Revised safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Bacillus subtilis strain LMG S‐24584 produced by a modified process
Abstract The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos NV. In a previous opinion, the Panel noted the presence of recombinant DNA in all food enzyme batches tested. As a follow‐u...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2024-12-01
|
| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2024.9126 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1841525859331080192 |
|---|---|
| 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 Silvia Peluso Magdalena Andryszkiewicz Daniele Cavanna Ana Gomes Natalia Kovalkovicova 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 Silvia Peluso Magdalena Andryszkiewicz Daniele Cavanna Ana Gomes Natalia Kovalkovicova Yi Liu |
| author_sort | EFSA Panel on Food Enzymes (FEZ) |
| collection | DOAJ |
| description | Abstract The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos NV. In a previous opinion, the Panel noted the presence of recombinant DNA in all food enzyme batches tested. As a follow‐up, the applicant changed the manufacturing process of the food enzyme and provided new data. The genetic modifications do not give rise to safety concerns and the production strain fulfils the requirements for the QPS approach to safety assessment. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in the processing of cereals and other grains for the production of baked products. Dietary exposure is estimated to be up to 0.010 mg TOS/kg body weight per day in European populations. As no concerns arising from the microbial source and its genetic modifications or from the manufacturing process have been identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. A search for the 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 upon dietary exposure cannot be excluded, but the likelihood 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. |
| format | Article |
| id | doaj-art-80d3b1e4433c43b5b16f05038ed66642 |
| institution | Kabale University |
| issn | 1831-4732 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-80d3b1e4433c43b5b16f05038ed666422025-01-17T06:31:16ZengWileyEFSA Journal1831-47322024-12-012212n/an/a10.2903/j.efsa.2024.9126Revised safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Bacillus subtilis strain LMG S‐24584 produced by a modified processEFSA Panel on Food Enzymes (FEZ)Holger ZornJosé Manuel Barat BavieraClaudia BolognesiFrancesco CataniaGabriele GadermaierRalf GreinerBaltasar MayoAlicja MortensenYrjö Henrik RoosMarize L. M. SolanoMonika SramkovaHenk Van LoverenLaurence VernisSilvia PelusoMagdalena AndryszkiewiczDaniele CavannaAna GomesNatalia KovalkovicovaYi LiuAbstract The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos NV. In a previous opinion, the Panel noted the presence of recombinant DNA in all food enzyme batches tested. As a follow‐up, the applicant changed the manufacturing process of the food enzyme and provided new data. The genetic modifications do not give rise to safety concerns and the production strain fulfils the requirements for the QPS approach to safety assessment. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in the processing of cereals and other grains for the production of baked products. Dietary exposure is estimated to be up to 0.010 mg TOS/kg body weight per day in European populations. As no concerns arising from the microbial source and its genetic modifications or from the manufacturing process have been identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. A search for the 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 upon dietary exposure cannot be excluded, but the likelihood 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.2024.91264‐β‐d‐xylan xylanohydrolaseBacillus subtilisEC 3.2.1.8EFSA‐Q‐2015‐00065EFSA‐Q‐2023‐00878Endo‐1,4‐β‐xylanase |
| 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 Silvia Peluso Magdalena Andryszkiewicz Daniele Cavanna Ana Gomes Natalia Kovalkovicova Yi Liu Revised safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Bacillus subtilis strain LMG S‐24584 produced by a modified process EFSA Journal 4‐β‐d‐xylan xylanohydrolase Bacillus subtilis EC 3.2.1.8 EFSA‐Q‐2015‐00065 EFSA‐Q‐2023‐00878 Endo‐1,4‐β‐xylanase |
| title | Revised safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Bacillus subtilis strain LMG S‐24584 produced by a modified process |
| title_full | Revised safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Bacillus subtilis strain LMG S‐24584 produced by a modified process |
| title_fullStr | Revised safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Bacillus subtilis strain LMG S‐24584 produced by a modified process |
| title_full_unstemmed | Revised safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Bacillus subtilis strain LMG S‐24584 produced by a modified process |
| title_short | Revised safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Bacillus subtilis strain LMG S‐24584 produced by a modified process |
| title_sort | revised safety evaluation of the food enzyme endo 1 4 β xylanase from the genetically modified bacillus subtilis strain lmg s 24584 produced by a modified process |
| topic | 4‐β‐d‐xylan xylanohydrolase Bacillus subtilis EC 3.2.1.8 EFSA‐Q‐2015‐00065 EFSA‐Q‐2023‐00878 Endo‐1,4‐β‐xylanase |
| url | https://doi.org/10.2903/j.efsa.2024.9126 |
| work_keys_str_mv | AT efsapanelonfoodenzymesfez revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT holgerzorn revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT josemanuelbaratbaviera revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT claudiabolognesi revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT francescocatania revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT gabrielegadermaier revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT ralfgreiner revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT baltasarmayo revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT alicjamortensen revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT yrjohenrikroos revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT marizelmsolano revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT monikasramkova revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT henkvanloveren revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT laurencevernis revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT silviapeluso revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT magdalenaandryszkiewicz revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT danielecavanna revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT anagomes revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT nataliakovalkovicova revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess AT yiliu revisedsafetyevaluationofthefoodenzymeendo14bxylanasefromthegeneticallymodifiedbacillussubtilisstrainlmgs24584producedbyamodifiedprocess |