Roadmap for the integration of gastro‐intestinal (GI) tract microbiomes (human and domestic animal) in risk assessments under EFSA's remit

Abstract

This report describes the work developed during the execution of the Review Impact MICrobiome In Assesment (RIMICIA) project. This project has performed a comprehensive and critical assessment of the evidence-based research about: i) the impact of dietary compounds in the human and some domestic animals (i.e., poultry, ruminants and pigs) gut microbiome; ii) the most representative in vitro and in vivo models of the human gut microbiota currently used in microbiome research studies; and iii) the methodology used to measure changes in the microbiota. This project has also gathered and appraised information www.efsa.europa.eu/publications EFSA Supporting publication 2024:EN-8597The present document has been produced and adopted by the bodies identified above as authors. In accordance with Article 36 of Regulation (EC) No 178/2002, this task has been carried out exclusively by the authors in the context of a grant agreement between the European Food Safety Authority and the authors. The present document is published complying with the transparency principle to which the Authority is subject. It cannot be considered as an output adopted by the Authority. The European Food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors.2Organisation for Economic Co-operation and Development (OECD) or other international test guidelines and, ultimately, into regulatory programs.

Novel foods, food enzymes, and food additives derived from food by-products of plant or animal origin: principles and overview of the EFSA safety assessment

“…This translates through addressing challenges such as zoonotic and (re-)emerging infectious diseases, non-communicable diseases linked to environmental risk factors, antimicrobial resistance (AMR), and climate change mitigation ( 80–82 ). For instance, in the context of antimicrobial resistance, the incorporation of the gut microbiome in food safety risk assessment of xenobiotics is also investigated to elucidate their involvement in the balance between health and disease ( 83 , 84 ). Additionally, the use of alternative tools, such as New Approach Methodologies, is also investigated for the new risk assessment approaches, fostering a future with less or no animal testing in food safety ( 85–87 ).…”

Roadmap for the integration of environmental microbiomes in risk assessments under EFSA's remit

“…Considering the integrated perspective of the One Health framework, the implementation of guidance or methodology to systematically account for possible effects on microbiomes or effects by microbiomes on human/animal/plant health has become necessary. Two thematic grants were awarded in 2020: one to evaluate the impact on/by gastro-intestinal (GI) tract microbiomes (human and domestic animal) in assessments under EFSA's remit (Lot 1; see Moreno et al, 2023Moreno et al, , 2024; and one to evaluate the impact on/by environmental microbiomes (plants, wildlife, soil) in assessments under EFSA's remit (Lot 2).…”

New developments in biotechnology applied to microorganisms

“…Therefore, the term microbiome is broader than microbiota (Hou et al., 2022 ). No EFSA guidance addresses the impact of NGT‐Ms on the gut microbiome (Moreno et al., 2024 ). However, the term gut microbiota and the requirements to assess the impact on the human and animal gut are mentioned in the GMM guidance (EFSA GMO Panel, 2011a ).…”