European Union Evaluation of the safety of a food enzyme endonuclide of -1,3 (4) -beta-glucanase

On February 22, 2023, the European Union Food Safety Authority issued an opinion on the safety evaluation of endo-1,3(4) -beta-glucanase (endo,3(4) -beta-glucanase).

It is understood that the food enzyme is produced by the non-GM Cellulosimicrobium funkei strain AE-TN and is intended for use in baking processes and yeast processing.

After assessment, the panel concluded that the risk of anaphylaxis through dietary exposure could not be ruled out under the intended conditions of use, but that the likelihood of this occurring was low. However, due to the presence of living cells producing the strain in the food enzyme, the panel concluded that the food enzyme cannot be considered safe. Some of the original reports are as follows:

The food enzyme endo-1,3(4) -beta-glucanase (3-(1 -- 3; 3(4)-glucanohydrolase; 1 -- 4) -beta-d-glucan; 3(4) -Glucanohydrolase; EC 3.2.1.6) is produced with the non-genetically modified Cellulosimicrobium funkei strain AE-TN by Amano Enzyme Inc. Ec 3.2.1.6) is produced with the non-genetically modified Cellulosimicrobium Funkei strain AE- tn by Amano enzyme Inc. The food enzyme was shown to contain viable cells of the production strain, which belongs to a species that has been implicated in opportunistic infections in humans. The food enzyme is intended to be used in baking processes and yeast processing. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 1.75 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 1,788 mg TOS/kg bw per day, the highest dose tested, which, Panel identified a no observed adverse effect level of 1,788 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 1,022. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is low. However, due to the presence of viable cells of the production strain in the food enzyme, the Panel concluded that the food enzyme cannot be considered safe.