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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.

What You Need to Know? ๐Ÿ‘‡

What are the key chemical specifications required for color additive petitions in medical devices?

Chemical specifications must define the article of commerce and include volatile matter, soluble/insoluble matter, residual salts, unreacted intermediates, subsidiary colors, heavy metals, total color content, and particle size parameters if relevant. Specifications should reflect representative batch compositions used in safety testing.

How many manufacturing batches must be analyzed to demonstrate specification compliance?

FDA recommends analyzing five or more batches, including those used for safety testing, unless valid justification is provided for a different sampling scheme. Samples should be manufactured according to the process described in the petition and be representative of future production.

What analytical methods are required for color additive enforcement in medical devices?

Petitioners must provide validated analytical methods for determining all specified substances, including detailed procedures, calibration data, recovery studies, and survey results. Methods must be practical, specific, precise, accurate, and performable by properly equipped laboratories with consistent results.

How is exposure calculated for color additives used in medical devices?

Exposure is typically calculated by averaging 100% migration over the deviceโ€™s lifetime. Required information includes color additive composition, impurity levels, device lifetime (maximum and typical), and anticipated color additive levels. Actual migration studies may also be performed.

What manufacturing process information must be included in color additive petitions?

The petition must include complete descriptions of synthesis/extraction methods, reaction conditions, purification processes, production controls, and quality assurance measures. Alternative manufacturing methods and all substances used in preparation must be identified, regardless of chemical changes during processing.

When is exemption from batch certification possible for medical device color additives?

Exemption requires demonstrating that certification isnโ€™t necessary for public health protection. FDA considers composition, manufacturing process, impurities, toxic potential, analytical methods, and compositional variability. Color additives exempt for one use may still require certification for other applications.


What You Need to Do ๐Ÿ‘‡

  1. Compile comprehensive chemical identity and composition data including CAS/IUPAC names
  2. Develop detailed specifications for purity and impurities with validated analytical methods
  3. Document complete manufacturing process showing reproducible composition
  4. Generate stability data under intended storage and use conditions
  5. Prepare exposure estimates based on intended applications
  6. Develop and validate analytical methods for finished products
  7. Create compliant labeling for bulk containers and finished products
  8. Prepare migration studies if used in medical devices with body contact
  9. Document justification if requesting exemption from batch certification
  10. 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 ๐Ÿ”—

  • 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 ID: c005303337421b74b670559f6b8117d4
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