RT Journal Article
T1 Safety evaluation of the food enzyme xylose isomerase from the genetically modified Streptomyces rubiginosus strain DP-Pzn37.
A1 EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
A1 Silano, Vittorio
A1 Barat Baviera, José Manuel
A1 Bolognesi, Claudia
A1 Cocconcelli, Pier Sandro
A1 Crebelli, Riccardo
A1 Gott, David Michael
A1 Grob, Konrad
A1 Lampi, Evgenia
A1 Mortensen, Alicja
A1 Rivière, Gilles
A1 Steffensen, Inger-Lise
A1 Tlustos, Christina
A1 van Loveren, Henk
A1 Vernis, Laurence
A1 Zorn, Holger
A1 Glandorf, Boet
A1 Herman, Lieve
A1 Engel, Karl-Heinz
A1 Smith, Andrew
A1 Želježić, Davor
A1 Aguilera-Gómez, Margarita
A1 Gomes, Ana
A1 Kovalkovičová, Natália
A1 Liu, Yi
A1 Maia, Joaquim
A1 Rainieri, Sandra
A1 Chesson, Andrew
K1 D‐xylose aldose‐ketose‐isomerase
K1 EC 5.3.1.5
K1 Streptomyces rubiginosus
K1 food enzyme
K1 glucose isomerase
K1 xylose isomerase
AB 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.
YR 2020
FD 2020-01-20
LK https://hdl.handle.net/10668/26727
UL https://hdl.handle.net/10668/26727
LA en
DS RISalud
RD Apr 6, 2025