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Food safety
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فتح في المتصفح →Regulation (EU) 2026/697 of the European Parliament and of the Council of 11 March 2026 on cooperation among enforcement authorities responsible for the enforcement of Directive (EU) 2019/633 on unfair trading practices in business-to-business relationships in the agricultural and food supply chain
This EU regulation establishes cooperation mechanisms among national enforcement authorities to combat unfair trading practices in agricultural and food supply chains. It strengthens cross-border enforcement of Directive (EU) 2019/633 by enabling information sharing, joint investigations, and coordinated penalty imposition where suppliers face exploitation by larger buyers, addressing power imbalances that harm farmers' living standards.
Regulation (EU) 2026/697 of the European Parliament and of the Council of 11 March 2026 on cooperation among enforcement authorities responsible for the enforcement of Directive (EU) 2019/633 on unfair trading practices in business-to-business relationships in the agricultural and food supply chain
This EU regulation establishes cooperation mechanisms among enforcement authorities to combat unfair trading practices in agricultural and food supply chains, as defined under Directive (EU) 2019/633. It addresses cross-border enforcement challenges by strengthening information-sharing and coordinated investigations between Member States' authorities to ensure uniform protection for agricultural suppliers and farmers against exploitative buyer practices.
Infant Formula
21 CFR Part 107 establishes labeling requirements, nutrient standards, and exemption criteria for infant formula under the Federal Food, Drug, and Cosmetic Act. Manufacturers must comply with nutrient content specifications, labeling formats declaring calories and specific nutrients (vitamins, minerals, biotin, choline, inositol), and special provisions for exempt formulas designed for infants with inborn errors of metabolism or low birth weight. Non-compliance renders formulas misbranded or adulterated.
Nutritional Quality Guidelines for Foods
21 CFR Part 104 establishes nutritional quality guidelines for foods, prescribing minimum nutrient levels for food classes. Products complying with guidelines may use a government-approved statement on labeling. The regulation prohibits misleading claims about nutritional differences and requires prominent declarations when nutrients are added at inappropriate levels or in excess of guideline maximums. It establishes uniform fortification principles to maintain desirable nutritional quality in the food supply while preventing random fortification that could cause nutrient imbalances.
Environmental Impact Considerations
21 CFR Part 25 establishes FDA procedures for implementing the National Environmental Policy Act (NEPA), requiring environmental impact assessments for major Federal actions related to FDA-regulated products including drugs, biologics, and medical devices. The regulation defines key NEPA terms and establishes supplemental procedures consistent with FDA's authority under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act.
Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
21 CFR Part 113 establishes regulatory requirements for thermally processed low-acid foods packaged in hermetically sealed containers. The regulation defines key concepts including commercial sterility, aseptic processing, critical factors, and equipment specifications to ensure microorganisms capable of reproducing under normal storage conditions are eliminated, protecting public health and maintaining product safety in shelf-stable food manufacturing.
Regulatory Hearing Before the Food and Drug Administration
21 CFR Part 16 establishes procedures for regulatory hearings before the FDA when the Commissioner considers regulatory actions affecting drugs, devices, food, cosmetics, and tobacco products. Hearings are available under specific statutory provisions including premarket approval withdrawals, device bans, mandatory recalls, investigational device exemptions, and tobacco product orders. The procedures apply when the Commissioner discretionarily offers a hearing or when statutory provisions mandate one, but exclude informal presentations and certain admission refusals.
Color Additives
21 CFR Part 70 establishes federal regulations governing color additives used in foods, drugs, and cosmetics under the Federal Food, Drug, and Cosmetic Act. The regulation defines color additives as dyes, pigments, or synthetic substances capable of imparting color when added to food, drugs, cosmetics, or the human body, and clarifies exemptions for natural food ingredients and substances where color is incidental to primary function. The FDA's Color Certification Branch administers certification procedures for regulated color additives.
Protection of Human Subjects
21 CFR Part 50 establishes requirements for the protection of human subjects in clinical investigations regulated by the FDA. It applies to investigations involving drugs, biological products, medical devices, food additives, dietary supplements, and related products submitted for FDA approval. The regulation defines the scope of coverage, applicable regulatory sections, and key definitions for research and marketing permit applications across multiple FDA-regulated product categories.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
21 CFR Part 117 establishes current good manufacturing practice (CGMP), hazard analysis, and risk-based preventive controls requirements for human food manufacturing, processing, packing, and holding facilities in the US. The regulation defines applicability, key food safety terms (including critical control points, allergen cross-contact, environmental pathogens), and compliance obligations under the Federal Food, Drug, and Cosmetic Act to prevent adulteration and contamination.
Food Labeling
21 CFR Part 101 establishes federal requirements for food labeling on packaged products. It defines the principal display panel as the most prominently displayed label surface and specifies its measurement for rectangular, cylindrical, and irregularly shaped containers. The information panel must appear immediately contiguous to the principal display panel and contain required disclosures in conspicuous, legible text of at least one-sixteenth inch height. These provisions ensure consumers can readily access mandatory nutritional and ingredient information at retail.
