The European Food Safety Authority has updated its safety assessment of the food enzyme triacylglycerol lipase (EC 3.1.1.3), produced using a genetically modified strain of Aspergillus oryzae (NZYM-FL) by Novozymes A/S, following a request to extend its use across additional food manufacturing processes.
The enzyme had previously been evaluated and deemed safe for use in two food manufacturing processes. The current reassessment expands its intended application to a total of eight processes, reflecting broader industrial use.
The processess are as follows: The food enzyme is intended for use across eight food manufacturing processes at updated levels, including
1.dairy (milk: 216 mg TOS/kg RM)
2.eggs (whole egg: 55.2 vs 184 previously)
3.cereals and baked products (flour: 31.3)
4.distilled alcohol (cereals: 1.2)
5.plant-based analogues (cereals/nuts/seeds: 3.1)
6.yeast products (292), and fats and oils processing (degumming of crude fats/oils).
EFSAs evaluation distinguishes between processes based on residual enzyme presence. In two processes, the food enzyme-total organic solids (TOS) are effectively removed, eliminating the need for dietary exposure assessment. For the remaining six processes, where residual TOS may be present, EFSA conducted a detailed exposure analysis.
The estimated dietary exposure to the enzyme was calculated at up to 0.494 mg TOS/kg body weight per day across European population groups. This exposure level was compared against the previously established No Observed Adverse Effect Level (NOAEL) of 340 mg TOS/kg body weight per day (mid-dose from toxicological studies).
From this, EFSA derived a Margin of Exposure (MoE) of at least 688, which is considered sufficiently high to indicate an adequate safety margin under the intended conditions of use.The Panel integrated these updated exposure estimates with prior toxicological and safety data and concluded that the enzyme does not pose safety concerns when used across the revised range of applications.
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