Description
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
3subject to FSVP enforcement discretion
Additives used to impart color to food requiring safety evaluation
Substances added directly to food requiring safety evaluation
Stakeholders
3Entity responsible for receiving written comments regarding the guidance
Office within CFSAN overseeing food additive safety evaluations
Regulatory staff responsible for specific questions regarding food additive petitions
Regulatory Context
Regulatory Activities
2The process of providing feedback on the guidance document
Submissions required for food contact substances.; Preparation of Food Contact Notifications for Food Contact Substances
Attributes
3One of the three attributes used to define pharmacologic class.
Estimated dietary consumption used to determine Concern Level
Regulatory classification (I, II, or III) based on toxicological potential and exposure
Technical Details
Testing Methods
7Recommended for Concern Level III
Studies focused on teratogenicity, addressed in a separate guideline
Report results of segment I, II, III reproduction studies
Required for Concern Level III
Extrapolation from subchronic toxicity studies to chronic use
Minimum toxicity test for safety evaluation
Safety information in a FAP; Safety studies included in the petition
Identified Hazards
Hazards
2Section XI of the guidance.
Reason for limiting Class 2 solvents
Related CFR Sections (1)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (Status: Final)
- CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators (Status: Final)
- CPG Sec. 400.900 Class I Recalls of Prescription Drugs (Status: Final)
- CPG Sec. 454.100 OTC Ear Drop Preparations (Status: Final)
- CPG Sec. 430.300 Labeling Shipping Containers of Drugs (Status: Final)
- CPG Sec. 455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full Disclosure and Claims (Status: Final)