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)

• CELEX: Regulation (EC) No 2037/2000
• Articles: 15

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

Schedules & Appendices

ANNEX I

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

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

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

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

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

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

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

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

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

ANNEX X

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