The European Parliament and the Council of the European Union have reached a provisional agreement on the progressive introduction of the Entry/Exit System (EES) at the EU’s external borders. This agreement was achieved by negotiating teams from both institutions, including representatives from the Polish presidency of the Council and the European Parliament, under the guidance of Rapporteur Assita Kanko. The EES is designed to record the entry and exit of non-EU nationals on short-stay visas by registering biometric data—such as facial images, fingerprints, and passport details—to enhance border security, expedite the border check process, and reduce queues.

The European Parliament and Council have reached a provisional agreement on revising the Waste Framework Directive to reduce textile and food waste. The new rules introduce binding food waste reduction targets and establish Extended Producer Responsibility (EPR) schemes for textiles. These measures aim to promote a circular economy and enhance sustainability across the EU. The Directive will enter into force 20 days after publication in the Official Journal, with Member States required to transpose it into national legislation within 20 months.

The European Parliament has approved amendments to the EU Carbon Border Adjustment Mechanism (EU CBAM) by 617 votes to 18, with 19 abstentions. The changes, part of the 26 February 2025 ‘Omnibus I’ simplification package, introduce a new 50-tonne per importer annual threshold exempting 90% of importers, mainly SMEs and individuals, while still covering 99% of CO2 emissions from iron, steel, aluminium, cement and fertiliser imports. The amendments simplify authorisation, emissions reporting and verification processes, and strengthen anti-abuse measures. The text requires Council endorsement and will apply three days after publication in the EU Official Journal.

MLex: Party coordinators have approved a push by the European Parliament to examine whether the EU’s 20-year-old IP enforcement rulebook needs updating, as debate intensifies over patent injunctions and proportionality.

The European Parliament Committee on Civil Liberties, Justice and Home Affairs (LIBE Committee) has submitted written evidence to the House of Lords European Affairs Committee (EAC)'s inquiry into data adequacy and its implications for the UK-EU relationship. The LIBE Committee starts its submission by making remarks on the Data Protection and Digital Information Bill (DPDIB) currently reviewed by the UK Parliament, including the definition of 'singling out' and 'pseudonymised data'. The LIBE Committee then provides responses to the questions asked by the Lords Committee. The LIBE Committee expresses reserves in relation to changes to the role of the ICO as set out by the DPDIB, deeming that they 'constitute a significant departure from the EU data protection supervision model, where the independence of the national supervision authority is an important cornerstone'. The LIBE Committee then goes on to point out that the topic of onward transfers and 'Henry VIII' clauses set out in the DPIB may be factors influencing the next European Commission when deciding whether to renew the adequacy decisions for the UK in June 2025. It is also concerned that the provisions of the DPDIB permitting automated decision making and large database of personal data to be used for AI training and development without informing the data subjects or seeking their consent would be contrary to Article 22 of the EU’s General Data Protection Regulation, Regulation (EU) 2016/679 (EU GDPR). The LIBE Committee further shares its concerns that the UK adequacy status could lead to the bypassing of the EU rules on international transfers to countries or international organisations not deemed adequate under EU law, and that the UK could become a transit country for data that cannot be sent from the EU/EEA to 'inadequate' third countries.

MLex: The European Parliament’s International Trade committee approved the compromise agreement between the EU institutions on the EU-US trade deal on 2 June 2026. The vote paves the way for the parliament as a whole, in their plenary session on 16 June 2026 in Strasbourg, to vote on the deal which was provisionally signed last year in Scotland.

What is the Payment Accounts Directive and what are the key protections it offers consumers? The Payment Accounts Directive (PAD) is intended to enhance transparency and comparability for consumers in respect of payment accounts. In particular, the PAD: • makes it easier for consumers to compare fees charged by banks and other service providers across the European Union (EU) • facilitates consumer switching of payment accounts; and • entitles all EU consumers to open a payment account that enables them to perform essential functions such as receiving their salary and paying bills This Practice Note provides a background to, and gives an overview of, the provisions of the PAD and the technical standards and guidelines made under it. This Practice Note should be read in conjunction with Practice Note: UK payment accounts requirements—essentials, which provides an overview of the UK implementation of the PAD through the Payment Accounts Regulations 2015, SI 2015/2038 (PARs 2015). It also looks at UK developments after implementation of the PARs 2015, as well as developments the transitional period came

