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EFSA - European Food Safety Authority

01/18/2023 | Press release | Distributed by Public on 01/18/2023 05:03

Safety evaluation of the food enzyme triacylglycerol lipase from the non‐genetically modified Rhizopus arrhizus strain AE‐N

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Metadata

EFSA Journal 2023;21(1):7756
DOI:
https://doi.org/10.2903/j.efsa.2023.7756
Keywords:
triacylglycerol lipase, food enzyme, triacylglycerol acylhydrolase, EC 3.1.1.3, lipase, Rhizopus arrhizus
On request from:
European Commission
Question Number:
EFSA‐Q‐2014‐00732
Contact:
fip[at] efsa.europa.eu

Panel members at the time of adoption

José Manuel Barat Baviera, Claudia Bolognesi, Andrew Chesson, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Claude Lambré, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren and Laurence Vernis Holger Zorn.

Abstract

The food enzyme triacylglycerol lipase (EC 3.1.1.3) is produced with the non‐genetically modified Rhizopus arrhizus strain AE‐N by Amano Enzyme Inc. It is considered free from viable cells of the production organism. The food enzyme is intended to be used in an immobilised form in the modification of fats and oils by interesterification. Since residual amounts of total organic solids (TOS) are removed during refinement of the fats and oils, dietary exposure was not calculated. 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 1,806 mg TOS/kg body weight (bw) per day, the highest dose tested. 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 by dietary exposure cannot be excluded, but the likelihood for this to occur 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.

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