Ensuring the Safety of Bacillolysin, a Bacillus Metalloprotease Produced by Non-Genetically Modified Strain DP-Cyb74: EU Assessment

In a recent development, the European Union (EU) has conducted a comprehensive safety evaluation of bacillolysin, a food enzyme produced by the non-genetically modified Bacillus amyloliquefaciens strain DP-Cyb74. The assessment aimed to determine the safety of this enzyme, which plays a role in various food manufacturing processes. This article provides an overview of the EU assessment and its findings regarding the safety of bacillolysin.

Key Findings:

Following a thorough evaluation, an expert panel concluded that under the anticipated conditions of use, the risk of allergic reactions due to dietary exposure to bacillolysin is minimal. The data provided suggested that this food enzyme does not give rise to safety concerns. It is worth noting that although the possibility of allergic reactions cannot be completely ruled out, it is considered unlikely.

Production and Intended Use:

Bacillolysin is produced by the non-genetically modified Bacillus amyloliquefaciens strain DP-Cyb74. This strain has met all the requirements for the qualified presumption of safety (QPS) approach to safety assessment. The food enzyme is intended for use in six different food manufacturing processes.

Evaluation Process:

The EU assessment involved a search for similarities between the amino acid sequence of the food enzyme and known allergens. No matches were found, indicating a reduced likelihood of allergenicity. As the production strain qualified for the QPS approach and no concerns were identified during the production process, the expert panel determined that no additional toxicological studies were necessary, apart from the assessment of allergenicity.

Based on the evaluation conducted by the EU, bacillolysin produced by the non-genetically modified strain DP-Cyb74 is considered safe for its intended use. While a low risk of allergic reactions remains, the data provided supports the conclusion that this food enzyme does not pose safety concerns under the anticipated conditions of use.

By ensuring the safety of food enzymes like bacillolysin, regulatory bodies like the EU play a crucial role in maintaining consumer confidence and upholding high standards of food safety within the industry.