2005/626/EC: Commission Decision of 23 August 2005 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2005 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council (notified under document number C(2005) 333)   (Text with EEA relevance)
Date: 2005-08-23
Institutions: European Commission
Subjects: international convention, production quota, research body, stratospheric pollutant, therapeutics, type of business

30.8.2005

EN

Official Journal of the European Union

L 224/7

II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 23 August 2005

on the allocation of quantities of controlled substances allowed for essential uses in the Community
in 2005 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council

(notified under document number C(2005) 333)

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

(Text with EEA relevance)

(2005/626/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community,

establishing the European

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)

(2)

(3)

The Community has already phased out the production
and consumption of chlorofluorocarbons, other
fully
halogenated chlorofluorocarbons, halons, carbon tetra-
chloride,1,1,1-trichloroethane, hydrobromofluorocarbon
and bromo-chloromethane.

Each year
the Commission is required to determine
essential uses for these controlled substances, the quan-
tities that may be used and the companies that may use
them.

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.

(5)

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, Decision VII/11 and Decision XI/15 of the Parties
to the Montreal Protocol.

Inhalers

Lithuania,

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 chlorofluoro-
(MDIs), Austria,
carbon-free Metered-Dose
Belgium, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary,
Ireland,
Latvia,
Poland, Norway,
Luxembourg,
Portugal, The Netherlands, Slovak Republic, Slovenia,
Spain, Sweden and the United Kingdom have notified
the United Nations Environment Programme (2)
that
chlorofluorocarbons (CFCs) are no longer essential for
the manufacture of CFC-MDIs that contain active ingre-
dients belonging to the therapeutic categories of ‘short-
‘inhaled steroids’
acting beta agonist bronchiodilators’,
and ‘anticholinergic bronchiodilators’. 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 reduced the demand for CFCs in
the Community. In addition, Article 4(6) of Regulation

(1) OJ L 244, 29.9.2000, p. 1. Regulation as

(EC) No 2077/2004 (OJ

last amended by
L 359,

Commission Regulation
4.12.2004, p. 28).

(2) www.unep.org/ozone/dec12-2-3.shtml

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Official Journal of the European Union

30.8.2005

(EC) No 2037/2000 prevents CFC-MDI products being
imported and placed on the market unless the CFCs in
these products
the
are
conditions described in Article 3(1).

considered essential under

The quantity of controlled substances of Group VII
6.
(hydrobromofluorocarbons)
to Regulation (EC) No
subject
2037/2000 that may be used for essential laboratory uses in
the Community in 2005 shall be 3,04 ODP kilograms.

(6)

(7)

(8)

The Commission has published a Notice (1) on the 22
July 2004 to those companies in the Community of 25
Member States
the
request
Commission for the use of controlled substances for
essential uses in the Community in 2005 and has
received declarations on intended essential uses of
controlled substances in 2005.

consideration by

that

For the purpose of ensuring that interested companies
in due time
and operators may continue to benefit
from the licensing system,
the
is appropriate that
present decision shall apply from 1 January 2005.

it

in this Decision are in
The measures provided for
accordance with the opinion of
the Management
Committee established by Article 18(1) of Regulation
(EC) No 2037/2000,

HAS ADOPTED THIS DECISION:

Article 1

The quantity of controlled substances of Group I (chloro-
1.
fluorocarbons 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 2005 shall be 1 029 770,00 ODP (2)
kilograms.

2.
The quantity of controlled substances of Group I (chloro-
fluorocarbons 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 2005 shall be 63 081,71 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 2005 shall be
70,705 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 2005 shall be 145 240,293 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 2005 shall be 815,30 ODP kilograms.

(1) OJ C 187, 22.7.2004, p. 24.
(2) Ozone-depleting Potential.

7.
The quantity of controlled substances of group IX (bromo-
chloromethane) subject to Regulation (EC) No 2037/2000 that
may be used for essential laboratory uses in the Community in
2005 shall be 12,048 ODP kilograms.

Article 2

The chlorofluorocarbon metered-dose inhalers (CFC-MDIs) listed
in Annex I shall not be placed on markets that have determined
CFCs for these products to be non-essential.

Article 3

During the period 1 January to 31 December 2005 the
following rules shall apply:

1. The allocation of essential medical use quotas for chloro-
fluorocarbons 11, 12, 113, 114 and 115 shall be to the
companies indicated in Annex II.

