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)

(Only the Danish, Dutch, English, Estonian, French, German, Italian, Slovenian and Spanish texts are authentic)

(Text with EEA relevance)

(2007/211/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 [1], 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 [2] to 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.

(6) 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. Inaddition, 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).

(7) The Commission has published a Notice [3] on the 22 July 2006 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 2007 and has received declarations on intended essential uses of controlled substances for 2007.

(8) 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 2007.

(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 2007 shall be 316257,00 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 65900,9 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 147110436 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 12048 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 Stra?e 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 Stra?e 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 Stra?e 250

D-64271 Darmstadt

Mikro+Polo d.o.o.

Zagreb?ka 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.

Lesko?kova 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 Stra?e 40

Postfach 10 02 62

D-30918 Seelze

Sigma Aldrich Logistik GmbH

Riedstra?e 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

Done at Brussels, 27 March 2007.

For the Commission

Stavros Dimas

Member of the Commission

[1] OJ L 244, 29.9.2000, p. 1. Regulation as last amended by Council Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).

[2] www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp

[3] OJ C 171, 22.7.2006, p. 27.

[4] Ozone-depleting potential.

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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 | | | | | | |

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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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)

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ANNEX X

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

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