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. 2021 Oct 18;19(10):e06870.
doi: 10.2903/j.efsa.2021.6870. eCollection 2021 Oct.

Safety evaluation of the food enzyme d-psicose 3-epimerase from the genetically modified Corynebacterium glutamicum strain FIS002

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, Boet Glandorf, Lieve Herman, Yi Liu, Joaquim Maia, Elsa Nielsen, Andrew Chesson

Safety evaluation of the food enzyme d-psicose 3-epimerase from the genetically modified Corynebacterium glutamicum strain FIS002

EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) et al. EFSA J. .

Abstract

This assessment addresses a food enzyme preparation consisting of the immobilised intact but non-viable cells of the genetically modified Corynebacterium glutamicum strain FIS002 by CJ-Tereos Sweeteners Europe SAS. The production strain produces the food enzyme d-fructose 3-epimerase (d-psicose 3-epimerase; EC 5.1.3.30). The food enzyme preparation is used in processing fructose to produce a speciality carbohydrate d-allulose (synonym d-psicose). Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of d-allulose, 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 (NOAEL) of 1,796 mg TOS/kg body weight (bw) per day, the highest dose tested. A search for similarity of the amino acid sequence of the 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 sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reactions to occur is low. The food enzyme preparation contains multiple copies of an antimicrobial resistance gene, which is considered a hazard. However, under the specific intended conditions of use described by the applicant, and based on the evidence showing the removal of TOS during the production of d-allulose and the absence of recombinant DNA in the d-allulose, the Panel concluded that the identified hazard associated with the food enzyme d-psicose 3-epimerase produced with the genetically modified C. glutamicum strain FIS002 will not result in a risk.

Keywords: Corynebacterium glutamicum; EC 5.1.3.30; d‐allulose 3‐epimerase; d‐psicose 3‐epimerase; food enzyme; genetically modified microorganism.

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