Safety evaluation of food enzyme xylanase from a genetically modified Bacillus subtilis (strain LMG S-27588)
Autor: | EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), ., Silano, Vittorio, Bolognesi, Claudia, Castle, Laurence, Chipman, Kevin, Cravedi, Jean Pierre, Fowler, Paul, Franz, Roland, Grob, Konrad, Gürtler, Rainer, Husøy, Trine, Kärenlampi, Sirpa, Mennes, Wim, Milana, Maria Rosaria, Pfaff, Karla, Rivière, Gilles, Srinivasan, Jannavi, Tavares Poças, Maria de Fátima, Tlustos, Christina, Wölfle, Detlef, Zorn, Holger, Glandorf, Boet, Jany, Klaus‐Dieter, Marcon, Francesca, Penninks, Andre, Smith, Andrew, Arcella, David, Gomes, Ana, Kovalkovicova, Natalia, Liu, Yi, Maia, Joaquim, Engel, Karl‐Heinz |
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Přispěvatelé: | European Food Safety Authority (EFSA), ToxAlim (ToxAlim), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Ecole Nationale Vétérinaire de Toulouse (ENVT), Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Ecole d'Ingénieurs de Purpan (INPT - EI Purpan), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Recherche Agronomique (INRA), Veritati - Repositório Institucional da Universidade Católica Portuguesa |
Jazyk: | angličtina |
Rok vydání: | 2018 |
Předmět: |
EC 3.2.1.8
4-β-xylanase enzyme alimentaire Ingénierie des aliments Plant Science Bacillus subtilis medicine.disease_cause law.invention Endo-1 law [SDV.IDA]Life Sciences [q-bio]/Food engineering TX341-641 Food science 2. Zero hunger chemistry.chemical_classification Genetically modified microorganism biology Strain (biology) 4-beta-D-xylan xylanohydrolase 04 agricultural and veterinary sciences 040401 food science 4‐β‐d‐xylan xylanohydrolase Genetically modified organism Alimentation et Nutrition Recombinant DNA Xylanase nutrition humaine No-observed-adverse-effect level Veterinary (miscellaneous) TP1-1185 Microbiology 0404 agricultural biotechnology endo‐1 4‐β‐xylanase medicine 4-β-d-xylan xylanohydrolase Food and Nutrition Food engineering Food enzyme Nutrition. Foods and food supply Chemical technology biology.organism_classification food enzyme xylanase endo-1 4-beta-xylanase genetically modified microorganism Enzyme Scientific Opinion chemistry Endo-1 4-β-xylanase Animal Science and Zoology Parasitology [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition Genotoxicity Food Science |
Zdroj: | Repositório Científico de Acesso Aberto de Portugal Repositório Científico de Acesso Aberto de Portugal (RCAAP) instacron:RCAAP EFSA Journal EFSA Journal, European Food Safety Authority, 2018, 16 (5), 10 p. ⟨10.2903/j.efsa.2018.5169⟩ EFSA Journal, Vol 16, Iss 5, Pp n/a-n/a (2018) EFSA Journal 5 (16), 10 p.. (2018) |
ISSN: | 1831-4732 2314-9396 |
Popis: | International audience; The food enzyme considered in this opinion is an endo-l,4-beta-xylanase (4-beta-D-xylan xylanohydrolase; EC 3.2.1.8) produced from the genetically modified Bacillus subtilis strain LMG S-27588 by the company Puratos N. V. The production strain was not detected in the food enzyme. The endo-1,4-beta-xylanase is intended to be used in baking processes. Based on the maximum use levels recommended and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.325 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests with the food enzyme indicated no genotoxic concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived (443 mg TOS/kg bw per day), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens; no match was found. The Panel considered that there are no indications for food allergic reactions to this endo-1,4-beta-xylanase by dietary exposure. Based on the genetic modifications, the manufacturing process, the compositional and biochemical data, the dietary exposure assessment, the findings in the toxicological studies and allergenicity assessment, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use. The Panel noted that recombinant DMA was present in all batches of the food enzyme tested. |
Databáze: | OpenAIRE |
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