Emergency Permit Control
21 CFR Part 108 establishes emergency permit control procedures for food manufacturers, processors, and packers. The FDA Commissioner may issue temporary emergency permits when a facility fails to meet mandatory conditions of applicable food safety regulations. The rule specifies procedures for permit determination, including notification, objection filing within 3 working days, expedited hearings for imminent health hazards, and permit revocation once compliance is demonstrated. Permits remain valid only as long as necessary to protect public health.
General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics
21 CFR Part 81 establishes general specifications and restrictions for provisional color additives used in foods, drugs, and cosmetics under the Color Additive Amendments of 1960. The regulation lists provisionally approved color additives, requires progress reports, and prohibits their use in eye-area products. It also documents termination of provisional listings for specific colors due to safety concerns, including Ext. D&C Yellow Nos. 9 and 10 (due to β-naphthylamine contamination) and FD&C Red No. 1 (due to demonstrated toxicity in animal feeding studies).
Good Laboratory Practice for Nonclinical Laboratory Studies
21 CFR Part 58 establishes Good Laboratory Practice (GLP) standards for nonclinical laboratory studies supporting FDA applications for regulated products including drugs, medical devices, biologics, food and color additives, and electronic products. The regulation ensures quality and integrity of safety data submitted under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act by defining requirements for test articles, control articles, study scope, and application types covered.
Acidified Foods
21 CFR Part 114 establishes current good manufacturing practice requirements for acidified foods—low-acid foods to which acids are added to achieve a finished pH of 4.6 or below. Processors must employ quality control procedures and employ supervisory personnel trained in food handling, pH controls, and acidification. The regulation defines key terms including acidified foods, scheduled processes, and water activity, and exempts certain products like carbonated beverages, jams, and refrigerated foods from coverage.
General Administrative Rulings and Decisions
21 CFR Part 2 establishes FDA administrative procedures for declaring imminent hazards to public health and conducting examination and investigation samples of foods, drugs, and cosmetics. An imminent hazard exists when evidence shows a product poses significant health threat requiring immediate correction. FDA officers collecting official samples must gather at least twice the estimated quantity needed for analysis, with exceptions for limited availability, cost exceeding $150, or samples from importers or labeled manufacturers. The regulation governs sample handling, preservation, and evidentiary retention for enforcement actions under the Federal Food, Drug, and Cosmetic Act.
Listing of Certified Provisionally Listed Colors and Specifications
21 CFR Part 82 establishes specifications and certification requirements for provisionally listed coal-tar colors used in food, drugs, and cosmetics. The regulation defines key terms including alumina, blanc fixe, and gloss white, and sets permissible limits for impurities such as lead, arsenic, and heavy metals in straight colors and certifiable mixtures. It outlines requirements for batch composition, diluent safety, and certification procedures for color products intended for food, drug, and cosmetic applications.
Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
21 CFR Part 110 establishes current good manufacturing practice (CGMP) standards for manufacturing, packing, and holding human food. The regulation defines key terms including acid foods, critical control points, food-contact surfaces, microorganisms, pests, sanitization, and quality control operations. It sets mandatory requirements (indicated by "shall") and advisory procedures to prevent food adulteration and ensure food safety through proper manufacturing and sanitation practices.
Color Additive Certification
21 CFR Part 80 establishes the FDA's color additive certification procedures and fee schedules. Manufacturers must submit certification requests with prescribed samples and fees ($0.45/lb minimum $288 for straight colors; tiered fees for repacks). Requests require duplicate submission, responsible officer signature, and advance deposit option. The regulation governs batch certification, foreign manufacturer requirements, and refund procedures for advance deposits.
Unavoidable Contaminants in Food for Human Consumption and Food-Packaging Material
21 CFR Part 109 establishes the regulatory framework for unavoidable contaminants in food and food-packaging materials. It defines naturally occurring versus added poisonous or deleterious substances, and authorizes the FDA to establish tolerances, regulatory limits, and action levels for contaminants. The regulation distinguishes between substances controlled as food additives under section 409 of the Federal Food, Drug, and Cosmetic Act and those managed through tolerance or action level mechanisms, with EPA typically controlling pesticide residues.
Shell Eggs
21 CFR Part 115 establishes refrigeration requirements for shell eggs held for retail distribution in the United States. Shell eggs must be promptly placed under refrigeration and maintained at or below 7.2°C (45°F) while held at retail establishments, with exemptions for eggs processed to destroy viable Salmonella. The regulation empowers FDA to order diversion or destruction of non-compliant eggs and allows states and localities to assist in enforcement through inspections and administrative remedies.
Foods for Special Dietary Use
21 CFR Part 105 establishes regulatory requirements for foods marketed for special dietary uses, including those for medical conditions, specific age groups, and fortified products. The regulation defines labeling requirements for hypoallergenic foods, infant foods, and weight-management foods, mandating clear ingredient disclosure, allergen source identification, and processing information where applicable.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
21 CFR Part 112 establishes standards for growing, harvesting, packing, and holding of produce for human consumption. It covers raw agricultural commodities including fruits, vegetables, and nuts grown domestically or imported into the US, with specific exemptions for produce rarely consumed raw, farm-direct consumption, and items undergoing commercial processing that reduces microorganisms of public health significance.
Listing of Color Additives Exempt from Certification
21 CFR Part 73 establishes permitted color additives exempt from FDA certification for food use, including diluents in color additive mixtures. It specifies GRAS substances and approved diluents for general food coloring, marking food supplements and produce, and coating shell eggs, with detailed specifications for substances like annatto extract including limits on arsenic and lead contamination.
