Corpus mondial de réglementations
Parcourir 15,074 réglementations de 36 régulateurs
2,983 mis à jour au cours des 30 derniers jours. Corpus public — aucune inscription requise pour consulter.
Affichage de 1–50 sur 54 réglementations
Operations Programs for Reactor Facilities
REGDOC-2.3.4 establishes requirements and guidance for developing and implementing operations programs at nuclear reactor facilities, including conventional power plants, advanced reactors, and small modular reactors. Licensees may apply risk-informed and graded approaches proportional to facility risk profiles, based on operational experience and best practices from water-cooled reactors.
Aging Management
REGDOC-2.6.3 establishes Canadian Nuclear Safety Commission requirements for managing aging of structures, systems, and components in power reactor facilities throughout their licensed service life. Licensees must implement coordinated engineering, operational, inspection, and maintenance programs to control physical aging and obsolescence, ensuring required safety functions remain reliable and available in accordance with the licensing basis.
Fitness for Duty: Managing Worker Fatigue
REGDOC-2.2.4 establishes Canadian Nuclear Safety Commission requirements for managing worker fatigue at high-security nuclear facilities. Licensees must implement human performance programs using a graded approach proportionate to facility risk to minimize worker errors affecting nuclear safety and security.
Human Performance, Version 2
REGDOC-2.2.1 Version 2 establishes human performance management requirements for Canadian Class I nuclear facilities and uranium mines/mills. Licensees must systematically manage human, technological, and organizational factors using a risk-proportionate graded approach, incorporating IAEA standards and ISO human-centered management principles to achieve safe and effective performance.
Maintenance Programs for Nuclear Power Plants
REGDOC-2.6.2 establishes Canadian Nuclear Safety Commission requirements for maintenance programs at nuclear power plants. Licensees must develop comprehensive policies, processes and procedures for monitoring, inspection, testing, repair and replacement of all structures, systems and components based on safety importance, emphasizing preventive maintenance and continuous improvement aligned with international IAEA standards.
Deterministic Safety Analysis
REGDOC-2.4.1 establishes Canadian Nuclear Safety Commission requirements for deterministic safety analysis at nuclear power plants and small reactor facilities (below 200 MWt). The document prescribes methods for safety analysis reports, design basis event selection, acceptance criteria, and documentation using a risk-informed, graded approach, incorporating Fukushima lessons and international safety practices.
Nuclear Criticality Safety, Version 1.1
REGDOC-2.4.3 Version 1.1 establishes Canadian Nuclear Safety Commission requirements for preventing criticality accidents in handling, storage, processing, and transportation of fissionable materials outside reactors. It defines minimum physical constraints and limits applicable during facility construction, operation, decommissioning, and abandonment, aligned with IAEA and ANSI/ANS standards.
Design, Testing and Performance of Exposure Devices, Version 1.1
REGDOC-2.5.7 Version 1.1 establishes Canadian Nuclear Safety Commission requirements for design, testing, and certification of exposure devices used in industrial radiography with sealed radioactive sources. The regulation mandates compliance with ISO 3999:2004 and specifies technical requirements for sealed source design, safety mechanisms, automatic securing devices, calibration, endurance and vibration testing, and labelling for portable non-destructive testing equipment used to inspect welds, castings, and building components.
Chemistry Control for Reactor Facilities
REGDOC-2.6.4 establishes chemistry control program requirements for Canadian reactor facilities (NPPs, advanced reactors, SMRs, research reactors) to ensure structural integrity of safety-critical systems, protect fuel, minimize radioactive material buildup, and achieve ALARA environmental releases. Licensees may propose risk-informed or alternative approaches proportionate to their facility's risk profile.
Safety Analysis for Class IB Nuclear Facilities
REGDOC-2.4.4 establishes safety analysis requirements for Canadian Class IB nuclear facilities processing uranium, thorium, plutonium and other nuclear substances. Licensees must implement managed safety analysis programs using risk-informed graded approaches to systematically evaluate hazards, document design measures, and maintain records demonstrating facility safety commensurate with their risk profiles.
