Safety evaluation of the food enzyme β‐galactosidase from the non‐genetically modified Neobacillus sp. strain AE‐LT
Abstract The food enzyme β‐galactosidase (EC 3.2.1.23) is produced with the non‐genetically modified Neobacillus sp. strain AE‐LT by Amano Enzyme Inc. The strain is not cytotoxic and does not harbour any known virulence factor or antimicrobial resistance gene. The presence of viable cells of the pro...
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| Format: | Article |
| Language: | English |
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Wiley
2022-10-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2022.7573 |
| _version_ | 1811324696207032320 |
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| author | 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 Natália Kovalkovičová Yi Liu Giulio diPiazza Sandra Rainieri Rita Ferreira de Sousa Andrew Chesson |
| author_facet | 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 Natália Kovalkovičová Yi Liu Giulio diPiazza Sandra Rainieri Rita Ferreira de Sousa Andrew Chesson |
| author_sort | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The food enzyme β‐galactosidase (EC 3.2.1.23) is produced with the non‐genetically modified Neobacillus sp. strain AE‐LT by Amano Enzyme Inc. The strain is not cytotoxic and does not harbour any known virulence factor or antimicrobial resistance gene. The presence of viable cells of the production strain in the food enzyme could not be excluded, but the likelihood of this being a hazard is considered low. The food enzyme is intended to be used for lactose hydrolysis in milk processing and the manufacture of galacto‐oligosaccharides (GOS). The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 2.971 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 1,223 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 412. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is 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. |
| first_indexed | 2024-04-13T14:20:05Z |
| format | Article |
| id | doaj.art-aabf6d4aa7c740e8b9c61c7337495229 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-13T14:20:05Z |
| publishDate | 2022-10-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-aabf6d4aa7c740e8b9c61c73374952292022-12-22T02:43:31ZengWileyEFSA Journal1831-47322022-10-012010n/an/a10.2903/j.efsa.2022.7573Safety evaluation of the food enzyme β‐galactosidase from the non‐genetically modified Neobacillus sp. strain AE‐LTEFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)Claude LambréJosé Manuel Barat BavieraClaudia BolognesiPier Sandro CocconcelliRiccardo CrebelliDavid Michael GottKonrad GrobEvgenia LampiMarcel MengelersAlicja MortensenGilles RivièreInger‐Lise SteffensenChristina TlustosHenk Van LoverenLaurence VernisHolger ZornNatália KovalkovičováYi LiuGiulio diPiazzaSandra RainieriRita Ferreira de SousaAndrew ChessonAbstract The food enzyme β‐galactosidase (EC 3.2.1.23) is produced with the non‐genetically modified Neobacillus sp. strain AE‐LT by Amano Enzyme Inc. The strain is not cytotoxic and does not harbour any known virulence factor or antimicrobial resistance gene. The presence of viable cells of the production strain in the food enzyme could not be excluded, but the likelihood of this being a hazard is considered low. The food enzyme is intended to be used for lactose hydrolysis in milk processing and the manufacture of galacto‐oligosaccharides (GOS). The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 2.971 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 1,223 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 412. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is 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.https://doi.org/10.2903/j.efsa.2022.7573food enzymeβ‐galactosidaseEC 3.2.1.23β‐d‐galactoside galatohydrolaseBacillus circulansNeobacillus sp. |
| spellingShingle | 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 Natália Kovalkovičová Yi Liu Giulio diPiazza Sandra Rainieri Rita Ferreira de Sousa Andrew Chesson Safety evaluation of the food enzyme β‐galactosidase from the non‐genetically modified Neobacillus sp. strain AE‐LT EFSA Journal food enzyme β‐galactosidase EC 3.2.1.23 β‐d‐galactoside galatohydrolase Bacillus circulans Neobacillus sp. |
| title | Safety evaluation of the food enzyme β‐galactosidase from the non‐genetically modified Neobacillus sp. strain AE‐LT |
| title_full | Safety evaluation of the food enzyme β‐galactosidase from the non‐genetically modified Neobacillus sp. strain AE‐LT |
| title_fullStr | Safety evaluation of the food enzyme β‐galactosidase from the non‐genetically modified Neobacillus sp. strain AE‐LT |
| title_full_unstemmed | Safety evaluation of the food enzyme β‐galactosidase from the non‐genetically modified Neobacillus sp. strain AE‐LT |
| title_short | Safety evaluation of the food enzyme β‐galactosidase from the non‐genetically modified Neobacillus sp. strain AE‐LT |
| title_sort | safety evaluation of the food enzyme β galactosidase from the non genetically modified neobacillus sp strain ae lt |
| topic | food enzyme β‐galactosidase EC 3.2.1.23 β‐d‐galactoside galatohydrolase Bacillus circulans Neobacillus sp. |
| url | https://doi.org/10.2903/j.efsa.2022.7573 |
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