Ensuring the Safety of Bacillus Subtilisin Protease Produced by Genetically Modified Bacillus licheniformis NZYM-CB: EU Evaluation

In a recent development, the European Union's food safety authority has conducted a safety assessment regarding the Bacillus subtilisin protease produced by the genetically modified strain NZYM-CB of Bacillus licheniformis. This evaluation aimed to determine the safety of this food enzyme, which is used in various food production processes. The assessment considered potential risks and allergic reactions associated with its consumption.

Overview of the EU Evaluation:

On April 5, 2024, the European Union's food safety authority released its opinion on the safety evaluation of the Bacillus subtilisin protease. The enzyme is derived from the genetically modified strain NZYM-CB of Bacillus licheniformis and is intended for use in six different food manufacturing processes. The expert panel conducted a thorough assessment to evaluate the potential risks posed by the enzyme.

Safety Findings:

Based on the evaluation, the expert panel concluded that under the expected conditions of use, there is a potential risk of allergic reactions, particularly for individuals sensitive to melon and pomegranate. However, this risk does not exceed the risk associated with consuming melon or pomegranate directly. The data provided indicated that this food enzyme does not give rise to safety concerns when used as intended.

Genetic Modifications and Safety:

The genetically modified Bacillus licheniformis strain NZYM-CB used to produce the protease does not raise any safety concerns. The modifications made to the strain were thoroughly assessed, and it was determined that they do not pose risks to consumer safety. The food enzyme is considered free from viable cells of the production organism and its DNA, further ensuring its safety.

Allergy Risk Assessment:

In the evaluation, a search for similarities between the amino acid sequence of the food enzyme and known allergens was conducted. The analysis revealed 20 matches, including two food allergens (melon and pomegranate). Therefore, individuals with sensitivities to melon and pomegranate may have a potential risk of allergic reactions upon dietary exposure to the enzyme.

The EU evaluation of the Bacillus subtilisin protease produced by the genetically modified strain NZYM-CB of Bacillus licheniformis confirms its safety under the anticipated conditions of use. While there is a potential risk of allergic reactions for individuals sensitive to melon and pomegranate, this risk is not higher than that associated with consuming the respective fruits directly. The thorough assessment of genetic modifications and safety considerations ensures the suitability of this food enzyme for various food production processes.