall be 381,5 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 2008 shall be 150,00 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 2008 shall be 0,96 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 2008 shall be 13,368 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 chlorofluorocarbons for metered-dose inhalers on those markets to be non-essential.
Article 3 
During the period 1 January to 31 December 2008 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 2008 and shall expire on 31 December 2008.
Article 5 
This Decision is addressed to the following undertakings:

 Acros Organics bvbaJanssen Pharmaceuticalaan 3A°B-2440 Geel
 Airbus FranceService EVICSBP M6322Route de Bayonne 316F-31060 Toulouse Cedex 16
 Bie & BerntsenSandbækvej 7DK-2610 Rødovre
 Boehringer Ingelheim GmbHBinger Straße 173D-55216 Ingelheim am Rhein
 Carlo Erba Reactifs-SDSZI de Valdonne, BP 4F-13124 Peypin
 Chiesi Farmaceutici SpAVia Palermo 26/AI-43100 Parma
 CNRS — Département GaliléeObservatoire de la Côte d'Azur — Siège SocialBoulevard de l'Observatoire, BP 4229F-06304 Nice Cedex 4
 Eras Labo222 RN 90F-38330 Saint-Nazaire-les-Eymes
 Harp InternationalGellihirion Industrial EstateRhondda, Cynon TaffPontypridd CF37 5SXUnited Kingdom
 Health Protection Inspectorate-LaboratoriesPaldiski mnt 81EE-10617 Tallinn

 Honeywell Specialty Chemicals Seelze GmbHWunstorfer Straße 40Postfach 100262D-30918 Seelze
 Ineos Fluor LtdPO Box 13The HeathRuncornCheshire WA7 4QXUnited Kingdom
 Laboratorio Aldo-Union SABaronesa de Maldá 73Espluges de LlobregatE-08950 Barcelona
 LGC Standards GmbHMercatorstraße 51D-46485 Wesel
 Mallinckrodt Baker EMEATeugseweg 207418 AM DeventerNederland
 MebromAssenedestraat 4B-9940 Rieme Ertvelde
 Merck KGaAFrankfurter Straße 250D-64271 Darmstadt
 Mikro+Polo d.o.o.Zagrebška cesta 22SI-2000 Maribor
 Ministry of DefenseDefence Fuel Lubricants and Chemicals Service/Chemical LaboratoryPO Box 10.0001780 CA Den HelderNederland
 Panreac Química SAUPol. Ind. Pla de la BrugueraC/Garraf 2E-08211 Castellar del Vallès — Barcelona
 Sanolabor d.d.Leskoškova 4LjubljanaSlovenia
 SICOR SpAVia Terrazzano 77I-20017 Rho
 Sigma Aldrich Chimie SARL80, rue de LuzaisL'Isle d'Abeau ChesnesF-38297 St-Quentin-Fallavier
 Sigma Aldrich CompanyThe Old Brickyard, New RoadGillingham SP8 4XTUnited Kingdom
 Sigma Aldrich Laborchemikalien GmbHWunstorfer Straße 40D-30926 Seelze
 Sigma Aldrich Logistik GmbHRiedstraße 2D-89555 Steinheim
 Tazzetti Fluids SRLCorso Europa n. 600/aI-10070 Volpiano (TO)
 Valeas SpA PharmaceuticalsVia Vallisneri, 10I-20133 Milano
 Valvole Aerosol Research Italiana (VARI) SpA — LINDAL Group ItaliaVia del Pino, 10I-23854 Olginate (LC)
 VWR I.SAS.201, rue CarnotF-94126 Fontenay-sous-Bois
Done at Brussels, 17 April 2008.
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:


LIST OF NON-ESSENTIAL SUBSTANCES
Table 1
Short-acting beta agonist bronchodilators
Country 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
Bulgaria X X X X X X X X X X X
Cyprus 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
Estonia X X X X X X X X X X X
Finland X X X X X X X X X X X
France X X X X X X X X X X 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 X X X X X X X X X X
Italy X X X X X X X X X X 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 X X X X X X X X X X
Malta X X X X X X X X X X X
Netherlands X X X X X X X X X X X
Poland X X X X X X X X X X X
Portugal X X X X X X X X X X X
Romania X X X X X X X X X X X
Slovakia 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 X X X X X X X X X X
Sweden X X X X X X X X X X X
United Kingdom X X X X X X X X X X X
Table 2
Inhaled steroids
Country Beclomethasone Dexamethasone Flunisolide Fluticasone Budesonide Triamcinolone
Austria X X X X X X
Belgium X X X X X X
Bulgaria 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 X  X X X X
Hungary X X X X X X
Ireland X   X  
Italy X X X X X X
Latvia X X X X X X
Lithuania X X X X X X
Luxembourg X X X X X X
Malta X   X  
Netherlands X X X X X X
Poland X X X X X X
Portugal X X X X X X
Romania X X X X X X
Slovakia X X X X X X
Slovenia X X X X X X
Spain X   X X 
Sweden X   X  
United Kingdom    X  
Table 3
Non-steroidal anti-inflammatories
Country Cromoglicic acid Nedrocromil    
Austria X X    
Belgium X X    
Bulgaria X X    
Cyprus X X    
Czech Republic X X    
Denmark X X    
Estonia X X    
Finland X X    
France X X    
Germany X X    
Greece X X    
Hungary X     
Ireland      
Italy X X    
Latvia X X    
Lithuania X X    
Luxembourg X     
Malta  X    
Netherlands X X    
Poland X X    
Portugal X     
Romania X X    
Slovakia X X    
Slovenia X X    
Spain  X    
Sweden X X    
United Kingdom X X    
Table 4
Anticholinergic bronchodilators
Country Ipratropium bromide Oxitropium bromide    
Austria X X    
Belgium X X    
Bulgaria 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 X X    
Lithuania X X    
Luxembourg X X    
Malta X X    
Netherlands X X    
Poland X X    
Portugal X     
Romania X X    
Slovakia X X    
Slovenia X X    
Spain X X    
Sweden X X    
United Kingdom X X    
Table 5
Long-acting beta agonist bronchodilators
Country Formoterol Salmeterol    
Austria X X    
Belgium X X    
Bulgaria X X    
Cyprus X     
Czech Republic X X    
Denmark  X    
Estonia X X    
Finland X X    
France X X    
Germany X X    
Greece      
Hungary X X    
Ireland X X    
Italy X X    
Latvia X X    
Lithuania X X    
Luxembourg X X    
Malta X X    
Netherlands X X    
Poland X X    
Portugal X X    
Romania X X    
Slovakia X X    
Slovenia X X    
Spain  X    
Sweden X X    
United Kingdom X X    
Table 6
Combinations of active ingredients in a single MDI
Country      
Austria X All products     
Belgium X All products     
Bulgaria X All products     
Cyprus      
Czech Republic X All products     
Denmark X All products     
Estonia      
Finland X All products     
France X All products     
Germany X All products     
Greece X All products     
Hungary X All products     
Ireland      
Italy Budesonide + Fenoterol Fluticasone+ Salmeterol    
Latvia X All products     
Lithuania X All products     
Luxembourg X All products     
Malta X All products     
Netherlands X All products     
Poland X All products     
Portugal X All products     
Romania X All products     
Slovakia X All products     
Slovenia X All products     
Spain      
Sweden X All products     
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:

 Boehringer Ingelheim GmbH (DE)
 Chiesi Farmaceutici SpA (IT)
 Laboratorio Aldo Union SA (ES)
 SICOR SpA (IT)
 Valeas SpA Pharmaceuticals (IT)
 (VARI) SpA — LINDAL Group Italia (IT)

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:

 Bie & Berntsen (DK)
 Carlo Erba Reactifs-SDS (FR)
 CNRS — Département Galilée (FR)
 Harp International (UK)
 Honeywell Specialty Chemicals (DE)
 Ineos Fluor (UK)
 LGC Standards (DE)
 Mallinckrodt Baker (NL)
 Merck KGaA (DE)
 Mikro + Polo (SI)
 Panreac Quimica (ES)
 Sanolabor (SI)
 Sigma Aldrich Chimie (FR)
 Sigma Aldrich Company (UK)
 Sigma Aldrich Logistik (DE)
 Tazzetti Fluids (IT)
 VWR ISAS (FR)

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)
 Eras Labo (FR)
 Ineos Fluor (UK)
 Ministry of Defence (NL)

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)
 Carlo Erba Reactifs-SDS (FR)
 Health Protection Inspectorate-Laboratories (EE)
 Honeywell Specialty Chemicals (DE)
 Mallinckrodt Baker (NL)
 Merck KGaA (DE)
 Mikro + Polo (SI)
 Panreac Quimica (ES)
 Sanolabor d.d. (SI)
 Sigma Aldrich Chimie (FR)
 Sigma Aldrich Company (UK)
 Sigma Aldrich Laborchemikalien (DE)
 Sigma Aldrich Logistik (DE)
 VWR ISAS (FR)

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)
 Merck KgaA (DE)
 Mikro + Polo (SI)
 Panreac Quimica (ES)
 Sanolabor d.d. (SI)
 Sigma Aldrich Chimie (FR)
 Sigma Aldrich Company (UK)
 Sigma Aldrich Logistik (DE)

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:

 Mebrom NV (BE)
 Sigma Aldrich Logistik (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)

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)
 Sigma Aldrich Company (UK)
 Sigma Aldrich Logistik (DE)

ANNEX X

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