Patent Term Restoration
This regulation establishes FDA procedures for reviewing patent term restoration applications under 35 U.S.C. 156 for patents related to drugs, medical devices, food additives, and color additives. It defines the FDA's role in determining patent eligibility, calculating regulatory review periods, and adjudicating due diligence challenges through informal hearings.
Hazard Analysis and Critical Control Point (HACCP) Systems
21 CFR Part 120 establishes mandatory Hazard Analysis and Critical Control Point (HACCP) systems for juice processing. The regulation requires all juice sold or used as a beverage ingredient to be processed according to HACCP requirements, with applicability phased in for small and very small businesses between 2002 and 2004. The rule defines key terms including critical control points, critical limits, food hazards, and control measures to prevent biological, chemical, and physical contamination risks.
Color Additive Petitions
21 CFR Part 71 establishes the petition process for proposing color additives for use in foods, drugs, cosmetics, or human body coloring. Petitioners must submit detailed information including the additive's chemical identity, composition, physical and chemical properties, production methods, and safety data. Petitions require specification of intended uses, proposed conditions of use, and supporting toxicological and analytical data to demonstrate safety and suitability for FDA approval.
Enforcement Policy
FDA enforcement policy governing regulatory actions under the Federal Food, Drug, and Cosmetic Act. Establishes procedures for recalls, corrections, and voluntary removals of violative products including foods, drugs, devices, cosmetics, biologics, and tobacco. Defines recall classifications based on health hazard severity and clarifies distinctions between recalls, market withdrawals, and stock recoveries.
Institutional Review Boards
21 CFR Part 56 establishes standards for Institutional Review Boards (IRBs) that oversee clinical investigations of FDA-regulated products including drugs, medical devices, biological products, foods, dietary supplements, and electronic products. The regulation defines the composition, operation, and responsibilities of IRBs to protect the rights and welfare of human research subjects.
Listing of Color Additives Subject to Certification
21 CFR Part 74 establishes regulations for certified color additives used in food, including dietary supplements. The regulation specifies identity requirements, purity specifications, permissible uses, and labeling standards for FD&C Blue No. 1 and FD&C Blue No. 2. These synthetic dyes must meet strict composition and contamination limits for volatile matter, impurities, heavy metals (chromium, manganese, arsenic, lead), and total color content, and all batches require certification per 21 CFR Part 80.
General
This regulation establishes procedures for states and political subdivisions to petition the FDA for exemption from federal food labeling and composition preemption under the Federal Food, Drug, and Cosmetic Act. States may request exemptions if their requirements do not conflict with federal law, do not unduly burden interstate commerce, and address specific information needs not met by federal requirements. Petitions must demonstrate state authority, preemption applicability, and that requirements differ from federal standards.
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
21 CFR Part 111 establishes Current Good Manufacturing Practice (CGMP) requirements for dietary supplement manufacturers, packagers, labelers, and distributors in the US. The regulation applies to all entities manufacturing or importing dietary supplements, with exemptions for retail-only storage. Key definitions include batch/lot identification, component specifications, in-process materials, and microorganism standards to ensure product identity, purity, strength, and composition.
Common or Usual Name for Nonstandardized Foods
This FDA regulation establishes requirements for the common or usual names of nonstandardized foods. Names must accurately describe the basic nature and characterizing properties of foods in simple, direct terms and be uniform across identical products. When characterizing ingredients materially affect price or consumer perception, their percentage must be declared on the principal display panel in specified font sizes and format. Presence or absence of key ingredients must also be disclosed when it could mislead consumers about the product's composition.
Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications
21 CFR Part 106 establishes current good manufacturing practice (cGMP), quality control, and quality factor requirements for infant formula manufacturers under the Federal Food, Drug, and Cosmetic Act. Manufacturers must comply with processing standards, quality factors, and record-keeping procedures; non-compliance renders formula adulterated. The regulation mandates manufacturer registration, submission, and notification to the FDA.
Dietary Supplements That Present a Significant or Unreasonable Risk
This regulation designates dietary supplements containing ephedrine alkaloids as adulterated products under the Federal Food, Drug, and Cosmetic Act because they present an unreasonable risk of illness or injury under recommended or ordinary conditions of use.
General Enforcement Regulations
General enforcement regulations under the Federal Food, Drug, and Cosmetic Act establishing that FDA regulations apply to causing prohibited acts, defining key terms like labeling and label, and clarifying the agency's statutory authorities for food, drug, and cosmetic regulation including provisions on package labeling and net quantity declarations.
Production, Storage, and Transportation of Shell Eggs
21 CFR Part 118 establishes production, storage, and transportation requirements for shell eggs from farms with 3,000 or more laying hens. Covered producers must implement biosecurity programs to prevent Salmonella Enteritidis contamination, maintain proper refrigeration, conduct flock testing, and comply with registration requirements unless eggs receive approved antimicrobial treatment. Requirements apply to farms, shell egg processing facilities, and transporters handling eggs for the table market.
Prior-Sanctioned Food Ingredients
21 CFR Part 181 establishes regulatory procedures for food ingredients with prior FDA or USDA approval before September 6, 1958. These prior-sanctioned ingredients are exempt from food additive classification but remain subject to safety review. The FDA may impose limitations, conditions, or prohibitions on use if scientific evidence shows potential health risks, and may issue emergency action levels pending final regulations.
