Contained Use

Directive 2009/41/EC on the contained use of genetically modified microorganisms (GMMs), which is based on an article corresponding to the current Article 192(1) TFEU, lays down common measures for the contained use of GMMs with a view to protecting human health and the environment (Art 1). The term ‘micro-organisms’ includes viruses, viroids, and animal and plant cells in culture. Subject to some specification, a GMM is a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination. As ‘contained use’ counts any activity in which micro-organisms are genetically modified or in which GMMs are cultured, stored, transported, destroyed, disposed of, or used in any other way, and for which specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment. GMMs which have been placed on the market in accordance with Directive 2001/18/EC or pursuant to other relevant EU legislation are generally exempted from the application of the Directive. (Arts 2 and 3.)

All appropriate measures are to be taken to avoid adverse effects on human health and the environment which might arise from the contained use of GMMs. To that end the user, that is, any natural or legal person responsible for the contained use of GMMs, shall carry out an assessment of the risks to human health and the environment that the contained use may pose. The assessment shall result in the final classification of any contained use in either of four classes, where Class 1 applies to activities of no or negligible risk and Class 4 to activities of high risk. Based on the classification and subject to some exceptions, the user shall apply the general principles and the appropriate containment and other protective measures specified in Annex IV, so as to keep workplace and environmental exposure to any GMMs to the lowest reasonably practicable level, and so that a high level of safety is ensured. The assessment as well as the containment and other protective measures applied must be reviewed periodically. (Arts 4 and 5.)

When premises are to be used for the first time for contained uses, the user shall be required to notify the competent authorities. A Class 3 or higher class of contained use may not proceed without the prior consent of the competent authority. (Arts 6 and 9.)

In the case of any accident within the scope of the Directive, the Member State concerned is required to inform the Commission as soon as possible (Art 15).