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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2017]
[CITE: 21CFR172.834]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

Subpart I--Multipurpose Additives

Sec. 172.834 Ethoxylated mono- and diglycerides.

The food additive ethoxylated mono-and diglycerides (polyoxyethylene (20) mono- and diglycerides of fatty acids) (polyglycerate 60) may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive is manufactured by:

(1) Glycerolysis of edible fats primarily composed of stearic, palmitic, and myristic acids; or

(2) Direct esterification of glycerol with a mixture of primarily stearic, palmitic, and myristic acids;

to yield a product with less than 0.3 acid number and less than 0.2 percent water, which is then reacted with ethylene oxide.

(b) The additive meets the following specifications:

Saponification number, 65-75.

Acid number, 0-2.

Hydroxyl number, 65-80.

Oxyethylene content, 60.5-65.0 percent.

(c) The additive is used or intended for use in the following foods when standards of identity established under section 401 of the Act do not preclude such use:

Use Limitations
1. As an emulsifier in pan-release agents for and as a dough conditioner in yeast-leavened bakery productsNot to exceed levels required to produce the intended effects, total not to exceed 0.5 percent by weight of the flour used.
2. As an emulsifier in cakes and cake mixesNot to exceed 0.5 percent by weight of the dry ingredients.
3. As an emulsifier in whipped vegetable oil toppings and topping mixesNot to exceed 0.45 percent by weight of the finished whipped vegetable oil toppings.
4. As an emulsifier in icings and icing mixesNot to exceed 0.5 percent by weight of the finished icings.
5. As an emulsifier in frozen dessertsNot to exceed 0.2 percent by weight of the finished frozen desserts.
6. As an emulsifier in edible vegetable fat-water emulsions intended for use as substitutes for milk or cream in beverage coffeeNot to exceed 0.4 percent by weight of the finished vegetable fat-water emulsions.

(d) When the name "polyglycerate 60" is used in labeling it shall be followed by either "polyoxyethylene (20) mono-and diglycerides of fatty acids" or "ethoxylated mono- and diglycerides" in parentheses.

[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 37973, July 26, 1977; 50 FR 49536, Dec. 3, 1985]

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