Safety evaluation of the food enzyme containing endo‐polygalacturonase and endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Aspergillus fijiensis strain NZYM‐RE
Abstract The food enzyme has two declared activities, endo‐polygalacuronase ((1→4)‐α‐D‐galacturonan glycanohydrolase; EC 3.2.1.15) and endo‐1,3(4)‐β‐glucanase (3‐(1→3;1→4)‐β‐D‐glucan 3(4)‐glucanohydrolase; EC 3.2.1.6) and is produced with the non‐genetically modified Aspergillus fijiensis strain NZY...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2022-12-01
|
| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2022.7648 |
| _version_ | 1797975441482448896 |
|---|---|
| author | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Vittorio Silano 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 Jaime Aguilera Magdalena Andryszkiewicz Natalia Kovalkovicova Daniele Cavanna Yi Liu Giulio diPiazza Rita Ferreira deSousa Andrew Chesson |
| author_facet | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Vittorio Silano 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 Jaime Aguilera Magdalena Andryszkiewicz Natalia Kovalkovicova Daniele Cavanna 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 has two declared activities, endo‐polygalacuronase ((1→4)‐α‐D‐galacturonan glycanohydrolase; EC 3.2.1.15) and endo‐1,3(4)‐β‐glucanase (3‐(1→3;1→4)‐β‐D‐glucan 3(4)‐glucanohydrolase; EC 3.2.1.6) and is produced with the non‐genetically modified Aspergillus fijiensis strain NZYM‐RE by Novozymes A/S. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in eight food manufacturing processes, i.e. distilled alcohol production, brewing processes, baking processes, cereal‐based processes, wine and wine vinegar production, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices and refined olive oil production. Since residual amounts of total organic solids (TOS) are removed during distilled alcohol production and refined olive oil production, dietary exposure was not calculated for these two processes. For the remaining six food manufacturing processes, dietary exposure was estimated to be up to 0.553 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 3,677 mg TOS/kg bw per day, the highest dose tested, resulting in a margin of exposure of at least 6,649. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and nine matches were found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production), the risk of allergic reactions by dietary exposure to this food enzyme, particularly in individuals suffering from the oral allergy syndrome or sensitised to papaya, cannot be excluded. The Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. |
| first_indexed | 2024-04-11T04:35:34Z |
| format | Article |
| id | doaj.art-34437a1ca0a44c02b56c07ea3fc5f074 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-11T04:35:34Z |
| publishDate | 2022-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-34437a1ca0a44c02b56c07ea3fc5f0742022-12-28T12:23:02ZengWileyEFSA Journal1831-47322022-12-012012n/an/a10.2903/j.efsa.2022.7648Safety evaluation of the food enzyme containing endo‐polygalacturonase and endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Aspergillus fijiensis strain NZYM‐REEFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)Vittorio SilanoJosé Manuel Barat BavieraClaudia BolognesiPier Sandro CocconcelliRiccardo CrebelliDavid Michael GottKonrad GrobEvgenia LampiMarcel MengelersAlicja MortensenGilles RivièreInger‐Lise SteffensenChristina TlustosHenk Van LoverenLaurence VernisJaime AguileraMagdalena AndryszkiewiczNatalia KovalkovicovaDaniele CavannaYi LiuGiulio diPiazzaRita Ferreira deSousaAndrew ChessonAbstract The food enzyme has two declared activities, endo‐polygalacuronase ((1→4)‐α‐D‐galacturonan glycanohydrolase; EC 3.2.1.15) and endo‐1,3(4)‐β‐glucanase (3‐(1→3;1→4)‐β‐D‐glucan 3(4)‐glucanohydrolase; EC 3.2.1.6) and is produced with the non‐genetically modified Aspergillus fijiensis strain NZYM‐RE by Novozymes A/S. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in eight food manufacturing processes, i.e. distilled alcohol production, brewing processes, baking processes, cereal‐based processes, wine and wine vinegar production, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices and refined olive oil production. Since residual amounts of total organic solids (TOS) are removed during distilled alcohol production and refined olive oil production, dietary exposure was not calculated for these two processes. For the remaining six food manufacturing processes, dietary exposure was estimated to be up to 0.553 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 3,677 mg TOS/kg bw per day, the highest dose tested, resulting in a margin of exposure of at least 6,649. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and nine matches were found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production), the risk of allergic reactions by dietary exposure to this food enzyme, particularly in individuals suffering from the oral allergy syndrome or sensitised to papaya, cannot be excluded. 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.2022.7648food enzymeendo‐polygalacturonaseendo‐1,3(4)‐β‐glucanaseEC 3.2.1.15EC 3.2.1.6Aspergillus fijiensis |
| spellingShingle | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Vittorio Silano 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 Jaime Aguilera Magdalena Andryszkiewicz Natalia Kovalkovicova Daniele Cavanna Yi Liu Giulio diPiazza Rita Ferreira deSousa Andrew Chesson Safety evaluation of the food enzyme containing endo‐polygalacturonase and endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Aspergillus fijiensis strain NZYM‐RE EFSA Journal food enzyme endo‐polygalacturonase endo‐1,3(4)‐β‐glucanase EC 3.2.1.15 EC 3.2.1.6 Aspergillus fijiensis |
| title | Safety evaluation of the food enzyme containing endo‐polygalacturonase and endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Aspergillus fijiensis strain NZYM‐RE |
| title_full | Safety evaluation of the food enzyme containing endo‐polygalacturonase and endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Aspergillus fijiensis strain NZYM‐RE |
| title_fullStr | Safety evaluation of the food enzyme containing endo‐polygalacturonase and endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Aspergillus fijiensis strain NZYM‐RE |
| title_full_unstemmed | Safety evaluation of the food enzyme containing endo‐polygalacturonase and endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Aspergillus fijiensis strain NZYM‐RE |
| title_short | Safety evaluation of the food enzyme containing endo‐polygalacturonase and endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Aspergillus fijiensis strain NZYM‐RE |
| title_sort | safety evaluation of the food enzyme containing endo polygalacturonase and endo 1 3 4 β glucanase from the non genetically modified aspergillus fijiensis strain nzym re |
| topic | food enzyme endo‐polygalacturonase endo‐1,3(4)‐β‐glucanase EC 3.2.1.15 EC 3.2.1.6 Aspergillus fijiensis |
| url | https://doi.org/10.2903/j.efsa.2022.7648 |
| work_keys_str_mv | AT efsapanelonfoodcontactmaterialsenzymesandprocessingaidscep safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT vittoriosilano safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT josemanuelbaratbaviera safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT claudiabolognesi safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT piersandrococconcelli safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT riccardocrebelli safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT davidmichaelgott safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT konradgrob safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT evgenialampi safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT marcelmengelers safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT alicjamortensen safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT gillesriviere safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT ingerlisesteffensen safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT christinatlustos safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT henkvanloveren safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT laurencevernis safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT jaimeaguilera safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT magdalenaandryszkiewicz safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT nataliakovalkovicova safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT danielecavanna safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT yiliu safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT giuliodipiazza safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT ritaferreiradesousa safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre AT andrewchesson safetyevaluationofthefoodenzymecontainingendopolygalacturonaseandendo134bglucanasefromthenongeneticallymodifiedaspergillusfijiensisstrainnzymre |