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Date Published: 28/06/2025
Online Published: 14/05/2025
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DOI: https://doi.org/10.56283/1859-0381/892
Issue
Vol. 21 No. 3 (2025)
Section
ORIGINAL RESEARCH
How to Cite
1.
DOAN TTL, DAO GB, LUU TTN, et al. COMPREHENSIVE IN VITRO ASSESSMENT OF THE SAFETY PROFILE OF Bacillus subtilis Eramic 25 AND ITS POTENTIAL FOR APPLICATION IN THE DEVELOPMENT OF FUNCTIONAL FOODS AND HEALTH SUPPLEMENTS. Tạp chí Dinh dưỡng và Thực phẩm. 2025;21(3):1-12. doi:10.56283/1859-0381/892

COMPREHENSIVE  IN VITRO ASSESSMENT OF THE SAFETY PROFILE OF Bacillus subtilis Eramic 25 AND ITS POTENTIAL FOR APPLICATION IN THE DEVELOPMENT OF FUNCTIONAL FOODS AND HEALTH SUPPLEMENTS

Thi Thuy Linh DOAN1, Gia Bach DAO2, Thi Thuy Ngan LUU1, Ba Binh NGO1, Thi Thanh Hoa HOANG2, Vu Trung NGUYEN3, Thi Hoi LE2,
1 Eramic Technology Era Joint Stock Company, Vietnam
2 Hanoi Medical University, Vietnam
3 Pasteur Institute in Ho Chi Minh City

Main Article Content

Abstract

Aims: This study aimed to comprehensively assess the in vitro safety profile of Bacillus subtilis Eramic 25 in accordance with the guidelines of GRAS, the United States Food and Drug Administration (FDA), and the European Food Safety Authority (EFSA), through the evaluation of antimicrobial activity, cytotoxicity, and the presence of antibiotic resistance and virulence genes associated with safety.

Methods: The conducted assays included the evaluation of antibacterial activity against pathogenic bacteria, cytotoxicity testing on two cell lines, Vero and HT-29, as well as genomic analysis to identify the presence of virulence genes and antibiotic resistance genes

Results: The B. subtilis Eramic 25 strain does not inhibit selected common pathogens, and exhibits no cytotoxic effects on Vero and HT-29 cell lines. Furthermore, genomic analysis confirmed that this strain does not genes encoding for toxins and hemolytic genes. Antibiotic resistance genes are not located on plasmids or transposable elements, indicating a very low risk of horizontal gene transfer of antibiotic resistance.

Conclusion: B. subtilis Eramic 25 meets the in vitro safety criteria recommended by GRAS, FDA, and EFSA. These findings support the potential application of this strain in the production of probiotics, functional foods, and food products for human consumption, and provide a basis for animal studies and clinical trials on human.

Keywords

𝐵𝑎𝑐𝑖𝑙𝑙𝑢𝑠 𝑠𝑢𝑏𝑡𝑖𝑙𝑖𝑠, cytotoxin, toxin genes, antibiotic resistance genes

Article Details

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