2004/209/EC: Commission Decision of 28 January 2004 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2004 pursuant to Regulation (EC) No 2037/2000 of the European Parliament and of the Council (notified under document number C(2004) 103)
Date: 2004-01-28
Institutions: European Commission
Subjects: chemical product, dangerous substance, production quota, quantitative restriction, stratospheric pollution, type of business

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Official Journal of the European Union

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II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 28 January 2004

on the allocation of quantities of controlled substances allowed for essential uses in the Com-
munity in 2004 pursuant to Regulation (EC) No 2037/2000 of the European Parliament and of the
Council

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

(notified under document number C(2004) 103)

(2004/209/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 Euro-
pean 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)

(4)

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

(5)

Each year the Commission has to determine essential
uses for these controlled substances, the quantities 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.

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 (groups II and III substances) to 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, Deci-
sion VII/11 and Decision XI/15 of the Parties to the
Montreal Protocol.

inhalers

Pursuant to paragraph 3 of Decision XII/2 of the twelfth
the Parties to the Montreal Protocol on
meeting of
measures to facilitate the transition to chlorofluoro-
carbon-free metered-dose
(MDIs), Austria,
Belgium, Denmark, Finland, France, Germany, Greece,
Ireland, Luxembourg, Norway, Portugal, the Netherlands
and the United Kingdom have recently determined that
chlorofluorocarbons (CFCs) are no longer essential for
the manufacture of specific short-acting beta agonist
CFC-MDIs (2). Article 4(4)(i)(b) of Regulation (EC) No
2037/2000 in effect 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 (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).

(1) OJ L 244, 29.9.2000, p. 1. Regulation as last amended by Regu-

lation (EC) No 1804/2003 (OJ L 265, 16.10.2003, p. 1).

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

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(6)

(7)

The Commission has published a Notice (1)
to those
companies in the Community that request consideration
by the Commission for the use of controlled substances
for essential uses in the Community in 2004, and has
received declarations on intended essential uses of
controlled substances in 2004.

The measures provided for in this Decision are in
accordance with the opinion of
the Management
Committee established pursuant to Article 18 of Regu-
lation (EC) No 2037/2000,

HAS ADOPTED THIS DECISION:

Article 1

1.
The quantity of controlled substances of group I (chloro-
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 2004 shall be 1 428 553,000 ODP
(ozone depletion potential) 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 2004 shall be 63 198,365 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 2004
shall be 19 268,700 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
2004 shall be 141 694,630 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 Community in
2004 shall be 525,800 ODP kilograms.

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 2004 shall be 3,070 ODP kilograms.

7.
The quantity of controlled substances of group IX
(bromochloromethane) subject to Regulation (EC) No 2037/
laboratory uses in the
2000 that may be used for essential
Community in 2004 shall be 13 248 ODP kilograms.

Article 2

chlorofluorocarbon metered-dose

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

inhalers

(1) OJ C 162, 11.7.2003, p. 19.

Article 3

During the period 1 January to 31 December 2004 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
indicated in
to the

companies

shall be

tetrachloride
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 chlorofluorocar-
bons, carbon tetrachloride, 1,1,1-trichloroethane, hydrobro-
mofluorocarbons and bromochloromethane shall be as set
out in Annex IX.

Article 4

This Decision is addressed to:

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

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

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

IG Sprühtechnik GmbH
Im Hemmet 1
D-79664 Wehr

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Jaba Farmaceutica SA
Rua da Tapada Grande n.o 2
P-2710-089 Abrunheira, Sintra

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

Schering-Plough Labo NV
Industriepark 30
B-2220 Heist Op Den Berg

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)

Acros Organics bvba
Janssen Pharmaceuticalaan 3a
B-2440 Geel

Biosolove BV
Waalreseweg 17
5554 HA Valkenswaard
Nederland

Carl Roth GmbH
Schoemperlenstr. 1-5
D-76185 Karlsruhe

Fisher Scientific
Bishop Meadow Road
LE11 5RG Loughborough
United Kingdom

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

Katholieke Universiteit Leuven
Krakenstraat 3
B-3000 Leuven

LGC Promochem GmbH
Mercatorstr. 51
D-46485 Wesel

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

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

Sigma Aldrich Chemie GmbH
Riedstraße 2
D-89555 Steinheim

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

VWR ISAS
201 rue Carnot
F-94126 Fontenay-sous-Bois

Airbus France
route de Bayonne 316
F-31300 Toulouse

University of Technology Vienna
Institute of Industrial Electronics and Material Science
Gusshausstraße 27-29
A-1040 Wien

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
Liverpool L24 9JD
United Kingdom

