European Union Assesses the Safety of Mucorpepsin Produced by Non-Genetically Modified Rice Black Root Mold Strain FRO

The European Union (EU) recently conducted an evaluation to assess the safety of mucorpepsin, an enzyme produced by the non-genetically modified rice black root mold strain FRO. The assessment aimed to determine the potential risks associated with the use of this enzyme in food manufacturing processes. This article presents the key findings and conclusions of the EU's safety evaluation.

The European Food Safety Authority (EFSA) released its opinion on the safety evaluation of mucorpepsin on January 19, 2024. Mucorpepsin is a food enzyme derived from the non-genetically modified Rhizomucor miehei strain FRO, and it is primarily used in the production of cheese, edible rennet casein, and fermented dairy products.

After a thorough assessment, the expert panel concluded that under the anticipated conditions of use, the risk of allergic reactions resulting from dietary exposure to this food enzyme is considered low, except for individuals sensitized to mustard proteins. The evaluation took into account the possibility of allergic reactions but determined that the likelihood is minimal. The EFSA identified a margin of exposure of at least 27,778, indicating a significant safety margin.

The food enzyme mucorpepsin is produced by DSM Food Specialties B.V., and it does not contain viable cells of the production organism. The EFSA estimated that the dietary exposure to mucorpepsin for European populations is up to approximately 0.072 mg total organic solids (TOS) per kilogram of body weight per day. Genotoxicity tests conducted on the enzyme did not raise any safety concerns.

To assess systemic toxicity, a 90-day oral toxicity study was conducted on rats, with the highest tested dose being 2000 mg TOS/kg bw per day. The study revealed no observed adverse effects at this dose level. Additionally, the amino acid sequence of the food enzyme was compared to known allergens, and five matches were found. However, the risk of allergic reactions from dietary exposure to this food enzyme is considered low, except for individuals sensitized to mustard proteins.

Based on the comprehensive evaluation and the provided data, the EFSA concluded that the use of mucorpepsin in food manufacturing processes, as intended, does not raise any safety concerns. It is important to note that this evaluation specifically pertains to the non-genetically modified rice black root mold strain FRO and its production of mucorpepsin.

In conclusion, the recent safety evaluation conducted by the European Union on the non-genetically modified rice black root mold strain FRO-produced mucorpepsin reaffirms its safety for use in the production of various dairy products. With a low risk of allergic reactions and a significant safety margin, this food enzyme can continue to contribute to the food manufacturing industry while ensuring consumer safety.