# L_2007094EN.01003901.xml

| 4.4.2007 | EN | Official Journal of the European Union | L 94/39 |
| --- | --- | --- | --- |

4.4.2007

EN

Official Journal of the European Union

L 94/39

---

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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. 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)

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).

| (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. |
| --- | --- |

(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. |
| --- | --- |

(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, |
| --- | --- |

(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 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. |
| --- | --- |

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. |
| --- | --- |

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. |
| --- | --- |

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. |
| --- | --- |

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. |
| --- | --- |

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. |
| --- | --- |

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. |
| --- | --- |

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. |
| --- | --- |

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. |
| --- | --- |

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 |

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 |

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 |

Boehringer Ingelheim GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

| | Chiesi Farmaceutici SpA |
| --- | --- |
| Via Palermo 26/A |
| I-43100 Parma (PR) |

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 |

Inyx Pharmaceuticals Ltd

Astmoor Industrial Estate

9 Arkwright Road Runcorn

Cheshire WA7 1NU

United Kingdom

| | IVAX Ltd |
| --- | --- |
| Unit 301, |
| Waterford Industrial Estate |
| Weterford, Ireland |

IVAX Ltd

Unit 301,

Waterford Industrial Estate

Weterford, Ireland

| | Laboratorio Aldo Union S.A. |
| --- | --- |
| Baronesa de Maldá 73 |
| Esplugues de Llobregat |
| E-08950 Barcelona |

Laboratorio Aldo Union S.A.

Baronesa de Maldá 73

Esplugues de Llobregat

E-08950 Barcelona

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

SICOR SpA

Via Terrazzano 77

I-20017 Rho (MI)

| | Valeas SpA Pharmaceuticals |
| --- | --- |
| Via Vallisneri, 10 |
| I-20133 Milano (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) |

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 |

Acros Organics bvba

Janssen Pharmaceuticalaan 3a

B-2440 Geel

| | Airbus France |
| --- | --- |
| 316, route de Bayonne |
| F-31300 Toulouse |

Airbus France

316, route de Bayonne

F-31300 Toulouse

| | Bie & Berntsen A-S |
| --- | --- |
| Transformervej 8 |
| DK-2730 Herlev |

Bie & Berntsen A-S

Transformervej 8

DK-2730 Herlev

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

Carlo Erba Reactifs-SDS

Z.I. de Valdonne, BP 4

F-13124 Peypin

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

Eras Labo

222, RN 90

F-38330 Saint-Nazaire-les-Eymes

| | Harp International |
| --- | --- |
| Gellihirion Industrial Estate, |
| Rhondda, Cynon Taff, |
| UK-Pontypridd CF37 5SX |

Harp International

Gellihirion Industrial Estate,

Rhondda, Cynon Taff,

UK-Pontypridd CF37 5SX

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

Health Protection Inspectorate-Laboratories

Paldiski mnt 81

EE-10617 Tallinn

| | Honeywell Specialty Chemicals |
| --- | --- |
| Wunstorfer Straße 40 |
| Postfach 10 02 62 |
| D-30918 Seelze |

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 |

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 |

Ineos Fluor Ltd

PO Box 13, The Heath

Runcorn, Cheshire WA7 4QF

United Kingdom

| | LGC Promochem GmbH |
| --- | --- |
| Mercatorstr. 51 |
| D-46485 Wesel |

LGC Promochem GmbH

Mercatorstr. 51

D-46485 Wesel

| | Mallinckrodt Baker BV |
| --- | --- |
| Teugseweg 20 |
| 7418 AM Deventer |
| Nederland |

Mallinckrodt Baker BV

Teugseweg 20

7418 AM Deventer

Nederland

| | Mebrom NV |
| --- | --- |
| Assenedestraat 4 |
| B-9940 Rieme Ertvelde |

Mebrom NV

Assenedestraat 4

B-9940 Rieme Ertvelde

| | Merck KgaA |
| --- | --- |
| Frankfurter Straße 250 |
| D-64271 Darmstadt |

Merck KgaA

Frankfurter Straße 250

D-64271 Darmstadt

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

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 |

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 |

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 |

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 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 Laborchemikalien

Wunstorfer Straße 40

Postfach 10 02 62

D-30918 Seelze

| | Sigma Aldrich Logistik GmbH |
| --- | --- |
| Riedstraße 2 |
| D-89555 Steinheim |

Sigma Aldrich Logistik GmbH

Riedstraße 2

D-89555 Steinheim

| | Tazzetti Fluids Srl |
| --- | --- |
| Corso Europa, 600/a |
| I-10088 Volpiano (TO) |

Tazzetti Fluids Srl

Corso Europa, 600/a

I-10088 Volpiano (TO)

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

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).

1

(2)  www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp

2

(3)  
  OJ C 171, 22.7.2006, p. 27.

3

(4)  Ozone-depleting potential.

