32003D0316
2003/316/EC: Commission Decision of 28 March 2003 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2003 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council (Text with EEA relevance) (notified under document number C(2003) 747)
Official Journal L 115 , 09/05/2003 P. 0075 - 0081
Commission Decision
of 28 March 2003
on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2003 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council
(notified under document number C(2003) 747)
(Only the Danish, Dutch, English, Finnish, French, German, Italian, Portuguese, Spanish and Swedish texts are authentic)
(Text with EEA relevance)
(2003/316/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), as last amended by Commission Decision 2003/160/EC(2), and in particular to Articles 3(1) and 7 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 X/19 of the Parties to the Montreal Protocol authorises the production and consumption necessary to satisfy essential uses of controlled substances listed in Annexes A and B 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) Substances required for essential uses that are not listed in Annexes A and B of the Montreal Protocol must be specifically approved by the Parties. This requirement applies to essential uses of hydrobromofluorocarbons and bromochloromethane that are listed in Annex C of the Montreal Protocol.
(6) 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, 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(3). 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) of Regulation (EC) No 2037/2000 prevents products being imported and placed on the market containing CFCs unless the CFCs are considered essential under the conditions described in Article 3(1).
(7) The Commission has published a notice(4) to those companies in the Community that intend to use controlled substances for essential uses in the Community in 2003, and has received declarations on intended essential uses of controlled substances in 2003.
(8) The measures provided for in this Decision are in accordance with the opinion of the Committee that followed the procedures established under 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 2003 shall be 1895260,00 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 2003 shall be 87211,365 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 2003 shall be 6358,70 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 2003 shall be 133811,70 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 2003 shall be 789,68 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 2003 shall be 11335 ODP kilograms
7. The quantity of controlled substances of group "New" (bromochloromethane) subject to Regulation (EC) No 2037/2000 that may be used for essential laboratory uses in the Community in 2003 shall be 1248 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 2003 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
This Decision is addressed to:
3M Health Care Ltd 3M House Morley Street Loughborough Leicestershire LE11 1EP United Kingdom
Acros Organics bvba Janssen Pharmaceuticalaan 3a B - 2440 Geel
Agfa-Gevaert NV Septestraat 27 B - 2640 Mortsel
Atofina SA Cours Michelet - La Défense 10 F - 92091 Paris La Défense
Aventis London Road, Holmes Chapel Cheshire CW4 8BE United Kingdom
Bespak PLC North Lynn Industrial Estate King's Lynn Norfolk PE30 2JJ United Kingdom
Bie & Berntsen A/S Sandbækvej 7 DK - 2610 Rødovre
Biosolve BV Waalreseweg 17 5554 HA Valkenswaard Nederland
Boehringer Ingelheim GmbH Binger Straße 173 D - 55216 Ingelheim am Rhein
Butterworth Laboratories Ltd 54 Waldegrave Road, Teddington Middlesex TW11 8NY United Kingdom
Carl Roth GmbH Schoemperlenstr. 1-5 D - 76185 Karlsruhe
Chiesi Farmaceutici SpA Via Palermo 26/A I - 43100 Parma
Dow Benelux BV Herbert H. Dowweg 4542 NM Hoek Nederland
Ecotechnics SpA Via L. Longo 21/23 I - 50019 Sesto Fiorentino, Firenze
Environnement SA 111, Bd Robespierre, BP 4513 F - 78304 Poissy
Fisher Scientific Bishop Meadow Road Loughborough LE11 5RG United Kingdom
GlaxoSmithKline Speke Boulevard Speke Liverpool L24 9JD United Kingdom
Groupe de Physique des Solides - CNRS Université Paris 7 Denis-Diderot et Paris 6 Pierre et Marie Curie F - 75251 Paris Cedex 5
Honeywell Specialty Chemicals Wunstorfer Straße 40 Postfach 100262 D - 30918 Seelze
