Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Abstract The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used...
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Autor*in:	EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel) [verfasserIn] Vittorio Silano [verfasserIn] José Manuel Barat Baviera [verfasserIn] Claudia Bolognesi [verfasserIn] Beat Johannes Brüschweiler [verfasserIn] Pier Sandro Cocconcelli [verfasserIn] Riccardo Crebelli [verfasserIn] David Michael Gott [verfasserIn] Konrad Grob [verfasserIn] Evgenia Lampi [verfasserIn] Alicja Mortensen [verfasserIn] Gilles Rivière [verfasserIn] Inger‐Lise Steffensen [verfasserIn] Christina Tlustos [verfasserIn] Henk Van Loveren [verfasserIn] Laurence Vernis [verfasserIn] Holger Zorn [verfasserIn] Boet Glandorf [verfasserIn] Francesca Marcon [verfasserIn] André Penninks [verfasserIn] Jaime Aguilera [verfasserIn] Magdalena Andryszkiewicz [verfasserIn] Davide Arcella [verfasserIn] Joaquim Maia [verfasserIn] Yi Liu [verfasserIn] Andrew Chesson [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2019

Schlagwörter:	food enzyme endo‐1 3(4)‐β‐glucanase 4‐β‐xylanase

Übergeordnetes Werk:	In: EFSA Journal - Wiley, 2018, 17(2019), 3, Seite n/a-n/a
Übergeordnetes Werk:	volume:17 ; year:2019 ; number:3 ; pages:n/a-n/a

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.2903/j.efsa.2019.5631

Katalog-ID:	DOAJ067335594

Internformat


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245	1	0	\|a Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)
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520			\|a Abstract The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended 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 0.411 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. Systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. From this study, the Panel identified a no observed adverse effect level (NOAEL) of at least 620 mg TOS/kg bw per day, the highest dose tested. When the NOAEL is compared to the estimated dietary exposure, this results in a margin of exposure of at least 1,500. A search was made for similarity of the amino acid sequence of the declared activities with those of known allergens. Four matches were found with endo‐1,3(4)‐β‐glucanase to known respiratory allergens, two from dust mites and two Aspergillus fumigatus allergens. The Panel considered that an allergic reaction upon oral ingestion of enzymes produced by M. thermophiloides strain NZYM‐ST in individuals respiratory sensitised to these allergens cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that, under the intended conditions of use and based on the data provided, this food enzyme does not give rise to safety concerns.
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700	0		\|a Christina Tlustos \|e verfasserin \|4 aut
700	0		\|a Henk Van Loveren \|e verfasserin \|4 aut
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700	0		\|a André Penninks \|e verfasserin \|4 aut
700	0		\|a Jaime Aguilera \|e verfasserin \|4 aut
700	0		\|a Magdalena Andryszkiewicz \|e verfasserin \|4 aut
700	0		\|a Davide Arcella \|e verfasserin \|4 aut
700	0		\|a Joaquim Maia \|e verfasserin \|4 aut
700	0		\|a Yi Liu \|e verfasserin \|4 aut
700	0		\|a Andrew Chesson \|e verfasserin \|4 aut
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912			\|a GBV_ILN_235
912			\|a GBV_ILN_285
912			\|a GBV_ILN_293
912			\|a GBV_ILN_602
912			\|a GBV_ILN_636
912			\|a GBV_ILN_2004
912			\|a GBV_ILN_2005
912			\|a GBV_ILN_2006
912			\|a GBV_ILN_2007
912			\|a GBV_ILN_2009
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912			\|a GBV_ILN_2014
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allfields	10.2903/j.efsa.2019.5631 doi (DE-627)DOAJ067335594 (DE-599)DOAJ9e75290246de454ca527ff3c2caba9cd DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel) verfasserin aut Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST) 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended 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 0.411 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. Systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. From this study, the Panel identified a no observed adverse effect level (NOAEL) of at least 620 mg TOS/kg bw per day, the highest dose tested. When the NOAEL is compared to the estimated dietary exposure, this results in a margin of exposure of at least 1,500. A search was made for similarity of the amino acid sequence of the declared activities with those of known allergens. Four matches were found with endo‐1,3(4)‐β‐glucanase to known respiratory