Safety evaluation of the food enzyme α‐amylase from the genetically modified Pseudomonas fluorescens strain BD15754
Abstract The food enzyme α‐amylase (4‐a‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Pseudomonas fluorescens strain BD15754 by BASF Enzymes LLC1. The food enzyme is free from viable cells of the production organism and recombinant DNA. The α‐amylase is intended to...
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| Format: | Article |
| Language: | English |
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Wiley
2020-03-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2020.6043 |
| _version_ | 1819135239913472000 |
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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 Rivière Inger‐Lise Steffensen Christina Tlustos Henk van Loveren Laurence Vernis Holger Zorn Boet Glandorf Lieve Herman Jaime Aguilera Magdalena Andryszkiewicz 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 Rivière Inger‐Lise Steffensen Christina Tlustos Henk van Loveren Laurence Vernis Holger Zorn Boet Glandorf Lieve Herman Jaime Aguilera Magdalena Andryszkiewicz Yi Liu Andrew Chesson |
| author_sort | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The food enzyme α‐amylase (4‐a‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Pseudomonas fluorescens strain BD15754 by BASF Enzymes LLC1. The food enzyme is free from viable cells of the production organism and recombinant DNA. The α‐amylase is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups, consequently, dietary exposure was not calculated. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) at the highest dose of 887 mg TOS/kg body weight (bw) per day. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reactions to occur is considered to be low. However, the food enzyme contains residual amounts of a highly important antimicrobial for human medicine, with the consequent risk of promoting the development of resistance. Therefore, the Panel concludes that the food enzyme α‐amylase, produced with the genetically modified P. fluorescens strain BD15754 cannot be considered safe. |
| first_indexed | 2024-12-22T10:15:56Z |
| format | Article |
| id | doaj.art-224dc60979c049e7a5c7c7e360a659f8 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-22T10:15:56Z |
| publishDate | 2020-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-224dc60979c049e7a5c7c7e360a659f82022-12-21T18:29:43ZengWileyEFSA Journal1831-47322020-03-01183n/an/a10.2903/j.efsa.2020.6043Safety evaluation of the food enzyme α‐amylase from the genetically modified Pseudomonas fluorescens strain BD15754EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)Vittorio SilanoJosé Manuel Barat BavieraClaudia BolognesiPier Sandro CocconcelliRiccardo CrebelliDavid Michael GottKonrad GrobEvgenia LampiAlicja MortensenGilles RivièreInger‐Lise SteffensenChristina TlustosHenk van LoverenLaurence VernisHolger ZornBoet GlandorfLieve HermanJaime AguileraMagdalena AndryszkiewiczYi LiuAndrew ChessonAbstract The food enzyme α‐amylase (4‐a‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Pseudomonas fluorescens strain BD15754 by BASF Enzymes LLC1. The food enzyme is free from viable cells of the production organism and recombinant DNA. The α‐amylase is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups, consequently, dietary exposure was not calculated. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) at the highest dose of 887 mg TOS/kg body weight (bw) per day. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reactions to occur is considered to be low. However, the food enzyme contains residual amounts of a highly important antimicrobial for human medicine, with the consequent risk of promoting the development of resistance. Therefore, the Panel concludes that the food enzyme α‐amylase, produced with the genetically modified P. fluorescens strain BD15754 cannot be considered safe.https://doi.org/10.2903/j.efsa.2020.6043food enzymeα‐amylase1,4‐a‐d‐glucan glucanohydrolaseEC 3.2.1.1Pseudomonas fluorescensgenetically 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 Rivière Inger‐Lise Steffensen Christina Tlustos Henk van Loveren Laurence Vernis Holger Zorn Boet Glandorf Lieve Herman Jaime Aguilera Magdalena Andryszkiewicz Yi Liu Andrew Chesson Safety evaluation of the food enzyme α‐amylase from the genetically modified Pseudomonas fluorescens strain BD15754 EFSA Journal food enzyme α‐amylase 1,4‐a‐d‐glucan glucanohydrolase EC 3.2.1.1 Pseudomonas fluorescens genetically modified microorganism |
| title | Safety evaluation of the food enzyme α‐amylase from the genetically modified Pseudomonas fluorescens strain BD15754 |
| title_full | Safety evaluation of the food enzyme α‐amylase from the genetically modified Pseudomonas fluorescens strain BD15754 |
| title_fullStr | Safety evaluation of the food enzyme α‐amylase from the genetically modified Pseudomonas fluorescens strain BD15754 |
| title_full_unstemmed | Safety evaluation of the food enzyme α‐amylase from the genetically modified Pseudomonas fluorescens strain BD15754 |
| title_short | Safety evaluation of the food enzyme α‐amylase from the genetically modified Pseudomonas fluorescens strain BD15754 |
| title_sort | safety evaluation of the food enzyme α amylase from the genetically modified pseudomonas fluorescens strain bd15754 |
| topic | food enzyme α‐amylase 1,4‐a‐d‐glucan glucanohydrolase EC 3.2.1.1 Pseudomonas fluorescens genetically modified microorganism |
| url | https://doi.org/10.2903/j.efsa.2020.6043 |
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