The Carbon Border Adjustment Mechanism (CBAM) is a European Union regulation which has been introduced to reduce carbon emissions produced by manufactured goods imported from jurisdictions with less stringent carbon emissions regulations.
Join the Cooley international products and business litigation teams for a 45-minute, rapid-fire webinar to discuss the latest EU proposal to restrict PFAS, ongoing initiatives to regulate PFAS in the UK and US, and associated liability risks for product stakeholders.
This week, the European Council and Parliament reached provisional agreement on a new European Union (EU) directive to ‘empower consumers for the green transition’.
This webinar is brought to you by the International Consumer Product Health and Safety Organization (ICPHSO) and the European Commission’s Product Safety Unit.
On 12 July 2023, a study was published in the British Journal of Clinical Pharmacology on different models in Europe for directly shipping drugs to patients during decentralized clinical trials (DCTs ), which are conducted in environments such as a participant’s home or a local address, rather than investigative sites. […]
The European Commission has adopted Commission Delegated Directive (EU) 2023/1526, which amends Directive 2011/65/EU of the European Parliament and European Council as regards an exemption for lead as a thermal stabilizer in polyvinyl chloride (PVC) used as base material in sensors for in vitro diagnostic medical devices (IVDs). Directive 2011/65/EU […]
The European Commission has now adopted the sustainability reporting standards that will be mandatory for companies in-scope of the European Union’s Corporate Sustainability Reporting Directive (CSRD). For full insight into the mandatory ESG reporting Standards the full article can be found here. Please reach out to our team if you […]
Join Cooley’s International Products Team for a 30 minute overview and discussion of the key proposals contained in the UK’s long awaited Product Safety Review and their potential impact on those doing business in the UK.
European Commission Publishes Guidance on Transition from Clinical Trials Directive to Clinical Trials Regulation
On 19 July 2023, the European Commission published a guidance document concerning the steps to be taken in the transition of clinical trials from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR).
The European Commission published its legislative proposal to revise the Toy Safety Directive on 28 July 2023. This long-awaited proposal follows the evaluation of the Toy Safety Directive published in 2020 that identified a number of areas where it was thought that the existing rules could be strengthened. The draft legislation includes proposed reforms we expect could influence other European Union sector-specific product rules, such as proposed requirements for a Digital Product Passport to provide certain compliance information.