2002/612/EC: Commission Decision of 16 April 2002 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2002 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council (Text with EEA relevance) (notified under document number C(2002) 1410)
Date: 2002-04-16
Institutions: European Commission
Subjects: chemical product, dangerous substance, ozone, pharmaceutical legislation, production quota, research body, technical regulations, therapeutics, type of business

L 196/38

EN

Official Journal of the European Communities

25.7.2002

COMMISSION DECISION

of 16 April 2002

on the allocation of quantities of controlled substances allowed for essential uses in the Commu-
nity in 2002 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council

(notified under document number C(2002) 1410)

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

(Text with EEA relevance)

(2002/612/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(6)

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), as last amended by
Regulation (EC) No 2039/2000 (2), and in particular to Articles
3 and 7 thereof;

Whereas:

(1)

(2)

(3)

(4)

(5)

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

Each year the Commission has to determine what the
essential uses of
the
quantities that may be used and the companies that may
use them.

these controlled substances are,

Decision IV/25 of the Parties to the Montreal Protocol
on substances that deplete the ozone layer, hereinafter
‘Montreal Protocol’, sets out the criteria used by the
Commission for determining any essential uses.

Decision XII/9 of the Parties to the Montreal Protocol
authorises the levels of production and consumption
necessary
controlled
substances for metered dose inhalers (MDIs) for the treat-
ment of asthma and chronic obstructive pulmonary
disease (COPD).

essential uses of

to satisfy

Decision X/19 of the Parties to the Montreal Protocol
authorises the production and consumption necessary to
satisfy essential uses of controlled substances for labora-
tory 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 Deci-
sion XI/15 of the Parties to the Montreal Protocol.

to authorise,

Decision VIII/9 of the Parties to the Montreal Protocol
allows the Secretariat
in an emergency
situation, consumption of quantities not exceeding 20
tonnes of ozone-depleting substances (ODS) for essential
uses on application by a Party, and the Community
applied for such an emergency use to be allowed for oil-
in-water testing in 2002.

in the Community that

The Commission has published a notice (3)
to those
companies
intend to use
controlled substances for essential uses in the Commu-
nity in 2002, and has received declarations on intended
essential uses of controlled substances in 2002.

To meet the need for controlled substances for essential
uses, production may be authorised in accordance with
Article 3(5) of Regulation (EC) No 2037/2000 or an
import may be licensed in accordance with Article 6 of
that Regulation.

The measures provided for in this Decision are in accor-
dance with the opinion of the Committee established
pursuant to Article 18 of Regulation (EC) No 2037/
2000,

(7)

(8)

(9)

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 2002 shall be 2 558 948,00 ODP
(ozone depletion potential) weighted 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 2002 shall be 135 971,59 ODP
weighted kilograms.

(1) OJ L 244, 29.9.2000, p. 1.
(2) OJ L 244, 29.9.2000, p. 26.

(3) OJ C 205, 21.7.2001, p. 2.

25.7.2002

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Official Journal of the European Communities

L 196/39

The quantity of controlled substances of group III (halons)
3.
subject to Regulation (EC) No 2037/2000 that may be used for
essential
laboratory use in the Community in 2002 shall be
3 758,70 ODP weighted kilograms.

Article 3

This Decision is addressed to:

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
2002 shall be 151 668,50 ODP weighted 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
2002 shall be 641,18 ODP weighted kilograms.

6.
The quantity of controlled substances of group VII (hydro-
bromofluorocarbons) subject to Regulation (EC) No 2037/2000
that may be used for essential laboratory uses in the Commu-
nity in 2002 shall be 4,53 ODP weighted kilograms.

7.
The quantity of controlled substances of groups I and IV
subject to Regulation (EC) No 2037/2000 that may be used for
testing in the Community in 2002 shall be
oil-in-water
11 927,50 ODP weighted kilograms of CFC 113 and 4 502,50
ODP weighted kilograms of carbon tetrachloride.

