Relevance of new scientific information (Santos‐Vigil et al., 2018*) in relation to the risk assessment of genetically modified crops with Cry1Ac

allergenicity, adjuvanticity, Cry1Ac, Bt protein, GMOs, GM plant
First published in EFSA Supporting Publications
14 November 2018
9 November 2018
Technical Report


Following a request from the European Commission, EFSA assessed the scientific publication by Santos‐Vigil et al. (2018). The outstanding question was whether or not the new scientific information contains elements that could lead the EFSA GMO Panel to reconsider the outcome of its previous risk assessments on genetically modified crops expressing Cry1Ac protein. Santos‐Vigil et al. (2018) investigated the allergenic potential and immunological effects of the Cry1Ac protein and compared it with ovalbumin after intragastric administration to BALB/c mice, using a specific model of food‐allergy. Shortcomings in the study design and data interpretation limit the possibility to attribute findings to the intrinsic properties of the Cry1Ac protein. The publication by Santos‐Vigil et al. (2018) does not bring new elements that would lead the EFSA GMO Panel to reconsider the outcome of its previous scientific opinions on genetically modified crops with Cry1Ac. Therefore, EFSA considers that the previous risk assessment conclusions on GM crops with Cry1Ac remain valid and applicable.

gmo [at]
Question Number
On request from
European Commission