Safety evaluation of the food enzyme bacillolysin from the non-genetically modified Bacillus amyloliquefaciens strain DP-Cyb74
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View abstract on PubMed
Summary
This summary is machine-generated.The food enzyme bacillolysin, produced by a non-genetically modified Bacillus amyloliquefaciens strain, is safe for use in food manufacturing. Allergenicity assessments confirmed a low likelihood of allergic reactions in consumers.
Area Of Science
- Food enzyme safety assessment
- Microbiology and biotechnology
- Toxicology and allergenicity
Background
- Bacillolysin (EC 3.4.24.28) is a food enzyme produced by Bacillus amyloliquefaciens DP-Cyb74.
- The production strain meets Qualified Presumption of Safety (QPS) requirements.
- The enzyme is intended for use in six food manufacturing processes.
Purpose Of The Study
- To assess the safety of bacillolysin for use in food.
- To evaluate potential risks associated with dietary exposure.
- To determine the necessity of toxicological studies beyond allergenicity assessment.
Main Methods
- Safety assessment based on the Qualified Presumption of Safety (QPS) approach.
- Evaluation of the enzyme's production process.
- Amino acid sequence analysis for allergenicity screening.
- Estimation of dietary exposure to total organic solids (TOS).
Main Results
- The production strain met QPS criteria, and the production process raised no safety concerns.
- Estimated dietary exposure to bacillolysin TOS is up to 1.536 mg/kg body weight/day.
- No significant similarity was found between the enzyme's amino acid sequence and known allergens, indicating a low risk of allergic reactions.
Conclusions
- No toxicological studies were deemed necessary beyond allergenicity assessment.
- The food enzyme bacillolysin does not present safety concerns under the specified conditions of use.
- While the risk of allergic reactions cannot be entirely excluded, it is considered unlikely.
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