COMMISSION DECISION
of 27 March 2007
on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2007 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council
(notified under document number C(2007) 1285)
(Only the Danish, Dutch, English, Estonian, French, German, Italian, Slovenian and Spanish texts are authentic)
(Text with EEA relevance)
(2007/211/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) to the United Nations Environment Programme the active ingredients for which chlorofluorocarbons (CFCs) are no longer essential for the manufacture of CFC-MDIs for placing on the market of the European Community.
(6)
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).
(7)
The Commission has published a Notice (3) on the 22 July 2006 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 2007 and has received declarations on intended essential uses of controlled substances for 2007.
(8)
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 2007.
(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 2007 shall be 316 257,00 ODP (4) 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 2007 shall be 65 900,9 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 2007 shall be 718,7 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 2007 shall be 147 110 436 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 2007 shall be 672,0 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 2007 shall be 150,0 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 2007 shall be 3,52 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 2007 shall be 12 048 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 chlorofluorocarbons for metered-dose inhalers on those markets to be non-essential.
Article 3
During the period 1 January to 31 December 2007 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 2007 and shall expire on 31 December 2007.
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 Europe Ltd
North Lynn Industrial Estate
Bergen Way, 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 (PR)
Inyx Pharmaceuticals Ltd
Astmoor Industrial Estate
9 Arkwright Road Runcorn
Cheshire WA7 1NU
United Kingdom
IVAX Ltd
Unit 301,
Waterford Industrial Estate
Weterford, Ireland
Laboratorio Aldo Union S.A.
Baronesa de Maldá 73
Esplugues de Llobregat
E-08950 Barcelona
SICOR SpA
Via Terrazzano 77
I-20017 Rho (MI)
Valeas SpA Pharmaceuticals
Via Vallisneri, 10
I-20133 Milano (MI)
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
Airbus France
316, route de Bayonne
F-31300 Toulouse
Bie & Berntsen A-S
Transformervej 8
DK-2730 Herlev
Carlo Erba Reactifs-SDS
Z.I. de Valdonne, BP 4
F-13124 Peypin
Eras Labo
222, RN 90
F-38330 Saint-Nazaire-les-Eymes
Harp International
Gellihirion Industrial Estate,
Rhondda, Cynon Taff,
UK-Pontypridd CF37 5SX
Health Protection Inspectorate-Laboratories
Paldiski mnt 81
EE-10617 Tallinn
Honeywell Specialty Chemicals
Wunstorfer Straße 40
Postfach 10 02 62
D-30918 Seelze
Institut scientifique de service public (ISSeP)
Rue du Chéra, 200
B-4000 Liège
Ineos Fluor Ltd
PO Box 13, The Heath
Runcorn, Cheshire WA7 4QF
United Kingdom
LGC Promochem GmbH
Mercatorstr. 51
D-46485 Wesel
Mallinckrodt Baker BV
Teugseweg 20
7418 AM Deventer
Nederland
Mebrom NV
Assenedestraat 4
B-9940 Rieme Ertvelde
Merck KgaA
Frankfurter Straße 250
D-64271 Darmstadt
Mikro+Polo d.o.o.
Zagrebška 22
SI-2000 Maribor
Ministry of Defense
Directorate Material RNL Navy
P.O. Box 2070
2500 ES The Hague
Nederland
Panreac Química S.A.
Pol. Ind. Pla de la Bruguera
C/ Garraf 2
E-08211 Castellar del Vallès, Barcelona
Sanolabor d.d.
Leskoškova 4
SI-1000 Ljubljana
Sigma Aldrich Chimie SARL
80, rue de Luzais
L’Isle d’Abeau-Chesnes
F-38297 Saint-Quentin-Fallavier
Sigma Aldrich Laborchemikalien
Wunstorfer Straße 40
Postfach 10 02 62
D-30918 Seelze
Sigma Aldrich Logistik GmbH
Riedstraße 2
D-89555 Steinheim
Tazzetti Fluids Srl
Corso Europa, 600/a
I-10088 Volpiano (TO)
VWR I.S.A.S.
201, rue Carnot
F-94126 Fontenay-sous-Bois
Done at Brussels, 27 March 2007.