2008/409/EC: Commission Decision of 17 April 2008 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2008 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council (notified under document number C(2008) 1403) (Text with EEA relevance)
Date: 2008-04-17
Institutions: European Commission
Subjects: chemical product, dangerous substance, ozone, pollution control, stratospheric pollutant

4.6.2008

EN

Official Journal of the European Union

L 144/55

COMMISSION DECISION

of 17 April 2008

on the allocation of quantities of controlled substances allowed for essential uses in the Community
in 2008 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council

(notified under document number C(2008) 1403)

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

(Text with EEA relevance)

(2008/409/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 2037/2000 of
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
and consumption of chlorofluorocarbons, other
fully
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.

(4)

Decision XIX/13 of the Parties to the Montreal Protocol
authorises the production in the European Community of

(5)

(6)

(7)

200 tonnes of chlorofluorocarbons (CFCs) in 2008 for
the manufacturing and use of Metered-Dose Inhalers
(MDIs) qualifying for essential uses of CFCs as defined
in Decision IV/25.

Decision XIX/18 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
controlled
production
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

Pursuant to paragraph 3 of Decision XII/2 of the Parties
to the Montreal Protocol on measures to facilitate the
transition to chlorofluorocarbon-free MDIs, all Member
States have notified (2) the United Nations Environment
Programme the active ingredients for which chlorofluor-
ocarbons (CFCs) are no longer essential for the manu-
facture 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.
These non-essentiality determinations have
therefore
reduced the demand for CFCs used in MDIs that are
placed on the market of the European Community. In
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).

(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) www.unep.org/ozone/Information_for_the_Parties/

3Bi_dec12-2-3.asp

L 144/56

EN

Official Journal of the European Union

4.6.2008

(8)

(9)

The Commission has published a Notice (1) on the
18 July 2007 to those companies in the Community
of 27 Member States that request consideration by the
Commission for the use of controlled substances for
essential uses in the Community in 2008 and has
received declarations on intended essential uses of
controlled substances for 2008.

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 2008.

it

The quantity of controlled substances of Group V (1,1,1-
5.
trichloroethane) subject to Regulation (EC) No 2037/2000 that
may be used for essential
laboratory uses in the European
Union in 2008 shall be 381,5 ODP kilograms.

The quantity of controlled substances of Group VI (methyl
6.
bromide) subject to Regulation (EC) No 2037/2000 that may be
used for laboratory and analytical uses in the Community in
2008 shall be 150,00 ODP kilograms.

(10)

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.
The quantity of controlled substances of Group VII
to Regulation (EC) No
subject
(hydrobromofluorocarbons)
2037/2000 that may be used for essential laboratory uses in
the Community in 2008 shall be 0,96 ODP kilograms.

HAS ADOPTED THIS DECISION:

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
2008 shall be 13,368 ODP kilograms.

Article 1

1.
The quantity of controlled substances of Group I (chloro-
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 2008 shall be 155 460,00 ozone-
depleting potential (ODP) kilograms.

The quantity of controlled substances of Group I (chloro-
2.
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 2008 shall be 56 213,60 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 2008 the
following rules shall apply:

3.
The quantity of controlled substances of Group III (halons)
subject to Regulation (EC) No 2037/2000 that may be used for
essential
laboratory use in the Community in 2008 shall be
418,7 ODP kilograms.

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.

The quantity of controlled substances of Group IV (carbon
4.
tetrachloride) subject to Regulation (EC) No 2037/2000 that
may be used for essential
laboratory uses in the Community
in 2008 shall be 150 832,836 ODP kilograms.

(1) OJ C 164, 18.7.2007, p. 37.

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.

4.6.2008

EN

Official Journal of the European Union

L 144/57

3. The allocation of essential laboratory use quotas for halons

shall be to the companies indicated in Annex IV.

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

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

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.

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

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.

Article 4

This Decision shall apply from 1 January 2008 and shall expire
on 31 December 2008.

This Decision is addressed to the following undertakings:

Article 5

Acros Organics bvba
Janssen Pharmaceuticalaan 3A°
B-2440 Geel

Bie & Berntsen
Sandbækvej 7
DK-2610 Rødovre

Carlo Erba Reactifs-SDS
ZI de Valdonne, BP 4
F-13124 Peypin

CNRS — Département Galilée
Observatoire de la Côte d'Azur — Siège Social
Boulevard de l'Observatoire, BP 4229
F-06304 Nice Cedex 4

Harp International
Gellihirion Industrial Estate
Rhondda, Cynon Taff
Pontypridd CF37 5SX
United Kingdom

Honeywell Specialty Chemicals Seelze GmbH
Wunstorfer Straße 40
Postfach 100262
D-30918 Seelze

Laboratorio Aldo-Union SA
Baronesa de Maldá 73
Espluges de Llobregat
E-08950 Barcelona

Airbus France
Service EVICS
BP M6322
Route de Bayonne 316
F-31060 Toulouse Cedex 16

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

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

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

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

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

LGC Standards GmbH
Mercatorstraße 51
D-46485 Wesel

L 144/58

EN

Official Journal of the European Union

4.6.2008

Mallinckrodt Baker EMEA
Teugseweg 20
7418 AM Deventer
Nederland

Merck KGaA
Frankfurter Straße 250
D-64271 Darmstadt

Mebrom
Assenedestraat 4
B-9940 Rieme Ertvelde

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

Ministry of Defense
Defence Fuel Lubricants and Chemicals Service/
Chemical Laboratory
PO Box 10.000
1780 CA Den Helder
Nederland

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

Sanolabor d.d.
Leskoškova 4
Ljubljana
Slovenia

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

Sigma Aldrich Laborchemikalien GmbH
Wunstorfer Straße 40
D-30926 Seelze

Tazzetti Fluids SRL
Corso Europa n. 600/a
I-10070 Volpiano (TO)
Valvole Aerosol Research Italiana (VARI) SpA —
LINDAL Group Italia
Via del Pino, 10
I-23854 Olginate (LC)

Done at Brussels, 17 April 2008.

