FDA Color Additive Petition Services

FDA Color Additive Petitions

Secure FDA approval for your color additives with expert petition preparation and regulatory strategy from dicentra.

What Is a Color Additive Petition?

A color additive petition is the formal process for obtaining FDA authorization to use a specific color additive in foods, dietary supplements, drugs, or cosmetics. This petition provides the FDA with technical, manufacturing, and safety data that support the proposed use and ensures public safety.

When Is a Color Additive Petition Required?

You may need to file a color additive petition when:

A new color additive is introduced for a use not yet authorized by the FDA.
You wish to expand or modify existing permitted uses of a color additive.
Manufacturing or specifications for an approved colorant are updated.
You are seeking to establish new safety data for an existing color additive.

Petitions ensure that colorants meet FDA safety, composition, and labeling standards for their intended use.

Our FDA Color Additive Petition Services

dicentra provides end-to-end support for FDA color additive petitions, including:

Regulatory strategy and project planning
Technical data gap assessment
Preparation of chemistry, manufacturing, and safety sections
Analytical method validation review
Dossier compilation and FDA submission
Post-submission follow-up and FDA communication support

Industries and Use Cases We Support

Food and beverage manufacturers
Dietary supplement companies
Pharmaceutical ingredient suppliers
Cosmetic and personal care brands
Ingredient developers introducing new colorants or natural pigments

Why Choose dicentra?

Over two decades of regulatory experience with the FDA and Health Canada
Deep expertise in toxicology, ingredient safety, and chemistry data evaluation
Proven success in regulatory submissions for color additives, GRAS, and food ingredients
Strategic guidance to minimize data requests and review delays
A multidisciplinary team supporting science, compliance, and safety documentation

Related Services

GRAS Submissions
Food Additive Petitions
Ingredient Safety Assessments
Label & Claims Review
Toxicological Risk Assessment

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