2. The allocation of essential laboratory use quotas for chloro-
fluorocarbons 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 essential laboratory use quotas for hydro-
bromofluorocarbons shall be to the companies indicated in
Annex VII.

7. The allocation of essential laboratory use quotas for bromo-
chloromethane shall be to the companies indicated in Annex
VIII.

8. The essential use quotas for chlorofluorocarbons 11, 12,
113, 114 and 115, other fully halogenated chlorofluoro-
carbons, carbon tetrachloride, 1,1,1-trichloroethane, hydro-
bromofluorocarbons and bromochloromethane shall be as
set out in Annex IX.

30.8.2005

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Official Journal of the European Union

L 224/9

This Decision is addressed to the following undertakings:

Article 4

3M Health Care Ltd
3M House Morley Street
Loughborough
Leicestershire LE11 1EP
United Kingdom

Bespak PLC
North Lynn Industrial Estate
King's Lynn
PE30 2JJ — Norfolk
United Kingdom

Chiesi Farmaceutici SpA
Via Palermo 26/A
I-43100 Parma

IG Sprühtechnik GmbH
Im Hemmet 1
D-79664 Wehr

GlaxoSmithKline Pharmaceuticals SA
Siedziba w Poznaniu
ul. Grunwaldzka 189
60-322 Poznań
Poland

Laboratorio Aldo Union SA
Baronesa de Maldá, 73
Espluges de Llobregat
E-08950 Barcelona

Valeas SpA Pharmaceuticals
Via Vallisneri, 10
I-20133 Milano

Valvole Aerosol Research Italiana (VARI)
Spa — LINDAL Group Italia
Via del Pino, 10
Olginate (LC)
I-23854

Agfa-Gevaert NV
Septestraat 27
B-2640 Mortsel

Biosolove BV
Waalreseweg 17
5554 HA Valkenswaard
Nederland

Elcom Group
Okružní 988
CZ-735 14 Orlová-Lutyně

Honeywell Specialty Chemicals
Wunstorfer Straße 40
Postfach 100262
D-30918 Seelze

Institut scientifique de service public (ISSeP)
Rue du Chéra, 200
B-4000 Liège

Aventis
London Road, Holmes Chapel
Cheshire CW4 8BE
United Kingdom

Boehringer Ingelheim GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

GlaxoSmithKline
Speke Boulevard
Speke
L24 9JD — Liverpool
United Kingdom

Inyx Pharmaceuticals Ltd
Astmoor Industrial Estate
9 Arkwright Road RUNCORN
Cheshire WA7 1NU
United Kingdom

IVAX Ltd
Unit 301 Industrial Park
Waterford
Ireland

SICOR S.p.A
Via Terrazzano 77
I-20017 Rho (MI)

Valois SA
50, avenue de l'Europe
F-78160 Marly Le Roi

Acros Organics bvba
Janssen Pharmaceuticalaan 3a
B-2440 Geel

Bie & Berntsen
Sandbækvej 7
DK-2610 Rødovre

Carl Roth GmbH
Schoemperlenstraße 3—5
D-76185 Karlsruhe

Health Protection Inspectorate-Laboratories
Paldiski mnt 81
EE-10617 Tallinn

Ineos Fluor Ltd
PO Box 13, The Heath
Runcorn Cheshire WA7 4QF
United Kingdom

Katholieke Universiteit Leuven
Krakenstraat 3
B-3000 Leuven

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LGC Promochem GmbH
Mercatorstraße 51
D-46485 Wesel

Merck KGaA
Frankfurter Straße 250
D-64293 Darmstadt

Ministry of Defense
Directorate Material RNLNavy
PO Box 2070
2500 ES The Hague
Nederland

Rohs Chemie GmbH
Berliner Str. 54
D-53819 Neunkirchen-Seelscheid

SDS Solvants, Documentation, Synthèses SA
Z.I. de Valdonne, BP 4
F-13124 Peypin

Sigma Aldrich Chimie SARL
80, rue de Luzais
L'Isle-d'Abeau Chesne
F-38297 Saint-Quentin-Fallavier

Sigma Aldrich Laborchemikalien
Wunstorfer Straße 40, Postfach 100262
D-30918 Seelze

