Contained use of genetically modified microorganisms
Directive 2009/41/EC on the contained use of genetically modified microorganisms
WHAT IS THE AIM OF THE DIRECTIVE?
It lays down rules for the contained use* of genetically modified microorganisms (GMMs)* in order to protect human health and the environment in the EU.
Classifications and notifications
Users of GMMs must assess the contained uses regarding the risk to human health and the environment. The assessment results in one of the following classes.
Class 1: for activities with no or negligible risk.
Class 2: for activities with low risk.
Class 3: for activities with moderate risk.
Class 4: for activities with high risk.
When a contained use of a GMM is to be carried out for the first time, the user must submit a notification containing information (listed in Annex V of the directive) to the competent authority of their EU country. This is to satisfy them that the proposed installation is appropriate for the purposes of the activity so that there is no risk to human health and the environment.
Following the notification to the competent authorities, class 1 contained use may proceed without further notification.
Class 2 contained use can proceed immediately after notification provided the premises were the subject of previous notification to carry out class 2 or higher. However, if this is not the case and in the absence of a refusal from the competent authority, class 2 contained use may proceed 45 days after the submission of the notification (or earlier with the agreement of the authority).
A class 3 or 4 contained use may not proceed without the prior consent of the competent authority, which must communicate its decision in writing.
Before a contained use begins, EU countries must ensure that:
in order to react in the case of an accident, an emergency plan is drawn up for cases where failure of the containment measures could lead to serious danger; and
persons at risk of being affected by an accident are informed of all aspects related to their safety.
Should an accident occur, the respective EU country must ensure that the GMM user informs the competent authorities and communicates the information necessary for assessing the situation and taking action.
FROM WHEN DOES THE DIRECTIVE APPLY?
It applies from 10 June 2009.
This directive repeals and consolidates Directive 90/219/EEC and its successive amendments into a single act.
It lays down minimal standards applicable to the contained use of GMMs. EU countries are permitted to take stronger measures.
* KEY TERMS
Contained use: Any activity in which microorganisms are genetically modified, cultured, stored, transported, destroyed, disposed of or used in any other way and for which containment/safety measures are used to limit their contact with the general population and the environment.
GMMs: Micro-organisms, such as bacteria, viruses or fungi, that have had their genetic material altered in a way that does not occur naturally by mating and/or natural recombination.
Accidents: In the context of this directive, these refer to any incident involving a significant and unintended release of GMMs in the course of their contained use that could be hazardous to human health or the environment.
Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (OJ L 125, 21.5.2009, pp. 75-97)
last update 07.07.2016