On August 13, 2021, the European Food Safety Authority’s scientific opinions published a safety evaluation report on the Food enzyme catalase (hydrogen‐peroxide: hydrogen‐peroxide oxidoreductase; EC 18.104.22.168) produced from the genetically modified Aspergillus niger strain DP‐Azw58.
The assessment is summarized herein:
The food enzyme is considered free from viable cells of the production organism and its DNA.
It is intended to be used in egg processing.
Based on the maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1 μg TOS/kg body weight (bw) per day.
Genotoxicity tests did not indicate a safety concern and no observation on adverse effect level of 1,288 mg TOS/kg bw per day.
An amino acid sequence of the food enzyme to known allergens resulted in one match and was reviewed under the intended conditions of use. The risk of allergic sensitization and elicitation reactions by dietary exposure cannot be excluded but has a very low risk.
The food enzyme does not give rise to safety concerns under the intended conditions of use.