Open AccessSafety evaluation of the food enzyme xylose isomerase from the genetically modified Streptomyces rubiginosus strain DP ‐Pzn37
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,
Engel KarlHeinz,
Smith Andrew,
Želježić Davor,
AguileraGómez Margarita,
Gomes Ana,
Kovalkovičová Natália,
Liu Yi,
Maia Joaquim,
Rainieri Sandra,
Chesson Andrew
Publication year - 2020
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.2020.5978
Subject(s) - food science , xylose , fructose , chemistry , enzyme , strain (injury) , xylose isomerase , enzyme assay , biochemistry , high fructose corn syrup , food additive , fermentation , biology , anatomy
The food enzyme is a d ‐xylose aldose‐ketose‐isomerase ( EC 5.3.1.5) produced with the genetically modified Streptomyces rubiginosus strain DP ‐Pzn37 by Danisco US Inc. Although the production strain contains antibiotic resistance genes, the food enzyme was shown to be free from viable cells of the production organism and its DNA . The food enzyme is intended to be used in an immobilised form for the isomerisation of glucose for the production of high fructose syrups. Residual amounts of total organic solids ( TOS ) are eliminated by the use of an immobilised food enzyme and further removed by the purification steps applied during the production of high fructose syrups using the immobilised enzyme; consequently, dietary exposure was not calculated. Genotoxicity tests did not raise safety concerns. The systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 85.2 mg TOS /kg body weight (bw) per day, the highest dose tested. 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 conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered to be low. Based on the data provided, the immobilisation process and the removal of total organic solids during the production of high fructose syrups, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.