Commission Decision

of 11 April 2006

on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2006 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council

(notified under document number C(2006) 1483)

(Only the Danish, Dutch, English, Estonian, Finnish, French, German, Italian, Slovenian, Spanish and Swedish texts are authentic)

(Text with EEA relevance)

(2006/540/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 XV/8 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.

(5) Pursuant to paragraph 3 of Decision XII/2 of the Parties to the Montreal Protocol on measures to facilitate the transition to chlorofluorocarbon-free Metered-Dose Inhalers (MDIs), all Member States have notified(2) the United Nations Environment Programme that chlorofluorocarbons (CFCs) are no longer essential for the manufacture of salbutamol CFC-MDIs for placing on the market of the European Community. Austria, Belgium, Czech Republic, Denmark, Estonia, Germany, Greece, Hungary, Latvia, Lithuania, Norway, Portugal, The Netherlands, the Slovak Republic and Slovenia have notified UNEP that the use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of ‘short-acting beta agonist bronchiodilators’, specifically terbutaline(3), fenoterol, orciprenaline, reproterol, carbuterol, hexoprenaline, pirbuterol, clenbuterol, bitolterol and procaterol. Belgium, the Czech Republic, Estonia, Germany, Hungary, Latvia, the Netherlands, the Slovak Republic, Slovenia and Sweden have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of ‘inhaled steroids’, specifically beclomethasone, dexamethasone, flunisolide, fluticasone, budesonide(4) and triamcinolone. Denmark (beclomethasone, fluticasone), Ireland (beclomethasone, fluticasone), Finland (beclomethasone, fluticasone), France (beclomethasone, fluticasone), Italy (beclomethasone, fluticasone, budesonide), Malta (fluticasone, budesonide), Portugal (fluticasone, budesonide), Slovenia (beclomethasone, fluticasone, budesonide), Spain (beclomethasone, fluticasone) and the United Kingdom (fluticasone) have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of ‘inhaled steroids’ shown in parentheses after each Member State. Belgium, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Latvia, the Netherlands, the Slovak Republic and Slovenia have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of ‘non-steroidal anti-inflammatories’, specifically cromoglicic acid and nedrocromil. Portugal has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contains the active ingredient cromoglicic acid. Spain has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contains the active ingredient nedrocromil. Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Latvia, Malta, the Netherlands, the Slovak Republic, Spain, Sweden and the United Kingdom have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of ‘anticholinergic bronchodilators’, specifically ipatropium bromide and oxitropium bromide. Portugal has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contains the active ingredient ipatropium bromide. Germany has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain the active ingredients belonging to the therapeutic category of ‘long-acting beta agonist bronchiodilators’, specifically formoterol and salmeterol. Italy has notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contains the active ingredient formoterol. Germany and the Netherlands have notified UNEP that use of CFCs is not considered essential for the manufacture of MDIs for placing on the market of the European Community that contain combinations of active ingredients. 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).

(6) The Commission has published a Notice(5) on 8 July 2005 to those companies in the Community of 25 Member States that request consideration by the Commission for the use of controlled substances for essential uses in the Community in 2006 and has received declarations on intended essential uses of controlled substances for 2006.

(7) 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 2006.

(8) 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 1U.K.

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 2006 shall be 539 000,0 ODP(6) 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 2006 shall be 256 761,86 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 2006 shall be 482,70 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 2006 shall be 149 641,536 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 2006 shall be 754,00 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 2006 shall be 300,00 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 2006 shall be 4,49 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 2006 shall be 13,308 ODP kilograms.

Article 2U.K.

The chlorofluorocarbon metered-dose inhalers listed in Annex I shall not be placed on markets where the Competent Authority has determined chlorofluorocarbonsfor metered-dose inhalers on those markets to be non-essential.

Article 3U.K.

During the period 1 January to 31 December 2006 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 4U.K.

This Decision shall apply from 1 January 2006 and shall expire on 31 December 2006.

Article 5U.K.

This Decision is addressed to the following undertakings:

Done at Brussels, 11 April 2006.

For the Commission

Stavros Dimas

Member of the Commission

ANNEX IU.K.

