Following a request from the European Commission, [the European Food Safety Authority] assessed the scientific publication by Santos‐Vigil et al. (2018). The outstanding question was whether or not the [Santos‐Vigil study] contains elements that could lead the EFSA GMO Panel to reconsider the outcome of its previous risk assessments on [Bt insect-resistant] genetically modified crops ….
The EFSA GMO Panel assessed the safety of [Bt insect-resistance] in the context of various GM plants applications (table 1) [beginning in 2010] …. the EFSA GMO Panel assessed different variants of the Cry1Ac proteins, all fully characterized in structure and function, and did not identify concerns regarding the safety of any of them.
Santos Vigil et al. (2018) report that Cry1Ac is moderately allergenic, able to
provoke intestinal lymphoid hyperplasia, and even to trigger anaphylaxis in a specific animal model
under the experimental conditions tested ….
…[I]t has been experimentally shown that no [allergenic] effect is detectable when Cry proteins are expressed at the levels observed in the GM plants so far assessed by the EFSA GMO Panel …. Consequently, on the basis of available knowledge, EFSA and other risk assessment bodies conclude that there are currently no indications of safety concern …. in the context of the GM plants assessed.
Therefore, EFSA considers that the previous risk assessment conclusions on GM crops with Cry1Ac remain valid and applicable.