| Food facility registration (FDA, 21 CFR 1.225 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, unless an exemption applies, and renews between October 1 and December 31 of every even-numbered year, such as 2026 and 2028. | SQF certification isn't FDA registration; SQF 2.4.1 Food Legislation, Mandatory |
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| Current good manufacturing practices and preventive controls (FDA, 21 CFR Part 117) | Beverage and packaged ice plants follow FDA's CGMPs (subpart B) and, unless an exemption applies, its hazard analysis and risk-based preventive controls (subpart C). Subparts C and G don't apply to activities subject to the juice HACCP rule (Part 120) at a plant that must comply with it and does, and the low-acid canned food exemption covers only the microbiological hazards regulated under Part 113. FDA regulates packaged ice in interstate commerce as a food made under its CGMPs. | SQF 2.4.2 Good Manufacturing Practices and 2.4.3 Food Safety Plan, Mandatory; FSSC 22000 ISO 22000 clause 8.2 (prerequisite programs) and 8.5 (hazard control) |
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| Juice HACCP (FDA, 21 CFR Part 120) | Covers juice sold as such or used as an ingredient in beverages. A retail establishment is outside the rule only if it provides juice directly to consumers; one that also sells or distributes juice to other businesses is covered (120.3). The HACCP plan must consistently achieve at least a 5-log reduction of the pertinent microorganism, lasting at least the product's shelf life (120.24). Processors subject to Part 113 or 114, and those using a single thermal step that makes the juice shelf-stable or a thermal concentration process that treats all ingredients, are exempt from the 5-log requirement if the thermal process is in their written hazard analysis; that juice must be processed and packaged in one facility operating under CGMPs. Whoever develops the hazard analysis and HACCP plan, verifies or modifies it, or reviews records needs training in applying HACCP to juice processing at least equivalent to an FDA-recognized standardized curriculum, or equivalent job experience (120.13). | SQF FSC 14 (FSC 15 for UHT juice); 2.4.3 and 2.5.1 Validation and Effectiveness, Mandatory; FSSC 22000 ISO 22000 clause 8.5.3 validation |
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| Low-acid canned and aseptic drinks (FDA, 21 CFR Parts 108 and 113) | A low-acid food is any food other than an alcoholic beverage with a finished equilibrium pH above 4.6 and a water activity above 0.85 (113.3). A plant that thermally processes low-acid foods in hermetically sealed containers, including aseptic systems, registers the establishment with FDA within 10 days of starting and files its scheduled processes (108.35), and processing runs under the operating supervision of a person who attended a school approved by FDA and satisfactorily completed its course (113.10). | SQF FSC 15 or 16; 2.5.1 Validation and Effectiveness, Mandatory; FSSC 22000 ISO 22000 clause 8.5.3 |
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| Acidified drinks (FDA, 21 CFR Parts 108 and 114) | Acidified foods are low-acid foods to which acids or acid foods are added, with a water activity above 0.85 and a finished equilibrium pH of 4.6 or below (114.3(b)). Acid foods, with a natural pH of 4.6 or below, aren't acidified foods. Also excluded: carbonated beverages; jams, jellies and preserves; acid foods with small amounts of low-acid food that don't significantly change the pH; and foods stored, distributed and retailed under refrigeration. Covered plants register with FDA within 10 days of starting and file their scheduled processes within 60 days of registering and before packing any new product (108.25), and processing runs under the supervision of a person who attended a school approved by FDA and satisfactorily completed its course (114.10). | SQF 2.4.3 and 2.5.1, Mandatory; FSSC 22000 ISO 22000 clause 8.5 |
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| Juice percentage labeling (FDA, 21 CFR 101.30 and 102.33) | A beverage that purports to contain fruit or vegetable juice declares its percentage of juice, such as "Contains __ percent ___ juice" (101.30). If the name of a beverage with more than 0 and less than 100 percent juice uses the word "juice," it must include a qualifying term such as "beverage," "cocktail" or "drink" (102.33(a)). | SQF 2.3.2.7 labels accurate and legal; FSSC 22000 2.5.2 product labeling |
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| Major food allergen labeling (FDA, 21 U.S.C. 343(w)) | Each major food allergen in a packaged food is declared by the name of its food source, in a "Contains" statement or within the ingredient list. Sesame became the ninth major food allergen on January 1, 2023, joining milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans. | SQF 2.8.1 Allergen Management, Mandatory; FSSC 22000 2.5.6 and 2.5.2 |
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| Energy drinks: beverage or dietary supplement (FDA guidance, January 2014) | FDA's final guidance says beverages are conventional foods, and that liquid products can be represented as conventional foods because of factors such as their name, packaging, serving size, recommended daily intake and marketing. The classification decides which FDA rules apply. | SQF FSC 16 (Food Manufacturing code) for beverages; FSC 31 (SQF Food Safety Code: Dietary Supplements Manufacturing) for supplements |
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| Arsenic and lead in juice (FDA guidance) | FDA's final guidance sets an action level of 10 parts per billion (ppb) for inorganic arsenic in single-strength apple juice (June 2023). FDA's 2022 draft guidance proposes lead action levels of 10 ppb for apple juice and 20 ppb for other single-strength juices. | SQF 2.3.2.9 (chemical limits in finished product specifications) and 2.4.3; FSSC 22000 ISO 22000 clause 8.5.2 |
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| Alcohol beverages (TTB, and FDA 21 CFR 117.5(i)) | The Alcohol and Tobacco Tax and Trade Bureau (TTB) says that when kombucha reaches 0.5% alcohol or more by volume at any time during production, it must be made on TTB-qualified premises and is subject to TTB regulation, regardless of the finished drink's alcohol content. Part 117 subparts C and G don't apply to alcoholic beverages at a facility that holds the required TTB permit, registration or approval and is registered with FDA; the CGMPs in subpart B still apply. | SQF FSC 16; FSSC 22000 category CIV |
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| Food Traceability Rule (FDA, 21 CFR Part 1, Subpart S) | No beverage, bottled water or ice is on FDA's Food Traceability List by name, but the rule also covers foods that contain a listed food as an ingredient in the same form, such as fresh. If you receive a listed food, such as fresh-cut fruit, and apply a kill step to it, you keep a record of the kill step and your receiving records for that food, unless you have a written kill-step agreement under 1.1305(d)(6) (1.1305(d)(3)). Congress directed FDA not to enforce the rule before July 20, 2028. | SQF 2.6.2 Product Trace, Mandatory; FSSC 22000 ISO 22000 clause 8.3 traceability |
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