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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)

EU Decision 2008/409 · Adopted 17 April 2008 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

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 layerf1, 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 notifiedf2 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 Noticef3 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:

Annotations to the whole text

Footnotes

f1

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).

f2

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

f3

OJ C 164, 18.7.2007, p. 37.

Contents

  1. 1Article 1
  2. 2Article 2
  3. 3Article 3
  4. 4Article 4
  5. 5Article 5
  6. Signature
  7. Annex IAnnex I
  8. Division
  9. Annex IIESSENTIAL MEDICAL USES
  10. Annex IIIESSENTIAL LABORATORY USES
  11. Annex IVESSENTIAL LABORATORY USES
  12. Annex VESSENTIAL LABORATORY USES
  13. Annex VIESSENTIAL LABORATORY USES
  14. Annex VIILABORATORY AND ANALYTICAL CRITICAL USES
  15. Annex VIIIESSENTIAL LABORATORY USES
  16. Annex IXESSENTIAL LABORATORY USES
  17. Annex XAnnex X

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 155 460,0 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 56 213,6 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.

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.

3

During the period 1 January to 31 December 2008 the following rules shall apply:

  1. 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. 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. 3..

    The allocation of essential laboratory use quotas for halons shall be to the companies indicated in Annex IV.

  4. 4..

    The allocation of essential laboratory use quotas for carbon tetrachloride shall be to the companies indicated in Annex V.

  5. 5..

    The allocation of essential laboratory use quotas for 1,1,1-trichloroethane shall be to the companies indicated in Annex VI.

  6. 6..

    The allocation of laboratory and analytical critical use quotas for methyl bromide shall be to the companies indicated in Annex VII.

  7. 7..

    The allocation of essential laboratory use quotas for hydrobromofluorocarbons shall be to the companies indicated in Annex VIII.

  8. 8..

    The allocation of essential laboratory use quotas for bromochloromethane shall be to the companies indicated in Annex IX.

  9. 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.

4

This Decision shall apply from 1 January 2008 and shall expire on 31 December 2008.

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

Signature

Done at Brussels, 17 April 2008.

For the Commission

Stavros Dimas

Member of the Commission

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
CountrySalbutamolTerbutalineFenoterolOrciprenalineReproterolCarbuterolHexoprenalinePirbuterolClenbuterolBitolterolProcaterol
AustriaXXXXXXXXXXX
BelgiumXXXXXXXXXXX
BulgariaXXXXXXXXXXX
CyprusXXXXXXXXXXX
Czech RepublicXXXXXXXXXXX
DenmarkXXXXXXXXXXX
EstoniaXXXXXXXXXXX
FinlandXXXXXXXXXXX
FranceXXXXXXXXXXX
GermanyXXXXXXXXXXX
GreeceXXXXXXXXXXX
HungaryXXXXXXXXXXX
IrelandXXXXXXXXXXX
ItalyXXXXXXXXXXX
LatviaXXXXXXXXXXX
LithuaniaXXXXXXXXXXX
LuxembourgXXXXXXXXXXX
MaltaXXXXXXXXXXX
NetherlandsXXXXXXXXXXX
PolandXXXXXXXXXXX
PortugalXXXXXXXXXXX
RomaniaXXXXXXXXXXX
SlovakiaXXXXXXXXXXX
SloveniaXXXXXXXXXXX
SpainXXXXXXXXXXX
SwedenXXXXXXXXXXX
United KingdomXXXXXXXXXXX
Table 2
Inhaled steroids
CountryBeclomethasoneDexamethasoneFlunisolideFluticasoneBudesonideTriamcinolone
AustriaXXXXXX
BelgiumXXXXXX
BulgariaXXXXXX
Cyprus
Czech RepublicXXXXXX
DenmarkXX
EstoniaXXXXXX
FinlandXX
FranceXX
GermanyXXXXXX
GreeceXXXXX
HungaryXXXXXX
IrelandXX
ItalyXXXXXX
LatviaXXXXXX
LithuaniaXXXXXX
LuxembourgXXXXXX
MaltaXX
NetherlandsXXXXXX
PolandXXXXXX
PortugalXXXXXX
RomaniaXXXXXX
SlovakiaXXXXXX
SloveniaXXXXXX
SpainXXX
SwedenXX
United KingdomX
Table 3
Non-steroidal anti-inflammatories
CountryCromoglicic acidNedrocromil
AustriaXX
BelgiumXX
BulgariaXX
CyprusXX
Czech RepublicXX
DenmarkXX
EstoniaXX
FinlandXX
FranceXX
GermanyXX
GreeceXX
HungaryX
Ireland
ItalyXX
LatviaXX
LithuaniaXX
LuxembourgX
MaltaX
NetherlandsXX
PolandXX
PortugalX
RomaniaXX
SlovakiaXX
SloveniaXX
SpainX
SwedenXX
United KingdomXX
Table 4
Anticholinergic bronchodilators
CountryIpratropium bromideOxitropium bromide
AustriaXX
BelgiumXX
BulgariaXX
CyprusXX
Czech RepublicXX
DenmarkXX
EstoniaXX
FinlandXX
France
GermanyXX
GreeceXX
HungaryXX
IrelandXX
Italy
LatviaXX
LithuaniaXX
LuxembourgXX
MaltaXX
NetherlandsXX
PolandXX
PortugalX
RomaniaXX
SlovakiaXX
SloveniaXX
SpainXX
SwedenXX
United KingdomXX
Table 5
Long-acting beta agonist bronchodilators
CountryFormoterolSalmeterol
AustriaXX
BelgiumXX
BulgariaXX
CyprusX
Czech RepublicXX
DenmarkX
EstoniaXX
FinlandXX
FranceXX
GermanyXX
Greece
HungaryXX
IrelandXX
ItalyXX
LatviaXX
LithuaniaXX
LuxembourgXX
MaltaXX
NetherlandsXX
PolandXX
PortugalXX
RomaniaXX
SlovakiaXX
SloveniaXX
SpainX
SwedenXX
United KingdomXX
Table 6
Combinations of active ingredients in a single MDI
Country
AustriaX All products
BelgiumX All products
BulgariaX All products
Cyprus
Czech RepublicX All products
DenmarkX All products
Estonia
FinlandX All products
FranceX All products
GermanyX All products
GreeceX All products
HungaryX All products
Ireland
ItalyBudesonide + FenoterolFluticasone+ Salmeterol
LatviaX All products
LithuaniaX All products
LuxembourgX All products
MaltaX All products
NetherlandsX All products
PolandX All products
PortugalX All products
RomaniaX All products
SlovakiaX All products
SloveniaX All products
Spain
SwedenX All products
United Kingdom

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

Annex IIESSENTIAL 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 IIIESSENTIAL 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 IVESSENTIAL 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 VESSENTIAL 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 VIESSENTIAL 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 VIILABORATORY 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 VIIIESSENTIAL 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 IXESSENTIAL 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.