Safety evaluation of the food enzyme endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Rasamsonia composticola strain 427‐FS
Abstract The food enzyme endo‐1,3(4)‐β‐glucanase (3‐(1–3,1–4)‐β‐d‐glucan 3(4)‐glucanohydrolase; EC 3.2.1.6) is produced with the non‐genetically modified Rasamsonia composticola 427‐FS strain by Kerry Ingredients & Flavours Ltd. The food enzyme is free from viable cells of the production organis...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2023-01-01
|
| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2023.7751 |
| _version_ | 1797792517280759808 |
|---|---|
| author | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Claude Lambré 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 Holger Zorn Jaime Aguilera Magdalena Andryszkiewicz Yi Liu Elsa Nielsen Karin Nørby Rita Ferreira deSousa Andrew Chesson |
| author_facet | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Claude Lambré 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 Holger Zorn Jaime Aguilera Magdalena Andryszkiewicz Yi Liu Elsa Nielsen Karin Nørby 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 endo‐1,3(4)‐β‐glucanase (3‐(1–3,1–4)‐β‐d‐glucan 3(4)‐glucanohydrolase; EC 3.2.1.6) is produced with the non‐genetically modified Rasamsonia composticola 427‐FS strain by Kerry Ingredients & Flavours Ltd. The food enzyme is free from viable cells of the production organism. The food enzyme is intended to be used in six manufacturing processes, i.e. baking processes, other cereal‐based processes, brewing processes, grain treatment for the production of starch and gluten fractions, distilled alcohol production and yeast processing. Since residual amounts of total organic solids (TOS) are removed by distillation and during grain processing, dietary exposure was calculated only for the remaining four processes. It was estimated to be up to 0.809 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 866 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 1,070. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by 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. |
| first_indexed | 2024-03-13T02:35:14Z |
| format | Article |
| id | doaj.art-59d07003a9b34c169968cd7d2ace355d |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-03-13T02:35:14Z |
| publishDate | 2023-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-59d07003a9b34c169968cd7d2ace355d2023-06-29T07:10:37ZengWileyEFSA Journal1831-47322023-01-01211n/an/a10.2903/j.efsa.2023.7751Safety evaluation of the food enzyme endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Rasamsonia composticola strain 427‐FSEFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)Claude LambréJosé Manuel Barat BavieraClaudia BolognesiPier Sandro CocconcelliRiccardo CrebelliDavid Michael GottKonrad GrobEvgenia LampiMarcel MengelersAlicja MortensenGilles RivièreInger‐Lise SteffensenChristina TlustosHenk Van LoverenLaurence VernisHolger ZornJaime AguileraMagdalena AndryszkiewiczYi LiuElsa NielsenKarin NørbyRita Ferreira deSousaAndrew ChessonAbstract The food enzyme endo‐1,3(4)‐β‐glucanase (3‐(1–3,1–4)‐β‐d‐glucan 3(4)‐glucanohydrolase; EC 3.2.1.6) is produced with the non‐genetically modified Rasamsonia composticola 427‐FS strain by Kerry Ingredients & Flavours Ltd. The food enzyme is free from viable cells of the production organism. The food enzyme is intended to be used in six manufacturing processes, i.e. baking processes, other cereal‐based processes, brewing processes, grain treatment for the production of starch and gluten fractions, distilled alcohol production and yeast processing. Since residual amounts of total organic solids (TOS) are removed by distillation and during grain processing, dietary exposure was calculated only for the remaining four processes. It was estimated to be up to 0.809 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 866 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 1,070. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by 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.2023.7751food enzymeendo‐1,3(4)‐β‐glucanase3‐(1→3;1→4)‐β‐d‐glucan 3(4)‐glucanohydrolaseEC 3.2.1.6laminarinaseRasamsonia composticola |
| spellingShingle | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Claude Lambré 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 Holger Zorn Jaime Aguilera Magdalena Andryszkiewicz Yi Liu Elsa Nielsen Karin Nørby Rita Ferreira deSousa Andrew Chesson Safety evaluation of the food enzyme endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Rasamsonia composticola strain 427‐FS EFSA Journal food enzyme endo‐1,3(4)‐β‐glucanase 3‐(1→3;1→4)‐β‐d‐glucan 3(4)‐glucanohydrolase EC 3.2.1.6 laminarinase Rasamsonia composticola |
| title | Safety evaluation of the food enzyme endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Rasamsonia composticola strain 427‐FS |
| title_full | Safety evaluation of the food enzyme endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Rasamsonia composticola strain 427‐FS |
| title_fullStr | Safety evaluation of the food enzyme endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Rasamsonia composticola strain 427‐FS |
| title_full_unstemmed | Safety evaluation of the food enzyme endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Rasamsonia composticola strain 427‐FS |
| title_short | Safety evaluation of the food enzyme endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Rasamsonia composticola strain 427‐FS |
| title_sort | safety evaluation of the food enzyme endo 1 3 4 β glucanase from the non genetically modified rasamsonia composticola strain 427 fs |
| topic | food enzyme endo‐1,3(4)‐β‐glucanase 3‐(1→3;1→4)‐β‐d‐glucan 3(4)‐glucanohydrolase EC 3.2.1.6 laminarinase Rasamsonia composticola |
| url | https://doi.org/10.2903/j.efsa.2023.7751 |
| work_keys_str_mv | AT efsapanelonfoodcontactmaterialsenzymesandprocessingaidscep safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT claudelambre safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT josemanuelbaratbaviera safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT claudiabolognesi safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT piersandrococconcelli safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT riccardocrebelli safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT davidmichaelgott safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT konradgrob safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT evgenialampi safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT marcelmengelers safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT alicjamortensen safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT gillesriviere safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT ingerlisesteffensen safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT christinatlustos safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT henkvanloveren safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT laurencevernis safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT holgerzorn safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT jaimeaguilera safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT magdalenaandryszkiewicz safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT yiliu safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT elsanielsen safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT karinnørby safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT ritaferreiradesousa safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs AT andrewchesson safetyevaluationofthefoodenzymeendo134bglucanasefromthenongeneticallymodifiedrasamsoniacomposticolastrain427fs |