2007/211/EC: Commission decision of 27 March 2007 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2007 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council (notified under document number C(2007) 1285) (Text with EEA relevance)

Regulation (EC) No 2037/2000 · Decision · 15 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

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 2007 shall be 316 257,00 ODP ( 4 ) 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 2007 shall be 65 900,9 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 2007 shall be 718,7 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 2007 shall be 147 110 436 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 2007 shall be 672,0 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 2007 shall be 150,0 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 2007 shall be 3,52 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 2007 shall be 12 048 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 2007 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 2007 and shall expire on 31 December 2007.

Article 5

This Decision is addressed to the following undertakings: 3M Health Care Ltd 3M House Morley Street Loughborough Leicestershire LE11 1EP United Kingdom Bespak Europe Ltd North Lynn Industrial Estate Bergen Way, King's Lynn Norfolk PE30 2JJ United Kingdom Boehringer Ingelheim GmbH Binger Straße 173 D-55216 Ingelheim am Rhein Chiesi Farmaceutici SpA Via Palermo 26/A I-43100 Parma (PR) Inyx Pharmaceuticals Ltd Astmoor Industrial Estate 9 Arkwright Road Runcorn Cheshire WA7 1NU United Kingdom IVAX Ltd Unit 301, Waterford Industrial Estate Weterford, Ireland Laboratorio Aldo Union S.A. Baronesa de Maldá 73 Esplugues de Llobregat E-08950 Barcelona SICOR SpA Via Terrazzano 77 I-20017 Rho (MI) Valeas SpA Pharmaceuticals Via Vallisneri, 10 I-20133 Milano (MI) Valvole Aerosol Research Italiana (VARI) SpA — LINDAL Group Italia Via del Pino, 10 I-23854 Olginate (LC) Acros Organics bvba Janssen Pharmaceuticalaan 3a B-2440 Geel Airbus France 316, route de Bayonne F-31300 Toulouse Bie & Berntsen A-S Transformervej 8 DK-2730 Herlev Carlo Erba Reactifs-SDS Z.I. de Valdonne, BP 4 F-13124 Peypin Eras Labo 222, RN 90 F-38330 Saint-Nazaire-les-Eymes Harp International Gellihirion Industrial Estate, Rhondda, Cynon Taff, UK-Pontypridd CF37 5SX Health Protection Inspectorate-Laboratories Paldiski mnt 81 EE-10617 Tallinn Honeywell Specialty Chemicals Wunstorfer Straße 40 Postfach 10 02 62 D-30918 Seelze Institut scientifique de service public (ISSeP) Rue du Chéra, 200 B-4000 Liège Ineos Fluor Ltd PO Box 13, The Heath Runcorn, Cheshire WA7 4QF United Kingdom LGC Promochem GmbH Mercatorstr. 51 D-46485 Wesel Mallinckrodt Baker BV Teugseweg 20 7418 AM Deventer Nederland Mebrom NV Assenedestraat 4 B-9940 Rieme Ertvelde Merck KgaA Frankfurter Straße 250 D-64271 Darmstadt Mikro+Polo d.o.o. Zagrebška 22 SI-2000 Maribor Ministry of Defense Directorate Material RNL Navy P.O. Box 2070 2500 ES The Hague Nederland Panreac Química S.A. Pol. Ind. Pla de la Bruguera C/ Garraf 2 E-08211 Castellar del Vallès, Barcelona Sanolabor d.d. Leskoškova 4 SI-1000 Ljubljana Sigma Aldrich Chimie SARL 80, rue de Luzais L’Isle d’Abeau-Chesnes F-38297 Saint-Quentin-Fallavier Sigma Aldrich Laborchemikalien Wunstorfer Straße 40 Postfach 10 02 62 D-30918 Seelze Sigma Aldrich Logistik GmbH Riedstraße 2 D-89555 Steinheim Tazzetti Fluids Srl Corso Europa, 600/a I-10088 Volpiano (TO) VWR I.S.A.S. 201, rue Carnot F-94126 Fontenay-sous-Bois

Supplementary provisions

ANNEX ISupplementary provisions

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: Source: www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp 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 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 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 Portugal X X X X X X X X X X X Norway 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 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 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 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 Poland Portugal X X X The Netherlands X X X X X X Norway Slovakia X X X X X X Slovenia X X X X X X Spain X X Sweden X X United Kingdom X Table 3 Non steroidal anti inflammatories Country Cromoglicic acid Nedrocromil Austria X X Belgium 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 X Poland Portugal X The Netherlands X X Norway Slovakia X X Slovenia X X Spain X Sweden X X United Kingdom Table 4 Anticholinergic bronchodilators Country Ipratropium bromide Oxitropium Bromide Austria X X 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 X X Lithuania X X Luxembourg X X Malta X X Netherlands X X Poland Portugal X Norway 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 Cyprus X Czech Republic X X Denmark 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 Poland Portugal Norway Slovakia X X Slovenia X X Spain X Sweden X X United Kingdom Table 6 Combinations of active ingredients in a single MDI Country Austria X All products Belgium X All products Cyprus Czech Republic X All products Denmark 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 Poland Portugal Norway Slovakia X All products Slovenia X All products Spain Sweden X All products United Kingdom

ANNEX IISupplementary provisions

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: 3 M Health Care Ltd (UK) Bespak Europe Ltd (UK) Boehringer Ingelheim GmbH (DE) Chiesi Farmaceutici SpA (IT) Inyx Pharmaceuticals Ltd (UK) Ivax Ltd (IE) Laboratorio Aldo Union SA (ES) SICOR SpA (IT) Valeas SpA Pharmaceuticals (IT) Valvole Aerosol Research Italiana (VARI) SpA — LINDAL Group Italia (IT)

ANNEX IIISupplementary provisions

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 A-S (DK) Carlo Erba Reactifs-SDS (FR) Harp International (UK) Honeywell Specialty Chemicals (DE) Ineos Fluor (UK) LGC Promochem (DE) Mallinckrodt Baker (NL) Merck KGaA (DE) Mikro+Polo d.o.o. (SI) Panreac Química S.A. (ES) Sanolabor d.d. (SI) Sigma Aldrich Chimie (FR) Sigma Aldrich Logistik (DE) Tazzetti Fluids (IT) VWR I.S.A.S. (FR)

ANNEX IVSupplementary provisions

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 Defense (NL) Sigma Aldrich Chimie (FR)

ANNEX VSupplementary provisions

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 A-S (DK) Carlo Erba Reactifs-SDS (FR) Health Protection Inspectorate-Laboratories (EE) Honeywell Specialty Chemicals (DE) Institut scientifique de service public (ISSeP) (BE) Mallinckrodt Baker (NL) Merck KGaA (DE) Mikro+Polo d.o.o. (SI) Panreac Química S.A. (ES) Sanolabor d.d. (SI) Sigma Aldrich Chimie (FR) Sigma Aldrich Laborchemikalien (DE) Sigma Aldrich Logistik (DE)

ANNEX VISupplementary provisions

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 A-S (DK) Merck KGaA (DE) Mikro+Polo d.o.o. (SI) Panreac Química S.A. (ES) Sanolabor d.d. (SI) Sigma Aldrich Chimie (FR) Sigma Aldrich Logistik (DE)

ANNEX VIISupplementary provisions

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 VIIISupplementary provisions

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) Sigma Aldrich Chimie (FR)

ANNEX IXSupplementary provisions

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 Logistik (DE)

ANNEX XSupplementary provisions

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

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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