Open AccessSafety evaluation of the food enzyme chitinase from Streptomyces violaceoruber (strain pC hi)
Author(s) -
Silano Vittorio,
Barat Baviera José Manuel,
Bolognesi Claudia,
Brüschweiler Beat Johannes,
Cocconcelli Pier Sandro,
Crebelli Riccardo,
Gott David Michael,
Grob Konrad,
Lampi Evgenia,
Mortensen Alicja,
Rivière Gilles,
Steffensen IngerLise,
Tlustos Christina,
Van Loveren Henk,
Vernis Laurence,
Zorn Holger,
Glandorf Boet,
Herman Lieve,
Aguilera Jaime,
Liu Yi,
Chesson Andrew
Publication year - 2019
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.2019.5767
Subject(s) - chitinase , food science , food safety , strain (injury) , genotoxicity , enzyme , toxicology , biology , toxicity , microbiology and biotechnology , medicine , biochemistry , anatomy
The food enzyme, a chitinase ( EC 3.2.1.14), is produced with the genetically modified Streptomyces violaceoruber strain pC hi by Nagase. No information was provided regarding the presence of antimicrobial resistance genes in the production strain, other than that used in the genetic modification. The chitinase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–total organic solids ( TOS ) was estimated on the basis of individual data from the EFSA Comprehensive European Food Consumption Database. The exposure estimate is up to 0.829 mg TOS /kg body weight 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‐days oral toxicity study in rats. The Panel identified a no observed adverse effect level at the highest dose tested of 791 mg TOS /kg body weight, which, compared with the dietary exposure, results in margin of exposure of at least 1,171. Similarity of the amino acid sequence to those of known allergens was searched and no matches were found. The Panel considered that there are no indications for food allergic reactions to this chitinase. Based on the data provided and the derived margin of exposure, the Panel concluded that the food enzyme chitinase produced with the genetically modified S. violaceoruber strain pC hi does not give rise to safety concerns arising from the toxicological studies and the production process under the intended conditions of use. The CEP Panel was unable to conclude on the absence of viable cells and DNA from the genetically modified production strain in the food enzyme, for which uncertainty remains on the possible presence of gene(s) conferring antimicrobial resistance.