Implementation and Simplification
STRATEGY2025-02-11
- Systematic Implementation Strategies: The Commission will prepare a dedicated implementation strategy for each major legislative act, identifying transposition challenges, tracking arrangements, and support measures including for SMEs; directives will be accompanied by explanatory templates and transposition roadmaps for Member States. [from 2025]
- Implementation Dialogues: Each Commissioner will host at least two stakeholder dialogues per year to assess progress and identify areas needing policy attention, with outcomes reported in annual enforcement and implementation progress reports. [from H1 2025]
- Administrative Burden Reduction Targets: The Commission expands its burden reduction targets from reporting costs to all recurring administrative costs, aiming to cut the EUR 150 billion EU-wide baseline by at least 25% for companies and 35% for SMEs by end of mandate. [2025–2029]
- Omnibus Package on Sustainability: Simplifies CSRD, CSDDD, and EU Taxonomy requirements to reduce supply-chain trickle-down effects on SMEs, ease CBAM obligations for smaller importers, and better align sustainability reporting with investor needs. [2025]
- Omnibus Package on Investment Simplification: Facilitates deployment of InvestEU and the European Fund for Strategic Investments and streamlines related reporting requirements. [2025]
- Omnibus Package on Small Mid-Caps and Paper Removal: Introduces proportionate requirements for small mid-cap companies and removes paper-format obligations from product legislation. [2025]
- Cybersecurity Act Review and Digital Acquis Fitness Check: Reviews the Cybersecurity Act to enable streamlined multi-purpose reporting and avoid duplication, as part of a broader first-year assessment of whether the digital acquis adequately reflects the needs of SMEs and small mid-caps. [2025]
- European Data Union Strategy: Addresses existing data rules to create a simplified and coherent legal framework enabling businesses and administrations to share data seamlessly and at scale, while maintaining privacy and security standards. [2025]
- CAP Simplification Package: Addresses sources of complexity and excessive administrative burden for farmers and national administrations in managing, monitoring, and reporting under the Common Agricultural Policy, leveraging digitalisation. [2025]
- Industrial Decarbonisation Accelerator Act: Extends accelerated permitting procedures to additional sectors in transition, broadening the scope of streamlined authorisation processes beyond the Renewable Energy Directive. [2025]
- REACH Targeted Revision: Simplifies EU chemicals rules to reduce compliance burdens for the chemicals industry without lowering health, safety, or environmental protection standards. [2025]
- European Business Wallet: Enables businesses to manage national, cross-border, and EU regulatory requirements, notifications, and compliance processes in one unified, user-friendly digital platform, building on the Digital Wallet. [2025]
- MFF Simplification Proposal: Presents a new long-term EU budget designed to reduce financial landscape fragmentation, ease administrative burdens for beneficiaries and implementing authorities, and improve access to EU funds while retaining financial safeguards. [2025]
- Stress-Testing of EU Acquis: Continuous cross-portfolio review of the entire body of EU legislation for cumulative impacts, inconsistencies, and simplification potential, with each Commissioner responsible for their area and results feeding annually into the Commission Work Programme. [from 2025]
- Reality Checks: Hands-on exchanges with practitioners, particularly SMEs and small mid-caps, to verify the real-world assumptions underpinning EU legislation, identify practical hurdles, and feed findings into stress-testing and future simplification proposals. [from H1 2025]
- Reinforced SME and Competitiveness Checks: Systematic application of reinforced SME and competitiveness impact assessments to all legislation affecting companies, covering cost competitiveness, international position, innovation capacity, and cumulative sectoral effects, with stronger sector focus informed by the Draghi report. [from 2025]
- Impact Assessments for Delegated and Implementing Acts: Delegated and implementing acts involving significant policy choices or impacts not previously assessed will be subject to dedicated impact assessments or cost-savings analyses, with particular attention to SME effects. [from 2025]
- Digital-Ready Policymaking — Embeds digital considerations from the outset of legislative design, including use of regulatory sandboxes, cross-border interoperability for public administrations, expansion of the Single Digital Gateway, and systematic application of 'digital by default' and 'once-only' principles. [from 2025]
- Methodology for Co-Legislator Amendment Assessment: The Commission will propose a simple methodology enabling the European Parliament and Council to estimate the administrative costs of significant amendments without delaying legislative negotiations. [Q2 2025]
- Annual Overview Report on Implementation and Simplification: Annual cross-Commission report presenting progress on burden reduction targets, enforcement actions, and national implementation, with interactive data published on Europa. [from 2025]
- IIA Better Lawmaking Renewal: The Commission will work with the European Parliament and Council to renew the Interinstitutional Agreement on Better Lawmaking, clarifying institutional roles in delivering simpler and more effective rules. [2025]
Action items (13)
Better Regulation Communication
Planned for Q2 2026.Just like the EU’s rules, its better regulation framework must be simplified to enable a simpler and faster Europe. The Commission will therefore apply a more rigorous and structured application of the proportionality principle in better regulation and put forward a communication to that effect in the first half of 2026.
