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Sec. 555.800 Polysorbates 20, 40, 60, 65, 80, 85 - Common or Usual Names (CPG 7120.09)

BACKGROUND:

*By an order published in the Federal Register of May 7, l969 (34 F.R. 7372), revisions were made in the applicable food additives regulations designating each of the above-named substances by its common or usual name without reference to the chemical name, except where it is desirable for informational purposes to include initially the chemical name as a synonym.*

POLICY:

The following is a listing of recognized common or usual names and the corresponding chemical synonyms of the polysorbates:

Common or Usual Name Chemical Name

Polysorbate 20 polyoxyethylene (20) sorbitan monolaurate

Polysorbate 40 poloxyethylene (20) sorbitan monopalmitate

Polysorbate 60 polyoxyethylene (20) sorbitan monostearate

Polysorbate 65 polyoxyethylene (20) sorbitan tristearate

Polysorbate 80 polyoxyethylene (20) sorbitan monooleate

Polysorbate 85 polyoxyethylene (20) sorbitan trioleate

The common or usual names of these chemicals should be used for purposes of label declaration of ingredients in accordance with the provisions of section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act. The chemical name may be used in addition to, but not in lieu of, the common or usual name.

*Material between asterisks is new or revised.*

Issued: 12/3/73
Reissued: 10/1/80
Revised: 2/1/89