TY - JOUR
T1 - Safety evaluation of the food enzyme thermolysin from the non-genetically modified Anoxybacillus caldiproteolyticus strain AE-TP
AU - EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
AU - Lambré, Claude
AU - Barat Baviera, José Manuel
AU - Bolognesi, Claudia
AU - Cocconcelli, Pier Sandro
AU - Crebelli, Riccardo
AU - Gott, David Michael
AU - Grob, Konrad
AU - Lampi, Evgenia
AU - Mengelers, Marcel
AU - Mortensen, Alicja
AU - Rivière, Gilles
AU - Steffensen, Inger-Lise
AU - Tlustos, Christina
AU - Van Loveren, Henk
AU - Vernis, Laurence
AU - Zorn, Holger
AU - Herman, Lieve
AU - Roos, Yrjö
AU - Andryszkiewicz, Magdalena
AU - Liu, Yi
AU - Lunardi, Simone
AU - Nielsen, Elsa
AU - Nørby, Karin
AU - Chesson, Andrew
PY - 2024
Y1 - 2024
N2 - The food enzyme thermolysin (EC. 3.4.24.27) is produced with the non-genetically modified Anoxybacillus caldiproteolyticus strain AE-TP by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. It is intended to be used in eight food manufacturing processes. Dietary exposure was estimated to be up to 0.973 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 700 mg TOS/kg bw per day, the mid-dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 719. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no matches were found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is 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.
AB - The food enzyme thermolysin (EC. 3.4.24.27) is produced with the non-genetically modified Anoxybacillus caldiproteolyticus strain AE-TP by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. It is intended to be used in eight food manufacturing processes. Dietary exposure was estimated to be up to 0.973 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 700 mg TOS/kg bw per day, the mid-dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 719. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no matches were found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is 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.
KW - Anoxybacillus caldiproteolyticus
KW - EC 3.4.24.27
KW - Food enzyme
KW - Thermoase
KW - Thermolysin
U2 - 10.2903/j.efsa.2024.8634
DO - 10.2903/j.efsa.2024.8634
M3 - Journal article
C2 - 38410144
SN - 1831-4732
VL - 22
JO - EFSA Journal
JF - EFSA Journal
IS - 2
M1 - e8634
ER -