2009/52/EC: Commission Decision of 18 December 2008 on the allocation of quantities of controlled substances 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 (notified under document number C(2008) 8398)
Date: 2008-12-18
Institutions: European Commission
Subjects: chemical product, dangerous substance, ozone, pollution control, stratospheric pollutant

24.1.2009

EN

Official Journal of the European Union

L 21/53

COMMISSION DECISION

of 18 December 2008

on the allocation of quantities of controlled substances 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

(notified under document number C(2008) 8398)

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

(2009/52/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

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)

(4)

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.

the Commission is required to determine
Each year
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.

The Parties to the Montreal Protocol authorised the
production in the European Community of 22 tonnes
of chlorofluorocarbons (CFCs) in 2009 for the manufac­
turing 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
production
controlled
substance listed in Annex E of the Montreal Protocol
necessary to satisfy laboratory and analytical critical
uses of methyl bromide.

to the Montreal Protocol authorises
and

consumption

the

of

(6)

(7)

(8)

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 the United Nations Environment
Programme the active ingredients for which chlorofluo­
rocarbons (CFCs) are no longer essential for the manu­
the
facture of MDIs for placing on the market of
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
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 (2)
to those
companies in the Member States that request consider­
the use of controlled
ation by the Commission for
substances
in the Community in
2009 and has
received declarations on intended
essential uses of controlled substances for 2009.

for essential uses

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

(2) OJ C 114, 9.5.2008, p. 27.

L 21/54

EN

Official Journal of the European Union

24.1.2009

(9)

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,

The quantity of controlled substances of group IX (bromo­
8.
chloromethane) subject to Regulation (EC) No 2037/2000 that
may be used for essential laboratory and analytical uses in the
Community in 2009 shall be 11,088 ODP kilograms.

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 2009 shall be 21 360,00 ozone
depleting potential (ODP) 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
and analytical uses
in the Community in 2009 shall be
60 280,8 ODP kilograms.

3.
The quantity of controlled substances of Group III (halons)
subject to Regulation (EC) No 2037/2000 that may be used for
essential
laboratory and analytical use in the Community in
2009 shall be 115,7 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 2009 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 and analytical use
quotas for chlorofluorocarbons 11, 12, 113, 114 and 115
and other fully halogenated chlorofluorocarbons shall be to
the companies indicated in Annex III.

3. The allocation of essential

laboratory and analytical use
quotas for halons shall be to the companies indicated in
Annex IV.

4.
The quantity of controlled substances of Group IV (carbon
tetrachloride) subject to Regulation (EC) No 2037/2000 that
may be used for essential laboratory and analytical uses in the
Community in 2009 shall be 129 390,8 ODP kilograms.

4. The allocation of essential

laboratory and analytical use
quotas for carbon tetrachloride shall be to the companies
indicated in Annex V.

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 and analytical uses in the
Community in 2009 shall be 355,65 ODP kilograms.

5. The allocation of essential

laboratory and analytical use
quotas for 1,1,1-trichloroethane shall be to the companies
indicated in Annex VI.

6.
The quantity of controlled substances of Group VI (methyl
bromide) subject to Regulation (EC) No 2037/2000 that may be
in the
and analytical
used for
Community in 2009 shall be 36,3 ODP kilograms.

critical uses

laboratory

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

quotas
companies indicated in Annex VIII.

for hydrobromofluorocarbons

laboratory and analytical use
to the

shall be

The quantity of controlled substances of Group VII
7.
to Regulation (EC) No
(hydrobromofluorocarbons)
2037/2000 that may be used for essential
laboratory and
analytical uses in the Community in 2009 shall be 57,96
ODP kilograms.

subject

8. The allocation of essential

laboratory and analytical use
quotas for bromochloromethane shall be to the companies
indicated in Annex IX.

24.1.2009

EN

Official Journal of the European Union

L 21/55

9. The essential use quotas for chlorofluorocarbons 11, 12, 113, 114 and 115, other fully halogenated
chlorofluorocarbons, carbon tetrachloride, 1,1,1-trichloroethane, hydrobromofluorocarbons and bromo­
chloromethane and the laboratory and analytical critical use quotas for methyl bromide shall be as set
out in Annex X.

This Decision shall apply from 1 January 2009 and shall expire on 31 December 2009.

Article 4

This Decision is addressed to the following undertakings:

Article 5

Acros Organics bvba
Janssen Pharmaceuticalaan 3a

B-2440 Geel

Carlo Erba Réactifs-SDS

Z.I. de Valdonne, BP 4
F-13124 Peypin

Airbus France
316, route de Bayonne

F-31300 Toulouse

Chiesi Farmaceutici SpA

Via Palermo 26/A
I-43100 Parma

CNRS — Groupe de physique des solides
Université Paris 7 Denis Diderot et Paris 6