Commissioner for Implementation and Simplification
Announced on 11 February 2025.The Commissioner will lead a whole-of-Commission drive to make EU rules simpler, faster and better enforced. The agenda prioritises early implementation strategies with Member States, hands-on “reality checks” with practitioners, and twice-yearly implementation dialogues in every portfolio feeding annual progress reports and resolute enforcement against fragmentation and gold-plating. New quantified targets will cut recurring administrative costs by at least 25% (35% for SMEs), underpinned by omnibus simplification packages, streamlined permitting, and digital-by-default delivery. A rolling stress-test of the entire acquis will consolidate and clarify rules; reinforced SME/competitiveness checks, proportionate use of delegated/implementing acts, and digital tools (such as a European Business Wallet and once-only interoperability) will lower costs and speed compliance.
Defence Readiness Omnibus
The Commission will table a defence-sector omnibus to cut red tape and speed delivery across the European defence industrial base. Measures include cross-certification and mutual recognition of testing, fast-tracked construction and environmental permits, secure handling of confidential data, and easier access to finance, including ESG-sensitive capital. It will streamline EU defence programmes, simplify co-funding, and prepare revisions of defence procurement and intra-EU transfer rules, followed by a faster EDF process. The package also supports security-of-supply and readiness, and leverages Ukraine’s innovative defence ecosystem within Team Europe instruments. Together, it builds a scalable EU-wide market for defence equipment.
Digital Omnibus
Planned for 19 November 2025.The Commission will table a simplification package to cut compliance costs in the digital acquis while preserving protections. It will rationalise data rules (i.e. DGA, Free Flow of Non-Personal Data, Open Data), modernise cookie/tracking provisions to curb consent fatigue, and streamline overlapping cybersecurity incident reporting, with targeted adjustments to ensure predictable application of the AI Act. It will also clarify obligations under the European Digital Identity framework and align with the forthcoming Business Wallet, applying ‘one-in, one-out’. A Digital Fitness Check will assess cumulative effects and cross-border fragmentation.
Fitness Check on the Legislative Acquis in the Digital Policy Area
Planned for Q4 2025.The Commission will stress-test the EU’s digital rulebook to cut costs, remove overlaps and improve coherence, with results due in Q4 2025. It will assess cumulative burdens on businesses across data legislation, cookies and tracking, cybersecurity incident reporting, AI Act implementation, and the European Digital Identity framework, feeding simplification proposals. The exercise will complement the Digital Omnibus and examine cross-border fragmentation and costs, without lowering protections. Each Commissioner will review laws in remit under the steer of the Commissioner for Implementation and Simplification, drawing on “reality checks” with practitioners to ground changes in practice.
Infringement Procedures
Announced on 11 February 2025.The Commission will act decisively when cooperation fails to secure compliance. It will prioritise breaches with the greatest impact on citizens, businesses and Single Market integrity, combat unlawful gold-plating, and use pre-infringement dialogue to deliver swift fixes (75% success in 2024). Where necessary, it will open formal cases—currently about 1,500 —and refer them to the Court of Justice faster, seeking financial sanctions under Articles 260(2) and 260(3) TFEU. In 2023–24, 134 cases were referred, with sanctions requested in 55. Annual progress reports will track enforcement, while sectoral monitoring tools identify and remedy fragmentation early and communicate reasons for action clearly.
