TWN Info Service on Biosafety
27 February 2024
Third World Network
www.twn.my
Dear Friends and Colleagues
EU Path of Deregulation of NGTs Carries Environmental and Health Risks
The European Commission’s regulatory proposal on plants generated with new genomic techniques (NGTs) issued in July 2023 categorizes NGT plant applications based on their molecular characteristics, into category 1 NGT (NGT1) and category 2 NGT (NGT2), which is in divergence from the current legislation on GMOs.
This study sought to determine where the path of this proposal would lead to in practice, based on NGT plant applications 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.
The study also reveals that current NGT1 applications clearly have potential risks for both environment and health. Importantly, the regulatory proposal does not foresee any instrument to withdraw any authorization for NGT1 plants, even in cases where a hazard might be shown after release. The EC proposal for NGT1 plants might additionally act as incentive to design new plant varieties fulfilling the criteria for NGT1 and lead to more NGT1 plant applications entering the market without environmental risk assessment.
The study concludes that the analysis of a presumed equivalency with conventional plants is not a suitable criterion for assuming the safety of the NGT plant applications. Thus, proof that these applications pose less risks than other products of genetic engineering (i.e. transgenics) would be necessary. As the EU’s decision on NGTs will have far-reaching impacts on the environment, land usage and biodiversity, the authors call for it to decide responsibly which path it wants to take, based on the precautionary principle.
With best wishes,
Third World Network
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WHERE DOES THE EU-PATH ON NGTS LEAD US?
Bohle, F., Schneider, R., Mundorf, J., Zühl, L., Simon, S., & Engelhard, M.
Federal Agency for Nature Conservation, Germany
https://www.preprints.org/manuscript/202311.1897/v1
30 November 2023
(Preprint, not peer reviewed)
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.