Did you know? Color Additives Must Have FDA Approval and (Sometimes) Batch Certification

Color additives for most FDA-regulated products (tobacco and some medical device products are exceptions) must be approved by FDA and listed in the Code of Federal Regulations. If a color additive isn’t listed, its approval must be petitioned and approved by FDA prior to its use in products marketed in the US.

FDA has a strict system of approval for color additives under U.S. law [Federal Food, Drug, and Cosmetic Act (FD&C Act), sec. 721; 21 U.S.C. 379e] that specifically addresses that substance’s use, including specifications and restrictions. Called a Color Additive Petition, these submissions to FDA must include data demonstrating the additive’s safety and suitability as described in 21 CFR Part 71.

With the exception of coal-tar hair dyes in cosmetics, failure to meet U.S. color additive requirements causes a product to be adulterated [FD&C Act, sec. 601(e); 21 U.S. Code 361(e)]. Color additive violations are a common reason for detaining imported products at the U.S. border, preventing them from reaching store shelves–and consumers!

In addition to FDA color additive approval, some types of color additives must also be batch certified by FDA. Batch certification requires the color additive manufacturer to ship samples to FDA for testing and these batch samples must meet FDA’s requirements for identity and specifications as stated in the Code of Federal Regulations (CFR).

What does this mean for you? First and foremost, you must have a clear understanding of permissibility for color additives intended for use in your products. Second, you have an ally in EAS Consulting Group.

Our team of toxicologists and regulatory specialists can assist with understanding which colors are allowed by-product and formulation. We can work with you and FDA to design safety studies and submit the highly technical Food Color Additive Submissions. We can also act as an intermediary for submitting color batch samples to FDA for certification – which is particularly helpful for foreign firms who must enlist a U.S. Agent for all communications with FDA.

Interested in learning more? View our FDA submissions services sheet for examples of our capabilities with Color Additive Petitions, or contact us to learn more. For assistance with submitting color batch samples to FDA for certification, contact our regulatory specialist team.

No matter the type of product, FDA is very clear that the only permissible uses of approved color additives are those stated in their specific regulations. Get in compliance and stay in compliance. Choose EAS Consulting Group as your regulatory partner.