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Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus luchuensis strain FL100SC

Authors :
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
Lieve Herman
Magdalena Andryszkiewicz
Giovanni Bernasconi
Ana Gomes
Natalia Kovalkovicova
Yi Liu
Joaquim Maia
Sandra Rainieri
Andrew Chesson
Source :
EFSA Journal, Vol 19, Iss 4, Pp n/a-n/a (2021)
Publication Year :
2021
Publisher :
Wiley, 2021.

Abstract

Abstract The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase EC 3.1.1.3) is produced with a genetically modified Aspergillus luchuensis strain FL100SC by Advanced Enzyme Technologies Ltd. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The triacylglycerol lipase is intended to be used only in an immobilised form in the production of modified fats and oils by interesterification. Since residual amounts of total organic solids (TOS) are removed by filtration and purification steps applied during fats and oils processing for interesterification, no dietary exposure was calculated. Genotoxicity tests did not raise 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 (NOAEL) of 849 mg TOS/kg body weight (bw) per day, the highest dose tested. The similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and no match was found. The Panel considers that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Based on the data provided, including the immobilisation process and the absence of TOS in the final product, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Details

Language :
English
ISSN :
18314732
Volume :
19
Issue :
4
Database :
Directory of Open Access Journals
Journal :
EFSA Journal
Publication Type :
Academic Journal
Accession number :
edsdoj.4fb38dcc9a2040e5b80cac7f5fc3e7dd
Document Type :
article
Full Text :
https://doi.org/10.2903/j.efsa.2021.6561