EUROPEAN COMMISSION Brussels, 15.4.2019 SWD(2019) 156 final COMMISSION STAFF WORKING DOCUMENT Taking Stock of the Commission's Better Regulation Agenda Accompanying the document COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Better regulation: taking stock and sustaining our commitment {COM(2019) 178 final}



Table of Contents Section I Better regulation and the need to take stock 1.Introduction 2.The May 2015 Better Regulation Package Section II What have we learned? 3.Opening up policymaking 3.1.Feedback opportunities 3.2.Consultation 3.3.Contributing to law-making (the ‘Have Your Say’ portal) 3.4.Overall assessment and key drivers 4.Better tools for better policies 4.1.Impact assessment 4.2.Evaluation 4.3.Regulatory Scrutiny Board 4.4.Subsidiarity and proportionality 5.Keeping the existing stock of legislation fit for purpose 5.1.The REFIT programme 5.2.REFIT Platform 5.3.Communicating REFIT activities

5.4.Considering alternative approaches to simplification and burden reduction 5.5.Results of simplification efforts 6.Better regulation as a shared agenda 6.1.Joint Declaration on the EUs legislative priorities 6.2.Delegated acts 6.3.Impact assessment 6.4.‘Gold-plating’ of national transposing legislation 6.5.Other issues 7.Conclusions Annex I Better Regulation in the European Commission 1.The origins of better regulation 2.The different elements of better regulation Annex II Overview of consultation activities 1.Overview of consultation activities 2.OECD regulatory Policy Outlook 2018 3.Literature Review 4.Public consultation 4.1.General questions: The Commission and better regulation 4.2.Public consultations: Consulting the public and interested parties 4.3.Evaluations and REFIT: Evaluating existing EU laws

4.4.Impact assessments: Assessing new Commission proposals 4.5.Regulatory scrutiny: Scrutinising the quality of impact assessments and evaluations 4.6.Final questions on past and future progress 4.7.Conclusions of the public consultation questionnaire 4.8.Position papers 5.EU Institutions and consultative bodies 5.1.The European Parliament 5.2.The General Secretariat of the Council 5.3.The Council Working Group on Competitiveness and Growth 5.4.The Committee of the Regions 5.5.The European Economic and Social Committee 6.European Commission Officials 6.1.Impact assessment 6.2.Evaluation 6.3.Consultation 6.4.The Regulatory Scrutiny Board 6.5.The REFIT programme, Platform and Scoreboard 7.Other organisations and bodies 7.1.REFIT Platform 7.2.Task force on subsidiarity, proportionality and doing less more efficiently

7.3.Regulatory Scrutiny Board Section I

Better regulation and the need to take stock 1.Introduction The Juncker Commission came into office with a commitment to do different things and to do them differently. It wanted to focus on delivering the initiatives needed to support its 10 political priorities and address the issues that really matter to people in the EU. Under its Union for democratic change, it put better regulation principles at the heart of its policymaking processes and made them a key part of the efforts to improve the legitimacy of EU action. The Commission modified its internal structure and created the post of First Vice President in charge of Better Regulation. It changed its internal working methods and transformed its planning processes to deliver streamlined work programmes. Building on the origins of better regulation in improving European governance, this Commission wanted to strengthen the better regulation tools it inherited to inform timely and sound policy decisions that would deliver better policies for better results. To this end, in 2015, the Commission adopted a wide-ranging set of measures. Since then it has regularly reported the results it has achieved and the further improvements it has introduced. The Commission has now taken stock of how well the various better regulation tools and processes are functioning. Its aim is to highlight what is needed for possible further improvements and to support a public debate on the future of better regulation. This staff working document presents the findings of this exercise. It accompanies a Commission Communication discussing key results and mapping out avenues for possible future improvements. The stocktaking exercise has focused on the period since May 2015 and relied upon a mixture of evidence. We have used external assessments (from the OECD and the European Court of Auditors), reports from the Regulatory Scrutiny Board and a broad range of consultation activities. These include: –interviews and meetings to consult Commission staff working in a range of different departments and functions, including better regulation support staff, senior managers and members of Commissioners’ political teams, –a public consultation of all external stakeholders, –targeted consultation meetings with the administrative secretariats of the European Parliament, the Council of the European Union, the Committee of the Regions and the European Economic and Social Committee, –an opinion from the REFIT Platform, –discussion in the Competitiveness and Growth Working Party of the Council (better regulation). The Joint Research Centre has also published a review of the peer-reviewed and ‘grey’ literature written since 2015 in support of the current stocktaking exercise. 