The GPSR Risk Analysis Process

The GPSR Risk Analysis Process

EU GPSR Risk Analysis & Assessment

Ensuring product safety under the General Product Safety Regulation (GPSR – Regulation EU 2023/988) requires a structured risk analysis. This process helps manufacturers, importers, and EU Responsible Persons meet legal obligations while protecting consumer health. Below is an overview of a typical GPSR-compliant risk assessment structure. Download a template here: GPSR Solutions Risk Analysis Template

Section 1 – Economic Operator Information

This section includes all relevant supply chain contacts:

  • Manufacturer: Full legal name, address, phone, and email.
  • Authorised Representative: Required for non-EU brands. See details on appointing an EU Responsible Person.
  • Importer: EU-based entity legally placing the product on the market.
  • Responsible Person: Contact for safety and regulatory questions (may be the AR or importer).

Section 2 – General Product Description

Provide a clear product overview:

  • Product name and intended function
  • Key safety features (e.g. child appeal, small parts, electrical risk)
  • Materials or Bill of Materials (BOM)
  • Target user group (age grading)

Section 3 – Applicable Legal Requirements & Standards

Include all laws and standards relevant to your product:

  • General Product Safety Regulation (EU 2023/988)
  • REACH Regulation (EC 1907/2006)
  • Persistent Organic Pollutants Regulation (EU 2019/1021)
  • Low Voltage Directive (2014/35/EU) (if electrical)
  • Relevant harmonised standards: EN 71 (toys), EN 62133 (batteries), IEC 60335, etc.

Refer to our GPSR legal requirements guide.

Section 4 – Product Design Evaluation

Physical & Mechanical Hazards

  • Sharp edges, choking risks, entrapment
  • Standards: EN 71-1, ISO 8124-1

Flammability Hazards

  • Fire risk, heat exposure
  • Standards: EN 71-2, FFFSR (nightwear)

Chemical Hazards

  • SVHCs, restricted substances
  • Standards: REACH Annex XVII, EN 71-3, CLP labelling

Electrical Hazards

  • Battery safety, short circuits
  • Standards: EN 62133, IEC 60335, LVD 2014/35/EU

Hygiene & Microbiological Hazards

  • Contamination, bacteria/mold growth
  • Standards: USP 50/51, ISO 22196, EN 13697

Radiation & Optical Hazards

  • Laser/UV/LED exposure
  • Standards: IEC 62471, EN 62233, EMC Directive 2014/30/EU

Section 5 – Risk Analysis / Assessment Findings

Classify each hazard into risk levels:

  • Critical Risk: Life-threatening, requires strict controls
  • Major Risk: Significant harm mitigated by testing or labeling
  • Minor Risk: Addressed via design or clear instructions
  • Manufacturing Concerns: Covered by inspections or QA (e.g. foreign body, improper sealing)

Section 6 – Labelling Requirements

  • On-product labeling: Name, address, model/serial number
  • Warning symbols: Age warnings, CE mark, disposal icons
  • User documentation: Safety instructions in EU languages

See: GPSR labeling requirements

Final Declaration of Safety Compliance

Upon completion, confirm that the product complies with all applicable EU safety laws. This declaration supports market entry and can be referenced in your Declaration of Conformity.

GPSR Solutions helps importers and manufacturers prepare structured, defensible risk assessments tailored to EU requirements. Contact us to start your file today.

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Frequently Asked Questions

Do all products need a GPSR risk analysis?

Yes. All non-food consumer products sold in the EU must undergo a documented safety evaluation under Regulation (EU) 2023/988.

Can I use test reports instead of a risk analysis?

No. Test reports support safety claims but are not a substitute for a structured risk assessment.

What format should I use?

There is no official EU format, but using a template aligned with GPSR article structure is recommended. GPSR Solutions provides one in every bundle.

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