Back to Search Start Over

Safety evaluation of the food enzyme α-amylase from the non-genetically modified Aspergillus oryzae strain NZYM-NA.

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
Kovalkovičová N
Liu Y
Lunardi S
Ferreira de Sousa R
Chesson A
Source :
EFSA journal. European Food Safety Authority [EFSA J] 2023 Mar 30; Vol. 21 (3), pp. e07912. Date of Electronic Publication: 2023 Mar 30 (Print Publication: 2023).
Publication Year :
2023

Abstract

The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified Aspergillus oryzae strain NZYM-NA by Novozymes A/S. It was considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes: starch processing for the production of glucose and maltose syrups and other starch hydrolysates, distilled alcohol production, brewing processes, baking processes, cereal-based processes, plant processing for production of dairy analogues and fruit and vegetable processing for juice production. Since residual amounts of food enzyme-total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups and distillation, dietary exposure was not calculated for these processes. For the remaining five food manufacturing processes, dietary exposure was estimated to be up to 0.134 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 1,862 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 13,896. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production), the risk of allergic reactions by dietary exposure 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 /> (© 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 :
3
Database :
MEDLINE
Journal :
EFSA journal. European Food Safety Authority
Publication Type :
Academic Journal
Accession number :
37009441
Full Text :
https://doi.org/10.2903/j.efsa.2023.7912