Safety evaluation of an extension of use of the food enzyme pullulanase from the non‐genetically modified Pullulanibacillus naganoensis strain AE‐PL
Abstract The food enzyme pullulanase (pullulan 6‐α‐glucanohydrolase; EC 3.2.1.41) is produced with the non‐genetically modified Pullulanibacillus naganoensis strain AE‐PL by Amano Enzyme Inc. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme d...
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| 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.2024.8947 |
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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 Ana Criado Rita Sofia Ferreira deSousa Yi Liu Roos Anna deNijs |
| 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 Ana Criado Rita Sofia Ferreira deSousa Yi Liu Roos Anna deNijs |
| author_sort | EFSA Panel on Food Enzymes (FEZ) |
| collection | DOAJ |
| description | Abstract The food enzyme pullulanase (pullulan 6‐α‐glucanohydrolase; EC 3.2.1.41) is produced with the non‐genetically modified Pullulanibacillus naganoensis strain AE‐PL 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 one food manufacturing process. Subsequently, the applicant has requested to extend its use to include seven additional processes and to revise the previous use level. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of eight food manufacturing processes. As the food enzyme‐total organic solids (TOS) are not carried into the final foods in two food manufacturing processes, the dietary exposure was estimated only for the remaining six processes. The dietary exposure was calculated to be up to 0.004 mg TOS/kg body weight (bw) per day in European populations. The Panel evaluated the repeated dose 90‐day oral toxicity study in rats submitted in the previous application and identified a no observed adverse effect level of 643 mg TOS/kg bw per day, the highest dose tested. When compared with the calculated dietary exposure, this resulted in a margin of exposure of at least 160,750. 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-df462cb817bc43d087bc628976afebcf |
| institution | DOAJ |
| issn | 1831-4732 |
| language | English |
| publishDate | 2024-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-df462cb817bc43d087bc628976afebcf2025-08-20T03:13:07ZengWileyEFSA Journal1831-47322024-07-01227n/an/a10.2903/j.efsa.2024.8947Safety evaluation of an extension of use of the food enzyme pullulanase from the non‐genetically modified Pullulanibacillus naganoensis strain AE‐PLEFSA 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 CavannaAna CriadoRita Sofia Ferreira deSousaYi LiuRoos Anna deNijsAbstract The food enzyme pullulanase (pullulan 6‐α‐glucanohydrolase; EC 3.2.1.41) is produced with the non‐genetically modified Pullulanibacillus naganoensis strain AE‐PL 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 one food manufacturing process. Subsequently, the applicant has requested to extend its use to include seven additional processes and to revise the previous use level. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of eight food manufacturing processes. As the food enzyme‐total organic solids (TOS) are not carried into the final foods in two food manufacturing processes, the dietary exposure was estimated only for the remaining six processes. The dietary exposure was calculated to be up to 0.004 mg TOS/kg body weight (bw) per day in European populations. The Panel evaluated the repeated dose 90‐day oral toxicity study in rats submitted in the previous application and identified a no observed adverse effect level of 643 mg TOS/kg bw per day, the highest dose tested. When compared with the calculated dietary exposure, this resulted in a margin of exposure of at least 160,750. 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.2024.8947EC 3.2.1.41EFSA‐Q‐2015‐00451EFSA‐Q‐2023‐00662food enzymenon‐genetically modified microorganismpullulanase |
| 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 Ana Criado Rita Sofia Ferreira deSousa Yi Liu Roos Anna deNijs Safety evaluation of an extension of use of the food enzyme pullulanase from the non‐genetically modified Pullulanibacillus naganoensis strain AE‐PL EFSA Journal EC 3.2.1.41 EFSA‐Q‐2015‐00451 EFSA‐Q‐2023‐00662 food enzyme non‐genetically modified microorganism pullulanase |
| title | Safety evaluation of an extension of use of the food enzyme pullulanase from the non‐genetically modified Pullulanibacillus naganoensis strain AE‐PL |
| title_full | Safety evaluation of an extension of use of the food enzyme pullulanase from the non‐genetically modified Pullulanibacillus naganoensis strain AE‐PL |
| title_fullStr | Safety evaluation of an extension of use of the food enzyme pullulanase from the non‐genetically modified Pullulanibacillus naganoensis strain AE‐PL |
| title_full_unstemmed | Safety evaluation of an extension of use of the food enzyme pullulanase from the non‐genetically modified Pullulanibacillus naganoensis strain AE‐PL |
| title_short | Safety evaluation of an extension of use of the food enzyme pullulanase from the non‐genetically modified Pullulanibacillus naganoensis strain AE‐PL |
| title_sort | safety evaluation of an extension of use of the food enzyme pullulanase from the non genetically modified pullulanibacillus naganoensis strain ae pl |
| topic | EC 3.2.1.41 EFSA‐Q‐2015‐00451 EFSA‐Q‐2023‐00662 food enzyme non‐genetically modified microorganism pullulanase |
| url | https://doi.org/10.2903/j.efsa.2024.8947 |
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