Information from the Commission - Notice to users in the European Union of controlled substances allowed for essential uses in the Union in 2001 under Regulation (EC) EP-COUN 3613/1/2000 of the European Parliament and of the Council on substances that deplete the ozone layer
Date: 2000-08-05
Institutions: European Commission
Subjects: exchange of information, ozone, respiratory disease, stratospheric pollutant, therapeutics, type of business

C 224/16

EN

Official Journal of the European Communities

5.8.2000

Notice to users in the European Union of controlled substances allowed for essential uses in the
Union in 2001 under Regulation (EC) EP-COUN 3613/1/2000 of the European Parliament and of
the Council on substances that deplete the ozone layer

(2000/C 224/05)

This notice concerns the following substances:

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

(cid:151) other fully halogenated chlorofluorocarbons,

(cid:151) carbon tetrachloride,

(cid:151) halons,

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

(cid:151) hydrobromofluorocarbons (HBFCs).

This notice is addressed to undertakings that intend to:

1. Use the above substances within the Union for the manu-

facture of Metered Dose Inhalers (MDIs),

Decision XI/14 of the Parties to the Montreal Protocol auth-
orised the levels of production and consumption necessary to
satsify 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 2001, the quantity of CFCs 11, 12,
113 and 114 authorised by the Parties is 3 270 metric tonnes.
For laboratory uses, Decision XI/15 of the Parties authorised
the production and consumption necessary to satisfy essential
laboratory uses, subject
to the conditions applied to the
laboratory use exemption in Annex II to the report of the
Sixth Meeting of the Parties (2).

the production of MDIs

For

In accordance with Decision VI/9 of the Parties to the Montreal
the purity of controlled substances for laboratory
Protocol,
purposes should be at least 99,0 % for 1,1,1-trichloroethane
and 99,5 % for CFCs and carbon tetrachloride.

2. Use the above substances within the Union for the manu-

facture of cardiovascular surgical devices and,

The procedure allocating quantities of controlled substances for
the above essential uses foreseen by Regulation (EC) EP-COUN
3613/1/2000 is the following:

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

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

Users wishing to be considered by the Commission for the
award of essential use licences for the twelve month period
from 1 January to 31 December 2001, should apply to the
Commission for an essential use licence using the forms
provided in Annex I (MDIs) or II (Laboratory Uses) attached
to this notice.

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.

In accordance with Decision IV/25 of
the Parties to the
Montreal Protocol, Articles 3 and 4 of Regulation (EC)
EP-COUN 3613/1/2000 of
the European Parliament and of
the Council of 29 June 2000 on substances that deplete the
ozone layer (1) require the determination of quantities for
essential uses of
the above-mentioned controlled substances
which may be permitted in the Community in 2001.

1. Essential use applications may be made by any interested
user of substances listed at the beginning of this Notice for
metered dose inhalers
laboratory uses.
(MDIs) or
in
Requests should contain the information as set out
Annex I of this notice for MDIs or Annex II of this notice
for laboratory uses.

for

2. Interested parties should send their application no later

than 5 September 2000 to:

Mrs Marie-Jo De Block
Ozone Layer Protection
European Commission
Directorate-General Environment
Unit ENV.D.3
Rue de la Loi/Wetstraat 200
B-1049 Brussels.

Enquiries can be made in writing to the above address, by
Fax (32-2) 296 95 54 or by e-mail to
Marie-Jose.De-Block@cec.eu.int

A copy of the application should also be sent to the
competent authority of the Member State (cf. Annex
III).

(1) Not yet published in the Official Journal.

(2) Copies of these conditions are available form the address below.

5.8.2000

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Official Journal of the European Communities

C 224/17

3. Applications received within the period allowed under this
notice will be considered by the Commission in accordance
with the procedure set out in Article 18 of Regulation (EC)
EP-COUN 3613/1/2000 on substances
that deplete the
ozone layer.

4. On the basis of

the above procedure, a Commission
Decision will allocate quantities of controlled substances to
the users of those applications in the Union for 2001 for
which additional production and importation of controlled
substances will be permitted.

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.

