NEW PRODUCT SAFETY REGULATION: REGULATION (EU) 2023/988

On December 13, 2023, Regulation (EU) 2023/988, better known as the General Product Safety Regulation (GPSR), became fully operational, replacing Directive 2001/95/EC, which was integrated into the Consumer Code (Legislative Decree 206/2005). The new regulation was enacted to enhance the general safety of products, protect consumers, and improve the functioning of the internal market by adapting product safety rules to the challenges posed by modern technologies and online commerce. It also harmonizes regulations for all operators in the supply chain, from manufacturers to retailers, with a particular focus on online sales platforms. Key innovations include regulating "distance" sales, incorporating new technologies into the definition of a safe product, reducing autonomy for manufacturers, importers, distributors, and online platforms (now required to adopt specific and stringent measures to ensure product safety in collaboration with surveillance authorities), and improving alert and recall systems with more efficient mechanisms to report and remove dangerous products. All supply chain operators must comply with these changes and engage in ongoing dialogue with surveillance authorities, adopting precautionary strategies to prevent unsafe products from reaching consumers.

The GPSR applies to all new, used, repaired, or refurbished products introduced or made available on the market, except for certain specific categories such as medicines, food, feed, plants and animals, genetically modified organisms, animal by-products, plant protection products, aircraft, and antiques. It applies residually and subsidiarily where there are no specific provisions under European Union law governing product safety aspects. The regulation redefines the concept of product safety through the adoption of new evaluation criteria, strengthening protection throughout the product’s lifecycle. This includes considerations of its qualitative characteristics, packaging, labeling, interactions with other goods, labeling of age suitability for children, identification of risks for vulnerable consumer categories, warnings for unintended uses, and instructions for use and disposal.

The regulation introduces specific obligations for all operators in the supply chain. “Manufacturers” (a term that includes both those who physically produce the product and those who modify and place it on the market) are primarily responsible for product safety. Before introducing a product to the market, manufacturers must conduct a risk assessment and are required to prepare and retain technical documentation demonstrating product compliance for at least ten years. They must ensure traceability, including through electronic solutions like QR codes, and establish communication channels for complaints and notifications. Importers introducing products into the EU must verify compliance with regulatory requirements and the manufacturers' obligations, ensure products are accompanied by all necessary information, and collaborate with manufacturers and distributors to adopt corrective measures if risks are identified. Distributors, on the other hand, must ensure that manufacturers and importers comply with the regulation and ensure that storage and transportation do not compromise product safety. If they identify non-compliant or dangerous products, they are required to cease distribution and immediately inform the competent authorities and involved economic operators. The aim is to make all actors in the supply chain accountable, thereby enhancing consumer protection.

One of the GPSR’s main innovations is the strengthening of protections against dangerous products through the introduction of the new Safety Gate system. This mechanism ensures better product traceability and a timely alert system to prevent harm. It consists of: a portal for national authorities and the European Commission to exchange internal information on dangerous products (Safety Gate Rapid Alert System); a consumer-facing channel to report risky products and inform consumers (Safety Gate Portal); a web interface that allows manufacturers to fulfill their obligation to notify authorities and consumers about dangerous products and safety incidents, while also enabling immediate corrective actions (Safety Business Gateway).

A specific focus is dedicated to online marketplaces, which are required to verify product information, ensuring that it is clear and accessible, actively monitor products to identify and remove those that are dangerous or non-compliant, and collaborate with surveillance authorities. Additionally, they are required to establish a single communication channel for reporting issues and register on the Safety Gate portal. In cases of repeated violations, they can block products from the responsible operators.

If a product is removed for safety reasons or if safety notices (e.g., information on safe product use) must be distributed, economic operators and marketplaces are required to ensure that affected consumers are directly and immediately informed. If direct communication is not feasible, they must disseminate the information through other accessible channels, such as websites, social media, or other mass communication means, ensuring accessibility for persons with disabilities.

Finally, it should be noted that the Regulation does not establish a sanctioning system for violations of the obligations imposed on economic operators. Instead, it leaves it to the competence of individual EU Member States to establish appropriate sanctions that are effective, proportionate, and dissuasive

Authors: Avv. Gianfilippo Chiricozzi and Sofia De Paolis