2001/333/EC: Commission Decision of 13 February 2001 on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2001 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council on substances that deplete the ozone layer (Text with EEA relevance) (notified under document number C(2000) 4153)

Commission Decision
of 13 February 2001
on the allocation of quantities of controlled substances allowed for essential uses in the Community in 2001 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(2000) 4153)
(Only the Spanish, German, English, French, Italian, Dutch, Portuguese, Finnish and Swedish texts are authentic)
(Text with EEA relevance)
(2001/333/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 on substances that deplete the ozone layer(1), and in particular to Articles 3, 4 and 7 thereof,
Whereas:
(1) Because of concerns for the ozone layer, the Community has already phased out the production and consumption of certain controlled substances.
(2) Essential uses have to be decided for chlorofluorocarbons; other fully halogenated chlorofluorocarbons; halons; carbon tetrachloride; 1,1,1 trichloroethane; and hydrobromofluorocarbons (Article 3.1 and Article 4.4).
(3) The criteria used for assessing essential uses are in line with Decision IV/25 of the Parties to the Montreal Protocol and are:
I. 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.
II. 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) Decision XI/14 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) Decision XI/17 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) The Montreal Protocol's Technology and Economic Assessment Panel noted in its April 2000 report that the European Community's stockpile of CFCs has increased and recommended that it be reduced as production of CFC-based MDIs declines.
(7) The Commission has published a notice(2) to those companies in the European Community that use controlled substances which may be allowed for essential uses in the Community in 2001 pursuant to Regulation (EC) No 2037/2000, and has thereby received applications for quantities of controlled substances for essential uses in 2001.
(8) 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 2001.
(9) 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 18 of Regulation (EC) No 2037/2000.
(10) 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; the competent authority of the Member State concerned shall in turn notify the Commission well in advance of any such authorisation.
(11) Pursuant to Decision XI/17 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 2001.
(12) The list of essential uses and the quantities of the controlled substances are hereby given in the Annex as information for producer and user industries.
(13) The measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 18 of Regulation (EC) No 2037/2000,