6. Those users holding an essential use licence for a controlled
substance for 2001 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 licenced 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

ANNEX I

Form to be used to declare metered dose inhalers (MDIs)(1) for the treatment of asthma and other chronic
obstructive diseases

1. Name of the company:

........................................................................................................................................................................

.....................................................................................................................................................................................................................

Address of the company:

....................................................................................................................................................................

.....................................................................................................................................................................................................................

.....................................................................................................................................................................................................................

.....................................................................................................................................................................................................................

Contact person:

......................................................................................................................................................................................

Telephone number:

...............................................................................................................................................................................

Fax number:

............................................................................................................................................................................................

e-mail address:

........................................................................................................................................................................................

2. Quantity (kg) requested for 2001 for each trade name/active substance:

Substance (and formula)

CN code

kg requested

MDI Tradename(s) and active
substance (1)

Trichloorfluoromethane
CFC 11 (CFCl3)

Dichlorordifluoromethane
CFC 12 (CF2Cl2)

Trichlorortrifluoroethane
CFC 113 (C2F3Cl3)

Dichlorortetrafluoroethane
CFC 114 (C2F4Cl2)

Other (2)

2903 41 00

2903 42 00

2903 43 00

2903 44 00

(1) Photocopy this page if you need extra space to list the MDI with its trade name and active substance.
(2) To be specified.

___________
(1) Applications for the use of metered dose inhalers (MDIs) for the treatment of asthma and other chronic obstructive diseases will need
to be accompanied by a copy of the relevant marketing authorisation issued by the competent national authorities confirming this
specific use.

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Official Journal of the European Communities

5.8.2000

Total quantitys to be imported:

...........................................................................................................................................

(in kg)

Total quantity to be obtained from producers within the EU:

...................................................................................

(in kg)

3. Historical data:

Please indicate below the volume of the substances used in 1997, 1998 and 1999, as well as estimated for 2000.

Substance

1997
(kg)

1998
(kg)

1999
(kg)

2000 estimates
(kg)

CFC 11

CFC 12

CFC 113

CFC 114

Others (specify)

4. Name, address and telephone/fax numbers of manufacturer or supplier:

.....................................................................................................................................................................................................................

.....................................................................................................................................................................................................................

.....................................................................................................................................................................................................................

.....................................................................................................................................................................................................................

.....................................................................................................................................................................................................................

.....................................................................................................................................................................................................................

5. Please indicate below the stocks of CFCs currently held by your company

Substance

Stocks (kg)

CFC 11

CFC 12

CFC 113

CFC 114

Other

We hereby certify that we intend to use the declared substance for the essential use granted in the Community
in 2001, as indicated in this notice.

Place:

................................................................................................

Date:

..........................................................................................

Name:

...............................................................................................

Signature:

.................................................................................

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Official Journal of the European Communities

C 224/19

ANNEX II

Form to be used to declare laboratory uses

1. Name of the company:

........................................................................................................................................................................

.....................................................................................................................................................................................................................

Address of the company:

....................................................................................................................................................................

.....................................................................................................................................................................................................................

.....................................................................................................................................................................................................................

.....................................................................................................................................................................................................................

Contact person .......................................................................................................................................................................................

Telephone number:

...............................................................................................................................................................................

Fax number:

............................................................................................................................................................................................

e-mail address:

........................................................................................................................................................................................

2. Data concerning the volume requested for 2001:

Substance

Formula

CN code

Quantity requested
for 2001 (in kg)

Trichlororfluoromethane

Dichlorordifluoromethane

Trichlorofluoroethane

Dichlorotetrafluoroethane

Chlororpentafluoroethane

Carbon Tetrachloride

1,1,1-trichloroethane

Other (1)

CFC 11

CFC 12

CFC 113

CFC 114

CFC 115

CFCl3

CF2Cl2

C2F3Cl3

C2F4Cl2

C2F5Cl

CCl4

C2H3Cl3

2903 41 00

2903 42 00

2903 43 00

2903 44 00

2903 44 90

2903 14 00

2903 19 10

(1) To be specified (name, formula, CN-Code and purity)

Total quantities to be obtained from EU producers:

......................................................................................................

(in kg)

Total quantities to be imported:

..........................................................................................................................................

