Global regulations corpus
Browse 15,074 regulations from 36 regulators
2,983 updated in the last 30 days. Public corpus — no signup required to read.
Showing 1–50 of 58 regulations
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Waste: export and import
UK guidance on regulatory controls governing the transport of waste into and out of England, including documentation, permitting, and compliance requirements for waste exporters and importers.
DN31 2SY, Solenis UK Industries Limited: environmental permit surrender issued - EPR/KP3639QV/S003
Environmental permit surrender issued for Solenis UK Industries Limited (Grimsby Chemical Works, Grimsby) under the Industrial Emissions Directive (EPR/KP3639QV/S003).
Technical Regulations for Limiting Hazardous Substances in Electrical and Electronic Devic...
Saudi Arabia's technical regulations establish limits on hazardous substances in electrical and electronic devices, aligning with international standards to restrict materials like lead, mercury, cadmium, and brominated flame retardants in manufacturing and product safety.
Technical Regulations for Leather Products
Saudi Arabian Standards, Metrology and Quality Organization (SASO) technical regulations establishing standards for leather products, covering manufacturing specifications, quality requirements, and safety parameters applicable to leather goods production and trade.
Technical Regulation for Lubricating Oils
Saudi Arabian Standards Organization technical regulation establishing specifications and requirements for lubricating oils, covering quality, performance, testing, and safety criteria for mineral and synthetic lubricating oil products used in industrial, automotive, and mechanical applications.
Technical Regulation for Detergents
Saudi Arabia's technical regulation for detergents establishes standards governing the composition, labeling, and safety requirements for detergent products. The regulation ensures consumer protection and environmental compatibility through specified chemical limits and performance criteria.
Technical regulation for Paints (Dyes) and Varnishes
Saudi Arabian technical regulation establishing standards for paints, dyes, and varnishes. The regulation sets requirements for composition, performance, and safety characteristics of paint and varnish products to ensure quality and compliance with national standards.
Technical Regulation for Building Materials: Part (1): Sectors of Metals and their Alloys ...
Saudi Arabian technical regulation establishing standards for building materials in the metals and metal alloys sector. Sets requirements for properties, testing, labeling, and quality assurance of metallic materials used in construction applications.
Technical Regulation for Gas Appliances and their Accessories
Saudi technical regulation establishing safety and performance standards for gas appliances and their accessories. Sets requirements for design, manufacture, testing, and labeling to ensure safe operation and consumer protection.
Technical Regulation for Degradable Plastic Products
Saudi Arabia's technical regulation establishes standards for degradable plastic products, defining performance requirements, testing methods, and labeling specifications to ensure environmental compatibility and product quality in the market.
Technical Regulation for Electronic Devices Used in Electronic Smoking Systems
Saudi Arabia's SASO technical regulation establishes standards for electronic devices used in electronic smoking systems, covering design, safety, performance, and component specifications to ensure product quality and user protection.
Technical Regulation for Glue and Adhesive Materials
Saudi Arabian Standards Organization technical regulation establishing requirements and specifications for glue and adhesive materials, covering composition, performance, safety, and labeling standards for industrial and consumer applications.
Technical Regulation for Electrical Batteries
Saudi Arabia's technical regulation establishes standards for electrical batteries, covering design, manufacturing, safety, performance, and labeling requirements to ensure product quality, consumer safety, and environmental protection in battery production and commerce.
Food Additive Petitions
21 CFR Part 571 establishes the procedure for submitting food additive petitions to the FDA under the Federal Food, Drug, and Cosmetic Act. Petitioners must submit applications in triplicate with detailed information on the food additive's chemical identity, composition, manufacturing methods, analytical controls, stability data, and proposed uses. The regulation specifies content requirements including physical/chemical/biological properties, specifications, impurities, and manufacturing details for each entity involved in production.
Labeling and Packaging Requirements for Controlled Substances
21 CFR Part 1302 establishes labeling and packaging requirements for controlled substances distributed in the United States. Manufacturers must print schedule symbols on commercial containers and labeling in a prominent, easily identifiable manner. Specific exemptions apply to containers too small to accommodate labels, clinical research involving blind studies, and exported substances. All containers must be sealed to detect tampering. These requirements apply to imported controlled substances but not to those intended for export.
Substances Prohibited from Use in Animal Food or Feed
21 CFR Part 589 establishes prohibitions on substances in animal food and feed that present potential health risks or lack adequate safety data. The regulation prohibits gentian violet in all animal feed and propylene glycol in cat food, and restricts mammalian proteins in ruminant feed to prevent disease transmission. Violations render animal feed adulterated under the Federal Food, Drug, and Cosmetic Act.
Administrative Functions, Practices, and Procedures
21 CFR Part 1316 establishes administrative inspection procedures under the Controlled Substances Act and Controlled Substances Import and Export Act. The regulation authorizes DEA inspectors to enter controlled premises to inspect records, verify inventory, collect samples, and examine equipment and materials related to controlled substances and listed chemicals manufacturing, distribution, and storage.
Food Additives
21 CFR Part 570 establishes regulatory definitions and provisions governing food additives under the Federal Food, Drug, and Cosmetic Act. It defines food additives as substances not exempted that become food components or affect food characteristics, including packaging materials with migration potential. The regulation outlines safety standards, requiring reasonable certainty of harmlessness based on scientific procedures, and addresses general recognition of safety, cumulative dietary effects, and prior sanctions.
