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Safety evaluation of the food enzyme β-galactosidase from the non-genetically modified Papiliotrema terrestris strain AE-BLC.

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
Roos Y
Andryszkiewicz M
Cavanna D
Criado A
Liu Y
Lunardi S
Nielsen E
Nørby K
Chesson A
Source :
EFSA journal. European Food Safety Authority [EFSA J] 2024 Jan 12; Vol. 22 (1), pp. e8515. Date of Electronic Publication: 2024 Jan 12 (Print Publication: 2024).
Publication Year :
2024

Abstract

The food enzyme β-galactosidase (β-d-galactoside galactohydrolase; EC 3.2.1.23) is produced with the non-genetically modified Papiliotrema terrestris strain AE-BLC by Amano Enzyme Inc. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in the production of galacto-oligosaccharides (GOS) from lactose. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.441 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 1800 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 4082. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is low. 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.<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 :
1
Database :
MEDLINE
Journal :
EFSA journal. European Food Safety Authority
Publication Type :
Academic Journal
Accession number :
38222929
Full Text :
https://doi.org/10.2903/j.efsa.2024.8515