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
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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