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: "573.615"
section_subject: "Marine microalgae."
cfr_reference: "21 CFR 573.615"
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, marine microalgae, may be safely used as a source of docosahexaenoic acid (DHA) and other omega-3 fatty acids in accordance with the following prescribed conditions:
(a)The additive is dried whole cells of nonviable, nontoxigenic, nonpathogenic Schizochytrium sp. algae grown as a pure culture.
(b)The additive is used in complete, dry adult maintenance food for dogs in accordance with good manufacturing and feeding practices not to exceed 16.5 pounds per ton (7.5 kilograms (kg) per 1000 kg) of complete, dry, adult maintenance dog food.
(c)The additive consists of not less than 17.0 percent (4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenoic acid (docosahexaenoic acid or DHA).
(d)The additive meets the following specifications:
(e)To ensure the safe use of the additive, in addition to other information required by the Federal Food, Drug, and Cosmetic Act:
(1)The label and labeling of the additive, any feed premix, and complete feed, shall contain the name of the additive, marine microalgae.
(2)The label and labeling of the additive and any feed premix shall also contain:
(i)A statement to indicate that the maximum use level of the additive shall not exceed 16.5 pounds per ton (7.5 kg per 1000 kg) of complete, dry, adult maintenance dog food.