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Savings and investments union: Proposals for a regulation and a directive fostering EU market integration and efficient supervision
Savings and investments union Proposals for a regulation and a directive fostering EU market integration and efficient supervision
Josefina Capdevila Penalva with Sophie Annelotte Louwersheimer, Ex-Ante Impact Assessment Unit
Key findings
This IA accompanies three proposals designed to support the establishment of the savings and investment union, as well as the EU's efforts to deepen capital market integration, strengthen supervision and foster innovation. Overall, the IA is meaningful, but could have been shorter, in line with the Better Regulation Guidelines.The IA identifies three problems and two drivers. While the consequences are well-defined across the different stakeholder groups, the scale and scope of the problem remain difficult to assess due to the limited quantification provided.The principles of subsidiarity and proportionality are respected. The IA defines one general objective, which it breaks down into three specific objectives, but does not provide operational objectives.The European Commission has presented two policy packages: one for reducing barriers to cross-border operations and innovation and another for addressing supervisory divergence. Each package includes two policy options. These options are based on previous research and stakeholder consultation; however, the choice of options is quite limited, even though the IA specifies which options were discarded at an early stage and why.The IA only assesses the economic impact of the proposed legislation, omitting impacts on citizens. It would have been relevant to include a wider range of impacts such as territorial or digital effects. Additionally, the costs and benefits are mainly discussed qualitatively. The IA includes an SME test and a competitiveness check.The Commission consulted a broad range of stakeholders and included their views in the IA. In addition, the IA uses robust data sources, provides a clear monitoring plan and is transparent about its limitations. The IA openly knowledges that it did not address all the Regulatory Scrutiny Board's comments, due to time and data constraints. Finally, the legislative proposals are aligned with the IA.
Statement of purpose
This briefing provides an initial analysis of the strengths and weaknesses of the European Commission's impact assessment (IA) accompanying three proposals: a regulation for the further development of capital market integration and supervision within the Union (Amending Regulations (EU) No 1095/2010, No 648/2012, No 600/2014, No 909/2014, 2015/2365, 2019/1156 ,2021/23, 2022/858, 2023/1114, No 1060/2009, 2016/1011, 2017/2402, 2023/2631 and 2024/3005.); a directive for the further development of capital market integration and supervision within the Union (Amending Directives 2009/65/EC, 2011/61/EU and 2014/65/EU.); a regulation on settlement finality and on financial collateral arrangements (Repealing Directive 98/26/EC and amending Directive 2002/47/EC.). The proposals and the IA were adopted on 4 December 2025 and referred to the European Parliament's Committee on Economic and Monetary Affairs (ECON).
This briefing analyses whether the principal criteria laid down in the Commission's own Better Regulation Guidelines, as well as additional factors identified by the Parliament in its Impact Assessment Handbook, appear to be met by the IA. It does not attempt to deal with the substance of the proposal.
Background
This initiative is designed to support the objectives of the savings and investment union (SIU) strategy1 by supporting its pillars on market integration and scale and effective supervision (IA, p. 8). The SIU is one of the five horizontal enablers of the Commission's competitiveness compass, the roadmap to boost economic growth, by focusing on enabling more efficient financing (IA, p. 9).
In 2024, former Italian Prime Ministers Enrico Letta and Mario Draghi, each delivered reports on how to improve integration and supervision within the EU. Subsequently, in her 2025 State of the Union address, European Commission President Ursula von der Leyen highlighted the opportunity cost to Europeans resulting from shortcomings in the single market.2 Furthermore, the European Parliament adopted a resolution supporting capital markets integration and the Commission's intention to propose measures for a more unified supervisory landscape (IA, pp. 9-10).3
This IA provides a comprehensive overview of the legal context of the proposal, outlining the applicable laws for the trading,4 post-trading5 and asset management6 sectors, as well as the legal framework for innovation7 and supervision8 (IA, pp. 10-15). This IA focuses on three sectors within the EU capital market: trading, post-trading and asset management, giving special attention to regulatory barriers challenging the integration of the EU's capital markets. Regarding innovation, the IA focuses on distributed ledger technology (DLT), specifically on participation in the Distributed Ledger Technology Pilot Regulation (DLTPR) (IA, pp. 8-9, 14 and Annexes 7-11).
