Safety evaluation of the food enzyme endo‐polygalacturonase from the genetically modified Aspergillus niger strain EPG
Abstract The food enzyme endo‐polygalacturonase ((1–4)‐α‐d‐galacturonan glycanohydrolase; EC 3.2.1.15) is produced with the genetically modified Aspergillus niger strain EPG by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viabl...
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| Format: | Article |
| Language: | English |
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Wiley
2023-03-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2023.7837 |
| _version_ | 1797829781931163648 |
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| 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 Boet Glandorf Lieve Herman Yrjö Roos Jaime Aguilera Magdalena Andryszkiewicz Natália Kovalkovičová Yi Liu 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 Boet Glandorf Lieve Herman Yrjö Roos Jaime Aguilera Magdalena Andryszkiewicz Natália Kovalkovičová Yi Liu Andrew Chesson |
| author_sort | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The food enzyme endo‐polygalacturonase ((1–4)‐α‐d‐galacturonan glycanohydrolase; EC 3.2.1.15) is produced with the genetically modified Aspergillus niger strain EPG by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in fruit and vegetable processing for juice production. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.122 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 1,014 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure at least 8,311. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and 38 matches were found, two of which are food allergens. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, in particular for individuals sensitised to papaya or maize, but that the risk will not exceed that of consumption of papaya or maize. In addition, oral allergy reactions cannot be excluded in pollen‐sensitised individuals. 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 | 2024-04-09T13:25:41Z |
| format | Article |
| id | doaj.art-bca00d3482ce41e883d9d5928122d205 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-09T13:25:41Z |
| publishDate | 2023-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-bca00d3482ce41e883d9d5928122d2052023-05-10T11:11:19ZengWileyEFSA Journal1831-47322023-03-01213n/an/a10.2903/j.efsa.2023.7837Safety evaluation of the food enzyme endo‐polygalacturonase from the genetically modified Aspergillus niger strain EPGEFSA 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 ZornBoet GlandorfLieve HermanYrjö RoosJaime AguileraMagdalena AndryszkiewiczNatália KovalkovičováYi LiuAndrew ChessonAbstract The food enzyme endo‐polygalacturonase ((1–4)‐α‐d‐galacturonan glycanohydrolase; EC 3.2.1.15) is produced with the genetically modified Aspergillus niger strain EPG by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in fruit and vegetable processing for juice production. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.122 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 1,014 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure at least 8,311. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and 38 matches were found, two of which are food allergens. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, in particular for individuals sensitised to papaya or maize, but that the risk will not exceed that of consumption of papaya or maize. In addition, oral allergy reactions cannot be excluded in pollen‐sensitised individuals. 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.2023.7837food enzymeendo‐polygalacturonase(1–4)‐α‐d‐galacturonan glycanohydrolase; EC 3.2.1.15Aspergillus nigergenetically modified microorganism |
| 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 Boet Glandorf Lieve Herman Yrjö Roos Jaime Aguilera Magdalena Andryszkiewicz Natália Kovalkovičová Yi Liu Andrew Chesson Safety evaluation of the food enzyme endo‐polygalacturonase from the genetically modified Aspergillus niger strain EPG EFSA Journal food enzyme endo‐polygalacturonase (1–4)‐α‐d‐galacturonan glycanohydrolase; EC 3.2.1.15 Aspergillus niger genetically modified microorganism |
| title | Safety evaluation of the food enzyme endo‐polygalacturonase from the genetically modified Aspergillus niger strain EPG |
| title_full | Safety evaluation of the food enzyme endo‐polygalacturonase from the genetically modified Aspergillus niger strain EPG |
| title_fullStr | Safety evaluation of the food enzyme endo‐polygalacturonase from the genetically modified Aspergillus niger strain EPG |
| title_full_unstemmed | Safety evaluation of the food enzyme endo‐polygalacturonase from the genetically modified Aspergillus niger strain EPG |
| title_short | Safety evaluation of the food enzyme endo‐polygalacturonase from the genetically modified Aspergillus niger strain EPG |
| title_sort | safety evaluation of the food enzyme endo polygalacturonase from the genetically modified aspergillus niger strain epg |
| topic | food enzyme endo‐polygalacturonase (1–4)‐α‐d‐galacturonan glycanohydrolase; EC 3.2.1.15 Aspergillus niger genetically modified microorganism |
| url | https://doi.org/10.2903/j.efsa.2023.7837 |
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