CELEX: 32008D0409
Language: en
Date: 2008-04-17 00:00:00
Title: 2008/409/EC: Commission Decision of 17 April 2008 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2008 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council (notified under document number C(2008) 1403) (Text with EEA relevance)

4.6.2008   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 144/55
            
         
      COMMISSION DECISION
   
   of 17 April 2008
   on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2008 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council
   (notified under document number C(2008) 1403)
   (Only the Danish, Dutch, English, Estonian, French, German, Italian, Slovenian and Spanish texts are authentic)
   (Text with EEA relevance)
   (2008/409/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 XIX/13 of the Parties to the Montreal Protocol authorises the production in the European Community of 200 tonnes of chlorofluorocarbons (CFCs) in 2008 for the manufacturing and use of Metered-Dose Inhalers (MDIs) qualifying for essential uses of CFCs as defined in Decision IV/25.
            
         
               (5)
            
            
               Decision XIX/18 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.
            
         
               (6)
            
            
               Pursuant to paragraph 3 of Decision XII/2 of the Parties to the Montreal Protocol on measures to facilitate the transition to chlorofluorocarbon-free MDIs, all Member States have notified (2) 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.
            
         
               (7)
            
            
               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).
            
         
               (8)
            
            
               The Commission has published a Notice (3) on the 18 July 2007 to those companies in the Community of 27 Member States that request consideration by the Commission for the use of controlled substances for essential uses in the Community in 2008 and has received declarations on intended essential uses of controlled substances for 2008.
            
         
               (9)
            
            
               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 2008.
            
         
               (10)
            
            
               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 2008 shall be 155 460,00 ozone-depleting potential (ODP) 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 2008 shall be 56 213,60 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 2008 shall be 418,7 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 2008 shall be 150 832,836 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 2008 shall be 381,5 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 2008 shall be 150,00 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 2008 shall be 0,96 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 2008 shall be 13,368 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 2008 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 2008 and shall expire on 31 December 2008.
   Article 5
   This Decision is addressed to the following undertakings:
   
                
            
            
               
                           Acros Organics bvba
                        
                     
                           Janssen Pharmaceuticalaan 3A°
                        
                     
                           B-2440 Geel
                        
                     
         
                
            
            
               
                           Airbus France
                        
                     
                           Service EVICS
                        
                     
                           BP M6322
                        
                     
                           Route de Bayonne 316
                        
                     
                           F-31060 Toulouse Cedex 16
                        
                     
         
                
            
            
               
                           Bie & Berntsen
                        
                     
                           Sandbækvej 7
                        
                     
                           DK-2610 Rødovre
                        
                     
         
                
            
            
               
                           Boehringer Ingelheim GmbH
                        
                     
                           Binger Straße 173
                        
                     
                           D-55216 Ingelheim am Rhein
                        
                     
         
                
            
            
               
                           Carlo Erba Reactifs-SDS
                        
                     
                           ZI de Valdonne, BP 4
                        
                     
                           F-13124 Peypin
                        
                     
         
                
            
            
               
                           Chiesi Farmaceutici SpA
                        
                     
                           Via Palermo 26/A
                        
                     
                           I-43100 Parma
                        
                     
         
                
            
            
               
                           CNRS — Département Galilée
                        
                     
                           Observatoire de la Côte d'Azur — Siège Social
                        
                     
                           Boulevard de l'Observatoire, BP 4229
                        
                     
                           F-06304 Nice Cedex 4
                        
                     
         
                
            
            
               
                           Eras Labo
                        
                     
                           222 RN 90
                        
                     
                           F-38330 Saint-Nazaire-les-Eymes
                        
                     
         
                
            
            
               
                           Harp International
                        
                     
                           Gellihirion Industrial Estate
                        
                     
                           Rhondda, Cynon Taff
                        
                     
                           Pontypridd CF37 5SX
                        
                     
                           United Kingdom
                        
                     
         
                
            
            
               
                           Health Protection Inspectorate-Laboratories
                        
                     
                           Paldiski mnt 81
                        
                     
                           EE-10617 Tallinn
                        
                     
         
                
            
            
               
                           Honeywell Specialty Chemicals Seelze GmbH
                        
                     
                           Wunstorfer Straße 40
                        
                     
                           Postfach 100262
                        
                     
                           D-30918 Seelze
                        
                     
         
                
            
            
               
                           Ineos Fluor Ltd
                        
                     
                           PO Box 13
                        
                     
                           The Heath
                        
                     
                           Runcorn
                        
                     
                           Cheshire WA7 4QX
                        
                     
                           United Kingdom
                        
                     
         
                
            
            
               
                           Laboratorio Aldo-Union SA
                        
                     
                           Baronesa de Maldá 73
                        
                     
                           Espluges de Llobregat
                        
                     
                           E-08950 Barcelona
                        
                     
         
                
            
            
               
                           LGC Standards GmbH
                        
                     
                           Mercatorstraße 51
                        
                     
                           D-46485 Wesel
                        
                     
         
                
            
            
               
                           Mallinckrodt Baker EMEA
                        
                     
                           Teugseweg 20
                        
                     
                           7418 AM Deventer
                        
                     
                           Nederland
                        
                     
         
                
            
            
               
                           Mebrom
                        
                     
                           Assenedestraat 4
                        
                     
                           B-9940 Rieme Ertvelde
                        
                     
         
                
            
            
               
                           Merck KGaA
                        
                     
                           Frankfurter Straße 250
                        
                     
                           D-64271 Darmstadt
                        
                     
         
                
            
            
               
                           Mikro+Polo d.o.o.
                        
                     
                           Zagrebška cesta 22
                        
                     
                           SI-2000 Maribor
                        
                     
         
                
            
            
               
                           Ministry of Defense
                        
                     
                           Defence Fuel Lubricants and Chemicals Service/Chemical Laboratory
                        
                     
                           PO Box 10.000
                        
                     
                           1780 CA Den Helder
                        
                     
                           Nederland
                        
                     
         
                
            
            
               
                           Panreac Química SAU
                        
                     
                           Pol. Ind. Pla de la Bruguera
                        
                     
                           C/Garraf 2
                        
                     
                           E-08211 Castellar del Vallès — Barcelona
                        
                     
         
                
            
            
               
                           Sanolabor d.d.
                        
                     
                           Leskoškova 4
                        
                     
                           Ljubljana
                        
                     
                           Slovenia
                        
                     
         
                
            
            
               
                           SICOR SpA
                        
                     
                           Via Terrazzano 77
                        
                     
                           I-20017 Rho
                        
                     
         
                
            
            
               
                           Sigma Aldrich Chimie SARL
                        
                     
                           80, rue de Luzais
                        
                     
                           L'Isle d'Abeau Chesnes
                        
                     
                           F-38297 St-Quentin-Fallavier
                        
                     
         
                
            
            
               
                           Sigma Aldrich Company
                        
                     
                           The Old Brickyard, New Road
                        
                     
                           Gillingham SP8 4XT
                        
                     
                           United Kingdom
                        
                     
         
                
            
            
               
                           Sigma Aldrich Laborchemikalien GmbH
                        
                     
                           Wunstorfer Straße 40
                        
                     
                           D-30926 Seelze
                        
                     
         
                
            
            
               
                           Sigma Aldrich Logistik GmbH
                        
                     
                           Riedstraße 2
                        
                     
                           D-89555 Steinheim
                        
                     
         
                
            
            
               
                           Tazzetti Fluids SRL
                        
                     
                           Corso Europa n. 600/a
                        
                     
                           I-10070 Volpiano (TO)
                        
                     
         
                
            
            
               
                           Valeas SpA Pharmaceuticals
                        
                     
                           Via Vallisneri, 10
                        
                     
                           I-20133 Milano
                        
                     
         
                
            
            
               
                           Valvole Aerosol Research Italiana (VARI) SpA — LINDAL Group Italia
                        
                     
                           Via del Pino, 10
                        
                     
                           I-23854 Olginate (LC)
                        
                     
         
                
            
            
               
                           VWR I.SAS.
                        