Problem definition
The IA presents a clear and well-substantiated problem definition based on scientific evidence and feedback from the stakeholder consultation. In accordance with Tool#11 and Tool#13 of the Better Regulation Guidelines (BRG), it includes a problem tree (IA, p. 23), built around three problems caused by two main drivers (IA, pp. 22-47). It also analyses the consequences of the problems for the main stakeholder groups, as recommended by the BRG. The most affected stakeholders are trading venues, investment firms (notably brokers), central securities depositories (CSDs)9, central counterparties (CCPs)10, asset managers, distributed ledger technology (DLTs)11 -based structures, crypto-asset service providers (CASPs), investors, national competent authorities (NCA),12 the European Securities and Market Authority (ESMA) and the European Central Bank (ECB) (IA, Annex 3, pp. 144-151). The three problems to be tackled by this initiative are:
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A lack of market integration and scale, caused by inconsistent practices among NCAs, such as divergent national interpretations and applications of EU rules. This inconsistency results in uneven application of the common rules and market practices that favour national markets (IA, pp. 26-33). In comparison with the United States (US), the EU has a greater number of small entities, higher transaction costs and limited liquidity, leading to higher financing costs for companies and investors (IA, p. 25, p. 28). These findings were confirmed by stakeholder feedback in the targeted consultation accompanying this initiative13 (IA, pp. 108-143).
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Fragmented, less efficient and ineffective supervision, caused by differences in supervisory practices and outcomes for the same activities. These result in supervisory inefficiencies and add to the costs of running a business in the EU14 (IA, p. 33). The lack of uniform enforcement increases the cost of doing cross-border business in the EU, particularly for companies that are active in several EU countries. This problem was reported by stakeholders during the consultations (IA, p. 34, pp. 108-143).
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Hindered innovation and uptake of new technologies, caused by the difficulties businesses face in operating across borders and adopting new technologies like DLTs. Stakeholders argue that the Regulation on a pilot regime for market infrastructures based on DLT, in particular post-trade legislation, have not kept pace with technological advancements, have led to legal uncertainties (IA, pp. 37-38).
There are two problem drivers, illustrated in a problem tree (IA, p. 23), underlie the above-described problems:
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Barriers to cross-border activities and innovation. These include divergent and burdensome requirements across Member States, a lack of legislative adaptation to new technologies and insufficient direct interconnections in the post-trading sector (pp. 39-43);
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Non-aligned supervisory practices across Member States and weak tools and powers at EU level. Most supervisory powers lie with the Member States, which interpret and transpose EU law differently. Moreover, the EU level of governance does not have the authority to enforce supervisory convergence or to implement a comprehensive internal market supervisory approach (IA, pp. 44-47).
In accordance with the BRG, the IA presents the problems and their drivers in relation to the most affected stakeholder group. However, the IA does not mention whether all problems and drivers are equally relevant, nor weights the relevance of each problem driver.
The IA highlights that the problem drivers and the problems described lead to one main consequence: a less efficient EU capital market (IA, p. 48). In addition, the IA details that there are increased frictional costs because cross-border activities face undue frictional costs that affect their market structure and discourage competition (IA, p. 48, Annex 4, pp. 154-155). The high market entry barriers for firms from other Member States to compete on a level playing field with local firms have a negative impact on potential economies of scale. As a result, there is a significant home bias (especially in asset management and settlement payment), small-sized providers focused on domestic markets and significant price differences across Member States. According to the IA, this results in a decrease in market efficiency, as less competitive actors/offers can persist in the market, leading to a deadweight loss that negatively affects downstream users (IA, p. 48).
