title European Food Safety Authority Deems Food Enzyme Endo-1,4-β-xylanase Safe for Use in Baking and Cereal-Based Processes

On July 12th, 2023, the European Food Safety Authority (EFSA) released an opinion on the safety evaluation of a food enzyme, endo-1,4-β-xylanase, which is produced by the non-genetically modified microorganism Aspergillus tubingensis strain LYX and intended for use in baking and cereal-based processes.

After assessment, the expert panel concluded that, under the expected conditions of use, 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.

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 227 mg TOS/kg bw per day, the highest dose tested. When compared with the estimated dietary exposure, this resulted in a margin of exposure of at least 2,142.

Dietary exposure to the food enzyme – total organic solids (TOS) – was estimated to be up to 0.106 mg TOS/kg body weight (bw) per day in European populations. The panel also conducted a search for the similarity of the food enzyme's amino acid sequence to known allergens and found no match.

The EFSA's opinion provides assurance on the safety of the food enzyme endo-1,4-β-xylanase produced by Aspergillus tubingensis strain LYX under the intended conditions of use.