COMMISSION DECISION

of 16 December 1999

on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2000 under Council Regulation (EC) No 3093/94 on substances that deplete the ozone layer

(notified under document number C(1999) 4433)

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

(Text with EEA relevance)

(2000/22/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 3093/94 of 15 December 1994 on substances that deplete the ozone layer(1), and in particular Articles 3, 4 and 7 thereof,

(1) Whereas, because of concerns for the ozone layer, the Community has already phased out the production and consumption of certain controlled substances;

(2) Whereas essential uses have to be decided for chlorofluorocarbons (Articles 3(1) and 4(1)); other fully halogenated chlorofluorocarbons (Articles 3(2) and 4(2)); halons (Articles 3(3) and 4(3)); carbon tetrachloride (Articles 3(4) and 4(4)); 1,1,1-trichloroethane (Articles 3(5) and 4(5)); and HBFCs (Articles 3(7) and 4(7));

(3) Whereas the criteria used for assessing essential uses are in line with Decision IV/25 of the Parties to the Montreal Protocol and are as follows:

1. that a use of a controlled substance should qualify as "essential" only if:

(a) it is necessary for the health, safety, or is critical for the functioning of society (encompassing cultural and intellectual aspects); and

(b) there are no technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health;

2. that production and consumption, if any, of a controlled substance for essential uses should be permitted only if:

(a) all economically feasible steps have been taken to minimise the essential use and any associated emission of the controlled substance; and

(b) the controlled substance is not available in sufficient quantity and quality from existing stocks of banked or recycled controlled substances, also bearing in mind the needs of developing countries for controlled substances;

(4) Whereas Decision X/6 of the Parties to the Montreal Protocol authorises the levels of production and consumption necessary to satisfy essential uses of controlled substances for metered dose inhalers (MDIs) for the treatment of asthma and chronic obstructive pulmonary disease (COPD);

(5) Whereas Decision X/19 of the Parties to the Montreal Protocol authorises the production and consumption necessary to satisfy essential uses of controlled substances 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 and in Decision VII/11;

(6) Whereas the Commission has published a notice(2) to those companies in the European Community which use controlled substances that may be allowed for essential uses in the Community in 1999 pursuant to Council Regulation (EC) No 3093/94, and has thereby received applications for quantities of controlled substances for essential uses in 2000;

(7) Whereas, in the framework of the Montreal Protocol nomination and assessment procedures for essential uses, Parties are requested to identify the users who may take advantage of essential uses in 2000;

(8) Whereas the Commission issues licenses to the users identified pursuant to Articles 3, 4 and 7 and in accordance with the procedure set out in Article 16 of Council Regulation (EC) No 3093/94;

(9) Whereas, within this framework, a producer may be authorised by the competent authority of the Member State in which its relevant production is situated to produce the controlled substances for the purposes of meeting the licensed demands presented by the identified users; whereas the competent authority of the Member State concerned shall in turn notify the Commission well in advance of any such authorisation;

(10) Whereas, pursuant to Decision X/19 of the Parties to the Montreal Protocol, overall quantitative limits may be set for essential laboratory and analytical uses of controlled substances in the European Community during 2000;

(11) Whereas the list of essential uses and the quantities of the controlled substances are hereby given in Annex II as information for producer and user industries;

(12) Whereas the measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 16 of Council Regulation (EC) No 3093/94,

HAS ADOPTED THIS DECISION:

Article 1

Companies which may take advantage of the essential uses for their own account during 2000 for the manufacture of metered dose inhalers and for the coating of cardiovascular surgical material are listed in Annex I.

Article 2

The total quantities of controlled substances permitted for essential uses during 2000 shall be as specified in Annex II.

Article 3

Within the overall limits set out in Annex IIB, the Commission shall issue licenses to acquire controlled substances from producers in the Community or by import for essential laboratory and analytical uses.

