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e-CFR data is current as of March 4, 2021

Title 21Chapter ISubchapter EPart 573Subpart B → §573.615

Title 21: Food and Drugs
Subpart B—Food Additive Listing

§573.615   Marine microalgae.

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:

(1) Not less than 40 percent crude fat;

(2) Not more than 12 percent ash;

(3) Not more than 8 percent unsaponifiable matter;

(4) Not more than 5 percent insoluble impurities;

(5) Not more than 5 percent free fatty acids; and

(6) Not more than 6 percent water.

(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.

(ii) Adequate directions for use.

[83 FR 19935, May 7, 2018]

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