                     
                           201, rue Carnot
                        
                     
                           F-94126 Fontenay-sous-Bois
                        
                     
         
      Done at Brussels, 17 April 2008.
      
         
            For the Commission
         
         Stavros DIMAS
         
         
            Member of the Commission
         
      
   
   
      (1)  OJ L 244, 29.9.2000, p. 1. Regulation as last amended by Commission Decision 2007/540/EC (OJ L 198, 31.7.2007, p. 35).
   
      (2)  www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp
   
      (3)  OJ C 164, 18.7.2007, p. 37.
   
      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:
      LIST OF NON-ESSENTIAL SUBSTANCES
      
         Source: www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp
      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
               
            
                  Bulgaria
               
               
                  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
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  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
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
            
                  Portugal
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
            
                  Romania
               
               
                  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
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  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
               
            
                  Bulgaria
               
               
                  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
               
               
                  X
               
               
                   
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
            
                  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
               
               
                   
               
               
                   
               
            
                  Netherlands
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
            
                  Poland
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
            
                  Portugal
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
            
                  Romania
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
            
                  Slovakia
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
            
                  Slovenia
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
               
                  X
               
            
                  Spain
               
               
                  X
               
               
                   
               
               
                   
               
               
                  X
               
               
                  X
               
               
                   
               
            
                  Sweden
               
               
                  X
               
               
                   
               
               
                   
               
               
                  X
               
               
                   
               
               
                   
               
            
                  United Kingdom
               
               
                   
               
               
                   
               
               
                   
               
               
                  X
               
               
                   
               
               
                   
               
            
         
      Table 3
      Non-steroidal anti-inflammatories
      
                  Country
               
               
                  Cromoglicic acid
               
               
                  Nedrocromil
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Austria
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Belgium
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Bulgaria
               
               
                  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
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Netherlands
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Poland
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Portugal
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Romania
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Slovakia
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Slovenia
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Spain
               
               
                   
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Sweden
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  United Kingdom
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
         
      Table 4
      Anticholinergic bronchodilators
      
                  Country
               
               
                  Ipratropium bromide
               
               
                  Oxitropium bromide
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Austria
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Belgium
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Bulgaria
               
               
                  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
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Portugal
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Romania
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  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
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Bulgaria
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Cyprus
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Czech Republic
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Denmark
               
               
                   
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  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
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Poland
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Portugal
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Romania
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Slovakia
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Slovenia
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Spain
               
               
                   
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Sweden
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  United Kingdom
               
               
                  X
               
               
                  X
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
         
      Table 6
      Combinations of active ingredients in a single MDI
      
                  Country
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Austria
               
               
                  X All products
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Belgium
               
               
                  X All products
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Bulgaria
               
               
                  X All products
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Cyprus
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Czech Republic
               
               
                  X All products
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Denmark
               
               
                  X All products
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Estonia
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Finland
               
               
                  X All products
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  France
               
               
                  X All products
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Germany
               
               
                  X All products
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Greece
               
               
                  X All products
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  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
               
               
                  X All products
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Poland
               
               
                  X All products
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Portugal
               
               
                  X All products
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Romania
               
               
                  X All products
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Slovakia
               
               
                  X All products
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Slovenia
               
               
                  X All products
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Spain
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  Sweden
               
               
                  X All products
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
                  United Kingdom
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
               
                   
               
            
   
      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:
      
                   
               
               
                  
                     Boehringer Ingelheim GmbH (DE)
                  
               
            
                   
               
               
                  
                     Chiesi Farmaceutici SpA (IT)
                  
               
            
                   
               
               
                  
                     Laboratorio Aldo Union SA (ES)
                  
               
            
                   
               
               
                  
                     SICOR SpA (IT)
                  
               
            
                   
               
               
                  
                     Valeas SpA Pharmaceuticals (IT)
                  
               
            
                   
               
               
                  
                     (VARI) SpA — LINDAL Group Italia (IT)
                  