allergens, two from dust mites and two Aspergillus fumigatus allergens. The Panel considered that an allergic reaction upon oral ingestion of enzymes produced by M. thermophiloides strain NZYM‐ST in individuals respiratory sensitised to these allergens cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that, under the intended conditions of use and based on the data provided, this food enzyme does not give rise to safety concerns. food enzyme endo‐1 3(4)‐β‐glucanase 4‐β‐xylanase Nutrition. Foods and food supply Chemical technology Vittorio Silano verfasserin aut José Manuel Barat Baviera verfasserin aut Claudia Bolognesi verfasserin aut Beat Johannes Brüschweiler verfasserin aut Pier Sandro Cocconcelli verfasserin aut Riccardo Crebelli verfasserin aut David Michael Gott verfasserin aut Konrad Grob verfasserin aut Evgenia Lampi verfasserin aut Alicja Mortensen verfasserin aut Gilles Rivière verfasserin aut Inger‐Lise Steffensen verfasserin aut Christina Tlustos verfasserin aut Henk Van Loveren verfasserin aut Laurence Vernis verfasserin aut Holger Zorn verfasserin aut Boet Glandorf verfasserin aut Francesca Marcon verfasserin aut André Penninks verfasserin aut Jaime Aguilera verfasserin aut Magdalena Andryszkiewicz verfasserin aut Davide Arcella verfasserin aut Joaquim Maia verfasserin aut Yi Liu verfasserin aut Andrew Chesson verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 3, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:3 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5631 kostenfrei https://doaj.org/article/9e75290246de454ca527ff3c2caba9cd kostenfrei https://doi.org/10.2903/j.efsa.2019.5631 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2019 3 n/a-n/a
spelling	10.2903/j.efsa.2019.5631 doi (DE-627)DOAJ067335594 (DE-599)DOAJ9e75290246de454ca527ff3c2caba9cd DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel) verfasserin aut Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST) 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended 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 0.411 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. Systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. From this study, the Panel identified a no observed adverse effect level (NOAEL) of at least 620 mg TOS/kg bw per day, the highest dose tested. When the NOAEL is compared to the estimated dietary exposure, this results in a margin of exposure of at least 1,500. A search was made for similarity of the amino acid sequence of the declared activities with those of known allergens. Four matches were found with endo‐1,3(4)‐β‐glucanase to known respiratory allergens, two from dust mites and two Aspergillus fumigatus allergens. The Panel considered that an allergic reaction upon oral ingestion of enzymes produced by M. thermophiloides strain NZYM‐ST in individuals respiratory sensitised to these allergens cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that, under the intended conditions of use and based on the data provided, this food enzyme does not give rise to safety concerns. food enzyme endo‐1 3(4)‐β‐glucanase 4‐β‐xylanase Nutrition. Foods and food supply Chemical technology Vittorio Silano verfasserin aut José Manuel Barat Baviera verfasserin aut Claudia Bolognesi verfasserin aut Beat Johannes Brüschweiler verfasserin aut Pier Sandro Cocconcelli verfasserin aut Riccardo Crebelli verfasserin aut David Michael Gott verfasserin aut Konrad Grob verfasserin aut Evgenia Lampi verfasserin aut Alicja Mortensen verfasserin aut Gilles Rivière verfasserin aut Inger‐Lise Steffensen verfasserin aut Christina Tlustos verfasserin aut Henk Van Loveren verfasserin aut Laurence Vernis verfasserin aut Holger Zorn verfasserin aut Boet Glandorf verfasserin aut Francesca Marcon verfasserin aut André Penninks verfasserin aut Jaime Aguilera verfasserin aut Magdalena Andryszkiewicz verfasserin aut Davide Arcella verfasserin aut Joaquim Maia verfasserin aut Yi Liu verfasserin aut Andrew Chesson verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 3, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:3 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5631 kostenfrei https://doaj.org/article/9e75290246de454ca527ff3c2caba9cd kostenfrei https://doi.org/10.2903/j.efsa.2019.5631 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2019 3 n/a-n/a
