COMMISSION DECISION of 26 July 1995 on the quantities of controlled substances allowed for essential uses in the Community in 1996 under Council Regulation (EC) No 3093/94 on substances that deplete the ozone layer (95/324/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), especially Articles 3, 4 and 7,

Whereas because of the state of the concern for the ozone layer, the Community has decided to phase out certain controlled substances earlier than in the Montreal Protocol commencing on 1 January 1995;

Whereas Article 3 (1, 2, 3, 4, 5 and 7) of Regulation (EC) No 3093/94 states that the Commission shall determine every year any essential uses which may be permitted in the Community and any quantities of controlled substances which may be produced, placed on the market or used for these purposes;

Whereas those essential uses have to be decided for chlorofluorocarbons, pursuant to Articles 3 (1) and 4 (1); other fully halogenated chlorofluorocarbons, pursuant to Articles 3 (2) and 4 (2); halons, pursuant to Articles 3 (3) and 4 (3); carbon tetrachloride, pursuant to Articles 3 (4) and 4 (4); 1,1,1-trichloroethane pursuant to Articles 3 (5) and 4 (5); and HBFCs pursuant to Articles 3 (7) and 4 (7) of Regulation (EC) No 3093/94;

Whereas the criteria applied to assessing essential uses are in line with Decision IV/25 of the Parties to the Montreal Protocol and are:

(a) that a use of a controlled substance should qualify as 'essential` only if:

(i) it is necessary for the health, safety or is critical for the functioning of society (encompassing cultural and intellectual aspects); and (ii) there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health;

(b) that production and consumption, if any, of a controlled substance for essential uses should be permitted only if:

(i) all economically feasible steps have been taken to minimize the essential use and associated emission of the controlled substance; and (ii) 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 developing countries' need for controlled substances;

Whereas Decision VI/9 of the Parties to the Montreal Protocol authorizes the levels of production or consumption necessary to satisfy essential uses of controlled substances for (i) metered dose inhalers (MDIs) for the treatment of asthma, chronic obstructive pulmonary diseases (COPD) and for (ii) laboratory and analytical uses as specified in Annex of this Decision;

Whereas Decision VI/9 of the Protocol also requests Parties to endeavour to minimize use and emissions by all practical steps; in the case of metered dose inhalers, these steps include education of physicians and patients about other treatment options and good-faith efforts to eliminate or recapture emissions from filling and testing consistent with national laws and regulations;

Whereas after receiving a certain number of applications from Member States, the Commission nominates the essential uses and respective quantities for the European Community, on behalf of the Member States for 1996, in line with the abovementioned Montreal Protocol Decisions IV/25 and VI/9;

Whereas the list of essential uses and the quantities of the controlled substances are hereby given for the information of producer and user industries;

Whereas the allocation of quantities of controlled substances allowed for essential uses in the Community in 1996 shall be presented in a Commission Decision at a later stage;

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

HAS ADOPTED THIS DECISION:

Article 1

1. The agreed essential uses and the total quantities of chlorofluorocarbons, other fully halogenated chlorofluorocarbons, halons, carbon tetrachloride, 1,1,1-trichloroethane and HBFCs to be placed on the market or used for which production or importation could be authorized in 1996 are for the:

(a) production of metered dose inhalers (MDIs) for the treatment of asthma and other chronic obstructive pulmonary diseases:

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(b) laboratory uses in accordance with the conditions set out in Annex:

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2. This Decision shall apply from 1 January to 31 December 1996.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 26 July 1995.

For the Commission Ritt BJERREGAARD Member of the Commission

ANNEX

CONDITIONS APPLIED TO EXEMPTION FOR LABORATORY AND ANALYTICAL USES

1. Laboratory purposes are definied at this time to include equipment calibration; use as extraction solvents, diluents, or carriers in chemical analysis; biochemical research; inert solvents used for chemical reactions, as a carrier or laboratory chemical and for other critical analytical and laboratory purposes. Production for laboratory and analytical purposes is authorized provided that these laboratory and analytical chemicals shall contain only controlled substances manufactured to the following purities:

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2. These pure, controlled substances can be subsequently mixed by manufacturers, agents, or distributors with other chemicals controlled or not controlled by the Montreal Protocol as is customary for laboratory and analytical uses.

3. These high purity substances and mixtures containing controlled substances shall be supplied only in re-closable containers or high pressure cylinders smaller than three litres or in 10 millilitre or smaller glass ampoules, marked clearly as substances that deplete the ozone layer, restricted to laboratory use and analytical purposes and specifying that used or surplus substances should be collected and recycled, if practical. The material should be destroyed if recycling is not practical.