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.
(2)
Each year the Commission is required to determine essential uses for these controlled substances, the quantities that may be used and the companies that may use them.
(3)
Decision IV/25 of the Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer, hereinafter ‘the Montreal Protocol’, sets out the criteria used by the Commission for determining any essential uses and authorises the production and consumption necessary to satisfy essential uses of controlled substances in each Party.
(4)
Decision XV/8 of the Parties to the Montreal Protocol authorises the production and consumption necessary to satisfy essential uses of controlled substances listed in Annexes A, B and C (Group II and III substances) of the Montreal Protocol for laboratory and analytical uses as listed in Annex IV to the report of the Seventh Meeting of the Parties, subject to the conditions set out in Annex II to the report of the Sixth Meeting of the Parties, as well as Decisions VII/11, XI/15 and XV/5 of the Parties to the Montreal Protocol.Decision XVII/10 of the Parties to the Montreal Protocol authorises the production and consumption of the controlled substance listed in Annex E of the Montreal Protocol necessary to satisfy laboratory and analytical uses of methyl bromide.
(5)
Pursuant to paragraph 3 of Decision XII/2 of the Parties to the Montreal Protocol on measures to facilitate the transition to chlorofluorocarbon-free Metered-Dose Inhalers (MDIs), all Member States have notified (2) 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.
(7)
For the purpose of ensuring that interested companies and operators may continue to benefit in due time from the licensing system, it is appropriate that the present decision shall apply from 1 January 2006.
(8)
The measures provided for in this Decision are in accordance with the opinion of the Management Committee established by Article 18(1) of Regulation (EC) No 2037/2000,
HAS ADOPTED THIS DECISION:
Article 1
1. The quantity of controlled substances of Group I (chlorofluorocarbons 11, 12, 113, 114 and 115) subject to Regulation (EC) No 2037/2000 which may be used for essential medical uses in the Community in 2006 shall be 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.
2.
The allocation of essential laboratory use quotas for chlorofluorocarbons 11, 12, 113, 114 and 115 and other fully halogenated chlorofluorocarbons shall be to the companies indicated in Annex III.
3.
The allocation of essential laboratory use quotas for halons shall be to the companies indicated in Annex IV.
4.
The allocation of essential laboratory use quotas for carbon tetrachloride shall be to the companies indicated in Annex V.
5.
The allocation of essential laboratory use quotas for 1,1,1-trichloroethane shall be to the companies indicated in Annex VI.
6.
The allocation of laboratory and analytical critical use quotas for methyl bromide shall be to the companies indicated in Annex VII.
7.
The allocation of essential laboratory use quotas for hydrobromofluorocarbons shall be to the companies indicated in Annex VIII.
8.
The allocation of essential laboratory use quotas for bromochloromethane shall be to the companies indicated in Annex IX.
9.
The essential use quotas for chlorofluorocarbons 11, 12, 113, 114 and 115, other fully halogenated chlorofluorocarbons, carbon tetrachloride, 1,1,1-trichloroethane, hydrobromofluorocarbons and bromochloromethane shall be as set out in Annex X.
Article 4
This Decision shall apply from 1 January 2006 and shall expire on 31 December 2006.
Article 5
This Decision is addressed to the following undertakings:
3M Health Care Ltd
3M House Morley Street
Loughborough
Leicestershire LE11 1EP
United Kingdom
Bespak PLC
North Lynn Industrial Estate
King's Lynn
PE30 2JJ - Norfolk
United Kingdom
Boehringer Ingelheim GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein
on behalf of Boehringer Ingelheim (France)
Chiesi Farmaceutici SpA
Via Palermo, 26/A
I-43100 Parma
IVAX Ltd
Unit 301 Industrial Park
Waterford
Ireland
Laboratorio Aldo Union SA
Baronesa de Maldá, 73
Espluges de Llobregat
E-08950 Barcelona
SICOR SpA
Via Terrazzano, 77
I-20017 Rho (MI)
Valeas SpA Pharmaceuticals
Via Vallisneri, 10
I-20133 Milano
Valvole Aerosol Research Italiana (VARI)
Spa - LINDAL Group Italia
Via del Pino, 10
I-23854 Olginate (LC)
Acros Organics bvba
Janssen Pharmaceuticalaan 3o
B-2440 Geel
Airbus France
route de Bayonne 316
F-31300 Toulouse
Biosolove B.V.
Waalreseweg 17
5554 HA Valkenswaard
Nederland
Bie & Berntsen
Sandbækvej 7
DK-2610 Roedovre
Carlo Erba Reactifs-SDS
Z.I. de Valdonne, BP 4
F-13124 Peypin
CNRS - Groupe de Physique des Solides
Université Paris, 7 Denis Diderot & Paris
6 Pierre et Marie Curie
F-75251 Paris Cedex 5
Health Protection Inspectorate-Laboratories
Paldiski mnt 81
EE-10617 Tallinn
Honeywell Fluorine Products Europe
Kempenweg 90
P.O. Box 264
6000 AG Weert
Nederland
Honeywell Specialty Chemicals
Wunstorfer Straße 40
Postfach 100262
D-30918 Seelze
Ineos Fluor Ltd
PO Box 13, The Heath
Runcorn Cheshire WA7 4QF
United Kingdom
Institut Scientifique de Service Public (ISSeP)
Rue du Chéra, 200
B-4000 Liège
Katholieke Universiteit Leuven
Krakenstraat 3
B-3000 Leuven
LGC Promochem GmbH
Mercatorstraße 51
D-46485 Wesel
Mallinckrodt Baker BV
Teugseweg 20
7418 AM Deventer
Nederland
Merck KgaA
Frankfurter Straße 250
D-64271 Darmstadt
Mikro+Polo d.o.o.
Lackova 78
SLO-2000 Maribor
Ministry of Defense
Directorate Material RNL Navy
PO Box 2070
2500 ES The Hague
Nederland
Panreac Química SA
Riera de Sant Cugat 1
E-08110 Montcada I Reixac (Barcelona)
Sanolabor d.d.
Leskovškova 4
SLO-1000 Ljubljana
Sigma Aldrich Logistik GmbH
Riedstraße 2
D-89555 Steinheim
Sigma Aldrich Chimie SARL
80, rue de Luzais
L'isle-d'abeau Chesnes
F-38297 Saint-Quentin-Fallavier
Sigma Aldrich Company Ltd
The Old Brickyard
New Road Gillingham SP8 4XT
United Kingdom
Sigma Aldrich Laborchemikalien
Wunstorfer Straße 40
Postfach 100262
D-30918 Seelze
Sigma Aldrich Chemie GmbH
Riedstraße 2
D-89555 Steinheim
Tazzetti Fluids S.r.l.
Corso Europa, 600/a
I-10088 Volpiano (TO)
University of Technology Vienna
Institut of Industrial Electronics&Material Science
Gusshausstraße 27-29
A-1040 Wien
VWR I.S.A.S.
201, rue Carnot
F-94126 Fontenay-sous-Bois
YA-Kemia Oy - Sigma Aldrich Finland
Teerisuonkuja 4
FI-00700 Helsinki
Done at Brussels, 11 April 2006.