Commission Decision of 11 April 2006 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2006 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council (notified under document number C(2006) 1483) (Only the Danish, Dutch, English, Estonian, Finnish, French, German, Italian, Slovenian, Spanish and Swedish texts are authentic) (Text with EEA relevance) (2006/540/EC)

Commission Decision

of 11 April 2006

on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2006 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council

(notified under document number C(2006) 1483)

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

(Text with EEA relevance)

(2006/540/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) the United Nations Environment Programme that chlorofluorocarbons (CFCs) are no longer essential for the manufacture of salbutamol CFC-MDIs for placing on the market of the European Community. Austria, Belgium, Czech Republic, Denmark, Estonia, Germany, Greece, Hungary, Latvia, Lithuania, Norway, Portugal, The Netherlands, the Slovak Republic and Slovenia have notified UNEP that the use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of ‘short-acting beta agonist bronchiodilators’, specifically terbutaline(3), fenoterol, orciprenaline, reproterol, carbuterol, hexoprenaline, pirbuterol, clenbuterol, bitolterol and procaterol. Belgium, the Czech Republic, Estonia, Germany, Hungary, Latvia, the Netherlands, the Slovak Republic, Slovenia and Sweden have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of ‘inhaled steroids’, specifically beclomethasone, dexamethasone, flunisolide, fluticasone, budesonide(4) and triamcinolone. Denmark (beclomethasone, fluticasone), Ireland (beclomethasone, fluticasone), Finland (beclomethasone, fluticasone), France (beclomethasone, fluticasone), Italy (beclomethasone, fluticasone, budesonide), Malta (fluticasone, budesonide), Portugal (fluticasone, budesonide), Slovenia (beclomethasone, fluticasone, budesonide), Spain (beclomethasone, fluticasone) and the United Kingdom (fluticasone) have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of ‘inhaled steroids’ shown in parentheses after each Member State. Belgium, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Latvia, the Netherlands, the Slovak Republic and Slovenia have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of ‘non-steroidal anti-inflammatories’, specifically cromoglicic acid and nedrocromil. Portugal has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contains the active ingredient cromoglicic acid. Spain has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contains the active ingredient nedrocromil. Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Latvia, Malta, the Netherlands, the Slovak Republic, Spain, Sweden and the United Kingdom have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of ‘anticholinergic bronchodilators’, specifically ipatropium bromide and oxitropium bromide. Portugal has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contains the active ingredient ipatropium bromide. Germany has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of ‘long-acting beta agonist bronchiodilators’, specifically formoterol and salmeterol. Italy has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contains the active ingredient formoterol. Germany and the Netherlands have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain combinations of active ingredients. 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).

(6) The Commission has published a Notice(5) on 8 July 2005 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 2006 and has received declarations on intended essential uses of controlled substances for 2006.

(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 2006.

(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:

(1)

OJ L 244, 29.9.2000, p. 1. Regulation as last amended by Commission Regulation (EC) No 29/2006 (OJ L 6, 11.1.2006, p. 27).

(2)

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

(3)

Except Denmark.

(4)

Except Sweden.

(5)

OJ C 168, 8.7.2005, p. 20.