95/555/EC: Commission Decision of 20 December 1995 on the allocation of 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

COMMISSION DECISION  of 20 December 1995 on the allocation of 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 (95/555/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  (1), and in particular  Articles 3, 4 and 7 thereof,
Whereas, because of concerns for the ozone layer, the Community has decided to phase out certain  controlled substances earlier than provided for 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, pursuant to the abovementioned Regulation, those 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));
Whereas the criteria used for 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 a necessary for health or safety, or is critical for the functioning of society  (including cultural and intellectual aspects); and (ii)  there are no technically and economically feasible alternatives or substitutes that are  acceptable environmentally or from the health point of view;
(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, account also being taken of the needs of  developing countries 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 and chronic obstructive pulmonary diseases (COPD) and  for (ii) laboratory and analytical uses as specified in Annex I to this Decision;
Whereas the same Decision VI/9 also commits Parties to endeavouring to minimize use and emissions  by all possible means; whereas in the case of MDIs, these means include educating physicians and  patients about other treatment options and making real 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  published Decision 95/324/EC  (1) which recognizes the production of MDIs for the treatment of  asthma and other COPDs and laboratory uses as essential uses and specifies quantities for the  European Community on behalf of the Member States for 1996, in line with the Montreal Protocol  Decisions IV/25 and VI/9 mentioned above;
Whereas the quantity of 1,1,1-trichloroethane authorized in Decision 95/324/EC is not sufficient  for the essential laboratory and analytical uses;
Whereas, in order to increase the quantities of 1,1,1-trichloroethane to meet the essential  laboratory uses identified in Decision 95/324/EC, the Commission shall identify the distributors  who may supply the controlled substances for that purpose;
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 1996  pursuant to Regulation (EC) No 3093/94, and has thereby revealed applications for quantities of  controlled substances for essential uses for 1996;
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 1996;
Whereas the Commission issues licences to the users identified pursuant to Articles 3, 4 and 7 and  in accordance with the procedure set out in Article 16 of Regulation (EC) No 3093/94;
Whereas, consequently, within this framework a producer may be authorized by the competent  authority of the Member State in which its relevant production is situated to produce the  controlled substances for the purpose 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 authorization;
Whereas Article 16 of Regulation (EC) No 3093/94 sets out the procedure according to which  decisions can be taken concerning the implementation of the Regulation;
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;
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,