Food Additive Petitions
21 CFR Part 171 establishes procedural requirements for petitions requesting approval of food additives under section 409(b) of the Federal Food, Drug, and Cosmetic Act. Petitioners must submit detailed information on the additive's chemical identity, composition, manufacturing process, analytical controls, stability data, and safety assessments to the FDA's Office of Food Additive Safety. Submissions must be in triplicate (or quadruplicate for meat/poultry uses) with English translations of foreign materials and supporting documentation.
Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers
21 CFR Part 178 establishes regulations for indirect food additives used as adjuvants, production aids, and sanitizers. It permits hydrogen peroxide solution (max 35% by weight) to sterilize food-contact polymeric surfaces with residue limits not exceeding 0.5 ppm, and allows sanitizing solutions containing hypochlorite compounds on food-processing equipment and utensils, subject to adequate drainage before food contact.
Food Additives Permitted for Direct Addition to Food for Human Consumption
21 CFR Part 172 establishes regulations for food additives permitted for direct addition to human food. The regulation prescribes general provisions requiring additives be used only in quantities necessary to achieve their intended effect and meet food-grade standards. Subpart B details specific approvals, including anoxomer (CAS 60837-57-2), a polymeric antioxidant permitted for use in fats and oils up to 5,000 ppm, subject to defined purity, molecular weight, and heavy metal specifications.
Mitigation Strategies to Protect Food Against Intentional Adulteration
21 CFR Part 121 establishes mitigation strategies to protect food against intentional adulteration. It applies to domestic and foreign food facilities that manufacture, process, pack, or hold food for U.S. consumption and are required to register under the Federal Food, Drug, and Cosmetic Act. The rule defines key terms including actionable process steps, food defense, contaminants (biological, chemical, physical, or radiological agents), and verification/monitoring requirements to ensure mitigation strategies operate as intended.
Frozen Desserts
21 CFR Part 135 establishes federal standards for frozen desserts, particularly ice cream and frozen custard. Ice cream must contain minimum 10% milkfat and 10% nonfat milk solids, weigh at least 4.5 pounds per gallon with 1.6 pounds of total solids, and contain less than 1.4% egg yolk solids (except frozen custard at 1.4% minimum). Products must be made from pasteurized mixes heated to specified temperatures and may include optional dairy ingredients, sweeteners, and safe flavoring ingredients.
Food Additives Permitted in Food or in Contact with Food on an Interim Basis Pending Additional Study
21 CFR Part 180 establishes the regulatory framework for interim approval of food additives and food-contact substances when new safety or functionality concerns arise but evidence does not conclusively prove harm. Interim regulations permit continued use during study periods, subject to specified limitations, mandatory progress reporting every six months, and compliance with good laboratory practice standards. The FDA may revoke interim approvals if adequate studies are not initiated within 60 days or if interim results indicate health hazards.
Sweeteners and Table Sirups
21 CFR Part 168 establishes standardized specifications for sweeteners and table syrups, including dextrose anhydrous, dextrose monohydrate, and glucose syrup. Requirements cover minimum solids content, reducing sugar content, sulfated ash limits, and sulfur dioxide content, with testing methods referenced from AOAC official methods.
Indirect Food Additives: Polymers
21 CFR Part 177 establishes safety standards for acrylic and modified acrylic plastics used in food contact applications. The regulation permits semirigid and rigid acrylic polymers as articles or components in contact with food, provided they contain at least 50% polymer units from specified acrylic or methacrylic monomers. Optional additives include GRAS substances and approved compounds; specific monomers and copolymers are listed, with restrictions on minor monomers for repeated-use articles only.
Bakery Products
21 CFR Part 136 establishes federal standards for bakery products, particularly bread, rolls, and buns. It defines product categories by weight post-cooling, specifies mandatory and optional ingredients (flour, yeast, water, milk, eggs, sweeteners, etc.), sets minimum total solids content at 62%, and limits certain additives like monocalcium phosphate and carrageenan. All ingredients must be safe and suitable for consumption.
Indirect Food Additives: Paper and Paperboard Components
21 CFR Part 176 establishes safety standards for indirect food additives used as components in paper and paperboard intended for food contact. The regulation permits specific substances—including acrylamide-acrylic acid resins, alkyl ketene dimers, anti-offset agents, chelating agents, and chromium complexes—for use in paper manufacturing under defined conditions and concentration limits to prevent chemical migration into food while maintaining packaging performance.
Processing and Bottling of Bottled Drinking Water
21 CFR Part 129 establishes current good manufacturing practice requirements for processing and bottling of bottled drinking water. The regulation mandates that facilities use approved water sources, maintain sanitary conditions throughout processing, bottling, holding, and shipping, and implement controls ensuring product safety. Key requirements include plant construction standards with separated bottling rooms, proper ventilation, enclosed container washing areas, and use of nontoxic materials for water-contact surfaces.
Canned Fruit Juices
21 CFR Part 146 establishes federal standards for canned fruit juices, including definitions of ingredients (corn syrup, dextrose, glucose syrup, invert sugar, refined sugar) and compliance procedures. It specifies sampling and acceptance criteria for quality and container fill, with detailed lot definitions and defective unit classifications. The regulation includes specific identity standards for lemon juice requiring mechanical extraction from mature lemons with minimum soluble solids content.
