48 Terms

Compliance Glossary

Clear definitions of regulatory terminology. Click any term to learn more.

ASTM F963: Primary US toy safety standard mandated by CPSIA, covering mechanical, chemical, and flammability requirements.
Authorized Representative: EU-based person or company appointed by a non-EU manufacturer to handle regulatory compliance matters on their behalf.

California Proposition 65: California law requiring warnings for products containing chemicals known to cause cancer or reproductive harm.
CE Marking: Mandatory EU conformity marking indicating a product meets health, safety, and environmental standards for the European Economic Area.
Children's Product Certificate (CPC): Mandatory US certification document required for children's products, confirming third-party tested compliance with safety rules.
Conformity Assessment: The process of evaluating whether a product meets regulatory requirements before it can be placed on the market.
CPSIA: Consumer Product Safety Improvement Act—US law requiring third-party testing and certification for children's products.

Declaration of Conformity (DoC): Official document where a manufacturer declares their product meets all applicable EU or UK regulatory requirements.
Digital Product Passport (DPP): EU initiative requiring products to carry digital records of sustainability, recyclability, and compliance information throughout their lifecycle.

Ecodesign for Sustainable Products Regulation (ESPR): EU framework regulation establishing sustainability requirements for products including durability, repairability, recyclability, and energy efficiency standards.
Economic Operator: Any person or entity in the supply chain with compliance obligations: manufacturer, importer, distributor, or fulfilment provider.
EMC Directive: EU directive ensuring electronic devices neither cause nor suffer from electromagnetic interference.
EN 71 Toy Safety Standard: European harmonized standard specifying safety requirements for toys, essential for CE marking compliance.
Essential Requirements: Mandatory safety and performance objectives products must meet under EU directives to achieve CE marking.
EU Authorized Representative: A natural or legal person established in the EU, mandated by a non-EU manufacturer to act on their behalf for regulatory compliance obligations.
Extended Producer Responsibility (EPR): Environmental policy making producers financially responsible for end-of-life management of their products and packaging.

FCC Certification: Federal Communications Commission approval required for electronic devices sold in the US that emit radio frequency energy.
FCM (Food Contact Materials): Materials intended to contact food—regulated under EU 1935/2004 to prevent harmful substance transfer.

General Certificate of Conformity (GCC): US certification document required for non-children's consumer products, confirming compliance with applicable safety rules.
GPSR: General Product Safety Regulation (EU) 2023/988—the comprehensive EU framework for consumer product safety, traceability, and economic operator obligations.

Harmonized Standards: European technical standards that provide 'presumption of conformity' with EU legislation when correctly applied.

Importer of Record (IOR): The entity legally responsible for ensuring imported goods comply with all destination country regulations and customs requirements.

Low Voltage Directive (LVD): EU directive ensuring electrical equipment safety for products operating between 50-1000V AC or 75-1500V DC.

Machinery Regulation 2023/1230: Updated EU regulation replacing the Machinery Directive 2006/42/EC, introducing requirements for AI-enabled machinery, cybersecurity, and digital documentation.
Market Surveillance: Enforcement activities by public authorities to ensure products comply with legislation and don't endanger safety.
Market Withdrawal: Action to stop further distribution of a non-compliant product while not retrieving items already sold to consumers.
Medical Device Regulation (MDR): EU Regulation 2017/745 establishing comprehensive requirements for medical devices including clinical evidence, unique device identification, and post-market surveillance.

Notified Body: Independent third-party organization designated by an EU member state to assess product conformity for high-risk categories.

Personal Protective Equipment (PPE) Regulation: EU Regulation 2016/425 governing the design, manufacture, and marketing of personal protective equipment across three risk categories.
Product Liability: Legal responsibility for damages caused by defective or unsafe products, applying to manufacturers, importers, and sellers.
Product Passport: A standardized digital record containing comprehensive product information including materials composition, manufacturing origin, compliance status, and end-of-life instructions.
Product Recall: Formal action to retrieve dangerous products already sold to consumers—the most serious enforcement outcome.

QR Code Compliance Labeling: The use of QR codes on product labels and packaging to provide digital access to compliance documentation, safety information, and Digital Product Passport data.

Radio Equipment Directive (RED): EU directive governing wireless devices including Bluetooth, Wi-Fi, cellular, and radio frequency equipment.
RAPEX / Safety Gate: EU rapid alert system for dangerous non-food products, enabling swift information exchange across member states.
REACH Regulation: EU regulation requiring registration and safety assessment of chemicals in products sold in Europe.
Responsible Person (UK): Mandatory UK-based representative required for non-UK businesses selling products on the Great Britain market.
Risk Assessment: Systematic process identifying product hazards and evaluating risks to ensure safety requirements are met.
RoHS Directive: EU directive restricting hazardous substances in electrical and electronic equipment to protect health and environment.

SCIP Database: EU database maintained by ECHA where suppliers must notify articles containing Substances of Very High Concern above 0.1% concentration.
Supply Chain Due Diligence: Systematic verification process ensuring suppliers and products meet compliance, safety, and ethical standards.
SVHC (Substance of Very High Concern): Chemical substances identified under EU REACH regulation as posing serious risks to human health or the environment, subject to strict authorization and notification requirements.

Technical File: Comprehensive documentation package proving a product meets regulatory requirements—must be kept for 10 years.
Traceability: The ability to track a product through all stages of production and distribution—mandatory under GPSR.
Type Examination Certificate: Official certificate from a Notified Body confirming a product design meets applicable EU regulatory requirements.

UK Approved Body: UK-designated third-party organization authorized to perform conformity assessment for UKCA marked products.
UKCA Marking: UK Conformity Assessed marking required for products placed on the Great Britain market post-Brexit.

WEEE Directive: EU directive on waste electrical and electronic equipment, establishing producer responsibility for recycling and disposal.

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