POLYSORBATE 65

Overview

Chemical Names
Mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Synonyms
Polysorbate 65
CAS number
9005-71-4
INS
436
Functional Class
Food Additives
EMULSIFIER
INS matches
436

Evaluations

Evaluation year: 2026

ADI:
Group ADI of 0-25 mg/kg bw as total polyoxyethylene (20) sorbitan esters

Comments:
JECFA considered that the toxicological data reviewed support the previously identified NOAEL of 2500 mg/kg bw per day, the highest dose tested in two long-term toxicity studies in rats, used to establish the group ADI of 0–25 mg/kg bw for the polysorbates. JECFA therefore confirmed the group ADI of 0–25 mg/kg bw for the polyoxyethylene (20) sorbitan monoesters of lauric, oleic, palmitic and stearic acid and the triester of stearic acid.
Intake:
The highest estimate of dietary exposure was 24.5 mg/kg bw per day, for children aged 1–17 years in Europe. This estimate is within the upper bound of the group ADI. JECFA concluded that the use of polysorbates in accordance with the current uses and maximum levels in the GSFA does not pose a safety concern
Meeting:
102
Specs Code:
No

Evaluation year: 1973

ADI:
0-25 mg/kg bw
Comments:
As total polyoxyethylene (20) sorbitan esters
Meeting:
17
Specs Code:
R (1981)
Report: 
NMRS 53/TRS 539-JECFA 17/20
Tox Monograph: 
FAS 5/NMRS 53A-JECFA 17/254
Specification: 
FAO Combined Compendium of Food Additive Specifications
Previous Years:
1981, FNP 19-JECFA 25/169; COMPENDIUM/1129. R 1973, FNP 4-JECFA 17/282. R 1963, NMRS 35/TRS 281-JECFA 7/138, NMRS 35/TRS 281-JECFA 7/140. 0-25 (CONDITIONAL, 25-50; AS TOTAL POLYOXYETHYLENE INTAKE). CO. N
1981, FNP 19-JECFA 25/169; COMPENDIUM/1129. R 1973, FNP 4-JECFA 17/282. R 1963, NMRS 35/TRS 281-JECFA 7/138, NMRS 35/TRS 281-JECFA 7/140. 0-25 (CONDITIONAL, 25-50; AS TOTAL POLYOXYETHYLENE INTAKE). CO. N