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Standards & conformity
Toutes les réglementations du corpus Vantage taguées avec standards. Les éléments sont tagués par le cron d'enrichissement dès leur arrivée, plus toute attribution thématique pré-renseignée par le connecteur.
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Ouvrir dans le navigateur →Using unbound incinerator bottom ash aggregate in construction: RPS 325
Environment Agency regulatory position on using unbound incinerator bottom ash aggregate (IBAA) in construction.
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.
Plug-in solar: Regulatory amendment and interim product specification
We're seeking views on proposals to enable the safe and legal use of plug-in solar (plug-in microgeneration) products in the UK.
WEEE: evidence and national protocols guidance
How to issue evidence, meet and report on recovery and recycling targets and apply protocols on waste electrical and electronic equipment (WEEE).
Eskdalemuir seismic array: revised approach to managing onshore wind turbine interference
Proposals for an updated approach to managing onshore wind turbine interference with the Eskdalemuir seismic array.
IMO urges nations to put ocean policies into practice
The IMO calls on 176 Member States and the global shipping industry to implement ocean protection measures through its regulatory framework. Key initiatives include adoption of a 2026 Strategy targeting zero plastic waste discharges from ships by 2030, extension of underwater radiated noise reduction guidelines through 2028, development of binding instruments for biofouling control to prevent invasive species spread, and ongoing regulations to reduce greenhouse gas emissions from ships.
IMO treaty on hazardous and noxious cargo to enter into force in 2027
The 2010 HNS Convention enters into force on 29 November 2027, establishing the first comprehensive international liability and compensation regime for maritime transport of hazardous and noxious substances. Shipowners must maintain certified insurance; an HNS Fund capped at 250 million SDR provides additional compensation financed by post-incident cargo receiver contributions, covering over 2,000 substances including chemicals, oils, LNG, and LPG.
SR2024 No 2: using unbound incinerator bottom ash aggregate in construction
Standard rules for unbound incinerator bottom ash aggregate (IBAA) in construction as a deposit for recovery operation.
Waste electrical and electronic equipment (WEEE) public registers
Registers of electrical and electronic equipment (EEE) producers, approved exporters, approved authorised treatment facilities and producer compliance schemes.
IMO adopts first global Code for autonomous ships
The IMO adopted the MASS Code, a non-mandatory international framework effective 1 July 2026 governing autonomous and remotely operated cargo ships. The goal-based Code establishes safety, security, and environmental standards aligned with SOLAS, emphasizing cybersecurity, risk assessment, Remote Operations Centres, and human oversight. A mandatory version is targeted for adoption by 1 July 2030.
Recovering unused waste plastics coded 16 03 06: RPS 273
Environment Agency regulatory position on storing, treating and using plastic waste coded 16 03 06, when this waste code is not in your environmental permit or waste exemption.
Large Load Controllers: Tier 1 Cyber Assessment Framework and associated guidance
We're seeking views on a proposed Cyber Assessment Framework (CAF) profile for large electricity load controllers.
Air Plan Approval; Colorado; RACT Requirements for the 2008 8-Hour Ozone Standard for the Denver Metro/North Front Range Nonattainment Area
The U.S. Environmental Protection Agency (EPA) is proposing to approve portions of Colorado State Implementation Plan (SIP) submittals under the Clean Air Act (CAA) that address SIP obligations related to Reasonably Available Control Technology (RACT) requirements for the 2008 ozone National Ambient Air Quality Standards (NAAQS) for the Denver-Boulder-Greeley-Ft. Collins-Loveland, Colorado ozone nonattainment area. The EPA is proposing approval of portions of the RACT SIP submittals that address reporting requirements for certain source categories and reorganize certain state air pollution regulations. The EPA is also proposing to find that the State has addressed the EPA's prior limited disapproval.
Approval and Promulgation of Implementation Plans; Arizona; Revisions to the Cleaner Burning Gasoline, Winter Oxygenated Fuel, and Gasoline Set-Aside Programs
The Environmental Protection Agency (EPA) is proposing to approve a revision to the Arizona State Implementation Plan (SIP) submitted by the Arizona Department of Environmental Quality (ADEQ). This revision includes statutes and regulations amending the Cleaner Burning Gasoline (CBG) program, which is a control measure in the greater Phoenix metropolitan area to reduce emissions of ozone-forming pollutants, carbon monoxide (CO), and particulate matter. Additionally, this revision addresses the Winter Oxygenated Fuel program to control CO emissions in the Tucson area. Finally, this revision repeals the Arizona Gasoline Set[hyphen]aside (GSA) Program, applicable to the 1971 carbon monoxide nonattainment area covering Maricopa County and a portion of Pima County. The EPA is proposing to approve this SIP revision under the Clean Air Act (CAA or "Act"). This SIP revision is administrative in nature. This action proposes to update the existing SIP-approved CBG program with revisions that have been adopted and implemented by the State to clarify requirements, update references, and enhance flexibility of the program, and it will not impose any additional costs or regulatory burdens. We are taking comments on this proposal and plan to follow with a final action.
