U.S. FDA Registration & Labeling Compliance Assistance

FDA Cosmetic Color Additives Batch Certification

All cosmetic color ingredients and additives must be FDA approved for their specific intended use and cosmetic formulation. Cosmetic colors additives must be either FDA approved colors for specific uses, FDA certified colors (on a batch basis), or exempted from FDA color certification. Batch Certification is the procedure when FDA analyzes the composition of all the colors used in cosmetic formulation.

To obtain the color additive batch certification, cosmetic manufacturers must submit a sample of the color additive for each batch used in the product formulation along with the batch-specific documents. After proper examinations U.S. FDA will certify the color additive if the analysis of the batch sample meets the FDA requirements.

Color additive violations are some of the most common cause of FDA import detentions and refusals while importing cosmetic products into the United States. FDA Listing Inc. assists cosmetic manufacturers in demonstrating to FDA that color additives contained in the imported products are certified, and properly declared on the product label. Our experts we will assist you to initially determine if a batch certification needed for your used color additive and walk you through filling for batch certifications and approval. For assistance regarding cosmetic color additive review and certification click the start button.