The European Commission has published an Explanatory Notice and Template to guide providers of general-purpose AI (GPAI) models in meeting their obligation under Article 53(1)(d) of the EU AI Act (Regulation (EU) 2024/1689) to publicly disclose a sufficiently detailed summary of the data used to train their models. This requirement applies from 2 August 2025 and aims to promote transparency, support rights enforcement, and balance commercial confidentiality with public interest.

The European Commission's Directorate-General for Health and Food Safety has published frequently asked questions guidance on the European Health Data Space (EHDS), setting out the objectives, scope, and implementation of Regulation (EU) 2025/327 for relevant stakeholders. It establishes a framework for the secure use and sharing of electronic health data across the EU, structured around primary use for healthcare delivery, secondary use for research and policy purposes, and requirements for interoperable electronic health record systems, while granting patients enhanced rights to access, control, and share their data. The guidance explains obligations on Member States to establish digital health authorities and infrastructure, on manufacturers to ensure compliance and interoperability of systems, and on health data holders to make specified datasets available under regulated conditions overseen by health data access bodies. It also outlines a phased implementation from 2029 and 2031, supported by implementing acts and governance structures, and clarifies the relationship with existing EU legislation, including the GDPR, to enable secure, interoperable, and efficient use of health data across the Union. The 26 March 2026 update expands the guidance by adding new questions, including clarification for manufacturers of medical devices, in-vitro diagnostic devices, and high-risk AI systems interoperable with electronic health record systems (Q.24), addressing how EHDS requirements apply alongside existing regulatory frameworks.

The European Commission's Directorate-General for Health and Food Safety has published a comprehensive package of updated clinical trials guidance documents, all endorsed by the Clinical Trials Coordination and Advisory Group (CTAG) on 15 October 2025. The package includes new recommendations on criteria for selecting a reporting Member State under Article 85(2)(c) of the Clinical Trials Regulation, establishing a workshare criterion when proposed reporting Member States decline the role, which occurs in approximately 30% of applications. The Commission has updated its recommendation paper on decentralised elements in clinical trials (Version 02), superseding the December 2022 version, with revised national provision overviews and guidance on informed consent, investigational medicinal product delivery, and remote monitoring. A new recommendation paper addresses frequent issues identified during Part I and Part II assessments, based on feedback from national competent authorities and ethics committees, covering investigational medicinal product dossiers, protocols, and safety reporting. The package also includes revised guidance on auxiliary medicinal products, effective 1 December 2025 for new applications, featuring an updated classification system distinguishing between authorised, modified authorised, and unauthorised auxiliary medicinal products with corresponding application and safety reporting requirements.

The European Commission has published updated guidance on implementing the REPowerEU Gas Regulation. The update clarifies procedural details on prior authorisation of non-Russian gas imports. The guidance also confirms that the first implementation deadline in phasing out natural gas imports from Russia has come into effect. Consequently, imports under short or long-term liquified natural gas and pipeline gas contracts concluded or amended after 17 June 2025, become prohibited.

The European Commission has published updated guidance to support battery-sector stakeholders preparing for the Digital Batteries Passport under Regulation (EU) 2023/1542 concerning batteries and waste batteries. The guidance sets out data points relevant to electric vehicle batteries, light means of transport batteries and industrial batteries covered by the passport requirement. It identifies whether each data point is mandatory, optional, only applicable in certain circumstances, or not required to be completed or displayed when the passport requirements begin to apply in February 2027.

The European Commission has informed Amazon and Microsoft of its preliminary view that their cloud computing services, Amazon Web Services (AWS) and Microsoft Azure, should be designated as gatekeepers under the EU Digital Markets Act (EU DMA), provisionally concluding that they are important gateways between businesses and customers in the EU. The Commission considers that both companies, which are already designated as gatekeepers for other services, have significant and durable market positions supported by large and established user bases, lock-in effects, high switching costs, extensive ecosystems, and AI tools and partnerships that have become an important factor in cloud procurement. Amazon and Microsoft will now have the opportunity to respond before the Commission reaches a final decision, and the Commission stated that its preliminary findings do not prejudge the outcome of the investigation.

