Ensuring the Safety of Glutaminase Produced by Genetically Modified Bacillus licheniformis Strain NZYM-JQ: EU Assessment

In a recent development, the European Union's food safety authority has issued an opinion regarding the safety assessment of a specific enzyme called glutaminase. This enzyme is produced by a genetically modified strain of Bacillus licheniformis known as NZYM-JQ. The evaluation aimed to determine the safety of using this enzyme in food production processes.

Safety Evaluation Findings:

The expert panel conducted a thorough evaluation of the glutaminase enzyme and concluded that, under the intended conditions of use, it does not pose any safety concerns. The genetically modified production strain, NZYM-JQ, met the requirements for the qualified presumption of safety (QPS). The enzyme itself is free from viable cells of the production organism and its DNA. Therefore, toxicological studies were deemed unnecessary.

Risk of Allergic Reactions:

During the evaluation, the panel identified a potential risk of allergic reactions for individuals who are sensitized to birch and oak pollen. A search for amino acid sequence similarity revealed a match with a pollen allergen. While the risk of allergic reactions cannot be completely excluded, it is important to note that this risk is associated with individuals already sensitized to specific allergens.

Food Enzyme Utilization:

The glutaminase enzyme is intended for use in six different food manufacturing processes. Its dietary exposure was estimated to be up to 0.148 mg TOS/kg body weight per day in European populations. Based on the QPS status of the production strain and the absence of concerns related to the manufacturing process, the panel concluded that the use of this enzyme does not give rise to safety concerns.

The European Union's assessment of the safety of glutaminase produced by the genetically modified Bacillus licheniformis strain NZYM-JQ has determined that, under the intended conditions of use, the enzyme does not pose any safety concerns. However, individuals who are sensitized to birch and oak pollen may have a potential risk of allergic reactions. It is essential to consider this information when utilizing the enzyme in food production processes.