As regards problem magnitude, the IA, inspired by the International Monetary Fund (IMF), estimates that 'internal barriers to the single market are equivalent to a tariff of over 100 percent' (IA, p. 50). In this regard, the IA uses the main findings of the empirical literature (Holste and Bergström, IMF and ECB studies). However, the limited quantification complicates the effort to assess the scale and scope of the problem and its consequences. The annexes to the IA provide more sector-specific details and examples, including sector-specific problems and drivers that stem from the above-described problems. However, the level of detail provided varies between annexes. The trading, post-trade and asset management sectors are described in Annex 7 (IA, p. 171-177), Annex 8 (IA, pp. 217-240) and Annex 9 (pp. 291-300). Finally, the objectives relating to innovation and supervision are described in Annex 10 (pp. 329-340) and annex 11 (pp. 359-379).
Subsidiarity / proportionality
In line with existing legislation, the legal basis for the proposed amendments remains the same as the one for the original legislative act, Article 114 of the Treaty on the Functioning of the European Union (TFEU) for the Central Securities Depositories Regulation, the Markets in Financial Instruments Regulation, the European Market Infrastructure Regulation, the Markets in Crypto-Assets Regulation, the Money Market Funds Regulation, and the founding regulations of the European Securities and Markets Authority, the European Banking Authority and the European Insurance and Occupational Pensions Authority. The legal basis for the Markets in Financial Instruments Directive, the UCITS Directive, the Alternative Investment Fund Managers Directive, the Financial Collateral Directive and the Settlement Finality Directive is Article 53(1) TFEU.
The IA briefly explains the need for EU intervention regarding these amendments, arguing that national solutions are not sufficient due to the scale and cross-border effects of the proposed actions. Specifically, because Member States have divergent legal frameworks, supervisory traditions and market structures, reforms undertaken individually by a Member State would not result in the necessary convergence of regulatory and supervisory standards and market practices (IA, p. 52). EU-level action is expected to remove regulatory barriers, ensure a level playing field and increase market efficiency and competitiveness. The added value of this initiative would arguably be to reduce legal and operational uncertainties for businesses and investors, ensure consistent supervision and preserve the integrity of the single market (IA, p. 53).
According to the IA, the initiative is proportionate because it ensures a balance between EU and national competences in terms of entities and activities (IA, p. 53). Stakeholders consulted also highlighted a need for a more proportionate, simplified and harmonised regulatory framework that reduces burdens particularly in trade, post-trade, asset management and investment funds (IA, p. 115). Nonetheless, stakeholders also agreed that proportionality 'must not undermine investor protection, market stability, or financial integrity' (IA, p. 115). Proportionality was also considered in the assessment of the options (IA, pp. 55-67).
National parliaments had until 16 March 2026 to provide feedback on whether the proposals on capital market integration and supervision complied with the subsidiarity principle. At the time this briefing was written, no reasoned opinion or request for exchange of information had been received. National parliaments were also consulted on the subsidiarity aspects of the proposal concerning settlement finality and financial collateral arrangements, with a deadline for feedback of 6 April 2026. No responses had been received at the time this briefing was written.
The European Economic and Social Committee adopted an opinion on 16 July 2025 (before the publication of the IA).
Objectives of the initiative
The IA explains that the general objective is to 'integrate and thereby improve the functioning of EU capital markets for the benefit of investors, businesses and the wider EU economy' (IA, p. 53). This is in line with the savings and investments union's strategy, which aims to foster citizens' wealth and economic competitiveness in the EU. This general objective is broken down into three specific objectives (SO):
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SO 1: Enable further market integration and scale effects: This initiative aims to remove barriers to integration, increase the volume of cross-border transactions and reduce the costs of domestic and cross-border transactions (IA, p. 53).
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SO 2: Enable integrated supervision: This initiative seeks to make supervision more effective, more conducive to cross-border activities and more responsive to emerging risks, while reducing unnecessary burdens on firms (IA, p. 54).
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SO 3: Facilitate innovation: This initiative aims to remove regulatory obstacles to DLT-related innovation by creating a framework that enables the take-up of new technologies in the provision of financial services (IA, p. 54).