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:

Table 1

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

CountryShort-acting Beta Agonist Bronchodilators
SalbutamolTerbutalineFenoterolOrciprenalineReproterolCarbuterolHexoprenalinePirbuterolClenbuterolBitolterolProcaterol
AustriaXXXXXXXXXXX
BelgiumXXXXXXXXXXX
CyprusX
Czech RepublicXXXXXXXXXXX
DenmarkXXXXXXXXXX
EstoniaXXXXXXXXXXX
FinlandX
FranceX
GermanyXXXXXXXXXXX
GreeceXXXXXXXXXXX
HungaryXXXXXXXXXXX
IrelandX
ItalyX
LatviaXXXXXXXXXXX
LithuaniaXXXXXXXXXXX
LuxembourgX
MaltaX
NetherlandsXXXXXXXXXXX
PolandX
PortugalXXXXXXXXXXX
NorwayXXXXXXXXXXX
Slovak RepublicXXXXXXXXXXX
SloveniaXXXXXXXXXXX
SpainX
SwedenX
United KingdomX

Table 2

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

CountryInhaled steroids
BeclomethasoneDexamethasoneFlunisolideFluticasoneBudesonideTriamcinolone
Austria
BelgiumXXXXXX
Cyprus
Czech RepublicXXXXXX
DenmarkXX
EstoniaXXXXXX
FinlandXX
FranceXX
GermanyXXXXXX
Greece
HungaryXXXXXX
IrelandXX
ItalyXXX
LatviaXXXXXX
Lithuania
Luxembourg
MaltaXX
Poland
PortugalXX
NetherlandsXXXXXX
Norway
Slovak RepublicXXXXXX
SloveniaXXXXXX
SpainXX
SwedenXXXXX
United KingdomX

Table 3

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

CountryNon-steroidal anti-inflammatories
Cromoglicic acidNedrocromil
Austria
BelgiumXX
Cyprus
Czech RepublicXX
DenmarkXX
EstoniaXX
FinlandXX
FranceXX
GermanyXX
GreeceXX
Hungary
Ireland
Italy
LatviaXX
Lithuania
Luxembourg
Malta
Poland
PortugalX
NetherlandsXX
Norway
Slovak RepublicXX
SloveniaXX
SpainX
Sweden
United Kingdom

Table 4

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

CountryAnticholinergic Bronchodilators
Ipratropium bromideOxitropium Bromide
Austria
BelgiumXX
CyprusXX
Czech RepublicXX
DenmarkXX
EstoniaXX
FinlandXX
France
GermanyXX
GreeceXX
HungaryXX
IrelandXX
Italy
Latvia
Lithuania
Luxembourg
MaltaXX
NetherlandsXX
Poland
PortugalX
Norway
Slovak RepublicXX
Slovenia
SpainXX
SwedenXX
United KingdomXX

Table 5

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

CountryLong-acting Beta Agonist Bronchodilators
FormoterolSalmeterol
Austria
Belgium
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
GermanyXX
Greece
Hungary
Ireland
ItalyX
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Norway
Slovak Republic
Slovenia
Spain
Sweden
United Kingdom

Table 6

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

CountryCombinations of active ingredients in a single MDI
Austria
Belgium
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
GermanyX
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Norway
Slovak Republic
Slovenia
Spain
Sweden
United Kingdom

ANNEX IIU.K.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:

ANNEX IIIU.K.ESSENTIAL LABORATORY USES

Quota of controlled substances of Group I and II that may be used for laboratory and analytical uses, are allocated to:

ANNEX IVU.K.ESSENTIAL LABORATORY USES

Quota of controlled substances of Group III that may be used for laboratory and analytical uses are allocated to:

ANNEX VU.K.ESSENTIAL LABORATORY USES

Quota of controlled substances of Group IV that may be used for laboratory and analytical uses, are allocated to:

ANNEX VIU.K.ESSENTIAL LABORATORY USES

Quota of controlled substances of Group V that may be used for laboratory and analytical uses are allocated to:

ANNEX VIIU.K.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 Chemie GmbH (DE)

ANNEX VIIIU.K.ESSENTIAL LABORATORY USES

Quota of controlled substances of Group VII that may be used for laboratory and analytical uses are allocated to:

ANNEX IXU.K.ESSENTIAL LABORATORY USES

Quota of controlled substances of Group IX that may be used for laboratory and analytical uses are allocated to:

ANNEX XU.K.

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

(1)

OJ L 244, 29.9.2000, p. 1. Regulation as last amended by Commission Regulation (EC) No 29/2006 (OJ L 6, 11.1.2006, p. 27).

(2)

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

(3)

Except Denmark.

(4)

Except Sweden.

(6)

Ozone-depleting Potential.