COMMISSION DECISION
of 23 February 2005
on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2004 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council
(notified under document number C(2005) 293)
(Only the Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Italian, Portuguese, Slovenian and Spanish texts are authentic)
(Text with EEA relevance)
(2005/171/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 bromo-chloromethane.
(2)
Each year the Commission has 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, Decision VII/11 and Decision XI/15 of the Parties to the Montreal Protocol.
(5)
Pursuant to paragraph 3 of Decision XII/2 of the 12th Meeting of the Parties to the Montreal Protocol on measures to facilitate the transition to chlorofluorocarbon-free metered-dose inhalers (MDIs), Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Luxembourg, Norway, Portugal, the Netherlands, Sweden and the United Kingdom have notified the United Nations Environment Programme (2) that chlorofluorocarbons (CFCs) are no longer essential for the manufacture of specific short-acting beta agonist CFC-MDIs. 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 reduced the demand for CFCs in the Community. In addition, Article 4(6) 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 published a notice (3) on 11 July 2003 to those companies in the Community (15) that request consideration by the Commission for the use of controlled substances for essential uses in the Community in 2004 and a further notification to companies in the 10 new Member States on 11 May 2004 (4), and has received declarations on intended essential uses of controlled substances in 2004.
(7)
Commission Decision 2004/209/EC of 28 January 2004 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2004 pursuant to Regulation (EC) No 2037/2000 of the European Parliament and of the Council (5) should be amended in order to take account of the inclusion of specific quantities of ozone depleting substances required for essential uses in the 10 new Member States from 1 May 2004.
(8)
In the interests of legal clarity and transparency Decision 2004/209/EC should therefore be replaced.
(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 2004 shall be 1 428 533,000 ODP (ozone depletion potential) 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 2004 shall be 73 336,765 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 2004 shall be 19 268,700 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 2004 shall be 141 834,000 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 2004 shall be 529,300 ODP kilograms.
6. 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 2004 shall be 3,070 ODP kilograms.
7. 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 2004 shall be 13,248 ODP kilograms.
Article 2
The chlorofluorocarbon metered-dose inhalers (CFC-MDIs) listed in Annex I shall not be placed on markets that have determined CFCs for these products to be non-essential.
Article 3
During the period 1 January to 31 December 2004 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 essential laboratory use quotas for hydrobromofluorocarbons shall be to the companies indicated in Annex VII.
7.
The allocation of essential laboratory use quotas for bromochloromethane shall be to the companies indicated in Annex VIII.
8.
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 IX.
Article 4
Decision 2004/209/EC is repealed.
References to the repealed Decision shall be construed as references to this Decision.
Article 5
This Decision is addressed to the following undertakings:
3M Health Care Ltd
3M House Morley Street
Loughborough
Leicestershire LE11 1EP
United Kingdom
Aventis
London Road, Holmes Chapel
Cheshire CW4 8BE
United Kingdom
Bespak PLC
North Lynn Industrial Estate
King's Lynn
Norfolk PE30 2JJ
United Kingdom
Boehringer Ingelheim GmbH
Binger Strasse 173
D-55216 Ingelheim am Rhein
Chiesi Farmaceutici SpA
Via Palermo 26/A
I-43100 Parma
GlaxoSmithKline
Speke Boulevard
Speke
Liverpool L24 9JD
United Kingdom
IG Sprühtechnik GmbH
Im Hemmet 1
D-79664 Wehr
Inyx Pharmaceuticals Ltd
Astmoor Industrial Estate
9 Arkwright Road Runcorn
Cheshire WA7 1NU
United Kingdom
IVAX Ltd
Unit 301 Industrial Park
Waterford
Ireland
Jaba Farmaceutica SA
Rua da Tapada Grande, 2
P-2710-089, Abrunheira Sintra
Laboratorio Aldo Union SA
Baronesa de Maldá 73
Espluges de Llobregat
E-08950 Barcelona
Otsuka Pharmaceuticals (E)
Provenca, 388
E-08025 Barcelona
SICOR SpA
Via Terrazzano 77
I-20017 RHO Milano
Schering-Plough Labo NV
Industriepark 30
B-2220 Heist Op Den Berg
Valvole Aerosol Research Italiana
(VARI) Spa - LINDAL Group Italia
Via del Pino, 10
Olginate (LC)
I-23854 Italia
Valeas SpA Pharmaceuticals
Via Vallisneri, 10
I-20133 Milano
Valois SA
50 avenue de l’Europe
F-78160 Marly-Le-Roi
Acros Organics bvba
Janssen Pharmaceuticalaan 3a
B-2440 Geel
Airbus France
316, route de Bayonne
F-31300 Toulouse
Agfa-Gevaert NV
Septestraat 27
B-2640 Mortsel
Bie & Berntsen
Sandbækvej 7
DK-2610 Rødovre
Biosolove BV
Waalreseweg 17
5554 HA Valkenswaard
The Netherlands
Butterworth Laboratories Ltd
54 Waldegrave Road, Teddington
Middlesex TW11 8NY
United Kingdom
Carl Roth GmbH
Schoemperlenstr. 1-5
D-76185 Karlsruhe
Elcom Group
Okružní 988
CZ-735 14 Orlová - Lutyně
Environnement SA
111, Bld Robespierre
BP 4513
F-78304 Poissy
Fisher Scientific
Bishop Meadow Road
Loughborough LE11 5RG
United Kingdom
Health Protection Inspectorate-Laboratories
Paldiski mnt 81
EE-10617 Tallinn
Honeywell Specialty Chemicals
Wunstorfer Straße 40
Postfach 100262
D-30918 Seelze
Institut scientifique de service public (ISSeP)
Rue du Chéra 200
B-4000 Liège
Institut E. Malvoz (B)
Quai du Barbou, 4
B-4000 Liège
Ineos Fluor Ltd
PO Box 13, The Heath
Runcorn Cheshire WA7 4QF
United Kingdom
Katholieke Universiteit Leuven
Krakenstraat 3
B-3000 Leuven
Laboratoires sérobiologiques
3, rue de Seichamps
F-54425 Pulnoy
LGC Promochem GmbH
Mercatorstr. 51
D-46485 Wesel
Mallinckrodt Baker BV
Teugseweg 20
7418 AM Deventer
The Netherlands
Merck KgaA
Frankfurter Strasse 250
D-64271 Darmstadt
Mikro+Polo d.o.o.
Lackova 78
SLO-2000 Maribor
Panreac Química SA
Riera de Sant Cugat 1
E-08110 Montcada I Reixac (Barcelona)
Rohs Chemie GmbH
Berliner Str. 54
D-53819 Neunkirchen-Seelsheid
Sanolabor d.d.
Leskoškova 4
SLO-Ljubljana
SDS Solvants, Documentation, Synthèses SA
Z.I. de Valdonne, BP 4
F-13124 Peypin
Sigma Aldrich Chemie GmbH
Riedstrasse 2
D-89555 Steinheim
Sigma Aldrich Chimie SARL
80 rue de Luzais
L'Isle-d'Abeau Chesnes
F-38297 St-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
VWR I.S.A.S.
201, rue Carnot
F-94126 Fontenay-sous-bois
University Of Technology Vienna
Institut of Industrial Electronics and Material Science
Gusshausstrasse 27-29
A-1040 Wien
YA-Kemia Oy - Sigma-Aldrich Finland
Teerisuonkuja 4
FI-00700 Helsinki
Done at Brussels, 23 February 2005.