2.The May 2015 Better Regulation Package In May 2015, the Commission published an extensive package of new measures to improve and strengthen its better regulation policy in four areas where progress was considered necessary: (1)Opening up policymaking. To make the EU more transparent and accountable but also to ensure that policies are based on the best available evidence, the Commission took measures to consult more, listen better and better explain what it does and why. These measures include:

–creating feedback opportunities over the entire lifecycle of a policy from its initiation to its evaluation, including for the first time the possibility to give views on draft texts of delegated and implementing acts. –committing to systematic 12-week public consultations on new proposals and evaluations. This was later complemented by a commitment to translate public consultation questionnaires into all official languages for priority initiatives in Annex I of the Commission work programme and into English, French and German for all others. –introducing an improved template for the explanatory memorandum accompanying Commission proposals. This provides improved explanations of how better regulation principles are applied in the preparation of an initiative, and if not, why they are not. –designing a new, central web-based portal in several stages (‘Have Your Say’) to facilitate stakeholders’ participation in policymaking. (2)Utilising better tools for better policies. To inform political choices in a balanced and inclusive way, drawing lessons from the past and identifying the best and least costly policy solution, the Commission took measures such as: –integrating and improving guidelines (and supporting tools) on how to apply better regulation in practice. These guidelines address all aspects of the policy cycle and the connections between them. –to substitute the Impact Assessment Board with a new body to scrutinise the quality of impact assessments like its predecessor and, for the first time, evaluations. To safeguard its autonomy, this Regulatory Scrutiny Board (the Board) consists of seven full-time members who are independent of the policymaking process, including three appointed from outside of the EU institutions. –committing to explain publicly the reasons why the Commission may decide to take action even if the Board does not give a positive assessment of the quality of any accompanying impact assessment. (3)Keeping the existing stock of legislation fit for purpose. Even well designed legislation may become out of date, turn out to be more burdensome and less effective than originally thought or simply cease to achieve relevant objectives. For these reasons, managing existing EU legislation is as important as responding to new policy challenges, and the Commission therefore decided to: –commit to evaluate existing legislation before proposing changes (‘evaluate first’ principle); –strengthen and eventually mainstream its REFIT programme to verify the opportunities to deliver results more efficiently whenever existing EU legislation is revised; –establish a new REFIT Platform through which stakeholders can point the Commission to existing policies and legislation that could be simplified. (4)Advancing a common agenda with other EU institutions and Member States. The Commission has a key role in better regulation but cannot do it alone. The right to amend legislative proposals lies with the European Parliament and Council and the right to transpose and implement adopted legislation lies with Member States. That is why the Commission put forward a proposal for a new interinstitutional agreement on better law-making between the European Parliament, the Council of the European Union and the European Commission. Following negotiations, a new agreement was jointly approved in April 2016. The next section takes stock of the evidence and examines the views of the concerned parties on the results of these measures.



