Safety evaluation of an extension of use of the food enzyme thermolysin from the non‐genetically modified Anoxybacillus caldiproteolyticus strain AE‐TP
Abstract The food enzyme thermolysin (EC. 3.4.24.27) is produced with the non‐genetically modified Anoxybacillus caldiproteolyticus strain AE‐TP by Amano Enzyme Inc. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety...
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| Format: | Article |
| Language: | English |
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Wiley
2024-07-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2024.8939 |
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| author | EFSA Panel on Food Enzymes (FEZ) Holger Zorn José Manuel Barat Baviera Claudia Bolognesi Francesco Catania Gabriele Gadermaier Ralf Greiner Baltasar Mayo Alicja Mortensen Yrjö Henrik Roos Marize L. M. Solano Monika Sramkova Henk Van Loveren Laurence Vernis Daniele Cavanna Yi Liu Giulio diPiazza |
| author_facet | EFSA Panel on Food Enzymes (FEZ) Holger Zorn José Manuel Barat Baviera Claudia Bolognesi Francesco Catania Gabriele Gadermaier Ralf Greiner Baltasar Mayo Alicja Mortensen Yrjö Henrik Roos Marize L. M. Solano Monika Sramkova Henk Van Loveren Laurence Vernis Daniele Cavanna Yi Liu Giulio diPiazza |
| author_sort | EFSA Panel on Food Enzymes (FEZ) |
| collection | DOAJ |
| description | Abstract The food enzyme thermolysin (EC. 3.4.24.27) is produced with the non‐genetically modified Anoxybacillus caldiproteolyticus strain AE‐TP by Amano Enzyme Inc. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in eight food manufacturing processes. Subsequently, the applicant has requested to extend its use to one additional process, to withdraw two processes and to revise the use levels. In this assessment, EFSA updated the safety evaluation of this food enzyme for use in a total of seven food manufacturing processes. The dietary exposure to the food enzyme–total organic solids (TOS) was calculated to be up to 0.989 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level reported in the previous opinion (700 mg TOS/kg bw per day, the mid‐dose tested), the Panel derived a revised margin of exposure of at least 708. Based on the data provided for the previous evaluation and the revised margin of exposure in the present evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use. |
| format | Article |
| id | doaj-art-bfb39ad6a9f34fbd88798e84c68519be |
| institution | Kabale University |
| issn | 1831-4732 |
| language | English |
| publishDate | 2024-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-bfb39ad6a9f34fbd88798e84c68519be2025-08-20T03:50:44ZengWileyEFSA Journal1831-47322024-07-01227n/an/a10.2903/j.efsa.2024.8939Safety evaluation of an extension of use of the food enzyme thermolysin from the non‐genetically modified Anoxybacillus caldiproteolyticus strain AE‐TPEFSA Panel on Food Enzymes (FEZ)Holger ZornJosé Manuel Barat BavieraClaudia BolognesiFrancesco CataniaGabriele GadermaierRalf GreinerBaltasar MayoAlicja MortensenYrjö Henrik RoosMarize L. M. SolanoMonika SramkovaHenk Van LoverenLaurence VernisDaniele CavannaYi LiuGiulio diPiazzaAbstract The food enzyme thermolysin (EC. 3.4.24.27) is produced with the non‐genetically modified Anoxybacillus caldiproteolyticus strain AE‐TP by Amano Enzyme Inc. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in eight food manufacturing processes. Subsequently, the applicant has requested to extend its use to one additional process, to withdraw two processes and to revise the use levels. In this assessment, EFSA updated the safety evaluation of this food enzyme for use in a total of seven food manufacturing processes. The dietary exposure to the food enzyme–total organic solids (TOS) was calculated to be up to 0.989 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level reported in the previous opinion (700 mg TOS/kg bw per day, the mid‐dose tested), the Panel derived a revised margin of exposure of at least 708. Based on the data provided for the previous evaluation and the revised margin of exposure in the present evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.https://doi.org/10.2903/j.efsa.2024.8939Anoxybacillus caldiproteolyticusEC 3.4.24.27EFSA‐Q‐2016‐00083EFSA‐Q‐2023‐00003food enzymethermolysin |
| spellingShingle | EFSA Panel on Food Enzymes (FEZ) Holger Zorn José Manuel Barat Baviera Claudia Bolognesi Francesco Catania Gabriele Gadermaier Ralf Greiner Baltasar Mayo Alicja Mortensen Yrjö Henrik Roos Marize L. M. Solano Monika Sramkova Henk Van Loveren Laurence Vernis Daniele Cavanna Yi Liu Giulio diPiazza Safety evaluation of an extension of use of the food enzyme thermolysin from the non‐genetically modified Anoxybacillus caldiproteolyticus strain AE‐TP EFSA Journal Anoxybacillus caldiproteolyticus EC 3.4.24.27 EFSA‐Q‐2016‐00083 EFSA‐Q‐2023‐00003 food enzyme thermolysin |
| title | Safety evaluation of an extension of use of the food enzyme thermolysin from the non‐genetically modified Anoxybacillus caldiproteolyticus strain AE‐TP |
| title_full | Safety evaluation of an extension of use of the food enzyme thermolysin from the non‐genetically modified Anoxybacillus caldiproteolyticus strain AE‐TP |
| title_fullStr | Safety evaluation of an extension of use of the food enzyme thermolysin from the non‐genetically modified Anoxybacillus caldiproteolyticus strain AE‐TP |
| title_full_unstemmed | Safety evaluation of an extension of use of the food enzyme thermolysin from the non‐genetically modified Anoxybacillus caldiproteolyticus strain AE‐TP |
| title_short | Safety evaluation of an extension of use of the food enzyme thermolysin from the non‐genetically modified Anoxybacillus caldiproteolyticus strain AE‐TP |
| title_sort | safety evaluation of an extension of use of the food enzyme thermolysin from the non genetically modified anoxybacillus caldiproteolyticus strain ae tp |
| topic | Anoxybacillus caldiproteolyticus EC 3.4.24.27 EFSA‐Q‐2016‐00083 EFSA‐Q‐2023‐00003 food enzyme thermolysin |
| url | https://doi.org/10.2903/j.efsa.2024.8939 |
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