Safety evaluation of the thermolabile form of the food enzyme mucorpepsin from Rhizomucor miehei strain MMR 164

• Published in: EFSA journal 2022-08, Vol.20 (8), p.e07460-n/a
• Main Authors: Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Glandorf, Boet, Herman, Lieve, Aguilera, Jaime, Andryskiewicz, Magdalena, Arcella, Davide, Kovalkovičová, Natália, Liu, Yi, Maia, Joaquim, Rainieri, Sandra, Chesson, Andrew
• Format: Article
• Language: English
• Subjects: Allergens; Amino acid sequence; Amino acids; Aspartic endopeptidase; Body weight; Dosage; EC 3.4.23.23; Enzymes; Exposure; Food; Food additives; Food allergies; food enzyme; Food safety; Genetic modification; Genetically engineered microorganisms; Genotoxicity; Manufacturing; microbial rennet; Microorganisms; Milk; mucorpepsin; Mustard; non‐genetically modified microorganism; Nutrition; Organic solids; Proteins; Rhizomucor miehei; Safety; Scientific Opinion; Toxicity
• ISSN: 1831-4732; 1831-4732; 2314-9396
• DOI: 10.2903/j.efsa.2022.7460

The food enzyme mucorpepsin (aspartic endopeptidase, EC 3.4.23.23) is produced with the non‐genetically modified microorganism Rhizomucor miehei strain MMR 164. The enzyme is chemically modified by DuPont Nutrition Biosciences (now IFF) to produce a thermolabile form. The food enzyme is free from viable cells of the production organism. It is intended to be used in milk processing for cheese production. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.98 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1,320 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 1,300. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and five matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but is considered low except for individuals sensitised to mustard proteins, but this risk will not exceed that of mustard consumption. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.