The European Commission has received notifications from Apple indicating that its core platform services, Apple Ads and Apple Maps, meet the thresholds set out in the EU Digital Markets Act (DMA). The Commission has 45 working days to decide whether to designate Apple as a gatekeeper for these services. If designated, Apple will have six months to comply with DMA requirements. The DMA applies to core platform services with at least 45 million monthly active end users and 10,000 annual business users in each of the last three financial years, covering companies with a significant market position that constitute an important gateway between businesses and consumers.

The European Commission has announced that the six gatekeepers designated on 6 September 2023—Alphabet, Amazon, Apple, ByteDance, Meta and Microsoft—have submitted updated reports outlining the compliance measures implemented over the past year under the EU Digital Markets Act (DMA). They have also provided updated, independently audited reports on their consumer profiling techniques. The Commission will now conduct a detailed analysis of the reports to determine whether the measures adopted effectively comply with the relevant DMA obligations. Its evaluation will take into account input from interested third parties, as well as ongoing regulatory dialogue and related proceedings.

The European Commission has issued a recommendation adopting a voluntary sustainability reporting standard for small and medium-sized enterprises (SMEs). Developed by European Financial Reporting Advisory Group (EFRAG), the standard aims to reduce administrative burdens and improve SMEs’ access to sustainable finance. It supports companies outside the scope of DIRECTIVE (EU) 2022/2464 (Corporate Sustainability Reporting Directive (CSRD)) by easing information requests from larger undertakings. A formal delegated act to establish the standard is expected to follow, subject to ongoing legislative negotiations.

The European Commission has decided to refer Bulgaria, France, Luxembourg, the Netherlands, Poland, Spain and Sweden to the Court of Justice of the European Union (CJEU) for failing to transpose and notify national measures implementing Directive (EU) 2022/2557 the Directive on the resilience of critical entities (CER Directive). Member States were required to transpose the CER Directive into national law by 17 October 2024. The CER Directive requires Member States to conduct regular risk assessments to identify critical entities across key sectors, including energy, transport, health, water, banking and digital infrastructure, and to ensure these entities adopt appropriate measures to protect essential services from natural and man-made risks, such as terrorist attacks, cyber threats and sabotage. Following letters of formal notice issued in November 2024 and reasoned opinions issued in July 2025, the Commission has now referred the seven Member States to the CJEU court and requested the imposition of financial sanctions.

The European Commission has registered a European Citizens' Initiative (ECI) entitled 'European Public Social Network', which calls for legislation to establish a public social media platform at EU level. The Commission confirmed that the initiative meets the formal requirements set out in Regulation (EU) 2019/788 (the ECI Regulation) and is legally admissible, while noting that registration does not prejudge any final decision on the substance of the proposal or any subsequent action. The organisers now have six months to commence a 12-month period for collecting signatures, during which at least one million signatures from citizens in at least seven Member States must be obtained in order to secure a formal response from the Commission. The proposed platform would operate as a publicly funded service under societal oversight, offering an alternative to existing platforms while remaining impartial and guaranteeing rights without distinction.

The European Commission has registered two European Citizens’ Initiatives (ECIs) focused on biodiversity and ecosystem protection. The first initiative, 'Rights for Nature: Empower Citizens to Represent and Protect Ecosystems,' seeks to establish legal recognition for the rights of nature through an act such as a directive or regulation. Its aim is to shift the perception of nature from being treated as property to recognising ecosystems as living entities with intrinsic value. The proposal calls for ecosystems to have the right to exist, to regenerate their biocapacities and vital cycle and to be restored. The second initiative, 'Reconnecting Nature Through the Creation of European Biodiversity Corridors,' proposes that the Commission develop a coordination framework for enhancing ecological connectivity between inland water and land ecosystems. This approach is intended to overcome ecosystem fragmentation, support biodiversity and ecological resilience, promote the use of common tools, ensure effective cross-border coordination and strengthen the Natura 2000 network.