2007/211/EC: Commission decision of 27 March 2007 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2007 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council (notified under document number C(2007) 1285) (Text with EEA relevance)
Date: 2007-03-27
Institutions: European Commission
Subjects: chemical product, international convention, production quota, quantitative restriction, research body, stratospheric pollution, therapeutics, type of business

4.4.2007

EN

Official Journal of the European Union

L 94/39

COMMISSION

COMMISSION DECISION

of 27 March 2007

on the allocation of quantities of controlled substances allowed for essential uses in the Community
in 2007 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council

(notified under document number C(2007) 1285)

(Only the Danish, Dutch, English, Estonian, French, German, Italian, Slovenian and Spanish texts are authentic)

(Text with EEA relevance)

(2007/211/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community,

establishing the European

Having regard to Regulation (EC) No 2037/2000 of
the
European Parliament and of the Council of 29 June 2000 on
Substances that Deplete the Ozone Layer (1), and in particular
Article 3(1) thereof,

Whereas:

(1)

(2)

(3)

The Community has already phased out the production
fully
and consumption of chlorofluorocarbons, other
halogenated chlorofluorocarbons, halons, carbon tetra-
chloride, 1,1,1-trichloroethane, hydrobromofluorocarbon
and bromochloromethane.

Each year
the Commission is required to determine
essential uses for these controlled substances, the quan-
tities that may be used and the companies that may use
them.

Decision IV/25 of the Parties to the Montreal Protocol on
Substances that Deplete the Ozone Layer, hereinafter ‘the
Montreal Protocol’, sets out
the criteria used by the
Commission for determining any essential uses and
authorises the production and consumption necessary
to satisfy essential uses of controlled substances in each
Party.

(5)

(6)

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, as well as Decisions VII/11, XI/15 and XV/5 of
the Parties to the Montreal Protocol. Decision XVII/10 of
the
the Parties
production
controlled
substance listed in Annex E of the Montreal Protocol
necessary to satisfy laboratory and analytical uses of
methyl bromide.

to the Montreal Protocol authorises
and

consumption

the

of

to

Pursuant to paragraph 3 of Decision XII/2 of the Parties
to the Montreal Protocol on measures to facilitate the
transition
chlorofluorocarbon-free Metered-Dose
Inhalers (MDIs), all Member States have notified (2) to
the United Nations Environment Programme the active
ingredients for which chlorofluorocarbons (CFCs) are no
longer essential
for the manufacture of CFC-MDIs for
placing on the market of the European Community.

Article 4(4)(i)(b) of Regulation (EC) No 2037/2000
prevents CFCs from being used and placed on the
market unless they are considered essential under the
conditions described in Article 3(1) of that Regulation.
therefore
These non-essentiality determinations have
reduced the demand for CFCs used in MDIs that are
placed on the market of the European Community. In

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

(2) www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-

3.asp

L 94/40

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Official Journal of the European Union

4.4.2007

addition, Article 4(6) of Regulation (EC) No 2037/2000
prevents CFC-MDI products being imported and placed
on the market unless the CFCs in these products are
considered essential under the conditions described in
Article 3(1).

The Commission has published a Notice (1) on the 22
July 2006 to those companies in the Community of 25
Member States
the
request
Commission for the use of controlled substances for
essential uses in the Community in 2007 and has
received declarations on intended essential uses of
controlled substances for 2007.

consideration by

that

For the purpose of ensuring that interested companies
in due time
and operators may continue to benefit
from the licensing system,
the
is appropriate that
present decision shall apply from 1 January 2007.

it

in this Decision are in
The measures provided for
accordance with the opinion of
the Management
Committee established by Article 18(1) of Regulation
(EC) No 2037/2000,

(7)

(8)

(9)

HAS ADOPTED THIS DECISION:

Article 1

The quantity of controlled substances of Group I (chloro-
1.
fluorocarbons 11, 12, 113, 114 and 115) subject to Regulation
(EC) No 2037/2000 which may be used for essential medical
uses in the Community in 2007 shall be 316 257,00 ODP (2)
kilograms.

2.
The quantity of controlled substances of Group I (chloro-
fluorocarbons 11, 12, 113, 114 and 115) and Group II (other
fully halogenated chlorofluorocarbons) subject
to Regulation
(EC) No 2037/2000 which may be used for essential laboratory
uses in the Community in 2007 shall be 65 900,9 ODP
kilograms.

3.
The quantity of controlled substances of Group III (halons)
subject to Regulation (EC) No 2037/2000 that may be used for
laboratory use in the Community in 2007 shall be
essential
718,7 ODP kilograms.

