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U.S. FDA Approves Three New Natural Color Additives for Food Use

The FDA approved three natural-source color additives: galdieria extract blue, butterfly pea flower extract, and calcium phosphate, supporting the move away from synthetic petroleum-based dyes in U.S. foods.

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On May 9, 2025, the U.S. Food and Drug Administration (FDA) announced the approval of three new color additive petitions, representing a significant move toward increasing the availability of natural alternatives to synthetic dyes. The approved additives are galdieria extract blue, butterfly pea flower extract, and calcium phosphate, with details as follows:

The newly approved color additives include:

Galdieria extract blue

Other names

Galdieria sulphuraria extract, phycocyanin-rich

Status

Permanently listed, exempt from certification

Basic information

(1) A blue liquid or powder prepared from the aqueous extraction of the dried biomass of Galdieria sulphuraria, a naturally occurring species of red microalgae;

(2) Containing C-phycocyanin, the principal coloring component;

(3) Lead, not more than 0.5 mg/kg;

(4) Cadmium, not more than 0.5 mg/kg;

(5) Arsenic, not more than 0.5 mg/kg;

(6) Mercury, not more than 0.05 mg/kg;

Application

Nonalcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, and whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives).

Limitation

Good Manufacturing Practice (GMP)

Butterfly pea flower extract

Other names

/

Status

Permanently listed, exempt from certification

Basic information

(1) A dark blue liquid prepared by the aqueous extraction of dried butterfly pea flowers from Clitoria ternatea;

(2) A blue color that can be used to achieve a range of shades including bright blues, intense purple, and natural greens;

(3) pH, not less than 3.0 and not more than 4.5 at 25 °C;

(4) Lead, not more than 1 mg/kg;

(5) Arsenic, not more than 1 mg/kg;

(6) Mercury, not more than 1 mg/kg;

(7) Cadmium, not more than 1 mg/kg.

Application

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, soft candy, ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), plain corn chips, tortilla chips, and multigrain chips.

Limitation

Good Manufacturing Practice (GMP)

Calcium phosphate

Other names

Phosphoric acid, calcium salt

Status

Permanently listed, exempt from certification

Basic information

(1) A white, synthetically prepared powder consisting predominantly of precipitated Ca5OH(PO4)3;

(2) Loss on ignition, not more than 10%;

(3) Assay (Ca), 36.0-40.0%;

(4) Fluoride, not more than 75 mg/kg;

(5) Lead, not more than 0.25 mg/kg;

(6) Arsenic, not more than 3 mg/kg.

Application

Ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies.

Limitation

Ready-to-eat chicken, Not to exceed 1.5% by weight of finished food;

White candy melts, Not to exceed 0.25% by weight of finished food;

Doughnut sugar, Not to exceed 2.0% by weight of finished food;

Sugar for coated candies, Not to exceed 5.25% by weight of finished food;

The approvals align with the U.S. Department of Health and Human Services (HHS) initiative to phase out petroleum-based dyes and promote safer, natural alternatives in the food supply.

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), all color additives must be evaluated for safety prior to use in food. FDA assessments are based on dietary exposure estimates, toxicological data, and other relevant information, such as published literature. Once approved, the color additives are available for use by any manufacturer within the specified conditions of use.

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US Announces Nationwide Measures to Phase Out Petroleum-Based Food Dyes

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