Safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM‐SD
Abstract The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain NZYM‐SD by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qu...
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| Autor*in: |
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) [verfasserIn] Claude Lambré [verfasserIn] José Manuel Barat Baviera [verfasserIn] Claudia Bolognesi [verfasserIn] Pier Sandro Cocconcelli [verfasserIn] Riccardo Crebelli [verfasserIn] David Michael Gott [verfasserIn] Konrad Grob [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] Lieve Herman [verfasserIn] Magdalena Andryszkiewicz [verfasserIn] Davide Arcella [verfasserIn] Yi Liu [verfasserIn] Rita Ferreira de Sousa [verfasserIn] Andrew Chesson [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2022 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
In: EFSA Journal - Wiley, 2018, 20(2022), 6, Seite n/a-n/a |
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| Übergeordnetes Werk: |
volume:20 ; year:2022 ; number:6 ; pages:n/a-n/a |
| Links: |
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| DOI / URN: |
10.2903/j.efsa.2022.7368 |
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| Katalog-ID: |
DOAJ042624762 |
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| 245 | 1 | 0 | |a Safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM‐SD |
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| 520 | |a Abstract The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain NZYM‐SD by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes, namely baking processes and brewing processes and starch processing for glucose syrup production and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for baking and brewing processes. Dietary exposure was estimated to be up to 0.57 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. Similarity of the amino acid sequence to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues arising from the production process, the Panel concluded that the food enzyme glucan 1,4‐α‐maltohydrolase produced with the genetically modified B. licheniformis strain NZYM‐SD does not give rise to safety concerns under the intended conditions of use. | ||
| 650 | 4 | |a Food enzyme | |
| 650 | 4 | |a glucan 1,4‐α‐maltohydrolase | |
| 650 | 4 | |a 4‐alpha‐d‐glucan alpha‐maltohydrolase | |
| 650 | 4 | |a maltogenic amylase | |
| 650 | 4 | |a 3.2.1.133 | |
| 650 | 4 | |a Bacillus licheniformis | |
| 653 | 0 | |a Nutrition. Foods and food supply | |
| 653 | 0 | |a Chemical technology | |
| 700 | 0 | |a Claude Lambré |e verfasserin |4 aut | |
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| 700 | 0 | |a Henk Van Loveren |e verfasserin |4 aut | |
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| 700 | 0 | |a Yi Liu |e verfasserin |4 aut | |
| 700 | 0 | |a Rita Ferreira de Sousa |e verfasserin |4 aut | |
| 700 | 0 | |a Andrew Chesson |e verfasserin |4 aut | |
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10.2903/j.efsa.2022.7368 doi (DE-627)DOAJ042624762 (DE-599)DOAJ00b79e2750414d1c842a74b761062437 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 glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM‐SD 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain NZYM‐SD by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes, namely baking processes and brewing processes and starch processing for glucose syrup production and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for baking and brewing processes. Dietary exposure was estimated to be up to 0.57 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. Similarity of the amino acid sequence to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues arising from the production process, the Panel concluded that the food enzyme glucan 1,4‐α‐maltohydrolase produced with the genetically modified B. licheniformis strain NZYM‐SD does not give rise to safety concerns under the intended conditions of use. Food enzyme glucan 1,4‐α‐maltohydrolase 4‐alpha‐d‐glucan alpha‐maltohydrolase maltogenic amylase 3.2.1.133 Bacillus licheniformis Nutrition. Foods and food supply Chemical technology Claude Lambré 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 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 Lieve Herman verfasserin aut Magdalena Andryszkiewicz verfasserin aut Davide Arcella verfasserin aut Yi Liu verfasserin aut Rita Ferreira de Sousa verfasserin aut Andrew Chesson verfasserin aut In EFSA Journal Wiley, 2018 20(2022), 6, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:20 year:2022 number:6 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2022.7368 kostenfrei https://doaj.org/article/00b79e2750414d1c842a74b761062437 kostenfrei https://doi.org/10.2903/j.efsa.2022.7368 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 6 n/a-n/a |
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10.2903/j.efsa.2022.7368 doi (DE-627)DOAJ042624762 (DE-599)DOAJ00b79e2750414d1c842a74b761062437 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 glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM‐SD 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain NZYM‐SD by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes, namely baking processes and brewing processes and starch processing for glucose syrup production and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for baking and brewing processes. Dietary exposure was estimated to be up to 0.57 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. Similarity of the amino acid sequence to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues arising from the production process, the Panel concluded that the food enzyme glucan 1,4‐α‐maltohydrolase produced with the genetically modified B. licheniformis strain NZYM‐SD does not give rise to safety concerns under the intended conditions of use. Food enzyme glucan 1,4‐α‐maltohydrolase 4‐alpha‐d‐glucan alpha‐maltohydrolase maltogenic amylase 3.2.1.133 Bacillus licheniformis Nutrition. Foods and food supply Chemical technology Claude Lambré 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 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 Lieve Herman verfasserin aut Magdalena Andryszkiewicz verfasserin aut Davide Arcella verfasserin aut Yi Liu verfasserin aut Rita Ferreira de Sousa verfasserin aut Andrew Chesson verfasserin aut In EFSA Journal Wiley, 2018 20(2022), 6, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:20 year:2022 number:6 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2022.7368 kostenfrei https://doaj.org/article/00b79e2750414d1c842a74b761062437 kostenfrei https://doi.org/10.2903/j.efsa.2022.7368 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 6 n/a-n/a |