4.
The quantity of controlled substances of Group IV (carbon
tetrachloride) subject to Regulation (EC) No 2037/2000 that

may be used for essential
in 2007 shall be 147 110 436 ODP kilograms.

laboratory uses in the Community

5.
The quantity of controlled substances of Group V (1,1,1-
trichloroethane) subject to Regulation (EC) No 2037/2000 that
may be used for essential
laboratory uses in the European
Union in 2007 shall be 672,0 ODP kilograms.

6.
The quantity of controlled substances of Group VI (methyl
bromide) subject to Regulation (EC) No 2037/2000 that may be
used for laboratory and analytical uses in the Community in
2007 shall be 150,0 ODP kilograms.

The quantity of controlled substances of Group VII
7.
(hydrobromofluorocarbons)
to Regulation (EC) No
subject
2037/2000 that may be used for essential laboratory uses in
the Community in 2007 shall be 3,52 ODP kilograms.

8.
The quantity of controlled substances of group IX (bromo-
chloromethane) subject to Regulation (EC) No 2037/2000 that
may be used for essential laboratory uses in the Community in
2007 shall be 12 048 ODP kilograms.

Article 2

The chlorofluorocarbon metered-dose inhalers listed in Annex I
shall not be placed on markets where the Competent Authority
has determined chlorofluorocarbons for metered-dose inhalers
on those markets to be non-essential.

Article 3

During the period 1 January to 31 December 2007 the
following rules shall apply:

1. The allocation of essential medical use quotas for chloro-
fluorocarbons 11, 12, 113, 114 and 115 shall be to the
companies indicated in Annex II.

2. The allocation of essential laboratory use quotas for chloro-
fluorocarbons 11, 12, 113, 114 and 115 and other fully
halogenated chlorofluorocarbons shall be to the companies
indicated in Annex III.

(1) OJ C 171, 22.7.2006, p. 27.
(2) Ozone-depleting potential.

3. The allocation of essential laboratory use quotas for halons

shall be to the companies indicated in Annex IV.

4.4.2007

EN

Official Journal of the European Union

L 94/41

4. The allocation of essential laboratory use quotas for carbon
tetrachloride shall be to the companies indicated in Annex V.

8. The allocation of essential laboratory use quotas for bromo-
chloromethane shall be to the companies indicated in Annex
IX.

5. The allocation of essential laboratory use quotas for 1,1,1-
trichloroethane shall be to the companies indicated in Annex
VI.

6. The allocation of laboratory and analytical critical use quotas
for methyl bromide shall be to the companies indicated in
Annex VII.

9. The essential use quotas for chlorofluorocarbons 11, 12,
113, 114 and 115, other fully halogenated chlorofluoro-
carbons, carbon tetrachloride, 1,1,1-trichloroethane, hydro-
bromofluorocarbons and bromochloromethane shall be as
set out in Annex X.

7. The allocation of essential laboratory use quotas for hydro-
bromofluorocarbons shall be to the companies indicated in
Annex VIII.

This Decision shall apply from 1 January 2007 and shall expire
on 31 December 2007.

Article 4

This Decision is addressed to the following undertakings:

Article 5

3M Health Care Ltd
3M House Morley Street
Loughborough
Leicestershire LE11 1EP
United Kingdom

Boehringer Ingelheim GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

Inyx Pharmaceuticals Ltd
Astmoor Industrial Estate
9 Arkwright Road Runcorn
Cheshire WA7 1NU
United Kingdom

Laboratorio Aldo Union S.A.
Baronesa de Maldá 73
Esplugues de Llobregat
E-08950 Barcelona

Valeas SpA Pharmaceuticals
Via Vallisneri, 10
I-20133 Milano (MI)

Acros Organics bvba
Janssen Pharmaceuticalaan 3a
B-2440 Geel

Bie & Berntsen A-S
Transformervej 8
DK-2730 Herlev

Eras Labo
222, RN 90
F-38330 Saint-Nazaire-les-Eymes

Health Protection Inspectorate-Laboratories
Paldiski mnt 81
EE-10617 Tallinn

Bespak Europe Ltd
North Lynn Industrial Estate
Bergen Way, King's Lynn
Norfolk PE30 2JJ
United Kingdom

Chiesi Farmaceutici SpA
Via Palermo 26/A
I-43100 Parma (PR)

IVAX Ltd
Unit 301,
Waterford Industrial Estate
Weterford, Ireland

SICOR SpA
Via Terrazzano 77
I-20017 Rho (MI)

Valvole Aerosol Research Italiana (VARI) SpA —
LINDAL Group Italia
Via del Pino, 10
I-23854 Olginate (LC)

