LIPASE from FUSARIUM HETEROSPORUM expressed in OGATAEA POLYMORPHA

Overview

Chemical Names
Triacylglycerol acylhydrolase
Synonyms
Triglyceride lipase; tributyrase; butyrinase; glycerol ester hydrolase; tributyrinase; triacylglycerol ester hydrolase
CAS number
9001-62-1
Functional Class
Food Additives
ENZYME_PREPARATION

Evaluations

Evaluation year: 2015

ADI:
NOT SPECIFIED

Comments:
The Committee established an ADI “not specified” for lipase from F. heterosporum expressed in O. polymorpha when used in the applications specified and in accordance with good manufacturing practice.
Intake:
An estimate of the theoretical dietary exposure to this lipase enzyme preparation was made by the Committee based on the level of TOS in the lipase enzyme preparation and its maximum use levels in bakery products, pasta and noodles (44 mg TOS/kg flour) and egg yolk (220 mg TOS/kg egg) and in the degumming of edible oil (22 mg TOS/kg crude oil). The combination of these maximum levels with per capita food consumption data from the USA (supplied by the sponsor) or from the GEMS/Food cluster diets results in a potential total dietary exposure of 0.5 mg TOS/kg bw per day for a 60 kg individual.
Meeting:
80
Specs Code:
N
Report: 
TRS 995-JECFA 80/16
Tox Monograph: 
FAS 71-JECFA 80/27
Specification: 
FAO JECFA Monographs 17-JECFA 80/23

Toxicological study

Pivotal Study:
No treatment-related adverse effects were seen at the highest dose tested (669 mg TOS/kg bw per day) in the 13-week study of oral toxicity in rats.
Animal Specie:
Rat
NOAEL:
669 mg TOS/kg bw per day