Description
This document was revised in July 2009. See "Color Additive Petitions: FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices."
Scope & Applicability
Product Classes
1Contact Lenses
Medical devices for which color additive petitions are submitted
Regulatory Context
Attributes
1Limit of Detection
LoD; minimum and maximum amount of DNA providing expected results in 95% of runs.
Identified Hazards
Hazards
1Carcinogenic Impurities
Impurities of toxicological concern requiring risk assessment
Related CFR Sections (2)
- 21CFR25.32§ 25.32 Foods, food additives, and color additives.
The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:Read full regulation →
- 21CFR70.3§ 70.3 Definitions.
(a) Secretary means the Secretary of Health and Human Services.Read full regulation →
See Also (6)
- Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices (Status: Final)
- Non-Invasive Blood Pressure (NIBP) Monitor Guidance (Status: Final)
- Guidance for Industry: Templates for Reporting Toxicology Data (Status: Final)
- Color Additive Petitions - Medical Devices (Status: Final)
- Draft Guidance for Industry: Cosmetic Good Manufacturing Practices (Status: Draft)
- Replacing Color Additives in Approved or Marketed Drug Products: Draft Guidance for Industry (Status: Draft)