Evidence mapPaperPMID 42494136Full record

ReviewJournal of microbiology and biotechnology2026

Key Safety Criteria for Novel Microbial Food Ingredients: A Comparative Analysis of International Regulatory Frameworks.

Yejin Choi, Ji-Seon Hwang, Hyunok Doo, Jinok Kwak, Juyoun Kang, Haram Kim, Yeongjae Chae, Suyoung Lee, Sheena Kim, Ju-Hoon Lee and 1 more

Abstract readReviewComparative Study
In one paragraph

Review in Journal of microbiology and biotechnology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Yejin ChoiDepartment of Animal Biotechnology, Dankook University, Cheonan 31116, Republic of Korea.
Ji-Seon HwangDepartment of Agricultural Biotechnology, Seoul National University, Seoul 08826, Republic of Korea.
Hyunok DooDepartment of Animal Biotechnology, Dankook University, Cheonan 31116, Republic of Korea.
Jinok KwakDepartment of Animal Biotechnology, Dankook University, Cheonan 31116, Republic of Korea.
Juyoun KangDepartment of Animal Biotechnology, Dankook University, Cheonan 31116, Republic of Korea.
Haram KimDepartment of Animal Biotechnology, Dankook University, Cheonan 31116, Republic of Korea.
Yeongjae ChaeDepartment of Animal Biotechnology, Dankook University, Cheonan 31116, Republic of Korea.
Suyoung LeeDepartment of Animal Biotechnology, Dankook University, Cheonan 31116, Republic of Korea.
Sheena KimDepartment of Animal Biotechnology, Dankook University, Cheonan 31116, Republic of Korea.
Ju-Hoon LeeDepartment of Agricultural Biotechnology, Seoul National University, Seoul 08826, Republic of Korea.
Hyeun Bum KimDepartment of Animal Biotechnology, Dankook University, Cheonan 31116, Republic of Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the context of the research on food ingredients, "novel microorganisms (NMs)" refers to microorganisms without a documented history of safe consumption. The utilization of these novel microorganism-derived ingredients is expanding rapidly within the food and nutrition sectors, and such ingredients are broadly classified into three categories, live microorganisms, non-viable bacteria, and purified metabolites, each characterized by distinct risk profiles and unique regulatory requirements. Despite their growing prevalence, a globally harmonized protocol for safety assessment is currently lacking, leading individual nations to implement disparate safety frameworks within their respective regulatory systems. Consequently, this review aimed to provide a scientific foundation for the standardization of safety criteria by performing a comparative analysis of established guidelines from the European Union (EFSA), United States (FDA), Canada (Health Canada), Brazil (ANVISA), Thailand (Thai FDA), India (FSSAI), Japan (FSCJ), and Australia/New Zealand (FSANZ). Our analysis identified several universal safety parameters for live NMs, including hemolytic activity, antimicrobial resistance (AMR), toxigenic potential, the production of antimicrobial substances, metabolic profiling, and toxicological assessment. While toxicological evaluation, the production of antimicrobial substances, and the absence of live NMs were the consensus criteria for the safety evaluation of non-viable bacteria and purified microbial metabolites, an allergenicity evaluation is additionally required for purified microbial metabolites. Based on our analysis, this review proposed safety standards for novel microbial food ingredients including live microorganisms, non-viable bacteria, and purified metabolites by synthesizing these diverse regulatory landscapes.

Indexed as

Food IngredientsFood MicrobiologyFood SafetyBacteriaCanadaHumansUnited StatesFood IngredientsFood safetyMetabolitesNon-viable bacteriaNovel microorganisms

Identifiers

PMID42494136
PMCPMC13402210

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.