Registration of Manufacturers, Distributors, Importers and Exporters of List I Chemicals
This regulation establishes registration requirements for manufacturers, distributors, importers, and exporters of List I chemicals under DEA jurisdiction. Registration is mandatory for entities handling ephedrine, pseudoephedrine, phenylpropanolamine, and other designated List I chemicals. Annual fees apply: $3,699 for manufacturers and $1,850 for distributors, importers, and exporters. Registration must be submitted online via the DEA's secure portal with payment by ACH transfer or credit card. Separate registrations are required for independent activities (manufacturing, distributing, importing, exporting).
Quotas
This regulation establishes procedures for DEA quotas on Schedule I and II controlled substances. It defines three quota types—aggregate production, individual manufacturing, and procurement—and five subcategories covering commercial sale, transfers, product development, and replacement of disposed material. Quotas limit the total and per-manufacturer quantities of controlled substance APIs that may be produced or procured annually for pharmaceutical manufacturing.
Definitions
21 CFR Part 1300 establishes definitions for controlled substances under the Controlled Substances Act and related regulations. Key definitions include anabolic steroids (controlled hormonal substances chemically related to testosterone), automated dispensing systems for medication management, and basic chemical classes of controlled substances. The regulation clarifies DEA authority and distinguishes between controlled substances and dietary ingredients or botanical compounds that are exempt from classification.
Importation and Exportation of Controlled Substances
21 CFR Part 1312 establishes procedures for importation, exportation, and transshipment of controlled substances. Importers must obtain DEA authorization through registration and permits (for Schedules I-II and certain Schedule III-V substances) or import declarations (for other Schedule III-V substances). Each shipment requires separate authorization, and applicants must submit detailed information including drug names, dosage forms, NDC numbers, and quantities on DEA Form 357 through the DEA Diversion Control Division secure network.
Importation and Production Quotas for Ephedrine, Pseudoephedrine, and Phenylpropanolamine
21 CFR Part 1315 establishes procedures for setting annual importation and production quotas for ephedrine, pseudoephedrine, and phenylpropanolamine. The regulation applies to DEA-registered manufacturers and importers of these bulk chemicals and drug products, defines quota types including assessment of annual needs, individual manufacturing quotas, procurement quotas, and import quotas, and exempts personal imports not exceeding 7.5 grams per substance in any 30-day period.
Records and Reports of Listed Chemicals and Certain Machines; Importation and Exportation of Certain Machines
21 CFR Part 1310 establishes record-keeping and reporting requirements for regulated persons who handle DEA-designated listed chemicals and certain machines (tableting and encapsulating equipment). The regulation specifies two lists of chemicals subject to oversight, allows the DEA Administrator to add or remove substances via Federal Register notice, and requires manufacturers and distributors to maintain transaction records and file reports, particularly for ephedrine, pseudoephedrine, phenylpropanolamine, and gamma hydroxybutyric acid when shipped via postal or commercial carriers.
Retail Sale of Scheduled Listed Chemical Products
This regulation establishes requirements for retail sales of scheduled listed chemical products (ephedrine, pseudoephedrine, phenylpropanolamine) for personal use. It sets daily purchase limits (3.6 grams per substance per day), packaging requirements for nonliquid forms (blister packs or unit dose packets), and mandates loss reporting to the DEA within 15 days. Requirements apply to face-to-face retail sales and mail-order sales through regulated sellers and distributors.
Importation and Exportation of List I and List II Chemicals
21 CFR Part 1313 establishes procedures for importing, exporting, transshipping and in-transit shipment of List I and List II chemicals under the Chemical Diversion and Trafficking Act. Importers and exporters must notify the DEA at least 15 days before importing chemicals meeting threshold quantities, file declarations on DEA Form 486/486A, establish documented business relationships with customers, and maintain required records including supplier information and transaction frequency.
Food Additives Permitted in Feed and Drinking Water of Animals
21 CFR Part 573 establishes permitted food additives for animal feed and drinking water. Regulations cover acrylamide-acrylic acid resin as a thickener/suspending agent in aqueous feed suspensions, aminoglycoside 3'-phosphotransferase II enzyme for genetic modification of crops, ammoniated cottonseed meal as a protein source in ruminant feed (max 20% of ration), and ammoniated rice hulls as fiber and nonprotein nitrogen source in beef cattle feed (max 20% of ration). Each additive includes specifications, approved uses, and labeling requirements for safe application.
Regulations Under the Federal Caustic Poison Act
21 CFR Part 1230 establishes labeling and packaging requirements for caustic and corrosive substances shipped in interstate or foreign commerce. Containers must bear clear labels with the common name of the dangerous substance, prominent "Poison" warnings in 24-point Gothic capitals, and directions for medical treatment in case of internal or external injury. Labeling must be firmly affixed and readily visible. Manufacturers, wholesalers, and distributors are responsible for compliance, with limited exemptions for non-household containers at shipment.
Intentional Genomic Alterations in Animals
21 CFR Part 528 establishes regulatory pathways for intentional genomic alterations in animals, including rabbits producing recombinant human Factor VII in milk for hemophilia treatment, genetically modified Atlantic salmon with enhanced growth rates in contained freshwater facilities, pigs with CD163 gene deletion conferring PRRSV resistance, pigs with modified GGTA1 gene for use as food or therapeutic sources, and chickens producing human lysosomal acid lipase for medical treatment. Food and feed restrictions apply to certain lineages.