4

---

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 | | | | | | | | | | |

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 | | |

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 | | | | | | |

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 | | | | |

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 | | | | | | |

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 | | | | | | |

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 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) |
| --- | --- |

Bespak Europe Ltd (UK)

| | Boehringer Ingelheim GmbH (DE) |
| --- | --- |

Boehringer Ingelheim GmbH (DE)

| | Chiesi Farmaceutici SpA (IT) |
| --- | --- |

Chiesi Farmaceutici SpA (IT)

| | Inyx Pharmaceuticals Ltd (UK) |
| --- | --- |

Inyx Pharmaceuticals Ltd (UK)

| | Ivax Ltd (IE) |
| --- | --- |

Ivax Ltd (IE)

| | Laboratorio Aldo Union SA (ES) |
| --- | --- |

Laboratorio Aldo Union SA (ES)

| | SICOR SpA (IT) |
| --- | --- |

SICOR SpA (IT)

| | Valeas SpA Pharmaceuticals (IT) |
| --- | --- |

Valeas SpA Pharmaceuticals (IT)

| | Valvole Aerosol Research Italiana (VARI)
  SpA — LINDAL Group Italia (IT) |
| --- | --- |

Valvole Aerosol Research Italiana (VARI)

SpA — LINDAL Group Italia (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 A-S (DK) |
| --- | --- |

Bie & Berntsen A-S (DK)

| | Carlo Erba Reactifs-SDS (FR) |
| --- | --- |

Carlo Erba Reactifs-SDS (FR)

| | Harp International (UK) |
| --- | --- |

Harp International (UK)

| | Honeywell Specialty Chemicals (DE) |
| --- | --- |

Honeywell Specialty Chemicals (DE)

| | Ineos Fluor (UK) |
| --- | --- |

Ineos Fluor (UK)

| | LGC Promochem (DE) |
| --- | --- |

LGC Promochem (DE)

| | Mallinckrodt Baker (NL) |
| --- | --- |

Mallinckrodt Baker (NL)

| | Merck KGaA (DE) |
| --- | --- |

Merck KGaA (DE)

| | Mikro+Polo d.o.o. (SI) |
| --- | --- |

Mikro+Polo d.o.o. (SI)

| | Panreac Química S.A. (ES) |
| --- | --- |

Panreac Química S.A. (ES)

| | Sanolabor d.d. (SI) |
| --- | --- |

Sanolabor d.d. (SI)

| | Sigma Aldrich Chimie (FR) |
| --- | --- |

Sigma Aldrich Chimie (FR)

| | Sigma Aldrich Logistik (DE) |
| --- | --- |

Sigma Aldrich Logistik (DE)

| | Tazzetti Fluids (IT) |
| --- | --- |

Tazzetti Fluids (IT)

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

VWR I.S.A.S. (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) |
| --- | --- |

Eras Labo (FR)

| | Ineos Fluor (UK) |
| --- | --- |

Ineos Fluor (UK)

| | Ministry of Defense (NL) |
| --- | --- |

Ministry of Defense (NL)

| | Sigma Aldrich Chimie (FR) |
| --- | --- |

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 A-S (DK) |
| --- | --- |

Bie & Berntsen A-S (DK)

| | Carlo Erba Reactifs-SDS (FR) |
| --- | --- |

Carlo Erba Reactifs-SDS (FR)

| | Health Protection Inspectorate-Laboratories (EE) |
| --- | --- |

Health Protection Inspectorate-Laboratories (EE)

| | Honeywell Specialty Chemicals (DE) |
| --- | --- |

Honeywell Specialty Chemicals (DE)

| | Institut scientifique de service public (ISSeP) (BE) |
| --- | --- |

Institut scientifique de service public (ISSeP) (BE)

| | Mallinckrodt Baker (NL) |
| --- | --- |

Mallinckrodt Baker (NL)

| | Merck KGaA (DE) |
| --- | --- |

Merck KGaA (DE)

| | Mikro+Polo d.o.o. (SI) |
| --- | --- |

Mikro+Polo d.o.o. (SI)

| | Panreac Química S.A. (ES) |
| --- | --- |

Panreac Química S.A. (ES)

| | Sanolabor d.d. (SI) |
| --- | --- |

Sanolabor d.d. (SI)

| | Sigma Aldrich Chimie (FR) |
| --- | --- |

Sigma Aldrich Chimie (FR)

| | Sigma Aldrich Laborchemikalien (DE) |
| --- | --- |

Sigma Aldrich Laborchemikalien (DE)

| | Sigma Aldrich Logistik (DE) |
| --- | --- |

Sigma Aldrich Logistik (DE)

---

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) |
| --- | --- |

Bie & Berntsen A-S (DK)

| | Merck KGaA (DE) |
| --- | --- |

Merck KGaA (DE)

| | Mikro+Polo d.o.o. (SI) |
| --- | --- |

Mikro+Polo d.o.o. (SI)

| | Panreac Química S.A. (ES) |
| --- | --- |

Panreac Química S.A. (ES)

| | Sanolabor d.d. (SI) |
| --- | --- |

Sanolabor d.d. (SI)

| | Sigma Aldrich Chimie (FR) |
| --- | --- |

Sigma Aldrich Chimie (FR)

| | Sigma Aldrich Logistik (DE) |
| --- | --- |

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) |
| --- | --- |

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) |
| --- | --- |

| | Sigma Aldrich Chimie (FR) |
| --- | --- |

Sigma Aldrich Chimie (FR)

---

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) |
| --- | --- |

Sigma Aldrich Logistik (DE)

---

ANNEX X

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

---