Organization and Definitions
14 CFR Part 401 establishes the organizational structure and definitions governing commercial space transportation regulation in the United States. The Office of Commercial Space Transportation, located within the Federal Aviation Administration, is headed by an Associate Administrator responsible for licensing, permitting, and regulating commercial space launch and reentry activities. The regulation provides standard definitions for key terms used throughout commercial space transportation regulations, including crew, payload, flight safety systems, abort procedures, and casualty areas, establishing the foundational terminology for FAA oversight of the commercial space industry.
Care and Use of Animals in the Conduct of NASA Activities
NASA regulation 14 CFR Part 1232 establishes policies for the care and use of vertebrate animals in NASA activities, including those conducted at NASA facilities, spacecraft, and through contracts with external entities. The regulation requires compliance with the Animal Welfare Act of 1966 and implements minimum standards of care and treatment for animals used in NASA research, testing, teaching, and hardware development.
Environmental Quality
NASA establishes environmental quality policy requiring all NASA headquarters and field installations to protect and enhance environmental quality through systematic planning, research, and coordination with federal, state, and local authorities. The regulation assigns responsibility to the Associate Administrator for Management to coordinate environmental policies, develop agencywide standards and procedures, and ensure environmental factors are considered in all NASA decisions and actions.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Administrative Practices and Procedures
21 CFR Part 10 establishes administrative practices and procedures governing petitions, hearings, and administrative proceedings conducted by the FDA under the Federal Food, Drug, and Cosmetic Act and related laws. It defines key terms such as administrative action, administrative file, ex parte communication, and participant, and clarifies the applicability and scope of FDA administrative proceedings and related regulatory sections.
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.
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.
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.
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.
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.
Regulation of Combination Products
21 CFR Part 4 establishes current good manufacturing practice (CGMP) requirements for combination products, which are products containing two or more constituent parts (drugs, devices, or biological products). The regulation clarifies how CGMP rules apply to both co-packaged and single-entity combination products, defines key terms, and outlines the regulatory framework for designing and implementing CGMP operating systems at manufacturing facilities.
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.
Formal Evidentiary Public Hearing
This FDA regulation (21 CFR Part 12) establishes procedural rules for formal evidentiary public hearings before the FDA Commissioner. It covers initiation of proceedings for issuing, amending, or revoking regulations and orders related to food additives, color additives, drugs, medical devices, and biologics. The regulation specifies timelines for submitting petitions, objections, and hearing requests (typically 30 days), notification requirements, and incorporation of the Equal Access to Justice Act procedures for expense reimbursement.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
EPCRA Hazardous Chemical Inventory Reporting Requirements: Conformity With the 2024 OSHA Hazard Communication Standard
The Environmental Protection Agency is conforming the Emergency Planning and Community Right-to-Know Act hazardous chemical inventory reporting regulations to the Occupational Safety and Health Administration's Hazard Communication Standard amendments of 2012 and 2024. The Emergency Planning and Community Right-to-Know Act (EPCRA) and its regulations rely on the Occupational Safety and Health Administration's (OSHA's) Hazard Communication Standard for the definition of a hazardous chemical and for the categories of health and physical hazards that must be reported under the hazardous chemical inventory regulations. This action conforms the terminology used and information that must be reported on the hazardous chemical inventory forms to the Hazard Communication Standard amendments. As a result, this action improves first responder and community safety, reduces discrepancies and confusion, prevents interpretation burdens on facilities when using (Material) Safety Data Sheets to complete annual hazardous chemical inventory reports, and enhances clarity.
Agency Information Collection Activities; Proposed Information Collection Request; Comment Request; Microbial Rules (Renewal)
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), Microbial Rules (Renewal) (EPA ICR Number 1895.12, OMB Control Number 2040-0205) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through October 30, 2026. This notice allows for 60 days for public comments.
Congressional Review Act Revocation of 2024 Amendments to the National Emission Standards for Hazardous Air Pollutants: Rubber Tire Manufacturing
The U.S. Environmental Protection Agency (EPA) is amending the Code of Federal Regulations (CFR) to remove the provisions finalized by the EPA in a 2024 final rule titled "National Emission Standards for Hazardous Air Pollutants: Rubber Tire Manufacturing" ("2024 Rubber Tire Rule"). Under the Congressional Review Act (CRA), Congress passed, and the President signed, a joint resolution of disapproval of the 2024 Rubber Tire Rule. The 2024 Rubber Tire Rule promulgated first- time air emissions standards for the rubber processing subcategory of the rubber tire manufacturing source category. Under the joint resolution and by operation of the CRA, the 2024 Rubber Tire Rule has no legal force or effect, and the EPA thus is taking this final action to remove the provisions finalized in that rule.
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.
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.
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.
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.
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.
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.
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.
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.