Safety evaluation of a food enzyme containing cellulase and endo-1,3(4)-β-glucanase activities from the non-genetically modified Trichoderma reesei strain DP-Nzc104.

Summary

The EFSA Panel on Food Enzymes evaluated the safety of a cellulase and endo-1,3(4)-β-glucanase enzyme preparation produced from non-genetically modified Trichoderma reesei for use in six food manufacturing processes. Genotoxicity testing showed no safety concern, and a 90-day rat study established a no observed adverse effect level of 1000 mg TOS/kg bw per day, yielding a margin of exposure of at least 1664 relative to estimated dietary exposure. Whilst sequence homology searches identified matches to known food and respiratory allergens, the Panel concluded the enzyme does not raise safety concerns under the intended conditions of use, though allergic reactions upon dietary exposure cannot be entirely excluded.

Regional applicability

This is a European Food Safety Authority safety assessment applied across European populations. The findings and approved conditions of use are directly applicable to United Kingdom food manufacturing and regulatory compliance, though post-Brexit, UK food law implementation may require separate national consideration.

Key measures

Estimated dietary exposure (0.601 mg TOS/kg body weight per day), no observed adverse effect level (1000 mg TOS/kg bw per day), margin of exposure (≥1664), genotoxicity test results, allergen sequence homology matches

Outcomes reported

Safety assessment of a cellulase and endo-1,3(4)-β-glucanase enzyme preparation for use in food manufacturing, including genotoxicity, systemic toxicity, and allergenicity evaluations. Dietary exposure was estimated and compared against toxicological findings.

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