Section II

What have we learned? Activities completed The Commission has applied its better regulation policy to its policymaking activities. The table below gives a general overview for 1 January 2015 to 31 December 2018: Table 1 Better regulation activities 2015-2018. Numbers of: 2015 2016 2017 2018 Public consultations 105 120 112 80 Percentage of public consultations in all official languages 26% 21% 55% 71% Impact assessments 29 60 53 76 Evaluations* 53 65 74 67

* Evaluations cover regulatory instruments, expenditure measures, and communication and coordination activities. The main overarching evaluations are included but not the underlying thematic or geographic evaluations. 3.Opening up policymaking Answers to the public consultation identified stakeholder consultations and transparency as the two areas where most progress has been achieved since 2014. This is also reflected in an OECD comparative assessment of its member countries’ better regulation systems which, in 2018, ranked the Commission as first in the OECD for stakeholder engagement. At the same time, however, respondents to the public consultations flagged transparency and consultation as the two areas most in need of improvements in the future. These general findings confirm the continued validity of the Commission’s choice to focus on opening up policymaking and are reassuring in terms of the success achieved. They do, however, indicate the need to reflect further on what the key shortcomings are and how they can be tackled in a proportionate manner. The following analyses in greater detail outcomes and contributing factors, offering background evidence for future policy decisions. 3.1.Feedback opportunities Opportunities to give feedback over the entire lifecycle of a policy from its initiation to its evaluation were gradually introduced. Already in 2015, feedback on inception impact assessments, evaluation roadmaps and other types of roadmaps was made available. In 2016 for the first time it became possibile to provide views on draft texts of delegated and implementing acts and in 2017 on Commission proposals. Table 2 Roadmaps and inception impact assessments posted for feedback, 2015-2018. Numbers 2015 2016 2017 2018 Roadmaps 76 57 77 51 Inception impact assessments 30 59 65 21 Evaluation roadmaps 71 88 33 63 Commission proposals -* -* 78 154 * Commission proposals were made available for feedback as from 2017 The results of the public consultation show that around a fifth of respondents are not aware of the opportunities the Commission offers to contribute to policymaking. Since those answering the public consultation can be expected to be more knowledgeable about better regulation than the average stakeholder at large, this indicates a clear scope to further improve the knowledge and reach of EU tools. The satisfaction of those aware of the various opportunities varied, with the majority of respondents always being either satisfied or neutral. Slightly over a fifth of the respondents, however, expressed dissatisfaction with all tools. Roadmaps and inception impact assessments At the start of each new initiative the Commission publishes an inception impact assessment or, when no impact assessment is planned, a roadmap. At the start of each evaluation the Commission publishes an evaluation roadmap. These documents provide basic information about what the Commission intends to do, the analytical work it will undertake, and the consultation activities it will launch and, in the case of roadmaps, the reasons why no impact assessment is planned. For a period of 4 weeks, the public can provide comments on these documents, including the need for an impact assessment. The lead Commission department takes into account these comments when preparing the initiative. ·In the two-year period up until 31 December 2018, 86 inception impact assessments were posted to the web for stakeholder feedback. These attracted 1 253 feedback contributions (32 inception impact assessments received 0-5 contributions, with 2 inception impact assessments receiving more than 100 contributions). The highest number of responses were received for the fight against illegal content online (146) and construction products (121). Business groups accounted for approximately 59%, NGOs for 15%, EU citizens for 8% and public authorities for 5%. The most responses came from Belgium (24%), followed by Germany (16%), the UK (8%) and France (8%). ·In the two-year period up until 31 December 2018, 128 roadmaps were posted to the web for stakeholder feedback. These attracted 2 272 feedback contributions 79 roadmaps received 0-5 contributions, with 4 roadmaps receiving more than 100 contributions). Business groups accounted for approximately 20%, NGOs for 13%, EU citizens for 52% and public authorities for 3%. The most responses came from Spain (25%), followed by Belgium (15%), Italy (15%) and France (7%). ·In the two-year period up until 31 December 2018, 96 evaluation roadmaps were posted to the web for stakeholder feedback. These attracted 724 feedback contributions 63 roadmaps received 0-5 contributions, and none more than 100 contributions). Business groups accounted for approximately 44%, NGOs for 20%, EU citizens for 12% and public authorities for 7%. The most responses came from Belgium (33%), followed by Germany (14%), France (7%) and Spain (6%). Responses from the public consultation indicate that roadmaps and inception impact assessments are generally considered useful to prepare participation in policymaking and as tools to provide initial feedback. This is especially true among professionals. Professionals are also the group that provided most of the feedback to inception impact assessments and evaluation roadmaps. According to the REFIT Platform, feedback may be limited due to a lack of time. In its responses to the stocktaking consultation, the business community welcomed the opportunities to provide feedback on roadmaps and inception impact assessments. Delegated acts and implementing acts In many acts of Union law, the European Parliament and the Council empower the Commission to introduce or replace technical and specific elements needed to implement legislation or to ensure a consistent implementation by all Member States. The Commission has greatly enhanced transparency around the preparation of these acts of general application, known as delegated and implementing acts, allowing the public to comment on the draft legal text for a period of 4 weeks. These comments are taken into account before the Commission adopts a delegated act and before it presents a draft implementing act to the relevant committee for its opinion. Between 1 July 2016 and 31 December 2018, the Commission published 151 draft delegated acts, 191 draft implementing acts and 94 draft acts, following the regulatory procedure with scrutiny.

