Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Bacillus amyloliquefaciens strain BA
Abstract The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified microorganism Bacillus amyloliquefaciens strain BA by HBI Enzymes Inc. The enzyme under assessment is intended to be used in six food processes: baking processes, brewing proc...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2023-07-01
|
| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2023.8157 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849698883796467712 |
|---|---|
| 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 Yrjö Roos Magdalena Andryszkiewicz Kyriaki Apergi Cristina Fernàndez‐Fraguas Yi Liu Silvia Peluso Giulio diPiazza 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 Yrjö Roos Magdalena Andryszkiewicz Kyriaki Apergi Cristina Fernàndez‐Fraguas Yi Liu Silvia Peluso Giulio diPiazza Andrew Chesson |
| author_sort | EFSA Panel on Food Contact Materials; Enzymes and Processing Aids (CEP) |
| 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 microorganism Bacillus amyloliquefaciens strain BA by HBI Enzymes Inc. The enzyme under assessment is intended to be used in six food processes: baking processes, brewing processes, distilled alcohol production, starch processing for the production of glucose syrups and other starch hydrolysates, production of dairy analogues and production of rice‐based meals. Since residual amounts of total organic solids (TOS) are removed during distillation and during the production of glucose syrups and other starch hydrolysates, dietary exposure was calculated only for the remaining four food manufacturing processes. It was estimated to be up to 4.805 mg TOS/kg body weight (bw) per day in European populations. The applicant did not provide sufficient data to demonstrate that the production strain meets the qualified presumption of safety (QPS) criteria, or proof of absence of viable cells and DNA from the production organism in the food enzyme. Therefore, the Panel was not able to conclude on the safety of the microbial source. A margin of exposure could not be calculated in the absence of toxicological studies. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens 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 cannot be excluded, but the likelihood is low. Based on the data provided, the Panel could not conclude on the safety of this food enzyme, under the intended conditions of use. |
| format | Article |
| id | doaj-art-01716ad6bf6d4f1785d44967e1d4a0d5 |
| institution | DOAJ |
| issn | 1831-4732 |
| language | English |
| publishDate | 2023-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-01716ad6bf6d4f1785d44967e1d4a0d52025-08-20T03:18:46ZengWileyEFSA Journal1831-47322023-07-01217n/an/a10.2903/j.efsa.2023.8157Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Bacillus amyloliquefaciens strain BAEFSA 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 ZornYrjö RoosMagdalena AndryszkiewiczKyriaki ApergiCristina Fernàndez‐FraguasYi LiuSilvia PelusoGiulio diPiazzaAndrew ChessonAbstract The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified microorganism Bacillus amyloliquefaciens strain BA by HBI Enzymes Inc. The enzyme under assessment is intended to be used in six food processes: baking processes, brewing processes, distilled alcohol production, starch processing for the production of glucose syrups and other starch hydrolysates, production of dairy analogues and production of rice‐based meals. Since residual amounts of total organic solids (TOS) are removed during distillation and during the production of glucose syrups and other starch hydrolysates, dietary exposure was calculated only for the remaining four food manufacturing processes. It was estimated to be up to 4.805 mg TOS/kg body weight (bw) per day in European populations. The applicant did not provide sufficient data to demonstrate that the production strain meets the qualified presumption of safety (QPS) criteria, or proof of absence of viable cells and DNA from the production organism in the food enzyme. Therefore, the Panel was not able to conclude on the safety of the microbial source. A margin of exposure could not be calculated in the absence of toxicological studies. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens 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 cannot be excluded, but the likelihood is low. Based on the data provided, the Panel could not conclude on the safety of this food enzyme, under the intended conditions of use.https://doi.org/10.2903/j.efsa.2023.8157food enzymeα‐amylase4‐α‐d‐glucan glucanohydrolaseamylaseglycogenaseEC 3.2.1.1 |
| 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 Yrjö Roos Magdalena Andryszkiewicz Kyriaki Apergi Cristina Fernàndez‐Fraguas Yi Liu Silvia Peluso Giulio diPiazza Andrew Chesson Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Bacillus amyloliquefaciens strain BA EFSA Journal food enzyme α‐amylase 4‐α‐d‐glucan glucanohydrolase amylase glycogenase EC 3.2.1.1 |
| title | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Bacillus amyloliquefaciens strain BA |
| title_full | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Bacillus amyloliquefaciens strain BA |
| title_fullStr | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Bacillus amyloliquefaciens strain BA |
| title_full_unstemmed | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Bacillus amyloliquefaciens strain BA |
| title_short | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Bacillus amyloliquefaciens strain BA |
| title_sort | safety evaluation of the food enzyme α amylase from the non genetically modified bacillus amyloliquefaciens strain ba |
| topic | food enzyme α‐amylase 4‐α‐d‐glucan glucanohydrolase amylase glycogenase EC 3.2.1.1 |
| url | https://doi.org/10.2903/j.efsa.2023.8157 |
| work_keys_str_mv | AT efsapanelonfoodcontactmaterialsenzymesandprocessingaidscep safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT claudelambre safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT josemanuelbaratbaviera safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT claudiabolognesi safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT piersandrococconcelli safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT riccardocrebelli safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT davidmichaelgott safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT konradgrob safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT evgenialampi safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT marcelmengelers safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT alicjamortensen safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT gillesriviere safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT ingerlisesteffensen safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT christinatlustos safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT henkvanloveren safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT laurencevernis safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT holgerzorn safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT yrjoroos safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT magdalenaandryszkiewicz safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT kyriakiapergi safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT cristinafernandezfraguas safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT yiliu safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT silviapeluso safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT giuliodipiazza safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba AT andrewchesson safetyevaluationofthefoodenzymeaamylasefromthenongeneticallymodifiedbacillusamyloliquefaciensstrainba |