Description
This document is intended to clarify FDA's jurisdiction over antimicrobials that are used in or on food, including those used in or on edible food, in water that contacts edible food, and those used in the manufacture of, or in or on, food-contact articles, subsequent to the enactment of the Food Quality Protection Act of 1996 (FQPA), and the Antimicrobial Regulation Technical Corrections Act of 1998 (ARTCA).(1)
Scope & Applicability
Product Classes
6Subject of the guidance document; Substances intended to control microorganisms on food
Substances intended for use as a component of materials used in manufacturing, packing, or holding food
RACs; Fruits and vegetables subject to section 419 standards; Referred to as RACs in the context of packing and holding.
Food subject to canning, cooking, freezing, dehydration, or milling; Includes human food and animal feed
Sprouts in their raw or natural state
Defined under 201(q) of FFDCA
Identified Hazards
Hazards
1Objectionable animals or insects including birds, rodents, flies, and larvae
Related CFR Sections (3)
- 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 →
- 21CFR123.3§ 123.3 Definitions.
The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) and in parts 110 and 117 of this chapter are applicable to such terms when used in this part, except that the definitions and terms in parts 110 and 117 do not govern such terms where suRead full regulation →
- 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 →
See Also (8)
- CPG Sec 562.600 Preservatives; Use in Nonstandardized Foods; Label Declaration (Status: Final)
- CPG Sec 562.550 Safety and Labeling of Waxed (Coated) Fruits and Vegetables (Status: Final)
- Guidance for Industry: Estimating Dietary Intake of Substances in Food (Status: Final)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)
- Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions (Status: Final)
- Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting: Guidance for Industry (Status: Final)
- Guidance for Industry: Preparation of Food Contact Substance Notifications (Administrative) (Status: Final)
- CPG Sec 500.200 Food Additives -"GRAS" (Status: Final)