Indirect Food Additives: General
21 CFR Part 174 establishes general regulatory provisions for indirect food additives—substances used in food-contact articles such as packaging and processing equipment. It defines good manufacturing practice requirements, including limits on additive migration into food and purity standards for components. The regulation permits use of substances generally recognized as safe, those with prior approval, and those meeting negligible migration thresholds, provided they comply with all applicable Federal Food, Drug, and Cosmetic Act provisions.
Macaroni and Noodle Products
21 CFR Part 139 establishes standards of identity and labeling requirements for macaroni and noodle products. It defines macaroni, spaghetti, and vermicelli based on shape and diameter, specifies permitted optional ingredients including egg white, disodium phosphate, seasonings, salt, gum gluten, and glyceryl monostearate with quantitative limits, and requires labeling statements disclosing optional ingredients used in the finished product.
Secondary Direct Food Additives Permitted in Food for Human Consumption
21 CFR Part 173 establishes permitted secondary direct food additives for human consumption, including polymer substances and adjuvants. The regulation specifies acrylate-acrylamide resins, modified polyacrylamide resins, and ion-exchange membranes as safe food processing additives with defined usage limits and residual monomer restrictions. Acrylamide-based resins are approved as flocculents in sugar juice clarification and scale control, while ion-exchange membranes are permitted for juice processing and pH adjustment.
Cereal Flours and Related Products
21 CFR Part 137 establishes standardized requirements for cereal flours and related products. The regulation defines wheat flour specifications including granulation standards (≥98% passing 212 µm sieve), ash and protein limits, moisture content (≤15%), and permitted optional ingredients such as dough conditioners (ascorbic acid up to 200 ppm) and bleaching agents (chlorine, benzoyl peroxide, azodicarbonamide, etc.). All ingredients must be labeled per FDA requirements, with specific declarations required for bleached flour and enzyme additions.
Food Additives
21 CFR Part 170 establishes regulatory definitions and general provisions governing food additives under the Federal Food, Drug, and Cosmetic Act. A food additive is any substance not exempted by law whose intended use may result in it becoming a component of food or affecting food characteristics, including substances in food contact articles and packaging materials. The regulation defines key terms including food contact substances, common use in food, and safety standards requiring reasonable certainty of harmlessness under conditions of intended use, determined through scientific procedures or general recognition of safety.
Fish and Fishery Products
21 CFR Part 123 establishes food safety regulations for fish and fishery products, defining key terms and concepts including critical control points, critical limits, food safety hazards, and preventive measures. The regulation applies to processors engaged in commercial handling, preparation, manufacturing, and preservation of fish and molluscan shellfish intended for human consumption, but exempts harvesting, on-vessel preparation, and retail establishments.
Fish and Shellfish
21 CFR Part 161 establishes standards of identity and labeling requirements for fish and shellfish products, particularly oysters. The regulation specifies that canned oysters must be labeled with accurate total weight declarations and sets detailed processing standards for raw, shucked oysters, including water contact time limits (max 30 minutes), draining procedures, and packing requirements to ensure product quality and consumer safety.
Beverages
21 CFR Part 165 establishes standards for beverages, particularly bottled water. It defines key terms such as lot, sample, and analytical unit for quality testing purposes. Bottled water is defined as water sealed in containers with no added ingredients except optional safe antimicrobial agents and fluoride. The regulation specifies nomenclature for different water types including artesian, ground, mineral, and purified water, with specific chemical and source requirements for each category.
Fruit Butters, Jellies, Preserves, and Related Products
21 CFR Part 150 establishes standards of identity for fruit butters, jellies, preserves, and related products. Fruit butters must be smooth, semisolid foods made from specified fruit ingredients with optional additions such as sweeteners, spices, flavorings, salt, acidifying agents, juice, preservatives, antifoaming agents, and pectin. The mixture must contain at least five parts fruit ingredient to two parts sweetener by weight, with a minimum soluble solids content of 43 percent as determined by refractometer analysis.
Irradiation in the Production, Processing and Handling of Food
21 CFR Part 179 establishes safety standards for using ionizing radiation sources in food production, processing, and inspection. Approved sources include X-ray tubes (≤500 kVp), sealed isotope units (americium-241, cesium-137, cobalt-60, iodine-125, krypton-85, radium-226, strontium-90), californium-252 for moisture measurement, and machine sources up to 10 MeV. Facilities must comply with current good manufacturing practices, apply minimum effective doses not exceeding specified limits (10 grays for standard sources, 2 milligrays for californium-252), use scheduled processes, and ensure packaging compliance.
Milk and Cream
21 CFR Part 131 establishes standards of identity and labeling requirements for milk and cream products in the US. The regulation defines milk as lacteal secretion from healthy cows with minimum 8.25% milk solids not fat and 3.25% milkfat, requiring pasteurization or ultra-pasteurization for beverage use. Cream must contain at least 18% milkfat. The standards specify optional vitamin A and D fortification, permitted ingredients including fruit flavoring and stabilizers, and analytical methods for verifying composition, with detailed nomenclature and labeling requirements.