Airbus France
316, route de Bayonne
F-31300 Toulouse

Carlo Erba Reactifs-SDS
Z.I. de Valdonne, BP 4
F-13124 Peypin

Harp International
Gellihirion Industrial Estate,
Rhondda, Cynon Taff,
UK-Pontypridd CF37 5SX

Honeywell Specialty Chemicals
Wunstorfer Straße 40
Postfach 10 02 62
D-30918 Seelze

L 94/42

EN

Official Journal of the European Union

4.4.2007

Institut scientifique de service public (ISSeP)
Rue du Chéra, 200
B-4000 Liège

LGC Promochem GmbH
Mercatorstr. 51
D-46485 Wesel

Mebrom NV
Assenedestraat 4
B-9940 Rieme Ertvelde

Mikro+Polo d.o.o.
Zagrebška 22
SI-2000 Maribor

Panreac Química S.A.
Pol. Ind. Pla de la Bruguera
C/ Garraf 2
E-08211 Castellar del Vallès, Barcelona

Sigma Aldrich Chimie SARL
80, rue de Luzais
L’Isle d’Abeau-Chesnes
F-38297 Saint-Quentin-Fallavier

Sigma Aldrich Logistik GmbH
Riedstraße 2
D-89555 Steinheim

VWR I.S.A.S.
201, rue Carnot
F-94126 Fontenay-sous-Bois

Done at Brussels, 27 March 2007.

Ineos Fluor Ltd
PO Box 13, The Heath
Runcorn, Cheshire WA7 4QF
United Kingdom

Mallinckrodt Baker BV
Teugseweg 20
7418 AM Deventer
Nederland

Merck KgaA
Frankfurter Straße 250
D-64271 Darmstadt

Ministry of Defense
Directorate Material RNL Navy
P.O. Box 2070
2500 ES The Hague
Nederland

Sanolabor d.d.
Leskoškova 4
SI-1000 Ljubljana

Sigma Aldrich Laborchemikalien
Wunstorfer Straße 40
Postfach 10 02 62
D-30918 Seelze

Tazzetti Fluids Srl
Corso Europa, 600/a
I-10088 Volpiano (TO)

For the Commission

Stavros DIMAS
Member of the Commission

4.4.2007

EN

Official Journal of the European Union

L 94/43

ANNEX I

Pursuant to paragraph 3 of Decision XII/2 of the Twelfth Meeting of the Parties to the Montreal Protocol on measures to
facilitate the transition to chlorofluorocarbon-free metered-dose inhalers (MDIs), the following countries have determined
that, due to the presence of suitable non-CFC MDIs, CFCs no longer qualify as ‘essential’ under the Protocol when
combined with following active ingredients:

Table 1

Short acting beta agonist bronchodilators

l

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m
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t
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n
e
F

e
n

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a
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e
r
p
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c
r
O

l

o
r
e
t
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r
p
e
R

l

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r
e
t
u
b
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a
C

e
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l
a
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r
p
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x
e
H

l

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r
e
t
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b
r
i
P