Table 3 Delegated acts and implementing acts posted for feedback, 2015-2018. Numbers 2015 2016 2017 2018 Delegated acts - 24 61 66 Implementing acts - 42 73 76 Acts following regulatory procedure with scrutiny - 32 31 31 Between 2016 and 31 December 2018, the 151 delegated acts posted to the web for stakeholder feedback attracted 1 576 feedback contributions (100 delegated acts received 0-5 contributions, with 2 acts receiving more than 100 contributions). Business groups accounted for approximately 54%, NGOs for 11%, EU citizens for 20% and public authorities for 5%. The most responses came from Germany (20%), followed by Belgium (17.8%), the UK (11.8%) and France (9%). In the same period, the 191 implementing acts posted to the web for stakeholder feedback 1 770 feedback contributions ( 149 implementing acts received 0-5 contributions, with 4 acts receiving more than 100 contribution). Business groups accounted for approximately 54%, NGOs for 6%, EU citizens for 26% and public authorities for 6%. The most responses came from Belgium (13.1%), followed by the UK (13%), France (12.8%) and Italy (9%). In the same period, the 94 acts following regulatory procedure with scrutiny posted to the web for stakeholder feedback received 1005 feedback contributions (50 consultation with 0-5 contributions, with 2 acts receiving more than 100 contributions). Business group accounted for approximately 59%, NGOs for 13%, EU citizen for 11% and public authorities for 3%, The most responses came from Belgium 25%, followed by Germany 19%, the UK 8%, and France 8%. The low response rate to implementing and delegated acts, in particular from EU citizens, is likely to reflect limited awareness of the feedback mechanism but also the technical nature of the acts. This mechanism is mainly used by business groups. Similar to roadmaps and inception impact assessments, responses are generally low but may be more significant in a few cases of more general concern, such as the implementing act on drones or the one on the origin labelling on food. Proposals Prior to 2015, no formal transparent mechanism existed for the public to express its views about the legislative proposals presented to the European Parliament and the Council. The Commission introduced then a mechanism for stakeholders to comment on each proposal (and associated impact assessment) for a period of 8 weeks immediately following Commission adoption. The Commission reports this feedback to the European Parliament and the Council for them to consider during the legislative procedure. ·In the two-year period ending 31 December 2018, 232 Commission proposals were posted to the web for stakeholder feedback. These attracted 7 075 feedback contributions (152 proposals received 0-5 contributions). The proposal on a European defence fund alone attracted more than half of these contributions (4 071). All other proposals attracted on average 13 contributions. Of all the contributions, business groups accounted for approximately 42.9%, NGOs for 10.5%, EU citizens for 31.1% and public authorities for 2.7%. The most responses came from Belgium (16.8%), followed by Italy (16.3%), France (12.1%), and Germany (11.6%). The limited feedback reflects the limited awareness of the feedback mechanism as well as possibly a limited interest in its use. However, in the case of proposals of a general public interest, such as marine litter, drinking water or the defence fund, reponse rates were significantly higher. The European Parliament has made clear that it would prefer the Commission to limit its consultations to before it adopts as it considers that, during the legislative process itself, it is for the Parliament and Member States to carry out their own consultations, if they choose to. A similar concern is also raised in the opinion of the REFIT Platform on stakeholder consultation. The mechanism also receives the relative highest share of negative replies in terms of satisfaction from the participants to the public consultation (nearly a third). This is probably due to the reduced interest in offering feedback on items the Commission has already adopted. Nevertheless, practical experience shows that, at times, the mechanism can generate a high number of replies, which could be of particular value in cases where no impact assessment and/or no public consultation could be carried out for reasons of urgency. 