Safety evaluation of the food enzyme ribonuclease P from the non-genetically modified Penicillium citrinum strain AE-RP-4

The food enzyme ribonuclease P (EC 3.1.26.5) is produced with the non-genetically modified Penicillium citrinum strain AE-RP-4 by Amano Enzyme Inc. It is intended to be used in yeast processing only for the production of yeast extract. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.153 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise safety concerns. 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 (NOAEL) of 134.7 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 880. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Automated summary

This article introduces a non-genetically modified Penicillium citrinum strain AE-RP-4 produced by Amano Enzyme Inc., which produces the food enzyme ribonuclease P (EC 3.1.26.5) used in yeast processing for yeast extract production. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.153 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise safety concerns. The repeated dose 90-day oral toxicity study in rats identified a no observed adverse effect level (NOAEL) of 134.7 mg TOS/kg bw per day, resulting in a margin of exposure of at least 880 when compared to estimated dietary exposure. A search for similarity to known allergens found no match. The likelihood of allergic reactions upon dietary exposure is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.