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Directive 2001/18/EC of the European Parliament and of the CouncilShow full title
Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
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Changes over time for: ANNEX V
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ANNEX VU.K.CRITERIA FOR THE APPLICATION OF DIFFERENTIATED PROCEDURES (ARTICLE 7)
The criteria referred to in Article 7(1) are set out below.
1.
The taxonomic status and the biology (for example mode of reproduction and pollination, ability to cross with related species, pathogenecity) of the non-modified (recipient) organism shall be well-known.
2.
There shall be sufficient knowledge about the safety for human health and the environment of the parental, where appropriate, and recipient organisms in the environment of the release.
3.
Information shall be available on any interaction of particular relevance for the risk assessment, involving the parental, where appropriate, and recipient organism and other organisms in the experimental release ecosystem.
4.
Information shall be available to demonstrate that any inserted genetic material is well characterised. Information on the construction of any vector systems or sequences of genetic material used with the carrier DNA shall be available. Where a genetic modification involves the deletion of genetic material, the extent of the deletion shall be known. Sufficient information on the genetic modification shall also be available to enable identification of the GMO and its progeny during a release.
5.
The GMO shall not present additional or increased risks to human health or the environment under the conditions of the experimental release that are not presented by releases of the corresponding parental, where appropriate, and recipient organisms. Any capacity to spread in the environment and invade other unrelated ecosystems and capacity to transfer genetic material to other organisms in the environment shall not result in adverse effects.
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