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Regulatory Compliance Glossary

Your reference for compliance, identity verification, and regulatory terminology. Clear definitions of key terms.

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Traceability (Supply Chain)

Traceability refers to the ability to identify products and responsible economic operators throughout the supply chain. It supports effective recalls, enforcement actions, and regulatory compliance under the GPSR.

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Product Recall

A product recall is the process of removing unsafe products from consumers after they have been placed on the market. Recalls may be voluntary or authority-mandated and require clear communication and corrective action.

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Risk Assessment

A product safety risk assessment identifies potential hazards, evaluates associated risks, and outlines measures taken to reduce those risks. It forms a key part of compliance documentation under EU product safety legislation.

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Market Surveillance (GPSR)

Market surveillance refers to checks and enforcement actions carried out by EU and UK authorities to ensure products comply with safety and regulatory requirements. Authorities may request documentation, conduct testing, or impose corrective measures if non-compliance is identified.

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Technical Documentation

Technical Documentation is the structured evidence showing that a product meets applicable regulatory requirements. It may include risk assessments, test reports, design information, and declarations of conformity. Authorities can request this documentation at any time.

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Safety Gate (RAPEX)

Safety Gate, formerly RAPEX, is the EU’s rapid alert system for dangerous non-food consumer products. It allows authorities to share information about unsafe products and coordinate corrective actions across Member States.

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Authorised Representative (EU)

An EU Authorised Representative is an EU-established entity formally appointed by a non-EU manufacturer to carry out defined regulatory compliance duties. Depending on the applicable regulation, responsibilities may include holding documentation, responding to authorities, and assisting with corrective actions. The role must be clearly defined in a written mandate.

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Responsible Person (GPSR)

Under the GPSR, the Responsible Person is the EU-based economic operator accountable for ensuring that required product safety obligations are fulfilled. This may be the manufacturer, importer, authorised representative, or another designated operator. The Responsible Person must ensure documentation is available and cooperate with authorities where needed.

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Economic Operator

An Economic Operator includes any manufacturer, importer, authorised representative, distributor, or fulfilment provider involved in placing a product on the EU market. Under the GPSR and other EU laws, at least one economic operator must be established in the EU for certain products.

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General Product Safety Regulation (GPSR)

The General Product Safety Regulation (EU) 2023/988 sets updated safety requirements for consumer products placed on the EU market from 13 December 2024. It strengthens obligations for manufacturers, importers, authorised representatives, distributors, and online marketplaces. The regulation introduces clearer documentation, traceability, and enforcement requirements, replacing the previous General Product Safety Directive.

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