Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29544
Abstract The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Aspergillus niger strain DSM 29544 by Chr. Hansen. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It...
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| Autor*in: |
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) [verfasserIn] Vittorio Silano [verfasserIn] José Manuel Barat Baviera [verfasserIn] Claudia Bolognesi [verfasserIn] Pier Sandro Cocconcelli [verfasserIn] Riccardo Crebelli [verfasserIn] David Michael Gott [verfasserIn] Konrad Grob [verfasserIn] Claude Lambré [verfasserIn] Evgenia Lampi [verfasserIn] Marcel Mengelers [verfasserIn] Alicja Mortensen [verfasserIn] Gilles Rivière [verfasserIn] Inger‐Lise Steffensen [verfasserIn] Christina Tlustos [verfasserIn] Henk Van Loveren [verfasserIn] Laurence Vernis [verfasserIn] Holger Zorn [verfasserIn] Jaime Aguilera [verfasserIn] Magdalena Andryszkiewicz [verfasserIn] Giulio diPiazza [verfasserIn] Rita Ferreira deSousa [verfasserIn] Natalia Kovalkovikova [verfasserIn] Yi Liu [verfasserIn] Andrew Chesson [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2022 |
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| Übergeordnetes Werk: |
In: EFSA Journal - Wiley, 2018, 20(2022), 8, Seite n/a-n/a |
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| Übergeordnetes Werk: |
volume:20 ; year:2022 ; number:8 ; pages:n/a-n/a |
| Links: |
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| DOI / URN: |
10.2903/j.efsa.2022.7464 |
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| Katalog-ID: |
DOAJ030925193 |
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| 520 | |a Abstract The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Aspergillus niger strain DSM 29544 by Chr. Hansen. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in milk processing for cheese production and for production of fermented milk products. Based on the maximum use levels, dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.09 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 rats. The Panel identified a no observed adverse effect level of 84.1 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 930. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were 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 for this to occur is considered 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. | ||
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10.2903/j.efsa.2022.7464 doi (DE-627)DOAJ030925193 (DE-599)DOAJ397c77e8b4a744098987f03d9d4fa4d7 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) verfasserin aut Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29544 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Aspergillus niger strain DSM 29544 by Chr. Hansen. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in milk processing for cheese production and for production of fermented milk products. Based on the maximum use levels, dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.09 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 rats. The Panel identified a no observed adverse effect level of 84.1 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 930. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were 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 for this to occur is considered 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. food enzyme chymosin EC 3.4.23.4 rennin Aspergillus niger genetically modified microorganism Nutrition. Foods and food supply Chemical technology Vittorio Silano verfasserin aut José Manuel Barat Baviera verfasserin aut Claudia Bolognesi verfasserin aut Pier Sandro Cocconcelli verfasserin aut Riccardo Crebelli verfasserin aut David Michael Gott verfasserin aut Konrad Grob verfasserin aut Claude Lambré verfasserin aut Evgenia Lampi verfasserin aut Marcel Mengelers 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 Jaime Aguilera verfasserin aut Magdalena Andryszkiewicz verfasserin aut Giulio diPiazza verfasserin aut Rita Ferreira deSousa verfasserin aut Natalia Kovalkovikova verfasserin aut Yi Liu verfasserin aut Andrew Chesson verfasserin aut In EFSA Journal Wiley, 2018 20(2022), 8, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:20 year:2022 number:8 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2022.7464 kostenfrei https://doaj.org/article/397c77e8b4a744098987f03d9d4fa4d7 kostenfrei https://doi.org/10.2903/j.efsa.2022.7464 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 20 2022 8 n/a-n/a |
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10.2903/j.efsa.2022.7464 doi (DE-627)DOAJ030925193 (DE-599)DOAJ397c77e8b4a744098987f03d9d4fa4d7 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) verfasserin aut Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29544 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Aspergillus niger strain DSM 29544 by Chr. Hansen. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in milk processing for cheese production and for production of fermented milk products. Based on the maximum use levels, dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.09 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 rats. The Panel identified a no observed adverse effect level of 84.1 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 930. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were 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 for this to occur is considered 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. food enzyme chymosin EC 3.4.23.4 rennin Aspergillus niger genetically modified microorganism Nutrition. Foods and food supply Chemical technology Vittorio Silano verfasserin aut José Manuel Barat Baviera verfasserin aut Claudia Bolognesi verfasserin aut Pier Sandro Cocconcelli verfasserin aut Riccardo Crebelli verfasserin aut David Michael Gott verfasserin aut Konrad Grob verfasserin aut Claude Lambré verfasserin aut Evgenia Lampi verfasserin aut Marcel Mengelers 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 Jaime Aguilera verfasserin aut Magdalena Andryszkiewicz verfasserin aut Giulio diPiazza verfasserin aut Rita Ferreira deSousa verfasserin aut Natalia Kovalkovikova verfasserin aut Yi Liu verfasserin aut Andrew Chesson verfasserin aut In EFSA Journal Wiley, 2018 20(2022), 8, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:20 year:2022 number:8 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2022.7464 kostenfrei https://doaj.org/article/397c77e8b4a744098987f03d9d4fa4d7 kostenfrei https://doi.org/10.2903/j.efsa.2022.7464 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 20 2022 8 n/a-n/a |
