
COMMISSION DECISION of 18 December 2008 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2009 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council on substances that deplete the ozone layer (notified under document number C(2008) 8398) (Only the Dutch, English, French, German, Italian, Slovenian and Spanish texts are authentic) (2009/52/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) The Parties to the Montreal Protocol authorised the production in the European Community of 22 tonnes of chlorofluorocarbons (CFCs) in 2009 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 critical 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 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 to those companies in the Member States that request consideration by the Commission for the use of controlled substances for essential uses in the Community in 2009 and has received declarations on intended essential uses of controlled substances for 2009.

(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 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:


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 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
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:

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

ANNEX III
ESSENTIAL LABORATORY AND ANALYTICAL USES

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
ESSENTIAL LABORATORY AND ANALYTICAL USES

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
ESSENTIAL LABORATORY AND ANALYTICAL USES

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
ESSENTIAL LABORATORY AND ANALYTICAL USES

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

ANNEX VIII
ESSENTIAL LABORATORY AND ANALYTICAL USES

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
ESSENTIAL LABORATORY AND ANALYTICAL USES

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.
