Information from the Commission – Notice to users in the European Community 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 on substances that deplete the ozone layer (Text with EEA relevance)
Date: 2001-07-21
Institutions: European Commission
Subjects: chemical product, dangerous substance, environmental law, ozone, pharmaceutical legislation, technical regulations

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Official Journal of the European Communities

21.7.2001

Notice to users in the European Community 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 on substances that deplete the ozone layer (1)

(2001/C 205/02)

(Text with EEA relevance)

This notice concerns the following substances:

(cid:151) chlorofluorocarbons (CFCs) 11, 12, 113, 114 and 115,

(cid:151) other fully halogenated chlorofluorocarbons,

Decision IV/25 of
the Parties to the Montreal Protocol on
substances that deplete the ozone layer sets out criteria and
a procedure
for which
for determining (cid:145)essential uses(cid:146)
continued production and consumption would be allowed
after phase-out.

(cid:151) carbon tetrachloride,

(cid:151) halons,

(cid:151) 1,1,1-trichloroethane,

In accordance with Decision IV/25 of
the Parties to the
Montreal Protocol, Article 3(1) of Regulation (EC) No
2037/2000 of the European Parliament and of the Council of
1 October 2000 on substances that deplete the ozone layer, as
amended by Regulation (EC) No 2038/2000, requires the deter-
mination of quantities
the above-
mentioned controlled substances which may be permitted in
the Community in 2002.

for essential uses of

(cid:151) hydrobromofluorocarbons (HBFCs).

This notice is addressed to undertakings that intend to:

1. use the above substances within the Community for the

manufacture of metered dose inhalers (MDIs);

2. use the above substances within the Community for the

manufacture of cardiovascular surgical devises; and

Decision XI/14 of the Parties to the Montreal Protocol auth-
orised the levels of production and consumption necessary to
satisfy essential uses of CFCs for metered dose inhalers (MDIs)
for the treatment of asthma, chronic obstructive pulmonary
the coating of cardiovascular
diseases and CFC 113 for
surgical material.
in the
European Community in 2002, the quantity of CFCs 11, 12,
113 and 114 authorised by the Parties is 2 785 000 kg (two
million, seven hundred and eighty-five thousand kilograms).

the production of MDIs

For

3. acquire the above substances for laboratory and analytical
into the

uses directly from a producer or by import
Community.

the Parties to the
In accordance with Decision VI/9 of
Montreal Protocol,
the purity of controlled substances for
laboratory purposes should be at least 99,0 % for 1,1,1-trich-
loroethane and 99,45 % for CFCs and carbon tetrachloride.

Controlled substances for essential uses may be obtained from
production within the Community and if necessary by import
from sources outside the Community.

A user that requests consideration by the Commission for an
essential-use licence for the period 1 January 2002 to 31
December 2002 should apply to the Commission through
page http://europa.eu.int/comm/environment/ods/index.htm of
the Europa website. When requesting CFCs for MDI Excel
spreadsheet (cid:145)Form (cid:151) MDIs(cid:146) should be submitted; for laboratory
uses an applicant should submit an electronic spreadsheet
(Excel spreadsheet (cid:145)Form (cid:151) Laboratory ODS(cid:146)) on the website
or complete the form attached to this notice. Website
submission of documents is preferred.

(1) OJ L 244, 29.9.2000, p. 1; Regulation as amended by Regulation
(EC) No 2038/2000 (OJ L 244, 29.9.2000, p. 25), and Regulation
(EC) No 2039/2000 (OJ L 244, 29.9.2000, p. 26).

The procedure allocating quantities of controlled substances for
the above essential uses carried out under Regulation (EC) No
the
2037/2000 and Regulation (EC) No 2038/2000 is
following.

for MDIs,

1. Essential use applications may be made by any interested
user of substances listed at the beginning of this notice for
metered dose inhalers (MDIs) or for laboratory uses. For
the
CFCs
information requested in the spreadsheet on the website
or available from the Commission. For laboratory uses,
each applicant should provide the information requested
in the spreadsheet on the website, available from the
Commission or from Annex 1 attached to this notice.

should provide

each applicant

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Official Journal of the European Communities

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2. Interested parties should submit the required form on the
website or send their application no later than one month
after the date of the publication of this notification to:

Mrs Sabine Cardinal
European Commission
Directorate-General for the Environment
Unit ENV.E.1 Climate change
Rue de la Loi/Wetstraat 200
B-1049 Brussels.

