Recently, two major European legislative initiatives entered into force. These have an impact on economic operators who market products intended for consumers, such as manufacturers, importers, and distributors. With new rules on product safety and liability, the European Union aims to better protect consumers and modernize the regulatory framework, particularly in response to technological developments such as artificial intelligence, smart devices, and digital services. The new rules may have a direct impact on your business operations and on the liability risks across the entire distribution chain.

1. The new General Product Safety Regulation: new rules on product safety

General

Since 13 December 2024, new rules relating to the safety of consumer products apply following the entry into force of Regulation (EU) 2023/988 on general product safety (the Product Safety Regulation). This regulation is already directly applicable in all EU Member States for everyone falling within its scope, without transposition into national law being required.

In practical terms, the various actors in the distribution chain, namely manufacturers, importers, distributors and online product providers, will bear greater responsibility to ensure that products meet safety standards.

The rules apply to all products intended to be sold to consumers or likely to be used by them, both online and offline, whether new, second-hand, or repaired. Certain products fall outside the scope, including medical devices, pharmaceutical products, food, and animal feed.

The new product safety rules

In general, manufacturers and importers must ensure that products are (i) safe and compliant (i.e., designed, manufactured, and tested in accordance with all specific safety laws and standards applicable to these products and their components); (ii) traceable (i.e., the packaging or the products themselves must include, among other things, the manufacturer’s or importer’s contact details, and the chain of economic operators must be accurately documented); (iii) identifiable (products must include a visible and legible means of identification, such as a serial number); and (iv) accompanied by instructions and safety information in the language of the region where the product is marketed.

In addition, the various actors must comply with the following more specific obligations:

• The manufacturer must carry out an internal risk analysis and prepare and keep up to date the required technical documentation. This technical file contains at least a general description of the product, its essential characteristics relevant to safety assessment, as well as any other information demonstrating that the product meets the legal product safety requirements (e.g., risk assessments, checks performed, and test reports).
• The importer must, among other things, keep a copy of the technical documentation prepared by the manufacturer for 10 years from the date the product is placed on the market, and make it available to authorities. He must also verify whether consumers have communication channels to file complaints.
• The distributor must ensure that the distribution process is safe and verify that the manufacturer or importer complies with their obligations. Distributors must actively check product compliance and therefore be familiar with the various safety requirements. Immediate measures must be possible as soon as non-compliance is suspected. This includes, among other things, product recalls, immediate notification of the manufacturer or importer, or reporting non-compliance through the EU Safety Business Gateway platform to inform surveillance authorities.

Impact on AI-enabled products

The new Product Safety Regulation also affects products integrating artificial intelligence (AI). Products with AI features are not subject to separate rules under this regulation. However, whenever a product contains AI features, the entire product, including the embedded AI systems, must comply with the new product safety requirements.

In other words, the presence of AI in a product entails additional responsibilities in terms of product safety and risk management. Products whose functioning may evolve over time, for example through machine learning, must undergo an explicit assessment of potential safety hazards that may arise during their use.

Furthermore, AI applications must be sufficiently predictable, controllable, and traceable (see above). These increased responsibilities arising from the Product Safety Regulation come in addition to the obligations that businesses may incur under the European AI Regulation (also known as the “AI Act”), which entered into force on 1 August 2024.

2. The new Product Liability Directive

On 9 December 2024, the new Directive (EU) 2024/2853 on product liability (the Product Liability Directive) also entered into force. These rules determine when a company is liable for damage caused by a product, regardless of whether the company itself is at fault. Unlike the Product Safety Regulation, the new Product Liability Directive still needs to be transposed into national law. EU Member States have until 9 December 2026 to do so. However, the text provides for maximum harmonization, meaning Member States cannot introduce stricter or more lenient provisions. Products placed on the market before that date will remain subject to the old rules.

The Product Liability Directive expands manufacturers’ liability with stricter rules regarding digital and integrated products, such as software and digital services. Smart devices and AI systems are also included within its scope, and companies may be held liable if an AI system has defects that cause damage. Additionally, the notion of “damage” has been broadened. Economic operators within the EU may now also be held liable for psychological harm (in addition to traditional physical harm) and for damage resulting from the destruction or irreversible deterioration of (digital) data. For consumers, it will be easier to claim compensation. Thanks to legal presumptions, the burden of proof is reduced, and manufacturers will be required to disclose essential evidence. Product safety, including cybersecurity, will play a central role in assessing defectiveness. It is therefore likely that the Product Liability Directive will, in practice, lead to an increase in liability claims.

It should also be noted that under the new Product Liability Directive, a presumption of defectiveness is introduced when a product does not comply with the Product Safety Regulation.

3. What do the new rules mean for your business?

The new rules have significant consequences for businesses. It is therefore important to know what role your company plays in the distribution chain and how the new rules may affect your products and your liability.

Accordingly, it is important to review your commercial contracts with, among others, manufacturers, importers, distributors and other actors in the distribution chain, and adapt them to the new rules where necessary. Although the new Product Liability Directive is not yet applicable in Belgium, it is advisable to prepare your company for the upcoming changes and to integrate the future expansion of liability, the broader definition of damage, and the additional responsibilities into your contracts.

In view of the obligations arising from the Product Safety Regulation, we further see an increased importance of NDAs, non-compete clauses and prohibitions on reverse engineering to protect companies’ intellectual property rights and competitive position.

Please note that if specific legislation applies to the consumer products you market, the Product Safety Regulation may not apply (in whole or in part). For example, construction companies and manufacturers of construction products must verify whether their products fall under Regulation (EU) 305/2011 on construction products or under the Product Safety Regulation (or both). The same applies to companies marketing machinery and industrial equipment or, for example, toys. Above, we also pointed out the obligations that may arise from the AI Act.

Do you have questions about the new rules on product safety and liability? Please do not hesitate to contact us. We will be happy to assist you!