Description
Feeds can be maintainedSalmonella-negative in several ways, including the addition of chemical substances to the feeds. Such chemical substances are deemed to be food additives under section 201(s) (21 USC 321(s)) of the Federal Food, Drug, and Cosmetic Act (the Act) unless they are generally recognized as safe (GRAS) for use againstSalmonellain feed (Ref. 6). According to section 409(a) (21 USC 348(a)) of the Act, a food additive is deemed to be unsafe, unless it and its intended use conform to the terms of an exemption or existing regulation and/or (for food contact substances) an effective notification prescribing the conditions under which such additive may be safely used.
Scope & Applicability
Product Classes
2Included in the definition of food
Anti-Salmonella agents used in animal feed
Stakeholders
2Entity responsible for submitting applications under section 524B
Assist sponsors in the nonclinical evaluation
Regulatory Context
Attributes
2The lowest level of additive that achieves the intended effect
packaged to ensure the maintenance of their microbiological integrity during transportation
Related CFR Sections (2)
- 21CFR571.1§ 571.1 Petitions.
(a) Petitions to be filed with the Commissioner under the provisions of section 409(b) of the act shall be submitted in triplicate. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petition shall state petitiRead full regulation →
- 21CFR570.17§ 570.17 Exemption for investigational use and procedure for obtaining authorization to market edible products from experimental animals.
A food additive or food containing a food additive intended for investigational use by qualified experts shall be exempt from the requirements of section 409 of the act under the following conditions:Read full regulation →
Related Warning Letters (10)
- 2025-09-09
Foreign Supplier Verification Program (FSVP)
Jalisco Fresh Produce, Inc.
- 2025-03-18
Foreign Supplier Verification Program (FSVP)
Zacanta LLC
- 2024-10-08
Foreign Supplier Verification Program (FSVP)
Green Day Produce, Inc.
- 2024-09-24
Acidified Foods/Emergency Permit Control/Adulterated
Brewing Market Coffee
- 2024-08-27
Foreign Supplier Verification Program (FSVP)
Minland of Texas, Inc.
- 2024-05-21
FSVP/Seafood HACCP
Rash Catering Services, LLC
- 2023-10-10
Foreign Supplier Verification Program (FSVP)
Ikal LLC
- 2023-01-24
Foreign Supplier Verification Program (FSVP)
TL State Management, Inc.
- 2022-12-13
Foreign Supplier Verification Program (FSVP)
Gobwa Exotic Imports Inc.
- 2022-08-16
Foreign Supplier Verification Program (FSVP)
EH Maldonado and Company
See Also (8)
- CVM GFI #122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores (Status: Final)
- CVM GFI #221 Recommendations for Preparation and Submission of Animal Food Additive Petitions (Status: Final)
- CVM GFI #220 Use of Nanomaterials in Food for Animals (Status: Final)
- Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Fresh-cut Produce (Status: Draft)
- Guidance for Industry: What You Need to Know About Prior Notice of Imported Food Shipments (Status: Final)
- Guidance for Industry: Evaluating the Safety of Flood-affected Food Crops for Human Consumption (Status: Final)
- Guía para la industria: Evaluación de la inocuidad de los cultivos alimentarios para el consumo humano afectados por las inundaciones (Status: Final)
- Guidance for Industry: Food Labeling Guide (Status: Final)