Determining the safety of chromium tripicolinate for addition to foods as a nutrient supplement

• Published in: Food and chemical toxicology 2004-06, Vol.42 (6), p.1029-1042
• Main Authors: Berner, T.O, Murphy, M.M, Slesinski, R
• Format: Article
• Language: English
• Subjects: Adequate Intakes; Adolescent; Adult; Animals; beverages; Biological and medical sciences; Chemical and industrial products toxicology. Toxic occupational diseases; chemical structure; Child; Child, Preschool; Chromax®, GRAS; chromium; Chromium tripicolinate; Diet; Dietary Supplements; dose response; Female; Food Additives; Food safety; GRAS substances; health foods; Humans; Infant; Infant, Newborn; Male; Medical sciences; Metals and various inorganic compounds; Mice; Middle Aged; Nutrient supplement; Nutrition Policy; picolinic acid; Picolinic Acids - pharmacology; Picolinic Acids - toxicity; Rats; Safety; safety testing; Tolerable Upper Intake Level; Toxicology; Trivalent chromium
• ISSN: 0278-6915; 1873-6351
• DOI: 10.1016/j.fct.2004.02.015

Trivalent chromium is an essential element required for normal carbohydrate, lipid, and protein metabolism in humans and animals. This article describes how one particular form of trivalent chromium, chromium tripicolinate (Chromax®), a stable complex of trivalent chromium and picolinic acid, was determined to be safe for use as a nutrient supplement in foods (i.e., nutritional bars and beverages). A safety assessment of a nutrient supplement for use in food requires an evaluation of the safety of the product (Chromax®), as well as an evaluation of the safety of the intended dietary ingredient (chromium tripicolinate). In this assessment, the production process, final product specifications, and product analysis results for Chromax® were evaluated to determine the safety of the final product. Then, the Estimated Daily Intakes (EDIs) of trivalent chromium and picolinic acid from the proposed use of Chromax® were calculated using data from the USDA's most recent Continuing Survey of Food Intakes by Individuals. The EDI for trivalent chromium was compared to the Acceptable Daily Intake (ADI) for this compound derived from animal studies, corroborated with human data, while the EDI for picolinic acid was compared to existing in vivo exposure to this compound that occurs naturally in the body. As long as the EDI of trivalent chromium is less than the ADI for this compound and the EDI of picolinic acid is less than its estimated in vivo exposure, Chromax® can be considered safe for its intended use. Employing this approach, it was determined that Chromax® is safe, as well as generally recognized as safe (GRAS), for use in nutritional bars and beverages as a nutrient supplement at a maximum use level of 2.4 mg of Chromax® per product serving.