Address https://gelex.eu/eli/EU/decision/2006/540@2006-04-11/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2
   3. Article 3
   4. Article 4
   5. Article 5
3. ANNEX
4. ANNEX I Table 1 Table 2 Table 3 Table 4 Table 5 Table 6
5. ANNEX II ESSENTIAL MEDICAL USES
6. ANNEX III ESSENTIAL LABORATORY USES
7. ANNEX IV ESSENTIAL LABORATORY USES
8. ANNEX V ESSENTIAL LABORATORY USES
9. ANNEX VI ESSENTIAL LABORATORY USES
10. ANNEX VII LABORATORY AND ANALYTICAL CRITICAL USES
11. ANNEX VIII ESSENTIAL LABORATORY USES
12. ANNEX IX ESSENTIAL LABORATORY USES
13. ANNEX X

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 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 the United Nations Environment Programme that chlorofluorocarbons (CFCs) are no longer essential for the manufacture of salbutamol CFC-MDIs for placing on the market of the European Community. Austria, Belgium, Czech Republic, Denmark, Estonia, Germany, Greece, Hungary, Latvia, Lithuania, Norway, Portugal, The Netherlands, the Slovak Republic and Slovenia have notified UNEP that the use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of short-acting beta agonist bronchiodilators, specifically terbutaline, fenoterol, orciprenaline, reproterol, carbuterol, hexoprenaline, pirbuterol, clenbuterol, bitolterol and procaterol. Belgium, the Czech Republic, Estonia, Germany, Hungary, Latvia, the Netherlands, the Slovak Republic, Slovenia and Sweden have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of inhaled steroids, specifically beclomethasone, dexamethasone, flunisolide, fluticasone, budesonide and triamcinolone. Denmark (beclomethasone, fluticasone), Ireland (beclomethasone, fluticasone), Finland (beclomethasone, fluticasone), France (beclomethasone, fluticasone), Italy (beclomethasone, fluticasone, budesonide), Malta (fluticasone, budesonide), Portugal (fluticasone, budesonide), Slovenia (beclomethasone, fluticasone, budesonide), Spain (beclomethasone, fluticasone) and the United Kingdom (fluticasone) have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of inhaled steroids shown in parentheses after each Member State. Belgium, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Latvia, the Netherlands, the Slovak Republic and Slovenia have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of non-steroidal anti-inflammatories, specifically cromoglicic acid and nedrocromil. Portugal has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contains the active ingredient cromoglicic acid. Spain has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contains the active ingredient nedrocromil. Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Latvia, Malta, the Netherlands, the Slovak Republic, Spain, Sweden and the United Kingdom have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of anticholinergic bronchodilators, specifically ipatropium bromide and oxitropium bromide. Portugal has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contains the active ingredient ipatropium bromide. Germany has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of long-acting beta agonist bronchiodilators, specifically formoterol and salmeterol. Italy has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contains the active ingredient formoterol. Germany and the Netherlands have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain combinations of active ingredients. 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).

(6) The Commission has published a Notice on 8 July 2005 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 2006 and has received declarations on intended essential uses of controlled substances for 2006.

(7) 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 2006.

(8) 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 2006 shall be 539000,00 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 2006 shall be 256761,86 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 2006 shall be 482,70 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 2006 shall be 149641,536 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 2006 shall be 754,00 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 2006 shall be 300,00 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 2006 shall be 4,49 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 2006 shall be 13,308 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 chlorofluorocarbonsfor metered-dose inhalers on those markets to be non-essential.

Article 3

During the period 1 January to 31 December 2006 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 2006 and shall expire on 31 December 2006.

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 PLC North Lynn Industrial Estate King's Lynn PE30 2JJ — Norfolk United Kingdom

Boehringer Ingelheim GmbH Binger Straße 173 D-55216 Ingelheim am Rhein on behalf of Boehringer Ingelheim (France)

Chiesi Farmaceutici SpA Via Palermo, 26/A I-43100 Parma

IVAX Ltd Unit 301 Industrial Park Waterford Ireland

Laboratorio Aldo Union SA Baronesa de Maldá, 73 Espluges de Llobregat E-08950 Barcelona

SICOR SpA Via Terrazzano, 77 I-20017 Rho (MI)

Valeas SpA Pharmaceuticals Via Vallisneri, 10 I-20133 Milano

Valvole Aerosol Research Italiana (VARI) Spa — LINDAL Group Italia Via del Pino, 10 I-23854 Olginate (LC)

Acros Organics bvba Janssen Pharmaceuticalaan 3o B-2440 Geel

Airbus France route de Bayonne 316 F-31300 Toulouse

Biosolove B.V. Waalreseweg 17 5554 HA Valkenswaard Nederland

Bie & Berntsen Sandbækvej 7 DK-2610 Roedovre

Carlo Erba Reactifs-SDS Z.I. de Valdonne, BP 4 F-13124 Peypin

CNRS — Groupe de Physique des Solides Université Paris, 7 Denis Diderot & Paris 6 Pierre et Marie Curie F-75251 Paris Cedex 5

Health Protection Inspectorate-Laboratories Paldiski mnt 81 EE-10617 Tallinn

Honeywell Fluorine Products Europe Kempenweg 90 P.O. Box 264 6000 AG Weert Nederland

Honeywell Specialty Chemicals Wunstorfer Straße 40 Postfach 100262 D-30918 Seelze

Ineos Fluor Ltd PO Box 13, The Heath Runcorn Cheshire WA7 4QF United Kingdom

Institut Scientifique de Service Public (ISSeP) Rue du Chéra, 200 B-4000 Liège

Katholieke Universiteit Leuven Krakenstraat 3 B-3000 Leuven

LGC Promochem GmbH Mercatorstraße 51 D-46485 Wesel

Mallinckrodt Baker BV Teugseweg 20 7418 AM Deventer Nederland

Merck KgaA Frankfurter Straße 250 D-64271 Darmstadt

Mikro+Polo d.o.o. Lackova 78 SLO-2000 Maribor

Ministry of Defense Directorate Material RNL Navy PO Box 2070 2500 ES The Hague Nederland

Panreac Química SA Riera de Sant Cugat 1 E-08110 Montcada I Reixac (Barcelona)

Sanolabor d.d. Leskovškova 4 SLO-1000 Ljubljana

Sigma Aldrich Logistik GmbH Riedstraße 2 D-89555 Steinheim

Sigma Aldrich Chimie SARL 80, rue de Luzais L'isle-d'abeau Chesnes F-38297 Saint-Quentin-Fallavier

Sigma Aldrich Company Ltd The Old Brickyard New Road Gillingham SP8 4XT United Kingdom

Sigma Aldrich Laborchemikalien Wunstorfer Straße 40 Postfach 100262 D-30918 Seelze

Sigma Aldrich Chemie GmbH Riedstraße 2 D-89555 Steinheim

Tazzetti Fluids S.r.l. Corso Europa, 600/a I-10088 Volpiano (TO)

University of Technology Vienna Institut of Industrial Electronics&Material Science Gusshausstraße 27-29 A-1040 Wien

VWR I.S.A.S. 201, rue Carnot F-94126 Fontenay-sous-Bois

YA-Kemia Oy — Sigma Aldrich Finland Teerisuonkuja 4 FI-00700 Helsinki

Done at Brussels, 11 April 2006. For the Commission Stavros Dimas Member of the Commission

