Updated safety evaluation of the food enzyme AMP deaminase from the non‐genetically modified Streptomyces murinus strain AE‐DNTS

Summary

Scientists evaluated the safety of AMP deaminase, an enzyme used in food processing for yeast and mushroom extract production. The enzyme is produced from a naturally occurring bacterium and is intended to help break down adenosine monophosphate during food manufacturing. Through extensive testing including genetic mutation tests and animal studies, researchers found no safety concerns when used at recommended levels in food processing. The amount of enzyme that consumers might ingest through food is far below levels that could cause any adverse effects.

Background

AMP deaminase is a food enzyme produced from the non-genetically modified bacterium Streptomyces murinus strain AE-DNTS by Amano Enzyme Inc. A previous EFSA evaluation could not conclude on safety due to uncertainties in enzyme batch characterization and lack of reliable total organic solids (TOS) values.

Objective

To complete the safety evaluation of AMP deaminase by assessing new data provided by the applicant regarding enzyme batch characterization, genotoxicity testing, and systemic toxicity to establish safety under intended conditions of use in food manufacturing.

Results

All enzyme batches showed consistent enzyme activity/TOS ratios suitable as test items. Genotoxicity tests showed no safety concerns. The 90-day rat study identified a no observed adverse effect level (NOAEL) of 275 mg TOS/kg body weight per day. Estimated dietary exposure was up to 0.001 mg TOS/kg bw per day, resulting in a margin of exposure of at least 275,000.

Conclusion

The Panel concluded that AMP deaminase from non-genetically modified Streptomyces murinus strain AE-DNTS does not give rise to safety concerns under the intended conditions of use in yeast processing and mushroom extract production.
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