1999/59/EC: Commission Decision of 11 January 1999 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 1999 under Council Regulation (EC) No 3093/94 on substances that deplete the ozone layer (notified under document number C(1998) 4564) (Only the Spanish, German, English, French, Italian, Dutch and Finnish texts are authentic) (Text with EEA relevance)
Date: 1999-01-11
Institutions: European Commission
Subjects: chemical product, dangerous substance, derogation from EU law, medical device, ozone, production quota

L 19/18

EN

Official Journal of the European Communities

26. 1. 1999

COMMISSION DECISION

of 11 January 1999

on the allocation of quantities of controlled substances allowed for essential uses
in the Community in 1999 under Council Regulation (EC) No 3093/94 on
substances that deplete the ozone layer

(notified under document number C(1998) 4564)

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

(Text with EEA relevance)

(1999/59/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,

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

Whereas essential uses have to be decided for chloroflu-
orocarbons (Articles 3(1) and 4(1)); other fully halogenated
chlorofluorocarbons
and 4(2)); halons
(Articles 3(2)
(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));

Whereas the criteria used for assessing essential uses are
in line with Decision IV/25 of the Parties to the 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 for
the functioning of society (encompassing 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
controlled substance for essential uses
permitted only if:

any, of
a
should be

(b) the controlled substance is not available in suffi-
cient quantity and quality from existing stocks of
recycled controlled substances, also
banked or
bearing in mind the needs of developing countries
for controlled substances;

the

authorises

Whereas Decision IX/18 of the Parties to the Montreal
Protocol
levels of production and
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);

Whereas Decision IX/17 of the Parties to the Montreal
Protocol authorises
the production and consumption
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 (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 1999;

in the framework of

Whereas,
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 1999;

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

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;

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

(2) OJ C 242, 1. 8. 1998, p. 11.

26. 1. 1999

EN

Official Journal of the European Communities

L 19/19

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 IX/17 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 1999;

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,

ture of metered dose inhalers and for the coating of
cardiovascular surgical material are listed in Annex I.

Article 2

The total quantities of controlled substances permitted for
essential uses during 1999 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 1999 to 31

2.
December 1999.

HAS ADOPTED THIS DECISION:

Done at Brussels, 11 January 1999.

Article 1

Companies which may take advantage of the essential
uses for their own account during 1999 for the manufac-

For the Commission

Ritt BJERREGAARD

Member of the Commission

L 19/20

EN

Official Journal of the European Communities

26. 1. 1999

ANEXO I — BILAG I — ANHANG I — PAQAQTGLA I — 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 Uni(cid:155)n SA
Dr. J. Sabater Sanmarti
Baronese de Mald(cid:145) 73
Espluges de Llobregat
E-08950 Barcelona

Laboratorio Astra Espa(cid:157)a SA
Dr. E. Cabr(cid:130) Matas
Mestre Joan Corrales, 95-105
Esplugues de Llobregat
E-08950 Barcelona

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

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
Cheshire WA7 1NU
United Kingdom

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

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

IG Spr(cid:129)htechnik 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 Andr(cid:130)s
Poligono Industrial Can Pelegr(cid:146)
E-08740 Sant Andreu de la Barca

Laboratorios Miquel, SA
Sr. A. Costa Espelleta
Santany(cid:146), 16
E-08016 Barcelona

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

Orion Corporation
Mr Pasi Salokangas
Orionintie 1
FIN-02200 Espoo

Rh(cid:147)ne-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 — Societ(cid:133) 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 Andr(cid:130)s
Av. Barcelona, 69
E-08970 Sant Joan Desp(cid:146)

26. 1. 1999

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Official Journal of the European Communities

L 19/21

ANNEX II

A. MEDICAL USES

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

Company

1999 quota allocation
in tonnes
(CFCs)

3M (UK)

Bespak (UK)

Boehringer (D)

CCL Pharmaceuticals (UK)

Chiesi (I)

Glaxo Wellcome (UK)

IG Spr(cid:129)htechnik (D)

Lab. Aldo-Uni(cid:155)n (E)

Lab. Astra (E)

Lab. Lesvi (E)

Lab. Vita (E)

Leiras (FIN)

Norton (IRL)

Otsuka (E)

Orion (FIN)

Rh(cid:147)ne-Poulenc Rorer (UK)

Schering-Plough (B)

Sicor (I)

Valeas (I)

Valois (F)

Total

4 429

L 19/22

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Official Journal of the European Communities

26. 1. 1999

B. LABORATORY USES

Total quantities of controlled substances which may be produced or imported during 1999 for
laboratory and analytical uses.

Controlled
substance

Quantitative limit
(in tonnes)

CFCs

Carbon tetrachloride

1,1,1-trichloroethane

Other ODS

150

150

35

0,005

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 1999 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