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Safety evaluation of an extension of use of the food enzyme pullulanase from the non‐genetically modified Pullulanibacillus naganoensis strain AE‐PL

Authors :
EFSA Panel on Food Enzymes (FEZ)
Holger Zorn
José Manuel Barat Baviera
Claudia Bolognesi
Francesco Catania
Gabriele Gadermaier
Ralf Greiner
Baltasar Mayo
Alicja Mortensen
Yrjö Henrik Roos
Marize L. M. Solano
Monika Sramkova
Henk Van Loveren
Laurence Vernis
Daniele Cavanna
Ana Criado
Rita Sofia Ferreira deSousa
Yi Liu
Roos Anna deNijs
Source :
EFSA Journal, Vol 22, Iss 7, Pp n/a-n/a (2024)
Publication Year :
2024
Publisher :
Wiley, 2024.

Abstract

Abstract The food enzyme pullulanase (pullulan 6‐α‐glucanohydrolase; EC 3.2.1.41) is produced with the non‐genetically modified Pullulanibacillus naganoensis strain AE‐PL by Amano Enzyme Inc. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in one food manufacturing process. Subsequently, the applicant has requested to extend its use to include seven additional processes and to revise the previous use level. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of eight food manufacturing processes. As the food enzyme‐total organic solids (TOS) are not carried into the final foods in two food manufacturing processes, the dietary exposure was estimated only for the remaining six processes. The dietary exposure was calculated to be up to 0.004 mg TOS/kg body weight (bw) per day in European populations. The Panel evaluated the repeated dose 90‐day oral toxicity study in rats submitted in the previous application and identified a no observed adverse effect level of 643 mg TOS/kg bw per day, the highest dose tested. When compared with the calculated dietary exposure, this resulted in a margin of exposure of at least 160,750. Based on the data provided for the previous evaluation and the revised margin of exposure in the present evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.

Details

Language :
English
ISSN :
18314732
Volume :
22
Issue :
7
Database :
Directory of Open Access Journals
Journal :
EFSA Journal
Publication Type :
Academic Journal
Accession number :
edsdoj.f462cb817bc43d087bc628976afebcf
Document Type :
article
Full Text :
https://doi.org/10.2903/j.efsa.2024.8947