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 U.K.

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 316 257,0 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 U.K.

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 U.K.

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 U.K.

This Decision shall apply from 1 January 2007 and shall expire on 31 December 2007.

Article 5 U.K.

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.

For the Commission

Stavros Dimas

Member of the Commission

ANNEX I U.K.

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 countries have determined that, due to the presence of suitable non-CFC MDIs, CFCs no longer qualify as ‘essential’ under the Protocol when combined with following active ingredients:

Table 1
Short acting beta agonist bronchodilators
Country	Salbutamol	Terbutaline	Fenoterol	Orciprenaline	Reproterol	Carbuterol	Hexoprenaline	Pirbuterol	Clenbuterol	Bitolterol	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
Cyprus	X	X	X	X	X	X	X	X	X	X	X
Czech Republic	X	X	X	X	X	X	X	X	X	X	X
Denmark	X
Estonia	X	X	X	X	X	X	X	X	X	X	X
Finland	X	X	X	X	X	X	X	X	X	X	X
France	X	X	X	X	X	X	X	X	X	X	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
Hungary	X	X	X	X	X	X	X	X	X	X	X
Ireland	X	X	X	X	X	X	X	X	X	X	X
Italy	X	X	X	X	X	X	X	X	X	X	X
Latvia	X	X	X	X	X	X	X	X	X	X	X
Lithuania	X	X	X	X	X	X	X	X	X	X	X
Luxembourg	X	X	X	X	X	X	X	X	X	X	X
Malta	X	X	X	X	X	X	X	X	X	X	X
Netherlands	X	X	X	X	X	X	X	X	X	X	X
Poland	X
Portugal	X	X	X	X	X	X	X	X	X	X	X
Norway	X	X	X	X	X	X	X	X	X	X	X
Slovakia	X	X	X	X	X	X	X	X	X	X	X
Slovenia	X	X	X	X	X	X	X	X	X	X	X
Spain	X	X	X	X	X	X	X	X	X	X	X
Sweden	X	X	X	X	X	X	X	X	X	X	X
United Kingdom	X

Table 2
Inhaled steroids
Country	Beclomethasone	Dexamethasone	Flunisolide	Fluticasone	Budesonide	Triamcinolone
Austria	X	X	X	X	X	X
Belgium	X	X	X	X	X	X
Cyprus
Czech Republic	X	X	X	X	X	X
Denmark	X			X
Estonia	X	X	X	X	X	X
Finland	X			X
France	X			X
Germany	X	X	X	X	X	X
Greece
Hungary	X	X	X	X	X	X
Ireland	X			X
Italy	X	X	X	X	X	X
Latvia	X	X	X	X	X	X
Lithuania	X	X	X	X	X	X
Luxembourg	X	X	X	X	X	X
Malta				X	X
Poland
Portugal	X			X	X
The Netherlands	X	X	X	X	X	X
Norway
Slovakia	X	X	X	X	X	X
Slovenia	X	X	X	X	X	X
Spain	X			X
Sweden	X			X
United Kingdom				X

Table 3
Non steroidal anti inflammatories
Country	Cromoglicic acid	Nedrocromil
Austria	X	X
Belgium	X	X
Cyprus	X	X
Czech Republic	X	X
Denmark	X	X
Estonia	X	X
Finland	X	X
France	X	X
Germany	X	X
Greece	X	X
Hungary	X
Ireland
Italy	X	X
Latvia	X	X
Lithuania	X	X
Luxembourg	X
Malta	X	X
Poland
Portugal	X
The Netherlands	X	X
Norway
Slovakia	X	X
Slovenia	X	X
Spain		X
Sweden	X	X
United Kingdom

Table 4
Anticholinergic bronchodilators
Country	Ipratropium bromide	Oxitropium Bromide
Austria	X	X
Belgium	X	X
Cyprus	X	X
Czech Republic	X	X
Denmark	X	X
Estonia	X	X
Finland	X	X
France
Germany	X	X
Greece	X	X
Hungary	X	X
Ireland	X	X
Italy
Latvia	X	X
Lithuania	X	X
Luxembourg	X	X
Malta	X	X
Netherlands	X	X
Poland
Portugal	X
Norway
Slovakia	X	X
Slovenia	X	X
Spain	X	X
Sweden	X	X
United Kingdom	X	X

Table 5
Long acting beta agonist bronchodilators
Country	Formoterol	Salmeterol
Austria	X	X
Belgium	X	X
Cyprus	X
Czech Republic	X	X
Denmark
Estonia	X	X
Finland	X	X
France	X	X
Germany	X	X
Greece
Hungary	X	X
Ireland	X	X
Italy	X	X
Latvia	X	X
Lithuania	X	X
Luxembourg	X	X
Malta	X	X
Netherlands	X
Poland
Portugal
Norway
Slovakia	X	X
Slovenia	X	X
Spain		X
Sweden	X	X
United Kingdom

