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

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Title: New developments in biotechnology applied to animals: An assessment of the adequacy and sufficiency of current EFSA guidance for animal risk assessment.
Authors: Casacuberta, Josep (AUTHOR), Barro, Francisco (AUTHOR), Braeuning, Albert (AUTHOR), de Maagd, Ruud (AUTHOR), Epstein, Michelle M. (AUTHOR), Frenzel, Thomas (AUTHOR), Gallois, Jean‐Luc (AUTHOR), Koning, Frits (AUTHOR), Messéan, Antoine (AUTHOR), Moreno, F. Javier (AUTHOR), Nogué, Fabien (AUTHOR), Schulman, Alan H. (AUTHOR), Tebbe, Christoph (AUTHOR), Veromann, Eve (AUTHOR), Firbank, Leslie (AUTHOR), Glandorf, Debora (AUTHOR), Herskin, Mette S. (AUTHOR), Lillico, Simon Geoffrey (AUTHOR), Ornsrud, Robin (AUTHOR), Troedsson‐Wargelius, Anna (AUTHOR)
Source: EFSA Journal. Aug2025, Vol. 23 Issue 8, p1-63. 63p.
Subject Terms: *Biotechnology, *Food safety, *Agriculture, Risk assessment, Genome editing, Genomics
Company/Entity: European Food Safety Authority , European Union , European Commission
Abstract: 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. [ABSTRACT FROM AUTHOR]
Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: New developments in biotechnology applied to animals: An assessment of the adequacy and sufficiency of current EFSA guidance for animal risk assessment.
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  Data: <searchLink fieldCode="AR" term="%22Casacuberta%2C+Josep%22">Casacuberta, Josep</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Barro%2C+Francisco%22">Barro, Francisco</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Braeuning%2C+Albert%22">Braeuning, Albert</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22de+Maagd%2C+Ruud%22">de Maagd, Ruud</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Epstein%2C+Michelle+M%2E%22">Epstein, Michelle M.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Frenzel%2C+Thomas%22">Frenzel, Thomas</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gallois%2C+Jean‐Luc%22">Gallois, Jean‐Luc</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Koning%2C+Frits%22">Koning, Frits</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Messéan%2C+Antoine%22">Messéan, Antoine</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Moreno%2C+F%2E+Javier%22">Moreno, F. Javier</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Nogué%2C+Fabien%22">Nogué, Fabien</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Schulman%2C+Alan+H%2E%22">Schulman, Alan H.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Tebbe%2C+Christoph%22">Tebbe, Christoph</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Veromann%2C+Eve%22">Veromann, Eve</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Firbank%2C+Leslie%22">Firbank, Leslie</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Glandorf%2C+Debora%22">Glandorf, Debora</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Herskin%2C+Mette+S%2E%22">Herskin, Mette S.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lillico%2C+Simon+Geoffrey%22">Lillico, Simon Geoffrey</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ornsrud%2C+Robin%22">Ornsrud, Robin</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Troedsson‐Wargelius%2C+Anna%22">Troedsson‐Wargelius, Anna</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22EFSA+Journal%22">EFSA Journal</searchLink>. Aug2025, Vol. 23 Issue 8, p1-63. 63p.
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  Data: *<searchLink fieldCode="DE" term="%22Biotechnology%22">Biotechnology</searchLink><br />*<searchLink fieldCode="DE" term="%22Food+safety%22">Food safety</searchLink><br />*<searchLink fieldCode="DE" term="%22Agriculture%22">Agriculture</searchLink><br /><searchLink fieldCode="DE" term="%22Risk+assessment%22">Risk assessment</searchLink><br /><searchLink fieldCode="DE" term="%22Genome+editing%22">Genome editing</searchLink><br /><searchLink fieldCode="DE" term="%22Genomics%22">Genomics</searchLink>
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  Data: <searchLink fieldCode="DE" term="%22European+Food+Safety+Authority%22">European Food Safety Authority</searchLink> <br /><searchLink fieldCode="DE" term="%22European+Union%22">European Union</searchLink> <br /><searchLink fieldCode="DE" term="%22European+Commission%22">European Commission</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: 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. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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