Under the Federal Food, Drug, and Cosmetic Act (Title VII, Section 721), color additives, with the exception of coal tar hair dyes, must first be approved for FDA certification before they can be used in food, drug, or cosmetic or medical devices. Physical contact with people or animals for a considerable period of time.

FDA certification strictly regulates color additives used in the manufacturing process of food, beverages and dietary supplements. All color additives must be correctly declared on the product label. The use of unapproved color additives violates FDA certification regulations.

For color additives used in food and beverages and dietary supplements, FDA certification requires manufacturers to obtain batch certification or certification that is exempt from FDA certification. To obtain a color additive lot certification, manufacturers must submit a color additive sample for each lot along with the associated lot-specific paperwork. After proper inspection, if the sample analysis meets the requirements of FDA certification, the US FDA certification will certify your color additive.

a. Colorants requiring batch certification

b. Exempt batch certified colorants

Colorants that require batch certification are usually organic synthetic colorants, and the FDA ensures that each batch of products meets the relevant composition and purity requirements. For colorants that have passed batch certification but have been repackaged, repackaged batch certification is also required.

Colorants that are exempt from batch certification are usually of plant, animal, or mineral origin and do not require additional batch certification after a thorough evaluation by the FDA. Colorants exempt from certification must meet the composition and purity specifications and use restrictions described in their regulations

When applying for batch certification, manufacturers are required to submit a colorant sample and corresponding documentation to the FDA. All businesses outside the United States must appoint a U.S. agent in the batch certification application.