3.2.Consultation Box 1: Average replies to public consultations* * excludes consultations that received significantly higher responses in a given year and considered as outliers: the 2015 consultation on the evaluation of the Birds and Habitat Directive (552 472), the 2017 consultation on the common agricultural policy (322 912) and the2018 consultation on summertime arrangement (4 706 294). The Commission is obliged to consult widely before making legislative proposals. These consultations should consider local and regional dimensions, as appropriate . Consultation of the public and civil society is part of a wider agenda to improve the democratic legitimacy and ownership of what the Union does that dates back to the 2001 White Paper on European Governance. This was given a new boost under the Juncker Commission. In May 2015, the Commission introduced the requirement to conduct a 12-week public consultation to support all impact assessments and evaluations. For each new policy initiative, the Commission develops a consultation strategy that maps out the different consultation activities that the Commission will undertake. These will generally include a public consultation and a range of activities targeting particular stakeholders and information. According to the responses to the public consultation, the best known and the most valued way to contribute to policymaking is through public consultations. The Commission carried out 417 public consultations between 2015 and 2018, of which 303 to support new policy initiatives and 114 to support evaluations. The number of responses varies markedly depending on the nature of the topic addressed. There was a very large number of responses for topics of high popular interest for specific Member States or stakeholder groups. This was, for instance, the case for the consultation on summertime arrangements which attracted some 4.6 million responses (of which 70% from one Member State alone) and the consultation on the evaluation of the Birds and Habitat Directive which triggered more than half a million responses. The consultation on the future of the common agricultural policy reached more than 300 000 replies in 2017 (compared to 5 700 in 2010). In contrast, zero or very limited responses were registered for some very technical cases like the code of conduct for computerised reservation systems, or zinc oxide in cosmetics. Not taking into account the exceptional cases of the consultations on the summertime arrangements, birds and habitats and the future common agricultural policy, the average number of responses to a public consultation between 2015 and 2018 was around 1 119. A sample analysis suggests that in the case of public consultations supporting evaluations, response levels are relatively lower (on average 455 responses for evaluations vs on average 1 643 responses for new initiatives). For both types of consultations, the majority of contributions tend to come from Germany, the UK, Spain and Italy. Local and regional authorites account for a small proportion of the answers. The academic literature recognises that public consultation is a tool to promote participatory democracy . It promotes legitimacy, helps identify obstacles to effective implementation and avoids technocratic rulemaking. According to consultees, public consultation is the area where the Commission has made considerable progress since 2015. The literature also recognises a clear increase in stakeholder involvement, with sufficient time to take into account contributions received from consultees . However, external stakeholders raised concerns about the high number of consultations launched by the Commission and the demands this puts on respondents and the fatigue it can cause. In addition, industrial stakeholders asked for more transparency when presenting consultation results. They would also like the views of representative organisations listed in the transparency register to be weighted more heavily. 3.3.Contributing to law-making (the ‘Have Your Say’ portal) For easier and better interaction throughout the policy cycle with people and stakeholders, the Commission has progressively put in place a dedicated digital solution on the Europa website. Through this new web portal – known as ‘ Have your say ’ - the public can participate in all the feedback mechanisms and public consultations analysed above. It can also provide comments and suggestions to the REFIT Platform on how to simplify specific legislation and reduce unnecessary regulatory costs. In June 2018, the portal also began offering a timeline view for each ongoing or upcoming initiative. Since the portal’s launch in June 2016, the number of yearly visits to ‘ Have Your Say ’ has steadily increased, reaching almost 900 000 in 2018. A recent survey of 200 users also highlighted its user friendliness. 3.4.Overall assessment and key drivers The analysis suggests there is widespread recognition of the efforts the Commission has made to open up policymaking and a fair degree of satisfaction with the existing set of tools. The key features of the overall system are considered world class by the OECD and there is no significant share of stakeholders calling for a radical overhaul. At the same time, there is a widespread view that the system is not delivering up to its potential in terms of participation and evidence collection. To highlight possible areas for future changes, the following analyses the underlying factors.

