Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus niger strain PME
Abstract The food enzyme pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) is produced with the genetically modified Aspergillus niger strain PME 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...
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Wiley
2023-07-01
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| Online Access: | https://doi.org/10.2903/j.efsa.2023.8152 |
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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 Lieve Herman Jaime Aguilera Magdalena Andryszkiewicz Rita Ferreira deSousa Yi Liu Sandra Rainieri 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 Lieve Herman Jaime Aguilera Magdalena Andryszkiewicz Rita Ferreira deSousa Yi Liu Sandra Rainieri Andrew Chesson |
| author_sort | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The food enzyme pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) is produced with the genetically modified Aspergillus niger strain PME 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 recombinant DNA. It is intended to be used in fruit and vegetable processing, for juice production and fruit and vegetable processing for products other than juices. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.095 mg TOS/kg body weight (bw) per day in European populations. The toxicity studies were carried out with a xylanase obtained from A. niger strain XEA. The Panel considered this food enzyme as a suitable substitute for the pectinesterase to be used in the toxicological studies, because both production strains are derived from the same recipient strain, the location of the inserts is comparable, no partial inserts were present and the production methods are essentially the same. 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 (NOAEL) of 1,852 mg TOS/kg bw per day, the highest dose tested, resulting in a margin of exposure of at least 19,495. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with pollen allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to pollen allergens, cannot be excluded. 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-019e5703efcf43229db0e11cab0bf127 |
| institution | OA Journals |
| issn | 1831-4732 |
| language | English |
| publishDate | 2023-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-019e5703efcf43229db0e11cab0bf1272025-08-20T02:12:57ZengWileyEFSA Journal1831-47322023-07-01217n/an/a10.2903/j.efsa.2023.8152Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus niger strain PMEEFSA 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 ZornLieve HermanJaime AguileraMagdalena AndryszkiewiczRita Ferreira deSousaYi LiuSandra RainieriAndrew ChessonAbstract The food enzyme pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) is produced with the genetically modified Aspergillus niger strain PME 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 recombinant DNA. It is intended to be used in fruit and vegetable processing, for juice production and fruit and vegetable processing for products other than juices. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.095 mg TOS/kg body weight (bw) per day in European populations. The toxicity studies were carried out with a xylanase obtained from A. niger strain XEA. The Panel considered this food enzyme as a suitable substitute for the pectinesterase to be used in the toxicological studies, because both production strains are derived from the same recipient strain, the location of the inserts is comparable, no partial inserts were present and the production methods are essentially the same. 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 (NOAEL) of 1,852 mg TOS/kg bw per day, the highest dose tested, resulting in a margin of exposure of at least 19,495. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with pollen allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to pollen allergens, 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.2023.8152food enzymepectinesterasepectin pectylhydrolaseEC 3.1.1.11pectin methylesteraseAspergillus niger |
| 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 Lieve Herman Jaime Aguilera Magdalena Andryszkiewicz Rita Ferreira deSousa Yi Liu Sandra Rainieri Andrew Chesson Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus niger strain PME EFSA Journal food enzyme pectinesterase pectin pectylhydrolase EC 3.1.1.11 pectin methylesterase Aspergillus niger |
| title | Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus niger strain PME |
| title_full | Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus niger strain PME |
| title_fullStr | Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus niger strain PME |
| title_full_unstemmed | Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus niger strain PME |
| title_short | Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus niger strain PME |
| title_sort | safety evaluation of the food enzyme pectinesterase from the genetically modified aspergillus niger strain pme |
| topic | food enzyme pectinesterase pectin pectylhydrolase EC 3.1.1.11 pectin methylesterase Aspergillus niger |
| url | https://doi.org/10.2903/j.efsa.2023.8152 |
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