New developments in biotechnology applied to animals: An assessment of the adequacy and sufficiency of current EFSA guidance for animal risk assessment.

EFSA was requested by the European Commission to provide a scientific opinion on new developments in biotechnology, including new genomic techniques, as applied to animals for food, feed and other agricultural uses. A horizon-scanning exercise identified a variety of animals obtained with new genomic techniques, with the potential to reach the EU market in the short, medium and long term. No novel hazards have been identified that are linked to either the modification process or the newly introduced trait, when SDN-1, SDN-2 and comparable techniques (e.g. base editing or prime editing) were compared to established genomic techniques (EGTs) or conventional breeding. Hazards posed by SDN-3 are of the same nature as those posed by EGTs and the targeted insertion may reduce the potential hazards associated with the disruption of endogenous genes and/or regulatory elements in the recipient genome. Hazards posed by the new trait resulting from the introduced transgenic or intragenic DNA sequence are of the same nature as those posed by EGTs. Hazards posed by the new trait resulting from the introduced cisgenic DNA sequence are of the same nature as those posed by conventional breeding. Off-target mutations from genome editing are similar in nature to those from conventional breeding and do not pose novel hazards. Consequently, based on the currently available data, no new potential hazards, and thus, no new risks to humans, animals or the environment have been identified. A thorough evaluation of existing EFSA guidance documents for the risk assessment of GM animals revealed that their principles and recommendations provide the basis for assessing the risks of new genomic technique (NGT) animals for food, feed and other agricultural uses; however, the current texts cover only partially some areas (e.g. animal health and welfare) and may need updates, adaptations or enhancements on a case-by-case basis to fully address NGT-related risks.