Polysorbate 20, CAS# 9005-64-5, is a polysorbate surfactant manufactured through chemical synthesis, available as light yellow to orange viscous liquid. Polysorbate 20 is widely used as emulsifier. It is affirmed by US FDA as GRAS(generally recognized as safe) and widely accepted as safe food additive in many countries with E number E432.
No significant side effects reported.
Ingestion of Polysorbate 20 in large quantity may hurt our health, please follow the guideline of using Polysorbate 20: ADI 0-25 mg/kg bw
Special groups refer to newborns, children, pregnant and any other applicable vulnerable groups.
There is no evidence that Polysorbate 20 could have any negative effects on these vulnerable groups. It should be safe to use Polysorbate 20 in food for newborns and pregnant. However, we still recommend consumers to consult professionals before using large quantity of Polysorbate 20 for long period in food for newborns or pregnant.
Generally recognized as safe(GRAS) is a FDA designation that a specific substance or ingredient is generally considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements. Polysorbate 20 is considered safe by FDA according to existing data and granted GRAS status.
No breaking news or public health crises reported about Polysorbate 20 reported up to now.
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1. The effects of membrane filters used in biopharmaceutical processes on the concentration and composition of polysorbate 20.[Biotechnol Prog. 2013 Nov-Dec]
Author: Lei M, Hewitt D, Cornell C, Skidmore K, Kao YH, Sugahara J, Beane D, Ji J.
2. Characterization and stability study of polysorbate 20 in therapeutic monoclonal antibody formulation by multidimensional ultrahigh-performance liquid chromatography-charged aerosol detection-mass spectrometry.[Anal Chem. 2014 May 20]
Author: Li Y, Hewitt D, Lentz YK, Ji JA, Zhang TY, Zhang K.
3. The effects of membrane filters used in biopharmaceutical processes on the concentration and composition of polysorbate 20.[Biotechnol Prog. 2013 Nov-Dec]
Author: Lei M, Hewitt D, Cornell C, Skidmore K, Kao YH, Sugahara J, Beane D, Ji J.
4. Alcohols Effect on Critic Micelle Concentration of Polysorbate 20 and Cetyl Trimethyl Ammonium Bromine Mixed Solutions.[J Surfactants Deterg. 2013 Jul]
Author: Sidim T, Acar G.