Address https://gelex.eu/eli/EU/decision/2008/409@2008-04-17/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 LIST OF NON-ESSENTIAL SUBSTANCES Table 1 Table 2 Table 3 Table 4 Table 5 Table 6 Short-acting beta agonist bronchodilators Inhaled steroids Non-steroidal anti-inflammatories Anticholinergic bronchodilators Long-acting beta agonist bronchodilators Combinations of active ingredients in a single MDI
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 XIX/13 of the Parties to the Montreal Protocol authorises the production in the European Community of 200 tonnes of chlorofluorocarbons (CFCs) in 2008 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 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 CFC-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 on the 18 July 2007 to those companies in the Community of 27 Member States that request consideration by the Commission for the use of controlled substances for essential uses in the Community in 2008 and has received declarations on intended essential uses of controlled substances for 2008.

(9) 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 2008.

(10) 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 2008 shall be 155460,00 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 uses in the Community in 2008 shall be 56213,60 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 2008 shall be 418,7 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 2008 shall be 150832,836 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 2008 shall be 381,5 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 2008 shall be 150,00 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 2008 shall be 0,96 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 uses in the Community in 2008 shall be 13,368 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 2008 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 2008 and shall expire on 31 December 2008.

Article 5

This Decision is addressed to the following undertakings:

Acros Organics bvba Janssen Pharmaceuticalaan 3A° B-2440 Geel

Airbus France Service EVICS BP M6322 Route de Bayonne 316 F-31060 Toulouse Cedex 16

Bie & Berntsen Sandbækvej 7 DK-2610 Rødovre

Boehringer Ingelheim GmbH Binger Straße 173 D-55216 Ingelheim am Rhein

Carlo Erba Reactifs-SDS ZI de Valdonne, BP 4 F-13124 Peypin

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

CNRS — Département Galilée Observatoire de la Côte d'Azur — Siège Social Boulevard de l'Observatoire, BP 4229 F-06304 Nice Cedex 4

Eras Labo 222 RN 90 F-38330 Saint-Nazaire-les-Eymes

Harp International Gellihirion Industrial Estate Rhondda, Cynon Taff Pontypridd CF37 5SX United Kingdom

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

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

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

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

LGC Standards GmbH Mercatorstraße 51 D-46485 Wesel

Mallinckrodt Baker EMEA Teugseweg 20 7418 AM Deventer Nederland

Mebrom Assenedestraat 4 B-9940 Rieme Ertvelde

Merck KGaA Frankfurter Straße 250 D-64271 Darmstadt

Mikro+Polo d.o.o. Zagrebška cesta 22 SI-2000 Maribor

Ministry of Defense Defence Fuel Lubricants and Chemicals Service/Chemical Laboratory PO Box 10.000 1780 CA Den Helder Nederland

Panreac Química SAU Pol. Ind. Pla de la Bruguera C/Garraf 2 E-08211 Castellar del Vallès — Barcelona

Sanolabor d.d. Leskoškova 4 Ljubljana Slovenia

SICOR SpA Via Terrazzano 77 I-20017 Rho

Sigma Aldrich Chimie SARL 80, rue de Luzais L'Isle d'Abeau Chesnes F-38297 St-Quentin-Fallavier

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

Sigma Aldrich Laborchemikalien GmbH Wunstorfer Straße 40 D-30926 Seelze

Sigma Aldrich Logistik GmbH Riedstraße 2 D-89555 Steinheim

Tazzetti Fluids SRL Corso Europa n. 600/a I-10070 Volpiano (TO)

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)

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

Done at Brussels, 17 April 2008. For the Commission Stavros Dimas Member of the Commission

ANNEX

ANNEX I LIST OF NON-ESSENTIAL SUBSTANCES Table 1 Table 2 Table 3 Table 4 Table 5 Table 6 Short-acting beta agonist bronchodilators Inhaled steroids Non-steroidal anti-inflammatories Anticholinergic bronchodilators Long-acting beta agonist bronchodilators Combinations of active ingredients in a single MDI

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 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 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 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 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 Sweden X X United Kingdom X 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 Sweden X X United Kingdom X X 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 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 X X Portugal X Romania X X Slovakia X X Slovenia X X Spain X X Sweden X X United Kingdom X X Country Formoterol Salmeterol Austria X X Belgium X X Bulgaria X X Cyprus X Czech Republic X X Denmark X 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 X Poland X X Portugal X X Romania X X Slovakia X X Slovenia X X Spain X Sweden X X United Kingdom X X 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 X All products 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

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:

Boehringer Ingelheim GmbH (DE)

Chiesi Farmaceutici SpA (IT)

Laboratorio Aldo Union SA (ES)

SICOR SpA (IT)

Valeas SpA Pharmaceuticals (IT)

(VARI) SpA — LINDAL Group Italia (IT)

ANNEX III ESSENTIAL LABORATORY USES

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

Bie & Berntsen (DK)

Carlo Erba Reactifs-SDS (FR)

CNRS — Département Galilée (FR)

Harp International (UK)

Honeywell Specialty Chemicals (DE)

Ineos Fluor (UK)

LGC Standards (DE)

Mallinckrodt Baker (NL)

Merck KGaA (DE)

Mikro + Polo (SI)

Panreac Quimica (ES)

Sanolabor (SI)

Sigma Aldrich Chimie (FR)

Sigma Aldrich Company (UK)

Sigma Aldrich Logistik (DE)

Tazzetti Fluids (IT)

VWR ISAS (FR)

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 Defence (NL)

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)

Carlo Erba Reactifs-SDS (FR)

Health Protection Inspectorate-Laboratories (EE)

Honeywell Specialty Chemicals (DE)

Mallinckrodt Baker (NL)

Merck KGaA (DE)

Mikro + Polo (SI)

Panreac Quimica (ES)

Sanolabor d.d. (SI)

Sigma Aldrich Chimie (FR)

Sigma Aldrich Company (UK)

Sigma Aldrich Laborchemikalien (DE)

Sigma Aldrich Logistik (DE)

VWR ISAS (FR)

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)

Merck KgaA (DE)

Mikro + Polo (SI)

Panreac Quimica (ES)

Sanolabor d.d. (SI)

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:

Mebrom NV (BE)

Sigma Aldrich Logistik (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)

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 Company (UK)

Sigma Aldrich Logistik (DE)

ANNEX X

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

Versions

1. 2008-04-17