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10.2903/j.efsa.2022.7464 doi (DE-627)DOAJ030925193 (DE-599)DOAJ397c77e8b4a744098987f03d9d4fa4d7 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) verfasserin aut Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29544 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Aspergillus niger strain DSM 29544 by Chr. Hansen. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in milk processing for cheese production and for production of fermented milk products. Based on the maximum use levels, dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.09 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 rats. The Panel identified a no observed adverse effect level of 84.1 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 930. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were 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 for this to occur is considered 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. food enzyme chymosin EC 3.4.23.4 rennin Aspergillus niger genetically modified microorganism Nutrition. Foods and food supply Chemical technology Vittorio Silano verfasserin aut José Manuel Barat Baviera verfasserin aut Claudia Bolognesi verfasserin aut Pier Sandro Cocconcelli verfasserin aut Riccardo Crebelli verfasserin aut David Michael Gott verfasserin aut Konrad Grob verfasserin aut Claude Lambré verfasserin aut Evgenia Lampi verfasserin aut Marcel Mengelers 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 Jaime Aguilera verfasserin aut Magdalena Andryszkiewicz verfasserin aut Giulio diPiazza verfasserin aut Rita Ferreira deSousa verfasserin aut Natalia Kovalkovikova verfasserin aut Yi Liu verfasserin aut Andrew Chesson verfasserin aut In EFSA Journal Wiley, 2018 20(2022), 8, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:20 year:2022 number:8 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2022.7464 kostenfrei https://doaj.org/article/397c77e8b4a744098987f03d9d4fa4d7 kostenfrei https://doi.org/10.2903/j.efsa.2022.7464 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 20 2022 8 n/a-n/a |
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10.2903/j.efsa.2022.7464 doi (DE-627)DOAJ030925193 (DE-599)DOAJ397c77e8b4a744098987f03d9d4fa4d7 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) verfasserin aut Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29544 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Aspergillus niger strain DSM 29544 by Chr. Hansen. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in milk processing for cheese production and for production of fermented milk products. Based on the maximum use levels, dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.09 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 rats. The Panel identified a no observed adverse effect level of 84.1 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 930. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were 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 for this to occur is considered 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. food enzyme chymosin EC 3.4.23.4 rennin Aspergillus niger genetically modified microorganism Nutrition. Foods and food supply Chemical technology Vittorio Silano verfasserin aut José Manuel Barat Baviera verfasserin aut Claudia Bolognesi verfasserin aut Pier Sandro Cocconcelli verfasserin aut Riccardo Crebelli verfasserin aut David Michael Gott verfasserin aut Konrad Grob verfasserin aut Claude Lambré verfasserin aut Evgenia Lampi verfasserin aut Marcel Mengelers 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 Jaime Aguilera verfasserin aut Magdalena Andryszkiewicz verfasserin aut Giulio diPiazza verfasserin aut Rita Ferreira deSousa verfasserin aut Natalia Kovalkovikova verfasserin aut Yi Liu verfasserin aut Andrew Chesson verfasserin aut In EFSA Journal Wiley, 2018 20(2022), 8, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:20 year:2022 number:8 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2022.7464 kostenfrei https://doaj.org/article/397c77e8b4a744098987f03d9d4fa4d7 kostenfrei https://doi.org/10.2903/j.efsa.2022.7464 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 20 2022 8 n/a-n/a |
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10.2903/j.efsa.2022.7464 doi (DE-627)DOAJ030925193 (DE-599)DOAJ397c77e8b4a744098987f03d9d4fa4d7 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) verfasserin aut Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29544 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Aspergillus niger strain DSM 29544 by Chr. Hansen. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in milk processing for cheese production and for production of fermented milk products. Based on the maximum use levels, dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.09 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 rats. The Panel identified a no observed adverse effect level of 84.1 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 930. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were 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 for this to occur is considered 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. food enzyme chymosin EC 3.4.23.4 rennin Aspergillus niger genetically modified microorganism Nutrition. Foods and food supply Chemical technology Vittorio Silano verfasserin aut José Manuel Barat Baviera verfasserin aut Claudia Bolognesi verfasserin aut Pier Sandro Cocconcelli verfasserin aut Riccardo Crebelli verfasserin aut David Michael Gott verfasserin aut Konrad Grob verfasserin aut Claude Lambré verfasserin aut Evgenia Lampi verfasserin aut Marcel Mengelers 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 Jaime Aguilera verfasserin aut Magdalena Andryszkiewicz verfasserin aut Giulio diPiazza verfasserin aut Rita Ferreira deSousa verfasserin aut Natalia Kovalkovikova verfasserin aut Yi Liu verfasserin aut Andrew Chesson verfasserin aut In EFSA Journal Wiley, 2018 20(2022), 8, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:20 year:2022 number:8 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2022.7464 kostenfrei https://doaj.org/article/397c77e8b4a744098987f03d9d4fa4d7 kostenfrei https://doi.org/10.2903/j.efsa.2022.7464 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 20 2022 8 n/a-n/a |