Interinstitutional Agreement on Better Lawmaking
Planned for this term.The Commission will seek a renewed agreement with Parliament and Council to embed simplification and implementation across the full legislative cycle. It will align subsidiarity/proportionality checks, apply a shared methodology to estimate the costs of significant amendments, and integrate SME/competitiveness tests up front. Co-legislators will commit to fast-tracking simplification packages, limiting gold-plating and streamlining empowerments for delegated/implementing acts. Annual progress reporting will create accountability on enforcement and burden-reduction targets, while “digital-by-default/once-only” delivery and interoperability requirements are designed in from the start. Together, the institutions will stress-test the acquis to cut administrative costs without lowering standards.
Legislative Implementation Strategies
Announced on 11 February 2025.For every major EU law, the Commission will prepare a structured implementation strategy that maps legal, administrative and practical challenges, sets timelines, and defines targeted support. These strategies will use explanatory templates and national transposition roadmaps, track progress, and flag “gold plating” that fragments the Single Market. Delivery will be backed by expert-group peer support and EU agencies, plus investments in administrative capacity, digital tools and data (e.g. TSI, ComPAct, IMI, Single Digital Gateway). The Commission will hold twice-yearly implementation dialogues with stakeholders and publish annual progress reports to surface hurdles and simplification opportunities. Hands-on “reality checks” with practitioners will verify costs and fix bottlenecks early; where dialogue fails, swift infringement action will follow.
Medical Omnibus
Planned for 2026.The Commission will be ready to propose a targeted legislative package to simplify EU rules for medical devices and in-vitro diagnostics while safeguarding patient safety and public health, including in health emergencies. This follows a targeted evaluation of the MDR/IVDR to address identified bottlenecks and facilitate firms’ operations across the Single Market. Complementary enablers, such as the European Business Wallet, will reduce administrative barriers by enabling secure, verified data and credential sharing for compliance processes. The initiative aligns with the Life Sciences Strategy’s drive to streamline regulation and speed market access for innovation, especially for startups and SMEs.
Omnibus IV Package
The Commission will fast-track simplification by empowering common technical specifications when harmonised standards lag, and by digitalising compliance so firms can demonstrate conformity faster and paper-free. The package also extends existing SME mitigating measures to small mid-caps and removes redundant paper requirements in product laws, easing conformity assessment and cutting reporting overlaps. Together with the Single Market Strategy, it targets quicker time-to-market, legal certainty and lower costs while maintaining high safety and consumer protection. Delivery will be tied to measurable burden-reduction targets and periodic scorecards so businesses see real, near-term gains in every Member State.
Reality Checks
Announced on 11 February 2025.Reality Checks are hands-on diagnostics that bring Commission services to practitioners to test whether EU rules work in real life. Through targeted technical exchanges, teams identify hurdles in authorisations, permitting, control and compliance, capture good practices, and map where national transposition or “gold-plating” adds cost or fragmentation. Findings verify the assumptions behind legislation, quantify burdens and expected savings, and assess if planned simplifications are realistic. Results feed directly into evaluations and fitness checks, the gradual stress-test of the acquis, and the design of future simplification packages, ensuring evidence-based fixes and quicker, cheaper compliance without lowering standards.
Reporting Burden Goal
Announced on 11 February 2025.The Commission will deliver quantified, mandate-wide cuts to red tape: at least 25% for all firms and 35% for SMEs, applied to all administrative costs, not only reporting. Using Eurostat’s €150 billion estimate of recurring administrative costs (2022), this implies €37.5 billion in annual savings by end-mandate. Progress will be tracked in yearly enforcement and implementation reports, with dedicated SME measures and avoidance of national “gold-plating”. The drive complements “one-in, one-out” and will be executed via prioritised simplification packages and Omnibus proposals, while co-legislators preserve savings in negotiations and Member States streamline transposition and application.
SME & Competitiveness Checks
Announced on 11 February 2025.Will be mandatory for proposals with business impacts, combining a reinforced SME test with a sector-focused competitiveness lens. The check assesses four dimensions (i.e. cost/price effects, international competitiveness, innovation capacity, and specific SME impacts) and examines cumulative burdens across value chains. Findings will shape mitigation (e.g. lighter regimes, phased timing, digital-by-default delivery) and be transparently presented in impact assessments, with stronger analysis of indirect effects on SMEs. Fitness checks will also report on efficiency for SMEs. Results feed progress reports and a stress-test of the acquis, ensuring no new Single Market barriers and aligning rules with Europe’s overall growth agenda.
