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Safety evaluation of the food enzyme mucorpepsin from the non-genetically modified Rhizomucor miehei strain LP-N836.

Authors :
Lambré C
Barat Baviera JM
Bolognesi C
Cocconcelli PS
Crebelli R
Gott DM
Grob K
Lampi E
Mengelers M
Mortensen A
Rivière G
Steffensen IL
Tlustos C
Van Loveren H
Vernis L
Zorn H
Herman L
Roos Y
Aguilera J
Andryszkiewicz M
Fernàndez-Fraguas C
Kovalkovicova N
Liu Y
Lunardi S
di Piazza G
Chesson A
Source :
EFSA journal. European Food Safety Authority [EFSA J] 2024 Mar 06; Vol. 22 (3), pp. e8631. Date of Electronic Publication: 2024 Mar 06 (Print Publication: 2024).
Publication Year :
2024

Abstract

The food enzyme mucorpepsin (EC 3.4.23.23) is produced with the non-genetically modified Rhizomucor miehei strain LP-N836 by Meito Sangyo Co., Ltd. The native enzyme can be chemically modified to produce a more thermolabile form. The food enzyme is free from viable cells of the production organism. It is intended to be used in the processing of dairy products for the production of cheese and fermented dairy products. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.108 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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 95 mg TOS/kg bw per day, the mid-dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 880. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and four matches with respiratory allergens and one with a food allergen (mustard) were found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to mustard proteins, cannot be excluded. Based on the data provided, the Panel concluded that both the native and thermolabile forms of this food enzyme do not give rise to safety concerns under the intended conditions of use.<br />Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu.<br /> (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Details

Language :
English
ISSN :
1831-4732
Volume :
22
Issue :
3
Database :
MEDLINE
Journal :
EFSA journal. European Food Safety Authority
Publication Type :
Academic Journal
Accession number :
38450083
Full Text :
https://doi.org/10.2903/j.efsa.2024.8631