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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.
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.
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.
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.
Labeling
FDA regulation 21 CFR 201.1 establishes labeling requirements for finished pharmaceutical drug products, mandating that labels conspicuously display the manufacturer's, packer's, or distributor's name and place of business. The rule defines manufacturer status based on performance of specific operations including mixing, tableting, encapsulating, sterilizing, and filling; allows shared manufacturing designations when multiple parties perform different operations; and clarifies that certain contracted operations (soft-gelatin encapsulation, aerosol filling, sterilization by irradiation, lyophilization, and ethylene oxide sterilization) do not disqualify primary manufacturer designation.
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.
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.
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 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.
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.
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.
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 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.
Imprinting of Solid Oral Dosage Form Drug Products for Human Use
21 CFR Part 206 requires manufacturers to imprint solid oral dosage form drug products (tablets, capsules) with identification codes via embossing, debossing, engraving, or printing. The rule applies to prescription, over-the-counter, biological, and homeopathic drugs unless exempted. Exemptions include clinical investigation drugs, bioequivalence study drugs, extemporaneously compounded drugs, radiopharmaceuticals, and products where imprinting is technologically infeasible due to size or physical characteristics.
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.
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.
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.
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.
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.
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 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.
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.
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.
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: 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.
Joint Statement on Asbestos in Consumer Products
Joint Statement from OPSS, UKHSA and HSE.
Compliance with BAT-AELs for indirect emissions to water at chemical waste treatment installations: RPS 371
Environment Agency regulatory position on when you cannot comply with best available techniques associated emission limits (BAT-AELs) for certain substances discharged to sewer at chemical waste treatment installations.
Assessment and rating of noise from wind turbines: guidance
This report provides technical guidance for assessing and controlling operational noise from wind turbines.
Assessment and rating of wind turbine noise guidance: proposed updates
We're seeking views on updates to guidance on the assessment of noise from onshore wind turbines across the UK.
Grenfell Tower Inquiry Government Progress Report: May 2026
Report on the government’s progress in implementing the Grenfell Tower Inquiry Phase 2 recommendations.
Non-domestic Private Rented Sector minimum energy efficiency standards: EPC B implementation
We're seeking views on the government's proposed framework to improve implementation and enforcement of the EPC B target by 2030 for privately rented non-domestic buildings.
Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded
21 CFR Part 330 establishes requirements for over-the-counter human drugs to be recognized as safe, effective, and not misbranded. OTC drugs must comply with current good manufacturing practices, be manufactured at registered establishments, meet labeling requirements under the Federal Food, Drug, and Cosmetic Act, contain only safe inactive ingredients, and include required warnings such as keeping products out of reach of children and overdose instructions.
Special Requirements for Specific Human Drugs
This regulation establishes special requirements for specific human drugs under 21 CFR Part 250. It designates thyroid-containing drug preparations combined with central nervous system stimulants as misbranded when marketed for obesity treatment unrelated to hypothyroidism, finding no medical rationale for such use in patients with normal thyroid function. Additionally, stramonium preparations are regarded as misbranded if labeled for self-medication due to documented abuse potential and serious toxic effects including delirium and coma from oral ingestion.
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.
Anorectal Drug Products for Over-the-Counter Human Use
This FDA regulation (21 CFR Part 346) establishes standards for over-the-counter anorectal drug products for external or rectal use. It defines permitted active ingredients including local anesthetics (benzocaine, lidocaine, tetracaine), vasoconstrictors (ephedrine, epinephrine, phenylephrine), and protectants (petrolatum, mineral oil, lanolin, cocoa butter), with specified concentration ranges for safety and efficacy in treating symptoms of anorectal disorders.
Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
21 CFR Part 210 establishes minimum current good manufacturing practice (cGMP) standards for the manufacture, processing, packing, and holding of drugs to ensure safety, identity, strength, quality, and purity. Non-compliance renders drugs adulterated and subjects responsible persons to regulatory action. Requirements apply to drug manufacturers, human cell/tissue product handlers, and biological product producers, with exemptions for certain phase 1 investigational drugs.
Current Good Manufacturing Practice for Medical Gases
21 CFR Part 213 establishes current good manufacturing practice (cGMP) requirements for the preparation of designated medical gases for human and animal administration. The regulation defines key terms including batches, lots, components, acceptance criteria, and lot numbering requirements. It applies to manufacturers and processors involved in liquefied, nonliquefied, or cryogenic medical gas production, packaging, labeling, testing, and quality control operations.
