98/67/EC: Commission Decision of 16 December 1997 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 1998 under Council Regulation (EC) No 3093/94 on substances that deplete the ozone layer (Only the Dutch, English, Finnish, French, German, Italian and Spanish texts are authentic) (Text with EEA relevance)
Date: 1997-12-16
Institutions: European Commission
Subjects: international convention, marketing restriction, ozone, production quota, research body, stratospheric pollutant

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II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 16 December 1997

on the allocation of quantities of controlled substances allowed for essential uses
in the Community in 1998 under Council Regulation (EC) No 3093/94 on
substances that deplete the ozone layer

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

(Text with EEA relevance)

(98/67/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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

‘essential’ only if:

Having regard to the Treaty establishing the European
Community,

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

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

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

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

2. that production and consumption,

if
controlled substance for essential uses
permitted only if:

any, of
a
should be

Whereas essential uses have to be decided for chloro-
fluorocarbons (Articles 3.1 and 4.1); other fully halo-
genated 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);

(a) all economically feasible steps have been taken to
minimise the essential use and any associated emis-
sion 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;

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

(1) OJ L 333, 22. 12. 1994, p. 1.

Whereas Decision VII/9 of the Parties to the Montreal
Protocol authorises the levels of production and con-
sumption necessary to satisfy essential uses of controlled

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for essential laboratory and analytical uses of controlled
substances in the European Community during 1998;

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;

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 1

Companies which may take advantage of the essential
uses for their own account for the manufacture of metered
dose inhalers are listed in Annex I.

Article 2

The total quantities of controlled substances permitted for
essential uses during 1998 shall be as specified in Annex
II.

Article 3

limits set out

the
Within the overall
Commission shall
issue licenses to acquire controlled
substances from producers in the Community or by
import for essential laboratory and analytical uses.

in Annex IIB,

Article 4

This Decision is addressed to the companies listed

1.
in Annex I.

This Decision shall apply from 1 January 1998 to 31

2.
December 1998.

Done at Brussels, 16 December 1997.

For the Commission

Ritt BJERREGAARD

Member of the Commission

substances for metered dose inhalers (MDIs) for the treat-
ment of asthma and chronic obstructive pulmonary
disease (COPD);

Whereas Decisions VIII/10, VIII/11, VIII/12 and IX/19
set out further actions and measures to be taken by Parties
to the Montreal Protocol
to promote and facilitate a
smooth and efficient
transition away from CFC-based
MDIs and request each Party to develop and submit to
the Ozone Secretariat
if
possible by 1998;

its agreed transition strategy,

Whereas Decision VIII/9 of the Parties to the Montreal
the production and consumption
Protocol authorises
necessary to satisfy essential uses of 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;

Whereas the Commission has published a notice (1) to
those companies in the European Community which use
controlled substances that may be allowed for essential
uses in the Community in 1998 pursuant to Council
Regulation (EC) No 3093/94, and has thereby received
applications for quantities of controlled substances for
essential uses in 1998;

in the framework of

the Montreal Protocol
Whereas,
nomination and assessment procedures for essential uses,
Parties are requested to identify the users who may take
advantage of essential uses in 1998;

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;

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

Whereas, pursuant to Decision VIII/9 of the Parties to the
Montreal Protocol, overall quantitative limits may be set

(1) OJ C 285, 20. 9. 1997, p. 7.

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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
Mrs L. Humphreys
3M House
Morley Street
Loughborough
Leicestershire LE11 1EP
United Kingdom

Laboratorio Aldo Unión SA
Dr. J. Sabater Sanmarti
Baronese de Imald ´a 73
E-08950 Espluges de Llobregat

Laboratorio Astra Espa ˜na SA
Dr. E. Cabré Matas
Mestre Joan Corrales, 95-105
E-08950 Esplugues de Llobregat

Bespak plc
Mr T. Clutterbuck
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 WA7 1NU
United Kingdom

Chauvin Ankerpharm GmbH
Fr. Elzer-Vetter
Hansaallee 177 D
D-40549 Düsseldorf

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

Glaxo Wellcome
Mr Barry Rosenthal
Liverpool L24 9JD
United Kingdom

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

Leiras Oy
Mr Kai Buri,
Pansiontie 47
P.O. Box 415
FIN-20101 Turku

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

Laboratorios Miquel, SA
Sr. A. Costa Espelleta
Santanyí, 16
E-08016 Barcelona

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

Nycomed Austria GmbH
Dr. Vorreither
St.-Peter-Straße 25
A-4020 Linz

Orion Corporation
Mr Pasi Salokangas
Orionintie 1
FIN-02200 Espoo

Rhône-Poulenc Rorer
Mr K. J. Bradley
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. Chris Hall
50, avenue de l’Europe
F-78160 Marly-le-Roi

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

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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

1998 quota allocation
in tonnes
(CFCs)

3M (UK)

Bespak (UK)

Boehringer (D)

CCL Pharm (UK)

Chauvin Ankerpharm (D)

Chiesi (I)

Glaxo Wellcome (UK)

IG Sprühtechnik (D)

Lab. Aldo-Unión (E)

Lab. Astra (E)

Lab. Lesvi (E)

Lab. Miquel (E)

Lab. Vita (E)

Leiras (FI)

Norton (Irl)

Nycomed (A)

Orion (F)

Rhône-Poulenc Rorer (UK)

Schering-Plough (B)

Sicor (I)

Valeas (I)

Valois (F)

Total

5 462,5

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B. LABORATORY USES

Total quantities of controlled substances which may be produced or imported and placed in the
European Community during 1998 for laboratory and analytical uses.

Controlled
substance

Quantitative limit
(in tonnes)

CFCs

Carbon tetrachloride

1,1,1 trichloroethane

Other ODS

150

100

35

0,035

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 1998 for laboratory and
analytical purposes shall not exceed the quantities listed above.