THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 103s(1) thereof,

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

Having regard to the opinion of the Economic and Social Committee (2),

Acting in accordance with the procedure laid down in Article 189c of the Treaty (3),

(1) Whereas, within the meaning of the Treaty, action by the Community relating to the environment should be based on the principle that preventive action is to be taken and shall have as its objective to preserve, protect and improve the environment and to protect human health;

(2) Whereas contained uses of genetically modified micro-organisms (GMMs) should be classified in relation to the risks they present for human health and the environment; whereas such classification should be in line with international practice and based on an assessment of the risk;

(3) Whereas in order to ensure a high level of protection the containment and other protective measures applied to a contained use must correspond to the classification of the contained use; whereas in case of uncertainty the appropriate containment and other protective measures for the higher classification should be applied until less stringent measures are justified by appropriate data;

(4) Whereas appropriate measures should be adopted and used for the control of the disposal of material from contained uses of GMMs;

(5) Whereas GMMs which are disposed of without appropriate provisions for specific containment measures to limit their contact with the general population and the environment do not fall within the scope of the present Directive; other Community legislation such as Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (4) may apply;

(6) Whereas exemptions pursuant to this Directive do not entail exemptions pursuant to any other Community legislation that may apply, such as Directive 90/220/EEC;

(7) Whereas for all activities involving GMMs the principles of good microbiological practice and good occupational safety and hygiene should apply in accordance with relevant Community legislation;

(8) Whereas the containment and other protective measures applied to contained uses should be reviewed periodically;

(9) Whereas people employed in contained uses should be consulted in accordance with the requirements of relevant Community legislation, in particular Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (5);

(10) Whereas weaknesses have been identified in Directive 90/219/EEC (6); whereas the administrative procedures and notification requirements should be linked to the risk of the contained uses;

(11) Whereas Directive 90/219/EEC did not permit sufficient adaptation to technical progress; whereas the technical parts of that Directive need to be adapted to technical progress;

(12) Whereas the implementation of Directive 90/219/EEC could benefit from the addition of a list of GMMs that are safe for human health and the environment; whereas these GMMs should meet certain criteria in order to establish their safety;

(13) Whereas, to take account of the pace at which biotechnology is advancing, the nature of the criteria to be developed and the limited scope of this list, it is appropriate for the Council to define and revise these criteria;

(14) Whereas there is now considerable experience and knowledge of the risks associated with the contained use of GMMs;

(15) Whereas Directive 90/219/EEC should therefore be amended accordingly,

HAS ADOPTED THIS DIRECTIVE:

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(1) OJ C 356, 22.11.1997, p. 14 and OJ C 369, 6.12.1997, p. 12.
(2) OJ C 295, 7.10.1996, p. 52.
(3) Opinion of the European Parliament of 12 March 1997 (OJ C 115, 14.4.1997, p. 59), Council common position of 16 December 1997 (OJ C 62, 26.2.1998, p. 1) and Decision of the European Parliament of 16 June 1998 (OJ C 210, 6.7.1998).
(4) OJ L 117, 8.5.1990, p. 15. Directive as last amended by Commission Directive 97/35/EC (OJ L 169, 27.6.1997, p. 72).
(5) OJ L 374, 31.12.1990, p.1. Directive as last amended by Commission Directive 97/59/EC (OJ L 282, 15.10.1997, p. 33).
(6) OJ L 117, 8.5.1990, p. 1. Directive as amended by Commission Directive 94/51/EC (OJ L 297, 18.11.1994, p. 29).