Safety evaluation of the food enzyme endo-polygalacturonase from the non-genetically modified Rhizopus oryzae strain MC3-3-9.

Summary

This European Food Safety Authority safety evaluation of endo-polygalacturonase produced from non-genetically modified Rhizopus oryzae strain MC3-3-9 concludes that the enzyme does not give rise to safety concerns under intended conditions of use in four food manufacturing processes. The assessment incorporated genotoxicity testing, 90-day rat toxicity studies, and allergenicity screening, establishing a margin of exposure of at least 2265 between the estimated dietary exposure and the no observed adverse effect level. The Panel noted that whilst allergen homology matches were identified, the risk of allergic reactions upon dietary exposure cannot be entirely excluded.

Regional applicability

This is a European Food Safety Authority assessment directly applicable to food safety policy and authorisation of food enzymes within the European Union and associated regions. The dietary exposure calculations and safety conclusions are based on European population exposure data and would inform UK food enzyme approval frameworks, particularly relevant post-Brexit for any continued harmonisation with EFSA standards.

Key measures

No observed adverse effect level (NOAEL) of 872 mg total organic solids (TOS)/kg body weight per day; dietary exposure up to 0.385 mg TOS/kg bw per day; margin of exposure; genotoxicity test results; allergen homology matches

Outcomes reported

The study assessed the safety of endo-polygalacturonase food enzyme through genotoxicity testing, repeated-dose 90-day rat toxicity studies, and allergenicity screening. A margin of exposure of at least 2265 was calculated compared with estimated dietary exposure in European populations.

Topic tags