2003/316/EC: Commission Decision of 28 March 2003 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2003 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council (Text with EEA relevance) (notified under document number C(2003) 747)
Date: 2003-03-28
Institutions: European Commission
Subjects: atmosphere, dangerous substance, international convention, ozone, pollutant, production quota, research body, type of business

9.5.2003

EN

Official Journal of the European Union

L 115/75

COMMISSION

COMMISSION DECISION

of 28 March 2003

on the allocation of quantities of controlled substances allowed for essential uses in the Commu-
nity in 2003 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council

(notified under document number C(2003) 747)

(Only the Danish, Dutch, English, Finnish, French, German, Italian, Portuguese, Spanish and Swedish texts are
authentic)

(Text with EEA relevance)

(2003/316/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

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), as last amended by
Commission Decision 2003/160/EC (2), and in particular to
Articles 3(1) and 7 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, hydrobromofluorocar-
bons and bromochloromethane.

Each year the Commission has to determine essential
uses for these controlled substances, the quantities 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.

Decision X/19 of the Parties to the Montreal Protocol
authorises the production and consumption necessary to
satisfy essential uses of controlled substances listed in

(5)

(6)

Annexes A and B 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 condi-
tions set out in Annex II to the report of the Sixth
Meeting of the Parties, Decision VII/11 and Decision XI/
15 of the Parties to the Montreal Protocol.

Substances required for essential uses that are not listed
in Annexes A and B of the Montreal Protocol must be
specifically approved by the Parties. This requirement
applies to essential uses of hydrobromofluorocarbons
and bromochloromethane that are listed in Annex C of
the Montreal Protocol.

Inhalers

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 chlorofluoro-
carbon-free Metered-Dose
(MDIs), Austria,
Belgium, Denmark, Finland, France, Germany, Ireland,
Luxembourg, Norway, Portugal, the Netherlands and the
United Kingdom have recently determined that chloro-
fluorocarbons (CFCs) are no longer essential
for the
manufacture of specific short-acting beta agonist CFC-
MDIs (3). 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 reduced the

(1) OJ L 244, 29.9.2000, p. 1.
(2) OJ L 65, 8.3.2003, p. 29.

(3) www.unep.org/ozone/dec12-2-3.shtml

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demand for CFCs in the Community. In addition, Article
4(6) of Regulation (EC) No 2037/2000 prevents
products being imported and placed on the market
containing CFCs unless the CFCs are considered essential
under the conditions described in Article 3(1).

The quantity of controlled substances of Group VII
6.
(hydrobromofluorocarbons)
to Regulation (EC) No
subject
2037/2000 that may be used for essential laboratory uses in
the Community in 2003 shall be 11 335 ODP kilograms

(7)

(8)

in the Community that

The Commission has published a notice (1)
to those
companies
intend to use
controlled substances for essential uses in the Commu-
nity in 2003, and has received declarations on intended
essential uses of controlled substances in 2003.

The measures provided for in this Decision are in accor-
dance with the opinion of the Committee that followed
the procedures established under Article 18 of Regula-
tion (EC) No 2037/2000,

7.
The quantity of controlled substances of group ‘New’
(bromochloromethane) subject to Regulation (EC) No 2037/
2000 that may be used for essential
laboratory uses in the
Community in 2003 shall be 1 248 ODP kilograms.

Article 2

chlorofluorocarbon metered-dose

The
(CFC-MDIs)
listed in Annex I shall not be placed on markets that have
determined CFCs for these products to be non-essential.

inhalers

HAS ADOPTED THIS DECISION:

Article 3

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 2003 shall be 1 895 260,00 ODP
(ozone depletion potential) 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 2003 shall be 87 211,365 ODP
kilograms.

During the period 1 January to 31 December 2003 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;

3. the allocation of essential laboratory use quotas for halons

shall be to the companies indicated in Annex IV;

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

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 2003
shall be 6 358,70 ODP kilograms.

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

The quantity of controlled substances of Group IV
to Regulation (EC) No 2037/
laboratory uses in the

4.
(carbon tetrachloride) subject
2000 that may be used for essential
Community in 2003 shall be 133 811,70 ODP kilograms.

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 Community in
2003 shall be 789,68 ODP kilograms.

