Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

food enzyme, lysophospholipase, lecithinase B, EC 3.1.1.5, Lysolecithinase, Trichoderma reesei, genetically modified microorganism
First published in the EFSA Journal
22. Januar 2019
Adopted
4. Dezember 2018
Type
Scientific Opinion

Abstract

The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. 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 lysophospholipase food enzyme is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, consequently, dietary exposure was not 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 at the highest dose tested of 927 mg TOS/kg body weight (bw) per day. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided and the removal of TOS during the intended food production process, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.

Panel members at the time of adoption

José Manuel Barat Baviera, Claudia Bolognesi, Beat Johannes Brüschweiler, Andrew Chesson, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Alicja Mortensen, Gilles Riviere, Vittorio Silano, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis and Holger Zorn.
Panel on Food Additives and Flavourings
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2019.5548
EFSA Journal 2019;17(1):5548
Question Number
On request from
European Commission
Disclaimer
The full opinion will be published in accordance with Article 12 of Regulation (EC) No 1331/2008 once decision on confidentiality will be received from the European Commission.