Minimum Staff Complement
REGDOC-2.2.5 provides guidance to Canadian Class I nuclear facility licensees on demonstrating adequate staffing of qualified workers across all operating states—normal operations, anticipated occurrences, design-basis accidents, and emergencies—to ensure safe and compliant operation under the Nuclear Safety and Control Act.
Reliability Programs for Nuclear Power Plants
REGDOC-2.6.1 establishes Canadian Nuclear Safety Commission requirements for reliability programs at nuclear power plants. Licensees must develop and implement programs ensuring systems important to safety meet defined design and performance criteria throughout the facility's lifetime, covering assessment, modelling, evaluation and monitoring across all lifecycle phases from design through decommissioning.
Periodic Safety Reviews
REGDOC-2.3.3 establishes Canadian Nuclear Safety Commission requirements for periodic safety reviews of nuclear power plants. PSRs comprehensively assess plant design, condition, and operation against current codes, standards, and best practices using a graded risk-based approach to identify improvements ensuring safe long-term operation and conformance to modern safety levels.
Conduct of Licensed Activities: Construction and Commissioning Programs
REGDOC-2.3.1 establishes Canadian Nuclear Safety Commission requirements for construction and commissioning of nuclear reactor facilities, including power plants and small reactors for power generation, industrial heat, isotope production, and research applications. The document applies risk-informed, graded approaches to safety-critical structures, systems, and components and forms the licensing basis for regulated facilities.
Design of Industrial Radiography Installations
REGDOC-2.5.5 provides design guidance for industrial radiography installations using sealed nuclear sources (cobalt-60, iridium-192, selenium-75) for non-destructive testing of materials in welds, castings, and structures. Installations must incorporate adequate shielding and safety features to limit radiation exposure to certified operators, workers, and the public within regulatory limits while maintaining doses as low as reasonably achievable, and comply with applicable building, fire protection, and safety codes.
Safety Culture
REGDOC-2.1.2 establishes Canadian Nuclear Safety Commission requirements for Class I nuclear facilities and uranium mines/mills to develop and maintain healthy safety cultures. Organizations must foster shared values and common understandings that reinforce worker perceptions of safety importance through a risk-proportionate graded approach. Safety and security cultures coexist to limit risks from nuclear substances and facilities.
General Design Considerations: Human Factors
REGDOC-2.5.1 provides guidance for Canadian nuclear licensees on integrating human factors engineering into Class I nuclear facilities and uranium mining/milling operations. Licensees must develop human factors engineering program plans and conduct verification and validation activities to ensure health, safety, and environmental protection through systematic consideration of human performance in facility design and licensed activities.
Design of Reactor Facilities, Version 2.1
REGDOC-2.5.2 Version 2.1 establishes comprehensive design requirements for new water-cooled nuclear reactor facilities in Canada, aligning with IAEA safety standards and promoting defence-in-depth design principles. The document applies to new licence applications; existing facilities licensed before 2014 are exempt unless explicitly included in their licensing basis.
Nuclear Fuel Safety
REGDOC-2.4.5 establishes Canadian Nuclear Safety Commission requirements for nuclear fuel design, operation, monitoring, qualification, and performance assessment in operating reactor facilities. The regulation defines three core fuel safety functions: retaining radionuclides, maintaining coolable geometry, and supporting safe shutdown. It applies primarily to CANDU reactors while remaining technology-neutral and aligns with CSA and IAEA standards.
Management System
REGDOC-2.1.1 establishes management system requirements for Canadian Nuclear Safety Commission licensees operating Class 1A and 1B reactors, uranium mines and mills, and radioactive waste facilities. Licensees must develop and implement frameworks of processes, procedures, and practices aligned with CSA standard N286-12 to safely conduct licensed activities and ensure regulatory compliance.
