TY - JOUR
T1 - Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)
AU - EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
AU - Silano, Vittorio
AU - Baviera, Josémanuelbarat
AU - Bolognesi, Claudia
AU - Brüschweiler, Beatjohannes
AU - Cocconcelli, Piersandro
AU - Crebelli, Riccardo
AU - Gott, Davidmichael
AU - Grob, Konrad
AU - Lampi, Evgenia
AU - Mortensen, Alicja
AU - Riviere, Gilles
AU - Steffensen, Inger Lise
AU - Tlustos, Christina
AU - Vanloveren, Henk
AU - Vernis, Laurence
AU - Zorn, Holger
AU - Glandorf, Boet
AU - Marcon, Francesca
AU - Penninks, André
AU - Smith, Andrew
AU - Gomes, Ana
AU - Kovalkovičová, Natália
AU - Liu, Yi
AU - Maia, Joaquim
AU - Engel, Karlheinz
AU - Chesson, Andrew
N1 - Publisher Copyright:
© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
PY - 2019
Y1 - 2019
N2 - The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The lysophospholipase food enzyme is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, consequently, 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 at the highest dose tested of 927 mg TOS/kg body weight (bw) per day. 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 condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided and the removal of TOS during the intended food production process, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.
AB - The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The lysophospholipase food enzyme is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, consequently, 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 at the highest dose tested of 927 mg TOS/kg body weight (bw) per day. 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 condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided and the removal of TOS during the intended food production process, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.
KW - EC 3.1.1.5
KW - Food enzyme
KW - Genetically modified microorganism
KW - Lecithinase B
KW - Lysolecithinase
KW - Lysophospholipase
KW - Trichoderma reesei
UR - http://www.scopus.com/inward/record.url?scp=85095988392&partnerID=8YFLogxK
U2 - 10.2903/j.efsa.2019.5548
DO - 10.2903/j.efsa.2019.5548
M3 - Article
AN - SCOPUS:85095988392
SN - 1831-4732
VL - 17
SP - 1
EP - 13
JO - EFSA Journal
JF - EFSA Journal
IS - 1
ER -