EU Safety Evaluation of Non-Genetically Modified Rhizomucor miehei Strain M19-21 for Production of Mucorpepsin

In a recent development, the European Union (EU) has conducted a safety evaluation of mucorpepsin, an enzyme produced by the non-genetically modified Rhizomucor miehei strain M19-21. This evaluation aimed to assess the safety of using this enzyme in the processing of dairy products, specifically cheese and fermented dairy products. The findings of the evaluation shed light on the potential risks and safety considerations associated with mucorpepsin.

Safety Evaluation and Expert Opinion:

A panel of experts assessed the safety of mucorpepsin under the intended conditions of use. The evaluation took into account the maximum use levels and estimated dietary exposure in European populations. The food enzyme was chemically modified to produce a thermolabile form and was considered free from viable cells of the production organism.

The evaluation highlighted that, based on the provided data, mucorpepsin does not give rise to safety concerns. Genotoxicity tests did not indicate any safety issues, and a repeated dose 90-day oral toxicity study in rats identified a no observed adverse effect level. The panel concluded that the estimated dietary exposure to mucorpepsin, compared to the highest dose tested, resulted in a sufficient margin of exposure.

Allergenic Potential:

The evaluation also addressed the allergenic potential of mucorpepsin. A search for the similarity of the amino acid sequence of the food enzyme to known allergens revealed matches to respiratory allergens and one match to a food allergen, specifically mustard. As a result, the panel emphasized that individuals sensitized to mustard proteins may have a risk of allergic reactions upon dietary exposure to mucorpepsin. However, further analysis and data availability would be required to fully assess the extent of this risk.

The EU's safety evaluation of mucorpepsin produced by the non-genetically modified Rhizomucor miehei strain M19-21 provides valuable insights into the safety considerations associated with this food enzyme. Under the intended conditions of use, the evaluation suggests that mucorpepsin does not raise significant safety concerns. However, individuals with mustard protein allergies should exercise caution when consuming products that may contain mucorpepsin. This evaluation contributes to the ongoing efforts to ensure the safety of food enzymes used in the production of dairy products.