These SOs are directly derived from the general objective identified above. Better Regulation Guidelines Tool# 15 specifies that the IA should include operational objectives to define the deliverables in more detail. The IA does not include operational objectives despite providing 38 indicators (IA, p. 98-100, see the Section on 'Monitoring and evaluation' below) to monitor the progress of achieving the above-defined objectives.
Therefore, the S.M.A.R.T. criteria laid out in the Better Regulation Guidelines, according to which objectives should be specific, measurable, achievable, relevant and time-bound do not seem to be fully applied in this IA, as the general objective is quite broad and no quantitative targets are set for the specific objectives and indicators (IA, p. 99). As with the other sections, the annexes (7-11) provide more sector-specific details for the above-described specific objectives, as well as sector-specific SOs.15 In addition, there is no indication on the timeline.
Without giving further details, Annex 3 states that the initiative expects to contribute to two United Nations Sustainable Development Goals (UN SDGs): SDG 8 (decent work and economic growth) and SDG 9 (resilient infrastructure, inclusive and sustainable industrialization, foster innovation) (IA, p. 152).
Range of options considered
The IA defines two packages of policy options – options 2 and 3 – based on a call for evidence, a targeted consultation, a literature review, and previous studies and initiatives (IA, pp. 54-67). In addition, the IA states that the Commission, ESMA and the ECB have worked in close cooperation to ensure that the preferred options would be feasible and to identify required resources for their implementation (IA, p. 56). Option 1 is the baseline option of no policy action, under which EU capital markets would remain fragmented (IA, p. 55) and the problems and adverse outcomes described in the above section would therefore persist .
Option 2 involves updating the rules for trading, post-trading and asset management to make them more uniform and easier to follow. This includes relaxing some rules for companies operating across borders under a single license. It would also improve connections between central securities depositories. Additionally, the rules for post-trading would be adjusted to better support new technologies, and the pilot program for distributed ledger technology would be expanded. Investment funds would get immediate access to the entire EU market once authorised in one Member State, saving time and money. Asset management firms would also be able to share resources across the EU without strict delegation rules.
Regarding supervision, option 2 aims to strengthen ESMA, as it would directly supervise major financial infrastructures (such as trading platforms, CSDs and CASPs). ESMA would also coordinate the oversight of large asset managers and investment funds.
Option 3 builds on option 2 but goes further by requiring mandatory connections between major trading platforms and CSDs. It would also introduce group-level authorisation for asset managers, full flexibility in the DLT pilot programme and full ESMA supervision over all infrastructures, asset managers and CASPs.
The tables below provide an overview of the options and measures assessed in the IA.
| Policy options | |
|---|---|
| Trading | |
| Option 2 – Broad review | Option 3 – Far reaching review |
| Harmonising trading venue rules, enhancing passporting opportunities and introducing a 'Pan-European Market Operator' and a single-licence operation for trading venues | Same measures, complemented with mandatory connection for re-routing orders between significant trading venues |
| Simplifying intra-group allocation of resources across Member States | |
| Introducing a streamlined membership process to simplify brokers' direct access to trading venues | |
| Post-trading | |
| Option 2 – Broad review | Option 3 – Far reaching review |
| Limiting Member States' ability to impose additional requirements on issuers in order to improve freedom of issuance | Same measures |
| Increased technological neutrality of post-trade legislation | |
| Allowing authorised CSDs to expand to other Member States with only a notification. | Alternative measure: Allowing CSDs to expand to other Member States without notification and without intention to service markets |
| Mandating EU CSDs that work with Target 2 Securities (T2S) currency to connect to the T2S platform | Complementing measure: T2S legally becoming a CSD |
| Mandating EU CSD hubs to connect to each other, and non-hub CSD to connect to one hub | Alternative measure: All CSDs are required to connect to T2S CSD via bi-directional links and to serve all EU currencies. |
| Asset management | |
| Option 2 – Broad review | Option 3 – Far reaching review |
| A new 'passporting upon authorisation' regime, allowing undertakings for collective investment in transferable securities (UCTIS) and alternative investment funds (AIF) single-market access to their chosen Member State upon authorisation | Same measures |
| Creating a common EU marketing rules framework to reduce national divergences on marketing communication | |
| Facilitating use of inter-group resources and delegating function across entities within the same group in the EU | |
| Implementing EU depository passports for individual UCTIS and AIFs | Alternative measure: allowing group-level authorisation. |
| Innovation – DLTPR | |
| Option 2 – Broad review | Option 3 – Far reaching review |
| Removal of time limits | Same measures |
| Increasing the scope of eligible instruments to include all financial instruments | |
| Simplifying the pilot for small businesses | |
| Removing the product-specific thresholds and increasing the aggregated threshold16 | Alternative measure: removing all thresholds |
| Allowing crypto asset service providers (CASP) to participate | Complementing measure: allowing the participation of asset managers, payment institutions, central counterparties (CCPs) and authorised crowdfunding service providers as well |
| Allowing licensing for individual CSD services | Alternative measure: possibility of obtaining a license through a risk-based process |
Source: IA, pp. 62-63.
