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Directive 2009/41/EC: Main elements
(Last revised:
December 15, 2009
)
Directive 90/219/EEC on the contained use of genetically modified micro-organisms has been substantially amended several times (Commission Directive 94/51/EC, Council Directive 98/81/EC, Council Decision 2001/204/EC, Regulation EC 1882/2003). For this reason, it has been recast within Directive 2009/41/EC in the interests of clarity.
The main elements of Directive 2009/41/EC (repealing and replacing Directive 90/219/EEC) are:
- Classification of GMMs into 4 classes in relation of the risk they present for human health and the environment and categorisation of contained use activities into 4 classes according to purpose and scale;
- Administrative procedures and notification requirements directly linked to the risk of the contained use activities involving GMMs (four classes of risk are foreseen);
- Streamlined administrative procedures and reduced notification periods;
- Possibility for exemptions (under defined criteria) from the Directive of GMMs that are recognised as safe for human health and the environment;
- Description in general terms of the elements to be considered to perform risk assessment;
- Tables of containment and control measures, to ensure harmonisation and adequate environmental protection;
- Increased flexibility for amendment of the technical annexes, allowing timely adaptation to scientific and technical progress;
- New rules of comitology for quick adaptation to technical progress: the Commission is assisted by advisory committees if it proves to be necessary to amend not-essential elements of the Directive.
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