Food and Fermentation Industries >

2026 , Vol. 52 >Issue 2: 421 - 428

DOI: https://doi.org/10.13995/j.cnki.11-1802/ts.042722

Research progress on safety evaluation of probiotics

  • PANG Xuechun ,
  • CHENG Ying ,
  • YOU Chunping
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  • 1(State Key Laboratory of Dairy Biotechnology, Shanghai Engineering Research Center of Dairy Biotechnology, Dairy Research Institute, Bright Dairy & Food Co.Ltd., Shanghai 201103, China)
    2(School of Food Science and Technology, Shanghai Ocean University, Shanghai 201306, China)

Received date: 2025-03-14

  Revised date: 2025-06-05

  Online published: 2026-03-18

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Abstract

With the development of the health industry, probiotics are increasingly becoming part of people’s daily dietary lives.Conducting safety evaluations of probiotics at the strain level is of significant importance for human health.This study systematically reviews the research progress on the safety evaluation of probiotics based on the research achievements of experts both domestically and internationally, as well as related guidance documents on probiotic safety.It summarizes the standard procedures for safety evaluation and provides an outlook on the future development trends of evaluation methods.The safety evaluation process for probiotics comprises four components, including analysis of domestic and international safety evaluation data, strain classification and identification, in vitro assessments, and in vivo evaluations.Analysis of domestic and foreign safety evaluation data refers to a comprehensive analysis of the domestic and foreign use history and safety of bacterial species (including but not limited to their pathogenicity and toxicity-producing ability reports, clinical trial data, scientific and technological literature or reviews, etc.).The most effective method for strain classification and identification is whole genome sequencing, which assesses strain safety by analyzing virulence genes, genes related to undesirable characteristics, and antibiotic resistance genes in probiotics.In vitro evaluation includes testing for hemolytic activity, biogenic amine levels, antibiotic resistance, and D-lactic acid production.In vivo evaluation is primarily based on toxicological evaluation using animal models.This paper provides new ideas and theoretical references for selecting probiotic safety evaluation methods and alternative toxicological models.

Key words： probiotics; safety; genetic analysis; phenotypic testing; alternatives; food safety

Cite this article

PANG Xuechun , CHENG Ying , YOU Chunping . Research progress on safety evaluation of probiotics[J]. Food and Fermentation Industries, 2026 , 52(2) : 421 -428 . DOI: 10.13995/j.cnki.11-1802/ts.042722

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