Notice to users of controlled substances in the European Union allowed for essential uses in the Community in 2006 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council on ‘substances that deplete the ozone layer’
Date: 2005-07-08
Institutions: European Commission
Subjects: chemical product, dangerous substance, medical device, ozone, research body, stratospheric pollutant, type of business

C 168/20

EN

Official Journal of the European Union

8.7.2005

Notice to users of controlled substances in the European Union allowed for essential uses in the
Community in 2006 under Regulation (EC) No 2037/2000 of the European Parliament and of the
Council on ‘substances that deplete the ozone layer’ (1)

(2005/C 168/03)

This notice concerns the following substances:

— Chlorofluorocarbons (CFCs) 11, 12, 113, 114 and 115,

— Other fully halogenated chlorofluorocarbons,

— Carbon tetrachloride,

— Halons,

— 1,1,1 trichloroethane,

— Hydrobromofluorocarbons (HBFCs),

— Bromochloromethane.

This notice is addressed to users that intend to:

1. Use the above substances within the Community for the manufacture of Metered Dose Inhalers (MDIs),

2. Acquire the above substances for laboratory and analytical uses directly from a producer or by import

into the Community and not from distributor of the substances inside the Community.

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

Decision IV/25 of the Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer sets
out criteria and a procedure for determining ‘essential uses’ for which continued production and consump-
tion is allowed after phase-out.

Article 3(1) of Regulation (EC) No 2037/2000, as amended in Regulation (EC) No 2038/2000, requires the
determination of quantities for essential uses of the abovementioned controlled substances which may be
permitted in the Community in 2006, in accordance with Decision IV/25 of the Parties to the Montreal
Protocol

The Parties to the Montreal Protocol may take a Decision in December 2005 that authorises the maximum
levels of production and consumption necessary to satisfy essential uses of CFCs in 2006 for metered dose
inhalers (MDIs) for the treatment of asthma and chronic obstructive pulmonary diseases as specified in
Annex I, subject to the conditions established by the Meeting of the Parties in paragraph 2 of its Decision
VII/28.

In accordance with Decision X/19 of the Parties to the Montreal Protocol, the purity of controlled
substances for laboratory purposes should be at least 99,0 % for 1,1,1-trichloroethane and 99,5 % for CFCs
and carbon tetrachloride. These high purity substances and mixtures containing controlled substances shall
be supplied only in re-closable containers or high pressure cylinders smaller than three litres or in 10 milli-
litre or smaller glass ampoules, marked clearly as substances that deplete the ozone layer, restricted to
laboratory use and analytical purposes and specifying that used or surplus substances should be collected
and recycled, if practical. The material should be destroyed following the procedures described in Article
16(1) of the Regulation if recycling is not practical.

(1) OJ L 244 of 29.9.2000, p. 1 as last amended by Regulation (EC) No 2077/2004, OJ L 359 of 4.12.2004, p. 28.

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Decision XV/8 of the Parties to the Montreal Protocol authorises the production and consumption neces-
sary to satisfy essential uses of controlled substances listed in Annexes A, B and C (Group II and III
substances) of the Montreal Protocol 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.

Currently there are no exemptions permitted in the Montreal Protocol for the use of methyl bromide for
laboratory and analytical uses and therefore all uses of methyl bromide in the European Community are
not in compliance with the Regulation. Intended users are requested to contact the Commission at the
address below, or to contact the ODS website http://europa.eu.int/comm/environment/ods/home/home.cfm
for further information under ‘Methyl bromide Laboratory and Analytical Uses’.

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

1. An enterprise that has not been issued with a quota in 2005 and that requests consideration by the
Commission for an essential use quota for the period 1 January 2006 to 31 December 2006 should
make itself known to the Commission no later than 2 September 2005:

Ozone Layer Protection
European Commission
Directorate-General Environment
Unit ENV.C.4 — Industrial Emissions
BU9 6/137
B-1049 Brussels
Fax: (32-2) 299 87 64
E-mail: env-ods@cec.eu.int

2. Essential use applications may be made by any user of substances listed at the beginning of this Notice.
For CFCs for use in MDIs, each applicant should provide the information requested on the spreadsheet
available on the ODS website http://europa.eu.int/comm/environment/ods/home/home.cfm. For Labora-
tory Uses, each applicant should provide the information requested in the form on the website.

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

3. Only applications received by 2 September 2005 will be considered by the Commission in accordance

with the procedure set out in Article 18 of Regulation (EC) No 2037/2000.

4. The Commission will issue quotas to those users and shall notify them of the use for which they have
authorisation, the substance they are authorised to use and the quantity of the controlled substances
concerned.

5. Following the above procedure, the Commission on the basis of a Decision will notify applicants of the
quantities of controlled substances authorised in the Community for 2006 for which production and
importation of controlled substances will be permitted.

