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Contained use of genetically modified micro-organisms (GMMs)
Directive 2009/41/EC lays down common measures for the contained use of genetically modified micro-organisms (GMMs), aimed at protecting human health and the environment.
2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms.
Member States are required to take all measures necessary in order to avoid the contained use * of genetically modified micro-organisms * (GMMs) having negative consequences on human health and the environment.
The Directive does not cover:
- genetic modifications resulting from the use of certain techniques or methods listed in Annex II, part A;
- contained uses involving the GMMs listed in Annex II, part C. GMMs on this list meet the criteria laid down in Annex II, part B, establishing their safety for human health and the environment;
- the transport of GMMs by road, rail, inland waterway, sea or air;
- the storage, culture, transport, destruction, disposal or use of GMMs which have been placed on the market in accordance with Directive 2001/18/EC on the release of GMOs or pursuant to other Community legislation which provides for a specific environmental risk assessment similar to that laid down in the said Directive, provided that the contained use is in accordance with the conditions, if any, of the consent for placing on the market.
The assessment of GMM records shall result in a risk hierarchy of the contained uses consisting of four classes. The containment measures to be applied shall also be classified in a four-level hierarchy.
- Class 1: No or negligible risk, level 1 containment;
- Class 2: Low risk, level 2 containment;
- Class 3: Moderate risk, level 3 containment;
- Class 4: High risk, level 4 containment.
The contained use of GMMs requires an examination of the containment and protection measures taken, in order to avoid a release.
When contained uses are to be carried out in premises for the first time, the user shall be required, before commencing such use, to submit to the competent authorities a notification containing at least the information listed in Annex V, Part A, B or C, as appropriate. Following notification to the competent authorities of a class 1 contained use, subsequent class 1 contained use may proceed without further notification. Users of GMMs in class 1 contained uses shall be required to keep a record of each assessment, which shall be made available to the competent authority on request.
If the premises have been the subject of a previous notification to carry out class 2 or a higher class of contained uses and any associated consent requirements have been satisfied, the class 2 contained use may proceed immediately following the new notification. However, the applicant may himself request from the competent authority a decision on the grant of a formal authorisation. The decision must be made within a maximum of 45 days from the notification.
If the premises have not been the subject of a previous notification to carry out class 2 or a higher class of contained uses, the class 2 contained use may, in the absence of any indication to the contrary from the competent authority, proceed 45 days after submission of the notification or earlier with the agreement of the competent authority.
A class 3 or higher class of contained use may not proceed without the prior consent of the competent authority, which shall communicate its decision in writing:
- at the latest 45 days after submission of the new notification, in the case of premises which have been the subject of a previous notification to carry out class 3 or a higher class of contained uses and where any associated consent requirements have been satisfied for the same or a higher class than the contained use with which it is intended to proceed;
- at the latest 90 days after submission of the notification, in other cases.
The Annexes to the Directive detail the criteria for assessing the risks of GMMs to health and the environment, as well as the protective measures for each of the four levels of containment.
If they so wish, Member States may provide for groups or the public to be consulted on any aspect of proposed contained use.
Before a contained use commences, Member States shall ensure that:
- an emergency plan is drawn up in order to react effectively in the case of an accident *; and
- persons at risk of being affected by an accident are informed of all aspects related to their safety.
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. The Member State shall also inform the Commission and any Member State which may be affected by the accident.
The Commission shall create a register of accidents including an analysis of the causes of the accidents, the experience gained and measures taken to avoid similar accidents.
The Commission shall be assisted by a Committee which is to rule on matters related to the application of the Directive and adapting it in light of technical progress.
This Directive replaces and repeals Directive 90/219/EEC. It is a formal amendment aimed at bringing together the original Directive and its successive amendments into a single act, without any changes to the fundamental provisions nor any new transposition into national law being made.
Finally, this Directive lays down the minimal standards applicable to the contained use of genetically modified micro-organisms. Member States are permitted to take more stringent measures. They may also extend the scope of the Directive to contained uses involving genetically modified plants, animals or fish.
|Key terms of the Act|
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
OJ L 125 of 21.5.2009