2000/22/EC: Commission Decision of 16 December 1999 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2000 under Council Regulation (EC) No 3093/94 on substances that deplete the ozone layer (notified under document number C(1999) 4433) (Text with EEA relevance) (Only the Spanish, German, English, French, Italian, Dutch and Finnish texts are authentic)
Date: 1999-12-16
Institutions: European Commission
Subjects: dangerous substance, derogation from EU law, import restriction, medical device, ozone, production quota

L 7/14

EN

Official Journal of the European Communities

12. 1. 2000

COMMISSION DECISION

of 16 December 1999

on the allocation of quantities of controlled substances allowed for essential uses in the
Community in 2000 under Council Regulation (EC) No 3093/94 on substances that deplete the
ozone layer

(notified under document number C(1999) 4433)

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

(Text with EEA relevance)

(2000/22/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Regulation (EC) No 3093/94 of 15
December 1994 on substances that deplete the ozone layer (1),
and in particular Articles 3, 4 and 7 thereof,

(1) Whereas, because of concerns for the ozone layer, the
Community has already phased out the production and
consumption of certain controlled substances;

(Articles 3(1) and 4(1)); other

(2) Whereas essential uses have to be decided for chloro-
fluorocarbons
fully
halogenated chlorofluorocarbons (Articles 3(2) and 4(2));
halons (Articles 3(3) and 4(3)); carbon tetrachloride
(Articles 3(4) and 4(4)); 1,1,1-trichloroethane (Articles
3(5) and 4(5)); and HBFCs (Articles 3(7) and 4(7));

(3) Whereas the criteria used for assessing essential uses are
the Parties to the

in line with Decision IV/25 of
Montreal Protocol and are as follows:

1. that a use of a controlled substance should qualify as

‘essential’ only if:

(a) it is necessary for the health, safety, or is critical
the functioning of society (encompassing

for
cultural and intellectual aspects); and

(b) there are no technically and economically feasible
alternatives or substitutes that are acceptable
from the standpoint of environment and health;

2. that production and consumption,

if any, of a
controlled substance for essential uses should be
permitted only if:

(a) all economically feasible steps have been taken to
minimise the essential use and any associated
emission of the controlled substance; and

(b) the controlled substance is not available in suffi-
cient quantity and quality from existing stocks of
banked or recycled controlled substances, also

bearing in mind the needs of developing coun-
tries for controlled substances;

authorises

(4) Whereas Decision X/6 of the Parties to the Montreal
Protocol
levels of production and
the
consumption necessary to satisfy essential uses of
controlled substances for metered dose inhalers (MDIs)
for the treatment of asthma and chronic obstructive
pulmonary disease (COPD);

to satisfy

(5) Whereas Decision X/19 of the Parties to the Montreal
Protocol authorises the production and consumption
necessary
controlled
substances 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 and in
Decision VII/11;

essential uses of

(6) Whereas the Commission has published a notice (2) to
those companies in the European Community which use
controlled substances that may be allowed for essential
uses in the Community in 1999 pursuant to Council
Regulation (EC) No 3093/94, and has thereby received
applications for quantities of controlled substances for
essential uses in 2000;

(7) Whereas,

in the framework of the Montreal Protocol
nomination and assessment procedures for essential
uses, Parties are requested to identify the users who may
take advantage of essential uses in 2000;

(8) Whereas the Commission issues licenses to the users
identified pursuant to Articles 3, 4 and 7 and in accord-
ance with the procedure set out in Article 16 of Council
Regulation (EC) No 3093/94;

(9) Whereas, within this framework, a producer may be
authorised by the competent authority of the Member
State in which its relevant production is situated to
produce the controlled substances for the purposes of
meeting the licensed demands presented by the identi-
fied users; whereas the competent authority of
the
Member State concerned shall
in turn notify the
Commission well in advance of any such authorisation;

(1) OJ L 333, 22.12.1994, p. 1.

(2) OJ C 208, 22.7.1999, p. 12.

12. 1. 2000

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Official Journal of the European Communities

L 7/15

(10) Whereas, pursuant to Decision X/19 of the Parties to the
Montreal Protocol, overall quantitative limits may be set
for essential laboratory and analytical uses of controlled
substances in the European Community during 2000;

(11) Whereas the list of essential uses and the quantities of
the controlled substances are hereby given in Annex II
as information for producer and user industries;

(12) Whereas the measures provided for in this Decision are
in accordance with the opinion of
the Committee
referred to in Article 16 of Council Regulation (EC) No
3093/94,

HAS ADOPTED THIS DECISION:

Article 2

The total quantities of controlled substances permitted for
essential uses during 2000 shall be as specified in Annex II.

Article 3

Within the overall limits set out in Annex IIB, the Commission
shall
issue licenses to acquire controlled substances from
producers in the Community or by import for essential labora-
tory and analytical uses.

Article 4

This Decision is addressed to the companies listed in

1.
Annex I.

This Decision shall apply from 1 January 2000 to 31

2.
December 2000.

Article 1

Done at Brussels, 16 December 1999.

