THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,

Having regard to the proposal from the Commission (1),

In cooperation with the European Parliament (2),

Having regard to the opinion of the Economic and Social Committee (3),

Whereas, under the Treaty, action by the Community relating to the environment should be based on the principle that preventive action should be taken;

Whereas living organisms, whether released into the environment in large or small amounts for experimental purposes or as commercial products, may reproduce in the environment and cross national frontiers thereby affecting other Member States; whereas the effects of such releases on the environment may be irreversible;

Whereas the protection of human health and the environment requires that due attention be given to controlling risks from the deliberate release of genetically modified organisms (GMOs) into the environment;

Whereas disparity between the rules which are in effect or in preparation in the Member States concerning the deliberate release into the environment of GMOs may create unequal conditions of competition or barriers to trade in products containing such organisms, thus affecting the functioning of the common market; whereas it is therefore necessary to approximate the laws of the Member States in this respect;

Whereas measures for the approximation of the provisions of the Member States which have as their object the establishment and functioning of the internal market should, inasmuch as they concern health safety, environmental and consumer protection, be based on a high level of protection throughout the Community;

Whereas it is necessary to ensure the safe development of industrial products utilizing GMOs;

Whereas this Directive should not apply to organisms obtained through certain techniques of genetic modification which have conventionally been used in a number of applications and have a long safety record;

Whereas it is necessary to establish harmonized procedures and criteria for the case-by-case evaluation of the potential risks arising from the deliberate release of GMOs into the environment;

Whereas a case-by-case environmental risk assessment should always be carried out prior to a release;

Whereas the deliberate release of GMOs at the research stage is in most cases a necessary step in the development of new products derived from, or containing, GMOs;

Whereas the introduction of GMOs into the environment should be carried out according to the 'step by step' principle; whereas this means that the containment of GMOs is reduced and the scale of release increased gradually, step by step, but only if evaluation of the earlier steps in terms of protection of human health and the environment indicates that the next step can be taken;

Whereas no product containing, or consisting of, GMOs and intended for deliberate release shall be considered for placing on the market without it first having been subjected to satisfactory field testing at the research and development stage in ecosystems which could be affected by its use;

Whereas it is necessary to establish a Community authorization procedure for the placing on the market of products containing, or consisting of, GMOs where the intended use of the product involves the deliberate release of the organism(s) into the environment;

Whereas any person, before undertaking a deliberate release into the environment of a GMO, or the placing on the market of a product containing, or consisting of, GMOs, where the intended use of that product involves its deliberate release into the environment, shall submit a notification to the national competent authority;

Whereas that notification should contain a technical dossier of information including a full environmental risk assessment, appropriate safety and emergency response, and, in the case of products, precise instructions and conditions for use, and proposed labelling and packaging;

Whereas after notification, no deliberate release of GMOs should be carried our unless the consent of the competent authority has been obtained;

Whereas the competent authority should give its consent only after it has been satisfied that the release will be safe for human health and the environment;

Whereas it may be considered appropriate in certain cases to consult the public on the deliberate release of GMOs into the environment;

Whereas it is appropriate for the Commission, in consultation with the Member States, to establish a procedure for the exchange of information on deliberate releases of GMOs notified under this Directive;

Whereas it is important to follow closely the development and use of GMOs; whereas a list should be published of all the products authorized under this Directive;

Whereas, when a product containing a GMO or a combination of GMOs is placed on the market, and where such a product has been properly authorized under this Directive, a Member State may not on grounds relating to matters covered by this Directive, prohibit, restrict or impede the deliberate release of the organism in that product on its territory where the conditions set out in the consent are respected; whereas a safeguard procedure should be provided in case of risk to human health or the environment;

Whereas the provisions of this Directive relating to placing on the market of products should not apply to products containing, or consisting of, GMOs covered by other Community legislation which provides for a specific environmental risk assessment similar to that laid down in this Directive;

Whereas a Committee should be set up to assist the Commission on matters relating to the implementation of this Directive and to its adaptation to technical progress,

HAS ADOPTED THIS DIRECTIVE:

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(1), OJ No C198, 28.7.1988, p.19 and OJ No C246, 27.9.1989, p.5
(2), OJ No C158, 26.6.1989, p.225 and OJ No C96, 17.4.1990
(3), OJ No C23, 30.1.1989, p.45