Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)
Abstract The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food e...
Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Wiley
2018-10-01
|
Series: | EFSA Journal |
Subjects: | |
Online Access: | https://doi.org/10.2903/j.efsa.2018.5447 |
id |
doaj-93aef11b2f784fc69ab4be6fdb377550 |
---|---|
record_format |
Article |
spelling |
doaj-93aef11b2f784fc69ab4be6fdb3775502021-05-03T01:24:32ZengWileyEFSA Journal1831-47322018-10-011610n/an/a10.2903/j.efsa.2018.5447Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)Vittorio SilanoJosé Manuel Barat BavieraClaudia BolognesiBeat Johannes BrüschweilerPier Sandro CocconcelliRiccardo CrebelliDavid Michael GottKonrad GrobEvgenia LampiAlicja MortensenGilles RiviereInger‐Lise SteffensenChristina TlustosHenk vanLoverenLaurence VernisHolger ZornBoet GlandorfAndré PenninksDavor ŽelježićMagdalena AndryszkiewiczAna GomesNatália KovalkovičováYi LiuKarl Heinz EngelAndrew ChessonAbstract The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels recommended for the baking 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 0.017 mg TOS/kg body weight (bw) per day in European populations. 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 rodents. A comparison of the no observed adverse effect level of 37 mg TOS/kg bw per day from this study with the dietary exposure results in a sufficiently high margin of exposure. The amino acid sequence of the food enzyme did not match those of known allergens. 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 occurring is considered to be low. 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.https://doi.org/10.2903/j.efsa.2018.5447food enzymexylanaseendo‐14‐β‐xylanaseEC 3.2.1.84‐β‐d‐xylan xylanohydrolase |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Vittorio Silano José Manuel Barat Baviera Claudia Bolognesi Beat Johannes Brüschweiler Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Alicja Mortensen Gilles Riviere Inger‐Lise Steffensen Christina Tlustos Henk vanLoveren Laurence Vernis Holger Zorn Boet Glandorf André Penninks Davor Želježić Magdalena Andryszkiewicz Ana Gomes Natália Kovalkovičová Yi Liu Karl Heinz Engel Andrew Chesson |
spellingShingle |
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Vittorio Silano José Manuel Barat Baviera Claudia Bolognesi Beat Johannes Brüschweiler Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Alicja Mortensen Gilles Riviere Inger‐Lise Steffensen Christina Tlustos Henk vanLoveren Laurence Vernis Holger Zorn Boet Glandorf André Penninks Davor Želježić Magdalena Andryszkiewicz Ana Gomes Natália Kovalkovičová Yi Liu Karl Heinz Engel Andrew Chesson Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584) EFSA Journal food enzyme xylanase endo‐1 4‐β‐xylanase EC 3.2.1.8 4‐β‐d‐xylan xylanohydrolase |
author_facet |
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Vittorio Silano José Manuel Barat Baviera Claudia Bolognesi Beat Johannes Brüschweiler Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Alicja Mortensen Gilles Riviere Inger‐Lise Steffensen Christina Tlustos Henk vanLoveren Laurence Vernis Holger Zorn Boet Glandorf André Penninks Davor Želježić Magdalena Andryszkiewicz Ana Gomes Natália Kovalkovičová Yi Liu Karl Heinz Engel Andrew Chesson |
author_sort |
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
title |
Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584) |
title_short |
Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584) |
title_full |
Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584) |
title_fullStr |
Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584) |
title_full_unstemmed |
Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584) |
title_sort |
safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified bacillus subtilis (strain lmg s‐24584) |
publisher |
Wiley |
series |
EFSA Journal |
issn |
1831-4732 |
publishDate |
2018-10-01 |
description |
Abstract The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels recommended for the baking 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 0.017 mg TOS/kg body weight (bw) per day in European populations. 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 rodents. A comparison of the no observed adverse effect level of 37 mg TOS/kg bw per day from this study with the dietary exposure results in a sufficiently high margin of exposure. The amino acid sequence of the food enzyme did not match those of known allergens. 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 occurring is considered to be low. 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. |
topic |
food enzyme xylanase endo‐1 4‐β‐xylanase EC 3.2.1.8 4‐β‐d‐xylan xylanohydrolase |
url |
https://doi.org/10.2903/j.efsa.2018.5447 |
work_keys_str_mv |
AT efsapanelonfoodcontactmaterialsenzymesandprocessingaidscep safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT vittoriosilano safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT josemanuelbaratbaviera safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT claudiabolognesi safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT beatjohannesbruschweiler safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT piersandrococconcelli safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT riccardocrebelli safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT davidmichaelgott safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT konradgrob safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT evgenialampi safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT alicjamortensen safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT gillesriviere safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT ingerlisesteffensen safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT christinatlustos safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT henkvanloveren safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT laurencevernis safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT holgerzorn safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT boetglandorf safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT andrepenninks safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT davorzeljezic safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT magdalenaandryszkiewicz safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT anagomes safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT nataliakovalkovicova safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT yiliu safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT karlheinzengel safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 AT andrewchesson safetyevaluationofthefoodenzymeendo14bxylanasefromageneticallymodifiedbacillussubtilisstrainlmgs24584 |
_version_ |
1721485970683985920 |