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Safety evaluation of the food enzyme thermolysin from the non-genetically modified Anoxybacillus caldiproteolyticus strain DP-Fzj32
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DOI：10.2903/j.efsa.2026.10140.png)
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Abstract
En 中文
The food enzyme thermolysin (EC 3.4.24.27) is produced with the non-genetically modified Anoxybacillus caldiproteolyticus strain DP-Fzj32 by Danisco US Inc. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in three food manufacturing processes. Dietary exposure was estimated to be up to 0.874 mg food enzyme–total organic solids (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 108 mg TOS/kg bw per day, the highest dose tested. The calculated margins of exposure were 232 (infants), 314 (toddlers), 124 (children), 1200 (adolescents), 2250 (adults) and 2348 (the elderly). A search for the homology of the amino acid sequence of the thermolysin to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure cannot be excluded, but that 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, for infants, toddlers, adolescents, adults and the elderly. However, the margin of exposure is insufficient to exclude safety concerns for children.
Keywords:
Anoxybacillus caldiproteolyticus
EC 3.4.24.27
EFSA-Q-2015-00682
food enzyme
Geobacillus caldoproteolyticus
non-genetically modified microorganism
thermoase
thermolysin
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