| Supervision | |
|---|---|
| Option 2 – Improved supervisory convergence and an enhanced role for ESMA in supervision | Option 3 – ESMA: single supervisor for all entities |
| Improve supervisory convergence across the sectors by improving the incentives to use the tools through a more effective decision-making system | Same measure |
| Transfer supervisory powers over certain trading venues17 to ESMA. ESMA is to play a stronger role in the convergence and coordination of supervision | Transfer direct supervisory powers over all entities |
| Amend ESMA governance by creating an Executive Board and a Board of Supervisors, inclusion of a non-objection procedure. | Alternative measure: Executive Board makes final supervisory decisions, no powers for Board of Supervisors |
Source: IA, p. 67.
The IA compares the two options based on three goals: (1) increasing cross-border activity to create a more integrated market; (2) improving supervision by reducing fragmentation; and (3) encouraging innovation by removing regulatory barriers. The IA concludes that the additional measures under option 3 would not justify the extra costs and could pose unintended risks to competition and financial stability (IA, pp. 56-67).
The IA includes an overview of discarded policy options and the reasons for their rejection (IA, p. 68). However, it is unclear whether this overview encompasses the policy options discussed in the annexes. Below are the three discarded policy options:
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converting all directives in the trading, post-trading and asset management sectors into regulations;
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mandating that all EU CSDs establish bi-directional links;
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only improving ESMA's supervisory convergence while Member States retain most supervisory powers.
The IA provides additional details on the policy options in its annexes; the trading, post-trade and asset management sectors are described in Annex 7 (IA, p. 177), Annex 8 (IA, pp. 240-242) and Annex 9 (pp. 300-301). Moreover, the IA provides more granular information for various sectors. However, the relationship between the information in the annexes and the policy options set out in the main text is not clearly explained. The IA presents two policy options, but given that option 3 builds on option 2, this raises doubts as to whether the policy options meet the BRG Tool #16 requirement of offering a wide range of options.
Option 2 and option 3 are compared in terms of efficiency, effectiveness and coherence (IA, p. 85). Option 2 is the preferred policy option for facilitating cross-border operations and innovation. Aside from being assessed as the most effective, efficient and coherent, the benefits associated with option 2 outweigh the costs. Moreover, the costs are feasible and more predictable than the costs associated with option 3 (IA, pp. 83-85). Option 2 is also the preferred policy option when it comes to increasing supervisory alignment, because it is feasible and proportional and respects subsidiarity. However, the IA envisions option 2 as a potential first step for deeper integration in the future (IA, pp, 94-95).
