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Safety evaluation of the food enzyme endo-polygalacturonase from the non-genetically modified Aspergillus tubingensis strain MUCL 55013.

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
Andryszkiewicz M
Fernàndez-Fraguas C
Kovalkovičová N
Liu Y
Lunardi S
Nielsen E
di Piazza G
Chesson A
Source :
EFSA journal. European Food Safety Authority [EFSA J] 2023 Nov 20; Vol. 21 (11), pp. e08397. Date of Electronic Publication: 2023 Nov 20 (Print Publication: 2023).
Publication Year :
2023

Abstract

The food enzyme endo-polygalacturonase ((1→4)-α-d-galacturonan glycanohydrolase (endo-cleaving); EC 3.2.1.15)) is produced with the non-genetically modified Aspergillus tubingensis strain MUCL 55013 by Soufflet Biotechnologies. The food enzyme is free from viable cells of the production organism. It is intended to be used in 10 food manufacturing processes: processing of fruits and vegetables for the production of juices, other fruit and vegetable products, wine, distilled spirits from wine, alcoholic beverages other than grape wine; processing of plant-derived products for the production of refined and unrefined sugar, edible oils from plants, green coffee beans by demucilation, coffee extracts and tea and other herbal and fruit infusions. Since residual amounts of total organic solids (TOS) are removed in three processes, dietary exposure was calculated only for the remaining seven food manufacturing processes. Exposure was estimated to be up to 7.834 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 a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 2,097 mg TOS/kg bw per day, the highest dose tested, resulting in a margin of exposure of at least 268. A search for the similarity of the amino acid sequence of the food enzyme to known allergens found 14 matches, one of which was to a food allergen. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, in particular for individuals sensitised to papaya, but that the risk will not exceed that of consumption of papaya. In addition, oral allergy reactions cannot be excluded in pollen-sensitised individuals. 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 /> (© 2023 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 :
21
Issue :
11
Database :
MEDLINE
Journal :
EFSA journal. European Food Safety Authority
Publication Type :
Academic Journal
Accession number :
38027442
Full Text :
https://doi.org/10.2903/j.efsa.2023.8397