How to Conduct a Risk Analysis for Consumer Products
The European Union’s General Product Safety Regulation (EU) 2023/988 (GPSR) places new, clearer obligations on manufacturers to ensure the safety of consumer products before they are placed on the EU market. One of its core requirements is that manufacturers must conduct an internal risk analysis and document it thoroughly to demonstrate their products are safe under normal and foreseeable use conditions.
ANSWERED ON THIS PAGE
- Why is risk analysis important under the GPSR?
- What is a proportionate risk analysis?
- Important considerations when conducting a risk analysis
- How to document a risk analysis
- Why is post-market monitoring important?
Why is Risk Analysis important under the GPSR?
EU market surveillance authorities will expect manufacturers to prove they understand the risks their products pose, have taken appropriate steps to mitigate those risks, and can justify any remaining residual risks in a clear and transparent manner. An incomplete, generic, or poorly thought-out risk assessment can jeopardize your entire market strategy. It can lead to refused market entry, enforced recalls, or even fines and reputational harm that damage relationships with customers, distributors and retailers.
On the other hand, conducting a thorough, well-documented, and structured risk analysis is not just about checking a regulatory box. It is an essential step in building an inspection-ready technical documentation file that can stand up to scrutiny and reassure both regulators and business partners that your commitment to consumer safety is genuine and credible.
What is proportionate Risk Analysis?
The GPSR adopts a risk-based, proportionate approach. This means the level of detail in your risk analysis must reflect both the complexity of the product and the seriousness of any potential hazards. A basic product may only require a short analysis, while an electronic device with moving parts or hazardous substances demands a more in-depth evaluation
Importantly, the GPSR does not prescribe a single mandatory methodology. Manufacturers have the flexibility to choose structured approaches that fit their products, such as Failure Modes and Effects Analysis (FMEA), hazard checklists, or other systematic methods. However, manufacturers must assess:
- Foreseeable misuse: such as incorrect assembly, unintended interactions, or use by unintended user groups.
- Product appearance: including risks related to food-imitating products that children might accidentally ingest.
- Digital safety: for connected or smart products, potential cybersecurity or AI-driven malfunctions must be considered.
- Interoperability: does the product present new risks when used alongside common accessories or third-party items?
The GPSR is clear that warnings or instructions alone are not an acceptable substitute for safe design, where risks can be eliminated at the design level. For example, if a product has a sharp edge, simply warning users is not enough if that edge can be rounded off or shielded.
Important considerations when conducting a Risk Analysis
The GPSR enumerates specific factors that must be considered when evaluating a product’s safety. These include the product’s design and manufacture, its packaging and instructions, and any effect it might have in combination with other products. For example, if a gadget is likely to be used with a certain accessory, one should assess if the combination creates any new hazards. The appearance of the product is also critical. If a non-edible item looks like food (a food-imitating product), the GPSR explicitly deems it unsafe because children might ingest it. Likewise, if a product is not intended for kids but is likely to attract them, its safety must be assessed as if children will interact with it.
Another key consideration nowadays is digital safety: if a product has software or connectivity, the GPSR requires looking at cybersecurity risks that could impact safety. For instance, could a hacker cause a connected device to malfunction and create a hazard? Manufacturers of “smart” devices need to include such scenarios in their risk assessments. Similarly, products with AI or learning capabilities should be evaluated for how those evolving functions might introduce safety issues over time. E.g. a robotic toy that learns new behaviors must not learn to do something unsafe.
How to document a Risk Analysis
A GPSR-ready risk assessment should begin with administrative details that establish the basic context of the analysis, including the product’s name, description, and intended use, along with the manufacturer’s contact information.
Next, the documentation should clearly describe the product’s essential characteristics relevant to safety. This includes details such as materials, design features, any child-appealing elements, age grading, and explicit warnings or usage limitations. This level of detail is necessary to help authorities and your representative understand exactly what is being placed on the market and where potential risks may arise.
Manufacturers must also identify applicable legal requirements and standards, such as GPSR itself, REACH for chemical safety, or any relevant harmonized standards. Referencing test reports or certificates here strengthens the case for compliance.