(1) OJ C 193, 13.8.2002, p. 20.

6. the allocation of essential laboratory use quotas for hydro-
bromofluorocarbons shall be to the companies indicated in
Annex VII;

7. the allocation of essential laboratory use quotas for bromo-
chloromethane shall be to the companies indicated in
Annex VIII;

8. the essential use quotas for chlorofluorocarbons 11, 12,
113, 114 and 115, other fully halogenated chlorofluorocar-
bons, carbon tetrachloride, 1,1,1-trichloroethane, hydrobro-
mofluorocarbons and bromochloromethane shall be as set
out in Annex IX.

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This Decision is addressed to:

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

Acros Organics bvba
Janssen Pharmaceuticalaan 3a
B-2440 Geel

Agfa-Gevaert NV
Septestraat 27
B-2640 Mortsel

Atofina SA
Cours Michelet — La Défense 10
F-92091 Paris La Défense

Aventis
London Road, Holmes Chapel
Cheshire CW4 8BE
United Kingdom

Bespak PLC
North Lynn Industrial Estate
King's Lynn
Norfolk PE30 2JJ
United Kingdom

Bie & Berntsen A/S
Sandbækvej 7
DK-2610 Rødovre

Biosolve BV
Waalreseweg 17
5554 HA Valkenswaard
Nederland

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

Butterworth Laboratories Ltd
54 Waldegrave Road, Teddington
Middlesex TW11 8NY
United Kingdom

Carl Roth GmbH
Schoemperlenstr. 1-5
D-76185 Karlsruhe

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

Dow Benelux BV
Herbert H. Dowweg
4542 NM Hoek
Nederland

Ecotechnics SpA
Via L. Longo 21/23
I-50019 Sesto Fiorentino, Firenze

Environnement SA
111, Bd Robespierre, BP 4513
F-78304 Poissy

Article 4

Fisher Scientific
Bishop Meadow Road
Loughborough LE11 5RG
United Kingdom

GlaxoSmithKline
Speke Boulevard
Speke
Liverpool L24 9JD
United Kingdom

Groupe de Physique des Solides — CNRS
Université Paris 7 Denis-Diderot et Paris 6 Pierre
et Marie Curie
F-75251 Paris Cedex 5

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

IG Sprühtechnik GmbH
Im Hemmet 1
D-79664 Wehr

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

IVAX Ltd
Unit 301 Industrial Park
Waterford
Ireland

Jaba Farmacêutica SA
Rua da Tapada Grande, 2
P-2710-089 Abrunheira, Sintra

Katholieke Universiteit Leuven
Krakenstraat 3
B-3000 Leuven

Laboratorio Aldo Unión SA
Baronesa de Maldá 73
Esplugues de Llobregat
E-08950 Barcelona

Laboratorios Lesvi SA
Aptdo. Correos 65
E-08740 Sant Andreu de la Barca

Laboratoires sérobiologiques
3, rue de Seichamps
F-54425 Pulnoy

Laboratorios Vita SA
Avenue Barcelona 69
E-08970 Sant Joan Despí

LGC Promochem GmbH
Mercatorstr. 51
D-46485 Wesel

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Merck KGaA
Frankfurter Straße 250
D-64271 Darmstadt

Miza Pharmaceuticals Ltd
Astmoor Industrial Estate
9 Arkwright Road RUNCORN
Cheshire WA7 1NU
United Kingdom

Otsuka Pharmaceuticals SA (E)
Provenca 388
E-08025 Barcelona

Panreac Química SA
Riera de Sant Cugat 1
E-08110 Montcada I Reixac

Rathburn Chemicals Mfg Ltd
Caberston Road
Walkerburn EH43 6AS
Scotland

Rohs Chemie GmbH
Berliner Str. 54
D-53819 Neunkirchen-Seelsheid

Schering-Plough Labo NV
Industriepark 30
B-2220 Heist Op Den Berg

Sigma Aldrich Chemie GmbH
Riedstraße 2
D-89555 Steinheim

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

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

Sigma Aldrich Laborchemikalien
Wunstorfer Straße 40, Postfach 100262
D-30918 Seelze

Valeas SpA Pharmaceuticals
Via Vallisneri, 10
I-20133 Milano

Valois SA
50, avenue de l'Europe
F-78160 Marly-le-Roi

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

SDS Solvants, Documentation, Synthèses SA
ZI de Valdonne, BP 4
F-13124 Peypin

SICOR S.p.A
Via Terrazzano 77
I-20017 Rho Milano

VWR ISAS
201, rue Carnot
F-94126 Fontenay-sous-Bois
YΑ-Kemia Oy
Teerisuonkuja 4
FIN-00700 Helsinki

Done at Brussels, 28 March 2003.

