Open AccessSafety evaluation of the food enzyme phospholipase A1 from the genetically modified Aspergillus niger strain NZYM ‐ FP
Author(s) -
Silano Vittorio,
Barat Baviera José Manuel,
Bolognesi Claudia,
Cocconcelli Pier Sandro,
Crebelli Riccardo,
Gott David Michael,
Grob Konrad,
Lambré Claude,
Lampi Evgenia,
Mengelers Marcel,
Mortensen Alicja,
Rivière Gilles,
Steffensen IngerLise,
Tlustos Christina,
Loveren Henk,
Vernis Laurence,
Zorn Holger,
Andryszkiewicz Magdalena,
Kovalkovicova Natalia,
Liu Yi,
Rainieri Sandra,
Chesson Andrew
Publication year - 2020
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2020.6131
Subject(s) - food science , aspergillus niger , genotoxicity , enzyme , no observed adverse effect level , strain (injury) , food safety , toxicity , toxicology , biology , microbiology and biotechnology , chemistry , biochemistry , anatomy , organic chemistry
The food enzyme phospholipase A1 (phosphatidycholine 1‐acylhydrolase EC 3.1.1.32) is produced with the genetically modified Aspergillus niger strain NZYM ‐ FP 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 phospholipase A1 food enzyme is intended to be used for degumming of fats and oils. Since residual amounts of Total Organic Solids ( TOS ) are removed by the purification steps applied during degumming, dietary exposure estimation was not considered necessary. Genotoxicity tests did not raise safety concerns. The repeated dose 90‐day oral 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 ( NOAEL ) of 1,356 mg TOS /kg body weight (bw) per day, the highest dose tested. 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 upon dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Based on the data provided and the removal of TOS during the degumming of fats and oils, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.