Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.; Grob, K.... (2022). Safety evaluation of the food enzyme pullulanase from the genetically modified Bacillus licheniformis strain NZYM-LU. EFSA Journal. 20(6):1-14. https://doi.org/10.2903/j.efsa.2022.7359
Por favor, use este identificador para citar o enlazar este ítem: http://hdl.handle.net/10251/194008
Title:
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Safety evaluation of the food enzyme pullulanase from the genetically modified Bacillus licheniformis strain NZYM-LU
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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 pullulanase (pullulan 6-alpha-glucanohydrolase, EC 3.2.1.41) is produced with the genetically modified Bacillus licheniformis strain NZYM-LU by Novozyme A/S. The genetic modifications did not give rise ...[+]
[EN] The food enzyme pullulanase (pullulan 6-alpha-glucanohydrolase, EC 3.2.1.41) is produced with the genetically modified Bacillus licheniformis strain NZYM-LU by Novozyme A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for the qualified presumption of safety (QPS) status. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in brewing processes and in starch processing for production of glucose syrups and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for the brewing processes. It was estimated to be up to 0.59 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. The similarity of the amino acid sequence to those of known allergens was searched and no 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 low. Based on the data provided, the QPS status of the production strain and the absence of issues of concern arising from the production process, the Panel concluded that the food enzyme pullulanase produced with the genetically modified B. licheniformis strain NZYM-LU 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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Pullulanase
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Pullulan 6-alpha-glucanohydrolase
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EC 3.2.1.41
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Bacillus licheniformis
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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.2022.7359
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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.2022.7359
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Thanks:
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The Panel wishes to thank the trainee Erik Boinowitz and the interim Simone Lunardi for the support provided to this scientific output.
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Type:
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Artículo
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