Personnel Training, Version 2
REGDOC-2.2.2 establishes mandatory training system requirements for Canadian nuclear facility licensees. Licensees must develop, implement, and maintain comprehensive training programs covering analysis, design, development, implementation, evaluation, and documentation to ensure workers are competent and qualified to safely perform duties involving nuclear substances and equipment. A graded approach commensurate with risk may be applied.
Personnel Certification: Radiation Safety Officers
REGDOC-2.2.3 establishes Canadian Nuclear Safety Commission guidance for certifying Radiation Safety Officers at Class II nuclear facilities. It outlines application requirements, qualification criteria, and certification examination procedures to ensure RSOs are competent to perform their safety duties. An exemption applies to persons already certified in equivalent positions at Class I facilities.
Design of Rooms Where Unsealed Nuclear Substances Are Used
REGDOC-2.5.6 establishes Canadian Nuclear Safety Commission design requirements for rooms using unsealed nuclear substances. It provides guidance on room finishings, contamination control, ventilation systems, fume hoods, hot cells, and access control across intermediate-level, high-level, containment-level, and nuclear medicine facilities, implementing a risk-informed approach to minimize worker radiation doses per ALARA principles.
Design of Uranium Mines and Mills: Ventilation Systems, Version 1.1
REGDOC-2.5.4 is a Canadian Nuclear Safety Commission regulatory guide for ventilation system design in uranium mines and mills. It establishes requirements for ventilation-related information in licence applications for site preparation, construction, operation, and decommissioning of underground and surface licensable areas, applying a risk-informed, graded approach to protect worker and radiation safety consistent with modern national and international nuclear standards.
Probabilistic Safety Assessment (PSA) for Reactor Facilities, Version 2
REGDOC-2.4.2 Version 3 establishes requirements for probabilistic safety assessments (PSA) at Canadian reactor facilities including nuclear power plants, small reactors, and research reactors. Licensees must conduct systematic analyses demonstrating facility designs protect people and the environment from radiation, achieve balanced designs without disproportionate risk contributions, and prevent cliff-edge effects, using a graded approach aligned with IAEA standards.
Accident Management, Version 2
REGDOC-2.3.2 establishes Canadian Nuclear Safety Commission requirements for integrated accident management at reactor facilities. Licensees must develop, implement, and validate defence-in-depth strategies, operational procedures, and capabilities to manage abnormal and severe accidents, consistent with IAEA safety standards and informed by lessons from the 2011 Fukushima event.
License to Operate a Launch Site
FAA regulation 14 CFR Part 420 establishes licensing requirements for persons operating commercial launch sites in the United States. The rule prescribes application procedures, safety demonstrations, approval bases, license terms, and post-licensing compliance obligations. Applicants must meet equivalent safety standards, with exemptions for amateur rocket operations. The regulation defines key technical terms including debris dispersion, casualty areas, and coordinate systems used in launch safety analysis.
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.
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.
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.
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.
Yorkshire companies to pay hundreds of thousands after incidents
Following investigations by the Environment Agency, four Yorkshire companies will pay almost £470,000 after they breached environmental permits.
Human Drug Compounding
This regulation establishes FDA rules for human drug compounding under 21 CFR Part 216. It lists bulk drug substances approved for compounding (including Brilliant Blue G and several topical agents), identifies substances excluded from compounding (Oxitriptan, Piracetam, Silver Protein Mild, Tranilast), and sets FDA evaluation criteria based on physical/chemical characterization, safety, efficacy evidence, and historical use. Compounders cannot claim FDA approval for products made with listed substances.
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 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.
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.
Technical Regulation for simple pressure vessels
Saudi technical regulation establishing standards for simple pressure vessels, covering design, manufacturing, testing, and safety requirements to ensure equipment reliability and worker protection in industrial applications.
Technical Regulation for equipment safety: part 2
Saudi Arabian technical regulation establishing safety requirements for equipment. The regulation sets forth mandatory standards and compliance criteria to ensure equipment used in industrial and commercial applications meets prescribed safety benchmarks to protect workers and prevent hazards.
