
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 2009 shall be 21 360,0 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 and analytical uses in the Community in 2009 shall be 60 280,8 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 and analytical use in the Community in 2009 shall be 115,7 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 and analytical uses in the Community in 2009 shall be 129 390,8 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 and analytical uses in the Community in 2009 shall be 355,65 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 critical uses in the Community in 2009 shall be 36,3 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 and analytical uses in the Community in 2009 shall be 57,96 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 and analytical uses in the Community in 2009 shall be 11,088 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 2009 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 and analytical 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 and analytical use quotas for halons shall be to the companies indicated in Annex IV.
4.. The allocation of essential laboratory and analytical use quotas for carbon tetrachloride shall be to the companies indicated in Annex V.
5.. The allocation of essential laboratory and analytical 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 and analytical use quotas for hydrobromofluorocarbons shall be to the companies indicated in Annex VIII.
8.. The allocation of essential laboratory and analytical 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 and the laboratory and analytical critical use quotas for methyl bromide shall be as set out in Annex X.
Article 4 
This Decision shall apply from 1 January 2009 and shall expire on 31 December 2009.
Article 5 
This Decision is addressed to the following undertakings:

 Acros Organics bvbaJanssen Pharmaceuticalaan 3aB-2440 Geel
 Airbus France316, route de BayonneF-31300 Toulouse
 Carlo Erba Réactifs-SDSZ.I. de Valdonne, BP 4F-13124 Peypin
 Chiesi Farmaceutici SpAVia Palermo 26/AI-43100 Parma
 CNRS — Groupe de physique des solidesUniversité Paris 7 Denis Diderot et Paris 6Pierre et Marie CurieF-75251 Paris Cedex 5
 Harp InternationalGellihirion Industrial Estate Rhondda,Cynon TaffPontypridd CF37 5SXUNITED KINGDOM
 Honeywell Specialty ChemicalsWunstorfer Straße 40Postfach 10 02 62D-30918 Seelze
 Ineos Fluor LtdPO Box 13, The HeathRuncorn Cheshire WA7 4QFUNITED KINGDOM
 Institut scientifique de service publicRue du Chéra 200B-4000 Liège
 LGC Standards GmbHMercatorstraße 51D-46485 Wesel
 Mallinckrodt Baker BVTeugseweg 207418 AM DeventerNederland
 Merck KGaAFrankfurter Straße 250D-64271 Darmstadt
 Mikro + Polo d.o.o.Zagrebška cesta 22SI-2000 Maribor
 Ministry of DefenseDefence Fuel Lubricants and ChemicalsPO Box 10 0001780 CA Den HelderNederland
 Panreac Química SAPol. Ind. Pla de la Bruguera, C/Garraf, 2E-08211 Castellar del VallèsBarcelona
 Sigma Aldrich Chimie SARL80, rue de LuzaisL’Isle d’Abeau ChesnesF-38297 Saint-Quentin-Fallavier
 Sigma Aldrich CompanyThe Old Brickyard, New RoadGillingham SP8 4XTUNITED KINGDOM
 Sigma Aldrich LaborchemikalienWunstorfer Straße 40Postfach 10 02 62D-30918 Seelze
 Sigma Aldrich Logistik GmbHRiedstraße 2D-89555 Steinheim
 Solvay Organics GmbHHans-Böckler-Allee 20D-30173 Hannover
 Tazzetti Fluids SRLCorso Europa 600/aI-10088 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 ISAS201, rue CarnotF-94126 Fontenay-sous-Bois
Done at Brussels, 18 December 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:


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 X X X X X X
Czech Republic X X X X X X
Denmark X X X X X X
Estonia X X X X X X
Finland X X X X X X
France X X X X X X
Germany X X X X X X
Greece X 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 X X X
Sweden X X X X 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 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 X X
Germany X X
Greece X X
Hungary X X
Ireland X X
Italy  X
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 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 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 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  
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

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:

 Chiesi Farmaceutici SpA (IT)
 Valeas SpA Pharmaceuticals (IT)
 (VARI) SpA — LINDAL Group Italia (IT)

ANNEX III

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

 Carlo Erba Réactifs-SDS (FR)
 CNRS — Groupe de physique des solides (FR)
 Harp International (UK)
 Honeywell Specialty Chemicals (DE)
 Ineos Fluor (UK)
 LGC Standards (DE)
 Mallinckrodt Baker (NL)
 Merck KGaA (DE)
 Mikro + Polo (SI)
 Panreac Química (ES)
 Sigma Aldrich Chimie (FR)
 Sigma Aldrich Company (UK)
 Sigma Aldrich Logistik (DE)
 Tazzetti Fluids (IT)

ANNEX IV

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

 Airbus France (FR)
 Ineos Fluor (UK)
 Ministry of Defence (NL)

ANNEX V

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

 Acros Organics (BE)
 Carlo Erba Réactifs-SDS (FR)
 Honeywell Specialty Chemicals (DE)
 Institut Scientifique du Service Publique (BE)
 Mallinckrodt Baker (NL)
 Merck KGaA (DE)
 Mikro + Polo (SI)
 Panreac Quimica (ES)
 Sigma Aldrich Chimie (FR)
 Sigma Aldrich Company (UK)
 Sigma Aldrich Laborchemikalien (DE)
 Sigma Aldrich Logistik (DE)
 VWR ISAS (FR)

ANNEX VI

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

 Acros Organics (BE)
 Merck KGaA (DE)
 Mikro + Polo (SI)
 Panreac Química (ES)
 Sigma Aldrich Chimie (FR)
 Sigma Aldrich Company (UK)
 Sigma Aldrich Logistik (DE)

ANNEX VII

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

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

ANNEX VIII

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

 Ineos Fluor (UK)
 Sigma Aldrich Logistik (DE)
 Solvay Organics (DE)

ANNEX IX

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

 Ineos Fluor (UK)
 Sigma Aldrich Chimie (FR)
 Sigma Aldrich Company (UK)
 Sigma Aldrich Logistik (DE)

ANNEX X

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