TY - JOUR
T1 - Safety evaluation of the food enzyme endo-1,4-β-xylanase from a genetically modified Aspergillus niger (strain XEA)
AU - EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)
AU - Silano, Vittorio
AU - Bolognesi, Claudia
AU - Castle, Laurence
AU - Chipman, Kevin
AU - Cravedi, Jean Pierre
AU - Fowler, Paul
AU - Franz, Roland
AU - Grob, Konrad
AU - Gürtler, Rainer
AU - Husøy, Trine
AU - Kärenlampi, Sirpa
AU - Mennes, Wim
AU - Milana, Maria Rosaria
AU - Pfaff, Karla
AU - Riviere, Gilles
AU - Srinivasan, Jannavi
AU - Poças, Maria de Fátima Tavares
AU - Tlustos, Christina
AU - Wölfle, Detlef
AU - Zorn, Holger
AU - Chesson, Andrew
AU - Glandorf, Boet
AU - Herman, Lieve
AU - Jany, Klaus Dieter
AU - Marcon, Francesca
AU - Penninks, André
AU - Smith, Andrew
AU - van Loveren, Henk
AU - Želježić, Davor
AU - Aguilera-Gómez, Margarita
AU - Arcella, Davide
AU - Kovalkovičová, Natália
AU - Maia, Joaquim
AU - Liu, Yi
AU - Engel, Karl Heinz
PY - 2018/4
Y1 - 2018/4
N2 - The food enzyme is an endo-1,4-β-xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus niger (strain XEA), by DSM Food Specialities B.V. The food enzyme is intended to be used in baking and brewing processes. Based on maximum use levels recommended for the food processes and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.310 mg TOS/kg body weight per day in European populations. Genotoxicity tests with the food enzyme did not indicate a genotoxic concern. A repeated dose 90-day oral toxicity study in rodents, carried out with this endo-1,4-β-xylanase, showed no concern with respect to systemic toxicity. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no match was found. The Panel considers that there are no indications for allergic sensitisation and elicitation reactions by dietary exposure to the food enzyme endo-1,4-β-xylanase. Based on the microbial source, the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the dietary exposure assessment, the findings in the toxicological studies and the allergenicity assessment, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.
AB - The food enzyme is an endo-1,4-β-xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus niger (strain XEA), by DSM Food Specialities B.V. The food enzyme is intended to be used in baking and brewing processes. Based on maximum use levels recommended for the food processes and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.310 mg TOS/kg body weight per day in European populations. Genotoxicity tests with the food enzyme did not indicate a genotoxic concern. A repeated dose 90-day oral toxicity study in rodents, carried out with this endo-1,4-β-xylanase, showed no concern with respect to systemic toxicity. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no match was found. The Panel considers that there are no indications for allergic sensitisation and elicitation reactions by dietary exposure to the food enzyme endo-1,4-β-xylanase. Based on the microbial source, the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the dietary exposure assessment, the findings in the toxicological studies and the allergenicity assessment, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.
KW - 4-β-xylanase
KW - Aspergillus niger
KW - EC 3.2.1.8
KW - Endo-1
KW - Food enzyme
KW - Genetically modified microorganism
UR - http://www.scopus.com/inward/record.url?scp=85062070126&partnerID=8YFLogxK
U2 - 10.2903/j.efsa.2018.5228
DO - 10.2903/j.efsa.2018.5228
M3 - Article
C2 - 32625867
AN - SCOPUS:85062070126
SN - 1831-4732
VL - 16
JO - EFSA Journal
JF - EFSA Journal
IS - 4
M1 - e05228
ER -