Ensuring the Safety of Leucyl Aminopeptidase Produced by Genetically Modified Aspergillus oryzae Strain NZYM-BU: A Recent EU Assessment

In a recent development, the European Food Safety Authority (EFSA) has conducted an evaluation regarding the safety of leucyl aminopeptidase, an enzyme produced by a genetically modified Aspergillus oryzae strain known as NZYM-BU. The assessment aimed to determine the potential risks associated with the consumption of this enzyme, which is utilized in various food production processes. This article presents an overview of the EFSA's evaluation and its findings.

EFSA's Evaluation:

The EFSA's expert panel examined the safety of leucyl aminopeptidase produced by the genetically modified Aspergillus oryzae strain NZYM-BU. Following a thorough assessment, the panel concluded that the genetic modifications employed in the production of this food enzyme do not raise any safety concerns. Notably, the enzyme is devoid of viable cells from the production organism as well as its DNA.

Risk Assessment:

Under the anticipated conditions of use, the expert panel acknowledged that there is a low possibility of allergic reactions resulting from dietary exposure to the food enzyme. However, it is important to note that the risk of such reactions cannot be completely ruled out. Nevertheless, based on the data provided, the EFSA concluded that the intended use of this food enzyme does not pose any safety concerns.

Findings:

The dietary exposure to the food enzyme leucyl aminopeptidase, measured as TOS (total organic solids), was estimated to be up to 1.508 mg TOS/kg body weight per day in European populations. Genotoxicity tests conducted during the evaluation did not raise any safety concerns. Additionally, a 90-day oral toxicity study in rats revealed a no observed adverse effect level of 4,928 mg TOS/kg body weight per day, the highest dose tested. Comparing this level with the estimated dietary exposure, the EFSA derived a margin of exposure of at least 3,268, indicating a considerable safety margin.

In light of the EFSA's assessment, it has been determined that the production of leucyl aminopeptidase by the genetically modified Aspergillus oryzae strain NZYM-BU does not give rise to safety concerns under the intended conditions of use. While the possibility of allergic reactions cannot be completely excluded, the likelihood of such events occurring is low. This evaluation contributes to the ongoing efforts to ensure the safety of genetically modified food enzymes and provides valuable insights for regulatory decision-making.