U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. CPG Sec 555.800 Polysorbates 20, 40, 60, 65, 80, 85 - Common or Usual Names
  1. Search for FDA Guidance Documents

COMPLIANCE POLICY GUIDE (CPG)

CPG Sec 555.800 Polysorbates 20, 40, 60, 65, 80, 85 - Common or Usual Names February 1989

Final
Issued by:
Guidance Issuing Office
Human Foods Program
Office of Inspections and Investigations

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

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Back to Top