Hazard identification forms the heart of the analysis. Manufacturers should systematically consider potential risks, including physical, mechanical, thermal, chemical, electrical, and hygiene hazards. Each hazard must be thoughtfully described, with an explanation of any mitigation measures, such as design changes, safety standards testing, or labeling requirements.
Risk assessment findings must then be clearly documented, showing how severity and probability were estimated, what residual risk remains after mitigation, and whether those residual risks are acceptable or require a formal benefit-risk justification. For any risks that remain moderate or higher, manufacturers need to explain why further mitigation is impracticable and why the product benefits outweigh the risks.
Labeling and safety information is another critical part of the analysis. Manufacturers should describe how safety warnings, symbols, instructions for use, and multilingual labeling mitigate risks and ensure users understand how to use the product safely. Labeling is often one of the most effective and required control measures under GPSR. Read more about GPSR labeling requirements.
Finally, the assessment should conclude with an overall evaluation of residual risk, confirming that all known hazards have been identified and mitigated to the lowest practicable level. This conclusion must be clearly documented and approved, supporting the declaration that the product is safe under normal and foreseeable conditions of use.
By structuring the risk analysis in this way, manufacturers not only meet GPSR requirements but also create a defensible, transparent record that demonstrates a real commitment to consumer safety and positions their business for long-term success in the European market.
Why is Post-Market monitoring important?
GPSR compliance does not end once the product is on the market. The GPSR obliges manufacturers to investigate complaints and accidents, maintain a register of safety-related issues, and take corrective action if new hazards are identified. Examples of corrective actions include:
- Updating warnings or instructions,
- Issuing product recalls or withdrawals,
- Notifying market surveillance authorities via the EU Safety Business Gateway.
Monitoring consumer feedback through returns, online reviews, support requests, or distributor alerts is critical to identifying safety signals. A robust post-market process helps identify unexpected risks that may not have been captured during pre-market analysis.
Additionally, post-market data may be required by market authorities during inspections or investigations. A complete and well-documented risk file, updated over time, provides a strong compliance defense.
How EARP supports
As an independent Authorized Representative and Responsible Person, EARP verifies that your risk analysis is present and appropriately structured before accepting representation. But we do more than verify checkboxes:
- We share structured templates to support systematic hazard identification and evaluation.
- We review the logic and completeness of risk documentation before onboarding.
- We help clients understand EU authorities’ expectations for demonstrating control over product safety.
Our goal is to reduce compliance risks and ensure that when market surveillance authorities ask for your technical documentation, you are ready. Read more about EARP’s representation services.
Building market access on trust and transparency
A structured, well-documented risk analysis is the foundation of GPSR compliance. It is your evidence that you understand the product you are placing on the EU market and that you take consumer safety seriously. Manufacturers who invest in meaningful, proportionate risk assessments build credibility with regulators, distributors, and end-users alike.
At EARP, we help you turn these regulatory obligations into a competitive advantage.
GPSR Labeling FAQs
Your existing risk analyses (e.g., for CE-marking directives) can be a solid foundation, but you must ensure they address the GPSR’s general safety requirement. GPSR expects a clear, proportionate evaluation of hazards specific to consumer use, including foreseeable misuse and an explanation of how risks are controlled. Always review and adapt existing documents to fit GPSR’s scope.
Yes. Your risk analysis should consider risks introduced by suppliers or subcomponents, such as material safety, consistency of manufacturing, or changes in suppliers. Demonstrating control over your supply chain is essential to showing authorities that all risks have been identified and mitigated.
A risk analysis is not static. Manufacturers should review it at least annually, and whenever there are changes to the product’s design, materials, manufacturing process, intended use, or after significant customer feedback or incident reports. Keeping the analysis current demonstrates an ongoing commitment to safety.
Even simple or low-risk products need a documented risk analysis, but the depth should be proportionate. You must still identify hazards, explain mitigation measures, and justify why residual risks are acceptable. A short, clear analysis is often enough for truly low-risk items if it shows systematic thinking.
The GPSR does not mandate a single format, but it requires systematic, documented analysis. Using structured templates helps ensure consistency and completeness. Whatever format you choose, authorities expect clear hazard identification, risk evaluation, mitigation measures, and justification for any residual risks.
