Risk Analysis Now Mandatory Under the General Product Safety Regulation (GPSR) 2023/988
If your product requires CE marking, a risk analysis is an essential step. In the past, products that did not require CE certification were often exempt from risk analysis.
However, with the introduction of the new General Product Safety Regulation (GPSR) 2023/988, nearly all non-food products must now undergo a basic risk analysis to ensure consumer safety.
Under the GPSR 2023/988, manufacturers and importers in the European Union (EU) must conduct risk analyses to confirm that their products do not pose health or safety hazards. This regulation aligns with broader EU efforts to uphold strict product safety standards.
Key Elements of Risk Analysis Under GPSR 2023/988
1. Identification of Risks
- Hazard Identification: Manufacturers must pinpoint potential hazards—physical, chemical, biological, ergonomic, or related to improper product use.
- Product Characteristics: Risk evaluation must account for the product’s design, composition, intended use, and potential misuse by consumers.
2. Risk Assessment
- Probability and Severity: Evaluate the likelihood and severity of harm resulting from identified risks. This includes considering risks during both proper use and misuse of the product.
- Focus on Vulnerable Groups: Pay special attention to children, elderly individuals, and persons with disabilities, who may face greater risks.
3. Risk Acceptability Evaluation
- Acceptable Risk Levels: Assess whether risks are within acceptable thresholds. High or unacceptable risks necessitate corrective measures such as design changes or warnings.
- Compliance with Standards: Use existing safety standards and guidelines to benchmark risks and determine acceptability.
4. Mitigation Measures
- Risk Reduction Actions: Implement necessary adjustments, including design modifications, safety instructions, warning labels, or product recalls.
- Testing and Monitoring: Ensure ongoing risk management through continuous testing and product monitoring.
5. Documentation and Traceability
- Comprehensive Records: Maintain detailed documentation of the risk analysis process, covering identified risks, assessments, and actions. These records should be accessible for inspection by regulatory authorities.
- Continuous Updates: Regularly update the risk analysis to address new information, regulatory changes, or product modifications.
6. Reporting Obligations
- Danger Notification: Notify relevant authorities and take immediate action, such as recalls or market withdrawals, if a product poses serious safety risks.
- Regulatory Cooperation: Provide documentation and support to market surveillance authorities to address identified risks.
Conducting a Risk Analysis: Why It Matters and How to Get It Done
Risk analysis is an essential step in ensuring product safety and regulatory compliance, and for many products, it’s a legal requirement. At Smander, we conduct risk analyses for a wide range of product types, tailoring the process to match the specific needs of each case.
The scope of a risk analysis can vary greatly depending on the complexity of the product. While some manufacturers choose to perform their risk analysis independently, working with professionals can offer significant benefits, particularly for complex products or those subject to strict regulatory standards.
A Standardized Approach to Risk Analysis
Even when not legally mandated for all product categories, we perform risk analyses in alignment with EN 12100 and EN 13849-1:2023. These internationally recognized standards provide a consistent framework for assessing potential hazards and ensuring product safety.
This standardized approach is beneficial because:
- It ensures a high level of quality and thoroughness in the analysis.
- It remains relevant even if the product evolves over time, for instance, from a simple consumer product to a more complex machine.
- It provides clear documentation that can be valuable for regulatory compliance or future product modifications.
Should You Conduct a Risk Analysis on Your Own?
While it’s possible to carry out a risk analysis independently, it’s worth considering professional support, especially if the product is complex or unfamiliar with safety standards. A professional risk analysis can help identify potential issues that might be overlooked, ensure compliance with relevant regulations, and save time in the long run.
Getting Started
The first step to completing a risk analysis is to determine the level of assessment your product requires. Consulting with experienced professionals can help clarify the process, especially for products subject to specific safety regulations or standards.
Whether you handle the process independently or seek professional guidance, a thorough and well-documented risk analysis is a key part of delivering safe, reliable products to the market.