subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "573"
part_subject: "FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS"
subpart_code: "B"
subpart_subject: "Food Additive Listing"
section_number: "573.637"
section_subject: "Methyl esters of conjugated linoleic acid (cis-9, trans-11 and trans-10, cis-12-octadecadienoic acids)."
cfr_reference: "21 CFR 573.637"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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The food additive, methyl esters of conjugated linoleic acid (cis-9, trans-11 and trans-10, cis-12 octadecadienoic acids), may be safely used in swine feed in accordance with the prescribed conditions:
(a)The food additive is manufactured by the reaction of refined sunflower oil with methanol to produce fatty acid methyl esters, which then undergo conjugation to yield methyl esters of octadecadienoic acid. The additive consists of not less than 28 percent methyl ester of cis-9, trans-11-octadecadienoic acid, and not less than 28 percent methyl ester of trans-10, cis-12-octadecadienoic acid with the sum of the other methyl esters of octadecadienoic acid not to exceed 4 percent. The additive shall contain not less than 35 percent of other fatty acid esters composed of oleic acid, palmitic acid, stearic acid, linoleic acid, and other associated acid esters.
(b)The additive is used or intended for use in the feed of growing and finishing swine as a source of fatty acids at levels not to exceed 0.6% in the finished feed.
(c)The additive meets the following specifications:
(ii)A statement to indicate that methyl esters of conjugated linoleic acid (cis-9, trans-11 and trans-10, cis-12 octadecadienoic acids) must not be added to vitamin or mineral premixes.
(2)The label and labeling of the additive, any feed premix, or complete feed prepared therefrom shall bear adequate directions for use.