II
(Acts whose publication is not obligatory)
COMMISSION
COMMISSION DECISION
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
(notified under document number C(2004) 103)
(Only the Spanish, Danish, German, English, French, Italian, Dutch, Portuguese and Finnish texts are authentic)
(2004/209/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, hydrobromofluorocarbons and bromochloromethane. |
| (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. |
| (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 (groups II and III substances) to 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 twelfth meeting of the Parties to the Montreal Protocol on measures to facilitate the transition to chlorofluorocarbon-free metered-dose inhalers (MDIs), Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Luxembourg, Norway, Portugal, the Netherlands and the United Kingdom have recently determined that chlorofluorocarbons (CFCs) are no longer essential for the manufacture of specific short-acting beta agonist CFC-MDIs[2]. Article 4(4)(i)(b) of Regulation (EC) No 2037/2000 in effect 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) 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[3] to those companies in the Community that request consideration by the Commission for the use of controlled substances for essential uses in the Community in 2004, and has received declarations on intended essential uses of controlled substances in 2004. |
| (7) | The measures provided for in this Decision are in accordance with the opinion of the Management Committee established pursuant to Article 18 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 1 428 553,000 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 63 198,365 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 141 694,630 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 Community in 2004 shall be 525,800 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:
- The allocation of essential medical use quotas for chlorofluorocarbons 11, 12, 113, 114 and 115 shall be to the companies indicated in Annex II.
- 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.
- The allocation of essential laboratory use quotas for halons shall be to the companies indicated in Annex IV.
- The allocation of essential laboratory use quotas for carbon tetrachloride shall be to the companies indicated in Annex V.
- The allocation of essential laboratory use quotas for 1,1,1-trichloroethane shall be to the companies indicated in Annex VI.
- The allocation of essential laboratory use quotas for hydrobromofluorocarbons shall be to the companies indicated in Annex VII.
- The allocation of essential laboratory use quotas for bromochloromethane shall be to the companies indicated in Annex VIII.
- 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
This Decision is addressed to:
3M Health Care Ltd
3M House Morley Street
Loughborough
Leicestershire LE11 1EP
United Kingdom
Bespak PLC
North Lynn Industrial Estate
King's Lynn
Norfolk PE30 2JJ
United Kingdom
Chiesi Farmaceutici SpA
Via Palermo 26/A
I-43100 Parma
IG Sprühtechnik GmbH
Im Hemmet 1
D-79664 Wehr
Jaba Farmaceutica SA
Rua da Tapada Grande n.o 2
P-2710-089 Abrunheira, Sintra
Inyx Pharmaceuticals Ltd
Astmoor Industrial Estate
9 Arkwright Road
Runcorn
Cheshire WA7 1NU
United Kingdom
Schering-Plough Labo NV
Industriepark 30
B-2220 Heist Op Den Berg
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 3a
B-2440 Geel
Biosolove BV
Waalreseweg 17
5554 HA Valkenswaard
Nederland
Carl Roth GmbH
Schoemperlenstr. 1-5
D-76185 Karlsruhe
Fisher Scientific
Bishop Meadow Road
LE11 5RG Loughborough
United Kingdom
Honeywell Specialty Chemicals
Wunstorfer Straße 40
Postfach 100262
D-30918 Seelze
Katholieke Universiteit Leuven
Krakenstraat 3
B-3000 Leuven
LGC Promochem GmbH
Mercatorstr. 51
D-46485 Wesel
Panreac Quimica SA
Riera de Sant Cugat 1
E-08110 Montcada I Reixac (Barcelona)
Rohs Chemie GmbH
Berliner Str. 54
D-53819 Neunkirchen-Seelsheid
Sigma Aldrich Chemie GmbH
Riedstraße 2
D-89555 Steinheim
Sigma Aldrich Company Ltd
The Old Brickyard
New Road
Gillingham SP8 4XT
United Kingdom
VWR ISAS
201 rue Carnot
F-94126 Fontenay-sous-Bois
Airbus France
route de Bayonne 316
F-31300 Toulouse
University of Technology Vienna
Institute of Industrial Electronics and Material Science
Gusshausstraße 27-29
A-1040 Wien
Aventis
London Road, Holmes Chapel
Cheshire CW4 8BE
United Kingdom
Boehringer Ingelheim GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein
GlaxoSmithKline
Speke Boulevard
Speke
Liverpool L24 9JD
United Kingdom
IVAX Ltd
Unit 301 Industrial Park
Waterford
Ireland
Laboratorio Aldo Unión 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
Valois SA
50, avenue de l'Europe
F-78160 Marly Le Roi
Mallinckrodt Baker BV
Teugseweg 20
7418 AM Deventer
Nederland
Agfa-Gevaert NV
Septestraat 27
B-2640 Mortsel
Bie & Berntsen
Sandbækvej 7
DK-2610 Rødovre
Butterworth Laboratories Ltd
54 Waldegrave Road,
Teddington
Middlesex TW11 8NY
United Kingdom
Environnement SA
111 Bd Robespierre, BP 4513
F-78304 Poissy
Ineos Fluor Ltd
PO Box 13, The Heath
Runcorn
Cheshire WA7 4QF
United Kingdom
Laboratoires Sérobiologiques
3 rue de Seichamps
F-54425 Pulnoy
Merck KgaA
Frankfurter Straße 250
D-64271 Darmstadt
Institut Scientifique de Service Public (ISSeP)
Rue du Chéra 200
B-4000 Liège
SDS Solvants, Documentation, Synthèses SA
ZI de Valdonne, BP 4
F-13124 Peypin
Sigma Aldrich Chimie SARL
80 rue de Luzais
L'isle d'abeau Chesnes
F-38297 St Quentin Fallavier
Sigma Aldrich Laborchemikalien
Wunstorfer Straße 40
Postfach 100262
D-30918 Seelze
YA-Kemia Oy — Sigma Aldrich Finland
Teerisuonkuja 4
FIN-00700 Helsinki
Institut E. Malvoz (B)
Quai du Barbou, 4
B-4000 Liège
Done at Brussels, 28 January 2004.
