Safety evaluation of the food enzyme β‐galactosidase from the non‐genetically modified Aspergillus oryzae strain AE‐LA
Abstract The food enzyme β‐galactosidase (β‐d‐galactoside galactohydrolase; EC 3.2.1.23) is produced with the non‐genetically modified Aspergillus oryzae strain AE‐LA by Amano Enzyme Inc. The food enzyme was considered free from viable cells of the production organism. The food enzyme is intended to...
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| Format: | Article |
| Language: | English |
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Wiley
2022-10-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2022.7569 |
| _version_ | 1811245703737901056 |
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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 Yrjö Roos Magdalena Andryszkiewicz Ana Gomes 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 Yrjö Roos Magdalena Andryszkiewicz Ana Gomes 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 (β‐d‐galactoside galactohydrolase; EC 3.2.1.23) is produced with the non‐genetically modified Aspergillus oryzae strain AE‐LA by Amano Enzyme Inc. The food enzyme was considered free from viable cells of the production organism. The food enzyme is intended to be used for lactose hydrolysis in milk processing, production of fermented milk products, whey processing and the manufacture of enzyme‐modified dairy ingredients. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.651 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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 1,656 mg TOS/kg bw per day, the highest dose tested. This results in a margin of exposure of at least 1,003. 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 is considered to be low. Based on the data provided, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use. |
| first_indexed | 2024-04-12T14:42:18Z |
| format | Article |
| id | doaj.art-2f2e33a9165e46eeb74eb323c5414fd4 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-12T14:42:18Z |
| publishDate | 2022-10-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-2f2e33a9165e46eeb74eb323c5414fd42022-12-22T03:28:46ZengWileyEFSA Journal1831-47322022-10-012010n/an/a10.2903/j.efsa.2022.7569Safety evaluation of the food enzyme β‐galactosidase from the non‐genetically modified Aspergillus oryzae strain AE‐LAEFSA 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 ZornYrjö RoosMagdalena AndryszkiewiczAna GomesYi LiuGiulio diPiazzaSandra RainieriRita Ferreira de SousaAndrew ChessonAbstract The food enzyme β‐galactosidase (β‐d‐galactoside galactohydrolase; EC 3.2.1.23) is produced with the non‐genetically modified Aspergillus oryzae strain AE‐LA by Amano Enzyme Inc. The food enzyme was considered free from viable cells of the production organism. The food enzyme is intended to be used for lactose hydrolysis in milk processing, production of fermented milk products, whey processing and the manufacture of enzyme‐modified dairy ingredients. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.651 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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 1,656 mg TOS/kg bw per day, the highest dose tested. This results in a margin of exposure of at least 1,003. 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 is considered to be low. Based on the data provided, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.https://doi.org/10.2903/j.efsa.2022.7569Food enzymeβ‐galactosidaseβ‐d‐galactoside galactohydrolaseEC 3.2.1.23lactaseAspergillus oryzae |
| 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 Yrjö Roos Magdalena Andryszkiewicz Ana Gomes 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 Aspergillus oryzae strain AE‐LA EFSA Journal Food enzyme β‐galactosidase β‐d‐galactoside galactohydrolase EC 3.2.1.23 lactase Aspergillus oryzae |
| title | Safety evaluation of the food enzyme β‐galactosidase from the non‐genetically modified Aspergillus oryzae strain AE‐LA |
| title_full | Safety evaluation of the food enzyme β‐galactosidase from the non‐genetically modified Aspergillus oryzae strain AE‐LA |
| title_fullStr | Safety evaluation of the food enzyme β‐galactosidase from the non‐genetically modified Aspergillus oryzae strain AE‐LA |
| title_full_unstemmed | Safety evaluation of the food enzyme β‐galactosidase from the non‐genetically modified Aspergillus oryzae strain AE‐LA |
| title_short | Safety evaluation of the food enzyme β‐galactosidase from the non‐genetically modified Aspergillus oryzae strain AE‐LA |
| title_sort | safety evaluation of the food enzyme β galactosidase from the non genetically modified aspergillus oryzae strain ae la |
| topic | Food enzyme β‐galactosidase β‐d‐galactoside galactohydrolase EC 3.2.1.23 lactase Aspergillus oryzae |
| url | https://doi.org/10.2903/j.efsa.2022.7569 |
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