Safety evaluation of the food enzyme cellulase from Trichoderma reesei (strain DP-Nzc36)

被引:3
作者
Silano, Vittorio
Baviera, Jose Manuel Barat
Bolognesi, Claudia
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David Michael
Grob, Konrad
Lampi, Evgenia
Mortensen, Alicja
Riviere, Gilles
Steffensen, Inger-Lise
Tlustos, Christina
van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Herman, Lieve
Marcon, Francesca
Gomes, Ana
Kovalkovicova, Natalia
Liu, Yi
Maia, Joaquim
Chesson, Andrew
机构
关键词
food enzyme; cellulase; 4-(1,3; 1,4)-beta-D-glucan 4-glucanohydrolase; EC; 3.2.1.4; endo-1,4-beta-D-glucanase; Trichoderma reesei; genetically modified microorganism;
D O I
10.2903/j.efsa.2019.5839
中图分类号
TS2 [食品工业];
学科分类号
0832 ;
摘要
The food enzyme cellulase (4-(1,3;1,4)-beta-D-glucan 4-glucanohydrolase; EC 3.2.1.4) is produced with the genetically modified Trichoderma reesei strain DP-Nzc36 by Danisco US Inc. 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 food enzyme is intended to be used in distilled alcohol production, starch processing for the production of glucose syrups and brewing processes. Since residual amounts of the food enzyme are removed by distillation and starch processing, no dietary exposure was calculated for these food processes. Based on the maximum use levels recommended for brewing processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.131 mg TOS/kg body weight (bw) per day. 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 of at least 97.6 mg TOS/kg bw per day which, compared to the estimated dietary exposure, results in a margin of exposure of at least 745. 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 can be excluded in distilled alcohol production and is considered to be low when the enzyme is used in starch processing and brewing processes. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. (C) 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
引用
收藏
页数:15
相关论文
共 19 条
[1]   Guidance of the Scientific Panel of Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) on the Submission of a Dossier on Food Enzymes for Safety Evaluation by the Scientific Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids [J].
Anadon, Arturo ;
Bell, David ;
Binderup, Mona-Lise ;
Bursch, Wilfried ;
Castle, Laurence ;
Crebelli, Riccardo ;
Engel, Karl-Heinz ;
Franz, Roland ;
Gontard, Nathalie ;
Haertle, Thomas ;
Husoy, Trine ;
Jany, Klaus-Dieter ;
Leclercq, Catherine ;
Lhuguenot, Jean-Claude ;
Mennes, Wim C. ;
Milana, Maria Rosaria ;
Pfaff, Karla ;
Svensson, Kettil ;
Toldra, Fidel ;
Waring, Rosemary ;
Woelfle, Detlef .
EFSA JOURNAL, 2009, 7 (08)
[2]   Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use EFSA Panel on Genetically Modified Organisms (GMO) [J].
Andersson, Hans Christer ;
Arpaia, Salvatore ;
Bartsch, Detlef ;
Casacuberta, Josep ;
Davies, Howard ;
du Jardin, Patrick ;
Flachowsky, Gerhard ;
Herman, Lieve ;
Jones, Huw ;
Kaerenlampi, Sirpa ;
Kiss, Jozsef ;
Kleter, Gijs ;
Kuiper, Harry ;
Messean, Antoine ;
Nielsen, Kaare Magne ;
Perry, Joe ;
Poeting, Annette ;
Sweet, Jeremy ;
Tebbe, Christoph ;
von Wright, Atte Johannes ;
Wal, Jean-Michel .
EFSA JOURNAL, 2011, 9 (06)
[3]  
[Anonymous], 1997, BACT REV MUT TEST
[4]  
[Anonymous], 1997, IN VITR MAMM CHROM A, DOI 10.1787/9789264264649-en
[5]  
[Anonymous], 2010, Bibliographic review on the potential of microorganisms, microbial products and enzymes to induce respiratory sensitization, DOI DOI 10.2903/SP.EFSA.2010.EN-75
[6]   Why can patients with baker's asthma tolerate wheat flour ingestion? Is wheat pollen allergy relevant? [J].
Armentia, A. ;
Diaz-Perales, A. ;
Castrodeza, J. ;
Duenas-Laita, A. ;
Palacin, A. ;
Fernandez, S. .
ALLERGOLOGIA ET IMMUNOPATHOLOGIA, 2009, 37 (04) :203-204
[7]   Guidance of the Scientific Committee on a request from EFSA related to Uncertainties in Dietary Exposure Assessment Request No EFSA-Q-2004-019 Adopted on 14 December 2006 [J].
Barlow, Sue ;
Chesson, Andrew ;
Collins, John ;
Dybing, Erik ;
Flynn, Albert ;
Fruijtier-Polloth, Claudia ;
Hardy, Tony ;
Knaap, Ada ;
Kuiper, Harry ;
Le Neindre, Pierre ;
Schans, Jan ;
Schlatter, Josef ;
Silano, Vittorio ;
Skerving, Steffan ;
Vannier, Philippe .
EFSA JOURNAL, 2007, 5 (01)
[8]   Guidance on Safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements [J].
Barlow, Susan ;
Chesson, Andrew ;
Collins, John D. ;
Flynn, Albert ;
Galli, Corrado L. ;
Hardy, Anthony ;
Jany, Klaus-Dieter ;
Jeger, Michael-John ;
Knaap, Ada ;
Kuiper, Harry ;
Larsen, John-Christian ;
Lovell, David ;
Schlatter, Josef ;
Silano, Vittorio ;
Smulders, Frans ;
Vannier, Philippe .
EFSA JOURNAL, 2009, 7 (09)
[9]   Baker's asthma [J].
Brisman, J .
OCCUPATIONAL AND ENVIRONMENTAL MEDICINE, 2002, 59 (07) :498-502
[10]   Clinical responses to ingested fungal alpha-amylase and hemicellulase in persons sensitized to Aspergillus fumigatus? [J].
Cullinan, P ;
Cook, A ;
Jones, M ;
Cannon, J ;
Fitzgerald, B ;
Taylor, AJN .
ALLERGY, 1997, 52 (03) :346-349