Bohle, F., Schneider, R., Mundorf, J., Zühl, L., Simon, S., & Engelhard, M. (2024). Where does the EU-Path on New Genomic Techniques lead us?. Frontiers in Genome Editing, 6, 1377117.
Bohle, F., Schneider, R., Mundorf, J., Zühl, L., Simon, S., & Engelhard, M. (2024). Where does the EU-Path on New Genomic Techniques lead us?. Frontiers in Genome Editing, 6, 1377117.
Bohle, F., Schneider, R., Mundorf, J., Zühl, L., Simon, S., & Engelhard, M. (2024). Where does the EU-Path on New Genomic Techniques lead us?. Frontiers in Genome Editing, 6, 1377117.
Bohle, F., Schneider, R., Mundorf, J., Zühl, L., Simon, S., & Engelhard, M. (2024). Where does the EU-Path on New Genomic Techniques lead us?. Frontiers in Genome Editing, 6, 1377117.
Abstract
The broad and rapid application of new genomic techniques (NGTs) such as CRISPR-Cas has led to a fast increase in the number of genetically modified crops. With the recently published EU Commission’s (EC) regulatory proposal on plants generated with NGTs (July 5, 2023) the process of admission of such genetically modified plants is aimed to get accelerated and simplified. NGT plant applications shall be categorized based on their molecular characteristics into category 1 NGT (NGT1) and category 2 NGT (NGT2), which is in divergence from the current legislation centered around Directive 2001/18/EC. In the regulatory proposal NGT2 plants are envisioned to undergo a reduced risk assessment while for NGT1 plants no risk assessment is foreseen at all. To demonstrate were the path of the proposal leads to in practice, we applied the proposed criteria for categorization to a list of NGT plant applications that are currently in the commercialization pipeline. A key finding is that out of those plant applications affected by the EC proposal, 94% would be classified as NGT1 and thus would receive a market approval without risk assessment, monitoring and sufficient labeling provisions. The remaining 6% of applications would be classified as NGT2 plants for which, in deviation from the current regulation, an adapted risk assessment is proposed. A screening of intended traits in the pipeline highlights that certain NGT1 plants can pose similar environmental risks (e.g. invasiveness) compared to other genetically modified organisms (GMOs), as defined in Directive 2001/18/EC. For example, NGT1 applications based on RNAi technology can exhibit insecticidal effects with potential side effects on non-target organisms (i.e. other insects). Our quantitative and case-specific elaboration on how the current EC regulatory proposal would affect the environment, health or consumer protection will be informative for decision makers and politicians.
Biology and Life Sciences, Biology and Biotechnology
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