THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 130s thereof,

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

Having regard to the opinion of 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 shall be based on the principle that preventive action shall be taken and shall have as its objective to preserve, protect and improve the environment and to protect human health;

Whereas the Council Resolution of 19 October 1987 (4) concerning the Fourth Environmental Action Programme of the European Communities declares that measures concerning the evaluation and best use of biotechnology with regard to the environment are a priority area on which Community action should concentrate;

Whereas the development of biotechnology is such as to contribute to the economic expansion of the Member States; whereas this implies that genetically modified micro-organisms will be used in operation of various types and scale;

Whereas the contained use of genetically modified micro-organisms should be carried out in such way as to limit their possible negative consequences for human health and the environment, due attention being given to the prevention of accidents and the control of wastes;

Whereas micro-organisms, if relased in the environment in one Memeber State in the course of their contained use, may reproduce and spread, crossing national frontiers and thereby affecting other Member States;

Whereas, in order to bring about the safe development of biotechnology throughout the Community, it is necessary to establish common measures for the evaluation and reduction of the potential risks arising in the course of all operations involving the contained use of genetically modified micro-organisms and to set appropriate conditions of use;

Whereas the precise nature and scale of risks associated with genetically modified micro-organisms are not yet fully known and the risk involved must be assessed case by case; whereas, to evaluate risk for human health and the environment, it is necessary to lay down requirements for risk assessment;

Whereas genetically modified micro-organisms should be classified in relation to the risks they present; whereas criteria should be provided for this purpose; whereas particular attention should be given to operations using the more hazardous genetically modified micro-organisms;

Whereas appropriate containment measures should be applied at the various stages of an operation to control emissions and to prevent accidents;

Whereas any person, before undertaking for the first time the contained use of a genetically modified micro-organism in a particular installation, should forward to the competent authority a notification so that the authority may satisfy itself that the proposed installation is appropriate to carry out the activity in a manner that does not present a hazard to human health and the environment;

Whereas it is also necessary to establish appropriate procedures for the case-by-case notification of specific operations involving the contained use of genetically modified micro-organisms, taking account of the degree of risk involved;

Whereas, in the case of operations involving high risk, the consent of the competent authority should be given;

Whereas it may be considered appropriate to consult the public on the contained use of genetically modified micro-organisms;

Whereas appropriate measures should be taken to inform any person liable to be affected by an accident on all matters relating to safety;

Whereas emergency plans should be established to deal effectively with accidents;

Whereas, if an accident occurs, the user should immediately inform the competent authority and communicate the information necessary for assessing the impact of that accident and for taking the appropriate action;

Whereas it is appropriate for the Commission, in consultation with the Member States, to establish a procedure for the exchange of information on accidents and for the Commission to set up a register of such accidents;

Whereas the contained use of genetically modified micro-organisms throughout the Community should be monitored and to this end Member States should supply certain information to the Commission;

Whereas a committe 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:

(1), OJ No C198, 28.7.1988, p.9 and OJ No C246, 27.9.1989, p.6
(2), OJ No C158, 26.6.1989, p.122 and OJ No C96, 17.4.1990
(3), OJ No C23, 30.1.1989, p.45
(4), OJ No C328, 7.12. 1987, p.1