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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: 21CFR172.811]



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. 172.811 Glyceryl tristearate.

The food additive glyceryl tristearate may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive (CAS Reg. No. 555-43-1) is prepared by reacting stearic acid with glycerol in the presence of a suitable catalyst.

(b) The food additive meets the following specifications:

Acid number: Not to exceed 1.0.

Iodine number: Not to exceed 1.0.

Saponification number: 186-192.

Hydroxyl number: Not to exceed 5.0.

Free glycerol content: Not to exceed 0.5 percent.

Unsaponifiable matter: Not to exceed 0.5 percent.

Melting point (Class II): 69 deg. C-73 deg. C.

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

Uses Limitations
1. As a crystallization accelerator in cocoa products, in imitation chocolate, and in compound coatingsNot to exceed 1 percent of the combined weight of the formulation.
2. As a formulation aid as defined in 170.3(o)(14) of this chapter, lubricant and release agent as defined in 170.3(o)(18) of this chapter, and surface-finishing agent as defined in 170.3(o)(30) of this chapter in foodNot to exceed 0.5 percent.
3. As a formulation aid as defined in 170.3(o)(14) of this chapter in confectionsNot to exceed 3.0 percent of the combined weight of the formulation.
4. As a formulation aid as defined in 170.3(o)(14) of this chapter in fats and oils as defined in 170.3 (n)(12) of this chapterNot to exceed 1.0 percent of the combined weight of the formulation.
5. As a winterization and fractionation aid in fat and oil processingNot to exceed 0.5 percent by weight of the processed fat or oil.

(d) To assure safe use of the additive:

(1) In addition to the other information required by the act, the label or labeling of the additive shall bear the name of the additive.

(2) The label of the additive shall bear adequate directions to provide a final product that complies with the limitations prescribed in paragraph (c) of this section.

[53 FR 21632, June 9, 1988, as amended at 59 FR 24924, May 13, 1994]

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