11/12/2025 | Press release | Distributed by Public on 11/12/2025 05:39
The food enzyme AMP deaminase (AMP aminohydrolase; EC 3.5.4.6) is produced with the non‐genetically modified Streptomyces murinus strain AE‐DNTS by Amano Enzyme Inc. In a previous evaluation, the Panel could not conclude on the safety of this food enzyme due to uncertainties on the characterisation of the food enzyme batches for commercialisation and the batch used in the toxicological studies. In this assessment, the Panel evaluated the new data provided by the applicant and completed the safety evaluation of this food enzyme. The food enzyme is intended to be used in two food manufacturing processes. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.001 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 275 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, results in a margin of exposure of at least 275,000. Based on the new data provided and the previous evaluation, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.