Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Aspergillus sp. strain FUA
Abstract The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified Aspergillus sp. strain FUA by DSM Food Specialties B.V. The food enzyme is free from viable cells of the production organism. The food enzyme is intended to be used in four fo...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2025-01-01
|
| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2025.9167 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832576054243360768 |
|---|---|
| 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 Cristina Fernàndez‐Fraguas Magdalena Andryszkiewicz Natalia Kovalkovicova Eleonora Marini 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 Cristina Fernàndez‐Fraguas Magdalena Andryszkiewicz Natalia Kovalkovicova Eleonora Marini Yi Liu |
| author_sort | EFSA Panel on Food Enzymes (FEZ) |
| collection | DOAJ |
| description | Abstract The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified Aspergillus sp. strain FUA by DSM Food Specialties B.V. The food enzyme is free from viable cells of the production organism. The food enzyme is intended to be used in four food manufacturing processes. Since residual amounts of food enzyme‐total organic solids (TOS) are removed in the production of distilled alcohol, dietary exposure was calculated only for the remaining three food manufacturing processes. It was estimated to be up to 0.687 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 2000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 2911. A search for the homology of the amino acid sequence of the food enzyme to known allergens was made and three matches with respiratory allergens were found, one of which is also an oral allergen. Known sources of allergens were used in the food enzyme manufacturing process. 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-757a30c7ae754c8999fde137c27c580a |
| institution | Kabale University |
| issn | 1831-4732 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-757a30c7ae754c8999fde137c27c580a2025-01-31T12:06:04ZengWileyEFSA Journal1831-47322025-01-01231n/an/a10.2903/j.efsa.2025.9167Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Aspergillus sp. strain FUAEFSA Panel on Food Enzymes (FEZ)Holger ZornJosé Manuel Barat BavieraClaudia BolognesiFrancesco CataniaGabriele GadermaierRalf GreinerBaltasar MayoAlicja MortensenYrjö Henrik RoosMarize L. M. SolanoMonika SramkovaHenk Van LoverenLaurence VernisCristina Fernàndez‐FraguasMagdalena AndryszkiewiczNatalia KovalkovicovaEleonora MariniYi LiuAbstract The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified Aspergillus sp. strain FUA by DSM Food Specialties B.V. The food enzyme is free from viable cells of the production organism. The food enzyme is intended to be used in four food manufacturing processes. Since residual amounts of food enzyme‐total organic solids (TOS) are removed in the production of distilled alcohol, dietary exposure was calculated only for the remaining three food manufacturing processes. It was estimated to be up to 0.687 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 2000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 2911. A search for the homology of the amino acid sequence of the food enzyme to known allergens was made and three matches with respiratory allergens were found, one of which is also an oral allergen. Known sources of allergens were used in the food enzyme manufacturing process. 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.2025.91671,4‐α‐d‐glucan glucanohydrolaseAspergillus sp.EC 3.2.1.1EFSA‐Q‐2023‐000360food enzymeα‐amylase |
| 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 Cristina Fernàndez‐Fraguas Magdalena Andryszkiewicz Natalia Kovalkovicova Eleonora Marini Yi Liu Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Aspergillus sp. strain FUA EFSA Journal 1,4‐α‐d‐glucan glucanohydrolase Aspergillus sp. EC 3.2.1.1 EFSA‐Q‐2023‐000360 food enzyme α‐amylase |
| title | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Aspergillus sp. strain FUA |
| title_full | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Aspergillus sp. strain FUA |
| title_fullStr | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Aspergillus sp. strain FUA |
| title_full_unstemmed | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Aspergillus sp. strain FUA |
| title_short | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Aspergillus sp. strain FUA |
| title_sort | safety evaluation of the food enzyme α amylase from the non genetically modified aspergillus sp strain fua |
| topic | 1,4‐α‐d‐glucan glucanohydrolase Aspergillus sp. EC 3.2.1.1 EFSA‐Q‐2023‐000360 food enzyme α‐amylase |
| url | https://doi.org/10.2903/j.efsa.2025.9167 |
| work_keys_str_mv | AT efsapanelonfoodenzymesfez safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua AT holgerzorn safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua AT josemanuelbaratbaviera safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua AT claudiabolognesi safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua AT francescocatania safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua AT gabrielegadermaier safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua AT ralfgreiner safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua AT baltasarmayo safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua AT alicjamortensen safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua AT yrjohenrikroos safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua AT marizelmsolano safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua AT monikasramkova safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua AT henkvanloveren safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua AT laurencevernis safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua AT cristinafernandezfraguas safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua AT magdalenaandryszkiewicz safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua AT nataliakovalkovicova safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua AT eleonoramarini safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua AT yiliu safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedaspergillusspstrainfua |