Safety evaluation of an extension of use of the food enzyme endo‐polygalacturonase from the genetically modified Aspergillus oryzae strain AR‐183
Abstract The food enzyme endo‐polygalacturonase ((1 → 4)‐α‐d‐galacturonan glycanohydrolase EC 3.2.1.15) is produced with the genetically modified Aspergillus oryzae strain AR‐183 by AB ENZYMES GmbH. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food e...
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Wiley
2024-04-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2024.8701 |
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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 Yrjö Roos Daniele Cavanna Yi Liu 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 Daniele Cavanna Yi Liu Giulio diPiazza 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 oryzae strain AR‐183 by AB ENZYMES GmbH. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in five food manufacturing processes. Subsequently, the applicant requested to extend its use to two additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme for use in a total of seven food manufacturing processes. As the food enzyme‐total organic solids (TOS) is removed from the final foods in three food manufacturing processes, the dietary exposure to the food enzyme‐TOS was estimated only for the remaining four processes. Dietary exposure was up to 0.087 mg TOS/kg body weight (bw) per day in European populations. When combined with the NOAEL reported in the previous opinion (1000 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 11,494. Based on the data provided for the previous evaluation and the revised margin of exposure, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use. |
| format | Article |
| id | doaj-art-afd917a220744dba941d30fc7aab062f |
| institution | Matheson Library |
| issn | 1831-4732 |
| language | English |
| publishDate | 2024-04-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-afd917a220744dba941d30fc7aab062f2025-07-03T09:56:06ZengWileyEFSA Journal1831-47322024-04-01224n/an/a10.2903/j.efsa.2024.8701Safety evaluation of an extension of use of the food enzyme endo‐polygalacturonase from the genetically modified Aspergillus oryzae strain AR‐183EFSA 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 RoosDaniele CavannaYi LiuGiulio diPiazzaAndrew ChessonAbstract The food enzyme endo‐polygalacturonase ((1 → 4)‐α‐d‐galacturonan glycanohydrolase EC 3.2.1.15) is produced with the genetically modified Aspergillus oryzae strain AR‐183 by AB ENZYMES GmbH. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in five food manufacturing processes. Subsequently, the applicant requested to extend its use to two additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme for use in a total of seven food manufacturing processes. As the food enzyme‐total organic solids (TOS) is removed from the final foods in three food manufacturing processes, the dietary exposure to the food enzyme‐TOS was estimated only for the remaining four processes. Dietary exposure was up to 0.087 mg TOS/kg body weight (bw) per day in European populations. When combined with the NOAEL reported in the previous opinion (1000 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 11,494. Based on the data provided for the previous evaluation and the revised margin of exposure, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.https://doi.org/10.2903/j.efsa.2024.8701Aspergillus oryzaeEC 3.2.1.15EFSA‐Q‐2021‐00066EFSA‐Q‐2023‐00524endo‐polygalacturonasefood enzyme |
| 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 Daniele Cavanna Yi Liu Giulio diPiazza Andrew Chesson Safety evaluation of an extension of use of the food enzyme endo‐polygalacturonase from the genetically modified Aspergillus oryzae strain AR‐183 EFSA Journal Aspergillus oryzae EC 3.2.1.15 EFSA‐Q‐2021‐00066 EFSA‐Q‐2023‐00524 endo‐polygalacturonase food enzyme |
| title | Safety evaluation of an extension of use of the food enzyme endo‐polygalacturonase from the genetically modified Aspergillus oryzae strain AR‐183 |
| title_full | Safety evaluation of an extension of use of the food enzyme endo‐polygalacturonase from the genetically modified Aspergillus oryzae strain AR‐183 |
| title_fullStr | Safety evaluation of an extension of use of the food enzyme endo‐polygalacturonase from the genetically modified Aspergillus oryzae strain AR‐183 |
| title_full_unstemmed | Safety evaluation of an extension of use of the food enzyme endo‐polygalacturonase from the genetically modified Aspergillus oryzae strain AR‐183 |
| title_short | Safety evaluation of an extension of use of the food enzyme endo‐polygalacturonase from the genetically modified Aspergillus oryzae strain AR‐183 |
| title_sort | safety evaluation of an extension of use of the food enzyme endo polygalacturonase from the genetically modified aspergillus oryzae strain ar 183 |
| topic | Aspergillus oryzae EC 3.2.1.15 EFSA‐Q‐2021‐00066 EFSA‐Q‐2023‐00524 endo‐polygalacturonase food enzyme |
| url | https://doi.org/10.2903/j.efsa.2024.8701 |
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