# L_2006214EN.01003501.xml

| 4.8.2006 | EN | Official Journal of the European Union | L 214/35 |
| --- | --- | --- | --- |

4.8.2006

EN

Official Journal of the European Union

L 214/35

---

COMMISSION DECISION

of 11 April 2006

on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2006 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council

(notified under document number C(2006) 1483)

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

(Text with EEA relevance)

(2006/540/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) 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 (3), 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 (4) 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). |
| --- | --- |

(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) 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 (3), 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 (4) 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 (5) 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. |
| --- | --- |

(6)

The Commission has published a Notice (5) 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. |
| --- | --- |

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

(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 539 000,00 ODP (6) 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 256 761,86 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 149 641,536 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. |
| --- | --- |

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 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 |

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 |

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 |

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 |

Chiesi Farmaceutici SpA

Via Palermo, 26/A

I-43100 Parma

| | IVAX Ltd |
| --- | --- |
| Unit 301 Industrial Park |
| Waterford |
| Ireland |

IVAX Ltd

Unit 301 Industrial Park

Waterford

Ireland

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

Laboratorio Aldo Union SA

Baronesa de Maldá, 73

Espluges 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 |

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) |

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 |

Acros Organics bvba

Janssen Pharmaceuticalaan 3o

B-2440 Geel

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

Airbus France

route de Bayonne 316

F-31300 Toulouse

| | Biosolove B.V. |
| --- | --- |
| Waalreseweg 17 |
| 5554 HA Valkenswaard |
| Nederland |

Biosolove B.V.

Waalreseweg 17

5554 HA Valkenswaard

Nederland

| | Bie & Berntsen |
| --- | --- |
| Sandbækvej 7 |
| DK-2610 Roedovre |

Bie & Berntsen

Sandbækvej 7

DK-2610 Roedovre

| | 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

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

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 |

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 Fluorine Products Europe

Kempenweg 90

P.O. Box 264

6000 AG Weert

Nederland

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

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 |

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 |

Institut Scientifique de Service Public (ISSeP)

Rue du Chéra, 200

B-4000 Liège

| | Katholieke Universiteit Leuven |
| --- | --- |
| Krakenstraat 3 |
| B-3000 Leuven |

Katholieke Universiteit Leuven

Krakenstraat 3

B-3000 Leuven

| | LGC Promochem GmbH |
| --- | --- |
| Mercatorstraße 51 |
| D-46485 Wesel |

LGC Promochem GmbH

Mercatorstraße 51

D-46485 Wesel

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

Mallinckrodt Baker BV

Teugseweg 20

7418 AM Deventer

Nederland

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

Merck KgaA

Frankfurter Straße 250

D-64271 Darmstadt

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

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 |

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) |

Panreac Química SA

Riera de Sant Cugat 1

E-08110 Montcada I Reixac (Barcelona)

| | Sanolabor d.d. |
| --- | --- |
| Leskovškova 4 |
| SLO-1000 Ljubljana |

Sanolabor d.d.

Leskovškova 4

SLO-1000 Ljubljana

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

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 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 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 Laborchemikalien

Wunstorfer Straße 40

Postfach 100262

D-30918 Seelze

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

Sigma Aldrich Chemie GmbH

Riedstraße 2

D-89555 Steinheim

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

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 |

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 |

VWR I.S.A.S.

201, rue Carnot

F-94126 Fontenay-sous-Bois

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

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

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(1)  
  OJ L 244, 29.9.2000, p. 1. Regulation as last amended by Commission Regulation (EC) No 29/2006 (OJ L 6, 11.1.2006, p. 27).

1

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

2

(3)  Except Denmark.

3

(4)  Except Sweden.

4

(5)  
  OJ C 168, 8.7.2005, p. 20.

5

(6)  Ozone-depleting Potential.

