EU legislative process

This subtopic contains a range of resources relating to EU legislative process, procedures and principles relevant to the types of legislation which fall under the umbrella of EU law, including:

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EU Treaties (and all their amendments)
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Regulations
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Directives
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Decisions
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Opinions and Recommendations
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Tertiary legislation (including implementing and delegated legislation)

EU law is developed further by the case law of the Court of Justice of the European Union and legal principles developed by it.

The EU is based on the rule of law. Actions taken by the EU are founded on Treaties approved voluntarily and democratically by all Member States. Under the principle of conferral, if a policy area is not cited in a treaty, the European Commission cannot propose a law in that area as it is not an EU competence.

There are different types of EU legal documents. A treaty is a binding agreement betweenMember States setting out EU objectives, rules for relevant EU institutions, how decisions are made and the relationship between the EU and its Member States. Amendments allow for EU enlargement, and areas of co-operation.

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Latest EU Law News

European Commission adopts delegated regulation on EMIR active account requirements

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.

Commission publishes updated clinical trials guidance package

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.

Commission opens consultation on draft EU design IP procedures regulation

The European Commission has published a draft delegated regulation establishing rules for EU design-related intellectual property procedures managed by the European Union Intellectual Property Office. The regulation supplements Regulation (EC) No 6/2002 and replaces the existing Commission Implementing Regulation (EC) No 2245/2002, as required by Regulation 2024/2822 to align Regulation (EC) No 6/2002 with Articles 290 and 291 of the Treaty on the Functioning of the EU. The Commission plans to adopt the regulation in the first quarter of 2026. The consultation period runs from 29 October 2025 to 26 November 2025.

European Commission adopts Communication on the CRR

The European Commission has adopted a Communication on the prudential treatment of investment in equities by banks under legislative programmes in the Capital Requirements Regulation (CRR). The Communication aims to ensure the consistent application of this provision across the single market and ultimately increase equity investment while maintaining the soundness of the banking sector. The Communication also establishes a dedicated registry that will be made available on the Finance website to provide transparency on legislative programmes that meet the criteria of CRR.