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EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) @@aut@@ Vittorio Silano @@aut@@ José Manuel Barat Baviera @@aut@@ Claudia Bolognesi @@aut@@ Pier Sandro Cocconcelli @@aut@@ Riccardo Crebelli @@aut@@ David Michael Gott @@aut@@ Konrad Grob @@aut@@ Claude Lambré @@aut@@ Evgenia Lampi @@aut@@ Marcel Mengelers @@aut@@ Alicja Mortensen @@aut@@ Gilles Rivière @@aut@@ Inger‐Lise Steffensen @@aut@@ Christina Tlustos @@aut@@ Henk Van Loveren @@aut@@ Laurence Vernis @@aut@@ Holger Zorn @@aut@@ Jaime Aguilera @@aut@@ Magdalena Andryszkiewicz @@aut@@ Giulio diPiazza @@aut@@ Rita Ferreira deSousa @@aut@@ Natalia Kovalkovikova @@aut@@ Yi Liu @@aut@@ Andrew Chesson @@aut@@ |
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Hansen. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in milk processing for cheese production and for production of fermented milk products. Based on the maximum use levels, dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.09 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 rats. The Panel identified a no observed adverse effect level of 84.1 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 930. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were 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 for this to occur is considered low. 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TX341-641 TP1-1185 Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29544 food enzyme chymosin EC 3.4.23.4 rennin Aspergillus niger genetically modified microorganism |
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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 Claude Lambré Evgenia Lampi Marcel Mengelers Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Jaime Aguilera Magdalena Andryszkiewicz Giulio diPiazza Rita Ferreira deSousa Natalia Kovalkovikova Yi Liu Andrew Chesson |
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safety evaluation of the food enzyme chymosin from the genetically modified aspergillus niger strain dsm 29544 |
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TX341-641 |
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Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29544 |
| abstract |
Abstract The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Aspergillus niger strain DSM 29544 by Chr. Hansen. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in milk processing for cheese production and for production of fermented milk products. Based on the maximum use levels, dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.09 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 rats. The Panel identified a no observed adverse effect level of 84.1 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 930. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were 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 for this to occur is considered 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. |
| abstractGer |
Abstract The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Aspergillus niger strain DSM 29544 by Chr. Hansen. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in milk processing for cheese production and for production of fermented milk products. Based on the maximum use levels, dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.09 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 rats. The Panel identified a no observed adverse effect level of 84.1 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 930. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were 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 for this to occur is considered 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. |
| abstract_unstemmed |
Abstract The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Aspergillus niger strain DSM 29544 by Chr. Hansen. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in milk processing for cheese production and for production of fermented milk products. Based on the maximum use levels, dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.09 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 rats. The Panel identified a no observed adverse effect level of 84.1 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 930. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were 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 for this to occur is considered 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. |
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Safety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29544 |
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https://doi.org/10.2903/j.efsa.2022.7464 https://doaj.org/article/397c77e8b4a744098987f03d9d4fa4d7 https://doaj.org/toc/1831-4732 |
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Vittorio Silano José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Claude Lambré Evgenia Lampi Marcel Mengelers Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Jaime Aguilera Magdalena Andryszkiewicz Giulio diPiazza Rita Ferreira deSousa Natalia Kovalkovikova Yi Liu Andrew Chesson |
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Vittorio Silano José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Claude Lambré Evgenia Lampi Marcel Mengelers Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Jaime Aguilera Magdalena Andryszkiewicz Giulio diPiazza Rita Ferreira deSousa Natalia Kovalkovikova Yi Liu Andrew Chesson |
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10.2903/j.efsa.2022.7464 |
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2024-07-03T17:45:16.525Z |
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|
| score |
7.399583 |