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10.2903/j.efsa.2022.7368 doi (DE-627)DOAJ042624762 (DE-599)DOAJ00b79e2750414d1c842a74b761062437 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 glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM‐SD 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain NZYM‐SD by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes, namely baking processes and brewing processes and starch processing for glucose syrup production and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for baking and brewing processes. Dietary exposure was estimated to be up to 0.57 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. Similarity of the amino acid sequence to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues arising from the production process, the Panel concluded that the food enzyme glucan 1,4‐α‐maltohydrolase produced with the genetically modified B. licheniformis strain NZYM‐SD does not give rise to safety concerns under the intended conditions of use. Food enzyme glucan 1,4‐α‐maltohydrolase 4‐alpha‐d‐glucan alpha‐maltohydrolase maltogenic amylase 3.2.1.133 Bacillus licheniformis Nutrition. Foods and food supply Chemical technology Claude Lambré 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 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 Lieve Herman verfasserin aut Magdalena Andryszkiewicz verfasserin aut Davide Arcella verfasserin aut Yi Liu verfasserin aut Rita Ferreira de Sousa verfasserin aut Andrew Chesson verfasserin aut In EFSA Journal Wiley, 2018 20(2022), 6, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:20 year:2022 number:6 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2022.7368 kostenfrei https://doaj.org/article/00b79e2750414d1c842a74b761062437 kostenfrei https://doi.org/10.2903/j.efsa.2022.7368 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 6 n/a-n/a |
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10.2903/j.efsa.2022.7368 doi (DE-627)DOAJ042624762 (DE-599)DOAJ00b79e2750414d1c842a74b761062437 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 glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM‐SD 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain NZYM‐SD by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes, namely baking processes and brewing processes and starch processing for glucose syrup production and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for baking and brewing processes. Dietary exposure was estimated to be up to 0.57 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. Similarity of the amino acid sequence to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues arising from the production process, the Panel concluded that the food enzyme glucan 1,4‐α‐maltohydrolase produced with the genetically modified B. licheniformis strain NZYM‐SD does not give rise to safety concerns under the intended conditions of use. Food enzyme glucan 1,4‐α‐maltohydrolase 4‐alpha‐d‐glucan alpha‐maltohydrolase maltogenic amylase 3.2.1.133 Bacillus licheniformis Nutrition. Foods and food supply Chemical technology Claude Lambré 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 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 Lieve Herman verfasserin aut Magdalena Andryszkiewicz verfasserin aut Davide Arcella verfasserin aut Yi Liu verfasserin aut Rita Ferreira de Sousa verfasserin aut Andrew Chesson verfasserin aut In EFSA Journal Wiley, 2018 20(2022), 6, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:20 year:2022 number:6 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2022.7368 kostenfrei https://doaj.org/article/00b79e2750414d1c842a74b761062437 kostenfrei https://doi.org/10.2903/j.efsa.2022.7368 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 6 n/a-n/a |
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10.2903/j.efsa.2022.7368 doi (DE-627)DOAJ042624762 (DE-599)DOAJ00b79e2750414d1c842a74b761062437 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 glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM‐SD 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain NZYM‐SD by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes, namely baking processes and brewing processes and starch processing for glucose syrup production and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for baking and brewing processes. Dietary exposure was estimated to be up to 0.57 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. Similarity of the amino acid sequence to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues arising from the production process, the Panel concluded that the food enzyme glucan 1,4‐α‐maltohydrolase produced with the genetically modified B. licheniformis strain NZYM‐SD does not give rise to safety concerns under the intended conditions of use. Food enzyme glucan 1,4‐α‐maltohydrolase 4‐alpha‐d‐glucan alpha‐maltohydrolase maltogenic amylase 3.2.1.133 Bacillus licheniformis Nutrition. Foods and food supply Chemical technology Claude Lambré 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 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 Lieve Herman verfasserin aut Magdalena Andryszkiewicz verfasserin aut Davide Arcella verfasserin aut Yi Liu verfasserin aut Rita Ferreira de Sousa verfasserin aut Andrew Chesson verfasserin aut In EFSA Journal Wiley, 2018 20(2022), 6, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:20 year:2022 number:6 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2022.7368 kostenfrei https://doaj.org/article/00b79e2750414d1c842a74b761062437 kostenfrei https://doi.org/10.2903/j.efsa.2022.7368 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 6 n/a-n/a |
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Food enzyme glucan 1,4‐α‐maltohydrolase 4‐alpha‐d‐glucan alpha‐maltohydrolase maltogenic amylase 3.2.1.133 Bacillus licheniformis Nutrition. Foods and food supply Chemical technology |
