Safety evaluation of the food enzyme 4‐phytase from a genetically modified Trichoderma reesei (strain DP‐Nzt55)

food enzyme, 4‐phytase, EC 3.1.3.26, Trichoderma reesei, DP‐Nzt55, genetically modified microorganism
First published in the EFSA Journal
17 October 2019
Adopted
17 September 2019
Type
Scientific Opinion

Note: The full opinion will be published in accordance with Article 12 of Regulation (EC) No 1331/2008 once the decision on confidentiality will be received from the European Commission.

Abstract

The food enzyme Myo‐inositol‐hexakisphosphate 4‐phosphohydrolase (4‐phytase, EC 3.1.3.26) is produced with a genetically modified Trichoderma reesei DP‐Nzt55 by Danisco US Inc. The production strain contains a known antimicrobial resistance gene. However, based on the absence of viable cells and recombinant DNA of the production strain in the food enzyme, this is not considered to be a risk. The 4‐phytase is intended to be used in distilled alcohol production. Since residual amounts of total organic solids are removed by distillation (> 99%), toxicological data were not considered necessary and dietary exposure was not calculated. 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 can be excluded. 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.

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, Evgenia Lampi, Alicja Mortensen, Gilles Rivière, Vittorio Silano, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis and Holger Zorn.
Panel on Food Contact Materials, Enzymes and Processing Aids
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2019.5826
EFSA Journal 2019;17(10):5826
Question Number
On request from
European Commission