SICOR SpA
Via Terrazzano 77
I-20017 Rho

Sigma Aldrich Company
The Old Brickyard, New Road
Gillingham SP8 4XT
United Kingdom

Sigma Aldrich Logistik GmbH
Riedstraße 2
D-89555 Steinheim

Valeas SpA Pharmaceuticals
Via Vallisneri, 10
I-20133 Milano

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

For the Commission

Stavros DIMAS
Member of the Commission

4.6.2008

EN

Official Journal of the European Union

L 144/59

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:

LIST OF NON-ESSENTIAL SUBSTANCES

Table 1

Short-acting beta agonist bronchodilators

Country

l

o
m
a
t
u
b
l
a
S

e
n

i
l
a
t
u
b
r
e
T

l

o
r
e
t
o
n
e
F

e
n

i
l
a
n
e
r
p
i
c
r
O

l

o
r
e
t
o
r
p
e
R

l

o
r
e
t
u
b
r
a
C

e
n

i
l
a
n
e
r
p
o
x
e
H

l

o
r
e
t
u
b
r
i
P

l

o
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

Austria

Belgium

Bulgaria

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Poland

Portugal

Romania

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

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

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 144/60

EN

Official Journal of the European Union

4.6.2008

Table 2

Inhaled steroids

Country

Beclomethasone Dexamethasone

Flunisolide

Fluticasone

Budesonide

Triamcinolone

Austria

Belgium

Bulgaria

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Poland

Portugal

Romania

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

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

4.6.2008

EN

Official Journal of the European Union

L 144/61

Table 3

Non-steroidal anti-inflammatories

Country

Cromoglicic acid

Nedrocromil

Austria

Belgium

Bulgaria

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Poland

Portugal

Romania

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

L 144/62

EN

Official Journal of the European Union

4.6.2008

Table 4

Anticholinergic bronchodilators

Country

Ipratropium bromide

Oxitropium bromide

Austria

Belgium

Bulgaria

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Poland

Portugal

Romania

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

4.6.2008

EN

Official Journal of the European Union

L 144/63

Table 5

Long-acting beta agonist bronchodilators

Country

Formoterol

Salmeterol

Austria

Belgium

Bulgaria

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Poland

Portugal

Romania

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

L 144/64

EN

Official Journal of the European Union

4.6.2008

Table 6

Combinations of active ingredients in a single MDI

Country

Austria

Belgium

Bulgaria

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Poland

Portugal

Romania

Slovakia

Slovenia

Spain

Sweden

X All products

X All products

X All products

X All products

X All products

X All products

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

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

4.6.2008

EN

Official Journal of the European Union

L 144/65

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:

Boehringer Ingelheim GmbH (DE)

Chiesi Farmaceutici SpA (IT)

Laboratorio Aldo Union SA (ES)

SICOR SpA (IT)

Valeas SpA Pharmaceuticals (IT)
(VARI) SpA — LINDAL Group Italia (IT)

ANNEX III

ESSENTIAL LABORATORY USES

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

Bie & Berntsen (DK)

Carlo Erba Reactifs-SDS (FR)
CNRS — Département Galilée (FR)

Harp International (UK)

Honeywell Specialty Chemicals (DE)

Ineos Fluor (UK)

LGC Standards (DE)

Mallinckrodt Baker (NL)

Merck KGaA (DE)

Mikro + Polo (SI)

Panreac Quimica (ES)

Sanolabor (SI)

Sigma Aldrich Chimie (FR)

Sigma Aldrich Company (UK)

Sigma Aldrich Logistik (DE)

Tazzetti Fluids (IT)

VWR ISAS (FR)

L 144/66

EN

Official Journal of the European Union

4.6.2008

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 Defence (NL)

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 (DK)
Carlo Erba Reactifs-SDS (FR)
Health Protection Inspectorate-Laboratories (EE)
Honeywell Specialty Chemicals (DE)
Mallinckrodt Baker (NL)
Merck KGaA (DE)
Mikro + Polo (SI)
Panreac Quimica (ES)
Sanolabor d.d. (SI)
Sigma Aldrich Chimie (FR)
Sigma Aldrich Company (UK)
Sigma Aldrich Laborchemikalien (DE)
Sigma Aldrich Logistik (DE)
VWR ISAS (FR)

4.6.2008

EN

Official Journal of the European Union

L 144/67

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 (DK)
Merck KgaA (DE)
Mikro + Polo (SI)
Panreac Quimica (ES)
Sanolabor d.d. (SI)
Sigma Aldrich Chimie (FR)
Sigma Aldrich Company (UK)
Sigma Aldrich Logistik (DE)

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)

L 144/68

EN

Official Journal of the European Union

4.6.2008

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 Company (UK)

Sigma Aldrich Logistik (DE)

ANNEX X

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