Journal article
Authors list: EFSA CEP Panel; Barat Baviera, JM; Bolognesi, C; Chesson, A; Cocconcelli, PS; Crebelli, R; Gott, DM; Grob, K; Lambré, C; Lampi, E; Mengelers, M; Mortensen, A; Rivière, G; Steffensen, IL; Tlustos, C; Van Loveren, H; Vernis, L; Zorn, H; Herman, L; Andryszkiewicz, M; Cavanna, D; Nielsen, E; Norby, K; Liu, Y; Lunardi, S; de Sousa, RF; Chesson, A
Publication year: 2023
Journal: EFSA Journal
Volume number: 21
Issue number: 7
ISSN: 1831-4732
DOI Link: https://doi.org/10.2903/j.efsa.2023.8153
Publisher: Wiley
Abstract:
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.
Citation Styles
Harvard Citation style: EFSA CEP Panel, Barat Baviera, J., Bolognesi, C., Chesson, A., Cocconcelli, P., Crebelli, R., et al. (2023) Safety evaluation of the food enzyme ribonuclease P from the non-genetically modified Penicillium citrinum strain AE-RP-4, EFSA Journal, 21(7), Article e08153. https://doi.org/10.2903/j.efsa.2023.8153
APA Citation style: EFSA CEP Panel, Barat Baviera, J., Bolognesi, C., Chesson, A., Cocconcelli, P., Crebelli, R., Gott, D., Grob, K., Lambré, C., Lampi, E., Mengelers, M., Mortensen, A., Rivière, G., Steffensen, I., Tlustos, C., Van Loveren, H., Vernis, L., Zorn, H., Herman, L., ...Chesson, A. (2023). Safety evaluation of the food enzyme ribonuclease P from the non-genetically modified Penicillium citrinum strain AE-RP-4. EFSA Journal. 21(7), Article e08153. https://doi.org/10.2903/j.efsa.2023.8153