Canned Vegetables
21 CFR Part 155 establishes standards for canned vegetables, including procedures for determining drained weight, quality compliance, fill of container, and sampling/acceptance criteria. The regulation defines lot compliance based on defect limits, establishes sampling plans and acceptance numbers, and specifies color measurement standards using Munsell color discs for products like tomato concentrates.
Food Standards: General
21 CFR Part 130 establishes general provisions for food standards under the Federal Food, Drug, and Cosmetic Act. It defines key terms, procedures for establishing food standards through formal petition and public hearing processes, and FDA's review framework for Codex Alimentarius standards. All standardized foods must comply with ingredient listing requirements, use only safe and suitable ingredients, and cannot be adulterated or misbranded regardless of compliance with specific food definitions.
Indirect Food Substances Affirmed as Generally Recognized as Safe
21 CFR Part 186 establishes the regulatory framework for indirect food substances affirmed as Generally Recognized as Safe (GRAS) by the FDA. These substances migrate into food from food-contact surfaces such as packaging and containers, and must comply with specified purity standards and current good manufacturing practices. Use is limited to indirect food contact and is prohibited where it may deceive consumers or violate the Federal Food, Drug, and Cosmetic Act.
Substances Generally Recognized as Safe
21 CFR Part 182 establishes FDA regulations for substances generally recognized as safe (GRAS) for use in food. The regulation defines GRAS status, outlines good manufacturing practice requirements including quantity restrictions and food-grade purity standards, and lists approved food ingredients such as spices, essential oils, natural extractives, and synthetic flavoring substances that may be used in accordance with the established guidelines.
Vegetable Juices
21 CFR Part 156 establishes standards for vegetable juices, defining quality and composition metrics including color strength (measured by Munsell color disc comparison), tomato soluble solids content (determined by refractive index), and salt content (sodium chloride). The regulation specifies sampling and acceptance procedures to determine compliance with quality and fill standards for lots of canned vegetable juice products.
Dietary Supplements
21 CFR Part 190 establishes premarket notification requirements for dietary supplements containing new dietary ingredients not previously present in the food supply. Manufacturers or distributors must submit safety information to FDA at least 75 days before introducing such products to interstate commerce, including ingredient identification, usage conditions, safety history, and published evidence supporting safety conclusions. FDA acknowledges receipt and assigns a filing date; the product cannot be marketed during the 75-day review period unless FDA determines no safety concern exists.
Frozen Vegetables
21 CFR Part 158 establishes standards for frozen vegetables, specifically defining identity, size specifications, and labeling requirements. Frozen peas must be prepared from Pisum sativum L., blanched, drained, and frozen to −18 °C or lower. Standards address acceptable quality levels, defect criteria, size grading (minimum 80% by weight of declared size), and mandatory label declarations including product name, freezing method, flavoring, and condiments.
Cacao Products
21 CFR Part 163 establishes standards for cacao products, including specifications for cacao nibs. The regulation prescribes analytical methods for determining shell and fat content, defines cacao nibs as shelled cacao beans with maximum 1.75% shell content, permits optional alkali processing and neutralizing agents within specified limits, and requires labeling statements identifying processing methods used.
Indirect Food Additives: Adhesives and Components of Coatings
21 CFR Part 175 establishes safety standards for indirect food additives used in adhesives and coatings that contact food through packaging. Adhesives may be safely used in food packaging if they contain approved substances, remain separated from food by a functional barrier or meet contact limits, and are properly labeled. Pressure-sensitive adhesives for labels and tapes on poultry, dry foods, and processed fruits/vegetables must be formulated from safe substances or prior-approved components, with specified limits on antioxidants, optical brighteners, and photoinitiators.
Food Dressings and Flavorings
21 CFR Part 169 establishes food safety standards for dressings and flavorings. It defines vanilla beans, unit weights, and vanilla constituents for flavoring use. Mayonnaise standards require minimum 65% vegetable oil, specified acidifying ingredients (vinegar or citrus juice at ≥2.5% acidity), egg-derived ingredients, and permitted optional additives including salt, sweeteners, and spices, with all ingredients required to be safe and suitable.
Cheeses and Related Cheese Products
21 CFR Part 133 establishes federal standards of identity and compositional requirements for cheeses and related cheese products, including definitions of milk, cream, and pasteurization standards. It specifies analytical methods for measuring moisture, milkfat, and phosphatase levels in cheeses and requires proper labeling of pasteurized process cheese products with equal prominence of all name components.
Direct Food Substances Affirmed as Generally Recognized as Safe
21 CFR Part 184 establishes the regulatory framework for direct food substances affirmed as generally recognized as safe (GRAS) by the FDA. Ingredients listed must be used in accordance with current good manufacturing practice, appropriate food grade standards, and prescribed conditions of use. The regulation specifies that GRAS affirmation may be limited by food category, functional use, or usage level, and any use outside these limitations requires separate food additive authorization.
Canned Fruits
21 CFR Part 145 establishes federal standards of identity and quality for canned fruits. It defines key ingredients and processing terms including corn sirup, glucose sirup, invert sugar sirup, fruit juice, and packing media. The regulation specifies compositional requirements, density measurement procedures, and labeling standards to ensure safety and consistency in canned fruit products.
