Open AccessSafety evaluation of the food enzyme triacylglycerol lipase from Trichoderma reesei (strain RF10625)
Author(s) -
Silano Vittorio,
Barat Baviera José Manuel,
Bolognesi Claudia,
Cocconcelli Pier Sandro,
Crebelli Riccardo,
Gott David Michael,
Grob Konrad,
Lampi Evgenia,
Mortensen Alicja,
Rivière Gilles,
Steffensen IngerLise,
Tlustos Christina,
Van Loveren Henk,
Vernis Laurence,
Zorn Holger,
Glandorf Boet,
Herman Lieve,
Aguilera Jaime,
Arcella Davide,
Maia Joaquim,
Liu Yi,
Rainieri Sandra,
Chesson Andrew
Publication year - 2019
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2019.5837
Subject(s) - food science , genotoxicity , trichoderma reesei , enzyme , food safety , toxicity , no observed adverse effect level , biology , strain (injury) , enzyme assay , chemistry , toxicology , microbiology and biotechnology , biochemistry , cellulase , organic chemistry , anatomy
The food enzyme triacylglycerol acylhydrolase (EC 3.1.1.3) is produced with a genetically modified Trichoderma reesei strain RF10625 by AB Enzymes. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The food enzyme is intended to be used in baking processes and cereal‐based processes. Based on the maximum use levels, dietary exposure to the food enzyme Total Organic Solids (TOS) was estimated to be up to 0.119 mg TOS/kg body weight (bw) per day in European populations. 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 of 1,000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 8,400. Similarity of the amino acid sequence to those of known allergens was searched and no matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood to occur is considered to be 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.