For the Commission

Margot WALLSTRÖM

Member of the Commission

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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 Parties have determined
in December 2002 that, due to the presence of suitable non-CFC MDIs, CFCs no longer qualify as ‘essential’ under the
Protocol when combined with following products:

List of Non-Essential Substances

Product

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x

x

x

x

x

x

x

x

x

x

x

Country

Austria

Belgium

Denmark

Finland

France

Germany

Ireland

Luxembourg

Norway

Portugal

The Netherlands

United Kingdom

Source: www.unep.org/ozone/dec12-2-3.pdf

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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:

3M (UK)

Aventis (UK)

Bespak (UK)

Boehringer Ingelheim (D)

Chiesi (I)

Glaxo Smith Kline (UK)

IG Sprühtechnik (D)

IVAX (IRL)

Jaba Farmaceutica (P)

Lab Lesvi (E)

Lab Vita (E)

Lab. Aldo-Union (E)

MIZA Pharmaceuticals (UK)

Otsuka Pharmaceuticals (E)

Schering-Plough (B)

Sicor (I)

Valeas (I)

Valois (F)

VARI (I)

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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:

Agfa-Gevaert (B)

Atofina (F)

Bie & Berntsen (DK)

Biosolve (NL)

Butterworth Laboratories (UK)

Carl Roth (D)

Dow Benelux (NL)

Ecotechnics SpA (I)

Environnement SA (F)

Groupe de Physique des Solides (F)

Honeywell Specialty Chemicals (D)

Ineos Fluor (UK)

Katholieke Universiteit Leuven (B)

LGC Promochem (D)

Merck KGaA (D)

Panreac Quimica (E)

Rathburn Chemicals (UK)

SDS Solvants (F)

Sigma Aldrich Chemie (D)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

VWR ISAS (F)

ANNEX IV

Essential laboratory uses

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

Butterworth Laboratories (UK)

Ineos Fluor (UK)

Sigma Aldrich Company (UK)

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 (B)

Agfa-Gevaert (B)

Bie & Berntsen (DK)

Biosolve (NL)

Dow Benelux (NL)

Fisher Scientific (UK)

Katholieke Universiteit Leuven (B)

Laboratoires Sérologiques (F)

Merck KGaA (D)

Panreac Quimica (E)

Rathburn Chemicals (UK)

Rohs Chemie (D)

SDS Solvants (F)

Sigma Aldrich Chemie (D)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

Sigma Aldrich Laborchemikalien (D)

VWR ISAS (F)
YΑ-Kemia Oy (FIN)

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L 115/81

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 (B)

Agfa-Gevaert (B)

Dow Benelux (NL)

Katholieke Universiteit Leuven (B)

Merck KGaA (D)

Panreac Quimica (E)

Rathburn Chemicals (UK)

Sigma Aldrich Chemie (D)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

VWR ISAS (F)

ANNEX VII

Essential laboratory uses

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

Acros Organics (B)

Ineos Fluor (UK)

Sigma Aldrich Chimie (F)

Sigma Aldrich Company (UK)

Each quota cannot be debited until the Commission has notified each enterprise that the Parties to the Montreal Protocol
have approved the use of hydrobromofluorocarbons in 2003 for Essential Uses.

ANNEX VIII

Essential laboratory uses

Quota for bromochloromethane that may be used for laboratory and analytical uses are allocated to:

Ineos Fluor (UK)

Sigma Aldrich Chimie (F)

Each quota cannot be debited until the Commission has notified each enterprise that the Parties to the Montreal Protocol
have approved the use of bromochloromethane in 2003 for Essential Uses.

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

ANNEX IX