Contained use of genetically modified micro-organisms

This Directive lays down common measures for the contained use of genetically modified micro-organisms for the purpose of protecting human health and the environment.

ACT

Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms [See amending acts].

SUMMARY

Member States are required to regulate the contained use of genetically modified micro-organisms in order to minimise their potential negative effects on human health and the environment, as micro-organisms released in the environment of one Member State in the course of their contained use may spread into other Member States.

The Directive classifies genetically modified micro-organisms into two groups according to the level of hazard.

In order to minimise the risk to human health and the environment, the user must adhere to certain principles of safety and health. In addition, before undertaking for the first time in a particular installation the use of genetically modified micro-organisms, the user must submit to the authorities a notification enabling them to ensure that the proposed installation can be used for this activity without danger.

The notification will contain different information depending on the level of risk involved.

Member States may, if they wish, make provision for consulting groups or the public on any aspect of the proposed contained use.

Member States must ensure that an emergency plan is drawn up to ensure an effective response in the event of an accident and that the persons likely to be affected by an accident are informed about all matters relating to their safety.

In the event of an accident the user must immediately inform the competent authority and communicate all the information required to assess its impact and enable the appropriate measures to be adopted. In addition, the Member State must inform the Commission and any other Member State liable to be affected by the accident.

The Commission must set up a register of the accidents which have occurred, including an analysis of their causes, the experience gained and the measures taken to avoid similar accidents.

To enable the contained use of genetically modified micro-organisms to be monitored throughout the Community, Member States have to provide the Commission with certain information.

The Commission is assisted by a committee which deals with matters relating to the implementation of the Directive and its adaptation to technical progress.

Directive 98/81/EC made major amendments to bring Directive 90/219/EEC into line with the scientific knowledge and experience acquired since Directive 90/219/EEC came into force. The main amendments are:

• simplification of the administrative procedures;
• introduction of a link between the notification requirements and the risks posed by contained use;
• addition of a list of genetically modified micro-organisms posing no risk to human health or the environment.

RELATED ACTS

Proposal of 29 November 2007 for a Directive of the European Parliament and of the Council on the contained use of genetically modified micro-organisms [COM(2007) 736 final - Not published in the Official Journal]. The proposed Directive codifies Directive 90/219/EEC: it is a formal modification aimed at consolidating the original Directive and its subsequent amendments under a single act without changing the basic provisions.

Summary report of the Commission of 12 July 1999 concerning the application, by the Member States, of Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms [C(99) 2053 - Not published in the Official Journal]. Directive 90/219/EEC stipulates that, every three years, Member States must send the Commission a summary report of their experience with the Directive. A report based on the national reports is then presented by the Commission. This report covers the period 1993-96. France and Luxembourg did not submit a summary report for the period covered by this report.

This document contains the following information for each Member State:

• the national measures adopted to transpose the Directive;
• the designated competent authorities;
• an overview of activities and installations;
• experience in applying the various Articles of the Directive.

Report from the Commission, of 17 May 2001, based on the reports of Member States concerning their experiences with Directive 90/219/EEC on the contained use of genetically modified micro-organisms for the period 1996-99 [COM (2001) 263 final - Not published in the Official Journal]. The report covers the following in respect of each Member State:

• installations and activities;
• classification and risk assessment;
• notification and approval systems;
• accidents;
• inspections;
• problems with interpreting the provisions of the Directive;
• public consultation and information;
• accident and emergency plans;
• protection of confidential information;
• waste disposal.

At the time of writing of the report, Sweden, Finland and Denmark had transposed Directive 98/81/EC amending Directive 90/219/EEC. Transposition was not yet complete in the other Member States.

Commission Decision 91/448/EEC of 29 July 1991 concerning the guidelines for classification referred to in Article 4 of Directive 90/219/EEC [Official Journal L 239 of 28.8.1991]. This Decision was amended by Commission Decision 96/134/EC of 16 January 1996 [Official Journal L 31 of 09.02.1996].

Commission Decision 2000/608/EC of 27 September 2000 concerning the guidance notes for risk assessment outlined in Annex III of Directive 90/219/EC on the contained use of genetically modified micro-organisms [Official Journal L 258 of 12.10.2000].

Council Decision 2001/204/EC of 8 March 2001 supplementing Directive 90/219/EEC as regards the criteria for establishing the safety, for human health and the environment, of types of genetically modified micro-organisms [Official Journal L 73 of 15.3.2001].

Last updated: 15.05.2008