6

---

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:

Table 1

| 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

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

Table 2

| 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

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

Table 3

| 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

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

Table 4

| 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

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

Table 5

| 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

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

Table 6

| 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 | | | | | | |
| 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

Source: www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp

---

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) |
| --- | --- |

Bespak (UK)

| | Boehringer Ingelheim (DE) on behalf of Boehringer Ingelheim France |
| --- | --- |

Boehringer Ingelheim (DE) on behalf of Boehringer Ingelheim France

| | Chiesi (IT) |
| --- | --- |

Chiesi (IT)

| | IVAX (IE) |
| --- | --- |

IVAX (IE)

| | Lab Aldo-Union (ES) |
| --- | --- |

Lab Aldo-Union (ES)

| | Sicor (IT) |
| --- | --- |

Sicor (IT)

| | Valeas (IT) |
| --- | --- |

Valeas (IT)

| | V.A.R.I. (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) |
| --- | --- |

Bie & Berntsen (DK)

| | Biosolve (NL) |
| --- | --- |

Biosolve (NL)

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

Carlo Erba Reactifs-SDS (FR)

| | CNRS — Groupe de Physique des Solides (FR) |
| --- | --- |

CNRS — Groupe de Physique des Solides (FR)

| | Honeywell Fluorine Products Europe (NL) |
| --- | --- |

Honeywell Fluorine Products Europe (NL)

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

Honeywell Specialty Chemicals (DE)

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

Ineos Fluor (UK)

| | Katholieke Universiteit Leuven (BE) |
| --- | --- |

Katholieke Universiteit Leuven (BE)

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

LGC Promochem (DE)

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

Mallinckrodt Baker (NL)

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

Merck KGaA (DE)

| | Mikro + Polo (SI) |
| --- | --- |

Mikro + Polo (SI)

| | Panreac Química (ES) |
| --- | --- |

Panreac Química (ES)

| | Sanolabor (SI) |
| --- | --- |

Sanolabor (SI)

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

Sigma Aldrich Chimie (FR)

| | Sigma Aldrich Company (UK) |
| --- | --- |

Sigma Aldrich Company (UK)

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

Sigma Aldrich Logistik (DE)

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

Tazzetti Fluids (IT)

| | University of Technology Vienna (AT) |
| --- | --- |

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) |
| --- | --- |

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 (DK) |
| --- | --- |

Bie & Berntsen (DK)

| | Biosolve (NL) |
| --- | --- |

Biosolve (NL)

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

Carlo Erba Reactifs-SDS (FR)

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

Health Protection Inspectorate-Laboratories (EE)

| | Institut Scientifique de Service Public (ISSeP) (BE) |
| --- | --- |

Institut Scientifique de Service Public (ISSeP) (BE)

| | Katholieke Universiteit Leuven (BE) |
| --- | --- |

Katholieke Universiteit Leuven (BE)

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

Mallinckrodt Baker (NL)

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

Merck KGaA (DE)

| | Mikro + Polo (SI) |
| --- | --- |

Mikro + Polo (SI)

| | Panreac Química (ES) |
| --- | --- |

Panreac Química (ES)

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

Sanolabor d.d. (SI)

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

Sigma Aldrich Chimie (FR)

| | Sigma Aldrich Company (UK) |
| --- | --- |

Sigma Aldrich Company (UK)

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

Sigma Aldrich Laborchemikalien (DE)

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

Sigma Aldrich Logistik (DE)

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

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

| | YA-Kemia Oy (FI) |
| --- | --- |

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) |
| --- | --- |

Bie & Berntsen (DK)

| | Katholieke Universiteit Leuven (BE) |
| --- | --- |

Katholieke Universiteit Leuven (BE)

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

Mallinckrodt Baker (NL)

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

Merck KGaA (DE)

| | Mikro + Polo (SI) |
| --- | --- |

Mikro + Polo (SI)

| | Panreac Química (ES) |
| --- | --- |

Panreac Química (ES)

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

Sanolabor d.d. (SI)

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

Sigma Aldrich Chimie (FR)

| | Sigma Aldrich Company (UK) |
| --- | --- |

Sigma Aldrich Company (UK)

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

Sigma Aldrich Logistik (DE)

| | YA-Kemia Oy (FI) |
| --- | --- |

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:

---

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) |
| --- | --- |

Katholieke Universiteit Leuven (BE)

| | Sigma Aldrich Logistik (FR) |
| --- | --- |

Sigma Aldrich Logistik (FR)

| | Sigma Aldrich Company (UK) |
| --- | --- |

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) |
| --- | --- |

Katholieke Universiteit Leuven (BE)

| | Sigma Aldrich Logistik (FR) |
| --- | --- |

Sigma Aldrich Logistik (FR)

| | YA-Kemia Oy (FI) |
| --- | --- |

YA-Kemia Oy (FI)

---

ANNEX X

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

---