Outreach There is limited awareness among stakeholders about the opportunities to participate in policymaking and consultation activities. This is reflected in the response levels to public consultations and feedback opportunities and was repeatedly pointed out by Commission staff who were interviewed. In the spring of 2017, in a major move to reach out to a wider public, the Commission introduced a new requirement to translate its questionnaires into all official languages for its most important initiatives. Questionnaires for other initiatives would, as a minimum, be presented in English, French and German. All public consultations were available in at least two languages in 2018 and 71% were translated into all official languages (except Irish). Consultees to the public consultation received all these developments positively. Responses from NGOs, in particular, indicated that multilingual questionnaires were necessary. Finally, while too early to determine, the growing volume of responses may be linked to this greater accessibility by having consultations available in more languages. However, such developments come with a significant cost in terms of the speed with which a policy initiative can be developed, since a questionnaires may take 2 to 3 weeks to translate. Data now becoming available following completion of phase three of the ‘Have Your Say’ web portal will make it possible to analyse the geographical distribution of responses in greater detail. As for other possible ways of increasing awareness and outreach, Commission staff welcomed a greater involvement of local and national authorities, Member States, expert groups and Council working parties in gathering evidence more effectively about the different situations in the Member States and, where relevant, in the EU partner countries. Respondents suggested that awareness-raising campaigns should support individual consultations. This was echoed by Commission staff and in the academic literature. The literature review also highlighted a potential weakness, in that consultations currently seem to overly target those who already have access to the policymaking process . Duration of public consultations Stakeholders will answer only if they have sufficient time to do so. National authorities and local and regional authorities, in particular, have stressed the importance of having sufficient time to prepare comprehensive responses. It is for this reason that, in 2015, the Commission committed in principle to 12 weeks for consultations and 4 weeks for feedback. The twelve-week duration is appreciated by many respondents to the public consultation, although the literature review noted that this may be too short for replying to consultations on complex issues . There is a need to consider the impact of any longer consultation period on the overall time it takes to prepare a policy proposal. Commission staff proved very sensitive to this issue and argued that public consultations (and the opportunity to provide feedback on roadmaps) may substantially delay the policymaking process within the Commission. Staff argued for a shorter response period of 8 to 10 weeks. While in 2015 and 2016 over 90% of public consultations abided by the twelve-week consultation period, in 2018 this dropped to below 75%. Consultation questionnaires Although a relatively larger share of respondents to the public consultation were satisfied with the clarity and neutrality of the Commission’s questionnaires, almost a third expressed some dissatisfaction. In particular, consultees argued that questionnaires should be shorter and drafted in a non-technical and non-biased manner. In its opinion, the REFIT Platform raised concerns about the format, clarity and content of consultations. The literature review also noted that participants are often prevented from making comments outside of the multi-choice questions . Since 2017, it is always possible to upload supporting material. A number of Commission staff indicated that they did not have the necessary expertise to draft good, understandable and effective questionnaires. They wanted more training and guidance. Feedback to consultees The impact assessment reports, the staff working documents accompanying evaluations or a self-standing synopsis report should present the results of all consultation activities undertaken. These should also be summarised in the explanatory memorandum accompanying a Commission proposal. The aim is to provide feedback on how the input from consultees has been used. Nearly 40% of the respondents to the public consultation were (very) dissatisfied with the way the Commission reports on the result of its public consultations and feedback and what is does with this information. NGOs responding to the public consultation argued that it is often difficult to discern how the consultation process has affected policymaking. This is also supported by the literature review . More generally, consultees to the public consultation argued that there is no clear commitment on how to use consultation results for policymaking. The REFIT Platform also asks in its opinion for more transparency in the feedback provided. A wide range of consultees to the public consultation wanted systematic and timely reports presenting the results of consultation activities. They also wanted contributors to receive better individual feedback. Staff Opinion The quality, use and reporting of various consultation tools are influenced by the resources available and the expertise provided to the staff that works on them. This is reflected in the results of Commission staff interviews. A number of staff who were interviewed thought that public consultation has a more limited role in gathering useful evidence, particularly for technically complex legislation. Targeted consultations were perceived to be much more useful. Some Commission staff expressed a desire for more flexibility particularly with the requirement to conduct public consultations for all evaluations and impact assessments. In their opinion, the necessity for public consultation should be assessed in the context of each new initiative. Similarly, a number of Commission staff found public consultations burdensome, time-consuming and resource-intensive processes. The results were often considered disappointing in terms of response rates, overall coverage of stakeholdersand quality of responses. 4.Better tools for better policies 4.1.Impact assessment

