Color Additive Petitions: Chemical and Technical Requirements for Food, Drugs, Cosmetics, and Medical Devices
This guidance provides recommendations for the submission of chemical and technological data required for color additive petitions for use in food, drugs, cosmetics, or medical devices. It focuses on the technical requirements for demonstrating the identity, composition, stability, and analytical methods for color additives.
Recommended Actions
- Compile comprehensive chemical identity and composition data including CAS/IUPAC names
- Develop detailed specifications for purity and impurities with validated analytical methods
- Document complete manufacturing process showing reproducible composition
- Generate stability data under intended storage and use conditions
- Prepare exposure estimates based on intended applications
- Develop and validate analytical methods for finished products
- Create compliant labeling for bulk containers and finished products
- Prepare migration studies if used in medical devices with body contact
- Document justification if requesting exemption from batch certification
- Submit representative samples from at least 5 production/pilot batches
Key Considerations
Labelling
- Must include specimens of proposed labeling for the color additive
- Bulk container labeling must conform to 21 CFR 70.25 requirements
- Must show precautions needed to preserve stability if required
- Product labeling requirements per 21 CFR 101.22, 201.20, 501.22 and Part 701 if applicable
Safety
- Must demonstrate safety and suitability for intended use
- Must provide stability data to ensure identity, strength, quality and purity
- For medical devices, migration studies may be required if color additive comes in direct contact with body
Other considerations
- Must provide complete chemical identity and composition information
- Must include specifications for purity and impurity limits
- Must provide validated analytical methods for all specified substances
- Must include manufacturing process description showing reproducible composition
- Must provide exposure estimates based on intended use
- Must justify any request for exemption from batch certification
Relevant Guidances
- Color Additives in Medical Devices: Requirements for Direct Body Contact Applications
- Color Additives in Contact Lenses: Preparing and Submitting Petitions
Related references and norms
- CAS: Chemical Abstracts Service Registry
- IUPAC: International Union of Pure and Applied Chemistry Nomenclature
Original guidance
- Color Additive Petitions: Chemical and Technical Requirements for Food, Drugs, Cosmetics, and Medical Devices
- HTML
- Issue date: 2009-07-01
- Last changed date: 2024-10-01
- Status: FINAL
- Official FDA topics: Medical Devices, Food & Beverages, Drugs, Food & Color Additives, Cosmetics
- ReguVirta summary file ID: c005303337421b74b670559f6b8117d4
This post is licensed under CC BY 4.0 by the author.