Title 21

SECTION 573.685

573.685 Natamycin.

§ 573.685 Natamycin.

The food additive natamycin (CAS No. 7681-93-8) may be safely used in broiler chicken feeds in accordance with the following specifications:

(a) The additive is a stereoisomer of 22-[(3-amino-3,6,dideoxy-β-D-mannopyranosyl)oxy]-1,3,26-trihydroxy-12-methyl-10-oxo-6,11,28-trioxatricyclo[22.3.1.0 5, 7] octacosa-8,14,16,18,20-pentaene-25-carboxylic acid with the empirical formula C33H47NO13.

(b) The additive shall conform to U.S.P. specifications.

(c) The additive (as part of a premix composed of calcium carbonate, natamycin, and lactose) is used for retarding the growth of Aspergillus parasiticus in broiler chicken feeds for up to 14 days after the addition of natamycin.

(d) Each pound (454 grams (g)) of the premix shall contain 434 (g) of calcium carbonate, 10 g of natamycin activity, and 10 g of lactose. The premix shall be mixed into broiler chicken feed at the rate of 1 pound (0.454 kilograms (kg)) per ton (908 kg) of feed to provide natamycin at a level of 11 parts per million (ppm). The premix shall be thoroughly mixed into the dry components of the broiler chicken feed before adding the liquid components. Broiler feeds to which the natamycin premix is added shall be used within 4 weeks of addition of the premix.

(e) To assure the safe use of the additive, the label or labeling of the additive shall bear, in addition to other information required by the Federal Food, Drug, and Cosmetic Act, the following:

(1) The name and CAS number of the additive, and its purpose.

(2) A listing of ingredients consisting of calcium carbonate, the additive, and lactose and their proportions in the premix as prescribed under paragraph (d) of this section.

(3) Adequate directions for use to ensure a broiler chicken feed that is in compliance with the limitations prescribed in paragraph (d) of this section.

(4) An appropriate cautionary statement: “Caution: Store in a tightly-closed, light-resistant container in a cool, dry place.”

(5) An expiration date of 1 year from the date of manufacture.

(6) A contact address and telephone number for reporting adverse reactions experienced by users, or to request a copy of the Material Safety Data Sheet for natamycin.

[69 FR 19321, Apr. 13, 2004]

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