Safety evaluation of the food enzyme β‐galactosidase from the genetically modified Escherichia coli NCIMB 30325
Abstract The food enzyme is a β‐galactosidase (β‐D‐galactoside galactohydrolase; EC 3.2.1.23) produced with the genetically modified Escherichia coli strain NCIMB 30325 by Clasado Ingredients Ltd. The β‐galactosidase encoding gene is introduced into the recipient strain of E. coli using a self‐repli...
Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Wiley
2020-01-01
|
Series: | EFSA Journal |
Subjects: | |
Online Access: | https://doi.org/10.2903/j.efsa.2020.5977 |
id |
doaj-adf505724b8b4d4d895b6168e075aaeb |
---|---|
record_format |
Article |
spelling |
doaj-adf505724b8b4d4d895b6168e075aaeb2021-05-02T23:49:59ZengWileyEFSA Journal1831-47322020-01-01181n/an/a10.2903/j.efsa.2020.5977Safety evaluation of the food enzyme β‐galactosidase from the genetically modified Escherichia coli NCIMB 30325EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)Vittorio SilanoJosé Manuel Barat BavieraClaudia BolognesiPier Sandro CocconcelliRiccardo CrebelliDavid Michael GottKonrad GrobEvgenia LampiAlicja MortensenGilles RivièreInger‐Lise SteffensenChristina TlustosHenk Van LoverenLaurence VernisHolger ZornBoet GlandorfLieve HermanMagdalena AndryszkiewiczAna GomesNatália KovalkovičováYi LiuSandra RainieriClaudia Roncancio PeñaAndrew ChessonAbstract The food enzyme is a β‐galactosidase (β‐D‐galactoside galactohydrolase; EC 3.2.1.23) produced with the genetically modified Escherichia coli strain NCIMB 30325 by Clasado Ingredients Ltd. The β‐galactosidase encoding gene is introduced into the recipient strain of E. coli using a self‐replicating plasmid which also contains a gene, which confers resistance to an antibiotic listed as a critically important antimicrobial. This gene was detected in the food enzyme. The absence of viable cells of the production strain in the food enzyme was not demonstrated. The food enzyme is intended to be used only for the production of a mixture of galacto‐oligosaccharides (GOS). Genotoxicity tests did not raise a safety concern. Subchronic 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 900 mg total organic solids (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 conditions of use the risk for allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Given the risk associated with the presence of antibiotic resistance gene in the food enzyme and the lack of data showing the absence of viable cells, the Panel concludes that the use of β‐galactosidase produced with the genetically modified E. coli NCIMB 30325 cannot be considered safe.https://doi.org/10.2903/j.efsa.2020.5977food enzymeβ‐galactosidaseβ‐D‐galactoside galactohydrolaseEC 3.2.1.23Escherichia coligenetically modified microorganism |
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 Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Boet Glandorf Lieve Herman Magdalena Andryszkiewicz Ana Gomes Natália Kovalkovičová Yi Liu Sandra Rainieri Claudia Roncancio Peña Andrew Chesson |
spellingShingle |
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Vittorio Silano José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Boet Glandorf Lieve Herman Magdalena Andryszkiewicz Ana Gomes Natália Kovalkovičová Yi Liu Sandra Rainieri Claudia Roncancio Peña Andrew Chesson Safety evaluation of the food enzyme β‐galactosidase from the genetically modified Escherichia coli NCIMB 30325 EFSA Journal food enzyme β‐galactosidase β‐D‐galactoside galactohydrolase EC 3.2.1.23 Escherichia coli genetically modified microorganism |
author_facet |
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Vittorio Silano José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Boet Glandorf Lieve Herman Magdalena Andryszkiewicz Ana Gomes Natália Kovalkovičová Yi Liu Sandra Rainieri Claudia Roncancio Peña Andrew Chesson |
author_sort |
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
title |
Safety evaluation of the food enzyme β‐galactosidase from the genetically modified Escherichia coli NCIMB 30325 |
title_short |
Safety evaluation of the food enzyme β‐galactosidase from the genetically modified Escherichia coli NCIMB 30325 |
title_full |
Safety evaluation of the food enzyme β‐galactosidase from the genetically modified Escherichia coli NCIMB 30325 |
title_fullStr |
Safety evaluation of the food enzyme β‐galactosidase from the genetically modified Escherichia coli NCIMB 30325 |
title_full_unstemmed |
Safety evaluation of the food enzyme β‐galactosidase from the genetically modified Escherichia coli NCIMB 30325 |
title_sort |
safety evaluation of the food enzyme β‐galactosidase from the genetically modified escherichia coli ncimb 30325 |
publisher |
Wiley |
series |
EFSA Journal |
issn |
1831-4732 |
publishDate |
2020-01-01 |
description |
Abstract The food enzyme is a β‐galactosidase (β‐D‐galactoside galactohydrolase; EC 3.2.1.23) produced with the genetically modified Escherichia coli strain NCIMB 30325 by Clasado Ingredients Ltd. The β‐galactosidase encoding gene is introduced into the recipient strain of E. coli using a self‐replicating plasmid which also contains a gene, which confers resistance to an antibiotic listed as a critically important antimicrobial. This gene was detected in the food enzyme. The absence of viable cells of the production strain in the food enzyme was not demonstrated. The food enzyme is intended to be used only for the production of a mixture of galacto‐oligosaccharides (GOS). Genotoxicity tests did not raise a safety concern. Subchronic 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 900 mg total organic solids (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 conditions of use the risk for allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Given the risk associated with the presence of antibiotic resistance gene in the food enzyme and the lack of data showing the absence of viable cells, the Panel concludes that the use of β‐galactosidase produced with the genetically modified E. coli NCIMB 30325 cannot be considered safe. |
topic |
food enzyme β‐galactosidase β‐D‐galactoside galactohydrolase EC 3.2.1.23 Escherichia coli genetically modified microorganism |
url |
https://doi.org/10.2903/j.efsa.2020.5977 |
work_keys_str_mv |
AT efsapanelonfoodcontactmaterialsenzymesandprocessingaidscep safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT vittoriosilano safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT josemanuelbaratbaviera safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT claudiabolognesi safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT piersandrococconcelli safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT riccardocrebelli safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT davidmichaelgott safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT konradgrob safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT evgenialampi safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT alicjamortensen safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT gillesriviere safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT ingerlisesteffensen safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT christinatlustos safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT henkvanloveren safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT laurencevernis safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT holgerzorn safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT boetglandorf safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT lieveherman safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT magdalenaandryszkiewicz safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT anagomes safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT nataliakovalkovicova safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT yiliu safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT sandrarainieri safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT claudiaroncanciopena safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 AT andrewchesson safetyevaluationofthefoodenzymebgalactosidasefromthegeneticallymodifiedescherichiacolincimb30325 |
_version_ |
1721486542858354688 |