EU Warns New Food Enzymes May Trigger Health Crisis, Intake Exceeds Limits by 333 Times!

On October 25, 2024, the European Food Safety Authority issues an opinion on the safety evaluation of a food enzyme containing four enzyme activities. It is known that this food enzyme contains four activities of endo-poly galacturonase, pectin esterase, pectin lyase and non-reducing terminal α-L-arabinofuranoglycosidase. It is produced by Aspergillus Niger strain PEC and is designed to be used in seven food production processes.

After the assessment, the panel concluded that the food enzyme did not raise safety concerns under the intended conditions of use. Part of the original report:

The food enzyme has four stated activities: cohesive galacturonase ((1-4) -α-D-galacturonoglycan hydrolase (endonuclease); EC 3.2.1.15), pectin esterase (pectin pectin hydrolase; EC 3.1.1.11), pectin lyase ((1-4) -6-O-methyl-α-D-galactosidase lyase; EC 4.2.2.10) and non-reducing terminal α-L-arabfurfural sidase (α-L-arabfurfural side non-reducing terminal α-L-arabfurfural sidase; EC 3.2.1.55). It is produced by DSM Food Specialties B.V. using the non-transgenic Aspergillus Niger strain PEC. The food enzyme was previously assessed for safety and EFSA concluded that the food enzyme does not raise safety concerns when used in the manufacturing of three food products. Subsequently, the applicant requested that its use be extended to include four additional processes. In this assessment, EFSA updated the safety assessment of this food enzyme for use in a total of seven food manufacturing processes. Because food enzymes-total organic solids (TOS) were removed from the final food during one food production process, dietary exposure to TOS was only estimated for the remaining six food enzymes-total organic solids (TOS). The calculated dietary exposure in European populations is as high as 0.612 mg TOS/kg body weight (bw). When combined with previously reported levels of unobserved adverse effects (204 mg tols/kg body weight per day, the highest dose tested), the panel arrived at an exposure margin of at least 333. Based on previous assessments, evaluation of new data, and revised exposure limits, the panel concluded that the food enzyme does not raise safety concerns under the revised intended conditions of use.