| Food facility registration (FDA, 21 CFR 1.225, 1.226 and 1.230) | The owner, operator or agent in charge of a facility that manufactures or processes, packs or holds food for U.S. consumption registers it with FDA (1.225), unless an exemption in 1.226 applies. For example, a plant regulated exclusively by USDA throughout the entire facility doesn't register, but one that also makes FDA-regulated food does. A co-packer making FDA-regulated food registers its plant and renews between October 1 and December 31 of every even-numbered year, such as 2026 and 2028 (1.230). FDA's registration guidance says a broker that doesn't manufacture, process, pack or hold food doesn't need to register. | SQF certification isn't FDA registration; clause 2.4.1 requires you to comply with the food law that applies to you |
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| When your customer controls a hazard (FDA, 21 CFR 117.136) | A manufacturer doesn't have to apply a preventive control for a hazard that its customer, or an entity later in the distribution chain, will actually control, such as a customer that cooks a raw ingredient you make. It must disclose in documents accompanying the food that it's "not processed to control [identified hazard]" and annually obtain written assurance from the customer. It doesn't apply when no one after you will control the hazard, such as a finished product your customer only resells. FDA's January 2018 policy said it wouldn't enforce the written-assurance requirements until it completes a related rulemaking, while the disclosure is still required; check FDA's current policy. | 2.4.3 Food Safety Plan, Mandatory (your hazard analysis shows which hazards you control); 2.3.2.9 customer-approved specifications |
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| Supply-chain program (FDA, 21 CFR 117.405 and 117.415) | When a co-packer's hazard analysis identifies a hazard in a raw material or other ingredient that needs a control applied before receipt (a supply-chain-applied control), the co-packer, as the receiving facility, runs a risk-based supply-chain program, and "the receiving facility must approve suppliers." FDA's co-manufacturer guidance says co-manufacturers that manufacture or process ingredients they receive are receiving facilities. Another entity, such as the brand owner, may determine or conduct supplier verification activities if the receiving facility reviews and assesses its documentation and records that review. | 2.3.4 Approved Supplier Program, Mandatory |
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| Naming the manufacturer on the label (FDA, 21 CFR 101.5) | The label of a packaged food conspicuously states the name and place of business of the manufacturer, packer or distributor (city, state and ZIP code, plus the street address unless it's listed in a current city or telephone directory). Where the food isn't made by the company named on the label, the name must be qualified by a phrase such as "Manufactured for" or "Distributed by." | 2.3.2.7 labels accurate, legal and approved; 2.6.1.1 product labeled to the customer specification and/or regulatory requirements |
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| Meat and poultry made for another company (USDA FSIS, 9 CFR 317.2, 381.122 and 381.123) | The container bears the official establishment number of the plant where the product was processed under inspection, inside the USDA mark of inspection or in another location the rules allow (317.2(i), 381.123). On meat labels, a distributor's name is shown with a phrase such as "Prepared for"; on poultry labels, a distributor shown alone is qualified by a term such as "packed for," "distributed by" or "distributors" (317.2(g), 381.122). | 2.4.1 Food Legislation, Mandatory; FSC 8 and 9 use the Animal Product Manufacturing code |
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| Major food allergen labeling (FDA, 21 U.S.C. 343(w)) | On FDA-regulated packaged foods, each major food allergen must be declared by the name of its food source, either in a "Contains" statement next to the ingredient list or in parentheses within it. Sesame became the ninth major food allergen on January 1, 2023, joining milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans. Highly refined oils are exempt. This rule doesn't apply to USDA-inspected meat, poultry, catfish or processed egg products, which follow USDA FSIS labeling requirements. | 2.8.1 Allergen Management, Mandatory; 2.4.1.1 allergen labeling under food law |
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| Food Traceability Rule (FDA, 21 CFR Part 1, Subpart S) | When you transform a food on FDA's Food Traceability List, you assign a new traceability lot code (1.1320) and keep transformation records for each new lot (1.1350). Congress directed FDA not to enforce the rule before July 20, 2028. | 2.6.2 Product Trace, Mandatory |
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| Foreign co-packers (FDA Foreign Supplier Verification Programs, or FSVP, 21 CFR 1.500) | For food made by a foreign co-packer, the importer responsible for the foreign supplier verification program is the U.S. owner or consignee when the food is offered for import; if there's none, it's the foreign owner's or consignee's U.S. agent or representative, confirmed in a signed statement of consent. | SQF doesn't replace FSVP. If the brand owner's own site is SQF certified and the co-packed products are in its SQF scope, 2.3.3 also applies |
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| Reportable Food Registry (21 U.S.C. 350f) | The registered facility where a food is made, packed or held must report to FDA's Reportable Food Registry as soon as practicable, and no later than 24 hours, after determining there's a reasonable probability that the food will cause serious adverse health consequences or death to humans or animals. No report is required if the adulteration started at your plant, you found it before the food went to anyone else, including your customer, and you corrected it or destroyed the food. | 2.4.1.3 notify SQFI and your certification body within 24 hours of a regulatory warning or event; 2.6.3 Product Withdrawal and Recall, Mandatory |
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