Article 2

During the period 1 January to 31 December 2002 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 I;

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 II;

3. the allocation of essential laboratory use quotas for halons

shall be to the companies indicated in Annex III;

4. the allocation of essential laboratory use quotas for carbon
tetrachloride shall be to the companies indicated in Annex
IV;

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

6. the allocation of essential laboratory use quotas for hydro-
bromofluorocarbons shall be to the companies indicated in
Annex VI;

7. the allocation of essential laboratory use quotas for CFC 113
and carbon tetrachloride for oil-in-water testing shall be to
the companies indicated in Annex VII;

8. the essential use quotas for chlorofluorocarbons 11, 12,
113, 114 and 115, other fully halogenated chlorofluorocar-
bons, carbon tetrachloride, 1,1,1-trichloroethane and hydro-
bromofluorocarbons shall be as set out in Annex VIII.

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

Bespak plc
North Lynn Industrial Estate
King’s Lynn
Norfolk
PE30 2JJ
United Kingdom

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

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

GlaxoSmithKline
Speke Boulevard
Speke
Liverpool
L24 9JD
United Kingdom

IG Sprühtechnik GmbH
Im Hemmet 1
D-79664 Wehr

IVAX Ltd
Unit 301 Industrial Park
Waterford
Ireland

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

Laboratorio Aldo Unión SA
Baronessa de Maldá 73
Esplugues de Llobregat
E-08950 Barcelona

Laboratorios Lesvi SA
Apartado de Correos, 65
E-08740 Sant Andreu de la Barca (Barcelona)

Laboratorios Vita SA
Avinguda Barcelona 69
E-08970 Sant Joan Despí

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

L 196/40

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Official Journal of the European Communities

25.7.2002

Schering-Plough Labo NV
Industriepark 30
B-2220 Heist-op-den-Berg

SICOR SpA
Via Terrazzano, 77
I-20017
Rho (MI)

Valeas SpA Pharmaceuticals
Via Vallisneri, 10
I-20133 Milano

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

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

Agfa-Gevaert NV
Septestraat 27
B-2640 Mortsel

Atofina SA
Cours Michelet — La Défense 10
F-92091 Paris La Défense

Airbus France
316, route de Bayonne
F-31300 Toulouse

Bie & Bertsen
Sanbækvej 7
DK-2610 Rødovre

Biosolove BV
Waalreseweg 17
5554 HA Valkenswaard
Nederland

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

Carl Roth GmbH
Schoemperlenstraße 1-5
D-76231 Karlsruhe

Carlo Erba Réactifs
Parc d’Activités des Portes
Ch. du Vexin,
BP 616
F-27106 Val de Reuil Cedex

Dow Benelux BV
Herbert H. Dowweg
4530 AA Terneuzen
Nederland

Fisher Scientific GmbH
Im Heiligen Feld 17
D-58239 Schwerte

Fisher Scientific
Bishop Meadow Road
Loughborough
LE11 5RG
United Kingdom

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

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

Katholieke Universiteit Leuven
Krakenstraat 3
B-3000 Leuven

Laboratoires sérobiologiques
3, rue de Seichamps
F-54425 Pulnoy

Mallinckrodt Baker BV
Rijsterborgherweg 20
7412 VA Deventer
Nederland

Merck Eurolab
201, rue Carnot
F-94126 Fontenay-sous-bois

Merck KgaA
Frankfurter Straße 250
D-64271 Darmstadt

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

Promochem GmbH
Mercatorstraße 51
D-46485 Wesel

Rathburn Chemicals Mfg Ltd
Caberston Road
Walkerburn
EH43 6AS
United Kingdom

Codif International
61, rue du Commandant-l’Herminier
Rothéneuf
F-35404 Saint-Malo Cedex

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

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Official Journal of the European Communities

L 196/41

Sigma Aldrich Chemie GmbH
Riedstraße 2
D-89555 Steinheim

Sigma Aldrich Chimie SARL
80, rue de Luzais, L’isle d’abeau Chesnes
F-38297 Saint-Quentin-Fallavier

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

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

YA Kemia Oy
Teerisuonkuja 4
FIN-00700 Helsinki

Done at Brussels, 16 April 2002.

