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

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 com

SUBMITTER: EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) 

PROVIDER: S-EPMC10784851 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature