U.S. · Food additives · 21 CFR 172.840
Polysorbate 80 in food.
21 CFR 172.840 permits polysorbate 80 in food for listed uses, each with its own maximum, such as 0.1 percent in frozen desserts and 500 ppm in pickles.
21 CFR 172.840 says polysorbate 80 (polyoxyethylene (20) sorbitan monooleate) may be safely used in food under prescribed conditions: 0.1 percent of the finished frozen dessert as an emulsifier, 500 parts per million in pickles and pickle products, up to 1 percent of the weight of finished shortening or oil, 0.4 percent in whipped edible oil topping, 0.082 percent (dry weight) in gelatin desserts, and other listed uses, each with its own limit. The additive and premix labels must name it and the concentration, with directions that meet the limits.
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What 21 CFR 172.840 covers
Section 172.840 sits in part 172 of Title 21, "Food additives permitted for direct addition to food for human consumption." It says the food additive polysorbate 80, "which is a mixture of polyoxyethylene ethers of mixed partial oleic acid esters of sorbitol anhydrides and related compounds, may be safely used in food in accordance with the following prescribed conditions." The eCFR version on this page is current through October 29, 2026, and its history runs from 42 FR 14491 (March 15, 1977) to 85 FR 72907 (November 16, 2020). The page reports the printed text and says nothing about FDA statements outside it.
How it is made and what it must meet: (a) and (b)
Paragraph (a) describes manufacture: oleic acid (usually with associated fatty acids) is reacted with sorbitol to give a product with a maximum acid number of 7.5 and a maximum water content of 0.5 percent, which is then reacted with ethylene oxide. Paragraph (b) lists the specifications: saponification number 45-55, acid number 0-2, hydroxyl number 65-80, and oxyethylene content 65 percent to 69.5 percent.
Permitted uses and maximum amounts: paragraph (c)
| Use | Maximum | Paragraph |
|---|---|---|
| Emulsifier in ice cream, frozen custard, ice milk, fruit sherbet, nonstandardized frozen desserts (alone or with polysorbate 65) | 0.1 percent of the finished frozen dessert | (c)(1) |
| Yeast-defoamer formulations | 4 percent of the finished defoamer; 4 ppm in the yeast | (c)(2) |
| Solubilizing and dispersing agent in pickles and pickle products | 500 ppm | (c)(3) |
| Solubilizer in vitamin-mineral preparations | 175 mg (with calcium caseinate, no fat-soluble vitamins), 300 mg (fat-soluble vitamins, no caseinate), 475 mg (both), per recommended daily dose | (c)(4) |
| Surfactant in coarse crystal sodium chloride | 10 ppm in the finished salt | (c)(5) |
| Emulsifier for edible fats and oils in special dietary foods | Directions limiting intake to 360 mg per day | (c)(6) |
| Dispersing agent for dill oil in canned spiced green beans | 30 ppm | (c)(7) |
| Emulsifier in shortenings and edible oils | 1 percent of finished weight alone; combined with polysorbate 60, no more than 1 percent of each and 1 percent total; premix concentrates may exceed it with the paragraph (d) labeling | (c)(8) |
| Emulsifier in whipped edible oil topping | 0.4 percent of finished weight for the additive or additives together | (c)(9) |
| Wetting agent in poultry scald water, followed by potable water rinse | 0.0175 percent | (c)(10) |
| Dispersing agent in gelatin desserts and mixes | 0.082 percent on a dry-weight basis | (c)(11) |
| Adjuvant in herbicide and plant-growth regulator dilutions | Residues exempt from a tolerance; exempt from (d)(1) when so used | (c)(12) |
| Defoaming agent in creaming mixture for cottage cheese | 0.008 percent by weight of finished product | (c)(13) |
| Surfactant and wetting agent for colors in barbecue sauce | 0.005 percent by weight of the sauce | (c)(14) |
Labeling: paragraph (d)
To assure safe use, the label of the additive and of any intermediate premixes must bear the name of the additive and a statement of the concentration or strength of the additive in any intermediate premix. The label or labeling must carry adequate directions to produce a final product that complies with the limits in paragraph (c).
Worked example
A gelatin dessert mix is made with 0.08 percent polysorbate 80 on a dry-weight basis. The (c)(11) limit is 0.082 percent, so 0.08 is within it and 0.09 would not be. A pickle brine at 400 ppm is under the 500 ppm limit for (c)(3). An ice cream at 0.1 percent polysorbate 80 alone reaches the 0.1 percent ceiling; if polysorbate 65 is also used, the section says the maximum applies to the additives "alone or in combination," so the two together may not exceed 0.1 percent. The tool compares one amount with one row at a time and expresses each result in the unit the section uses.
Limits of this page
This page reports a regulation. It does not say whether a product is a given food category, whether standards of identity allow the use, or whether polysorbate 80 is advisable for any person. The ingredient name on a label is a separate question under 101.4. The tool does not convert between percent, ppm and milligrams.
Sources
Sources opened and read November 2, 2026.
Frequently asked questions
What is polysorbate 80 under the FDA regulation?
Polyoxyethylene (20) sorbitan monooleate, a mixture of polyoxyethylene ethers of mixed partial oleic acid esters of sorbitol anhydrides and related compounds (21 CFR 172.840).
What is the limit in frozen desserts?
0.1 percent of the finished frozen dessert, alone or combined with polysorbate 65 (172.840(c)(1)).
What is the limit in pickles?
500 parts per million (172.840(c)(3)).
What limit applies in shortening and oils?
1 percent of the weight of the finished shortening or oil when used alone (172.840(c)(8)(i)).
What must the additive label say?
The name of the additive and the concentration in any intermediate premix, with directions that produce a compliant final product (172.840(d)).
What specifications must the additive meet?
Saponification number 45-55, acid number 0-2, hydroxyl number 65-80, oxyethylene 65 to 69.5 percent (172.840(b)).
Does this page say polysorbate 80 is safe?
It reports the printed regulation only. For health questions ask a clinician; for current regulatory status check FDA.
Not legal or compliance advice
This page is general information drawn from the sources listed, not legal, tax or compliance advice, and it is not run by any government agency. Rules, forms and dates change and your agency, base jurisdiction or enforcement officer decides your case, so confirm with the office named on this page before you rely on it. Everything runs in your browser; nothing you enter is sent anywhere.