allfields_unstemmed	10.2903/j.efsa.2019.5631 doi (DE-627)DOAJ067335594 (DE-599)DOAJ9e75290246de454ca527ff3c2caba9cd DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel) verfasserin aut Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST) 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended 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 0.411 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. Systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. From this study, the Panel identified a no observed adverse effect level (NOAEL) of at least 620 mg TOS/kg bw per day, the highest dose tested. When the NOAEL is compared to the estimated dietary exposure, this results in a margin of exposure of at least 1,500. A search was made for similarity of the amino acid sequence of the declared activities with those of known allergens. Four matches were found with endo‐1,3(4)‐β‐glucanase to known respiratory allergens, two from dust mites and two Aspergillus fumigatus allergens. The Panel considered that an allergic reaction upon oral ingestion of enzymes produced by M. thermophiloides strain NZYM‐ST in individuals respiratory sensitised to these allergens cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that, under the intended conditions of use and based on the data provided, this food enzyme does not give rise to safety concerns. food enzyme endo‐1 3(4)‐β‐glucanase 4‐β‐xylanase Nutrition. Foods and food supply Chemical technology Vittorio Silano verfasserin aut José Manuel Barat Baviera verfasserin aut Claudia Bolognesi verfasserin aut Beat Johannes Brüschweiler verfasserin aut Pier Sandro Cocconcelli verfasserin aut Riccardo Crebelli verfasserin aut David Michael Gott verfasserin aut Konrad Grob verfasserin aut Evgenia Lampi verfasserin aut Alicja Mortensen verfasserin aut Gilles Rivière verfasserin aut Inger‐Lise Steffensen verfasserin aut Christina Tlustos verfasserin aut Henk Van Loveren verfasserin aut Laurence Vernis verfasserin aut Holger Zorn verfasserin aut Boet Glandorf verfasserin aut Francesca Marcon verfasserin aut André Penninks verfasserin aut Jaime Aguilera verfasserin aut Magdalena Andryszkiewicz verfasserin aut Davide Arcella verfasserin aut Joaquim Maia verfasserin aut Yi Liu verfasserin aut Andrew Chesson verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 3, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:3 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5631 kostenfrei https://doaj.org/article/9e75290246de454ca527ff3c2caba9cd kostenfrei https://doi.org/10.2903/j.efsa.2019.5631 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2019 3 n/a-n/a
allfieldsGer	10.2903/j.efsa.2019.5631 doi (DE-627)DOAJ067335594 (DE-599)DOAJ9e75290246de454ca527ff3c2caba9cd DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel) verfasserin aut Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST) 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended 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 0.411 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. Systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. From this study, the Panel identified a no observed adverse effect level (NOAEL) of at least 620 mg TOS/kg bw per day, the highest dose tested. When the NOAEL is compared to the estimated dietary exposure, this results in a margin of exposure of at least 1,500. A search was made for similarity of the amino acid sequence of the declared activities with those of known allergens. Four matches were found with endo‐1,3(4)‐β‐glucanase to known respiratory allergens, two from dust mites and two Aspergillus fumigatus allergens. The Panel considered that an allergic reaction upon oral ingestion of enzymes produced by M. thermophiloides strain NZYM‐ST in individuals respiratory sensitised to these allergens cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that, under the intended conditions of use and based on the data provided, this food enzyme does not give rise to safety concerns. food enzyme endo‐1 3(4)‐β‐glucanase 4‐β‐xylanase Nutrition. Foods and food supply Chemical technology Vittorio Silano verfasserin aut José Manuel Barat Baviera verfasserin aut Claudia Bolognesi verfasserin aut Beat Johannes Brüschweiler verfasserin aut Pier Sandro Cocconcelli verfasserin aut Riccardo Crebelli verfasserin aut David Michael Gott verfasserin aut Konrad Grob verfasserin aut Evgenia Lampi verfasserin aut Alicja Mortensen verfasserin aut Gilles Rivière verfasserin aut Inger‐Lise Steffensen verfasserin aut Christina Tlustos verfasserin aut Henk Van Loveren verfasserin aut Laurence Vernis verfasserin aut Holger Zorn verfasserin aut Boet Glandorf verfasserin aut Francesca Marcon verfasserin aut André Penninks verfasserin aut Jaime Aguilera verfasserin aut Magdalena Andryszkiewicz verfasserin aut Davide Arcella verfasserin aut Joaquim Maia verfasserin aut Yi Liu verfasserin aut Andrew Chesson verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 3, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:3 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5631 kostenfrei https://doaj.org/article/9e75290246de454ca527ff3c2caba9cd kostenfrei https://doi.org/10.2903/j.efsa.2019.5631 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2019 3 n/a-n/a
