2001/333/EC: Commission Decision of 13 February 2001 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2001 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council on substances that deplete the ozone layer (Text with EEA relevance) (notified under document number C(2000) 4153)
Date: 2001-02-13
Institutions: European Commission
Subjects: chemical product, dangerous substance, import restriction, international convention, ozone, production quota

27.4.2001

EN

Official Journal of the European Communities

L 118/57

COMMISSION

COMMISSION DECISION

of 13 February 2001

on the allocation of quantities of controlled substances allowed for essential uses in the
Community in 2001 under Regulation (EC) No 2037/2000 of the European Parliament and of the
Council on substances that deplete the ozone layer

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

(notified under document number C(2000) 4153)

(Text with EEA relevance)

(2001/333/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 on substances that deplete
the ozone layer (1), and in particular to Articles 3, 4 and 7
thereof,

Whereas:

(1)

(2)

(3)

Because of concerns for the ozone layer, the Community
has already phased out the production and consumption
of certain controlled substances.

Essential uses have to be decided for chlorofluorocar-
fully halogenated chlorofluorocarbons;
bons; other
halons; carbon tetrachloride; 1,1,1 trichloroethane; and
hydrobromofluorocarbons (Article 3.1 and Article 4.4).

The criteria used for assessing essential uses are in line
with Decision IV/25 of
the Parties to the Montreal
Protocol and are:

I. That a use of a controlled substance should qualify as

‘essential’ only if:

A.

it is necessary for the health, safety, or is critical
for
society (encompassing
cultural and intellectual aspects); and

the functioning of

B. there are no technically and economically feasible
alternatives or substitutes that are acceptable from
the standpoint of environment and health.

II. That production and consumption,

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

(4)

(5)

(6)

(7)

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 countries
for controlled substances.

Decision XI/14 of the Parties to the Montreal Protocol
authorises the levels of production and consumption
controlled
necessary
for the
substances for metered dose inhalers (MDIs)
treatment of asthma and chronic obstructive pulmonary
disease (COPD).

essential uses of

to satisfy

Decision XI/17 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 and in Decision VII/11.

The Montreal Protocol's Technology and Economic
Assessment Panel noted in its April 2000 report that the
European Community's stockpile of CFCs has increased
and recommended that it be reduced as production of
CFC-based MDIs declines.

to those
The Commission has published a notice (2)
companies
in the European Community that use
controlled substances which may be allowed for essen-
tial uses in the Community in 2001 pursuant to Regula-
tion (EC) No 2037/2000, and has thereby received
applications for quantities of controlled substances for
essential uses in 2001.

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

(2) OJ C 224, 5.8.2000, p. 16.

L 118/58

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Official Journal of the European Communities

27.4.2001

(8)

(9)

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 2001.

The Commission issues licenses to the users identified
pursuant to Articles 3, 4 and 7 and in accordance with
the procedure set out in Article 18 of Regulation (EC)
No 2037/2000.

(10) 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 identified users; the
competent authority of the Member State concerned
shall in turn notify the Commission well in advance of
any such authorisation.

(11)

(12)

(13)

to Decision XI/17 of

to the
Pursuant
Montreal Protocol, overall quantitative limits may be set
for essential laboratory and analytical uses of controlled
substances in the European Community during 2001.

the Parties

the
The list of essential uses and the quantities of
controlled substances are hereby given in the Annex as
information for producer and user industries.

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

HAS ADOPTED THIS DECISION:

Article 1

Companies which may take advantage of the essential uses for
their own account during 2001 for the manufacture of metered
dose inhalers and for the coating of cardiovascular surgical
material are listed in Article 5.

Article 2

The total quantities of controlled substances permitted for
essential uses during 2001 shall be as specified in the Annex.

Article 3

Within the overall limits set out in Part B of the Annex, the
Commission shall
controlled
licenses
substances from producers in the Community or by import for
essential

laboratory and analytical uses.

to acquire

issue

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

Aventis
Mr Bob Netrefa
London Road
Holmes Chapel
CW4 8BE
United Kingdom

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

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

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

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

Edwards Life Sciences
Dr. A. Bronkhorst
Energielaan 3
PO Box 169
5400 AD Uden
Nederland

Glaxo SmithKline
Mr Barry Rosenthal
Speke
Liverpool
L24 9JD
United Kingdom

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

Article 4

This Decision shall apply from 1 January 2001 to 31
December 2001.

Article 5

Companies which may take advantage of the essential uses for
their own account during 2001 for the manufacture of metered
dose inhalers and for the coating of cardiovascular surgical
material are:

Jaba Farmacêutica SA
Ana Maria Baptista de Almeida
Rua da Tapada Grande n.o 2
Abrunheira
P-2710-089 Sintra

Laboratorio Aldo Unión SA
Dr. J. Sabater Sanmartí
Baronesa de Maldà 73
Esplugues de Llobregat
E-08950 Barcelona

27.4.2001

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Official Journal of the European Communities

L 118/59

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

Orion Corporation
Mr Pasi Salokangas
Orionintie 1
FIN-02200 Espoo

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

Valeas SpA Pharmaceuticals
Dr. 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.

Done at Brussels, 13 February 2001.

For the Commission

Margot WALLSTRÖM

Member of the Commission

L 118/60

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27.4.2001

ANNEX

A. MEDICAL USES

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

(in kg (CFC))

Company

2001 quota allocation

3M (UK)

Aventis (UK)

Bespak (UK)

Boehringer (D)

CCL Pharmaceuticals (UK)

Chiesi (I)

Glaxo SmithKline (UK)

IG Sprühtechnik (D)

Jaba Farmacêutica (P)

Lab. Aldo-Unión (E)

Norton (IRL)

Orion (FIN)

Schering-Plough (B)

Valeas (I)

Valois (F)

VARI (I)

Total

2 614 662

B. LABORATORY USES

Total quantities of controlled substances that may be produced or imported during 2001 for laboratory and analytical
uses

(in kg)

Controlled substance

Quantitative limit

CFCs

Carbon tetrachloride

1,1,1 trichloroethane

Others (other CFCs, halons, HBFCs)

160 000

190 000

18 000

420

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 of
each controlled substance authorised during 2001 for laboratory and analytical purposes shall not exceed the quantities
listed above.

C. CARDIOVASCULAR SURGICAL MATERIALS

Controlled substance

CFC 113

(in kg)

Quantity

100