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On January 6, 2021, the European Food Safety Agency issued opinions on the safety evaluation of a food enzyme, cellulase.
It is understood that this food enzyme is produced by the non-genetically modified Penicillium funiculosum strain DP-Lzc35, and is intended to be used in the production, roasting and brewing process of distilled alcohol.
After evaluation, the expert team believes that under the expected use conditions, the risk of allergies and induced reactions caused by dietary exposure cannot be ruled out, but the possibility of this occurrence is very low. Based on the data provided, the team concluded that the food enzyme will not cause safety hazards under the expected use conditions. Part of the original report is as follows:
The food enzyme cellulase (4‐(1,3;1,4)‐β‐d‐glucan 4‐glucanohydrolase; EC 18.104.22.168) is produced with the non‐genetically modified Penicillium funiculosum Lzc35 by Danisco US Inc . The cellulase is intended to be used in distilled alcohol production, baking and brewing processes. Since residual amounts of total organic solids (TOS) are removed by distillation, dietary exposure was only calculated for baking and brewing processes. ba sed on the proposed maximum use levels, dietary exposure to the food enzyme–TOS was estimated to be up to 0.416 mg TOS/kg body weight (bw) per day. 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 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure , resulted in a margin of exposure of at least 200. Similarity of the amino acid s equence of the food enzyme 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 by dietary exposure cannot be excluded, but the likelihood is considered to be low. based on the data provided, the Panel concluded that this food enzyme does not give rise to safety co< em/>ncerns under the intended conditions of use.
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