YA-Kemia Oy — Sigma-Aldrich Finland
Teerisuonkuja 4
FI-00700 Helsinki

Mallinckrodt Baker BV
Teugseweg 20
7418 AM Deventer
Nederland

Mikro+Polo d.o.o.
Zagrebška cesta 22
SI-2000 Maribor

Panreac Quimica SA
Riera de Sant Cugat, 1
E-08110 Montcada I Reixac (Barcelona)

Sanolabor d.d.
Leskovškova 4
SI-1000 Ljubljana

Sigma Aldrich Chemie GmbH
Riedstraße 2
D-89555 Steinheim

Sigma Aldrich Company Ltd
The Old Brickyard
New Road Gillingham SP8 4XT
United Kingdom

VWR I.S.A.S.
201 rue Carnot
F-94126 Fontenay-sous-Bois

This Decision shall apply from 1 January 2005 and shall expire on 31 December 2005.

Article 5

Done at Brussels, 23 August 2005.

For the Commission

Stavros DIMAS
Member of the Commission

30.8.2005

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Official Journal of the European Union

L 224/11

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:

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Country

Austria

Belgium

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Latvia

Lithuania

Luxembourg

Poland

Portugal

The Netherlands

Norway

Slovak Republic

Slovenia

Spain

Sweden

UK

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

L 224/12

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Official Journal of the European Union

30.8.2005

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:

3M Health Care (UK)

Aventis (UK)

Bespak (UK)

Boehringer Ingelheim (DE)

Chiesi (IT)

Glaxo Smith Kline (ES, FR, PL, UK)

IG Sprühtechnik (DE)

Inyx Pharmaceuticals (UK)

IVAX (IE)

Laboratorio Aldo-Unión (ES)

Sicor (IT)

V.A.R.I. (IT)

Valeas (IT)

Valois (FR)

30.8.2005

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Official Journal of the European Union

L 224/13

ANNEX III

ESSENTIAL LABORATORY USES

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

Agfa-Gevaert (BE)

Bie & Berntsen (DK)

Biosolve (NL)

Carl Roth (DE)

Elcom Group (CZ)

Honeywell Specialty Chemicals (DE)

Ineos Fluor (UK)

Katholieke Universiteit Leuven (BE)

LGC Promochem (DE)

Mallinckrodt Baker (NL)

Merck KGaA (DE)

Mikro + Polo (SI)

Panreac Química (ES)

SDS Solvants (FR)

Sanolabor (SI)

Sigma Aldrich Chemie (DE)

Sigma Aldrich Chimie (FR)

Sigma Aldrich Company (UK)

L 224/14

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Official Journal of the European Union

30.8.2005

ANNEX IV

ESSENTIAL LABORATORY USES

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

Ineos Fluor (UK)

Ministry of Defense (NL)

Sigma Aldrich Chimie (FR)

Sigma Aldrich Company (UK)

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)

Agfa-Gevaert (BE)

Bie & Berntsen (DK)

Biosolve (NL)

Health Protection Inspectorate-Laboratories (EE)

Institut Scientifique de Service Public (ISSeP) (BE)

Katholieke Universiteit Leuven (BE)

Mallinckrodt Baker (NL)

Merck KGaA (DE)

Mikro + Polo (SI)

Panreac Química (ES)

Rohs Chemie (DE)

SDS Solvants (FR)

Sanolabor d.d. (SI)

Sigma Aldrich Chemie (DE)

Sigma Aldrich Chimie (FR)

Sigma Aldrich Company (UK)

Sigma Aldrich Laborchemikalien (DE)

VWR I.S.A.S. (FR)

YA-Kemia Oy (FI)

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Official Journal of the European Union

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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)

Katholieke Universiteit Leuven (BE)

Mallinckrodt Baker (NL)

Merck KGaA (DE)

Mikro + Polo (SI)

Panreac Química (ES)

Sanolabor d.d. (SI)

Sigma Aldrich Chemie (DE)

Sigma Aldrich Chimie (FR)

Sigma Aldrich Company (UK)

VWR I.S.A.S. (FR)

YA-Kemia Oy (FI)

ANNEX VII

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)

Sigma Aldrich Chimie (FR)

Sigma Aldrich Company (UK)

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Official Journal of the European Union

30.8.2005

ANNEX VIII

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 Chemie (DE)

ANNEX IX

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