Notice to users in the European Community 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

(1999/C 208/08)

This notice concerns the following substances:

- chlorofluorocarbons (CFCs) 11, 12, 113, 114 and 115,

- other fully halogented chlorofluorocarbons,

- carbon tetrachloride,

- halons,

- 1,1,1 trichloroethane,

- hydrobromofluorocarbons (HBFCs).

This notice is addressed to undertakings that:

1. intend to use the above substances within the Community for the manufacture of metered dose inhalers (MDIs), and

2. intend to acquire the above substances directly from a producer or by import into the Community for laboratory and analytical uses.

Controlled substances for essential uses may be obtained from production within the Community and if necessary by import from sources outside the Community.

Users wishing to be considered by the Commission for the award of essential use licences for the twelve-month period from 1 January 2000 to 31 December 2000, should apply to the Commission for an essential use licence using the form provided in Annex I or II to this notice.

Decision IV/25 of the Parties to the Montreal Protocol on substances that deplete the ozone layer sets out criteria and a procedure for determining "essential uses", for which continued production and consumption would be allowed after phase-out.

In accordance with Decision IV/25 of the Parties to the Montreal Protocol, Articles 3 and 4 of Council Regulation (EC) No 3093/94 of 15 December 1994(1) on substances that deplete the ozone layer require the determination of any essential uses of the abovementioned controlled substances which may be permitted in the Community in 2000.

Decision X/6 of the Parties to the Montreal Protocol authorised the levels of production and consumption necessary to satisfy essential uses of CFCs for metered dose inhalers (MDIs) for the treatment of asthma, chronic obstructive pulmonary diseases and CFC 113 for the coating of cardiovascular surgical material. For the production of MDIs in the European Community in 2000, the quantiy of CFCs 11, 12, 113 and 114 authrised by the Parties is 3770,2 tonnes. For laboratory uses, Decision X/19 of the Parties has authorised the production and consumption necessary to satisfy essential laboratory uses subject to the conditions applied to the laboratory use exemption as contained in Annex II to the report of the Sixth Meeting of the Parties(2).

In accordance with Decision VI/9 of the Parties to the Montreal Protocol, the purity of controlled substances for laboratory purposes should be at least 99,0 % for 1,1,1 trichloroethane and 99,5 % for CFCs and carbon tetrachloride.

The procedure allocating quantities of controlled substances for the above essential uses foressen by Council Regulation (EC) No 3093/94 is the following:

1. Essential use applications may be made by any interested users of metered dose inhales (MDIs) or laboratory uses. Requests should contain the information as set out in Annex I of this notice for MDIs or Annex II of this notice for laboratory uses.

2. Interested parties should send their application within one month of publication of this notice to: Dörthe Ohm , European Commission,

Directorate-General XI,

Environment, Nuclear Safety and Civil Protection, Unit D.3,

Rue de la Loi/Wetstraat 200 , B - 1049 Brussels .

Enquiries can be made in writing to the above address or by telephone (32-2) 296 36 92 or telefax (32-2) 296 95 54.

A copy of the application should also be sent to the competent authority of the Member State (See Annex III).

3. Applications received within the period allowed under this notice will be considered by the Commission in accordance with the procedure set out in Article 16 of Regulation (ESS 3093/94 on substances that deplete the ozone layer.

4. On the basis of the above procedure, a Commission Decision will allocate quantities of controlled substances to the users of those applications in the Community for 2000 for which additional production and importation of controlled substances will be permitted.

5. The Commission will then issue licences to those users identified and shall notify them of the use for which they have authorisation, the substance they are authorised to use and the quantity of the controlled substances concerned.

6. Those users holding an essential use licence for a controlled substance for 2000 will be able to present their licensed demands to a producer or if necessary request an import licence from the Commission for the purpose of meeting the licensed demand. The producer may be authorised by the competent authority of the Member State in which its relevant production is situated to produce the controlled substance for meeting that licensed demand. The competent authority of the Member State shall notify the Commission well in advance of any such authorisation.

(1) OJ L 333, 22.12.1994.

(2) Copies of these conditions are available from the address in subparagraph 2

ANNEX I

Form to be used to declare

METERED DOSE INHALERS (MDIs)(1)

for the treatment of asthma and other chronic obstructive diseases

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(1) Applications for the use of Metered Dose Inhalers (MDIs) for the treatment of asthma and other chronic obstructive diseases will need to be accompanied by a copy of the relevant marketing authorisation issued by the competent national authorities confirming this specific use.

ANNEX II

Form to be used to declare

LABORATORY USES

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ALLEGATO III//ANEXO III//ANEXO III//ANNEX III//ANNEXE III//ANHANG III//BIJLAGE III//BILAG III//BILAGA III//LIITE III//ΠΑΡΑΡΤΗΜΑ III

AUSTRIA

Mr Paul Krajnik Ministry of the Environment

Chemical Department

Stubenbastei 5 A - 1010 Wien

BELGIUM

Mrs Lutgarde Coppens Ministère de la Santé Publique et de l'Environnement

Département de l'Environnement

19, Boulevard Pacheco - bte 7 B - 1010 Brussels

DENMARK

Mr Henri Heron Miljøstyrelsen Strandgade 29 DK - 1401 Copenhagen K

FINLAND

Mrs Eliisa Irpola Finnish Environment Institute Kesäkatu 6 FIN - 00121 Helsinki

FRANCE

Mrs Laurence Musset Ministère de l'Environnement

DRPR/BSPC

20, Avenue de Ségur F - 75302 Paris 07 SP

GERMANY

Mr Heinrich W. Kraus Federal Ministry for the Environment

Dept. JG 115

Bernkasteler Straße 8 D - 53175 Bonn

GREECE

Mrs Elpida Politis Ministry for the Environment, Physical Planning and Public Works

International Activities and EEC Department

17 Ameliedos Street GR - 11523 Athens

IRELAND

Ms Nuala McLoughlin Department of the Environment

Environment International

Custom House IRL - Dublin 1

ITALY

Mrs Giuliana Gasparrini Ministry of Environment

Atmospheric Pollution Department

Via Ferratella in Laterano, 33 I - 00184 Roma

LUXEMBOURG

Mr Theo Weber Administration de l'Environnement 1, Rue Bender L - 1229 Luxembourg

PORTUGAL

Ms Cristina Vaz Nunes Ministério do Ambiente

Instituto de Meteorologia

Rua C ao Aeroporto de Lisboa P - 1700 Lisboa

SPAIN

Mr Ángel Rascón Ministerio de Medio Ambiente

DG de Calidad y Evaluación Ambiental

Pza. San Juan de la Cruz s/n

4a Planta - Despacho 4.60

E - 28071 Madrid

SWEDEN

Ms Maria Ujfalusi Swedish Environmental Protection Agency

Naturvårdsverket

Blekholmsterassen 36 S - 106 48 Stockholm

NEDERLAND

Dr. Joop A. van Haasteren Ministerie van Volkshuisvesting, Ruimtelijke Ordening en Milieubeheer Postbus 30945 Rijnstraat 8 2500 GX Den Haag Nederland

UNITED KINGDOM

Mrs Maria Nolan Department of the Environment, Transport and Regions

Global Atmosphere Division

3rd floor - zone 3/C2

Ashdown House

123, Victoria Street

UK - SW1E 6DE London