Assessment of impacts
In accordance with BRG Tool #18, an IA needs to consider 'impacts across the economic, environmental, and social pillars'. However, the IA considers that 'the package of the main policy options is not expected to have any direct significant social, environmental or fundamental right impacts' (IA, p. 69). For this reason, the IA focuses solely on the assessment of economic impacts. The IA provides a qualitative comparative table of impacts on stakeholders by policy option (IA, p. 86) and includes a summary table of the expected benefits and costs of the preferred initiative for the affected stakeholders (IA, pp. 145-150). The IA argues that no significant costs are expected for citizens (IA, p. 145, 151), and for this reason the overview of costs and benefits focuses on other stakeholders, businesses and administrations. Costs are categorised as direct and indirect and, based on their recurrence, as one-off or recurrent. In terms of benefits, the IA provides clear details on direct and indirect benefits, but its assessment is mostly qualitative. The IA states that the main reason for this is the 'inability of stakeholders to provide cost figures or estimation of benefits' (IA, p. 68) and that, consequently, many of the figures it refers to are estimates collected from a selection of stakeholders (IA, p. 68 and Annex 4).
The IA could have provided more detail on the underlying assumptions and been more transparent about the methodology used to calculate the macroeconomic impacts that led to the conclusion that EU GDP could cumulatively increase between €1.36 trillion and 3.62 trillion over 30 years (IA, p. 146). Nevertheless, the IA discusses the costs and benefits per sector.
For the trading sector, the IA could not quantify the level of one-off adaptation costs, but it expects that entities are likely to obtain a net benefit over the mid to longer term (IA, p. 74). For example, trading venues are expected to save between €47-120 million per year on cross-border activities.18
In post-trading, the IA concludes that harmonising standards, streamlining processes and decreasing compliance costs could decrease transaction costs by about 30% (IA, p. 76).
Similarly, the asset management sector would also benefit from the reduction of regulatory burdens. The IA does not provide quantification but affirms that the benefits would outweigh the costs related to changing the marketing process (IA, p. 77).
Regarding DLTPR, the IA states that the costs related to enhanced supervision at both the EU and the national level are minor and manageable, yet it does not provide quantification nor details about the risks associated with allowing a network of providers to issue accounts and transfer services in DLT. In fact, the IA considers that these risks 'could be somewhat offset by the heightened resilience of a distributed post-trading ecosystem' (IA, p. 78).
Regarding supervision, the IA provides a detailed overview of the costs that ESMA would face following the expansion of its supervisory tasks across the various sectors. These costs are as follows: €17-19.5 million for trading; €5.5-9.5 million for CCPs in post-trading; €5.5-7.5 million for CSDs; and €12-30 million for CASPs. In asset management, the coordination of supervision would cost €2-4 million and the oversight of cross-border fund distribution €2-3 million (IA, pp. 90-91).
The annexes (pp. 314-326) outline the impacts of all policy options for each sector and detail their pros and cons. However, these impacts are not always evidence-based, estimated or quantified. The report presents information in a fragmented manner; some relevant information is in the main text, and other important details are in the annexes, thus making it difficult to get an overview of the proposed policies and their impacts.
The territorial effects noted in the problem definition is not revisited in the assessment of impacts, nor are the effects on digitalisation.
SMEs / Competitiveness
As required by BRG Tool #23, the IA includes a four-step SME test (IA, pp. 160-162). The IA states that SMEs were consulted as part of the public consultation (IA, p. 161). The results of the consultation indicate no differences between SMEs and large companies in terms of impact, except that most supervisory measures would not affect SMEs, as they only apply to large market participants. Consequently, Annex 3 does not include a separate list of cost estimates for SMEs. From a qualitative perspective, SMEs will experience cost savings if they engage (or plan to engage) in cross-border activities (IA, p. 161). The IA asserts that this positive effect would be greater for SMEs than for larger companies engaging in cross-border activities, due to SMEs' smaller revenue base. However, it does not provide any quantification. According to the IA, there is no need to minimise negative impacts on SMEs, nor are there administrative cost-savings relevant to the 35 % burden reduction target for SMEs.
The IA also includes a section focused on a competitiveness check (IA, p. 158-159), in which it assesses the potential impact of the initiative on four dimensions: cost and price competitiveness (jointly with Annex 3 and Annexes 7-11), internal competitiveness (jointly with Annexes 7-11), capacity to innovate (jointly with Annex 10) and SME competitiveness (jointly with Annex 6). Overall, the impact is expected to be positive, especially on cost and price competitiveness, as this initiative is expected to stimulate cross-border activity by lowering the costs of cross-border provision. In addition, the reduction of frictional costs in cross-border service provision increases the potential for economies of scale.