               
            
   
      ANNEX III
      ESSENTIAL LABORATORY USES
      Quota of controlled substances of Groups I and II that may be used for laboratory and analytical uses, are allocated to:
      
                   
               
               
                  
                     Bie & Berntsen (DK)
                  
               
            
                   
               
               
                  
                     Carlo Erba Reactifs-SDS (FR)
                  
               
            
                   
               
               
                  
                     CNRS — Département Galilée (FR)
                  
               
            
                   
               
               
                  
                     Harp International (UK)
                  
               
            
                   
               
               
                  
                     Honeywell Specialty Chemicals (DE)
                  
               
            
                   
               
               
                  
                     Ineos Fluor (UK)
                  
               
            
                   
               
               
                  
                     LGC Standards (DE)
                  
               
            
                   
               
               
                  
                     Mallinckrodt Baker (NL)
                  
               
            
                   
               
               
                  
                     Merck KGaA (DE)
                  
               
            
                   
               
               
                  
                     Mikro + Polo (SI)
                  
               
            
                   
               
               
                  
                     Panreac Quimica (ES)
                  
               
            
                   
               
               
                  
                     Sanolabor (SI)
                  
               
            
                   
               
               
                  
                     Sigma Aldrich Chimie (FR)
                  
               
            
                   
               
               
                  
                     Sigma Aldrich Company (UK)
                  
               
            
                   
               
               
                  
                     Sigma Aldrich Logistik (DE)
                  
               
            
                   
               
               
                  
                     Tazzetti Fluids (IT)
                  
               
            
                   
               
               
                  
                     VWR ISAS (FR)
                  
               
            
   
      ANNEX IV
      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 Defence (NL)
                  
               
            
   
      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 (BE)
                  
               
            
                   
               
               
                  
                     Bie & Berntsen (DK)
                  
               
            
                   
               
               
                  
                     Carlo Erba Reactifs-SDS (FR)
                  
               
            
                   
               
               
                  
                     Health Protection Inspectorate-Laboratories (EE)
                  
               
            
                   
               
               
                  
                     Honeywell Specialty Chemicals (DE)
                  
               
            
                   
               
               
                  
                     Mallinckrodt Baker (NL)
                  
               
            
                   
               
               
                  
                     Merck KGaA (DE)
                  
               
            
                   
               
               
                  
                     Mikro + Polo (SI)
                  
               
            
                   
               
               
                  
                     Panreac Quimica (ES)
                  
               
            
                   
               
               
                  
                     Sanolabor d.d. (SI)
                  
               
            
                   
               
               
                  
                     Sigma Aldrich Chimie (FR)
                  
               
            
                   
               
               
                  
                     Sigma Aldrich Company (UK)
                  
               
            
                   
               
               
                  
                     Sigma Aldrich Laborchemikalien (DE)
                  
               
            
                   
               
               
                  
                     Sigma Aldrich Logistik (DE)
                  
               
            
                   
               
               
                  
                     VWR ISAS (FR)
                  
               
            
   
      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 (BE)
                  
               
            
                   
               
               
                  
                     Bie & Berntsen (DK)
                  
               
            
                   
               
               
                  
                     Merck KgaA (DE)
                  
               
            
                   
               
               
                  
                     Mikro + Polo (SI)
                  
               
            
                   
               
               
                  
                     Panreac Quimica (ES)
                  
               
            
                   
               
               
                  
                     Sanolabor d.d. (SI)
                  
               
            
                   
               
               
                  
                     Sigma Aldrich Chimie (FR)
                  
               
            
                   
               
               
                  
                     Sigma Aldrich Company (UK)
                  
               
            
                   
               
               
                  
                     Sigma Aldrich Logistik (DE)
                  
               
            
   
      ANNEX VII
      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
      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)
      
   
   
      ANNEX IX
      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 Company (UK)
                  
               
            
                   
               
               
                  
                     Sigma Aldrich Logistik (DE)
                  
               
            
   
      ANNEX X
      This Annex is not published because it contains confidential commercial information.