학술논문
Safety evaluation of the food enzyme phosphodiesterase I from the non‐genetically modified Leptographium procerum strain FDA
Document Type
article
Author
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP); Claude Lambré; José Manuel Barat Baviera; Claudia Bolognesi; Pier Sandro Cocconcelli; Riccardo Crebelli; David Michael Gott; Konrad Grob; Evgenia Lampi; Marcel Mengelers; Alicja Mortensen; Gilles Rivière; Inger‐Lise Steffensen; Christina Tlustos; Henk Van Loveren; Laurence Vernis; Holger Zorn; Yrjö Roos; Magdalena Andryszkiewicz; Daniele Cavanna; Ana Criado; Simone Lunardi; Elsa Nielsen; Karin Nørby; Yi Liu; Andrew Chesson
Source
EFSA Journal, Vol 22, Iss 4, Pp n/a-n/a (2024)
Subject
Language
English
ISSN
1831-4732
Abstract
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.