Safety evaluation of the food enzyme d‐psicose 3‐epimerase from the genetically modified Corynebacterium glutamicum strain FIS002

Abstract This assessment addresses a food enzyme preparation consisting of the immobilised intact but non‐viable cells of the genetically modified Corynebacterium glutamicum strain FIS002 by CJ‐Tereos Sweeteners Europe SAS. The production strain produces the food enzyme d‐fructose 3‐epimerase (d‐psi...

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Autores principales:	EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Boet Glandorf, Lieve Herman, Yi Liu, Joaquim Maia, Elsa Nielsen, Andrew Chesson
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	food enzyme d‐psicose 3‐epimerase d‐allulose 3‐epimerase EC 5.1.3.30 Corynebacterium glutamicum genetically modified microorganism Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185
Acceso en línea:	https://doaj.org/article/28f29737fdd3457fb02d1fdf290f81ec
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spelling	oai:doaj.org-article:28f29737fdd3457fb02d1fdf290f81ec2021-11-23T08:30:50ZSafety evaluation of the food enzyme d‐psicose 3‐epimerase from the genetically modified Corynebacterium glutamicum strain FIS0021831-473210.2903/j.efsa.2021.6870https://doaj.org/article/28f29737fdd3457fb02d1fdf290f81ec2021-10-01T00:00:00Zhttps://doi.org/10.2903/j.efsa.2021.6870https://doaj.org/toc/1831-4732Abstract This assessment addresses a food enzyme preparation consisting of the immobilised intact but non‐viable cells of the genetically modified Corynebacterium glutamicum strain FIS002 by CJ‐Tereos Sweeteners Europe SAS. The production strain produces the food enzyme d‐fructose 3‐epimerase (d‐psicose 3‐epimerase; EC 5.1.3.30). The food enzyme preparation is used in processing fructose to produce a speciality carbohydrate d‐allulose (synonym d‐psicose). Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of d‐allulose, 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 (NOAEL) of 1,796 mg TOS/kg body weight (bw) per day, the highest dose tested. A search for similarity of the amino acid sequence of the enzyme to known allergens was made 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 cannot be excluded, but the likelihood of such reactions to occur is low. The food enzyme preparation contains multiple copies of an antimicrobial resistance gene, which is considered a hazard. However, under the specific intended conditions of use described by the applicant, and based on the evidence showing the removal of TOS during the production of d‐allulose and the absence of recombinant DNA in the d‐allulose, the Panel concluded that the identified hazard associated with the food enzyme d‐psicose 3‐epimerase produced with the genetically modified C. glutamicum strain FIS002 will not result in a risk.EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)Claude LambréJosé Manuel Barat BavieraClaudia BolognesiPier Sandro CocconcelliRiccardo CrebelliDavid Michael GottKonrad GrobEvgenia LampiMarcel MengelersAlicja MortensenGilles RivièreInger‐Lise SteffensenChristina TlustosHenk Van LoverenLaurence VernisHolger ZornBoet GlandorfLieve HermanYi LiuJoaquim MaiaElsa NielsenAndrew ChessonWileyarticlefood enzymed‐psicose 3‐epimerased‐allulose 3‐epimeraseEC 5.1.3.30Corynebacterium glutamicumgenetically modified microorganismNutrition. Foods and food supplyTX341-641Chemical technologyTP1-1185ENEFSA Journal, Vol 19, Iss 10, Pp n/a-n/a (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	food enzyme d‐psicose 3‐epimerase d‐allulose 3‐epimerase EC 5.1.3.30 Corynebacterium glutamicum genetically modified microorganism Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185
spellingShingle	food enzyme d‐psicose 3‐epimerase d‐allulose 3‐epimerase EC 5.1.3.30 Corynebacterium glutamicum genetically modified microorganism Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185 EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Claude Lambré José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Marcel Mengelers Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Boet Glandorf Lieve Herman Yi Liu Joaquim Maia Elsa Nielsen Andrew Chesson Safety evaluation of the food enzyme d‐psicose 3‐epimerase from the genetically modified Corynebacterium glutamicum strain FIS002
description	Abstract This assessment addresses a food enzyme preparation consisting of the immobilised intact but non‐viable cells of the genetically modified Corynebacterium glutamicum strain FIS002 by CJ‐Tereos Sweeteners Europe SAS. The production strain produces the food enzyme d‐fructose 3‐epimerase (d‐psicose 3‐epimerase; EC 5.1.3.30). The food enzyme preparation is used in processing fructose to produce a speciality carbohydrate d‐allulose (synonym d‐psicose). Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of d‐allulose, 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 (NOAEL) of 1,796 mg TOS/kg body weight (bw) per day, the highest dose tested. A search for similarity of the amino acid sequence of the enzyme to known allergens was made 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 cannot be excluded, but the likelihood of such reactions to occur is low. The food enzyme preparation contains multiple copies of an antimicrobial resistance gene, which is considered a hazard. However, under the specific intended conditions of use described by the applicant, and based on the evidence showing the removal of TOS during the production of d‐allulose and the absence of recombinant DNA in the d‐allulose, the Panel concluded that the identified hazard associated with the food enzyme d‐psicose 3‐epimerase produced with the genetically modified C. glutamicum strain FIS002 will not result in a risk.
format	article
author	EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Claude Lambré José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Marcel Mengelers Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Boet Glandorf Lieve Herman Yi Liu Joaquim Maia Elsa Nielsen Andrew Chesson
author_facet	EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Claude Lambré José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Marcel Mengelers Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Boet Glandorf Lieve Herman Yi Liu Joaquim Maia Elsa Nielsen Andrew Chesson
author_sort	EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
title	Safety evaluation of the food enzyme d‐psicose 3‐epimerase from the genetically modified Corynebacterium glutamicum strain FIS002
title_short	Safety evaluation of the food enzyme d‐psicose 3‐epimerase from the genetically modified Corynebacterium glutamicum strain FIS002
title_full	Safety evaluation of the food enzyme d‐psicose 3‐epimerase from the genetically modified Corynebacterium glutamicum strain FIS002
title_fullStr	Safety evaluation of the food enzyme d‐psicose 3‐epimerase from the genetically modified Corynebacterium glutamicum strain FIS002
title_full_unstemmed	Safety evaluation of the food enzyme d‐psicose 3‐epimerase from the genetically modified Corynebacterium glutamicum strain FIS002
title_sort	safety evaluation of the food enzyme d‐psicose 3‐epimerase from the genetically modified corynebacterium glutamicum strain fis002
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/28f29737fdd3457fb02d1fdf290f81ec
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Safety evaluation of the food enzyme d‐psicose 3‐epimerase from the genetically modified Corynebacterium glutamicum strain FIS002

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