ArticleEFSA journal. European Food Safety Authority2024
EFSA statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain.
Article in EFSA journal. European Food Safety Authority, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 86 papers.
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Who cites it
86 citing papers in PubMed.
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- Towards an Omics-Guided Framework for Microbial Biological Control of Fungal and Oomycete Diseases inInternational journal of molecular sciences · 2026Review
- Current Single-cell Proteins as Ingredients: Functions, Challenges, and Regulatory Frameworks.Journal of microbiology and biotechnology · 2026Review
- Safety and efficacy of a feed additive consisting of l-threonine produced usingEFSA journal. European Food Safety Authority · 2026Article
- Comprehensive Evaluation of Safety and Probiotic Potential of Lactiplantibacillus plantarum HY7715 Isolated from Korean kimchi.Probiotics and antimicrobial proteins · 2026Article
- Safety and efficacy of feed additives consisting of l-lysine monohydrochloride and liquid l-lysine produced withEFSA journal. European Food Safety Authority · 2026Article
- Safety and efficacy of the feed additives consisting of l-isoleucine ≥ 90% and l-isoleucine ≥ 65% produced withEFSA journal. European Food Safety Authority · 2026Article
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- Screening of Fermentative Strains for Reducing the Allergenicity of a Whey Protein-Soy Protein System and Genomic Characterization of the Selected Strain.Foods (Basel, Switzerland) · 2026Article
- Whole-Genomic and Functional Characterization ofMicroorganisms · 2026Article
- Safety and efficacy of a feed additive consisting of l-isoleucine produced withEFSA journal. European Food Safety Authority · 2026Article
- Key Safety Criteria for Novel Microbial Food Ingredients: A Comparative Analysis of International Regulatory Frameworks.Journal of microbiology and biotechnology · 2026Review
- Safety of lacto-N-triose II as a novel food pursuant to Regulation (EU) 2015/2283.EFSA journal. European Food Safety Authority · 2026Article
- Safety and Next-Generation Probiotic Potential of Mitsuokella multacida AGMB01124 Newly Isolated from Healthy Swine Feces.Probiotics and antimicrobial proteins · 2026Article
- Safety and efficacy of a feed additive consisting of l-leucine produced withEFSA journal. European Food Safety Authority · 2026Article
- Safety ofEFSA journal. European Food Safety Authority · 2026Article
- Evolving Approaches to Bacterial Identification: A Review of Classical and Modern Techniques.International journal of molecular sciences · 2026Review
- A WGS workflow for identifying genetically modified and foodborne-pathogenicFood chemistry. Molecular sciences · 2026Article
26 more citing papers are in PubMed but not listed here.
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Authors and funding
1 author.
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Abstract
Microorganisms, genetically modified or not, may be used in the food chain either as active agents, biomasses or as production organisms of substances of interest. The placement of such microorganisms or their derived substances/products in the European market may be subject to a premarket authorisation process. The authorisation process requires a risk assessment in order to establish the safety and/or the efficacy of the microorganism(s) when used in the food chain as such, as biomasses or as production strains. This includes a full molecular characterisation of the microorganism(s) under assessment. For certain regulated products, the use of whole genome sequence (WGS) data of the microorganism is established as a requirement for the risk assessment. In this regard, data obtained from WGS analysis can provide information on the unambiguous taxonomic identification of the strains, on the presence of genes of concern (e.g. those encoding virulence factors, resistance to antimicrobials of clinical relevance for humans and animals, production of harmful metabolites or of clinically relevant antimicrobials) and on the characterisation of genetic modification(s) (where relevant). This document provides recommendations to applicants on how to describe and report the results of WGS analyses in the context of an application for market authorisation of a regulated product. Indications are given on how to perform genome sequencing and the quality criteria/thresholds that should be reached, as well as the data and relevant information that need to be reported, if required. This updated document replaces the EFSA 2021 Statement and reflects the current knowledge in technologies and methodologies to be used to generate and analyse WGS data for the risk assessment of microorganisms.
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