Notice to users of controlled substances in the European Union allowed for essential uses in the Community in 2008 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council on substances that deplete the ozone layer
Date: 2007-07-18
Institutions: European Commission
Subjects: chemical product, dangerous substance, medical diagnosis, production quota, research body, stratospheric pollutant

18.7.2007

EN

Official Journal of the European Union

C 164/37

Notice to users of controlled substances in the European Union allowed for essential uses in the
Community in 2008 under Regulation (EC) No 2037/2000 of the European Parliament and of the
Council on ‘substances that deplete the ozone layer’

(2007/C 164/10)

I. This Notice concerns the following substances:

Group I:

CFC 11, 12, 113, 114 or 115

Group II:

other fully halogenated CFCs

Group III:

halon 1211, 1301 or 2402

Group IV:

carbon tetrachloride

Group V:

1,1,1-trichloroethane

Group VI: methyl bromide

Group VII:

hydrobromofluorocarbons

Group VIII: hydrochlorofluorocarbons

Group IX:

bromochloromethane

II. 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 any distributor of the substances inside the Community.

III. Controlled substances for essential uses may be obtained from production within the Community and,

if necessary, by import from sources outside the Community.

IV. 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
consumption are allowed after phase-out.

V. Article 3(1) of Regulation (EC) No 2037/2000 of the European Parliament and of the Council (1)
requires the determination of quantities for essential uses of the above-mentioned controlled substances
which may be permitted in the Community in 2008 if no adequate alternatives are available and in
accordance with Decision IV/25 of the Parties to the Montreal Protocol.

VI. The Parties to the Montreal Protocol may take a Decision in September 2007 that authorises the
maximum levels of production and consumption necessary to satisfy essential uses of CFCs in 2007
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.

VII. Decision XV/8 of the Parties to the Montreal Protocol authorises the production and consumption
necessary 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.

(1) OJ L 244 of 29.9.2000, p. 1 as last amended by Council Regulation (EC) No 1791/2006 (OJ L 363 of 20.12.2006, p. 1).

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VIII. In accordance with Decision X/19 of the Parties to the Montreal Protocol, the purity of controlled
substances for laboratory and analytical uses 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 millilitre or smaller glass ampoules, marked clearly as substances that deplete
the ozone layer, restricted to laboratory and analytical uses and specifying that used or surplus
substances should be collected and recycled wherever possible. The material should be destroyed
following the procedures described in Article 16(1) of the Regulation if recycling is not practical.

IX. Adopted in December 2005, Decision XVII/10 of the Parties to the Montreal Protocol authorises the
production and consumption necessary to satisfy essential uses of methyl bromide, the controlled
substance listed in Annexe E (Group I substances) of the Montreal Protocol, for laboratory and analy-
tical uses as listed in Annex IV to the report of the Seventh Meeting of the Parties, subject to the condi-
tions set out in Annex II to the report of the Sixth Meeting of the Parties. The categories of permitted
laboratory and analytical critical use of methyl bromide are listed in paragraph 2 of Decision XVIII/15.
The uses listed in sub-paragraphs (a) and (c) of paragraph 6 of Decision VII/11 and Decision XI/15 are
excluded from the allowed laboratory and analytical uses.

X. More information, including the texts of the relevant Decisions quoted here above (Decisions IV/25,

XI/15, XV/8, XVI/16 XVII/10 and XVIII/15) can be found at:

http://ec.europa.eu/environment/ozone/pdf/2006_lab.pdf

XI. The procedure for allocating quantities of controlled substances for the above essential uses carried out
under the Regulation (EC) No 2037/2000 and Regulation (EC) No 2038/2000 of the European
Parliament and the Council (1) is the following:

1. An undertaking that has not been issued with a quota in 2007 and that requests consideration by
the Commission for an essential use quota for the period 1 January 2008 to 31 December 2008
should make itself known to the Commission no later than 1 September 2007 by submitting the
registration form available online at:

http://ec.europa.eu/environment/ozone/ods_documents/ods_registration_form.doc

After their registration in the ODS-database it is necessary to follow the procedure described in 2.

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, all registered undertakings will receive an application form from the
Commission.