allfieldsSound	10.2903/j.efsa.2019.5631 doi (DE-627)DOAJ067335594 (DE-599)DOAJ9e75290246de454ca527ff3c2caba9cd DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel) verfasserin aut Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST) 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended 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 0.411 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. Systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. From this study, the Panel identified a no observed adverse effect level (NOAEL) of at least 620 mg TOS/kg bw per day, the highest dose tested. When the NOAEL is compared to the estimated dietary exposure, this results in a margin of exposure of at least 1,500. A search was made for similarity of the amino acid sequence of the declared activities with those of known allergens. Four matches were found with endo‐1,3(4)‐β‐glucanase to known respiratory allergens, two from dust mites and two Aspergillus fumigatus allergens. The Panel considered that an allergic reaction upon oral ingestion of enzymes produced by M. thermophiloides strain NZYM‐ST in individuals respiratory sensitised to these allergens cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that, under the intended conditions of use and based on the data provided, this food enzyme does not give rise to safety concerns. food enzyme endo‐1 3(4)‐β‐glucanase 4‐β‐xylanase Nutrition. Foods and food supply Chemical technology Vittorio Silano verfasserin aut José Manuel Barat Baviera verfasserin aut Claudia Bolognesi verfasserin aut Beat Johannes Brüschweiler verfasserin aut Pier Sandro Cocconcelli verfasserin aut Riccardo Crebelli verfasserin aut David Michael Gott verfasserin aut Konrad Grob verfasserin aut Evgenia Lampi verfasserin aut Alicja Mortensen verfasserin aut Gilles Rivière verfasserin aut Inger‐Lise Steffensen verfasserin aut Christina Tlustos verfasserin aut Henk Van Loveren verfasserin aut Laurence Vernis verfasserin aut Holger Zorn verfasserin aut Boet Glandorf verfasserin aut Francesca Marcon verfasserin aut André Penninks verfasserin aut Jaime Aguilera verfasserin aut Magdalena Andryszkiewicz verfasserin aut Davide Arcella verfasserin aut Joaquim Maia verfasserin aut Yi Liu verfasserin aut Andrew Chesson verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 3, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:3 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5631 kostenfrei https://doaj.org/article/9e75290246de454ca527ff3c2caba9cd kostenfrei https://doi.org/10.2903/j.efsa.2019.5631 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2019 3 n/a-n/a
language	English
source	In EFSA Journal 17(2019), 3, Seite n/a-n/a volume:17 year:2019 number:3 pages:n/a-n/a
sourceStr	In EFSA Journal 17(2019), 3, Seite n/a-n/a volume:17 year:2019 number:3 pages:n/a-n/a
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	food enzyme endo‐1 3(4)‐β‐glucanase 4‐β‐xylanase Nutrition. Foods and food supply Chemical technology
isfreeaccess_bool	true
container_title	EFSA Journal
authorswithroles_txt_mv	EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel) @@aut@@ Vittorio Silano @@aut@@ José Manuel Barat Baviera @@aut@@ Claudia Bolognesi @@aut@@ Beat Johannes Brüschweiler @@aut@@ Pier Sandro Cocconcelli @@aut@@ Riccardo Crebelli @@aut@@ David Michael Gott @@aut@@ Konrad Grob @@aut@@ Evgenia Lampi @@aut@@ Alicja Mortensen @@aut@@ Gilles Rivière @@aut@@ Inger‐Lise Steffensen @@aut@@ Christina Tlustos @@aut@@ Henk Van Loveren @@aut@@ Laurence Vernis @@aut@@ Holger Zorn @@aut@@ Boet Glandorf @@aut@@ Francesca Marcon @@aut@@ André Penninks @@aut@@ Jaime Aguilera @@aut@@ Magdalena Andryszkiewicz @@aut@@ Davide Arcella @@aut@@ Joaquim Maia @@aut@@ Yi Liu @@aut@@ Andrew Chesson @@aut@@
publishDateDaySort_date	2019-01-01T00:00:00Z
hierarchy_top_id	618834982
id	DOAJ067335594
language_de	englisch