The initiative is included in the SME filter (see p. 31).
Simplification, burden reduction and other regulatory implications
In accordance with BRG Tool #2, this initiative aims to remove barriers to the cross-border provision of financial services in trading, post-trading and asset management. It seeks to simplify procedures and harmonise supervision requirements (IA, p. 98). Therefore, it aligns with the Commissions' regulatory fitness and performance programme (REFIT).
The IA follows the 'one in one out' approach described in BRG Tool #59. Businesses and administrations would face a one-off new administrative burden to adapt to legal changes and redirect reporting flows to ESMA. However, the IA does not quantify this burden (IA, p. 98 and Annex 4), but states that it expects it to be relatively small. Ongoing administrative costs are also expected to be minimal (IA, p. 98). The IA refers to the difficulty in establishing these costs, as they depend on factors such as the entity involved and the specific compliance requirements. Annex 3 (pp. 147-150) details some administrative burden reductions. In addition, the IA expects administrative costs for intragroup operations to decrease due to reduced divergence in requirements (IA, p. 98).
Monitoring and evaluation
As required by BRG Tool #43, the IA includes an overview of how this initiative would be monitored and evaluated. The IA suggests carrying out a review of this initiative five years after its entry into force, in alignment with the Commission's BRGs (IA, p. 98). Given the absence of operational objectives (see Section on 'Objectives of the initiative'), the IA presents a list of 38 indicators to monitor the achievement of the identified specific objectives (IA, pp. 99-100). These indicators appear to be relevant, accepted, credible, easy to monitor and robust (RACER) (IA, pp. 99-100). In addition to sector-specific indicators, the IA suggests including indicators to measure wider market impacts but does not list them or set quantitative targets for them (IA, p.99).
The IA presents a non-exhaustive list of data sources to be used for evaluation purposes, namely: websites of NCAs, ESMA databases on financial instruments (MiFID/MiFIR19), clearing (EMIR) and notifications (AIFMD/UCITS) and third-party databases. It also mentions industry associations' regular market reports, indicators for capital market development used by the Commission's Directorate-General for Financial Stability, Financial Services and Capital Markets Union (FISMA) and stakeholder engagement (IA, pp. 98-99). Finally, the IA also specifies that ESMA and the European System of Central Banks (ESCB) carry a joint responsibility for collecting data for post-trading indicators, and ESMA is responsible for collecting data on supervision indicators (IA, pp. 280, 406).
Stakeholder consultation
In accordance with Chapter 7 of the BRG, Annex 2 to the IA presents a detailed account of the consultation activities that were undertaken (IA, pp. 108-143). The Commission launched a call for evidence (8 May 2025 to 5 June 2025) and a parallel targeted stakeholder consultation (15 April 2025 to 10 June 2025). Moreover, workshops and multiple meetings with relevant sectoral stakeholders were organised between May 2025 and July 2025. This was followed by additional targeted outreach in September and October 2025 to gather more data on the impacts of regulatory and supervisory barriers (IA, p. 108).
The IA includes a detailed synopsis of the results from both the call for evidence and the targeted consultation. The call for evidence had 53 respondents, of whom 62.3 % were business associations, 20.8 % companies and businesses, 9.4 % individual EU citizens, 1.9 % NGOs and 5.7 % fell within a residual 'other' category (IA, p. 108). This call aimed to identify barriers in trading and post trading, examine the fitness of the current regulatory and supervisory frameworks and test potential improvements to ESMA's toolbox. Overall, respondents agreed on the need for more integration and supervisory convergence, provided that changes are balanced, transparent and inclusive. Business associations and companies tended to prefer incremental progress within the current institutional framework, while NGOs and some citizens favoured stronger EU-level oversight to ensure coherence and accountability (IA, pp. 108-109).