Harp International
Gellihirion Industrial Estate Rhondda,

Pierre et Marie Curie

F-75251 Paris Cedex 5

Honeywell Specialty Chemicals

Wunstorfer Straße 40

Postfach 10 02 62
D-30918 Seelze

Institut scientifique de service public

Rue du Chéra 200

B-4000 Liège

Mallinckrodt Baker BV

Teugseweg 20
7418 AM Deventer

Nederland

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

Panreac Química SA

Pol. Ind. Pla de la Bruguera, C/Garraf, 2
E-08211 Castellar del Vallès

Barcelona

Sigma Aldrich Company

The Old Brickyard, New Road
Gillingham SP8 4XT

UNITED KINGDOM

Sigma Aldrich Logistik GmbH

Riedstraße 2
D-89555 Steinheim

Cynon Taff

Pontypridd CF37 5SX
UNITED KINGDOM

Ineos Fluor Ltd

PO Box 13, The Heath

Runcorn Cheshire WA7 4QF
UNITED KINGDOM

LGC Standards GmbH

Mercatorstraße 51

D-46485 Wesel

Merck KGaA

Frankfurter Straße 250
D-64271 Darmstadt

Ministry of Defense

Defence Fuel Lubricants and Chemicals
PO Box 10 000

1780 CA Den Helder

Nederland

Sigma Aldrich Chimie SARL

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

Sigma Aldrich Laborchemikalien

Wunstorfer Straße 40
Postfach 10 02 62

D-30918 Seelze

Solvay Organics GmbH

Hans-Böckler-Allee 20
D-30173 Hannover

L 21/56

EN

Official Journal of the European Union

24.1.2009

Tazzetti Fluids SRL
Corso Europa 600/a

I-10088 Volpiano (TO)

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

Done at Brussels, 18 December 2008.

Valeas SpA Pharmaceuticals
Via Vallisneri 10

I-20133 Milano

VWR ISAS

201, rue Carnot

F-94126 Fontenay-sous-Bois

For the Commission

Stavros DIMAS
Member of the Commission

24.1.2009

EN

Official Journal of the European Union

L 21/57

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 21/58

EN

Official Journal of the European Union

24.1.2009

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

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

24.1.2009

EN

Official Journal of the European Union

L 21/59

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

X

L 21/60

EN

Official Journal of the European Union

24.1.2009

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

X

X

X

24.1.2009

EN

Official Journal of the European Union

L 21/61

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

X

X

X

X

X

L 21/62

EN

Official Journal of the European Union

24.1.2009

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

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

24.1.2009

EN

Official Journal of the European Union

L 21/63

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:

Chiesi Farmaceutici SpA (IT)

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

ANNEX III

ESSENTIAL LABORATORY AND ANALYTICAL USES

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

Carlo Erba Réactifs-SDS (FR)
CNRS — Groupe de physique des solides (FR)
Harp International (UK)

Honeywell Specialty Chemicals (DE)

Ineos Fluor (UK)

LGC Standards (DE)

Mallinckrodt Baker (NL)

Merck KGaA (DE)

Mikro + Polo (SI)

Panreac Química (ES)

Sigma Aldrich Chimie (FR)

Sigma Aldrich Company (UK)

Sigma Aldrich Logistik (DE)

Tazzetti Fluids (IT)

L 21/64

EN

Official Journal of the European Union

24.1.2009

ANNEX IV

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

ESSENTIAL LABORATORY AND ANALYTICAL USES

Airbus France (FR)

Ineos Fluor (UK)

Ministry of Defence (NL)

ANNEX V

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

ESSENTIAL LABORATORY AND ANALYTICAL USES

Acros Organics (BE)

Carlo Erba Réactifs-SDS (FR)

Honeywell Specialty Chemicals (DE)

Institut Scientifique du Service Publique (BE)

Mallinckrodt Baker (NL)

Merck KGaA (DE)

Mikro + Polo (SI)

Panreac Quimica (ES)

Sigma Aldrich Chimie (FR)

Sigma Aldrich Company (UK)

Sigma Aldrich Laborchemikalien (DE)

Sigma Aldrich Logistik (DE)

VWR ISAS (FR)

ANNEX VI

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

ESSENTIAL LABORATORY AND ANALYTICAL USES

Acros Organics (BE)

Merck KGaA (DE)

Mikro + Polo (SI)

Panreac Química (ES)

Sigma Aldrich Chimie (FR)

Sigma Aldrich Company (UK)

Sigma Aldrich Logistik (DE)

24.1.2009

EN

Official Journal of the European Union

L 21/65

ANNEX VII

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

LABORATORY AND ANALYTICAL CRITICAL USES

Sigma Aldrich Chimie (FR)

Sigma Aldrich Company (UK)

Sigma Aldrich Logistik (DE)

ANNEX VIII

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

ESSENTIAL LABORATORY AND ANALYTICAL USES

Ineos Fluor (UK)

Sigma Aldrich Logistik (DE)

Solvay Organics (DE)

ANNEX IX

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

ESSENTIAL LABORATORY AND ANALYTICAL USES

Ineos Fluor (UK)

Sigma Aldrich Chimie (FR)

Sigma Aldrich Company (UK)

Sigma Aldrich Logistik (DE)

ANNEX X

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