fullrecord	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">DOAJ067335594</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230309070221.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230228s2019 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.2903/j.efsa.2019.5631</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)DOAJ067335594</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)DOAJ9e75290246de454ca527ff3c2caba9cd</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">TX341-641</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">TP1-1185</subfield></datafield><datafield tag="100" ind1="0" ind2=" "><subfield code="a">EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel)</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2019</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Abstract The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended 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 0.411 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. Systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. From this study, the Panel identified a no observed adverse effect level (NOAEL) of at least 620 mg TOS/kg bw per day, the highest dose tested. When the NOAEL is compared to the estimated dietary exposure, this results in a margin of exposure of at least 1,500. A search was made for similarity of the amino acid sequence of the declared activities with those of known allergens. Four matches were found with endo‐1,3(4)‐β‐glucanase to known respiratory allergens, two from dust mites and two Aspergillus fumigatus allergens. The Panel considered that an allergic reaction upon oral ingestion of enzymes produced by M. thermophiloides strain NZYM‐ST in individuals respiratory sensitised to these allergens cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that, under the intended conditions of use and based on the data provided, this food enzyme does not give rise to safety concerns.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">food enzyme</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">endo‐1</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">3(4)‐β‐glucanase</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">4‐β‐xylanase</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Nutrition. Foods and food supply</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Chemical technology</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Vittorio Silano</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">José Manuel Barat Baviera</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Claudia Bolognesi</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Beat Johannes Brüschweiler</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Pier Sandro Cocconcelli</subfield><subfield code="e">verfasserin</subfield><subfield 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callnumber-first	T - Technology
author	EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel)
spellingShingle	EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel) misc TX341-641 misc TP1-1185 misc food enzyme misc endo‐1 misc 3(4)‐β‐glucanase misc 4‐β‐xylanase misc Nutrition. Foods and food supply misc Chemical technology Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)
authorStr	EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel)
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topic_title	TX341-641 TP1-1185 Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST) food enzyme endo‐1 3(4)‐β‐glucanase 4‐β‐xylanase
topic	misc TX341-641 misc TP1-1185 misc food enzyme misc endo‐1 misc 3(4)‐β‐glucanase misc 4‐β‐xylanase misc Nutrition. Foods and food supply misc Chemical technology
topic_unstemmed	misc TX341-641 misc TP1-1185 misc food enzyme misc endo‐1 misc 3(4)‐β‐glucanase misc 4‐β‐xylanase misc Nutrition. Foods and food supply misc Chemical technology
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title	Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)
ctrlnum	(DE-627)DOAJ067335594 (DE-599)DOAJ9e75290246de454ca527ff3c2caba9cd
title_full	Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)
author_sort	EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel)
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author_browse	EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel) 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 Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Boet Glandorf Francesca Marcon André Penninks Jaime Aguilera Magdalena Andryszkiewicz Davide Arcella Joaquim Maia Yi Liu Andrew Chesson
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author-letter	EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel)
doi_str_mv	10.2903/j.efsa.2019.5631
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title_sort	safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from mycothermus thermophiloides (strain nzym‐st)
callnumber	TX341-641
title_auth	Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)
