2009/52/EC: Commission Decision of 18 December 2008 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2009 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council on substances that deplete the ozone layer (notified under document number C(2008) 8398)
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 2009 shall be 21 360,00 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 and analytical uses in the Community in 2009 shall be 60 280,8 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 and analytical use in the Community in 2009 shall be 115,7 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 and analytical uses in the Community in 2009 shall be 129 390,8 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 and analytical uses in the Community in 2009 shall be 355,65 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 critical uses in the Community in 2009 shall be 36,3 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 and analytical uses in the Community in 2009 shall be 57,96 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 and analytical uses in the Community in 2009 shall be 11,088 ODP kilograms.
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.
During the period 1 January to 31 December 2009 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 and analytical 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 and analytical use quotas for halons shall be to the companies indicated in Annex IV.
4.
The allocation of essential laboratory and analytical use quotas for carbon tetrachloride shall be to the companies indicated in Annex V.
5.
The allocation of essential laboratory and analytical 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 and analytical use quotas for hydrobromofluorocarbons shall be to the companies indicated in Annex VIII.
8.
The allocation of essential laboratory and analytical 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 and the laboratory and analytical critical use quotas for methyl bromide shall be as set out in Annex X.
This Decision shall apply from 1 January 2009 and shall expire on 31 December 2009.
This Decision is addressed to the following undertakings:
Acros Organics bvba
Janssen Pharmaceuticalaan 3a
B-2440 Geel
Airbus France
316, route de Bayonne
F-31300 Toulouse
Carlo Erba Réactifs-SDS
Z.I. de Valdonne, BP 4
F-13124 Peypin
Chiesi Farmaceutici SpA
Via Palermo 26/A
I-43100 Parma
CNRS — Groupe de physique des solides
Université Paris 7 Denis Diderot et Paris 6
Pierre et Marie Curie
F-75251 Paris Cedex 5
Harp International
Gellihirion Industrial Estate Rhondda,
Cynon Taff
Pontypridd CF37 5SX
UNITED KINGDOM
Honeywell Specialty Chemicals
Wunstorfer Straße 40
Postfach 10 02 62
D-30918 Seelze
Ineos Fluor Ltd
PO Box 13, The Heath
Runcorn Cheshire WA7 4QF
UNITED KINGDOM
Institut scientifique de service public
Rue du Chéra 200
B-4000 Liège
LGC Standards GmbH
Mercatorstraße 51
D-46485 Wesel
Mallinckrodt Baker BV
Teugseweg 20
7418 AM Deventer
Nederland
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
PO Box 10 000
1780 CA Den Helder
Nederland
Panreac Química SA
Pol. Ind. Pla de la Bruguera, C/Garraf, 2
E-08211 Castellar del Vallès
Barcelona
Sigma Aldrich Chimie SARL
80, rue de Luzais
L’Isle d’Abeau Chesnes
F-38297 Saint-Quentin-Fallavier
Sigma Aldrich Company
The Old Brickyard, New Road
Gillingham SP8 4XT
UNITED KINGDOM
Sigma Aldrich Laborchemikalien
Wunstorfer Straße 40
Postfach 10 02 62
D-30918 Seelze
Sigma Aldrich Logistik GmbH
Riedstraße 2
D-89555 Steinheim
Solvay Organics GmbH
Hans-Böckler-Allee 20
D-30173 Hannover
Tazzetti Fluids SRL
Corso Europa 600/a
I-10088 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 ISAS
201, rue Carnot
F-94126 Fontenay-sous-Bois
Supplementary provisions
ANNEX ISupplementary provisions
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
X
X
X
X
X
X
Czech Republic
X
X
X
X
X
X
Denmark
X
X
X
X
X
X
Estonia
X
X
X
X
X
X
Finland
X
X
X
X
X
X
France
X
X
X
X
X
X
Germany
X
X
X
X
X
X
Greece
X
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
X
X
X
Sweden
X
X
X
X
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
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
X
X
Germany
X
X
Greece
X
X
Hungary
X
X
Ireland
X
X
Italy
X
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
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
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
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
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 IISupplementary provisions
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:
Chiesi Farmaceutici SpA (IT)
Valeas SpA Pharmaceuticals (IT)
(VARI) SpA — LINDAL Group Italia (IT)
ANNEX IIISupplementary provisions
ANNEX III
ESSENTIAL LABORATORY AND ANALYTICAL USES
Quota of controlled substances of Group I and II that may be used for essential laboratory and analytical uses, are allocated to:
Carlo Erba Réactifs-SDS (FR)
CNRS — Groupe de physique des solides (FR)
Harp International (UK)
Honeywell Specialty Chemicals (DE)
Ineos Fluor (UK)
LGC Standards (DE)
Mallinckrodt Baker (NL)
Merck KGaA (DE)
Mikro + Polo (SI)
Panreac Química (ES)
Sigma Aldrich Chimie (FR)
Sigma Aldrich Company (UK)
Sigma Aldrich Logistik (DE)
Tazzetti Fluids (IT)
ANNEX IVSupplementary provisions
ANNEX IV
ESSENTIAL LABORATORY AND ANALYTICAL USES
Quota of controlled substances of Group III that may be used for essential laboratory and analytical uses are allocated to:
Airbus France (FR)
Ineos Fluor (UK)
Ministry of Defence (NL)
ANNEX VSupplementary provisions
ANNEX V
ESSENTIAL LABORATORY AND ANALYTICAL USES
Quota of controlled substances of Group IV that may be used for essential laboratory and analytical uses, are allocated to:
Acros Organics (BE)
Carlo Erba Réactifs-SDS (FR)
Honeywell Specialty Chemicals (DE)
Institut Scientifique du Service Publique (BE)
Mallinckrodt Baker (NL)
Merck KGaA (DE)
Mikro + Polo (SI)
Panreac Quimica (ES)
Sigma Aldrich Chimie (FR)
Sigma Aldrich Company (UK)
Sigma Aldrich Laborchemikalien (DE)
Sigma Aldrich Logistik (DE)
VWR ISAS (FR)
ANNEX VISupplementary provisions
ANNEX VI
ESSENTIAL LABORATORY AND ANALYTICAL USES
Quota of controlled substances of Group V that may be used for essential laboratory and analytical uses are allocated to:
Acros Organics (BE)
Merck KGaA (DE)
Mikro + Polo (SI)
Panreac Química (ES)
Sigma Aldrich Chimie (FR)
Sigma Aldrich Company (UK)
Sigma Aldrich Logistik (DE)
ANNEX VIISupplementary provisions
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:
Sigma Aldrich Chimie (FR)
Sigma Aldrich Company (UK)
Sigma Aldrich Logistik (DE)
ANNEX VIIISupplementary provisions
ANNEX VIII
ESSENTIAL LABORATORY AND ANALYTICAL USES
Quota of controlled substances of Group VII that may be used for essential laboratory and analytical uses are allocated to:
Ineos Fluor (UK)
Sigma Aldrich Logistik (DE)
Solvay Organics (DE)
ANNEX IXSupplementary provisions
ANNEX IX
ESSENTIAL LABORATORY AND ANALYTICAL USES
Quota of controlled substances of Group IX that may be used for essential laboratory and analytical uses are allocated to:
Ineos Fluor (UK)
Sigma Aldrich Chimie (FR)
Sigma Aldrich Company (UK)
Sigma Aldrich Logistik (DE)
ANNEX XSupplementary provisions
ANNEX X
This Annex is not published because it contains confidential commercial information.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