Companies which may take advantage of the essential uses for
their own account during 2000 for the manufacture of metered
dose inhalers and for the coating of cardiovascular surgical
material are listed in Annex I.

For the Commission

Margot WALLSTRÖM

Member of the Commission

L 7/16

EN

Official Journal of the European Communities

12. 1. 2000

ANEXO I — BILAG I — ANHANG I — ΠΑΡΑΡΤΗΜΑ Ι — ANNEX I — ANNEXE I — ALLEGATO I — BIJLAGE I —
ANEXO I — LIITE I — BILAGA I

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

Laboratorio Aldo Unión SA
Dr. J. Sabater Sanmarti
Baronese de Maldá 73
Espluges de Llobregat
E-08950 Barcelona

Baxter BV
Dr. A. Bronkhorst
Energielaan 3
P.O. Box 169
NL-5400 AD Uden

Bespak plc
Mr Chris Halley
North Lynn Industrial Estate
King's Lynn
Norfolk PE30 2JJ
United Kingdom

Boehringer Ingelheim GmbH
Herrn J. Pink
D-55216 Ingelheim am Rhein

CCL Pharmaceuticals Ltd
Mrs C. King
Astmoor Industrial Estate
9 Arkwright Road
Runcorn
Cheshire WA7 1NU
United Kingdom

Chauvin ankerpharm
Ms Martina Elzer-Vetter
Hansallee 247
D-40549 Düsseldorf

Chiesi Farmaceutici SpA
Dott. P. Chiesi
Via Palermo, 26 A
I-43100 Parma

Glaxo Wellcome Operations
Mr Barry Rosenthal
Speke
Liverpool L24 9JD
United Kingdom

IG Sprühtechnik GmbH
Herrn F. Guck
Im Hemmet 1
D-79664 Wehr

Laboratorios Lesvi SA
Sr. Alejandro Biel Andrés
Poligono Industrial Can Pelegrí
E-08740 Sant Andreu de la Barca

Laboratorios Vita, SA
Sr. Alejandro Biel Andrés
Av. Barcelona, 69
E-08970 Sant Joan Despí

Norton Waterford Ltd
Mr Jim Kennedy
Unit 301 Industrial Park
Waterford
Ireland

Orion Corporation
Mr Pasi Salokangas
Orionintie 1
FIN-02200 Espoo

Otsuka
Sr. A. Costa Espelleta
Santanyí 16
E-08016 Barcelona

Rhône-Poulenc Rorer
Mr Bob Netrefa
London Road
Holmes Chapel
Cheshire CW4 8BE
United Kingdom

Schering-Plough Labo NV
Mr P. Gyselinck
Industriepark 30
B-2220 Heist op den Berg

SICOR — Società italiana corticosteroidi SpA
Dott. Roberto Giani
Via Terrazzano, 77
I-20017 RHO (Milano)

Valeas SpA Pharmaceuticals
Dott. Virgilio Bernareggi
Via Vallisneri, 10
I-20133 Milano

Valois SA
M. Salim Haffar
50, avenue de l'Europe
F-78160 Marly-le-Roi

VARI
Dr Bruno Boccardo
Via del Pino, 10
I-23854 Olginate

12. 1. 2000

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Official Journal of the European Communities

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ANNEX II

A. MEDICAL USES

Production of metered dose inhalers (MDIs) for the treatment of asthma and other chronic obstructive pulmonary diseases
(COPDs).

Company

2000 quota allocation
in tonnes
(CFC)

3M (UK)

Bespak (UK)

Boehringer (D)

CCL Pharmaceuticals (UK)

Chauvin ankerpharm (D)

Chiesi (I)

Glaxo Wellcome (UK)

IG Sprühtechnik (D)

Lab. Aldo-Unión (E)

Lab. Lesvi (E)

Lab. Vita (E)

Norton (IRL)

Otsuka (E)

Orion (FIN)

Rhône-Poulenc Rorer (UK)

Schering-Plough (B)

Sicor (I)

Valeas (I)

Valois (F)

Vari (I)

Total

3 530,1

L 7/18

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Official Journal of the European Communities

12. 1. 2000

Total quantities of controlled substances which may be produced or imported during 2000 for laboratory and analytical
uses.

B. MEDICAL USES

Controlled substance

Quantitative limit
(in tonnes)

CFCs

Carbon tetrachloride

1,1,1-trichloroethane

150

150

35

Other (other CFCs, halons, HBFCs)

0,060

Laboratory users or suppliers of laboratory chemicals needing to obtain controlled substances from producers or
importers under this essential use exemption should apply to the Commission for authorisation. The total quantity each
controlled substance authorised during 2000 for laboratory and analytical purposes shall not exceed the quantities listed
above.

C. CARDIOVASCULAR SURGICAL MATERIALS

Controlled substance

CFC 113

Quantity
(in tonnes)

0,100