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.
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.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Directive 90/219/EEC||2.5.1990||23.10.1991||JO L 117 of 8.5.1990|
|Amending act(s)||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Directive 98/81/EC||5.12.1998||5.6.2000||JO L 330 of 5.12.1998|
|Directive 2001/204/EC||15.3.2001||-||JO L 73 of 15.3.2001|
|Regulation (EC) No 1882/2003||20.11.2003||-||JO L 284 of 31.10.2003|
|Directive 2005/174/EC||5.3.2005||-||JO L 59 of 5.3.2005|