Consultees overwhelmingly support evidence-based policymaking. They also agree that the changes introduced in May 2015 have helped to consolidate the standing and culture of the impact assessment. The better regulation guidelines and toolbox represent a particular achievement because they provide a common framework for the policy cycle. This is reflected in the recent OECD comparative assessment: the Commission further refined and improved its impact assessment policy and maintained the third-placed ranking it had already achieved in 2014. Stakeholders’ concerns generally relate to the application of these guidance documents. The Regulatory Scrutiny Board observes that impact assessments are carried out for a wide variety of policy fields. For example, different types of initiatives require looking at different types of impacts, some more easily quantifiable than others. In their opinion, the Commission guidelines are sufficiently flexible to accommodate for this variety. Against this overall positive assessment, the following analyses key concerns and attempts to assess their magnitude. It also analyses underlying factors with a view to making possible future improvements. Which legislative proposals should be supported by an impact assessment? The Commission is committed to presenting impact assessments for its initiatives that have significant impacts and particularly for those presented in its work programme. The European Parliament and the Council have also committed to examining the Commission’s impact assessment at the outset of the legislative procedure. The Commission has clear guidance on when an impact assessment should be prepared. Impact assessments are only prepared where they are useful for the decision to be taken by the Commission. An impact assessment will not usually be prepared if there is little choice over the content of the initiative or if the impacts are not significant. There may be cases, however, where it is not possible or appropriate to follow each mandatory better regulation requirement (including carrying out an impact assessment where significant impacts can be expected). There may be a political imperative to move ahead quickly, an emergency that requires a rapid response or a need to comply with specific deadlines in legislation which cannot be met on the basis of normal planning. Any resulting exception must be centrally agreed within the Commission and brought to the attention of external stakeholders (via the roadmap, or the inception impact assessment and the explanatory memorandum). Alternative ways should observe as much as possible better regulation principles (like accompanying the proposal in question with astaff working document presenting the available evidence). External organisations such as the Impact Assessment Institute are continuously checking whether this occurs in practice. The stocktaking has recorded a widespread concern by stakeholders about what these rules imply in terms of number of legislative proposals without impact assessments. The European Parliament has noted that approximately 30% of priority initiatives in the Joint Declaration signed by the three institutions do not have an impact assessment. Similarly, an analysis of all proposals linked to the Commission work programme AnnexI and II between 2015 and 2018 shows that 28% were not accompanied by an impact assessment. For 19.5%, no impact assessment was actually needed according to the Commission requirements. For the remaining 8.5%, exceptions were granted. The need to act urgently, thus limiting the time available to gather evidence and prepare an impact assessment report with the associated consultation activities, was the most common reason justifying such exceptions. Proposals to address the migration crisis account for nearly half of all exceptions, but there were others to tackle the security and economic crises. Contrary to the Commission’s commitment, for a limited number of proposals (7% of all cases), no reason was publicly communicated for the lack of an impact assessment (be it due to an exception or not). Stakeholders consult and appreciate the Commission’s impact assessments. They notice and complain about cases where no impact assessment was provided. The European Parliament and the Council have been particularly critical because they base their own analyses on the Commission impact assessments and have reported that the impact assessment makes finding political agreement easier. Civil society, social partners and the business and research communities consider that the absence of an impact assessment undermines transparency and credibility. Some Commission officials consider exceptions undermine the fair application of the better regulation system across departments (and thus are an impediment to buying into the system). Which impacts should be assessed? Respondents to the public consultations were generally positive about the extent to which the Commission takes into account evidence and impacts. More than two thirds of those who expressed an opinion thought the Commission takes into account at least partially the evidence, social and environmental impacts and subsidiarity and the role of different levels of public authorities. There is, however, also a clear expectation that impacts could be better taken into account, although views differ on which impacts. Business organisations and many public authorities support a strong focus on economic considerations, including for small and medium enterprises (SMEs) and the digital dimension. Individuals, civil society and academia urge the Commission to look more at society as a whole and not to overemphasise the need to quantify impacts. Respondents to the public consultation also point to the impact that legislation has on equality, health, poverty and the safeguarding of fundamental rights and the need to uphold environmental and consumer