European Food Safety Authority Deems Food Enzyme Cellulase Safe for Use in Eight Food Manufacturing Processes, with Low Risk of Allergic Reactions

On July 12th, 2023, the European Food Safety Authority (EFSA) released an opinion on the safety evaluation of a food enzyme, cellulase, which is produced by the non-genetically modified Aspergillus niger strain 294 and intended for use in eight food manufacturing processes, including baking, cereal-based processes, brewing, grain treatment for the production of starch and gluten fractions, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, distilled alcohol production, and wine and wine vinegar production.

After assessment, the expert panel concluded that, under the expected conditions of use (excluding distilled alcohol production), the risk of allergic reactions through dietary exposure cannot be excluded but is low. Based on the provided data, the panel determined that the food enzyme does not raise safety concerns under the intended conditions of use for adolescents, adults, and the elderly.

The food enzyme was considered free from viable cells of the production organism, and genotoxicity tests did not indicate a safety concern. The systemic toxicity was evaluated by conducting a repeated dose 90-day oral toxicity study in rats, which identified a no observed adverse effect level of 794 mg TOS/kg bw per day, the highest dose tested. The panel calculated the margin of exposure for each age group and found it to be within safe limits.

Dietary exposure to the food enzyme – total organic solids (TOS) – was estimated to be up to 5.706 mg TOS/kg body weight (bw) per day in European populations, excluding distilled alcohol production and grain treatment for the production of starch and gluten fractions, as residual amounts of TOS are removed during these processes. The panel also conducted a search for the similarity of the food enzyme's amino acid sequence to known allergens and found four matches.

The EFSA's opinion provides assurance on the safety of the food enzyme cellulase produced by Aspergillus niger strain 294 under the intended conditions of use for adolescents, adults, and the elderly, with a low likelihood of causing allergic reactions through dietary exposure.