,EFSA has published a scientific opinion on the safety of a food enzyme preparation containing cellulase, endo-1,3(4)-?-glucanase and endo-1,4-?-xylanase activities, produced using the non-genetically modified Trichoderma reesei strain AR-999. Based on the available data, the Panel concluded that the food enzyme does not give rise to safety concerns under its intended conditions of use.
Enzyme Composition and Production
The food enzyme preparation contains the following enzymatic activities:
Cellulase (EC 3.2.1.4)
Endo-1,3(4)-?-glucanase (EC 3.2.1.6)
Endo-1,4-?-xylanase (EC 3.2.1.8)
The enzymes are produced by AB-Enzymes GmbH using a non-genetically modified production strain. EFSA confirmed that the final product is free from viable cells of the production organism, in line with EU safety requirements for food enzymes.
Intended Uses and Dietary Exposure
The food enzyme is intended for use in 11 different food manufacturing processes. In three of these processes, residual food enzymetotal organic solids (TOS) are effectively removed during processing. Consequently, dietary exposure was calculated for the remaining eight processes.
Estimated dietary exposure: up to 4.031 mg TOS/kg body weight per day in European Unionan populations.
Toxicological Assessment
Genotoxicity: Standard genotoxicity tests did not indicate any safety concern.
Repeated dose toxicity: A 90-day oral toxicity study in rats was used to assess systemic toxicity.
NOAEL: 1000 mg TOS/kg bw per day, the highest dose tested.
When compared with the estimated dietary exposure, this resulted in a margin of exposure (MoE) of at least 248, which the Panel considered adequate to support safety under the proposed uses.
Allergenicity Assessment
A comparison of the amino acid sequences of the three enzymes with known allergens identified a match with one food allergen. As a result, EFSA concluded that the risk of allergic reactions upon dietary exposure cannot be excluded. However, taking into account the overall weight of evidence, this potential risk did not alter the Panels final safety conclusion.
Conclusion
EFSA concluded that the food enzyme preparation containing cellulase, endo-1,3(4)-?-glucanase and endo-1,4-?-xylanase, produced with the non-GM Trichoderma reesei strain AR-999, does not pose a safety concern when used as intended in food manufacturing processes.