Americans love a good scare on Halloween.  But, of course – with ancient castles, centuries of folklore, and actual Transylvania, our friends in the European Union know how to celebrate the spooky season just as well as we do.  Unfortunately, there’s more than ghost stories to send a shiver down your spine in the EU these days.  This month, a joint committee of the European Parliament voted on new amendments to the proposed “digital age” update of the Product Liability Directive, which was initially enacted in the 1980s.  On the one hand, the proposal seems like a treat with its efforts to modernize the product liability framework to account for the changing product landscape and to address access issues for consumers.  But many European business leaders caution that this is more trick than treat.  Among other things, there are concerns that the traditional burden of proof requirements and safeguards on evidentiary disclosures will vanish into thin air.  Concerns abound that the proposals won’t benefit consumers or industry, but rather lawyers and litigation funders.  Scary stuff, indeed.

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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.

Continue reading “EU Publishes General Product Safety Regulation – Full Enforcement to Commence in December 2024”