Announced — not yet in mastersheet (18)
Systematic Implementation Strategies: The Commission will prepare a dedicated implementation strategy for each major legislative act, identifying transposition challenges, tracking arrangements, and support measures including for SMEs; directives will be accompanied by explanatory templates and transposition roadmaps for Member States. [from 2025]
No initiative recordImplementation Dialogues: Each Commissioner will host at least two stakeholder dialogues per year to assess progress and identify areas needing policy attention, with outcomes reported in annual enforcement and implementation progress reports. [from H1 2025]
No initiative recordAdministrative Burden Reduction Targets: The Commission expands its burden reduction targets from reporting costs to all recurring administrative costs, aiming to cut the EUR 150 billion EU-wide baseline by at least 25% for companies and 35% for SMEs by end of mandate. [2025–2029]
No initiative recordOmnibus Package on Investment Simplification: Facilitates deployment of InvestEU and the European Fund for Strategic Investments and streamlines related reporting requirements. [2025]
No initiative recordOmnibus Package on Small Mid-Caps and Paper Removal: Introduces proportionate requirements for small mid-cap companies and removes paper-format obligations from product legislation. [2025]
No initiative recordCybersecurity Act Review and Digital Acquis Fitness Check: Reviews the Cybersecurity Act to enable streamlined multi-purpose reporting and avoid duplication, as part of a broader first-year assessment of whether the digital acquis adequately reflects the needs of SMEs and small mid-caps. [2025]
No initiative recordEuropean Data Union Strategy: Addresses existing data rules to create a simplified and coherent legal framework enabling businesses and administrations to share data seamlessly and at scale, while maintaining privacy and security standards. [2025]
No initiative recordIndustrial Decarbonisation Accelerator Act: Extends accelerated permitting procedures to additional sectors in transition, broadening the scope of streamlined authorisation processes beyond the Renewable Energy Directive. [2025]
No initiative recordEuropean Business Wallet: Enables businesses to manage national, cross-border, and EU regulatory requirements, notifications, and compliance processes in one unified, user-friendly digital platform, building on the Digital Wallet. [2025]
No initiative recordMFF Simplification Proposal: Presents a new long-term EU budget designed to reduce financial landscape fragmentation, ease administrative burdens for beneficiaries and implementing authorities, and improve access to EU funds while retaining financial safeguards. [2025]
No initiative recordStress-Testing of EU Acquis: Continuous cross-portfolio review of the entire body of EU legislation for cumulative impacts, inconsistencies, and simplification potential, with each Commissioner responsible for their area and results feeding annually into the Commission Work Programme. [from 2025]
No initiative recordReality Checks: Hands-on exchanges with practitioners, particularly SMEs and small mid-caps, to verify the real-world assumptions underpinning EU legislation, identify practical hurdles, and feed findings into stress-testing and future simplification proposals. [from H1 2025]
No initiative recordReinforced SME and Competitiveness Checks: Systematic application of reinforced SME and competitiveness impact assessments to all legislation affecting companies, covering cost competitiveness, international position, innovation capacity, and cumulative sectoral effects, with stronger sector focus informed by the Draghi report. [from 2025]
No initiative recordImpact Assessments for Delegated and Implementing Acts: Delegated and implementing acts involving significant policy choices or impacts not previously assessed will be subject to dedicated impact assessments or cost-savings analyses, with particular attention to SME effects. [from 2025]
No initiative recordDigital-Ready Policymaking — Embeds digital considerations from the outset of legislative design, including use of regulatory sandboxes, cross-border interoperability for public administrations, expansion of the Single Digital Gateway, and systematic application of 'digital by default' and 'once-only' principles. [from 2025]
No initiative recordMethodology for Co-Legislator Amendment Assessment: The Commission will propose a simple methodology enabling the European Parliament and Council to estimate the administrative costs of significant amendments without delaying legislative negotiations. [Q2 2025]
No initiative recordAnnual Overview Report on Implementation and Simplification: Annual cross-Commission report presenting progress on burden reduction targets, enforcement actions, and national implementation, with interactive data published on Europa. [from 2025]
No initiative recordIIA Better Lawmaking Renewal: The Commission will work with the European Parliament and Council to renew the Interinstitutional Agreement on Better Lawmaking, clarifying institutional roles in delivering simpler and more effective rules. [2025]
No initiative record