abstract	Abstract The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended 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 0.411 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. Systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. From this study, the Panel identified a no observed adverse effect level (NOAEL) of at least 620 mg TOS/kg bw per day, the highest dose tested. When the NOAEL is compared to the estimated dietary exposure, this results in a margin of exposure of at least 1,500. A search was made for similarity of the amino acid sequence of the declared activities with those of known allergens. Four matches were found with endo‐1,3(4)‐β‐glucanase to known respiratory allergens, two from dust mites and two Aspergillus fumigatus allergens. The Panel considered that an allergic reaction upon oral ingestion of enzymes produced by M. thermophiloides strain NZYM‐ST in individuals respiratory sensitised to these allergens cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that, under the intended conditions of use and based on the data provided, this food enzyme does not give rise to safety concerns.
abstractGer	Abstract The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended 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 0.411 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. Systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. From this study, the Panel identified a no observed adverse effect level (NOAEL) of at least 620 mg TOS/kg bw per day, the highest dose tested. When the NOAEL is compared to the estimated dietary exposure, this results in a margin of exposure of at least 1,500. A search was made for similarity of the amino acid sequence of the declared activities with those of known allergens. Four matches were found with endo‐1,3(4)‐β‐glucanase to known respiratory allergens, two from dust mites and two Aspergillus fumigatus allergens. The Panel considered that an allergic reaction upon oral ingestion of enzymes produced by M. thermophiloides strain NZYM‐ST in individuals respiratory sensitised to these allergens cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that, under the intended conditions of use and based on the data provided, this food enzyme does not give rise to safety concerns.
abstract_unstemmed	Abstract The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended 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 0.411 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. Systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. From this study, the Panel identified a no observed adverse effect level (NOAEL) of at least 620 mg TOS/kg bw per day, the highest dose tested. When the NOAEL is compared to the estimated dietary exposure, this results in a margin of exposure of at least 1,500. A search was made for similarity of the amino acid sequence of the declared activities with those of known allergens. Four matches were found with endo‐1,3(4)‐β‐glucanase to known respiratory allergens, two from dust mites and two Aspergillus fumigatus allergens. The Panel considered that an allergic reaction upon oral ingestion of enzymes produced by M. thermophiloides strain NZYM‐ST in individuals respiratory sensitised to these allergens cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that, under the intended conditions of use and based on the data provided, this food enzyme does not give rise to safety concerns.
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container_issue	3
title_short	Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)
url	https://doi.org/10.2903/j.efsa.2019.5631 https://doaj.org/article/9e75290246de454ca527ff3c2caba9cd https://doaj.org/toc/1831-4732
remote_bool	true
author2	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 Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Boet Glandorf Francesca Marcon André Penninks Jaime Aguilera Magdalena Andryszkiewicz Davide Arcella Joaquim Maia Yi Liu Andrew Chesson
author2Str	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 Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Boet Glandorf Francesca Marcon André Penninks Jaime Aguilera Magdalena Andryszkiewicz Davide Arcella Joaquim Maia Yi Liu Andrew Chesson
ppnlink	618834982
callnumber-subject	TX - Home Economics
mediatype_str_mv	c
isOA_txt	true
hochschulschrift_bool	false
doi_str	10.2903/j.efsa.2019.5631
callnumber-a	TX341-641
up_date	2024-07-04T00:29:38.555Z
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Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

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