Advice on Information requirements and environmental risk assessment for New Genomic Technique (NGT) plants

COGEM was requested to provide input on the delegated and implementing acts under the new regulation for New Genomic Techniques (NGTs). The NGT regulation differentiates two categories: NGT1 plants that are exempt from GMO legislation and NGT2 plants which require an adapted environmental risk assessment.

In this advice, COGEM sets out which information is required to demonstrate NGT and NGT1 status, and which elements should be included in the environmental risk assessment of NGT2 plants. For all NGTs, it should be demonstrated that they are produced using only targeted mutagenesis and/or cisgenesis, and that they are free of foreign genetic material. If cisgenesis is used, it should be shown that the genetic material is present in the gene pool.

COGEM advises that, in the case of targeted mutagenesis in NGT1 plants, the changed and off-target regions should be sequenced. In the case of cisgenesis, the flanking regions should be identified. Lastly, a description has to be provided to show that no genes providing herbicide tolerance or producing insecticidal compounds are introduced.

For NGT2, COGEM advises a case-by-case approach in which an expert panel will determine the exact information requirements on the basis of preliminary information and a guidance document.