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NEWS
The European Commission adopted on 12 June 2025 a delegated act amending Regulation (EU) 2017/745, the Medical Devices Regulation (MDR), to introduce the Master UDI-DI solution for spectacle frames, spectacle lenses, and ready-to-wear reading spectacles. This solution, which already covers contact lenses, uses a single identifier, the Master UDI-DI, to represent certain devices with high individualisation, instead of assigning standard unique device identification (UDIs) to each device individually. The delegated act is currently under a scrutiny period and will be published afterwards. Additionally, a Medical Device Coordination Group guidance document is being developed to outline the implementation timelines for the Master UDI-DI concerning spectacle frames, spectacle lenses, and ready-to-wear reading spectacles and provide practical details for manufacturers.
NEWS
The European Commission has adopted a Commission Delegated Regulation amending Delegated Regulation (EU) 2019/979 to update prospectus classification metadata and expand incorporation by reference provisions. The amendments reflect the new prospectus types introduced by Regulation (EU) 2024/2809 under the Listing Act, including the EU Follow-on and EU Growth issuance prospectuses, and integrate requirements relating to European Green Bonds under Regulation (EU) 2023/2631. The Regulation permits incorporation by reference of documents approved under the former Prospectus Directive and pre-issuance disclosures for environmentally sustainable or sustainability-linked bonds. The measures are based on ESMA regulatory technical standards, with certain provisions applying from 10 July 2026.
NEWS
The European Commission has adopted a delegated regulation supplementing article Article 7a of the European Market Infrastructure Regulation (Regulation (EU) No 648/2012) (EMIR) (as introduced by Regulation  (EU 2024/2987) (EMIR 3)) containing regulatory technical standards (RTS) for active account requirements. The delegated regulation implements EMIR 3 provisions intended to reduce financial stability risks from EU exposure to third-country central counterparties by requiring certain counterparties to maintain operational active accounts at EU CCPs. The rules establish operational conditions including IT connectivity and stress testing requirements, representativeness obligations for euro and Polish zloty interest rate derivatives, and six-monthly reporting requirements to competent authorities.
NEWS
The European Commission has, as part of the Pharmaceutical Strategy, adopted the new Variations Regulation which amends Regulation (EU) 712/2012 and makes the lifecycle management of medicines more efficient by adapting the current system for variations to marketing authorisation. The new Regulations will be updated in line with recent scientific and technological developments and a rise in number of variation requests, facilitating a quicker post-authorisation process of medicines, quicker processing of variations and more efficient lifecycle management of medicines. Key changes include: the removal of the default type II classification for quality/manufacturing changes for biological products (including advanced therapies), the formalisation of the legal basis for the use of existing additional regulatory tools, the extension of Influenza vaccines approaches to Coronavirus vaccines, and reference to annual updates for all minor variations whilst retaining the flexibility of immediate submission in some cases. Proposed revisions to the classification of variations guideline is expected later this year which will complete this initial update of the variation framework.
NEWS
The European Commission has adopted a recommendation, with an accompanying guidance to Member States on good practices on accelerating permit-granting procedures for renewable energy and related infrastructure projects. The Commission also adopted guidance on designating renewables acceleration areas. The recommendation and guidance documents will support Member States to further boost the roll out of renewable energy, reduce reliance on fossil fuels imports and also include examples of good practice on faster and efficient permit-granting procedures, which will help streamline permitting procedures. The adopted recommendations and guidance documents will help reinforce industrial competitiveness, will deliver on the European Green Deal and harmonise the auctions for renewables, in line with the Net-Zero Industry Act.
NEWS
The European Commission has adopted the implementing regulation on Directive (EU) 2022/2555 (the NIS2 Directive), setting out cybersecurity risk management measures as well as the cases in which an incident should be considered significant. The implementing regulation will apply to particular categories of companies providing digital services, such as cloud computing service providers, data centre service providers, online marketplaces, online search engines and social networking platforms. The adoption by the Commission coincides with Member States having to transpose the NIS2 Directive into national law, and, from 18 October 2024, Member States must apply the necessary measures to comply with the NIS2 cybersecurity rules. The implementing regulation will come into force 20 days after it has been published in the Official Journal of the EU.
NEWS
The European Commission has adopted new measures under Regulation (EC) 1907/2006 (EU REACH) which restrict the use of sub-groups of per- and polyfluoroalkyl substances (PFAS), namely undecafluorohexanoic acid (PFHxA) and PFHxA‑related substances. The restrictions will ban the use of PFHxA in consumer textiles, food packaging, consumer mixtures such as waterproofing sprays, certain cosmetics, and some firefighting foam applications. These restrictions will enter into force 20 days after publication in the Official Journal of the European Union and will take effect after a transition period, which will vary depending on the use, between 18 months and five years.
NEWS
The European Commission has adopted a draft delegated regulation supplementing Article 59 of the Regulation (EU) 2019/943 (the Electricity Regulation), which establishes the first EU network code on sector-specific rules for cybersecurity aspects of cross-border electricity flows. The network code will help enhance the cyber resilience of critical EU energy infrastructure and services and will create a recurrent process of cybersecurity risk assessments in the electricity sector. These assessments are targeted at systematically highlighting the entities that perform digitalised processes with a critical or high effect in cross-border electricity flows, their cybersecurity risks, and the necessary mitigating measures required. It will support a high, common level of cybersecurity for cross-border electricity flows in Europe. The European Parliament and Council of the EU will now scrutinise the delegated act regarding the network code. They will each have a period of two months for objection to this secondary legislation, which can be extended by two months.
NEWS
The European Commission adopted the Clean Industrial State Aid Framework (CISAF) on 25 June 2025, replacing the Temporary Crisis and Transition Framework. The new framework, effective until 31 December 2030, simplifies State aid rules across five areas including renewable energy deployment, industrial decarbonisation, and clean technology manufacturing. EU Member States can now grant support up to €200m through predefined aid amounts, funding gaps, or competitive bidding. The framework introduces fast-track procedures for renewable energy schemes and allows support for energy-intensive users conditional on decarbonisation investments.
NEWS
The European Commission has adopted measures to address safety challenges of emerging air mobility concepts and services to ensure that their operations will be as safe as those in manned aviation. The measures target both manned aircraft capable of vertical take-off and landing (VTOL) and higher-risk unmanned drone operations. The measures aim to unify and streamline the regulatory landscape across Member States and will introduce new EU-wide airworthiness certification requirements and procedures for manned and unmanned VTOL, addressing both physical integrity and digital security risks. The measures also include ‘air taxi' pilot licence requirements, rules on integration into airspace and specific rules enabling these aircraft to perform emergency medical services and rescue operations.
NEWS
The European Commission has adopted a Regulation that grants a partial exemption for European farmers from the conditionality rule on land lying fallow. The Regulation will come into force on 14 February 2024 and apply retroactively from 1 January until 31 December 2024. The partial exemption will accommodate multiple requests regarding flexibility to respond to challenges EU farmers are facing.
NEWS
The European Commission has adopted new rules under Regulation (EU) 2021/2282, Regulation on Health Technology Assessment  (HTA Regulation) for joint clinical assessments (JCAs) of medicines at Union level to speed up EU patients' access to medicines. The new rules set out timelines and steps for conducting EU JCAs. Assessment reports will provide Member States authorities with scientific evidence at an early stage after a medicine's marketing authorisation to help decide its use in the national health system. These rules are the first of six Acts to be adopted in 2024 under the HTA Regulation.