EFSA releases draft scientific opinion on new developments in biotechnology applied to animals

The European Food Safety Authority (EFSA) has been tasked by the European Commission to evaluate recent advancements in biotechnology, particularly focusing on synthetic biology (SynBio) and new genomic techniques (NGTs) relevant to farmed animals—encompassing mammals, birds, fish, and invertebrates—bred for food, feed, and other agricultural products. This comprehensive assessment addresses all safety aspects related to NGT animals, including food and feed safety, animal health and welfare, and environmental safety.  

The initiative identifies a range of NGT animals poised to enter the EU market in the short, medium, and long term, featuring traits such as resistance to diseases and environmental stress, as well as hypoallergenic food products. While EFSA has previously issued four reports on NGTs, these focused solely on plants and microorganisms.  

A comprehensive horizon scanning exercise identified various NGT animals that could soon be available in the EU. These animals have been developed using techniques like site-directed nucleases (SDN), which modify DNA without the introduction of foreign genetic material. Most NGT applications have utilized SDN-1 techniques, followed by SDN-3 and SDN-2. Among the various techniques employed, CRISPR/Cas has emerged as the most frequently used. The primary traits targeted include increased meat and fiber yield, reproduction, biotic stress resistance, and production of hypoallergenic products.  

The assessment found that no novel hazards were associated with these genomic modifications when compared to traditional breeding methods. Specifically, the risks linked to SDN-1 and SDN-2 modifications were deemed comparable to conventional breeding, with no new potential hazards anticipated for humans, animals, or the environment.  
Additionally, the potential risks associated with SDN-3 modifications were found to be similar to those of established genomic techniques. The evaluation also noted that off-target mutations from genome editing are akin to those from conventional breeding, further supporting the conclusion that no new risks arise from these modifications.  

However, EFSA noted that existing guidelines might require updates to fully address certain areas, particularly concerning animal welfare and health. As the landscape of biotechnological advancements continues to evolve, EFSA's ongoing evaluation will help ensure that risk assessment frameworks remain robust and comprehensive.

In light of this, EFSA has launched a public consultation on its draft scientific opinion, running from January 22 to March 19. Interested parties are encouraged to submit their comments by the specified deadline, making sure to reference the relevant line and page numbers in their feedback. Additional data or supporting files can also be submitted using the designated function in the digital form.  

The findings underscore the significance of adapting regulatory frameworks to keep pace with innovations in the agri-food sector. It is anticipated that the Commission is gathering information to prepare a regulatory process for NGT animals, similar to the 2023 proposal for NGT plants currently under consideration by the European Parliament and Council, which exempts NGT1 plants from GMO regulations.    

 

Source:  

EFSA