Assessing the Safety of Genetically Engineered Aspergillus oryzae Strain AR-183 for Endo-Polygalacturonase Production: Insights from EU Evaluation

The European Union (EU) recently conducted an assessment regarding the safety of utilizing a genetically modified microbial strain, Aspergillus oryzae AR-183, for the production of endo-polygalacturonase, a food enzyme. This article provides an overview of the EU evaluation's findings, highlighting the safety considerations surrounding this novel application.

On April 5, 2024, the EU's food safety agency released its opinion on the safety evaluation of endo-polygalacturonase, an enzyme used in food processing. This specific food enzyme is derived from the genetically modified Aspergillus oryzae strain AR-183 and is intended for incorporation into seven different food production processes.

Following a thorough assessment, a panel of experts concluded that under the anticipated conditions of use, the utilization of this food enzyme does not raise safety concerns. The evaluation considered both the previously assessed manufacturing processes and two additional processes requested by the applicant. The food enzyme's safety evaluation was updated accordingly, encompassing a total of seven food manufacturing processes.

In the evaluation, it was noted that the food enzyme endo-polygalacturonase, produced by AB ENZYMES GmbH using the genetically modified Aspergillus oryzae strain AR-183, did not give rise to safety concerns in five previously evaluated food manufacturing processes. As for the remaining four processes, dietary exposure to the food enzyme-total organic solids (TOS) was estimated, with a maximum exposure of 0.087 mg TOS/kg body weight per day in European populations.

Considering the highest dose tested (NOAEL) reported in the previous opinion (1000 mg TOS/kg bw per day), a margin of exposure of at least 11,494 was derived by the panel. Based on the data provided for the previous evaluation and the revised margin of exposure, it was concluded that the use of this food enzyme does not pose safety concerns under the revised intended conditions of use.

The EU evaluation of the safety of utilizing genetically engineered Aspergillus oryzae strain AR-183 for the production of endo-polygalacturonase has indicated that this food enzyme is safe for use in various food manufacturing processes. The assessment considered the potential risks associated with dietary exposure and concluded that under the specified conditions, there are no significant safety concerns.

The evaluation conducted by the EU's food safety agency provides valuable insights into the safety considerations surrounding the use of genetically modified microbial strains in food production. As the global regulatory landscape continues to evolve, such assessments play a crucial role in ensuring the safety of novel food enzymes and fostering consumer confidence in the food industry.