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The new Regulation (EU) 2023/988 on product safety, in brief



The EU Product Safety Regulation (GPSR), which came into force in May 2023, represents a significant transformation in European legislation, aiming for a safer and more transparent internal market. It introduces clear obligations for economic operators and greater guarantees for consumers.

The Regulation, which becomes mandatory on December 13, 2024, replaces the previous General Product Safety Directive of 2001 (Directive 2001/95/EC) and provides a new EU framework on product safety to keep pace with the challenges of digitalization and the growing volume of goods and products sold online.

Scope of the Regulation

The Regulation continues to focus on ensuring a high level of safety for consumers, without borders within the internal market. It introduces a series of clear definitions, including the concepts of “risk,” “importer,” and “logistics service provider,” to improve the understanding and application of the rules.

The Regulation applies to products placed or made available on the market, insofar as there are no specific provisions of Union law with the same objective governing the safety of the products in question. If products are subject to specific safety requirements prescribed by Union law, this regulation applies only to aspects and risks or categories of risks not covered by those requirements.

Product Safety Assessment

The product safety assessment is detailed in Articles 6 and 8 of the Regulation. A presumption of conformity is introduced for products that comply with European standards published in the Official Journal of the EU. Crucial aspects such as cybersecurity and artificial intelligence are also outlined.

Product safety must be assessed considering the following criteria:

  • Product characteristics, such as design, technical features, composition, packaging, and instructions;
  • Effects on other products;
  • Presentation of the product, labeling, warnings, instructions, and safety information;
  • Categories of consumers using the product;
  • The appearance of the product, particularly aspects that mimic food or attract children;
  • Cybersecurity features and any evolving, learning, or predictive functionalities of the product.

Economic Operators

The regulation also establishes the indispensable condition for placing goods subject to the general product safety regulation on the EU market, requiring the presence of an economic operator established in the European Union who assumes the responsibilities defined in Article 16. This means they are responsible for:

  • Verifying the existence of an EU declaration of conformity or performance and related technical documentation when required;
  • Retaining these documents for the period prescribed by applicable regulations;
  • Providing market surveillance authorities with the necessary information and documentation to demonstrate the product’s compliance;
  • Reporting any safety risks to the authorities. If a product is recalled, consumers will be entitled to repairs, replacements, or refunds, and may also file complaints or take part in collective actions.

Online and Distance Selling

To ensure product safety, the Regulation introduces new duties for online sales platforms. Moving away from a purely passive role, authorities expect them to adopt internal processes for product safety and register with the Safety Gate portal, an online tool that allows consumers to report problems and dangerous products to national and European authorities. They must also provide a single point of contact, enabling product recipients to communicate directly with them. Finally, platforms must provide consumers with information about the manufacturer or person responsible for placing the product on the market, product identification, and any warnings associated with the products.

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Risk assessment for product safety according to EU Regulation 2023/988: Practical guide to Articles 6 and 8 with example

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:

  1. Identification of hazards: The producer must identify all potential risks associated with the product, including those related to intended use and reasonably foreseeable misuse.
  2. 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.
  3. 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.
  4. 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.

  1. 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.
  2. 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:

  1. 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.
  2. 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.
  3. 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.
  4. Monitoring: After the product is marketed, the manufacturer continues to monitor incident reports and updates the risk assessment if new data or problems arise.