Understanding the GPSR Risk Analysis Process
EU/2023/988 General Product Safety Regulation – Risk Analysis & Assessment
Ensuring product safety under the General Product Safety Regulation (GPSR) EU/2023/988 requires a structured risk analysis process. This systematic approach helps importers, manufacturers, and responsible persons meet compliance obligations while safeguarding consumer health and safety. Below is a breakdown of the key sections in a GPSR-compliant risk assessment. Download our GPSR Risk Analysis Template for a structured approach to evaluating product safety risks.
Section 1 – Economic Operator Information
This section identifies all economic operators involved in the product’s supply chain, including:
- Manufacturer: Details on name, trade name, full postal and electronic address, telephone number, and primary contact.
- Authorised Representative: If applicable, providing the same details as the manufacturer.
- Importer: Contact information to ensure traceability.
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Responsible Person: If different from the manufacturer, the designated EU representative handling compliance obligations.
Section 2 – General Product Description
A clear description of the product, including:
- Product name and function.
- Essential safety characteristics (e.g., food-imitating, child-appealing items, small parts, high-risk materials).
- Composition details (raw materials or Bill of Materials).
- Age grading (e.g., intended for adults, children over 12, infants, etc.).
Section 3 – Applicable Legal Requirements & Standards
Products must comply with relevant EU regulations, such as:
- General Product Safety Regulation (EU/2023/988).
- REACH Regulation (EC 1907/2006) (Annex XVII for restricted substances, SVHCs).
- Persistent Organic Pollutants Regulation (EU/2019/1021).
- Electromagnetic Compatibility Directive (2014/30/EU) for electronic products.
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Applicable EU harmonized standards ensuring product safety (e.g., EN71 for toys, IEC standards for electronics, etc.).
Section 4 – Product Design Evaluation
A hazard assessment identifies potential risks and mitigating measures:
Physical & Mechanical Hazards
- Sharp edges, moving parts, entrapment risks, small parts causing choking hazards.
- Stability concerns for items prone to tipping or collapsing.
- Compliance with standards like EN 71-1, ISO 8124.
Flammability & Thermal Hazards
- Fire risks, overheating, spontaneous combustion, contact with hot surfaces.
- Compliance with EN71-2, FFFSR, or relevant nightwear regulations.
Chemical Hazards
- Presence of restricted chemicals, toxic substances, heavy metals, allergens.
- Compliance with REACH Annex XVII, CLP labelling, EN71-3, RoHS Directive.
Electrical Hazards
- Battery and electric shock risks, short circuits, overheating components.
- Compliance with EN 62133, IEC 60335, Low Voltage Directive (2014/35/EU).
Hygiene & Microbiological Hazards
- Risk of bacterial or fungal contamination, materials that may harbor pathogens.
- Compliance with USP 50, 51, ISO 22196, EN 13697.
Radiation & Optical Hazards
- LED emissions, laser exposure, UV or IR radiation.
- Electromagnetic field (EMF) risks.
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Compliance with EN 62233, IEC 62471, EMC Directive (2014/30/EU).
Section 5 – Risk Analysis / Assessment Findings
Each identified hazard is categorized into risk levels:
- Critical Risk: Life-threatening hazards requiring strict control measures (e.g., electrical shock, toxic chemicals, choking hazards for infants).
- Major Risk: Significant injury/damage risks mitigated by testing and compliance protocols (e.g., fire hazards, mechanical entrapment, cuts, burns).
- Minor Risk: Low-severity risks addressed through product design and labeling (e.g., mild irritation from materials, minor flammability concerns).
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Manufacturing Concerns: Risks like foreign body contamination, improper assembly, material inconsistencies, mitigated by quality control (e.g., metal detection, visual inspection, weight checks).
Section 6 – Labelling Requirements
Proper labeling ensures user safety and regulatory compliance. This includes:
- Product labeling & safety instructions (e.g., age warnings, safety notices, proper usage guidelines).
- Packaging warnings & compliance symbols (e.g., CE marking, disposal instructions, caution labels).
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Specific safety information included with the product (e.g., manuals, maintenance guides, emergency warnings).
Final Declaration of Safety Compliance
Upon completion of the risk assessment, the product is deemed safe per GPSR requirements. A supplier representative must sign and stamp the document to confirm compliance.
At EaseCert, we simplify GPSR compliance for importers and manufacturers, ensuring your products meet EU safety requirements. Contact us for expert guidance on risk assessments, regulatory obligations, and certification solutions.
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