Technical Regulation for Machinery Safety – Part 3: Lifting Equipment
Technical regulation establishing safety requirements for lifting equipment in Saudi Arabia. Covers design, manufacture, installation, operation and maintenance standards to protect workers and prevent accidents during material handling and lifting operations.
Technical Regulation for Pressure Equipment
Saudi Arabian technical regulation establishing design, manufacturing, and safety requirements for pressure equipment. Sets standards for equipment that operates above specified pressure thresholds to ensure mechanical integrity, prevent failures, and protect workers and the public from hazards associated with pressurized systems.
Technical Regulation for Machinery Safety – Part 4: Cutting and Sawing Machines
Technical regulation establishing safety standards for cutting and sawing machines in Saudi Arabia. Covers design, construction, and operational requirements to protect workers from hazards associated with these machines, including guard systems, emergency stops, and safe operational procedures.
General Biological Products Standards
21 CFR Part 610 establishes general standards for licensed biological products in the US, requiring manufacturers to complete conformity tests on each product lot before release and permitting FDA oversight of lot samples and protocols. The regulation specifies testing requirements for potency, sterility, and safety, allows equivalent methods with FDA approval, and governs release procedures through the Center for Biologics Evaluation and Research or Center for Drug Evaluation and Research.
Performance Standards for Microwave and Radio Frequency Emitting Products
This regulation establishes performance standards for microwave ovens manufactured after October 6, 1971, setting limits on microwave radiation emission and requiring safety interlocks. Microwave ovens must not exceed 1 milliwatt per square centimeter power density at 5+ centimeters from the external surface before purchase, and 5 milliwatts per square centimeter thereafter. Devices must have at least two operative safety interlocks designed to prevent microwave generation when cavity access is possible, with at least one interlock resistant to human body contact and magnetic manipulation.
Controls to Satisfy the Requirements of the Act Applicable to the Manufacturing of Marihuana
21 CFR Part 1318 establishes regulatory controls for the registration and manufacturing of marihuana, including cultivation, growth, and harvest procedures. Registered manufacturers must deliver their total cannabis crops to the Administration within four months of harvest, with the Administration taking physical possession and controlling access. Applicants must demonstrate compliance with statutory requirements and public interest considerations under the Controlled Substances Act and international Single Convention obligations.
Medical Device Reporting
21 CFR Part 803 establishes medical device reporting requirements for device user facilities, manufacturers, importers, and distributors. Device user facilities must report deaths and serious injuries caused or contributed to by devices, maintain adverse event files, and submit annual summaries. Manufacturers and importers must report similar events and device malfunctions, while distributors must maintain incident records without reporting obligations. These requirements protect public health by ensuring devices remain safe, effective, and not adulterated or misbranded.
Technical Regulations for Tanks — Part 3: Dry Gas Transport Tanks
Saudi Arabian mandatory technical regulations establishing construction, pressure rating, safety device, marking, and inspection specifications for tanks used in road transport of dry gases.
Technical Regulation — Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres
Saudi Arabian technical regulation mandating design, certification, and labeling requirements for equipment and protective systems used in potentially explosive atmospheres. Applies to oil & gas, refinery, and petrochemical operations operating in classified hazardous zones. Establishes conformity assessment and compliance marking procedures.
Technical Regulation — Requirements for Machinery Safety
Saudi Arabian technical regulation establishing essential health and safety requirements for industrial machinery placed on the market, aligned with EU Machinery Directive 2006/42/EC standards for machinery design, construction, and risk management.
Directive 2022/2557 on the resilience of critical entities
The CER Directive (2022/2557), effective 16 January 2023, requires EU Member States to identify critical entities by 17 July 2026 providing essential services across eleven sectors, including energy subsectors (electricity, aggregation, demand response, energy storage, district heating/cooling, oil, gas, hydrogen). These entities must enhance resilience against cyberattacks, natural disasters, and other threats to protect public health, safety, and the economy.