Safety evaluation of the food enzyme aqualysin 1 from a genetically modified Bacillus subtilis (strain LMGS 25520)
| 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, Riviere, Gilles, Srinivasan, Jannavi, Tavares Poças, Maria de Fátima, Tlustos, Christina, Wölfle, Detlef, Zorn, Holger, Chesson, Andrew, Glandorf, Boet, Herman, Lieve, Jany, Klaus‐Dieter, Marcon, Francesca, Penninks, André, Smith, Andrew, Želježić, Davor, Aguilera‐Gómez, Margarita, Andryszkiewicz, Magdalena, Arcella, Davide, Kovalkovičová, Natália, Liu, Yi, 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: |
enzyme alimentaire
Ingénierie des aliments Plant Science Bacillus subtilis medicine.disease_cause law.invention law aqualysin 1 [SDV.IDA]Life Sciences [q-bio]/Food engineering TX341-641 Food science genetically modified microorganism Aqualysin 1 food enzyme 2. Zero hunger chemistry.chemical_classification Genetically modified microorganism Strain (biology) 04 agricultural and veterinary sciences 040401 food science Genetically modified organism Alimentation et Nutrition Recombinant DNA nutrition humaine No-observed-adverse-effect level Veterinary (miscellaneous) TP1-1185 Biology Microbiology 0404 agricultural biotechnology medicine EC 3.4.21.111 Food enzyme Food and Nutrition Food engineering lysine alimentaire Nutrition. Foods and food supply Chemical technology biology.organism_classification Enzyme chemistry Animal Science and Zoology Parasitology [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition Genotoxicity Food Science |
| Zdroj: | EFSA Journal EFSA Journal, European Food Safety Authority, 2018, 16 (5), 20 p. ⟨10.2903/j.efsa.2018.5170⟩ EFSA Journal 5 (16), 20 p.. (2018) EFSA Journal, Vol 16, Iss 5, Pp n/a-n/a (2018) Repositório Científico de Acesso Aberto de Portugal Repositório Científico de Acesso Aberto de Portugal (RCAAP) instacron:RCAAP |
| ISSN: | 2314-9396 |
| Popis: | International audience; The food enzyme considered in this opinion is aquaiysin 1 (EC 3,4.21.111), produced from the genetically modified strain Bacillus subtilis LMGS 25520 by Puratos NV. The production strain was not detected in the food enzyme. Aquaiysin 1 is intended to be used in baking processes. Based on the maximum use level 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 2.13 mg TOS/kg body weight per day in European populations. Genotoxicity tests indicated no genotoxic concerns. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens and 23 matches were found (20 respiratory and 3 dermal allergens). However, the Panel considered that there are no indications for food allergic reactions to the food enzyme. The genetic modifications performed, the manufacturing process, the compositional and biochemical data, the allergenicity and the genotoxicity assessment did not raise safety concerns. The Panel considered the margin of exposure (MOE) calculated from the no observed adverse effect level (INOAEL) determined from the repeated dose 90-day oral toxicity study and the estimated dietary exposure as insufficient to conclude that there is no safety concern for this food enzyme under the intended conditions of use. The Panel noted that recombinant DNA was present in all batches of the food enzyme tested. |
| Databáze: | OpenAIRE |
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