6. Those users holding an essential use quota for a controlled substance for 2005 will be able to make a
request to a Community producer via the ODS website or, if necessary, request an import licence from
the Commission for a controlled substance up to their quota limit. The producer must be authorised by
the competent authority of the Member State in which its relevant production is situated to produce
the controlled substance for meeting that licensed demand. The competent authority of the Member
State shall notify the Commission well in advance of any such authorisation.

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8.7.2005

BELGIQUE/BELGÏE

ANNEX I

IRELAND

Mr Alain Wilmart
Ministère Fédéral des Affaires Sociales de la Santé Publique et de
l'Environnement
Place Victor Horta, 40 — Bte 10
B-1060 Bruxelles

Mr Patrick O'Sullivan
Inspector (Environment)
Dept of Environment Heritage and Local Government
Custom House
Dublin 1
Ireland

ČESKÁ REPUBLIKA

Mr Jakub Achrer
Ministry of the Environment of the Czech Republik
Air Pollution Prevention Department
Vršovická 65
CZ-100 10 Praha 10

DANMARK

Mr Mikkel Aaman Sørensen
Miljøstyrelsen (EPA)
Strandgade 29
DK-1401 København K

DEUTSCHLAND

Mr Rolf Engelhardt
Ministry for Environment
Dept. IG 11 5
P.O. Box 120629
DE-53048 Bonn

EESTI

Ms Valentina Laius
Ministry of the Environment of the Republic of Estonia
Environment Management and Technology Department
Narva mnt 7A
EE-15172 Tallin

ΕΛΛΑΣ

Mrs Elpida Politis
Ministry for the Environment, Physical Planning and Public Works
International Activities and EEC Department
17 Ameliedos Street
EL-115 23 Athens

ITALIA

Mr Alessandro Giuliano Peru
Dept of Environment and Territory
DG per la ricerca Ambientale e lo Sviluppo
Via Cristoforo Colombo 44
IT-00147 Roma

ΚΥΠΡΟΣ

Dr. Charalambos Hajipakkos
Environment Service
Ministry of Agriculture, Natural Resources and Environment
CY-Nicosia

LATVIJA

Mr Armands Plate
Ministry of Environment
Environmental Protection Department
Peldu Iela 25
LV-1494 — Riga

LIETUVA

Ms Marija Teriosina
Ministry of Environment
Chemicals Management Division
Jaksto str. 4/9
LT-2600 Vilnius

LUXEMBOURG

Mr Pierre Dornseiffer
Administration de l'Environnement
Division Air/Brut
16, rue Eugène Ruppert
L-2453 Luxembourg

MAGYARORSZÁG

Mr Robert Toth
PO Box 351
Ministry of Environment and Water
Department for Air Pollution and Noise Control
HU-1394 Budapest

ESPAŇA

MALTA

Mr Alberto Moral Gonzalez
Ministerio de Medio Ambiente
Subdirección General de Calidad Ambiental
Pza San Juan de la Cruz s/n
ES-28071 Madrid

FRANCE

Mr Matthieu LASSUS
Ministère de l'Environnement
DRPR/BSPC
20, avenue de Ségur
F-75302 Paris 07 SP

Ms Charmaine Vassallo
Malta Environment and Planning Authority
Environment Protection Directorate
Pollution Control, Wastes and Minerals
C/o Quality Control Laboratory
Industrial Estate Kordin
MT-PAOLA

NEDERLAND

Mr M. Hildebrand
Ministry of Environment
Rijnstraat 8
2500 GX Den Haag
Nederland

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ÖSTERREICH

Mr Paul Krajnik
Ministry of the Agriculture, Forestry, Environment and Water Manage-
ment
Chemicals Department
Stubenbastei 5
AT-1010 Wien

POLSKA

Pan Janusz Kozakiewicz
Instytut Chemii Przemysłowej
Biuro Ochrony Warstwy Ozonowej
ul. Rydygiera 8
PL-01-793 Warszawa

PORTUGAL

Dra. Cristina Vaz Nunes
Ministério do Ambiente
Rua da Murgueira 9/9A –Zambujal Ap. 7585
PT-2611-865 Amadora

SLOVENIJA

Ms Irena Malešič
Ministry of the Environment and Spacial Planning
Environmental Agency of the Republic of Slovenia
Vojkova 1b
SL-1000 Ljubljana

SLOVENSKO

Mr Lubomir Ziak
Ministry of the Environment
Air Protection Department
Nam. L. Stura 1
SK-812 35 Bratislava

SUOMI/FINLAND

Mrs Eliisa Irpola
Finnish Environment Institute
Chemicals Division
Mechelininkatu 34a
FIN-00260 Helsinki

SVERIGE

Ms Maria Ujfalusi
Swedish Environmental Protection Agency
Naturvårdsverket
Blekholmsterassen 36
SE-106 48 Stockolm

UNITED KINGDOM

Mr Stephen Reeves
Global Atmosphere Division
UK Dept of Environment, Food and Rural Affairs
3rd floor — zone 3/A3
Ashdown House
123 Victoria Street
London SW1E 6DE
United Kingdom