The European Food Safety Authority (EFSA) Panel on Genetically Modified Organisms (GMO) has concluded that, under specific conditions, field trials for comparative analysis may not always be required for the risk assessment of genetically modified plants containing stacked transformation events obtained by conventional crossing. In a statement published on 9 July 2026 and adopted on 17 June 2026, the GMO Panel reviewed 20 years of experience from 61 applications and proposed criteria for derogations from current data requirements, while maintaining consumer and environmental protection.
The statement addresses three terms of reference from EFSA. First, the GMO Panel summarized its experience assessing stacked events between 2003 and 2025, finding that most stacks involved herbicide tolerance or insect resistance traits achieved through newly expressed proteins (NEPs), and that none of the comparative analyses indicated unexpected interactions between events. Second, the Panel recommended improvements in how applicants present molecular characterization data, including a tabular format for sequencing, bioinformatic analysis, and protein expression data to facilitate interaction assessment. Third, the Panel defined two criteria under which comparative field trials may be waived: all intended traits in the stack must be achieved through NEPs, and none of those NEPs should be a metabolic modifier. When these criteria are met, a derogation may be considered on a case-by-case basis under Article 5(2) of Implementing Regulation (EU) 503/2013. Additionally, if no interactions affect NEP expression levels, a derogation from dietary exposure assessment may also be considered.
The statement impacts several stakeholders. For applicants (biotechnology companies), the streamlined requirements could reduce the cost and time of field trials for certain stacks, lowering regulatory burdens. For EFSA and national competent authorities, the case-by-case derogation approach introduces flexibility but may require additional scrutiny to verify that conditions are met. For consumers, the Panel asserts that the highest level of protection is maintained, as the derogation only applies when traits are well-characterized and non-metabolic. For environmental and civil society groups, the change may raise concerns about reduced empirical data, though the Panel emphasizes that all stacks must still include a structured discussion of potential interactions. The statement does not alter existing requirements for single-event risk assessments or for stacks involving RNA interference or other non-NEP traits.