For Laboratory Uses, each applicant should apply by completing the relevant form online via the
ODS-database available at:

http://ec.europa.eu/environment/ozone/ods.htm

In addition to the online submission a signed print of the import declaration form needs to be sent to
the Commission:

European Commission
Directorate-General Environment
Unit ENV.C.4 — Industrial Emissions & Protection of the ozone layer
BU-5 2/200
B-1049 Brussels
Fax (32-2) 292 06 92
E-mail: env-ods@ec.europa.eu

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

(1) OJ L 244 of 29.9.2000, p. 25.

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XII. Only applications received by 1 September 2007 will be considered by the Commission.

XIII. 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.

XIV. 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 2008 for which production
and importation of controlled substances will be permitted.

XV. Those users holding an essential use quota for a controlled substance for 2007 will be able to make a
request to a Community producer via the ODS-database 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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Official Journal of the European Union

18.7.2007

ANNEX I

Substances covered

Group

Substances

Ozone-depleting potential (1)

Group I

Group II

Group III

Group IV

Group V

Group VI

Group VII

CFCl3

CF2Cl2

C2F3Cl3

C2F4Cl2

C2F5Cl

CF3Cl

C2FCl5

C2F2Cl4

C3FCl7

C3F2Cl6

C3F3Cl5

C3F4Cl4

C3F5Cl3

C3F6Cl2

C3F7Cl

CF2BrCl

CF3Br

C2F4Br2

CCl4

(CFC 11)

(CFC 12)

(CFC 113)

(CFC 114)

(CFC 115)

(CFC 13)

(CFC 111)

(CFC 112)

(CFC 211)

(CFC 212)

(CFC 213)

(CFC 214)

(CFC 215)

(CFC 216)

(CFC 217)

(halon 1211)

(halon 1301)

(halon 2402)

(carbon tetrachloride)

C2H3Cl3 (2)

(1,1,1-trichloroethane)

(methyl bromide)

CH3Br

CHFBr2

CHF2Br

CH2FBr

C2HFBr4

C2HF2Br3

C2HF3Br2

C2HF4Br

C2H2FBr3

C2H2F2Br2

C2H2F3Br

C2H3FBr2

C2H3F2Br

C2H4FBr

C3HFBr6

1,0

1,0

0,8

1,0

0,6

1,0

1,0

1,0

1,0

1,0

1,0

1,0

1,0

1,0

1,0

3,0

10,0

6,0

1,1

0,1

0,6

1,00

0,74

0,73

0,8

1,8

1,6

1,2

1,1

1,5

1,6

1,7

1,1

0,1

1,5

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Official Journal of the European Union

C 164/41

Group

Substances

Ozone-depleting potential (1)

Group VIII

C3HF2Br5
C3HF3Br4
C3HF4Br3
C3HF5Br2
C3HF6Br
C3H2FBr5
C3H2F2Br4
C3H2F3Br3
C3H2F4Br2
C3H2F5Br

C3H3FBr4
C3H3F2Br3
C3H3F3Br2
C3H3F4Br

C3H4FBr3
C3H4F2Br2
C3H4F3Br

C3H5FBr2
C3H5F2Br

C3H6FBr

CHFCl2
CHF2Cl
CH2FCl
C2HFCl4
C2HF2Cl3
C2HF3Cl2
C2HF4Cl
C2H2FCl3
C2H2F2Cl2
C2H2F3Cl
C2H3FCl2
CH3CFCl2
C2H3F2Cl
CH3CF2Cl
C2H4FCl
C3HFCl6
C3HF2Cl5
C3HF3Cl4
C3HF4Cl3
C3HF5Cl2
CF3CF2CHCl2
CF2ClCF2CHClF
C3HF6Cl
C3H2FCl5
C3H2F2Cl4
C3H2F3Cl3
C3H2F4Cl2
C3H2F5Cl

(HCFC 21) (3)

(HCFC 22) (3)

(HCFC 31)

(HCFC 121)

(HCFC 122)

(HCFC 123) (3)

(HCFC 124) (3)

(HCFC 131)

(HCFC 132)

(HCFC 133)

(HCFC 141)

(HCFC 141b) (3)

(HCFC 142)

(HCFC 142b) (3)

(HCFC 151)

(HCFC 221)

(HCFC 222)

(HCFC 223)

(HCFC 224)

(HCFC 225)

(HCFC 225ca) (3)

(HCFC 225cb) (3)

(HCFC 226)

(HCFC 231)

(HCFC 232)

(HCFC 233)

(HCFC 234)

(HCFC 235)

