European Union Evaluates Safety of a Thermophilic Bacterial Protease

In a recent development, the European Union (EU) has conducted an assessment to evaluate the safety of a thermophilic bacterial protease. The evaluation was carried out by the European Food Safety Authority (EFSA), and the findings were published on the Foodmate website. This article provides an overview of the assessment and its implications for food production.

On February 26, 2024, the EFSA released its opinion on the safety evaluation of a food enzyme called thermolysin. This specific food enzyme is derived from the non-genetically modified Anoxybacillus caldiproteolyticus strain AE-TP, and it is intended for use in eight different food manufacturing processes.

After a comprehensive evaluation, the expert panel concluded that under the expected conditions of use, the thermolysin enzyme does not pose any safety concerns. Although the risk of allergic reactions through dietary exposure cannot be entirely excluded, the likelihood of such reactions is considered to be low. The EFSA panel based its conclusions on various factors, including dietary exposure estimates and genotoxicity tests, which did not indicate any safety concerns.

The evaluation also assessed the potential for allergic reactions by comparing the amino acid sequence of the food enzyme to known allergens. However, no matches were found, further supporting the conclusion that the risk of allergic reactions is minimal.

The EFSA panel estimated that the dietary exposure to thermolysin in European populations could be up to 0.973 mg TOS/kg body weight per day. To determine the systemic toxicity, a 90-day oral toxicity study was conducted on rats. Based on the study results, a no observed adverse effect level of 700 mg TOS/kg body weight per day was identified, resulting in a significant margin of exposure.

In summary, the recent safety evaluation conducted by the EU's EFSA on the thermophilic bacterial protease, thermolysin, concluded that it does not give rise to safety concerns under the intended conditions of use. While a minimal risk of allergic reactions through dietary exposure cannot be completely ruled out, the likelihood of such reactions is considered to be low. These findings provide valuable insights for the food industry and regulatory authorities regarding the safety of using thermolysin as a food enzyme in various production processes.