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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: 21CFR186.1551]



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. 186.1551 Hydrogenated fish oil.

(a) Hydrogenated fish oil (CAS Reg. No. 91078-95-4) is a class of oils produced by partial hydrogenation of oils expressed from fish, primarily menhaden, and secondarily herring or tuna. Hydrogenation of fish oils uses catalysts composed of either elemental nickel, elemental copper, or a mixture of these elements. The crude hydrogenated fish oil is further processed by alkali refining, bleaching, and deodorization by steam stripping.

(b) Hydrogenation of fish oils results in a final product with a melting point greater than 32 deg. C as determined by Section Cc 1-25, Official and Tentative Methods of the American Oil Chemists' Society method (reapproved 1973) or equivalent. The product has an approximate fatty acid composition of 30 to 45 percent saturated fatty acids, 40 to 55 percent monoenoic fatty acids, 7 to 15 percent dienoic fatty acids, 3 to 10 percent trienoic fatty acids, and less than 2 percent tetraenoic or higher polyenoic fatty acids. The approximate percentages of total fatty acids by carbon chain length are 15 to 30 percent each of C16, C18, C20, C22, less than 10 percent C14 or lower carbon chain length, and less than 1 percent C24 or higher carbon chain length fatty acids.

(c) The ingredient is used as a constituent of cotton and cotton fabrics used for dry food packaging.

(d) The ingredient is used at levels not to exceed good manufacturing practice in accordance with 186.1(b)(1).

(e) Prior sanctions for this ingredient different from the use established in this section do not exist or have been waived.

[44 FR 28323, May 15, 1979, as amended at 49 FR 5614, Feb. 14, 1984; 58 FR 17099, Apr. 1, 1993]

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