EU Commission wants to exempt many New GE plants from risk assessment

Proposed deregulation goes against science

5 July 2023 / The EU Commission today published a proposal for the deregulation of plants derived from of New GE (new genetic engineering or new genomic techniques, NGTs). For this purpose, the Commission has attempted to establish a new ‘Category 1’ of plants derived from New GE processes which would be exempt from current GMO regulation. New GE plants in this new category would be seen as safe as those derived from conventional breeding. The plants would not be subjected to mandatory risk assessment, they would only require notification. In addition, there would be no labelling requirements for food derived from these plants or a request for methods of detection.

As shown in a backgrounder published by Testbiotech today, the proposed criteria lack scientific support. If applied, the criteria would lead to New GE plants that are substantially different from those achieved with conventional breeding being classified as equivalent and could be marketed and released without specific controls.

One example of plants that may escape future regulation are the well-known GABA tomatoes, which are supposed to have a blood-pressure lowering effect. There was broad criticism of the fact that none of the risks to health or the environment from these CRISPR/Cas fruits were investigated before being brought to market in Japan. According to the new proposed regulation, the intended characteristics of the tomatoes might be investigated under the ‘novel food’ act, but issues such as unintended genetic changes and effects on the environment may be set aside.

Another example is CRISPR/Cas camelina with a change in its oil composition that strongly differs from that in conventionally-bred plants, and which are intended for use in agrofuels production. These plants may also be exempt from current regulation. As a consequence, they could spread uncontrolled into the environment and also enter the food chain unnoticed, despite not having undergone detailed health or environmental risk assessment.

In both cases, it seems the number and size of the genetic changes falls within the new category that is meant to define equivalence to conventional breeding. In fact, the genetic differences are so significant that it would be no problem to develop methods to detect such plants.

In general, the proposed criteria seem to be arbitrary and unclear, making them difficult to interpret in detail. For example, the number of genetic changes as suggested as criteria to make distinctions, lacks any scientific justification. Furthermore, the criteria do not comprise hugely relevant genomic characteristics such as differences in the site of intended and unintended mutations, the resulting gene combinations and their specific effects are all disregarded.

Another reason for concern: according to the EU Commission proposals, New GE-plants belonging to non-domesticated trees, grasses, mosses and algae could be exempt from regulation. Many of the respective species can spread in the ecosystems beyond the fields and have the potential to disturb and disrupt the ecological networks.

Due to the intended and unintended genetic changes that can result from processes of New GE, Testbiotech concludes that process-based risk assessment will remain a necessity for all NGT organisms, even in future. Without detailed risk assessment, no conclusion can be drawn on whether or not a New GE plant may be considered to be as safe as a plant derived from conventional breeding. Therefore, Testbiotech proposes deleting this category from the regulatory proposal.

Christoph Then,, Tel + 49 151 54638040