Safety evaluation of the food enzyme endonuclease from the non‐genetically modified Penicillium citrinum strain NP 11–15
Abstract The food enzyme endonuclease (Aspergillus nuclease S1; EC 3.1.30.1) is produced with the non‐genetically modified Penicillium citrinum strain NP 11–15 by Shin Nihon Chemical Co., Ltd. The food enzyme is free from viable cells of the production organism. It is intended to be used in the proc...
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| Format: | Article |
| Language: | English |
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Wiley
2024-10-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2024.9032 |
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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 Magdalena Andryszkiewicz Daniele Cavanna Ana Criado Simone Lunardi Yi Liu |
| 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 Magdalena Andryszkiewicz Daniele Cavanna Ana Criado Simone Lunardi Yi Liu |
| author_sort | EFSA Panel on Food Enzymes (FEZ) |
| collection | DOAJ |
| description | Abstract The food enzyme endonuclease (Aspergillus nuclease S1; EC 3.1.30.1) is produced with the non‐genetically modified Penicillium citrinum strain NP 11–15 by Shin Nihon Chemical Co., Ltd. The food enzyme is free from viable cells of the production organism. It is intended to be used in the processing of yeast and yeast products. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.006 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 1010 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 168,333. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, especially for individuals allergic to Penicillium. However, the likelihood of such reactions will not exceed the likelihood of allergic reactions to Penicillium. 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. |
| format | Article |
| id | doaj-art-3f2ac54564c94e91a7ea4d60ae9f7fd0 |
| institution | Kabale University |
| issn | 1831-4732 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-3f2ac54564c94e91a7ea4d60ae9f7fd02024-12-12T08:20:40ZengWileyEFSA Journal1831-47322024-10-012210n/an/a10.2903/j.efsa.2024.9032Safety evaluation of the food enzyme endonuclease from the non‐genetically modified Penicillium citrinum strain NP 11–15EFSA Panel on Food Enzymes (FEZ)Holger ZornJosé Manuel Barat BavieraClaudia BolognesiFrancesco CataniaGabriele GadermaierRalf GreinerBaltasar MayoAlicja MortensenYrjö Henrik RoosMarize L. M. SolanoMonika SramkovaHenk Van LoverenLaurence VernisMagdalena AndryszkiewiczDaniele CavannaAna CriadoSimone LunardiYi LiuAbstract The food enzyme endonuclease (Aspergillus nuclease S1; EC 3.1.30.1) is produced with the non‐genetically modified Penicillium citrinum strain NP 11–15 by Shin Nihon Chemical Co., Ltd. The food enzyme is free from viable cells of the production organism. It is intended to be used in the processing of yeast and yeast products. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.006 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 1010 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 168,333. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, especially for individuals allergic to Penicillium. However, the likelihood of such reactions will not exceed the likelihood of allergic reactions to Penicillium. 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.2024.9032deoxyriboEFSA‐Q‐2015‐00845endonucleasefood enzymenon‐geneticallynuclease S1 |
| 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 Magdalena Andryszkiewicz Daniele Cavanna Ana Criado Simone Lunardi Yi Liu Safety evaluation of the food enzyme endonuclease from the non‐genetically modified Penicillium citrinum strain NP 11–15 EFSA Journal deoxyribo EFSA‐Q‐2015‐00845 endonuclease food enzyme non‐genetically nuclease S1 |
| title | Safety evaluation of the food enzyme endonuclease from the non‐genetically modified Penicillium citrinum strain NP 11–15 |
| title_full | Safety evaluation of the food enzyme endonuclease from the non‐genetically modified Penicillium citrinum strain NP 11–15 |
| title_fullStr | Safety evaluation of the food enzyme endonuclease from the non‐genetically modified Penicillium citrinum strain NP 11–15 |
| title_full_unstemmed | Safety evaluation of the food enzyme endonuclease from the non‐genetically modified Penicillium citrinum strain NP 11–15 |
| title_short | Safety evaluation of the food enzyme endonuclease from the non‐genetically modified Penicillium citrinum strain NP 11–15 |
| title_sort | safety evaluation of the food enzyme endonuclease from the non genetically modified penicillium citrinum strain np 11 15 |
| topic | deoxyribo EFSA‐Q‐2015‐00845 endonuclease food enzyme non‐genetically nuclease S1 |
| url | https://doi.org/10.2903/j.efsa.2024.9032 |
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