Safety evaluation of the food enzyme triacylglycerol lipase from the non‐genetically modified Mucor circinelloides strain AE‐LMH
Abstract The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the non‐genetically modified Mucor circinelloides strain AE‐LMH by Amano Enzyme Inc. The food enzyme is considered free from viable cells of the production organism. The food enzyme is intend...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2023-01-01
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| Series: | EFSA Journal |
| Online Access: | https://doi.org/10.2903/j.efsa.2023.7755 |
| _version_ | 1797792490971987968 |
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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 Boet Glandorf Lieve Herman Jaime Aguilera Magdalena Andryszkiewicz Natalia Kovalkovicova Yi Liu Giulio diPiazza Rita Ferreira deSousa 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 Boet Glandorf Lieve Herman Jaime Aguilera Magdalena Andryszkiewicz Natalia Kovalkovicova Yi Liu Giulio diPiazza Rita Ferreira deSousa Andrew Chesson |
| author_sort | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the non‐genetically modified Mucor circinelloides strain AE‐LMH by Amano Enzyme Inc. The food enzyme is considered free from viable cells of the production organism. The food enzyme is intended to be used in baking processes, egg processing and the manufacture of enzyme‐modified dairy ingredients (EMDI). Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.242 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 784 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 3,240. A search for the 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 of such reactions 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 | 2024-03-13T02:34:52Z |
| format | Article |
| id | doaj.art-040786e5bdf94bbfb57639b489266887 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-03-13T02:34:52Z |
| publishDate | 2023-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-040786e5bdf94bbfb57639b4892668872023-06-29T07:10:37ZengWileyEFSA Journal1831-47322023-01-01211n/an/a10.2903/j.efsa.2023.7755Safety evaluation of the food enzyme triacylglycerol lipase from the non‐genetically modified Mucor circinelloides strain AE‐LMHEFSA 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 ZornBoet GlandorfLieve HermanJaime AguileraMagdalena AndryszkiewiczNatalia KovalkovicovaYi LiuGiulio diPiazzaRita Ferreira deSousaAndrew ChessonAbstract The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the non‐genetically modified Mucor circinelloides strain AE‐LMH by Amano Enzyme Inc. The food enzyme is considered free from viable cells of the production organism. The food enzyme is intended to be used in baking processes, egg processing and the manufacture of enzyme‐modified dairy ingredients (EMDI). Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.242 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 784 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 3,240. A search for the 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 of such reactions 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.2023.7755 |
| 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 Boet Glandorf Lieve Herman Jaime Aguilera Magdalena Andryszkiewicz Natalia Kovalkovicova Yi Liu Giulio diPiazza Rita Ferreira deSousa Andrew Chesson Safety evaluation of the food enzyme triacylglycerol lipase from the non‐genetically modified Mucor circinelloides strain AE‐LMH EFSA Journal |
| title | Safety evaluation of the food enzyme triacylglycerol lipase from the non‐genetically modified Mucor circinelloides strain AE‐LMH |
| title_full | Safety evaluation of the food enzyme triacylglycerol lipase from the non‐genetically modified Mucor circinelloides strain AE‐LMH |
| title_fullStr | Safety evaluation of the food enzyme triacylglycerol lipase from the non‐genetically modified Mucor circinelloides strain AE‐LMH |
| title_full_unstemmed | Safety evaluation of the food enzyme triacylglycerol lipase from the non‐genetically modified Mucor circinelloides strain AE‐LMH |
| title_short | Safety evaluation of the food enzyme triacylglycerol lipase from the non‐genetically modified Mucor circinelloides strain AE‐LMH |
| title_sort | safety evaluation of the food enzyme triacylglycerol lipase from the non genetically modified mucor circinelloides strain ae lmh |
| url | https://doi.org/10.2903/j.efsa.2023.7755 |
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