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Lower risk classification of “NGT1“ plants scientifically untenable

- According to the plans of the EU Commission, new genetically modified plants in the “NGT1“ category could be released in future without risk assessment and labelling because they allegedly pose a lower risk. This is scientifically not justifiable, as shown by a preliminary publication from the Federal Agency for Nature Conservation (BfN).

Federal Agency for Nature Conservation (BfN)

According to the EU Commission's current draft legislation, certain genetically modified plants produced using NGT are to be exempted from the applicable European legal framework for genetically modified organisms (GMOs). The categorisation of “NGT1 plants“, which according to the Commission's proposal are supposed to pose a lower risk than “conventional” GMOs, is justified by the fact that the genetic modifications are allegedly equivalent to those occurring in nature or in conventional breeding (“presumption of equivalence“). Estimates suggest that 94 percent of all NGT plants would fall into the “NGT1“ category.

Equating NGT with conventional breeding is inadmissible

Three staff members of the German Federal Agency for Nature Conservation (BfN) have scientifically examined the criteria for classification as “NGT1“. In their study, which has now been published in advance as a “Preprint“, they conclude that the approach of equating certain NGT applications with conventional breeding is inadmissible in such a general manner: “The proposal does not take into account the risk-related intended and unintended effects on the phenotype. It is therefore neither scientifically justified nor suitable for adequately addressing the potential risks of NGT plants,“ the authors say. The proposed presumption of equivalence is therefore not scientifically justified in its current form and is not adequate for protection under the precautionary principle.

The hazard potential posed by the risks mentioned in the publication is even assessed as “significant“ should the cultivation of NGT1 plants increase significantly in the European Union. Only a case-by-case assessment can keep pace with technical progress, including the use of artificial intelligence (AI), and ensure future-proof regulation.

Commission proposal scientifically immature and untenable

The publication by BfN staff clearly shows that the EU Commission's proposal is not scientifically justified and needs to be revised urgently. An arbitrary and unscientific risk classification of NGT plants must not form the basis of future European consumer protection. All NGTs should continue to be subject to the proven EU genetic engineering legislation, as the European Court of Justice already ruled in its landmark decision in 2018.

Juliane Mundorf, Samson Simon, Margret Engelhard: The European Commission’s Regulatory Proposal on New Genomic Techniques in Plants: A Spotlight on Equivalence, Complexity, and Artificial Intelligence (Preprint)

Bohle, Schneider, Mundorf, Zühl, Simon, Engelhard: Where does the EU-path on new genomic techniques lead us?

Deliberate circumvention of risk assessment for NGT plants with ChatGPT

Start of trilogue negotiations on the regulation of new genetic engineering