Scope & Applicability
Product Classes
4article of food that will cause serious adverse health consequences
The primary product category regulated by this guidance.
Products containing dietary ingredients intended to supplement the diet; The final product category for which the NDI is intended.
The primary product category covered by the guidance; Essential food product that is the sole source of nutrition for many infants.
Stakeholders
6food firms that are responsible parties as defined in the statute
Federal, state, or local officials who may voluntarily submit reports.
Foreign manufacturers of human or animal food for US consumption.
Considered a separate legal person even if the responsible party maintains ownership.
直接上游来源
直接下游接收人
Regulatory Context
Attributes
2The timeframe within which a report must be submitted after determination.
Property of a device that may be changed via established protocols
Identified Hazards
Hazards
5biological hazard in dried milk powder; Microbiological hazard in pet treats; hazard in animal-derived protein ingredients; biological hazard requiring control in turmeric
Criteria for determining if a food is reportable.
biological hazard in frozen ice cream novelty; Biological hazard in cheese
Risk associated with improper storage temperature of mushrooms.
Presence of major food allergens not disclosed on labeling
Related CFR Sections (5)
- 21CFR1.226§ 1.226 Who does not have to register under this subpart?
This subpart does not apply to the following facilities:Read 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 →
- 21CFR1.225§ 1.225 Who must register under this subpart?
(a) You must register your facility under this subpart if you are the owner, operator, or agent in charge of either a domestic or foreign facility, as defined in this subpart, and your facility is engaged in the manufacturing/processing, packing, or holding of food for consumption in the United StatRead full regulation →
- 21CFR107.240§ 107.240 Notification requirements.
(a) Telephone report. When a determination is made that an infant formula is to be recalled, the recalling firm shall telephone within 24 hours the appropriate Food and Drug Administration district office listed in § 5.115 of this chapter and shall provide relevant information about the infant formuRead full regulation →
- 21CFR7.3§ 7.3 Definitions.
(a) Agency means the Food and Drug Administration.Read full regulation →
See Also (8)
- French Translation of Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry (Questions et Réponses relatives au Registre des aliments à signaler) (Status: Final)
- Orientación preliminar de la industria: Preguntas y respuestas sobre el Registro de productos sanitarios en productos agroalimentarios, según establecido por la Ley de Enmiendas a la Alimentación y Medicamentos (FDA), 2007 (Edición 2) (Status: Draft)
- Guide pour l’industrie: Questions et réponses concernant le Registre de denrées alimentaires à signaler Reportable Food Registry (RFR) tel qu’établi par le Food and Drug Administration Amendments Act de 2007 (FDAAA) (2ème édition) (Status: Draft)
- Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2) (Status: Draft)
- Draft Guidance for Industry: Questions and Answers on the Accredited Third-Party Certification Program (Status: Draft)
- 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)