The EU Regulation 2023/988, which came into force to strengthen product safety in the European market, introduces new requirements for risk assessment regarding the safety of products placed on the market. Articles 6 and 8 of this regulation focus respectively on the obligations of producers and those of importers and distributors, including risk assessment as one of the key elements to ensure that products are safe.
Obligations of the producer (Art. 6)
Article 6 stipulates that the producer must ensure that products are designed and manufactured in compliance with safety requirements. In this context, the producer must conduct a risk assessment, which involves:
- Identification of hazards: The producer must identify all potential risks associated with the product, including those related to intended use and reasonably foreseeable misuse.
- Assessment of the probability and severity of the risk: After identifying the risks, it is necessary to evaluate both the likelihood of occurrence and the severity of the consequences for the user or consumer.
- Definition of mitigation measures: Based on the assessment, the producer must adopt appropriate safety measures, such as adding warnings, adjusting the design, or using safer materials.
- Continuous monitoring and review: Risk assessment is not static. The producer must monitor risk evolution over time, taking into account feedback, incident reports, or changes in product use.
Obligations of importers and distributors (Art. 8)
Article 8 specifies that importers and distributors also have responsibilities for product safety. They must verify that producers have adequately conducted the risk assessment and report any discrepancies or new risks.
- Documentary verification: Before placing a product on the market, importers and distributors must ensure that the producer has conducted a risk assessment and that documentation is available.
- Random checks: When necessary, they may conduct random tests to verify product safety and report any anomalies.
Practical Example: Children’s Toy
Imagine a manufacturer designing a new plastic toy for children. To comply with EU Regulation 2023/988, they must follow these steps for risk assessment:
- Identification of hazards: Potential risks include choking hazards due to small parts, chemical risks from materials used, and physical injury from sharp edges or moving parts.
- Assessment of probability and severity: The manufacturer assesses that the risk of choking is high for children under three years old, while the chemical risk is moderate. The severity of a choking incident is extreme, while the severity of chemical exposure is moderate.
- Mitigation measures: The toy is redesigned to eliminate small parts, and the materials used are certified as non-toxic. In addition, labels are added specifying that the toy is not suitable for children under three years old.
- Monitoring: After the product is marketed, the manufacturer continues to monitor incident reports and updates the risk assessment if new data or problems arise.
