GPSR (General Product Safety Regulation): Risk Assessment, Traceability and Compliance Roadmap for 2025

Brief summary: GPSR (General Product Safety Regulation) strengthens safety, traceability, incident management and recall processes for consumer products entering the EU market. The key to success is to properly establish the risk assessment file; combining labels/warnings, usage instructions, technical documentation and supply chain traces in a consistent structure.

What is GPSR? (Summary)

Scope

General safety of consumer products in the EU; a wide range from toys to electronic accessories, devices in contact with cosmetics, to online (e-commerce) sales.

Objective

To proactively manage consumer health and safety; making compliance permanent through transparent labeling that informs consumers, standard recall notifications, visible warnings in digital channels and market surveillance.

Actors

Manufacturer, importer, distributor, authorized representative and online marketplaces.

Why is Risk Assessment Critical?

Single Source Verification

Product hazard definitions, user profiles (children, elderly, etc.), reasonably foreseeable use and misuse scenarios are collected in a single file.

Basis for Design Decisions

Material selection, edge/wall/heat safety, chemical contact, electrical/electronic safety, battery management, software-update effects (if any) are proven with this file.

Basis for Labels and Instructions

Warnings, pictograms, age restrictions, assembly/usage instructions and disposal information must be consistent with the risk assessment.

Readiness for Incident/Recall Management

In case of possible non-compliance, risk class and action plan (stop/recall/corrective action) are predefined.

6 Fundamental Pillars of GPSR Compliance

1. Risk Assessment & Technical File

• Product definition, component list, material and chemical contact analysis
• Basic safety principles in electrical/electronic products (heat, fire, shock, EMC)
• Mechanical/ergonomic risks, small part choking risk (children's products)
• Update effects and cyber-security aspects in software/connected products (if any)
• Reference to applicable harmonized standards and test reports

2. Label, Warning and Usage Instructions

• Language compliance (according to EU market), comprehensibility of pictograms and warnings
• Manufacturer/importer information, product model/batch/serial number
• Assembly/usage/maintenance and disposal instructions (consumer-friendly placement)

3. Traceability and Supply Chain

• Part/batch/serial tracking; approved list for suppliers and critical component evidence
• Traceable marking in packaging and logistics processes

4. Market Surveillance and Incident Management (Incident Response)

• Complaint/incident collection channels (website, email, QR code)
• Internal classification matrix: "minor – major – serious risk"
• Notification threshold to authorities (Safety Gate/SBG) and internal process flow

5. Recall & Communication

• Standard recall notification template (clear to consumers, plain language)
• Channel plan: web-banner, email/SMS, marketplace announcements, social media
• Return, repair, replacement, compensation mechanisms and record keeping

6. Online Sales (Marketplaces) & Product Pages

• Visibility of safety warnings on product pages (text + visual)
• Accessibility of seller/importer information, correct categorization
• Avoiding misleading practices similar to dark patterns

Risk Examples by Product Group (Summary)

• Electronic/smart devices: Heating, short circuit, battery swelling, behavior change after software update.
• Kitchen/household items: Material migration, sharp edge, fragility.
• Children's products: Small parts, chemical contact, strangulation; age/month classification.
• Sports/games/accessories: Fall/impact, material breakage, lack of usage instructions.
• Non-cosmetic consumer products: Skin contact, irritation risk; secondary chemical exposure.

GPSR Risk Assessment — Example Content List (Practical Template)

1. Product definition (model, variant, intended use)
2. Target user groups and exposure scenarios
3. Hazard analysis (mechanical, chemical, electrical, thermal, software/cyber)
4. Risk assessment matrix (probability x severity) and acceptance criteria
5. Harmonized standards / test report references
6. Remaining risks and risk communication (label, instruction, warning)
7. Monitoring plan (complaint, incident, CAPA) and versioned revision record

Common Mistakes

1. Risk assessment being incomplete or scattered in the technical file
2. Warnings not being visible on product pages; language/terminology errors
3. Manufacturer/importer information being given inconsistently on labels and pages
4. Ineffective recall management due to weak batch/serial traceability
5. Incident collection and Safety Gate notification threshold processes not being defined

10-Step Quick GPSR Readiness Plan

1. Product inventory and risk classification (high/medium/low)
2. Copy risk assessment template to projects; fill in product-specific
3. Align label–instruction–product page language with risk file
4. Audit supply chain/serial–batch trace; close missing areas
5. Check visibility of safety content for marketplace product pages
6. Standardize complaint/incident collection channels (QR, form, email)
7. Document internal "serious risk" threshold and notification steps
8. Prepare recall notification (template) and communication flow
9. Training: short module for customer service, sales and e-commerce teams
10. Periodic review: versioning and CAPA records

Conclusion

GPSR compliance starts with a solid risk assessment file, visible warnings, traceable supply chain and a practical incident/recall plan. If you want ready templates and quick gap analysis for your product family, contact us.

Pier Compliance — Product Safety & EU Compliance

info@piercompliance.com

www.piercompliance.com