Safety evaluation of the food enzyme pectin lyase from the genetically modified Trichoderma reesei strain RF6199
Abstract The food enzyme pectin lyase ((1‐4)‐6‐O‐methyl‐α‐D‐galacturonan lyase; EC 4.2.2.10) is produced with the genetically modified Trichoderma reesei strain RF6199 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable ce...
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| Format: | Article |
| Language: | English |
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Wiley
2022-12-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2022.7675 |
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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 Magdalena Andryszkiewicz Ana Gomes Natália Kovalkovičová Yi Liu Kim Renée Rygaard Nielsen Giulio diPiazza Karl‐Heinz Engel 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 Magdalena Andryszkiewicz Ana Gomes Natália Kovalkovičová Yi Liu Kim Renée Rygaard Nielsen Giulio diPiazza Karl‐Heinz Engel Andrew Chesson |
| author_sort | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The food enzyme pectin lyase ((1‐4)‐6‐O‐methyl‐α‐D‐galacturonan lyase; EC 4.2.2.10) is produced with the genetically modified Trichoderma reesei strain RF6199 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in six manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for fruit brandies, fruit and vegetable processing for products other than juices, wine and wine vinegar production, refined and unrefined sugar production and coffee bean demucilation. Foods obtained from fruit processing for fruit brandies and coffee bean demucilation, as well as refined sugars, were excluded from dietary exposure estimation. For the remaining four processes, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.2 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 1,000 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 5,000. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood of such reactions 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. |
| first_indexed | 2024-04-11T04:35:26Z |
| format | Article |
| id | doaj.art-1386bf99778540249d7018fac263db1a |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-11T04:35:26Z |
| publishDate | 2022-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-1386bf99778540249d7018fac263db1a2022-12-28T12:23:02ZengWileyEFSA Journal1831-47322022-12-012012n/an/a10.2903/j.efsa.2022.7675Safety evaluation of the food enzyme pectin lyase from the genetically modified Trichoderma reesei strain RF6199EFSA 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 HermanMagdalena AndryszkiewiczAna GomesNatália KovalkovičováYi LiuKim Renée Rygaard NielsenGiulio diPiazzaKarl‐Heinz EngelAndrew ChessonAbstract The food enzyme pectin lyase ((1‐4)‐6‐O‐methyl‐α‐D‐galacturonan lyase; EC 4.2.2.10) is produced with the genetically modified Trichoderma reesei strain RF6199 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in six manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for fruit brandies, fruit and vegetable processing for products other than juices, wine and wine vinegar production, refined and unrefined sugar production and coffee bean demucilation. Foods obtained from fruit processing for fruit brandies and coffee bean demucilation, as well as refined sugars, were excluded from dietary exposure estimation. For the remaining four processes, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.2 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 1,000 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 5,000. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood of such reactions 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.2022.7675food enzymepectin lyase(1‐4)‐6‐O‐methyl‐α‐D‐galacturonan lyaseEC 4.2.2.10pectin trans‐eliminaseTrichoderma reesei |
| 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 Magdalena Andryszkiewicz Ana Gomes Natália Kovalkovičová Yi Liu Kim Renée Rygaard Nielsen Giulio diPiazza Karl‐Heinz Engel Andrew Chesson Safety evaluation of the food enzyme pectin lyase from the genetically modified Trichoderma reesei strain RF6199 EFSA Journal food enzyme pectin lyase (1‐4)‐6‐O‐methyl‐α‐D‐galacturonan lyase EC 4.2.2.10 pectin trans‐eliminase Trichoderma reesei |
| title | Safety evaluation of the food enzyme pectin lyase from the genetically modified Trichoderma reesei strain RF6199 |
| title_full | Safety evaluation of the food enzyme pectin lyase from the genetically modified Trichoderma reesei strain RF6199 |
| title_fullStr | Safety evaluation of the food enzyme pectin lyase from the genetically modified Trichoderma reesei strain RF6199 |
| title_full_unstemmed | Safety evaluation of the food enzyme pectin lyase from the genetically modified Trichoderma reesei strain RF6199 |
| title_short | Safety evaluation of the food enzyme pectin lyase from the genetically modified Trichoderma reesei strain RF6199 |
| title_sort | safety evaluation of the food enzyme pectin lyase from the genetically modified trichoderma reesei strain rf6199 |
| topic | food enzyme pectin lyase (1‐4)‐6‐O‐methyl‐α‐D‐galacturonan lyase EC 4.2.2.10 pectin trans‐eliminase Trichoderma reesei |
| url | https://doi.org/10.2903/j.efsa.2022.7675 |
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