The targeted questionnaire consisted of two parts and had 297 respondents in total. Both parts focused on existing barriers. Part 1 concentrated on simplification and burden reduction for trading, post-trading and asset management, liquidity deepening and cross-border operations in trading and post-trading. Part 2 addressed supervision, cross-border asset management services and investment funds, as well as horizontal obstacles in trading and post-trading (IA, p. 109). However, the number of respondents varied between part 1 (228 respondents) and part 2 (219 respondents), as well as across individual questions (IA, pp. 109-114).
Throughout the document, the IA presents the diverging views held across the different stakeholder groups, frequently referencing the feedback from the stakeholder consultations (IA, pp. 109-143). However, because both the call for evidence and the targeted consultation focused on existing barriers to trading, post-trading, asset management and supervision, with special attention given to cross-border operations, the findings mainly inform the problem definition. Consequently, they offer limited insight into stakeholder views on the policy options presented in the IA.
Supporting data and analytical methods used
Besides the stakeholder consultations and targeted interviews, the IA draws on two external studies titled 'Study of barriers to and drivers of, the scaling-up of funds investing in innovative and growth companies' and 'Study on consolidation and reducing fragmentation in trading and post-trading infrastructures in Europe' (IA, p. 154). Moreover, the IA is also based on a literature review and a mapping of existing data (IA, pp. 154-155).
Annex 1 provides an overview of all sources cited in the IA (IA, pp. 105-107). These sources are relevant and are quoted clearly throughout the IA. In addition, the IA provides extensive details and reflections on the data and analytics behind the expected growth of the EU economy, which are based on external papers (IA, p. 155-157).
The IA openly acknowledges the limitations underlying the data and analytical methods. According to the IA, 'extensive data collection required for more advanced modelling of impacts were not within the scope' (IA, p. 155). In addition, the IA admits that the evidence provided in relation to costs and cost savings was limited, and its representativeness of actual costs is unclear. Finally, the IA recognises significant data gaps concerning the costs and pricing of the services provided, attributing this partly to the reluctance of stakeholders to reveal cost structures or estimates (IA, p. 153).
Follow-up to Commission Regulatory Scrutiny Board opinion
On 8 October 2025, the Regulatory Scrutiny Board issued a negative opinion on the draft IA. The RSB highlighted significant shortcomings in key parts of the draft IA, including an unclear description of the problem's magnitude, a lack of clearly defined objectives for reducing regulatory and market barriers, and a lack of clarity regarding how these objectives related to the policy options. Furthermore, the RSB considered that impacts were not sufficiently assessed, noting a lack of quantification of costs and benefits across options and stakeholders, as well as a lack of quantification and evaluation of the methodologies used.
Following this first negative opinion, the IA report was resubmitted to the RSB and received a positive opinion with reservations on 14 November 2025. However, the RSB suggested that FISMA (the lead DG) take the following steps:
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strengthen the economic analysis, with a focus on increased quantification of cost and benefits for each option and across stakeholder groups;
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demonstrate the robustness of macroeconomic estimates.
In line with the requirements of the BRG, Annex 1 of the IA explains (pp. 101-107) how the points raised by the RSB in the two opinions have been addressed. The Commission claims to have corrected the shortcomings identified except for the inclusion of additional modelling, the extrapolation of effects and the provision of more detailed breakdowns on costs and savings, which was not followed 'due to lack of data and time' (IA, p. 101). Since the previous draft IA is not publicly available, the extent to which the corrections have been incorporated into it could not be verified. Nevertheless, it seems that some shortcomings identified by the RSB remained unresolved.
Coherence between the Commission's legislative proposal and IA
The three proposals – for a regulation and a directive on supervision and capital market integration and for a regulation on settlement finality and on financial collateral arrangements20 – appear to be in line with the IA's preferred option. In addition, the proposals highlight that they are in line with the Charter of Fundamental Rights of the EU.21
Endnotes
Classification
Policy areas: Economics and Monetary Issues | Financial and Banking Issues | Ex-ante Impact Assessment
Committees: Economic and Monetary Affairs (ECON)
Statement on the use of AI
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