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) (c. 409)

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

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

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

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.