Aims of PSD2 The EU Second Payment Services Directive (Directive (EU) 2015/2366) (PSD2) entered into force in January 2016 and applied as of 13 January 2018. A range of delegated acts and regulatory technical standards under PSD2 have since been published and adopted. PSD2 incorporated, repealed and replaced the original Payment Services Directive 2007/64/EC (PSD1). The main aims of PSD2 are to increase competition, enhance consumer protections and create a single market for payments across the EEA. PSD2 brings a wider range of payments systems in scope and has wide-ranging implications for market participants. Regulation (EU) 2024/886 (the EU Instant Payments Regulation or EU IPR) subsequently amended PSD2’s safeguarding and payment-system access provisions. Member States were required to implement these amendments by 9 April 2025. The changes allow safeguarding at a central bank, at that bank’s discretion, and introduce conditions for payment institutions and electronic money institutions seeking or maintaining participation in payment systems designated under Directive 98/26/EC, including

Key information EU POPs Regulation Title Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (recast) (EU POPs Regulation) Entry into force 15 July 2019 Transposition deadline None—Regulations are directly applicable on Member States and do not require transposition Repeals Regulation (EC) 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EECFor more information, see Practice Note: Persistent Organic Pollutants (POPs) Regulation (EC) 850/2004—snapshot [Archived] Subject Chemicals; Hazardous substances; Persistent organic pollutants Background Persistent organic pollutants (POPs) are organic substances that persist in the environment, accumulate in living organisms and pose a risk to health and the environment. They can be transported by air, water or migratory species. Chemical substances that have been identified as POPs include: • pesticides (such as DDT) • industrial chemicals (such as polychlorinated biphenyls, which were widely used in electrical equipment), and • unintentional by-products formed during industrial processes,

The application of Joint Clinical Assessments (JCA) of medicines under Regulation (EU) 2021/2282 (EU HTA) which is initiated through a PICO framework- Population, Intervention, Comparator(s), and Outcomes - that defines the JCA scope was implemented in January 2025 for oncology medicines and advanced therapeutics. The Coordination Group on HTA (HTACG) published the 'Guidance on the scoping process' in November 2024 followed by six 'PICO simulation exercises' in February 2025. The EFPIA has issued a response to these support materials by presenting a three questions that require further clarification and recommendations for the successful implementation of the JCA process under the HTA Regulation. In particular, it cites the interplay between population and comparator is an area of concern which determines the number of PICOs required and states that 'further refinement is needed' for how PICOs are proposed, consolidated, and communicated. It highlights that the overall scoping process lacks transparency on how assessors and co-assessors formulate initial PICO proposals and suggests that a formal consultation process with health tech developers be introduced during the drafting of proposed PICOs. It questions the logic of consolidated decisions and feels the role of Member State dialogue is unclear in the guidance and PICO exercises. Finally, it cautions that if the JCA contains an overwhelming volume of data or insufficient evidence where the consolidated PICO imposes an evidence standard then this can undermine the purpose of the JCA.

Pharmacovigilance is the process of collecting and understanding information relating to the adverse effects of medicinal product throughout their use in patients. Before medicinal products are authorised for use, information regarding their safety and efficacy is obtained from clinical trials. It is essential, however, that safety continues to be monitored throughout patient use because post-authorisation medicinal products will typically be used in a larger number of patients, for a longer period of time and in combination with other medicinal products, meaning that adverse effects may occur that were not apparent during clinical trials. Consequently, EU law requires marketing authorisation holders (MAH), the European Medicines Agency (EMA), and national competent authorities (ie the medicines regulatory authorities in EU Member States) to operate a pharmacovigilance system. The overall EU pharmacovigilance system operates through co-operation between EU Member States, the EMA and the European Commission. The EMA co-ordinates the system and operates services and processes to support

Key information EU PIC Regulation Title Regulation (EU) 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (recast) Entry into force 16 August 2012Applicable from 1 March 2014 Transposition deadline N/A—Regulations are directly applicable on Member States and do not require national transposition Amendments —Commission Delegated Regulation (EU) No 1078/2014 of 7 August 2014 amending Annex I to Regulation (EU) 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals. Entry into force 4 November 2020. Application date 1 December 2014—Commission Delegated Regulation (EU) 2015/2229 of 29 September 2015 amending Annex I to Regulation (EU) 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals. Entry into force 23 December 2015. Application date 1 February 2016—Commission Delegated Regulation (EU) 2018/172 of 28 November 2017 amending Annexes I and V to Regulation (EU) 649/2012 of the European Parliament and of the Council