l

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r
e
t
u
b
n
e
l
C

l

o
r
e
t
l
o
t
i
B

l

o
r
e
t
a
c
o
r
P

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Country

Austria

Belgium

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Poland

Portugal

Norway

Slovakia

Slovenia

Spain

Sweden

United Kingdom

L 94/44

EN

Official Journal of the European Union

4.4.2007

Table 2

Inhaled steroids

Country

Beclomethasone Dexamethasone

Flunisolide

Fluticasone

Budesonide

Triamcinolone

Austria

Belgium

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Poland

Portugal

The Netherlands

Norway

Slovakia

Slovenia

Spain

Sweden

United Kingdom

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

4.4.2007

EN

Official Journal of the European Union

L 94/45

Table 3

Non steroidal anti inflammatories

Country

Cromoglicic acid

Nedrocromil

Austria

Belgium

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Poland

Portugal

The Netherlands

Norway

Slovakia

Slovenia

Spain

Sweden

United Kingdom

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

L 94/46

EN

Official Journal of the European Union

4.4.2007

Table 4

Anticholinergic bronchodilators

Country

Ipratropium bromide

Oxitropium Bromide

Austria

Belgium

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Poland

Portugal

Norway

Slovakia

Slovenia

Spain

Sweden

United Kingdom

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

4.4.2007

EN

Official Journal of the European Union

L 94/47

Table 5

Long acting beta agonist bronchodilators

Country

Formoterol

Salmeterol

Austria

Belgium

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Poland

Portugal

Norway

Slovakia

Slovenia

Spain

Sweden

United Kingdom

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

L 94/48

EN

Official Journal of the European Union

4.4.2007

Table 6

Combinations of active ingredients in a single MDI

Country

Austria

Belgium

Cyprus

X All products

X All products

Czech Republic

X All products

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Poland

Portugal

Norway

Slovakia

Slovenia

Spain

Sweden

X All products

X All products

X All products

X All products

Budesonide + Fenoterol

Fluticasone + Salmeterol

X All products

X All products

X All products

X All products

X All products

X All products

X All products

United Kingdom

Source: www.unep.org/ozone/Information_for_the_Parties/3Bi_dec12-2-3.asp

4.4.2007

EN

Official Journal of the European Union

L 94/49

ANNEX II

Essential medical uses

Quota of controlled substances of Group I that may be used in the production of metered dose inhalers (MDIs) for the
treatment of asthma and other chronic obstructive pulmonary diseases (COPDs) are allocated to:

3 M Health Care Ltd (UK)

Bespak Europe Ltd (UK)

Boehringer Ingelheim GmbH (DE)

Chiesi Farmaceutici SpA (IT)

Inyx Pharmaceuticals Ltd (UK)

Ivax Ltd (IE)

Laboratorio Aldo Union SA (ES)

SICOR SpA (IT)

Valeas SpA Pharmaceuticals (IT)

Valvole Aerosol Research Italiana (VARI)
SpA — LINDAL Group Italia (IT)

ANNEX III

Essential laboratory uses

Quota of controlled substances of Group I and II that may be used for laboratory and analytical uses, are allocated to:

Acros Organics bvba (BE)

Bie & Berntsen A-S (DK)

Carlo Erba Reactifs-SDS (FR)

Harp International (UK)

Honeywell Specialty Chemicals (DE)

Ineos Fluor (UK)

LGC Promochem (DE)

Mallinckrodt Baker (NL)

Merck KGaA (DE)

Mikro+Polo d.o.o. (SI)

Panreac Química S.A. (ES)

Sanolabor d.d. (SI)

Sigma Aldrich Chimie (FR)

Sigma Aldrich Logistik (DE)

Tazzetti Fluids (IT)

VWR I.S.A.S. (FR)

L 94/50

EN

Official Journal of the European Union

4.4.2007

ANNEX IV

Essential laboratory uses

Quota of controlled substances of Group III that may be used for laboratory and analytical uses are allocated to:

Airbus France (FR)

Eras Labo (FR)

Ineos Fluor (UK)

Ministry of Defense (NL)

Sigma Aldrich Chimie (FR)

ANNEX V

Essential laboratory uses

Quota of controlled substances of Group IV that may be used for laboratory and analytical uses, are allocated to:

Acros Organics (BE)
Bie & Berntsen A-S (DK)
Carlo Erba Reactifs-SDS (FR)
Health Protection Inspectorate-Laboratories (EE)
Honeywell Specialty Chemicals (DE)
Institut scientifique de service public (ISSeP) (BE)
Mallinckrodt Baker (NL)
Merck KGaA (DE)
Mikro+Polo d.o.o. (SI)
Panreac Química S.A. (ES)
Sanolabor d.d. (SI)
Sigma Aldrich Chimie (FR)
Sigma Aldrich Laborchemikalien (DE)
Sigma Aldrich Logistik (DE)

ANNEX VI

Essential laboratory uses

Quota of controlled substances of Group V that may be used for laboratory and analytical uses are allocated to:

Acros Organics (BE)
Bie & Berntsen A-S (DK)
Merck KGaA (DE)
Mikro+Polo d.o.o. (SI)
Panreac Química S.A. (ES)
Sanolabor d.d. (SI)
Sigma Aldrich Chimie (FR)
Sigma Aldrich Logistik (DE)

4.4.2007

EN

Official Journal of the European Union

L 94/51

ANNEX VII

Laboratory and analytical critical uses

Quota of controlled substances of Group VI that may be used for laboratory and analytical critical uses are allocated to:

Mebrom NV (BE)

Sigma Aldrich Logistik (DE)

ANNEX VIII

essential laboratory uses

Quota of controlled substances of Group VII that may be used for laboratory and analytical uses are allocated to:

Ineos Fluor (UK)

Sigma Aldrich Chimie (FR)

ANNEX IX

Essential laboratory uses

Quota of controlled substances of Group IX that may be used for laboratory and analytical uses are allocated to:

Ineos Fluor (UK)

Sigma Aldrich Logistik (DE)

ANNEX X

This Annex is not published because it contains confidential commercial information.