Notice to users of controlled substances in the European Union allowed for essential uses in the Community in 2009 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council on substances that deplete the ozone layer
Date: 2008-05-09
Institutions: European Commission
Subjects: chemical product, dangerous substance, production quota, research body, stratospheric pollutant

9.5.2008

EN

Official Journal of the European Union

C 114/27

Notice to users of controlled substances in the European Union allowed for essential uses in the
Community in 2009 under Regulation (EC) No 2037/2000 of the European Parliament and of the
Council on substances that deplete the ozone layer

(2008/C 114/13)

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 and Decision XIX/13 of the Parties to the Montreal Protocol on Substances that
Deplete the Ozone Layer set 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 and Decision XIX/13 of the Parties to the Montreal Protocol (2).

VI. The Parties to the Montreal Protocol may take a Decision in November 2008 authorising the
maximum levels of production of CFCs for essential uses in 2009 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 XVIII/15 and Decision XIX/18 of the Parties to the Montreal Protocol authorises the produc-
tion 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.
Authorised uses are 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. The uses listed in
paragraph 6 of Decision VII/11, subparagraphs (a) to (c) of Decision XI/15 and in subparagraph (3) of
Decision XIX/18 are excluded from the allowed laboratory and analytical uses.

(1) OJ L 244, 29.9.2000, p. 1. Regulation as last amended by Commission Decision 2007/540/EC (OJ L 198, 31.7.2007,

p. 35).

(2) The list of active ingredients deemed essential for the production of CFC-MDI is available via:

http://ozone.unep.org/Exemption_Information/Essential_Use_Nominations/Measures_by_Parties_to_facilitate_the_tran-
sition_to_chlorofluorocarbon_EC.shtml

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Official Journal of the European Union

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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. More information, including the texts of the relevant decisions of the Parties to the Montreal Protocol

on laboratory and analytical uses quoted here above can be found at:

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

X.

The procedure 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 of the European Parliament
and of the Council is the following:

1. An undertaking that has not been issued with a quota in 2008 and that requests consideration by
the Commission for an essential use quota for the period 1 January 2009 to 31 December 2009
should make itself known to the Commission no later than 1 July 2008 by submitting the registra-
tion form for the Main-ODS-database available online at:

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

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 Essential Laboratory Use
form online via the ODS-database available at: http://ec.europa.eu/environment/ozone/ods.htm. In addi-
tion 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 and Protection of the ozone layer
BU-5 2/053
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. A list
of contact points in all Member States is available online at:

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

XI. Only applications received by 1 August 2008 will be considered by the Commission.

XII. 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.

XIII. Following the above procedure the Commission will notify applicants by a Decision of the quantities
of controlled substances allowed for essential uses in the community in 2009 for which production
and importation will be permitted.

9.5.2008

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Official Journal of the European Union

C 114/29

XIV. Those users holding an essential use quota for a controlled substance for 2009 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.

C 114/30

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Official Journal of the European Union

9.5.2008

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
C3HF2Br5
C3HF3Br4
C3HF4Br3
C3HF5Br2
C3HF6Br
C3H2FBr5
C3H2F2Br4

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

1,9

1,8

2,2

2,0

3,3

1,9

2,1

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Official Journal of the European Union

C 114/31

Group

Substances

Ozone-depleting potential (1)

Group VIII

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

(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)

CF3CF2CHCl2

CF2ClCF2CHClF

(HCFC 225ca) (3)

(HCFC 225cb) (3)

C3HF6Cl

C3H2FCl5

C3H2F2Cl4

C3H2F3Cl3

C3H2F4Cl2

C3H2F5Cl

C3H3FCl4

C3H3F2Cl3

C3H3F3Cl2

C3H3F4Cl

C3H4FCl3

(HCFC 226)

(HCFC 231)

(HCFC 232)

(HCFC 233)

(HCFC 234)

(HCFC 235)

(HCFC 241)

(HCFC 242)

(HCFC 243)

(HCFC 244)

(HCFC 251)

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

0,090

0,130

0,120

0,140

0,010

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Group

Substances

Ozone-depleting potential (1)

C3H4F2Cl2
C3H4F3Cl
C3H5FCl2
C3H5F2Cl
C3H6FCl

CH2BrCl

(HCFC 252)

(HCFC 253)

(HCFC 261)

(HCFC 262)

(HCFC 271)

Halon 1011/bromochloro-
methane

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.