Regulatory

Liability for defective products is being massively tightened. The new Product Liability Directive, adopted by the European Parliament in March 2024, will almost completely change the strict liability system that has been in place for over 40 years.

One of the most significant recent reforms in product safety law is the adoption of the so-called General Product Safety Regulation (EU) 2023/988 (GPSRthe new “General Part,” if you will, of European product safety law. It entered into force on June 12, 2023, and will replace the current 2001 Product Safety Directive when it takes effect on December 13, 2024.

Why does the GPSR exist and what is new? 8 facts for take away:

1. Purpose and scope
   The purpose of the GPSR is to “improve the functioning of the internal market while providing a high level of consumer protection.” The aim is thus to guarantee the greatest possible product safety with the least possible interference with the free market. A revision of the existing legal framework was necessary, among other things, because of the development of new technologies and online sales.
   The GPSR applies in principle to consumer products on the Union market, with some exceptions such as pharmaceuticals, food or feed. If a product is subject to sector-specific Union harmonization legislation, such as the Medical Devices Regulation, these take precedence if they already regulate a particular subject. In addition, such products are generally excluded from some parts of the GPSR.
2. Harmonization of the legal framework
   The GPSR is based on the endeavor to create the greatest possible coherence with the sector-specific harmonization and standardization legislation and with the EU Market Surveillance Regulation, and to close gaps between the legal frameworks wherever possible. This is implemented, for example, by including the fulfillment service provider, setting the time of “making available on the market” in online sales to the time of offer, and extensive referencing as in Articles 16 and 23.
   Recital 3 hereby also justifies the choice of the legal instrument of a regulation: the objective of coherence with the legal framework for market surveillance of products falling within the scope of Union harmonization legislation could be better achieved if both areas were governed by regulations.
3. Extension and redefinition of the criteria for the assessment of safety
   For the assessment of the safety of consumer products, Art. 6 GPSR contains a new and comprehensive catalog of aspects to be considered. When a product is considered “safe” and when it is not is thus described in more concrete terms than was previously the case – although on a case-by-case-basis, of course, it will remain a matter of interpretation.
   The well-known criteria such as the characteristics of the product, including its composition and packaging, the effect of the product on other products where a joint use is foreseeable, the presentation of the product and the consumer groups exposed to a risk when using the product remain relevant. The GPSR adds to these the appearance of a product where it is likely to lead consumers to use the product in a way different to what it was designed for as well as the product’s cybersecurity features that may be required and any evolving, learning, and predictive functions of the product.
4. New obligations for non-harmonized products
   Due to the broad scope and an expansion of obligations for various economic actors, new obligations will also arise in the non-harmonized area, especially for manufacturers: for example, in the future, before placing a product on the market, they will have to conduct a more precisely described internal risk analysis, prepare technical documentation, establish publicly accessible communication channels for complaints, and maintain an internal complaints register.
5. New obligations in online commerce
   European product safety law is to finally arrive in the digitalized age with the GPSR. Providers of online marketplaces must therefore, among other things, establish a central contact point for market surveillance authorities and consumers, have an internal system for ensuring product safety and use the rapid alert system Safety-Gate (formerly: RAPEX). They also face extensive notification, information and cooperation obligations towards market surveillance authorities.
6. Need for an economic operator established in the EU
   Already since the entry into force of the Market Surveillance Regulation in 2021, a prerequisite for the lawful placing on the market of certain products has been the existence of an economic operator established in the Union and responsible for the product. The GPSR adopts this requirement and thus extends its scope to non-harmonized products.
7. New requirements for dealing with product recalls, including for online marketplaces
   The GPSR provides for a complex product recall system, which in essence, however, continues to be based on the essential steps of immediate corrective action and informing consumers and authorities. However, the Regulation provides for more precise requirements, for example with regard to the recall notice, which must meet specified formal and content-related requirements (including being headed with the term “product safety recall”) and be written in a language that is easy for consumers to understand. The Commission is to establish a template by means of an implementing act.
   As a result of a recall, the responsible economic operator must also offer “effective, cost-free and timely” remedies to affected consumers, such as the repair, replacement, and an adequate refund. This provision can be read as a kind of incorporation of warranty law into product safety law.
8. New obligations to report accidents
   In the future, manufacturers will be required to immediately report “accidents that occur in connection with the safety of products” via the online communication portal Safety Business Gateway. The notification is directed to the authorities of the Member State in which the accident occurred. The scope of this rule is not entirely clear, but its wording presumably limits it to cases of particularly serious accidents. The reporting obligation also serves in particular to create a comprehensive collection of data so that dangerous product groups and trends can be identified more quickly in the future.

Author:
Eva Ritte, M.A.