Safety evaluation of an extension of use of the food enzyme pullulanase from the non-genetically modified Pullulanibacillus naganoensis strain AE-PL
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View abstract on PubMed
Summary
This summary is machine-generated.The food enzyme pullulanase, produced by *Pullulanibacillus naganoensis*, is safe for expanded use in eight food processes. A high margin of exposure confirms no safety concerns for consumers.
Area Of Science
- Food Science and Technology
- Enzymology
- Toxicology
Background
- Pullulanase (pullulan 6-α-glucanohydrolase; EC 3.2.1.41) is a food enzyme produced by *Pullulanibacillus naganoensis*.
- A prior safety evaluation by EFSA concluded no safety concerns for one food manufacturing process.
- The applicant sought to extend its use to seven additional processes and revise the use level.
Purpose Of The Study
- To update the safety evaluation of the food enzyme pullulanase for eight food manufacturing processes.
- To assess potential risks associated with revised use levels and expanded applications.
Main Methods
- Dietary exposure was estimated for six of the eight processes, as enzyme-total organic solids (TOS) are not present in final products for two.
- A 90-day repeated dose oral toxicity study in rats was re-evaluated.
- Margin of exposure (MOE) was calculated by comparing the no observed adverse effect level (NOAEL) to estimated dietary exposure.
Main Results
- Estimated dietary exposure was up to 0.004 mg TOS/kg body weight per day.
- The NOAEL from the toxicity study was 643 mg TOS/kg bw per day.
- The calculated MOE was at least 160,750.
Conclusions
- The food enzyme pullulanase does not give rise to safety concerns under the revised intended conditions of use.
- The substantial margin of exposure supports the safety of the expanded application and revised use levels.
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