4. On the basis of

the above procedure, a Commission
decision will notify the quantities of controlled substances
issued to applicants in the Community 2002 for which
additional production and
controlled
substances will be permitted.

importation of

5. The Commission will then issue licences to those users and
shall notify them of the use for which they have author-
isation, the substance they are authorised to use and the
quantity of the controlled substances concerned.

Request
Mrs
(Sabine.Cardinal@cec.eu.int).

Cardinal

(No

for electronic forms can be made by faxing
e-mail

299 87 64)

(32-2)

or

A copy of the application should also be sent to the
competent authority of the Member State (refer to
Annex II for appropriate address).

3. Applications received by the due date will be considered by
the Commission in accordance with the procedure set out in
Article 18 of Regulation (EC) No 2037/2000 on substances
that deplete the ozone layer.

6. Those users holding an essential use licence for a controlled
substance for 2002 will be able to present their licensed
demands to a producer or if necessary request an import
licence from the Commission for the purpose of meeting
the licensed demand. The producer may be authorised by
the competent authority of the Member State in which its
relevant production is situated to produce the controlled
substance
The
that
competent authority of the Member State shall notify the
Commission well in advance of any such authorisation.

for meeting

demand.

licensed

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Official Journal of the European Communities

21.7.2001

REQUEST FOR THE USE OF OZONE DEPLETING SUBSTANCES FOR LABORATORY USES

ANNEX I

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Official Journal of the European Communities

21.7.2001

ALLEGATO II / ANEXO II / ANEXO II / ANNEX II / ANNEXE II / ANHANG II / BIJLAGE II / BILAG II / BILAGA II /
LIITE II / —`(cid:209)`(cid:209)(cid:212)˙(cid:204)` II

(cid:214)STERREICH

Paul Krajnik
Ministry of the Environment
Chemical Department
Stubenbastei 5
A-1010 Wien

BELGIQUE/BELGI¸

M./De heer Roland Marijnissen
MinistŁre de la santØ publique et de l’environnement/
Ministerie van Volksgezondheid en Leefmilieu
DØpartement de l’environnement
Boulevard Pacheco/Pachecolaan 19 (cid:151) bo(cid:238)te/bus 7
B-1010 Bruxelles/Brussel

DANMARK

Mikkel Aaman Słrensen
Miljłstyrelsen (EPA)
Strandgade 29
DK-1401 Kłbenhavn K

SUOMI/FINLAND

Eliisa Irpola
Finnish Environment Institute
Kes(cid:228)katu 6
FIN-00121 Helsinki

FRANCE

Madame Laurence Musset
MinistŁre de l’environnement
DRPR/BSPC
20, avenue de SØgur
F-75302 Paris 07 SP

DEUTSCHLAND

Heinrich W. Kraus
Federal Ministry for the Environment
Dept. JG 115
Bernkasteler Stra(cid:223)e
D-53175 Bonn

¯¸¸`˜`

Mrs Elpida Politis
Ministry for the Environment, Physical Planning and
Public Works
International Activities and EEC Department
17 Ameliedos Street
GR-11523 Athens

IRELAND

Ms Nuala McLoughlin
Inspector (Environment)
Department of Environment and Local Government
Custom House
Dublin 1
Ireland

ITALIA

Mrs Giuliana Gasparrini
Ministry of Environment
Atmospheric Pollution Department
Via Ferratella in Laterano 33
I-00184 Roma

LUXEMBOURG

M. Theo Weber
Administration de l’environnement
1, rue Bender
L-1229 Luxembourg

PORTUGAL

Dra. Cristina Vaz Nunes
MinistØrio do Ambiente
Rua da Murgueira-Zambujal
P-2721-865 Amadora

ESPA(cid:209)A

`ngel Rasc(cid:243)n
Ministerio de Medio Ambiente
D.G. de Calidad y Evaluaci(cid:243)n Ambiental
Pza. San Juan de la Cruz s/n
4a planta (cid:151) Despacho 4.60
E-28071 Madrid

SVERIGE

Maria Ujfalusi
Swedish Environmental Protection Agency
Naturv(cid:229)rdsverket
Blekholmsterrassen 36
S-106 48 Stockholm

NEDERLAND

Mevrouw ir. E.G. de Jeu
Ministerie van Volkshuisvesting, Ruimtelijke Ordening
en Milieubeheer
Postbus 30945
2500 GX Den Haag
Nederland

UNITED KINGDOM

Mrs Maria Nolan
Department of Environment, Transport and the Regions
Global Atmosphere Division
3rd floor (cid:151) zone 3/C2
Ashdown House
123 Victoria Street
London SW1E 6DE
United Kingdom