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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 Aug 30, 2024.

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 1]
[CITE: 21CFR73.69]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL

PART 73 -- LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

Subpart A - Foods

Sec. 73.69 Butterfly pea flower extract.

(a) Identity. (1) The color additive butterfly pea flower extract is a dark blue liquid prepared by the aqueous extraction of dried butterfly pea flowers from Clitoria ternatea. The extract is further processed by ultrafiltration to remove residues of plant products, followed by concentration and pasteurization. Citric acid may be used to control the pH. The color additive contains anthocyanins as the principal coloring component.

(2) Color additive mixtures for food use made with butterfly pea flower extract may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods.

(b) Specifications. Butterfly pea flower extract must conform to the following specifications and must be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:

(1) pH, not less than 3.0 and not more than 4.5 at 25 deg.C.

(2) Lead, not more than 1 milligram per kilogram (mg/kg) (1 part per million (ppm)).

(3) Arsenic, not more than 1 mg/kg (1 ppm).

(4) Mercury, not more than 1 mg/kg (1 ppm).

(5) Cadmium, not more than 1 mg/kg (1 ppm).

(c) Uses and restrictions. Butterfly pea flower extract may be safely used for coloring alcoholic beverages, sport and energy drinks, flavored or carbonated water, fruit drinks (including smoothies and grain drinks), carbonated soft drinks (fruit-flavored or juice, ginger ale, and root beer), fruit and vegetable juice, nutritional beverages, chewing gum, teas, coated nuts, liquid coffee creamers (dairy and non-dairy), ice cream and frozen dairy desserts, hard candy, dairy and non-dairy drinks, fruit preparations in yogurts, and soft candy in amounts consistent with good manufacturing practice, except that it may not be used for coloring foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of added color is authorized by such standards.

(d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes must conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.

[86 FR 49233, Sept. 2, 2021]

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