IVAX Ltd
Unit 301 Industrial Park
Waterford
Ireland

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

Otsuka Pharmaceuticals(E)
Provenca, 388
E-08025 Barcelona

SICOR SpA
Via Terrazzano, 77
I-20017 RHO Milano

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

Mallinckrodt Baker BV
Teugseweg 20
7418 AM Deventer
Nederland

Agfa-Gevaert NV
Septestraat 27
B-2640 Mortsel

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Bie & Berntsen
Sandbækvej 7
DK-2610 Rødovre

Butterworth Laboratories Ltd
54 Waldegrave Road,
Teddington
Middlesex TW11 8NY
United Kingdom

Environnement SA
111 Bd Robespierre, BP 4513
F-78304 Poissy

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

Laboratoires Sérobiologiques
3 rue de Seichamps
F-54425 Pulnoy

Merck KgaA
Frankfurter Straße 250
D-64271 Darmstadt

Institut Scientifique de Service Public (ISSeP)
Rue du Chéra 200
B-4000 Liège

SDS Solvants, Documentation, Synthèses SA
ZI de Valdonne, BP 4
F-13124 Peypin

Sigma Aldrich Chimie SARL
80 rue de Luzais
L'isle d'abeau Chesnes
F-38297 St Quentin Fallavier

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

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

Institut E. Malvoz (B)
Quai du Barbou, 4
B-4000 Liège

Done at Brussels, 28 January 2004.

For the Commission

Margot WALLSTRÖM

Member of the Commission

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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 Parties have determined
in December 2002 that, due to the presence of suitable non-CFC MDIs, CFCs no longer qualify as ‘essential’ according to
the Protocol when combined with following products:

Product

List of non-essential substances

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x

l

o
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x

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x

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x

x

x

x

x

x

x

x

x

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Country

Austria

Belgium

Denmark

Finland

France

Germany

Greece

Ireland

Luxembourg

Norway

Portugal

The Netherlands

United Kingdom

Source: www.unep.org/ozone/dec12-2-3.pdf

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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 (UK)

Aventis (UK)

Bespak (UK)

Boehringer Ingelheim (D)

Chiesi (I)

Glaxo Smith Kline (UK)

IG Sprühtechnik (D)

IVAX (IRL)

Jaba Farmaceutica (P)

Lab. Aldo-Union (E)

Inyx Pharmaceuticals (UK)

Otsuka Pharmaceuticals (E)

Schering-Plough (B)

Sicor (I)

Valeas (I)

Valois (F)

VARI (I)

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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:

Agfa-Gevaert (B)

Bie & Berntsen (DK)

Biosolve (NL)

Butterworth Laboratories (UK)

Carl Roth (D)

Environnement SA (F)

Honeywell Specialty Chemicals (D)

Ineos Fluor (UK)

Katholieke Universiteit Leuven (B)

LGC Promochem (D)

Merck KGaA (D)

Mallinckrodt Baker (NL)

Panreac Quimica (E)

SDS Solvants (F)

Sigma Aldrich Chemie (D)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

University of Technology Vienna (AUT)

Ya Kemia Oy — Sigma Aldrich (FIN)

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)

Butterworth Laboratories (UK)

Ineos Fluor (UK)

Sigma Aldrich Chimie (FR)

Sigma Aldrich Company (UK)

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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 (B)

Agfa-Gevaert (B)

Bie & Berntsen (DK)

Biosolve (NL)

Butterworth Laboratories (UK)

Fisher Scientific (UK)

Institut E. Malvoz (B)

Institut Scientifique de Service Public (ISSeP) (B)

Katholieke Universiteit Leuven (B)

Laboratoires Sérologiques (F)

Mallinckrodt Baker (NL)

Merck KGaA (D)

Panreac Quimica (E)

Rohs Chemie (D)

SDS Solvants (F)

Sigma Aldrich Chemie (D)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

Sigma Aldrich Laborchemikalien (D)

VWR ISAS (F)

YA-Kemia Oy (FIN)

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 (B)

Agfa-Gevaert (B)

Bie & Berntsen (DK)

Katholieke Universiteit Leuven (B)

Mallinckrodt Baker (NL)

Panreac Quimica (E)

Sigma Aldrich Chemie (D)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

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ANNEX VII

ESSENTIAL LABORATORY USES

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

Acros Organics (B)

Ineos Fluor (UK)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

ANNEX VIII

ESSENTIAL LABORATORY USES

Quota for bromochloromethane that may be used for laboratory and analytical uses are allocated to:

Ineos Fluor (UK)

Sigma Aldrich Chemie (D)

Sigma Aldrich Chimie (F)

ANNEX IX

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