For the Commission

Margot WALLSTRÖM

Member of the Commission

L 196/42

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Official Journal of the European Communities

25.7.2002

ANNEX I

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)

Bespak (UK)

Boehringer Ingelheim (D)

Chiesi (I)

Glaxo Smith Kline (UK)

IG Sprühtechnik (D)

IVAX (IRL)

Jaba Farmacêutica (P)

Laboratorios Lesvi (E)

Laboratorios Vita (E)

Laboratorio Aldo-Unión (E)

Miza Pharmaceuticals (UK)

Schering-Plough (B)

Sicor (I)

V.A.R.I. (I)

Valeas (I)

Valois (F)

ANNEX II

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 (B)

Atofina (F)

Bie & Berntsen (DK)

Biosolve (NL)

Carl Roth (D)

Carlo Erba Réactifs (F)

Dow Benelux (NL)

Fisher Scientific (D)

Fisher Scientific (UK)

Honeywell Specialty Chemicals (D)

Ineos Fluor (UK)

Katholieke Universiteit Leuven (B)

Merck Eurolab (F)

Merck (D)

Panreac Química (E)

Promochem (D)

Rathburn Chemicals (UK)

SDS Solvants (F)

Sigma Aldrich Chemie (D)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

YA Kemia Oy (FIN)

ANNEX III

ESSENTIAL LABORATORY USES

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

Airbus (F)

Butterworth Laboratories (UK)

Ineos Fluor (UK)

Sigma Aldrich Company (UK)

25.7.2002

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Official Journal of the European Communities

L 196/43

ANNEX IV

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)

Carlo Erba Réactifs (F)

Codif International (F)

Dow Benelux (NL)

Fisher Scientific (UK)

Katholieke Universiteit Leuven (B)

Laboratoires Sérologiques (F)

Mallinckrodt Baker (NL)

Merck Eurolab (F)

Merck (D)

Panreac Química (E)

Rathburn Chemicals (UK)

SDS Solvants (F)

Sigma Aldrich Chemie (D)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

Sigma Aldrich Laborchemikalien (D)

YA Kemia Oy (FIN)

ANNEX V

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)

Dow Benelux (NL)

Katholieke Universiteit Leuven (B)

Mallinckrodt Baker (NL)

Merck (D)

Panreac Química (E)

Rathburn Chemicals (UK)

Sigma Aldrich Chemie (D)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

ANNEX VI

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 (F)

Sigma Aldrich Company (UK)

L 196/44

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Official Journal of the European Communities

25.7.2002

ANNEX VII

EMERGENCY ESSENTIAL LABORATORY USE

Quota of controlled substances CFC 113 and carbon tetrachloride that may be imported for the temporarily exempted
use of oil-in-water testing are allocated to:

Bie & Berntsen (DK)

Biosolve (NL)

Carlo Erba Réactifs (F)

Carl Roth (D)

Fisher Scientific (D)

Honeywell Specialty Chemicals (D)

Mallinckrodt Baker (NL)

Merck (D)

Promochem (D)

Rathburn Chemicals (UK)

16 430 ODP weighted kilograms of controlled substances may be imported for oil-in-water testing for use by labora-
tories in Denmark, Finland, the Netherlands, Spain and Sweden. No Member State may authorise production of ozone
depleting substances for oil-in-water testing. Laboratories and suppliers cannot supply ozone depleting substances from
stocks for oil-in-water testing.

The importers listed in Annex VII shall not supply the controlled substances imported for the exempted use to users in
Austria, Belgium, France, Germany, Greece, Ireland, Italy, Luxembourg, Portugal and the United Kingdom from 1 January
2002.

Enterprises using ozone depleting substances for oil-in-water testing in Austria, Belgium, France, Germany, Greece,
Ireland, Italy, Luxembourg, Portugal and the United Kingdom from 1 January 2002 will be in non-compliance with
Regulation No (EC) 2037/00.