Open AccessSafety evaluation of the food enzyme chymosin from the genetically modified Aspergillus niger strain DSM 29544
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,
Van Loveren Henk,
Vernis Laurence,
Zorn Holger,
Aguilera Jaime,
Andryszkiewicz Magdalena,
Piazza Giulio,
Sousa Rita Ferreira,
Kovalkovikova Natalia,
Liu Yi,
Chesson Andrew
Publication year - 2022
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.2022.7464
Subject(s) - food science , genotoxicity , chymosin , aspergillus niger , food safety , biology , enzyme , no observed adverse effect level , fermentation in food processing , animal feed , toxicity , strain (injury) , microbiology and biotechnology , toxicology , chemistry , body weight , biochemistry , genetics , lactic acid , organic chemistry , anatomy , bacteria , endocrinology
The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Aspergillus niger strain DSM 29544 by Chr. Hansen. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in milk processing for cheese production and for production of fermented milk products. Based on the maximum use levels, 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 raise 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 84.1 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 930. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were 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 low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.