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Commission Decision of 23 August 2005 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2005 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council (notified under document number C(2005) 333) (Only the Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Italian, Slovenian, Spanish and Swedish texts are authentic) (Text with EEA relevance) (2005/626/EC)

EU Decision 2005/626 · Adopted 23 August 2005 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

Commission Decision

of 23 August 2005

on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2005 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council

(notified under document number C(2005) 333)

(Only the Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Italian, Slovenian, Spanish and Swedish texts are authentic)

(Text with EEA relevance)

(2005/626/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 layerf1, 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 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, 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, Poland, Norway, Portugal, The Netherlands, Slovak Republic, Slovenia, Spain, Sweden and the United Kingdom have notified the United Nations Environment Programmef2 that chlorofluorocarbons (CFCs) are no longer essential for the manufacture of CFC-MDIs that contain active ingredients belonging to the therapeutic categories of ‘short-acting beta agonist bronchiodilators’, ‘inhaled steroids’ and ‘anticholinergic bronchiodilators’. 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 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 Noticef3 on the 22 July 2004 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 2005 and has received declarations on intended essential uses of controlled substances in 2005.

(7)

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 2005.

(8)

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:

Annotations to the whole text

Footnotes

f1

OJ L 244, 29.9.2000, p. 1. Regulation as last amended by Commission Regulation (EC) No 2077/2004 (OJ L 359, 4.12.2004, p. 28).

f2

www.unep.org/ozone/dec12-2-3.shtml

f3

OJ C 187, 22.7.2004, p. 24.

Contents

  1. 1Article 1
  2. 2Article 2
  3. 3Article 3
  4. 4Article 4
  5. 5Article 5
  6. Signature
  7. Annex IAnnex I
  8. Annex IIESSENTIAL MEDICAL USES
  9. Annex IIIESSENTIAL LABORATORY USES
  10. Annex IVESSENTIAL LABORATORY USES
  11. Annex VESSENTIAL LABORATORY USES
  12. Annex VIESSENTIAL LABORATORY USES
  13. Annex VIIESSENTIAL LABORATORY USES
  14. Annex VIIIESSENTIAL LABORATORY USES
  15. Annex IXAnnex IX

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 2005 shall be 1 029 770,0 ODPf1 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 2005 shall be 63 081,71 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 2005 shall be 70,705 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 2005 shall be 145 240,293 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 2005 shall be 815,30 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 2005 shall be 3,04 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 2005 shall be 12,048 ODP kilograms.

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.

3

During the period 1 January to 31 December 2005 the following rules shall apply:

  1. 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. 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. 3..

    The allocation of essential laboratory use quotas for halons shall be to the companies indicated in Annex IV.

  4. 4..

    The allocation of essential laboratory use quotas for carbon tetrachloride shall be to the companies indicated in Annex V.

  5. 5..

    The allocation of essential laboratory use quotas for 1,1,1-trichloroethane shall be to the companies indicated in Annex VI.

  6. 6..

    The allocation of essential laboratory use quotas for hydrobromofluorocarbons shall be to the companies indicated in Annex VII.

  7. 7..

    The allocation of essential laboratory use quotas for bromochloromethane shall be to the companies indicated in Annex VIII.

  8. 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.

4

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

    PE30 2JJ — Norfolk

    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

    L24 9JD — Liverpool

    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

  • GlaxoSmithKline Pharmaceuticals SA

    Siedziba w Poznaniu

    ul. Grunwaldzka 189

    60-322 Poznań

    Poland

  • IVAX Ltd

    Unit 301 Industrial Park

    Waterford

    Ireland

  • Laboratorio Aldo Union SA

    Baronesa de Maldá, 73

    Espluges de Llobregat

    E-08950 Barcelona

  • SICOR S.p.A

    Via Terrazzano 77

    I-20017 Rho (MI)

  • 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

    Olginate (LC)

    I-23854

  • Acros Organics bvba

    Janssen Pharmaceuticalaan 3a

    B-2440 Geel

  • Agfa-Gevaert NV

    Septestraat 27

    B-2640 Mortsel

  • Bie & Berntsen

    Sandbækvej 7

    DK-2610 Rødovre

  • Biosolove BV

    Waalreseweg 17

    5554 HA Valkenswaard

    Nederland

  • Carl Roth GmbH

    Schoemperlenstraße 3—5

    D-76185 Karlsruhe

  • Elcom Group

    Okružní 988

    CZ-735 14 Orlová-Lutyně

  • Health Protection Inspectorate-Laboratories

    Paldiski mnt 81

    EE-10617 Tallinn

  • Honeywell Specialty Chemicals

    Wunstorfer Straße 40

    Postfach 100262

    D-30918 Seelze

  • Ineos Fluor Ltd

    PO Box 13, The Heath

    Runcorn Cheshire WA7 4QF

    United Kingdom

  • Institut scientifique de service public (ISSeP)

    Rue du Chéra, 200

    B-4000 Liège

  • Katholieke Universiteit Leuven

    Krakenstraat 3

    B-3000 Leuven

  • LGC Promochem GmbH

    Mercatorstraße 51

    D-46485 Wesel

  • Mallinckrodt Baker BV

    Teugseweg 20

    7418 AM Deventer

    Nederland

  • Merck KGaA

    Frankfurter Straße 250

    D-64293 Darmstadt

  • Mikro+Polo d.o.o.

