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Safety evaluation of the food enzyme glucan 1,4-α-glucosidase from the non-genetically modified <i>Aspergillus niger</i> strain AGME 1415.


ABSTRACT: The food enzyme glucan 1,4-α-glucosidase (4-α-d-glucan α-glucohydrolase; EC 3.2.1.3) is produced with the non-genetically modified Aspergillus niger strain AGME 1415 by ENMEX SA de CV, a Kerry Company. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in two food manufacturing processes, dietary exposure was calculated only for the remaining five processes. It was estimated to be up to 7.143 mg TOS/kg body weight 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 identi

SUBMITTER: EFSA Panel on Food Enzymes (FEZ) 

PROVIDER: S-EPMC11976454 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature