Safety evaluation of the food enzyme maltogenic amylase from the genetically modified Bacillus licheniformis strain DP‐Dzr50
Abstract The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain DP‐Dzr50 by Danisco US Inc. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. Howe...
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| Format: | Article |
| Language: | English |
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Wiley
2020-01-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2020.5972 |
| _version_ | 1829510547571212288 |
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| author | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Vittorio Silano José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Alicja Mortensen Gilles Riviere Inger‐Lise Steffensen Christina Tlustos Henk vanLoveren Laurence Vernis Holger Zorn Boet Glandorf Lieve Herman Magdalena Andryszkiewicz Davide Arcella Ana Gomes Natália Kovalkovičová Yi Liu Andrew Chesson |
| author_facet | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Vittorio Silano José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Alicja Mortensen Gilles Riviere Inger‐Lise Steffensen Christina Tlustos Henk vanLoveren Laurence Vernis Holger Zorn Boet Glandorf Lieve Herman Magdalena Andryszkiewicz Davide Arcella Ana Gomes Natália Kovalkovičová Yi Liu Andrew Chesson |
| author_sort | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain DP‐Dzr50 by Danisco US Inc. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in distilled alcohol production, starch processing for the production of glucose syrups, baking and brewing processes. Since residual amounts of the food enzyme are removed by distillation and starch processing, no dietary exposure was calculated for these processes. Based on the maximum use levels recommended for baking and brewing 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 0.199 mg TOS/kg body weight (bw) per day. 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 at least 80 mg TOS/kg bw per day which, compared to the estimated dietary exposure, results in a margin of exposure of at least 400. Similarity of the amino acid sequence to those of known allergens was searched and three matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure can be excluded in distilled alcohol production and is considered to be low in starch processing, baking and brewing. 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. |
| first_indexed | 2024-12-16T12:07:03Z |
| format | Article |
| id | doaj.art-e8ad4db43b5044b9b524b514849f2887 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-16T12:07:03Z |
| publishDate | 2020-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-e8ad4db43b5044b9b524b514849f28872022-12-21T22:32:18ZengWileyEFSA Journal1831-47322020-01-01181n/an/a10.2903/j.efsa.2020.5972Safety evaluation of the food enzyme maltogenic amylase from the genetically modified Bacillus licheniformis strain DP‐Dzr50EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)Vittorio SilanoJosé Manuel Barat BavieraClaudia BolognesiPier Sandro CocconcelliRiccardo CrebelliDavid Michael GottKonrad GrobEvgenia LampiAlicja MortensenGilles RiviereInger‐Lise SteffensenChristina TlustosHenk vanLoverenLaurence VernisHolger ZornBoet GlandorfLieve HermanMagdalena AndryszkiewiczDavide ArcellaAna GomesNatália KovalkovičováYi LiuAndrew ChessonAbstract The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain DP‐Dzr50 by Danisco US Inc. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in distilled alcohol production, starch processing for the production of glucose syrups, baking and brewing processes. Since residual amounts of the food enzyme are removed by distillation and starch processing, no dietary exposure was calculated for these processes. Based on the maximum use levels recommended for baking and brewing 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 0.199 mg TOS/kg body weight (bw) per day. 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 at least 80 mg TOS/kg bw per day which, compared to the estimated dietary exposure, results in a margin of exposure of at least 400. Similarity of the amino acid sequence to those of known allergens was searched and three matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure can be excluded in distilled alcohol production and is considered to be low in starch processing, baking and brewing. 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.https://doi.org/10.2903/j.efsa.2020.5972food enzymemaltogenic amylaseglucan 1,4‐α‐maltohydrolaseEC 3.2.1.133Bacillus licheniformisgenetically modified microorganism |
| spellingShingle | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Vittorio Silano José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Alicja Mortensen Gilles Riviere Inger‐Lise Steffensen Christina Tlustos Henk vanLoveren Laurence Vernis Holger Zorn Boet Glandorf Lieve Herman Magdalena Andryszkiewicz Davide Arcella Ana Gomes Natália Kovalkovičová Yi Liu Andrew Chesson Safety evaluation of the food enzyme maltogenic amylase from the genetically modified Bacillus licheniformis strain DP‐Dzr50 EFSA Journal food enzyme maltogenic amylase glucan 1,4‐α‐maltohydrolase EC 3.2.1.133 Bacillus licheniformis genetically modified microorganism |
| title | Safety evaluation of the food enzyme maltogenic amylase from the genetically modified Bacillus licheniformis strain DP‐Dzr50 |
| title_full | Safety evaluation of the food enzyme maltogenic amylase from the genetically modified Bacillus licheniformis strain DP‐Dzr50 |
| title_fullStr | Safety evaluation of the food enzyme maltogenic amylase from the genetically modified Bacillus licheniformis strain DP‐Dzr50 |
| title_full_unstemmed | Safety evaluation of the food enzyme maltogenic amylase from the genetically modified Bacillus licheniformis strain DP‐Dzr50 |
| title_short | Safety evaluation of the food enzyme maltogenic amylase from the genetically modified Bacillus licheniformis strain DP‐Dzr50 |
| title_sort | safety evaluation of the food enzyme maltogenic amylase from the genetically modified bacillus licheniformis strain dp dzr50 |
| topic | food enzyme maltogenic amylase glucan 1,4‐α‐maltohydrolase EC 3.2.1.133 Bacillus licheniformis genetically modified microorganism |
| url | https://doi.org/10.2903/j.efsa.2020.5972 |
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