Article 4

1. This Decision is addressed to the companies listed in Annex I.

2. This Decision shall apply from 1 January 2000 to 31 December 2000.

Done at Brussels, 16 December 1999.

For the Commission

Margot WALLSTRÖM

Member of the Commission

(1) OJ L 333, 22.12.1994, p. 1.

(2) OJ C 208, 22.7.1999, p. 12.

ANEXO I/BILAG I/ANHANG I/ΠΑΡΑΡΤΗΜΑ Ι/ANNEX I/ANNEXE I/ALLEGATO I/BIJLAGE I/ANEXO I/LIITE I/BILAGA I

3M Health Care Ltd Mr Brian Edwards 3M House

Morley Street

Loughborough Leicestershire LE11 1EP United Kingdom

Laboratorio Aldo Unión SA Dr. J. Sabater Sanmarti Baronese de Maldá 73

Espluges de Llobregat

E - 08950 Barcelona

Baxter BV Dr. A. Bronkhorst Energielaan 3 P.O. Box 169 NL - 5400 AD Uden

Bespak plc Mr Chris Halley North Lynn Industrial Estate King's Lynn Norfolk PE30 2JJ United Kingdom

Boehringer Ingelheim GmbH Herrn J. Pink D - 55216 Ingelheim am Rhein

CCL Pharmaceuticals Ltd Mrs C. King Astmoor Industrial Estate

9 Arkwright Road

Runcorn Cheshire WA7 1NU United Kingdom

Chauvin ankerpharm Ms Martina Elzer-Vetter Hansallee 247 D - 40549 Düsseldorf

Chiesi Farmaceutici SpA Dott. P. Chiesi Via Palermo, 26 A I - 43100 Parma

Glaxo Wellcome Operations Mr Barry Rosenthal Speke Liverpool L24 9JD United Kingdom

IG Sprühtechnik GmbH Herrn F. Guck Im Hemmet 1 D - 79664 Wehr

Laboratorios Lesvi SA Sr. Alejandro Biel Andrés Poligono Industrial Can Pelegrí E - 08740 Sant Andreu de la Barca

Laboratorios Vita, SA Sr. Alejandro Biel Andrés Av. Barcelona, 69 E - 08970 Sant Joan Despí

Norton Waterford Ltd Mr Jim Kennedy Unit 301 Industrial Park Waterford Ireland

Orion Corporation Mr Pasi Salokangas Orionintie 1 FIN - 02200 Espoo

Otsuka Sr. A. Costa Espelleta Santanyí 16 E - 08016 Barcelona

Rhône-Poulenc Rorer Mr Bob Netrefa London Road Holmes Chapel Cheshire CW4 8BE United Kingdom

Schering-Plough Labo NV Mr P. Gyselinck Industriepark 30 B - 2220 Heist op den Berg

SICOR - Società italiana corticosteroidi SpA Dott. Roberto Giani Via Terrazzano, 77 I - 20017 RHO (Milano)

Valeas SpA Pharmaceuticals Dott. Virgilio Bernareggi Via Vallisneri, 10 I - 20133 Milano

Valois SA M. Salim Haffar 50, avenue de l'Europe F - 78160 Marly-le-Roi

VARI Dr Bruno Boccardo Via del Pino, 10 I - 23854 Olginate

ANNEX II

A. MEDICAL USES

Production of metered dose inhalers (MDIs) for the treatment of asthma and other chronic obstructive pulmonary diseases (COPDs).

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B. MEDICAL USES

Total quantities of controlled substances which may be produced or imported during 2000 for laboratory and analytical uses.

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Laboratory users or suppliers of laboratory chemicals needing to obtain controlled substances from producers or importers under this essential use exemption should apply to the Commission for authorisation. The total quantity each controlled substance authorised during 2000 for laboratory and analytical purposes shall not exceed the quantities listed above.

C. CARDIOVASCULAR SURGICAL MATERIALS

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