Cooley’s Highlights From ICPHSO 2025 Annual Meeting and Training Symposium
Cooley’s international products team will be attending the ICPHSO 2025 Annual Meeting and Training Symposium, “Fostering Bridges Within the Product Safety Community,” in Orlando, Florida, from February 17 – 20, 2025. We will be posting highlights from the plenary panel sessions on our Productwise blog throughout the event.
European Commission Publishes Guidance on EU Batteries Regulation Removability Requirements
New European Commission (EC) guidance on the European Union Batteries Regulation 2023/1542 has been published, which is relevant to anyone who places products containing batteries on the EU market. The new guidance sheds light on the challenging Article 11 requirement that portable batteries be ‘readily removable and replaceable by the end user at any time during the lifetime of the product’.
Fourth Circuit Ruling Guts the Practice of Medicine Defense in FDA Cases
Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson[1] upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for a four-year, $4.7 million Medicare fraud scheme involving repeated use of surgical devices approved for one-time use.
Daniel Grooms, Andrew Goldstein, Zach Hafer, Sonia Nath, Matt Nguyen, Son Nguyen, Jim Santel
The EU’s General Product Safety Regulation: New Accident Reporting Obligations
In the third in a series of blogs on the General Product Safety Regulation, the Cooley products team unpacks the new accident reporting obligations being introduced across the European Economic Area (EEA) – made up of European Union Member States, plus Iceland, Liechtenstein and Norway – and Northern Ireland.
Rod Freeman , Claire Temple , Jamie Humphreys , Tracey Bischofberger
One-Year Delay to EU’s Anti-Deforestation Law Close to Approval
On 3 December 2024, provisional agreement was reached on the proposal to delay the application of the European Union’s Deforestation Regulation (EUDR) by 12 months. According to the provisional agreement, the targeted amendment will not affect the substance of the existing legislation as it was originally agreed. The EUDR only allows in-scope products and commodities that are ‘deforestation-free’ to be placed or made available on the EU market and/or exported from the EU. This includes certain products made from cattle, wood, cocoa, soy, palm oil, coffee and rubber.
EU’s General Product Safety Regulation: An Expanded Concept of Safety
In the second in a series of blogs on the European Union’s new General Product Safety Regulation, the Cooley products team takes a look at the expanded concept of safety under the new rules and why this matters.
It’s Official! Europe’s Product Liability Rules Enter Into Force on 9 December 2024
The European Union’s Product Liability Directive (PLD) has been published and will enter into force on 9 December 2024. A 24-month transition period means that the new PLD regime will apply in EU member states by 9 December 2026.
UK Product Safety Review and Beyond: The Government’s Next Steps
On 5 November 2024, the UK government published its response to the Product Safety Review (PSR) undertaken by the UK product safety regulator, the Office for Product Safety and Standards (OPSS). This response outlines the key proposals in the review and proposals aimed at modernising the UK’s product safety regime. It was published as a result of comments made during the second reading of the Product Regulation and Metrology (PRM) Bill.
New UK CMA Guidance Published – Can Fashion Companies Thread the Needle of Responsible Environmental Claims?
On 18 September 2024, the UK’s Competition and Markets Authority (CMA) published new guidance to explain how fashion retail businesses can navigate their obligations under the UK’s Consumer Protection from Unfair Trading Regulations 2008 and the Green Claims Code when making environmental claims.
The EU’s General Product Safety Regulation: What’s New?
In the first of a series of blogs, the Cooley products team takes a look at what’s new under the European Union’s General Product Safety Regulation.