    Zagrebška cesta 22

    SI-2000 Maribor

  • Ministry of Defense

    Directorate Material RNLNavy

    PO Box 2070

    2500 ES The Hague

    Nederland

  • Panreac Quimica SA

    Riera de Sant Cugat, 1

    E-08110 Montcada I Reixac (Barcelona)

  • Rohs Chemie GmbH

    Berliner Str. 54

    D-53819 Neunkirchen-Seelscheid

  • Sanolabor d.d.

    Leskovškova 4

    SI-1000 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 Chesne

    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

  • VWR I.S.A.S.

    201 rue Carnot

    F-94126 Fontenay-sous-Bois

  • YA-Kemia Oy — Sigma-Aldrich Finland

    Teerisuonkuja 4

    FI-00700 Helsinki

5

This Decision shall apply from 1 January 2005 and shall expire on 31 December 2005.

Signature

Done at Brussels, 23 August 2005.

For the Commission

Stavros Dimas

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 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:

Source: www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp
CountrySalbutamolTerbutalineFenoterolOrciprenalineReproterolCarbuterolHexoprenalinePirbuterolClenbuterolBitolterolProcaterolBeclamethasoneDexamethasoneFlunisolideFluticasoneBudesonideTriamcinoloneIpratropium bromideOxitropium bromide
Austria
Belgium
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Latvia
Lithuania
Luxembourg
Poland
Portugal
The Netherlands
Norway
Slovak Republic
Slovenia
Spain
Sweden
UK

Annex IIESSENTIAL 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 Health Care (UK)

  • Aventis (UK)

  • Bespak (UK)

  • Boehringer Ingelheim (DE)

  • Chiesi (IT)

  • Glaxo Smith Kline (ES, FR, PL, UK)

  • IG Sprühtechnik (DE)

  • Inyx Pharmaceuticals (UK)

  • IVAX (IE)

  • Laboratorio Aldo-Unión (ES)

  • Sicor (IT)

  • V.A.R.I. (IT)

  • Valeas (IT)

  • Valois (FR)

Annex IIIESSENTIAL 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 (BE)

  • Bie & Berntsen (DK)

  • Biosolve (NL)

  • Carl Roth (DE)

  • Elcom Group (CZ)

  • Honeywell Specialty Chemicals (DE)

  • Ineos Fluor (UK)

  • Katholieke Universiteit Leuven (BE)

  • LGC Promochem (DE)

  • Mallinckrodt Baker (NL)

  • Merck KGaA (DE)

  • Mikro + Polo (SI)

  • Panreac Química (ES)

  • SDS Solvants (FR)

  • Sanolabor (SI)

  • Sigma Aldrich Chemie (DE)

  • Sigma Aldrich Chimie (FR)

  • Sigma Aldrich Company (UK)

Annex IVESSENTIAL LABORATORY USES

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

  • Ineos Fluor (UK)

  • Ministry of Defense (NL)

  • Sigma Aldrich Chimie (FR)

  • Sigma Aldrich Company (UK)

Annex VESSENTIAL LABORATORY USES

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

  • Acros Organics (BE)

  • Agfa-Gevaert (BE)

  • Bie & Berntsen (DK)

  • Biosolve (NL)

  • Health Protection Inspectorate-Laboratories (EE)

  • Institut Scientifique de Service Public (ISSeP) (BE)

  • Katholieke Universiteit Leuven (BE)

  • Mallinckrodt Baker (NL)

  • Merck KGaA (DE)

  • Mikro + Polo (SI)

  • Panreac Química (ES)

  • Rohs Chemie (DE)

  • SDS Solvants (FR)

  • Sanolabor d.d. (SI)

  • Sigma Aldrich Chemie (DE)

  • Sigma Aldrich Chimie (FR)

  • Sigma Aldrich Company (UK)

  • Sigma Aldrich Laborchemikalien (DE)

  • VWR I.S.A.S. (FR)

  • YA-Kemia Oy (FI)

Annex VIESSENTIAL 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 (DK)

  • Katholieke Universiteit Leuven (BE)

  • Mallinckrodt Baker (NL)

  • Merck KGaA (DE)

  • Mikro + Polo (SI)

  • Panreac Química (ES)

  • Sanolabor d.d. (SI)

  • Sigma Aldrich Chemie (DE)

  • Sigma Aldrich Chimie (FR)

  • Sigma Aldrich Company (UK)

  • VWR I.S.A.S. (FR)

  • YA-Kemia Oy (FI)

Annex VIIESSENTIAL 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)

  • Sigma Aldrich Company (UK)

Annex VIIIESSENTIAL 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 Chemie (DE)

Annex IX

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