Journalartikel

Safety evaluation of the food enzyme phosphodiesterase I from the non-genetically modified Leptographium procerum strain FDA


AutorenlisteEFSA CEP Panel; Lambré, Claude; Barat Baviera, José Manuel; Bolognesi, Claudia; Cocconcelli, Pier Sandro; Crebelli, Riccardo; Gott, David Michael; Grob, Konrad; Lampi, Evgenia; Mengelers, Marcel; Mortensen, Alicja; Rivière, Gilles; Steffensen, Inger-Lise; Tlustos, Christina; Van Loveren, Henk; Vernis, Laurence; Zorn, Holger; Roos, Yrjö; Andryszkiewicz, Magdalena; Cavanna, Daniele; Criado, Ana; Lunardi, Simone; Nielsen, Elsa; Nørby, Karin; Liu, Yi; Chesson, Andrew

Jahr der Veröffentlichung2024

ZeitschriftEFSA Journal

Bandnummer22

Heftnummer4

eISSN1831-4732

DOI Linkhttps://doi.org/10.2903/j.efsa.2024.8724

VerlagWiley


Abstract
The food enzyme phosphodiesterase I (oligonucleotide 5 ' -nucleotidohydrolase; EC 3.1.4.1) is produced with the non-genetically modified Leptographium procerum strain FDA by DSM Food Specialties B.V. The food enzyme is free from viable cells of the production organism. It is intended to be used in the processing of yeast and yeast products. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.171 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 1000 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 5848. 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 the risk of allergic reactions by 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.



Autoren/Herausgeber




Zitierstile

Harvard-ZitierstilEFSA CEP Panel, Lambré, C., Barat Baviera, J., Bolognesi, C., Cocconcelli, P., Crebelli, R., et al. (2024) Safety evaluation of the food enzyme phosphodiesterase I from the non-genetically modified Leptographium procerum strain FDA, EFSA Journal, 22(4), Article e8724. https://doi.org/10.2903/j.efsa.2024.8724

APA-ZitierstilEFSA CEP Panel, Lambré, C., Barat Baviera, J., Bolognesi, C., Cocconcelli, P., Crebelli, R., Gott, D., Grob, K., Lampi, E., Mengelers, M., Mortensen, A., Rivière, G., Steffensen, I., Tlustos, C., Van Loveren, H., Vernis, L., Zorn, H., Roos, Y., Andryszkiewicz, M., ...Chesson, A. (2024). Safety evaluation of the food enzyme phosphodiesterase I from the non-genetically modified Leptographium procerum strain FDA. EFSA Journal. 22(4), Article e8724. https://doi.org/10.2903/j.efsa.2024.8724


Zuletzt aktualisiert 2025-21-05 um 17:28