Food and feed safety considerations for gene-edited and other genetically modified crops

Whilst transgenic food crops have been grown at a large scale since the mid-1990s, new plant breeding techniques, in particular gene editing, have recently started to emerge. For transgenic crops, a food and feed safety assessment usually has to be carried out under the legislation of many countries, and if found safe, these thus can be approved for marketing. This safety assessment is done according to an internationally harmonized approach involving the comparison between a genetically modified (GM) crop and its conventional non-GM counterpart. This includes an extensive compositional and phenotypic analysis, focusing on the differences to be found. The question arises if gene editing will challenge this current paradigm so that adjustment may be desirable. Elements of the assessment that are recurrent in most of the current application dossiers for transgenic crops include an extensive comparative analysis of compositional and phenotypic parameters of the plant, potential toxicity and allergenicity, nutritional impact, and the possibility for post-market monitoring. The EFSA GMO Panel has considered the possible reasons for modifying risk assessment requirements. It noted that, for the various types of DNA mutations which can be created, the current guidance is still applicable but that some flexibility is needed as less data will be needed on a case-by-case basis, owing to the higher precision of the modifications. Various countries already have started implementing regulations that accommodate gene editing, pointing at the similarity of some of the modifications, to those that also could have been obtained through conventional breeding and mutagenesis.