(in kg)

Total quantities to be supplied from sources (other than producers) within the EU:

..........................................

(in kg)

3. Please justify why the use of ozone depleting substances (ODS) is still necessary and explain the steps being taken to

identify non ODS alternatives, including the likely dates when ODS can be phased out in this use.

.....................................................................................................................................................................................................................

.....................................................................................................................................................................................................................

.....................................................................................................................................................................................................................

.....................................................................................................................................................................................................................

.....................................................................................................................................................................................................................

C 224/20

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Official Journal of the European Communities

5.8.2000

4. Historical data:

Please indicate below the volumes of any controlled substances used for essential laboratory and analytical uses in
1997, 1998 and 1999 as well as estimates for 2000.

Substance

1997
(kg)

1998
(kg)

1999
(kg)

2000 estimates
(kg)

5. Are you the end-user of the controlled substances?

NO, please go to 6.
YES, please go to 7.

6. Name, address and telephone/fax numbers of the producer or importer from which the controlled substances will be

obtained:
.....................................................................................................................................................................................................................
.....................................................................................................................................................................................................................
.....................................................................................................................................................................................................................
.....................................................................................................................................................................................................................
.....................................................................................................................................................................................................................
.....................................................................................................................................................................................................................

Names, addresses and telephone/fax number of your clients (add additional annexes if needed):
.....................................................................................................................................................................................................................
.....................................................................................................................................................................................................................
.....................................................................................................................................................................................................................
.....................................................................................................................................................................................................................
.....................................................................................................................................................................................................................
.....................................................................................................................................................................................................................

7. Do you intend to acquire the controlled substances directly from

a producers/importer or

a supplier or

distributor?

Name, address and telephone/fax numbers of producer or supplier (add additional annexes if needed)
.....................................................................................................................................................................................................................
.....................................................................................................................................................................................................................
.....................................................................................................................................................................................................................
.....................................................................................................................................................................................................................
.....................................................................................................................................................................................................................
.....................................................................................................................................................................................................................

8. Declaration:

We hereby certify that we intend to use the delcared substances for the essential use granted in the Commu-
nity for 2001 in accordance with the conditions applicable to the exemption for laboratory and analytical uses
and the conditions indicated in this notice.

Place:

................................................................................................

Date:

..........................................................................................

Name:

...............................................................................................

Signature:

.................................................................................

5.8.2000

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Official Journal of the European Communities

C 224/21

ALLEGATO III / ANEXO III / ANEXO III / ANNEX III / ANNEXE III / ANHANG III / BIJLAGE III / BILAG III /

BILAGA III / LIITE III / —`(cid:209)`(cid:209)(cid:212)˙(cid:204)` III

(cid:214)STERREICH

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

BELGIQUE

Mr Roland Marijnissen
MinistŁre de la SantØ Publique et de l’Environnement
DØpartement de l’Environnement
19, Boulevard Pacheco (cid:151) bte 7
B-1010 Brussels

DANMARK

Mrs Kirsten Doerge
Miljłstyrelsen
Strandgade 29
DK-1401 Copenhagen K

SUOMI/FINLAND

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

FRANCE

Mrs Laurence Musset
MinistŁre de l’Environnement
DRPR/BSPC
20, Avenue de SØgur
F-75302 Paris 07 SP

DEUTSCHLAND

Mr Heinrich W. Kraus
Federal Ministry for the Environment
Dept. JG 115
Bernkasteler Stra(cid:223)e 8
D-53175 Bonn

GREECE

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
Department of the Environment
Environment International
Custom House
IRL-Dublin 1

ITALIA

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

LUXEMBOURG

Mr Theo Weber
Administration de l’Environnement
1, Rue Bender
L-1229 Luxembourg

PORTUGAL

Ms Cristina Vaz Nunes
MinistØrio do Ambiente
Instituto de Meteorologia
Rua C ao Aeroporto de Lisboa
P-1700 Lisboa

ESPA(cid:209)A

Mr `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

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

NEDERLAND

Dr. Joop A. van Haasteren
Ministry of Housing, Physical Planning and Environment
Postbus 30945
Rihnstraat 8
2500 GX Den Haag
Nederland

UNITED KINGDOM

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