Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.; Grob, K.... (2022). Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Aspergillus oryzae strain NZYM-LJ. EFSA Journal. 20(7):1-16. https://doi.org/10.2903/j.efsa.2022.7381
Por favor, use este identificador para citar o enlazar este ítem: http://hdl.handle.net/10251/194005
Title:
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Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Aspergillus oryzae strain NZYM-LJ
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Author:
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Lambré, Claude
Barat Baviera, José Manuel
Bolognesi, Claudia
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David Michael
Grob, Konrad
Lampi, Evgenia
Mengelers, Marcel
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger-Lise
Tlustos, Christina
van Loveren, Henk
Vernis, Laurence
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UPV Unit:
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Universitat Politècnica de València. Escuela Técnica Superior de Ingeniería Agronómica y del Medio Natural - Escola Tècnica Superior d'Enginyeria Agronòmica i del Medi Natural
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Issued date:
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Abstract:
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[EN] The food enzyme phospholipase A1 (phosphatidylcholine 1-acylhydrolase; EC 3.1.1.32) is produced with the genetically modified Aspergillus oryzae strain NZYM-LJ by Novozymes A/S. The genetic modifications do not give ...[+]
[EN] The food enzyme phospholipase A1 (phosphatidylcholine 1-acylhydrolase; EC 3.1.1.32) is produced with the genetically modified Aspergillus oryzae strain NZYM-LJ by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in baking processes. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.09 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 957.3 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 10,600. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found. The Panel considered that, under the intended conditions of use the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Based on the data provided, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.
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Subjects:
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Food enzyme
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Phospholipase A1
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Phosphatidylcholine 1-acylhydrolase
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EC 31132
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Aspergillus oryzae
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Genetically modified microorganism
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Copyrigths:
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Reconocimiento - Sin obra derivada (by-nd)
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Source:
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EFSA Journal. (eissn:
1831-4732
)
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DOI:
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10.2903/j.efsa.2022.7381
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Publisher:
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Willey
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Publisher version:
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https://doi.org/10.2903/j.efsa.2022.7381
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Thanks:
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The Panel wishes to thank the following for the support provided to this scientific output: Erik Boinowitz, Simone Lunardi and Helen Regina.
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Type:
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Artículo
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