Comprehensive analysis of the legislative proposal made by the EU Commission
31 August 2023 / Testbiotech has today published a comprehensive analysis of the EU Commission proposal for the future deregulation of plants obtained from new genetic engineering (New GE or NGT). This is part of an EU-wide consultation. Currently, all organisms derived from genetic engineering processes must undergo risk assessment before they can be released, cultivated or consumed as food. The Commission now wants to abandon this basic principle of EU legislation. Testbiotech, however, is warning against such far-reaching deregulation.
Most New GE plants will in future simply need to be registered, and will not be subject to the mandatory risk assessment currently required. New GE plants will be legally equated with conventionally-bred plants, i. e. deregulated, even if they are biologically different.
The new legislation would not only apply to annual crops: wild, non-domesticated species, such as trees, wild herbs, grasses, mosses or algae, which can also spread in particularly sensitive ecosystems, could also be approved for release into the environment without further controls. The consequences for nature and the environment would not be monitored, and there would be no concepts or measures for removing New GE plants from the environment if this became necessary.
CRISPR/Cas gene scissors, in particular, have the potential to alter gene functions and properties of plants in ways that would not be expected through conventional breeding. The risks to humans and the environment cannot be regarded as lower in comparison to transgenic plants.
Many mutations in the genome of plants also occur naturally or arise from non-targeted mutagenesis processes. However, most of these mutations have no direct effect on the phenotype of the plants. If they do affect plant traits, it is usually not beyond the natural range of traits of the individual species. However, these biological limits do not apply to gene scissors - or only to a very limited extent. Even without inserting additional genes, the use of New GE can result in intended and unintended changes that go beyond the known characteristics of the individual species.
The technical potential and also the technical shortcomings of tools like CRISPR/Cas, make it essential that all genetic engineered organisms continue to be subject to in-depth risk assessment in the future. This includes using appropriate analytical procedures to assess the intended and unintended genetic changes caused by New GE processes for direct and indirect, immediate or delayed, and cumulative long-term effects.
New GE plants that have the potential to persist in the environment, where they can reproduce and spread for several years, must be particularly closely examined in this context. In case of major uncertainties they must not be released. In general, the introduction of genetically engineered organisms into the environment should be limited as far as possible. As is the rule elsewhere in sensitive areas of nature conservation, any interventions into the environment must be avoided as far as possible.
Christoph Then, firstname.lastname@example.org, Tel + 49 151 54638040