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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 2019.

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, 2019]
[CITE: 21CFR186.1256]



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 186 -- INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

Subpart B--Listing of Specific Substances Affirmed as GRAS

Sec. 186.1256 Clay (kaolin).

(a) Clay (kaolin) Al2O3.2SiO2.nH2O, Cas Reg. No. 1332-58-7) consists of hydrated aluminum silicate. The commercial products of clay (kaolin) contain varying quantities of alkalies and alkaline earths. Clay (kaolin) is a white to yellowish or grayish fine powder. There are at least three different minerals, kaolinite, dickite, and nacrite, classified as kaolin. Kaolinite or china clay is whiter, less contaminated with extraneous minerals, and less plastic in water.

(b) In accordance with 186.1(b)(1), the ingredient is used as an indirect human food ingredient with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used in the manufacture of paper and paperboard that contact food.

(2) The ingredient is used at levels not to exceed current good manufacturing practice.

(c) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived.

[47 FR 43367, Oct. 1, 1982]

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