Table 6
Combinations of active ingredients in a single MDI
Country
Austria	X All products
Belgium	X All products
Cyprus
Czech Republic	X All products
Denmark
Estonia
Finland	X All products
France	X All products
Germany	X All products
Greece
Hungary	X All products
Ireland
Italy	Budesonide + Fenoterol	Fluticasone + Salmeterol
Latvia	X All products
Lithuania	X All products
Luxembourg	X All products
Malta	X All products
Netherlands
Poland
Portugal
Norway
Slovakia	X All products
Slovenia	X All products
Spain
Sweden	X All products
United Kingdom

Source: www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp U.K.

ANNEX II U.K. 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:

• 3 M Health Care Ltd (UK)

• Bespak Europe Ltd (UK)

• Boehringer Ingelheim GmbH (DE)

• Chiesi Farmaceutici SpA (IT)

• Inyx Pharmaceuticals Ltd (UK)

• Ivax Ltd (IE)

• Laboratorio Aldo Union SA (ES)

• SICOR SpA (IT)

• Valeas SpA Pharmaceuticals (IT)

• Valvole Aerosol Research Italiana (VARI)

  SpA — LINDAL Group Italia (IT)

ANNEX III U.K. Essential laboratory uses

Quota of controlled substances of Group I and II that may be used for laboratory and analytical uses, are allocated to:

• Acros Organics bvba (BE)

• Bie & Berntsen A-S (DK)

• Carlo Erba Reactifs-SDS (FR)

• Harp International (UK)

• Honeywell Specialty Chemicals (DE)

• Ineos Fluor (UK)

• LGC Promochem (DE)

• Mallinckrodt Baker (NL)

• Merck KGaA (DE)

• Mikro+Polo d.o.o. (SI)

• Panreac Química S.A. (ES)

• Sanolabor d.d. (SI)

• Sigma Aldrich Chimie (FR)

• Sigma Aldrich Logistik (DE)

• Tazzetti Fluids (IT)

• VWR I.S.A.S. (FR)

ANNEX IV U.K. 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)

• Eras Labo (FR)

• Ineos Fluor (UK)

• Ministry of Defense (NL)

• Sigma Aldrich Chimie (FR)

ANNEX V U.K. Essential laboratory uses

Quota of controlled substances of Group IV that may be used for laboratory and analytical uses, are allocated to:

• Acros Organics (BE)

• Bie & Berntsen A-S (DK)

• Carlo Erba Reactifs-SDS (FR)

• Health Protection Inspectorate-Laboratories (EE)

• Honeywell Specialty Chemicals (DE)

• Institut scientifique de service public (ISSeP) (BE)

• Mallinckrodt Baker (NL)

• Merck KGaA (DE)

• Mikro+Polo d.o.o. (SI)

• Panreac Química S.A. (ES)

• Sanolabor d.d. (SI)

• Sigma Aldrich Chimie (FR)

• Sigma Aldrich Laborchemikalien (DE)

• Sigma Aldrich Logistik (DE)

ANNEX VI U.K. Essential laboratory uses

Quota of controlled substances of Group V that may be used for laboratory and analytical uses are allocated to:

• Acros Organics (BE)

• Bie & Berntsen A-S (DK)

• Merck KGaA (DE)

• Mikro+Polo d.o.o. (SI)

• Panreac Química S.A. (ES)

• Sanolabor d.d. (SI)

• Sigma Aldrich Chimie (FR)

• Sigma Aldrich Logistik (DE)

ANNEX VII U.K. Laboratory and analytical critical uses

Quota of controlled substances of Group VI that may be used for laboratory and analytical critical uses are allocated to:

• Mebrom NV (BE)

• Sigma Aldrich Logistik (DE)

ANNEX VIII U.K. essential laboratory uses

Quota of controlled substances of Group VII that may be used for laboratory and analytical uses are allocated to:

• Ineos Fluor (UK)

• Sigma Aldrich Chimie (FR)

ANNEX IX U.K. Essential laboratory uses

Quota of controlled substances of Group IX that may be used for laboratory and analytical uses are allocated to:

• Ineos Fluor (UK)

• Sigma Aldrich Logistik (DE)

ANNEX X U.K.

This Annex is not published because it contains confidential commercial information.

(1)

OJ L 244, 29.9.2000, p. 1. Regulation as last amended by Council Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).

(2)

www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp

(3)

OJ C 171, 22.7.2006, p. 27.

(4)

Ozone-depleting potential.