Antiemetic Drug Products for Over-the-Counter Human Use
21 CFR Part 336 establishes standards for over-the-counter antiemetic drug products in oral form. Approved active ingredients are cyclizine hydrochloride, dimenhydrinate, diphenhydramine hydrochloride, and meclizine hydrochloride, each with specific dosage limits and age restrictions. Products must be labeled as antiemetics for motion sickness prevention and treatment, with warnings regarding breathing problems, glaucoma, urinary difficulties, age restrictions, and drowsiness risks.
Current Good Manufacturing Practice for Positron Emission Tomography Drugs
Current Good Manufacturing Practice (CGMP) regulations for positron emission tomography (PET) drugs under 21 CFR Part 212. Establishes definitions and requirements for manufacturing PET drugs, including specifications for active pharmaceutical ingredients, batch production and control records, master production procedures, quality acceptance criteria, and final release authorizations by responsible persons in PET production facilities.
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.
External Analgesic Drug Products for Over-the-Counter Human Use
This FDA regulation establishes safety, efficacy, and labeling standards for over-the-counter external analgesic drug products for topical use, specifically male genital desensitizers containing benzocaine (3-7.5%) or lidocaine (metered spray ~10mg). Products must include required labeling for indications, warnings about potential rashes or irritation, and specific application directions, with mandatory disclosure that premature ejaculation may require medical supervision.
Interpretative Statements Re Warnings on Drugs and Devices for Over-the-Counter Sale
21 CFR Part 369 provides interpretative guidance on warning and caution statements for over-the-counter drugs and devices subject to the Federal Food, Drug, and Cosmetic Act. It establishes definitions, clarifies labeling requirements, and suggests warning language to help manufacturers ensure adequate user protection. The regulation emphasizes manufacturer responsibility for compliance and notes that suggested warnings are illustrative, not exhaustive.
Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely]
This regulation establishes standards for over-the-counter sunscreen drug products, including definitions of sun protection factor (SPF) categories, permitted active ingredients with concentration limits (such as titanium dioxide, zinc oxide, avobenzone, and oxybenzone), and testing procedures to ensure safety and efficacy for topical use.
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.
Current Good Manufacturing Practice for Finished Pharmaceuticals
21 CFR Part 211 establishes minimum current good manufacturing practice (cGMP) standards for finished pharmaceutical drug products for human and animal use. The regulation requires establishment of a quality control unit with authority to approve/reject components, containers, in-process materials, and finished products; mandates adequate laboratory facilities for testing; and requires personnel to have appropriate education, training, and experience in manufacturing operations and cGMP requirements.
Antiperspirant Drug Products for Over-the-Counter Human Use
FDA regulation 21 CFR Part 350 establishes safety, efficacy, and labeling standards for over-the-counter antiperspirant drug products. The regulation specifies permitted active ingredients (aluminum and aluminum-zirconium compounds) at defined concentration limits, requires proper product identification and indications labeling, and references compliance with general OTC drug provisions under 21 CFR Part 330.
Skin Protectant Drug Products for Over-the-Counter Human Use
21 CFR Part 347 establishes standards for over-the-counter skin protectant drug products, including lip balms and products for poison ivy/oak/sumac dermatitis. The regulation defines permitted active ingredients (such as allantoin, calamine, cocoa butter, dimethicone, glycerin, lanolin, mineral oil, petrolatum, zinc oxide) with specified concentration ranges, and astringent active ingredients (aluminum acetate, aluminum sulfate, witch hazel). Manufacturers must comply with labeling and combination requirements to be deemed safe and effective.
Current Good Manufacturing Practice for Type a Medicated Articles
21 CFR Part 226 establishes current good manufacturing practice (CGMP) requirements for Type A medicated articles used in animal feeds. The regulation mandates that manufacturers maintain adequate personnel qualifications, facility construction and maintenance standards, and equipment controls to ensure products meet safety, identity, strength, quality, and purity specifications. Requirements include proper building design with adequate space for segregated operations, appropriate environmental controls, and facility maintenance protocols to prevent contamination and cross-mixing of products.
Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use
21 CFR Part 343 establishes standards for over-the-counter analgesic, antipyretic, and antirheumatic drug products for oral use in humans. The regulation identifies aspirin and buffered aspirin as permitted active ingredients for cardiovascular and rheumatologic use, specifies requirements for product combinations with antacids, mandates dissolution testing standards, and prescribes detailed professional labeling requirements including comprehensive prescribing information with standardized section headings and content.