At a Glance
- The European Commission formally published the General Product Safety Regulation on May 23, 2023, and it will take effect on June 12, 2023.
- Full enforcement of the General Product Safety Regulation begins December 13, 2024, after an 18-month transition period.
- The new General Product Safety Regulations include new requirements related to adverse event reporting, pre-market risk assessments, safety recalls, and product labeling and documentation.
On May 23, 2023, the European Commission formally published the new General Product Safety Regulation, which reforms a variety of product safety regulations for manufacturers doing business in the European Union (EU) and its 27 member states. The European Parliament adopted the text of the regulation on March 30, 2023, and the European Council adopted it on April 25, 2023, but its official publication yesterday triggers the implementation and enforcement deadlines. Specifically, the regulation takes effect on June 12, 2023 (20 days from yesterday) and will include an 18-month transitionary period for EU member states, companies subject to the regulation and other actors to implement the new and revised regulations. Full enforcement begins December 13, 2024, after the conclusion of the transition period.
The regulations have been under consideration for many years and represent a major overhaul of product safety regulation in Europe. Product manufacturers should review the full set of regulations carefully and make any necessary adjustments to their procedures and processes to be in compliance with the new regulations before full enforcement takes effect on December 13, 2024. Among other things, the new General Product Safety Regulations include new requirements related to adverse event reporting, pre-market risk assessments, safety recalls, and product labeling and documentation. For example, manufacturers will be required to report “accidents caused by a product” “without delay” if the product is involved in an incident resulting in death or “serious adverse effects on health and safety.” Meanwhile, operators of online marketplaces are subject to an even more broadly worded requirement to report “accidents caused by a product … resulting in serious risk or actual damage of the health or safety of a consumer,” which extends the reporting requirement beyond incidents of actual injury.
The EU’s new General Product Safety Regulation represents another prong of regulatory and legislative changes in recent years in the EU that manufacturers and other companies doing business in Europe must understand and comply with going forward. These include the EU’s adoption of the Collective Redress Directive, which begins full enforcement on June 25, 2023, and provides new pathways for legal redress for consumers, including greater availability of consumer class actions in the EU in a variety of areas. In particular, the General Product Safety Regulation expressly includes provisions allowing collective actions to be pursued for breaches of all regulations, replacing a more limited collective redress provision under the current regulation. Moreover, the European Parliament and Council are reviewing proposals to enact the Revised Product Liability Directive and the AI Liability Directive, which would place additional regulatory burdens and liability risk on product manufacturers doing business in the EU.
