EU Regulation 2023/988

The new EU Regulation 2023/988 on general product safety, which will take effect on December 13, 2024, represents a significant step toward a safer European market for consumers. This regulation updates and replaces the previous Directive 2001/95/EC, introducing stricter requirements and a clear regulatory framework for companies operating within the EU. In this article, we will examine the main provisions, the responsibilities of economic operators, and how technological platforms like Certiblok can support businesses in ensuring compliance, safety, and document traceability through blockchain

Objectives and Scope

The purpose of Regulation (EU) 2023/988 is to ensure that all products placed on the European market are safe, thereby protecting consumers and improving internal market cohesion. The regulation applies to all products, including used, repaired, or refurbished items, with the exception of certain categories regulated by other laws, such as food, medicines, and specific transport equipment. This regulation also covers online commerce, a particularly sensitive area due to rapid growth and challenges in monitoring the compliance of digitally sold products.

Key Obligations for Manufacturers, Importers, and Distributors

The obligations under Regulation (EU) 2023/988 extend to all economic operators along the supply chain. In particular:

Manufacturers: Manufacturers must design and produce safe products, prepare and maintain up-to-date technical documentation, and ensure that each product is clearly identifiable through a batch or serial number. Additionally, manufacturers must ensure that products are accompanied by instructions and safety information in a language easily understandable by consumers in the Member State where the product is made available. A risk analysis is also required to identify and mitigate potential hazards, making products safe for vulnerable categories such as children and the elderly. Finally, it is mandatory to adopt measures to monitor the safety of products placed on the market and take corrective action when necessary.

Importers: Importers must verify that imported products comply with EU regulations and keep detailed records of product information. They must ensure that the manufacturer has carried out the appropriate conformity assessment and that technical documentation is available. Furthermore, importers must display on the product their name, registered trade name, or trademark, and the address where they can be contacted. For instance, an importer of household items must ensure that products comply with regulations such as fire safety standards, and, in case of non-compliance, must inform the manufacturer and relevant authorities.

Distributors: Distributors are required to ensure the safe storage and transportation of products and report any issues to manufacturers or importers, thereby facilitating the quick identification and recall of non-compliant products. They must check that the product bears the CE marking, is accompanied by the required documents, and includes instructions in a language understandable to consumers in the Member State where the product is made available. They must also ensure that the manufacturer and importer have met their respective obligations.

Technical Documentation and Safety Assessment

A key aspect of compliance is technical documentation, which must include all relevant information on the product, including instruction manuals and safety warnings. The documentation must be kept for at least ten years from the date the product is placed on the market and must be ready for inspection by competent authorities. It should contain a complete description of the product, its design and manufacture, as well as risk assessments and measures taken to ensure compliance. Safety assessment requires companies to consider various aspects, including product characteristics, effects on other products, presentation, consumer categories, and cybersecurity features necessary to protect the product from external influences.

In the toy sector, subject to strict standards due to the young audience, Regulation (EU) 2023/988 has strengthened controls. For example, a company manufacturing electronic toys must include safety measures to prevent risks of strangulation, choking, and cybersecurity vulnerabilities. With Certiblok, the company can maintain a complete record of certifications and safety tests for each product, and through the automatic notifications module, it can schedule alerts for each deadline or required update. This approach simplifies preparation for inspections and ensures that documentation is readily available in case of product recalls.

Compliance management can become complex, especially for companies with large product catalogs. A relevant example is the electronics sector, where many internet-connected devices, such as smart home devices, must ensure cybersecurity in addition to physical safety. An IoT device manufacturer, for instance, must implement strict controls to prevent vulnerabilities that could compromise user safety and maintain accurate documentation of every software or hardware modification.

Technological Support for Compliance

Companies are required to implement preventive measures, such as risk assessments and internal quality controls, and to provide detailed technical documentation that certifies product safety. The documentation must be ready and available to supervisory authorities and should cover aspects such as:

Risk analysis: identifying and mitigating risks associated with the intended and reasonably foreseeable use of the product.
Traceability: every product must be identifiable through an information chain that allows monitoring in the event of a recall.
Requirements for e-commerce: ensuring that product information is clear and that platforms can promptly remove items deemed dangerous.

Technological platforms like Certiblok can support businesses in complying with Regulation (EU) 2023/988, offering solutions for managing technical documentation and product traceability through blockchain. These tools facilitate secure data storage, quick access to information, and transparency along the supply chain, crucial elements for ensuring product safety and consumer trust.

Regulation (EU) 2023/988 further holds companies operating in the European market accountable, requiring careful and timely management of documentation and compliance procedures. Certiblok offers an innovative platform that not only meets safety and traceability requirements but also enables integrated management of deadlines and audit processes, simplifying daily work and reducing the risk of penalties.

Gianluigi Michelotto
Co Founder Certiblok

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