IG Sprühtechnik GmbH Im Hemmet 1 D - 79664 Wehr
Ineos Fluor Ltd PO Box 13, The Heath Runcorn Cheshire WA7 4QF United Kingdom
IVAX Ltd Unit 301 Industrial Park Waterford Ireland
Jaba Farmacêutica SA Rua da Tapada Grande, 2 P - 2710-089 Abrunheira, Sintra
Katholieke Universiteit Leuven Krakenstraat 3 B - 3000 Leuven
Laboratorio Aldo Unión SA Baronesa de Maldá 73 Esplugues de Llobregat E - 08950 Barcelona
Laboratorios Lesvi SA Aptdo. Correos 65 E - 08740 Sant Andreu de la Barca
Laboratoires sérobiologiques 3, rue de Seichamps F - 54425 Pulnoy
Laboratorios Vita SA Avenue Barcelona 69 E - 08970 Sant Joan Despí
LGC Promochem GmbH Mercatorstr. 51 D - 46485 Wesel
Merck KGaA Frankfurter Straße 250 D - 64271 Darmstadt
Miza Pharmaceuticals Ltd Astmoor Industrial Estate
9 Arkwright Road
RUNCORN Cheshire WA7 1NU United Kingdom
Otsuka Pharmaceuticals SA (E) Provenca 388 E - 08025 Barcelona
Panreac Química SA Riera de Sant Cugat 1 E - 08110 Montcada I Reixac
Rathburn Chemicals Mfg Ltd Caberston Road Walkerburn EH43 6AS Scotland
Rohs Chemie GmbH Berliner Str. 54 D - 53819 Neunkirchen-Seelsheid
Schering-Plough Labo NV Industriepark 30 B - 2220 Heist Op Den Berg
SDS Solvants, Documentation, Synthèses SA ZI de Valdonne, BP 4 F - 13124 Peypin
SICOR S.p.A Via Terrazzano 77 I - 20017 Rho Milano
Sigma Aldrich Chemie GmbH Riedstraße 2 D - 89555 Steinheim
Sigma Aldrich Chimie SARL 80, rue de Luzais, L'Îsle 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
Valeas SpA Pharmaceuticals Via Vallisneri, 10 I - 20133 Milano
Valois SA 50, avenue de l'Europe F - 78160 Marly-le-Roi
Valvole Aerosol Research Italiana (VARI) SpA - LINDAL Group Italia Via del Pino, 10 I - 23854 Olginate (LC)
VWR ISAS 201, rue Carnot F - 94126 Fontenay-sous-Bois
YΑ-Kemia Oy Teerisuonkuja 4 FIN - 00700 Helsinki
Done at Brussels, 28 March 2003.
For the Commission
Margot Wallström
Member of the Commission
(1) OJ L 244, 29.9.2000, p. 1.
(2) OJ L 65, 8.3.2003, p. 29.
(3) www.unep.org/ozone/dec12-2-3.shtml
(4) OJ C 193, 13.8.2002, p. 20.
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" under the Protocol when combined with following products:
List of Non-Essential Substances
>TABLE>
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 Lesvi (E)
Lab Vita (E)
Lab. Aldo-Union (E)
MIZA 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 Group I and II that may be used for laboratory and analytical uses, are allocated to:
Agfa-Gevaert (B)
Atofina (F)
Bie & Berntsen (DK)
Biosolve (NL)
Butterworth Laboratories (UK)
Carl Roth (D)
Dow Benelux (NL)
Ecotechnics SpA (I)
Environnement SA (F)
Groupe de Physique des Solides (F)
Honeywell Specialty Chemicals (D)
Ineos Fluor (UK)
Katholieke Universiteit Leuven (B)
LGC Promochem (D)
Merck KGaA (D)
Panreac Quimica (E)
Rathburn Chemicals (UK)
SDS Solvants (F)
Sigma Aldrich Chemie (D)
Sigma Aldrich Chimie (F)
Sigma Aldrich Company (UK)
VWR ISAS (F)
ANNEX IV
Essential laboratory uses
Quota of controlled substances of Group III that may be used for laboratory and analytical uses are allocated to:
Butterworth Laboratories (UK)
Ineos Fluor (UK)
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)
Dow Benelux (NL)
Fisher Scientific (UK)
Katholieke Universiteit Leuven (B)
Laboratoires Sérologiques (F)
Merck KGaA (D)
Panreac Quimica (E)
Rathburn Chemicals (UK)
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)
YΑ-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)
Dow Benelux (NL)
Katholieke Universiteit Leuven (B)
Merck KGaA (D)
Panreac Quimica (E)
Rathburn Chemicals (UK)
Sigma Aldrich Chemie (D)
Sigma Aldrich Chimie (F)
Sigma Aldrich Company (UK)
VWR ISAS (F)
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)
Each quota cannot be debited until the Commission has notified each enterprise that the Parties to the Montreal Protocol have approved the use of hydrobromofluorocarbons in 2003 for Essential Uses.
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 Chimie (F)
Each quota cannot be debited until the Commission has notified each enterprise that the Parties to the Montreal Protocol have approved the use of bromochloromethane in 2003 for Essential Uses.
ANNEX IX
[This Annex is not published because it contains confidential commercial information.]
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