ANNEX

ANNEX I Table 1 Table 2 Table 3 Table 4 Table 5 Table 6

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 Country Short-acting Beta Agonist Bronchodilators 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 Czech Republic X X X X X X X X X X X Denmark X X X X X X X X X X Estonia X X X X X X X X X X X Finland X France 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 Italy 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 Malta 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 Slovak Republic 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 Sweden X United Kingdom X Source: www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp Country Inhaled steroids Beclomethasone Dexamethasone Flunisolide Fluticasone Budesonide Triamcinolone Austria 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 Latvia X X X X X X Lithuania Luxembourg Malta X X Poland Portugal X X Netherlands X X X X X X Norway Slovak Republic X X X X X X Slovenia X X X X X X Spain X X Sweden X X X X X United Kingdom X Source: www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp Country Non-steroidal anti-inflammatories Cromoglicic acid Nedrocromil Austria Belgium X X Cyprus Czech Republic X X Denmark X X Estonia X X Finland X X France X X Germany X X Greece X X Hungary Ireland Italy Latvia X X Lithuania Luxembourg Malta Poland Portugal X Netherlands X X Norway Slovak Republic X X Slovenia X X Spain X Sweden United Kingdom Source: www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp Country Anticholinergic Bronchodilators Ipratropium bromide Oxitropium Bromide Austria 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 Lithuania Luxembourg Malta X X Netherlands X X Poland Portugal X Norway Slovak Republic X X Slovenia Spain X X Sweden X X United Kingdom X X Source: www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp Country Long-acting Beta Agonist Bronchodilators Formoterol Salmeterol Austria Belgium Cyprus Czech Republic Denmark Estonia Finland France Germany X X Greece Hungary Ireland Italy X Latvia Lithuania Luxembourg Malta Netherlands Poland Portugal Norway Slovak Republic Slovenia Spain Sweden United Kingdom Source: www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp Country Combinations of active ingredients in a single MDI Austria Belgium Cyprus Czech Republic Denmark Estonia Finland France Germany X Greece Hungary Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Poland Portugal Norway Slovak Republic Slovenia Spain Sweden United Kingdom

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:

3M Health Care (UK)

Bespak (UK)

Boehringer Ingelheim (DE) on behalf of Boehringer Ingelheim France

Chiesi (IT)

IVAX (IE)

Lab Aldo-Union (ES)

Sicor (IT)

Valeas (IT)

V.A.R.I. (IT)

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 (DK)

Biosolve (NL)

Carlo Erba Reactifs-SDS (FR)

CNRS — Groupe de Physique des Solides (FR)

Honeywell Fluorine Products Europe (NL)

Honeywell Specialty Chemicals (DE)

Ineos Fluor (UK)

Katholieke Universiteit Leuven (BE)

LGC Promochem (DE)

Mallinckrodt Baker (NL)

Merck KGaA (DE)

Mikro + Polo (SI)

Panreac Química (ES)

Sanolabor (SI)

Sigma Aldrich Chimie (FR)

Sigma Aldrich Company (UK)

Sigma Aldrich Logistik (DE)

Tazzetti Fluids (IT)

University of Technology Vienna (AT)

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)

Ineos Fluor (UK)

Ministry of Defense (NL)

Sigma Aldrich Chimie (FR)

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)

Biosolve (NL)

Carlo Erba Reactifs-SDS (FR)

Health Protection Inspectorate-Laboratories (EE)

Institut Scientifique de Service Public (ISSeP) (BE)

Katholieke Universiteit Leuven (BE)

Mallinckrodt Baker (NL)

Merck KGaA (DE)

Mikro + Polo (SI)

Panreac Química (ES)

Sanolabor d.d. (SI)

Sigma Aldrich Chimie (FR)

Sigma Aldrich Company (UK)

Sigma Aldrich Laborchemikalien (DE)

Sigma Aldrich Logistik (DE)

VWR I.S.A.S. (FR)

YA-Kemia Oy (FI)

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)

Katholieke Universiteit Leuven (BE)

Mallinckrodt Baker (NL)

Merck KGaA (DE)

Mikro + Polo (SI)

Panreac Química (ES)

Sanolabor d.d. (SI)

Sigma Aldrich Chimie (FR)

Sigma Aldrich Company (UK)

Sigma Aldrich Logistik (DE)

YA-Kemia Oy (FI)

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 Chemie GmbH (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)

Katholieke Universiteit Leuven (BE)

Sigma Aldrich Logistik (FR)

Sigma Aldrich Company (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)

Katholieke Universiteit Leuven (BE)

Sigma Aldrich Logistik (FR)

YA-Kemia Oy (FI)

ANNEX X

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

Versions

1. 2006-04-11