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EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) @@aut@@ Claude Lambré @@aut@@ José Manuel Barat Baviera @@aut@@ Claudia Bolognesi @@aut@@ Pier Sandro Cocconcelli @@aut@@ Riccardo Crebelli @@aut@@ David Michael Gott @@aut@@ Konrad Grob @@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@@ Lieve Herman @@aut@@ Magdalena Andryszkiewicz @@aut@@ Davide Arcella @@aut@@ Yi Liu @@aut@@ Rita Ferreira de Sousa @@aut@@ Andrew Chesson @@aut@@ |
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The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes, namely baking processes and brewing processes and starch processing for glucose syrup production and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for baking and brewing processes. Dietary exposure was estimated to be up to 0.57 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. Similarity of the amino acid sequence to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues arising from the production process, the Panel concluded that the food enzyme glucan 1,4‐α‐maltohydrolase produced with the genetically modified B. licheniformis strain NZYM‐SD does not give rise to safety concerns under the intended conditions of use.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Food enzyme</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">glucan 1,4‐α‐maltohydrolase</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">4‐alpha‐d‐glucan alpha‐maltohydrolase</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">maltogenic amylase</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">3.2.1.133</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Bacillus licheniformis</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Nutrition. 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TX341-641 TP1-1185 Safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM‐SD Food enzyme glucan 1,4‐α‐maltohydrolase 4‐alpha‐d‐glucan alpha‐maltohydrolase maltogenic amylase 3.2.1.133 Bacillus licheniformis |
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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 Lieve Herman Magdalena Andryszkiewicz Davide Arcella Yi Liu Rita Ferreira de Sousa Andrew Chesson |
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TX341-641 TP1-1185 |
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Elektronische Aufsätze |
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EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
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10.2903/j.efsa.2022.7368 |
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safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified bacillus licheniformis strain nzym‐sd |
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TX341-641 |
| title_auth |
Safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM‐SD |
| abstract |
Abstract The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain NZYM‐SD by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes, namely baking processes and brewing processes and starch processing for glucose syrup production and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for baking and brewing processes. Dietary exposure was estimated to be up to 0.57 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. Similarity of the amino acid sequence to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues arising from the production process, the Panel concluded that the food enzyme glucan 1,4‐α‐maltohydrolase produced with the genetically modified B. licheniformis strain NZYM‐SD does not give rise to safety concerns under the intended conditions of use. |
| abstractGer |
Abstract The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain NZYM‐SD by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes, namely baking processes and brewing processes and starch processing for glucose syrup production and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for baking and brewing processes. Dietary exposure was estimated to be up to 0.57 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. Similarity of the amino acid sequence to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues arising from the production process, the Panel concluded that the food enzyme glucan 1,4‐α‐maltohydrolase produced with the genetically modified B. licheniformis strain NZYM‐SD does not give rise to safety concerns under the intended conditions of use. |
| abstract_unstemmed |
Abstract The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain NZYM‐SD by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes, namely baking processes and brewing processes and starch processing for glucose syrup production and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for baking and brewing processes. Dietary exposure was estimated to be up to 0.57 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. Similarity of the amino acid sequence to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues arising from the production process, the Panel concluded that the food enzyme glucan 1,4‐α‐maltohydrolase produced with the genetically modified B. licheniformis strain NZYM‐SD does not give rise to safety concerns under the intended conditions of use. |
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Safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM‐SD |
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https://doi.org/10.2903/j.efsa.2022.7368 https://doaj.org/article/00b79e2750414d1c842a74b761062437 https://doaj.org/toc/1831-4732 |
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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 Lieve Herman Magdalena Andryszkiewicz Davide Arcella Yi Liu Rita Ferreira de Sousa Andrew Chesson |
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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 Lieve Herman Magdalena Andryszkiewicz Davide Arcella Yi Liu Rita Ferreira de Sousa Andrew Chesson |
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10.2903/j.efsa.2022.7368 |
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2024-07-04T01:39:30.532Z |
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|
| score |
7.399913 |