Substances Prohibited from Use in Human Food
21 CFR Part 189 prohibits specified substances from use in human food due to public health risks or insufficient safety data. It establishes rules for prohibited cattle materials, including specified risk materials (brain, spinal cord, eyes), small intestine, material from nonambulatory disabled cattle, and mechanically separated beef. Certain tallow and derivatives are permitted if they meet purity standards. The FDA may modify the prohibited list based on new scientific evidence.
Margarine
21 CFR Part 166 establishes labeling requirements for margarine and oleomargarine products. Manufacturers must display the word "margarine" or "oleomargarine" prominently on all package panels in type at least as large as any other label text, meeting specific height, area, and boldness criteria. Products must comply with identity standards and include full ingredient statements. Requirements apply to both colored and uncolored margarine sold in interstate commerce.
Eggs and Egg Products
21 CFR Part 160 establishes standards of identity and composition for eggs and egg products, including dried eggs and frozen eggs. Dried eggs must contain at least 95% egg solids and be free of viable Salmonella, with optional glucose removal via enzyme or yeast procedures and anticaking agents (silicon dioxide ≤1% or sodium silicoaluminate <2%). Frozen eggs must similarly be Salmonella-free and may contain monosodium or monopotassium phosphate (≤0.5% by weight). All ingredients must be labeled.
Tree Nut and Peanut Products
21 CFR Part 164 establishes standardized definitions and labeling requirements for mixed nuts products. Mixed nuts must contain at least three to four shelled tree nut and/or peanut ingredients in specified varieties, with each ingredient comprising 2-80% by weight. The regulation prescribes labeling requirements, including disclosure of predominant nut ingredients exceeding 50% by weight, and testing procedures to verify compliance with composition and fill standards.
Receipt of Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities-March 2026
This document announces the Agency's receipt of and solicits public comment on initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities. The Agency is providing this notice in accordance with the Federal Food, Drug, and Cosmetic Act (FFDCA). EPA uses the month and year in the title to identify when the Agency compiled the petitions identified in this notice of filing. Unit II. of this document identifies certain petitions received in 2024 and 2025 that are currently being evaluated by EPA, along with information about each petition, including who submitted the petition and the requested action.
Nestlé to Produce 1.5 Billion KitKat Bars with Regeneratively Farmed Wheat
Nestlé announced a partnership to produce 1.5 billion KitKat bars using regeneratively farmed wheat, supporting sustainable agriculture practices in food manufacturing.
Qualifying Pathogens
21 CFR Part 317 defines 'qualifying pathogens' under the Federal Food, Drug, and Cosmetic Act—microorganisms posing serious public health threats for which expedited drug development pathways apply. The regulation lists 21 qualifying pathogens including Mycobacterium tuberculosis, Staphylococcus aureus, and Streptococcus pneumoniae.
Antidiarrheal Drug Products for Over-the-Counter Human Use
This regulation establishes standards for over-the-counter antidiarrheal drug products for oral use. It defines antidiarrheal drugs as those treating diarrhea symptoms and identifies bismuth subsalicylate and kaolin as approved active ingredients. The regulation mandates specific labeling requirements including use statements, warnings about contraindications (bloody/black stool, fever, mucus in stool, ulcers, bleeding disorders), and special warnings for bismuth subsalicylate products including Reye's syndrome caution and salicylate allergy alerts.
Animal Food Labeling
This regulation establishes labeling requirements for packaged animal food, defining the principal display panel as the most visible label area and specifying its measurement for different container shapes. It requires all mandatory label information to appear prominently on either the principal display panel or information panel (positioned to its right), with minimum type size of 1/16 inch for legibility and conspicuousness.
Anticaries Drug Products for Over-the-Counter Human Use
FDA regulation 21 CFR Part 355 establishes standards for over-the-counter anticaries drug products for topical use on teeth. The regulation defines allowable active ingredients (primarily sodium fluoride), dosage forms (dentifrices, treatment rinses, preventive gels), and fluoride concentrations to prevent dental cavities. Products meeting these requirements are recognized as safe and effective.
Current Good Manufacturing Practice for Medicated Feeds
21 CFR Part 225 establishes current good manufacturing practice (CGMP) standards for medicated feeds to ensure drug safety, identity, strength, quality, and purity. The regulation applies to all facilities and equipment used in medicated feed production, requires qualified personnel with adequate training and supervision, and mandates proper building construction, maintenance, and sanitation to prevent contamination and pest infestation.
Miscellaneous External Drug Products for Over-the-Counter Human Use
FDA regulation 21 CFR Part 358 establishes requirements for over-the-counter wart remover drug products. Approved active ingredients are salicylic acid at specified concentrations in plaster or collodion-like vehicles. The regulation mandates labeling requirements including indications for common and plantar warts, warnings against use on irritated skin, diabetics, and certain wart types, and storage/application directions. Products must comply with general OTC drug standards and misbranding prohibitions.
General
21 CFR Part 500 establishes administrative rulings on food and animal drug manufacturing. It requires thermally processed low-acid foods in hermetically sealed containers to comply with processing and emergency permit regulations. Anthelmintic drugs for animals must include labeling directing users to consult veterinarians for parasitism diagnosis and treatment. Timed-release animal drugs are classified as new animal drugs requiring FDA approval or index listing to ensure safe and effective ingredient release rates.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
This regulation establishes current good manufacturing practice (CGMP), hazard analysis, and risk-based preventive controls for animal food facilities in the US. It defines applicability criteria, prohibits operation of non-compliant animal food manufacturing facilities, and establishes requirements for hazard analysis and preventive controls. Facilities manufacturing both human and animal food may comply with human food standards instead if requirements are met.