For the Commission
Margot WALLSTRÖM
Member of the Commission
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 Parties have determined in December 2002 that, due to the presence of suitable non-CFC MDIs, CFCs no longer qualify as ‘essential’ according to the Protocol when combined with following products:
List of non-essential substances
| Product Country |
Salbutamol | Terbutaline | Fenoterol | Orciprenaline | Reproterol | Carbuterol | Hexoprenaline | Pirbuterol | Clenbuterol | Biloterol | 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 |
| Denmark | 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 |
| Ireland | x | ||||||||||
| Luxembourg | x | ||||||||||
| Norway | x | x | x | x | x | x | x | x | x | x | x |
| Portugal | x | x | x | x | x | x | x | x | x | x | x |
| The Netherlands | x | x | x | x | x | x | x | x | x | x | x |
| United Kingdom | x | ||||||||||
Source: www.unep.org/ozone/dec12-2-3.pdf
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 (UK)
Aventis (UK)
Bespak (UK)
Boehringer Ingelheim (D)
Chiesi (I)
Glaxo Smith Kline (UK)
IG Sprühtechnik (D)
IVAX (IRL)
Jaba Farmaceutica (P)
Lab. Aldo-Union (E)
Inyx Pharmaceuticals (UK)
Otsuka Pharmaceuticals (E)
Schering-Plough (B)
Sicor (I)
Valeas (I)
Valois (F)
VARI (I)
ANNEX III
ESSENTIAL LABORATORY USES
Quota of controlled substances of groups I and II that may be used for laboratory and analytical uses, are allocated to:
Agfa-Gevaert (B)
Bie & Berntsen (DK)
Biosolve (NL)
Butterworth Laboratories (UK)
Carl Roth (D)
Environnement SA (F)
Honeywell Specialty Chemicals (D)
Ineos Fluor (UK)
Katholieke Universiteit Leuven (B)
LGC Promochem (D)
Merck KGaA (D)
Mallinckrodt Baker (NL)
Panreac Quimica (E)
SDS Solvants (F)
Sigma Aldrich Chemie (D)
Sigma Aldrich Chimie (F)
Sigma Aldrich Company (UK)
University of Technology Vienna (AUT)
Ya Kemia Oy — Sigma Aldrich (FIN)
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)
Butterworth Laboratories (UK)
Ineos Fluor (UK)
Sigma Aldrich Chimie (FR)
Sigma Aldrich Company (UK)
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 (B)
Agfa-Gevaert (B)
Bie & Berntsen (DK)
Biosolve (NL)
Butterworth Laboratories (UK)
Fisher Scientific (UK)
Institut E. Malvoz (B)
Institut Scientifique de Service Public (ISSeP) (B)
Katholieke Universiteit Leuven (B)
Laboratoires Sérologiques (F)
Mallinckrodt Baker (NL)
Merck KGaA (D)
Panreac Quimica (E)
Rohs Chemie (D)
SDS Solvants (F)
Sigma Aldrich Chemie (D)
Sigma Aldrich Chimie (F)
Sigma Aldrich Company (UK)
Sigma Aldrich Laborchemikalien (D)
VWR ISAS (F)
YA-Kemia Oy (FIN)
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 (B)
Agfa-Gevaert (B)
Bie & Berntsen (DK)
Katholieke Universiteit Leuven (B)
Mallinckrodt Baker (NL)
Panreac Quimica (E)
Sigma Aldrich Chemie (D)
Sigma Aldrich Chimie (F)
Sigma Aldrich Company (UK)
ANNEX VII
ESSENTIAL LABORATORY USES
Quota of controlled substances of group VII that may be used for laboratory and analytical uses are allocated to:
Acros Organics (B)
Ineos Fluor (UK)
Sigma Aldrich Chimie (F)
Sigma Aldrich Company (UK)
ANNEX VIII
ESSENTIAL LABORATORY USES
Quota for bromochloromethane that may be used for laboratory and analytical uses are allocated to:
Ineos Fluor (UK)
Sigma Aldrich Chemie (D)
Sigma Aldrich Chimie (F)
ANNEX IX
[This Annex is not published because it contains confidential commercial information.]
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