1,9

1,8

2,2

2,0

3,3

1,9

2,1

5,6

7,5

1,4

1,9

3,1

2,5

4,4

0,3

1,0

0,8

0,4

0,8

0,7

0,040

0,055

0,020

0,040

0,080

0,020

0,022

0,050

0,050

0,060

0,070

0,110

0,070

0,065

0,005

0,070

0,090

0,080

0,090

0,070

0,025

0,033

0,100

0,090

0,100

0,230

0,280

0,520

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Group

Substances

Ozone-depleting potential (1)

C3H3FCl4
C3H3F2Cl3
C3H3F3Cl2
C3H3F4Cl
C3H4FCl3
C3H4F2Cl2
C3H4F3Cl
C3H5FCl2
C3H5F2Cl
C3H6FCl

CH2BrCl

(HCFC 241)

(HCFC 242)

(HCFC 243)

(HCFC 244)

(HCFC 251)

(HCFC 252)

(HCFC 253)

(HCFC 261)

(HCFC 262)

(HCFC 271)

Halon 1011/bromochloro-
methane

0,090

0,130

0,120

0,140

0,010

0,040

0,030

0,020

0,020

0,030

0,120

Group IX

(1) These ozone-depleting potentials are estimates based on existing knowledge and will be reviewed and revised periodically in the light

of decisions taken by the Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer.

(2) This formula does not refer to 1,1,2-trichloroethane.
(3)

Identifies the most commercially-viable substance as prescribed in the Protocol.

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Official Journal of the European Union

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ANNEX II

Competent authorities of the Member States

BELGIQUE/BELGÏE

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

БЪЛГАРИЯ

Irina Sirashka
Global Atmospheric Processes Dept
Ministry of Environment and Water
22 Maria-Louisa Str.
BG-1000 Sofia

FRANCE

Mr Vincent Szleper
Ministère de l'Écologie
DPPR/BSPC
20, avenue de Ségur
F-75302 Paris 07 SP

IRELAND

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

ČESKÁ REPUBLIKA

ITALIA

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

Mr Alessandro Giuliano Peru
Ministry for the Environment, Land and Sea
DG per la Ricerca ambientale e lo sviluppo
Via Cristoforo Colombo, 44
I-00147 Roma

DANMARK

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

DEUTSCHLAND

Mr Rolf Engelhardt
Ministry for Environment
Dept. IG II 1
P.O. Box 12 06 29
D-53048 Bonn

EESTI

Ms Valentina Laius
Ministry of the Environment of the Republic of Estonia
Narva mnt 7a
EE-Tallinn 15172

ΕΛΛΑΣ

Ms Sotiria Koloutsou-Vakakis
Environmental Engineer Ph.D.
Ministry for the Environment, Physical Planning and Public Works,
Directorate for the Environment — Department of Air Quality
147 Patission
GR-112 51 Athens

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
A. Jaksto 4/9
LT-2694 Vilnius

LUXEMBOURG

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

ESPAÑA

MAGYARORSZÁG

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

Mr Róbert Tóth
Ministry of Environment and Water
Department of Environmental Development
Fő utca 44-50
H-1011 Budapest

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MALTA

ROMANIA

Ms Charmaine Ajao Vassallo
Environment and Planning Authority
Environment Protection Directorate
Industrial Estate Kordin
Paola

NEDERLAND

Ms Gudi Alkemade
Climate Change Directorate
Ministry of Environment
PO Box 30945
2500 GX Den Haag
Nederland

ÖSTERREICH

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

POLSKA

Mr Janusz Kozakiewicz
Industrial Chemistry Research Institute
Ozone Layer Protection Unit
8, Rydygiera Street
PL-01-793 Warsaw

PORTUGAL

Dra. Cristina Vaz Nunes
Ministry of Environment, Territorial Planning and Regional Develop-
ment
Institute of Environment
Rua da Murgueira 9/9A — Zambujal Ap. 785
P-2611-865 Amadora

Rodica Ella Morohoi
Ministry of Environment and Waters Management
12, Libertății Bv, District 5
Bucharest

SLOVENIJA

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

SLOVENSKO

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

SUOMI/FINLAND

Mrs Eliisa Irpola
Finnish Environment Institute
P.O.Box 140
FIN-00251 Helsinki

SVERIGE

Ms Maria Ujfalusi
Swedish Environmental Protection Agency
Naturvårdsverket
Blekholmsterassen 36
S-106 48 Stockholm

UNITED KINGDOM

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