Antacid Products for Over-the-Counter (OTC) Human Use
21 CFR Part 331 establishes standards for over-the-counter antacid products suitable for oral administration. It specifies permitted active ingredients (aluminum, magnesium, calcium, bismuth, bicarbonate, citrate, phosphate, and potassium compounds), minimum acid-neutralizing capacity requirements (5 meq), dosage limits by age group where applicable, and ingredient contribution thresholds (minimum 25% of total capacity). Products must comply with general OTC drug conditions under 21 CFR 330.1.
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
21 CFR Part 341 establishes safety and efficacy standards for over-the-counter cold, cough, allergy, bronchodilator, and antiasthmatic drug products in oral, inhalant, or topical forms. It defines product categories, lists approved active ingredients (including antihistamines, antitussives, and bronchodilators), and sets conditions for marketing these products without misbranding.
Common or Usual Names for Nonstandardized Animal Foods
21 CFR Part 502 establishes requirements for common or usual names of nonstandardized animal foods. Manufacturers must use simple, accurate names that identify the food's basic nature and characterizing properties. Percentage declarations of key ingredients and statements about ingredient presence or absence are required when they materially affect price, consumer acceptance, or could otherwise mislead consumers. Font size and placement requirements apply to percentage and presence/absence declarations on product labels.
New Animal Drugs
21 CFR Part 510 establishes regulatory definitions and general provisions for new animal drugs under the Federal Food, Drug, and Cosmetic Act. A new animal drug is defined as any drug intended for animals other than humans that is not generally recognized as safe and effective by qualified experts, or has been investigated for safety and effectiveness but not materially used. Newness can arise from new active substances, new combinations, new proportions, new animal species, new therapeutic uses, or new dosages and administration methods.
Unavoidable Contaminants in Animal Food and Food-Packaging Material
21 CFR Part 509 establishes the regulatory framework for managing unavoidable contaminants in animal food and food-packaging materials. It defines naturally occurring versus added poisonous or deleterious substances, and authorizes the FDA to establish tolerances, regulatory limits, and action levels for contaminants. The regulation specifies procedures for setting contamination thresholds at which food is deemed adulterated and requires public notice and comment for action level changes.
Miscellaneous Internal Drug Products for Over-the-Counter Human Use
21 CFR Part 357 establishes regulatory standards for over-the-counter anthelmintic drug products for oral administration. The regulation specifies that pyrantel pamoate is the approved active ingredient for treating pinworm infections. It defines labeling requirements including product identity, indications, warnings about potential side effects and contraindications (pregnancy, liver disease), dosage instructions based on body weight, and mandatory consumer package insert information covering pinworm identification, symptoms, life cycle, and transmission prevention.
Topical Antimicrobial Drug Products for Over-the-Counter Human Use
This regulation establishes standards for over-the-counter topical antimicrobial first aid antibiotic drug products, specifying approved active ingredients (bacitracin, neomycin sulfate, chlortetracycline hydrochloride, tetracycline hydrochloride, polymyxin B sulfate) and their permitted concentrations in ointment, cream, aerosol, and powder forms, as well as allowed combinations of these ingredients for treating minor cuts, scrapes, and burns.
Resin Acids, Esters With Glycerol in Pesticide Formulations; Exemption From the Requirement for a Tolerance
This regulation establishes an exemption from the requirement of a tolerance for residues of resin acids, esters with glycerol (CAS Reg. No. 8050-31-5) when used as an inert ingredient (surfactant) on growing crops and raw agricultural commodities pre- and post-harvest. Croda Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of resin acids, esters with glycerol when used in accordance with the terms of the exemption.
United States Department of Justice and Parties to Certain Litigation; Transfer of Information Potentially Containing Confidential Business Information
The EPA will transfer pesticide-related information submitted under FIFRA and FFDCA to the DOJ and litigation parties, including data claimed as confidential business information, in accordance with CBI disclosure regulations.
Sodium Nitrate in Pesticide Formulations; Exemption From the Requirement of a Tolerance
EPA establishes an exemption from tolerance requirements for sodium nitrate residues used as an inert ingredient in pesticide fumigant canisters applied post-harvest to raw agricultural commodities in sealed warehouses under 40 CFR 180.910, eliminating the need to set maximum permissible residue levels. The regulation also corrects a typographical error in the CAS number for d-Alpha tocopherol.
Receipt of Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities-February 2026
EPA notice announcing receipt of pesticide residue petitions and soliciting public comment on requests to establish or modify regulations for pesticide residues in various commodities under the Federal Food, Drug, and Cosmetic Act. The notice identifies petitions received in 2023–2026 currently under EPA evaluation.
Pydiflumetofen; Pesticide Tolerances
EPA establishes maximum permissible residue tolerances for pydiflumetofen on sugarcane and cane commodities. Syngenta Crop Protection petitioned under the FFDCA for these tolerance levels to permit lawful pesticide use on the specified food and feed crops.