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. If you want to discuss an alternative approach, contact Paul Honigfort, (240) 402-1206 orpaul.honigfort@fda.hhs.gov.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
2Approved substances for direct addition to food
Articles such as food-packaging or food processing equipment
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Regulatory Activities
1Submission process for exemption from food additive regulation
Document Types
1Required documentation under 21 CFR 514.1(b)(14).; Document evaluating environmental impact of investigational IGAs; Document used to examine potential for environmental impacts.; Document evaluating environmental impact of the action; Document required to determine environmental impacts
Attributes
2ADI limit for regulated direct food additives
0.5 parts per billion (ppb) dietary concentration
Technical Details
Substances
1Materials resistant to corrosion and abrasion
Testing Methods
2Search of existing toxicological information and impurities
Data obtained under worst-case conditions using food simulating solvents
Identified Hazards
Hazards
1The Single Exposure Carcinogen Database
Standards & References
External Standards
1Federal Insecticide, Fungicide, and Rodenticide Act governing sanitizers
Related CFR Sections (3)
- 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 →
- 21CFR25.15§ 25.15 General procedures.
(a) All applications or petitions requesting agency action require the submission of an EA or a claim of categorical exclusion. A claim of categorical exclusion shall include a statement of compliance with the categorical exclusion criteria and shall state that to the applicant's knowledge, no extraRead full regulation →
- 21CFR170.39§ 170.39 Threshold of regulation for substances used in food-contact articles.
(a) A substance used in a food-contact article (e.g., food-packaging or food-processing equipment) that migrates, or that may be expected to migrate, into food will be exempted from regulation as a food additive because it becomes a component of food at levels that are below the threshold of regulatRead full regulation →
See Also (8)
- Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN (Status: Final)
- Guidance for Industry: Questions and Answers About the Food Additive or Color Additive Petition Process (Status: Final)
- Draft Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety (Status: Draft)
- CVM GFI #221 Recommendations for Preparation and Submission of Animal Food Additive Petitions (Status: Final)
- National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions – Small Entity Compliance Guide: Guidance for Industry (Status: Final)
- CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter (Status: Final)
- Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS): Guidance for Industry (Status: Final)
- Over-the-Counter Monograph Order Requests: Format and Content (Status: Draft)