standards. Many consultees urge paying greater attention to the impacts on individuals, Member States or industrial sectors rather than providing aggregated estimates at EU level. Purnhagen & Feindt (2015) point to the lack of a consolidated approach in this regard. Some NGOs and academics propose systematically considering the Sustainable Development Goals in impact assessments or integrating the six mainstreaming objectives set out by the EU treaties. Others highlight the need to better assess impacts on developing countries as a key prerequisite to live up to the EU commitment to policy coherence for development. The Council’s General Secretariat acknowledges the usefulness of impact assessments for the legislative procedure. However, the Secretariat thinks that the impact assessment could provide even greater value if it anticipated the concerns of Member States and provided Member State-specific information about the expected impacts of policy options. Union legislation may have particularly significant effects at local and regional levels and for public authorities (‘territorial impacts’). This is understandably a concern for the Committee of the Regions, the European Economic and Social Committee and national authorities. It was also raised by the ‘Task force on subsidiarity and proportionality’ in its report of 10 July 2018. The Commission has developed methodologies for territorial impact assessments that have been tested on a number of legislative proposals since 2016. The Commission’s approach is to assess these impacts when they are relevant for the decision-making process and it is proportionate to do so (for example, if there are large variations between regions). In its October 2018 Communication, the Commission indicated that it intends to raise the importance of this issue in its guidance to staff. However, it is not always obvious that such effects are likely or that the raw data exist to allow a detailed assessment to be made. The more active involvement of local and regional authorities in consultation processes is an essential element of improving the quality of assessments of territorial impacts. Stakeholders’ demand for greater and more detailed analysis of impacts needs to be duly taken into account, but as Smismans cautions, the list of impacts the Commission is asked to address continues to grow. The quality of analyses presented in impact assessments (and evaluations) is often limited by the availability of relevant information. Commission officials draw attention to the difficulties they have in gathering reliable, comprehensive data and applying methodologies coherently and transparently across a wide variety of policy fields and across all Member States. This is part of a more general problem of knowing how legislation is working. The fact that only a tiny fraction of co-legislators’ amendments to the Commission’s are assessed each year places greater pressure on subsequent evaluations to establish whether the resultant legislation works effectively and efficiently. Mechanisms to ensure that relevant performance data are collected are also not systematically established. The stocktaking exercise shows that, above and beyond stakeholders’ legitimate individual preferences for specific types of impacts, there is a need to consider structural issues such as the great diversity of the Commission’s initiatives, the specific challenges of analysis at a supranational level and the existing constraints in terms of available resources, time and skills. While efficiency gains and marginal improvements to the current system are surely achievable and should be sought, these factors inevitably limit the quality and breadth of the analysis and lead to differing views on its proportionality. The importance of preserving the balance and comprehensiveness of the Commission approach to impact assessment should also be taken into account. One tool, too many objectives? Impact assessments serve several purposes. First and most importantly, they aim to inform the Commission’s political decisions on new political initiatives. However, they also serve other goals. They promote public transparency and accountability by explaining the evidence base and the analysis the Commission took into account when taking its decision. In doing so, impact assessments are also a key document the Commission uses to report on the results of its consultations and their use. They also play an important role in following up and reporting on the assessment of subsidiarity and proportionality and, whenever relevant, various cross-cutting policy commitments. Crucially, they also assist the European Parliament and the Council during the legislative procedure. Finally, by explaining expected causation chains, setting objectives and estimating expected impacts, impact assessments should serve as a key reference point for any subsequent evaluation.

Some Commission officials pointed out that the final impact assessment report has to satisfy competing demands and therefore represents a compromise. Some of the groups consulted wondered to what extent impact assessments inform policy development as opposed to merely justifying a pre-determined/preferred policy option. The Impact Assessment Institute (2017) (among other stakeholders and authors) argues that impact assessments should always be neutral and make a genuine attempt to assess all policy options. Other Commission officials questioned whether the resources required to prepare an impact assessment were proportionate to the benefits and the limited readership. Nonetheless, they find that the process of writing an impact assessment provides a good, systematic preparation for later negotiations and communication about the Commission’s proposals. The 40 or so pages of an impact assessment can prove insufficient in the case of complex legislative proposals with many dimensions. At the same time, the impact assessment report and the technical information in it can be overwhelming for the non-expert public and a complex read for policy-makers themselves. Respondents to the public consultation also frequently pointed out that the Commission’s impact assessments are outdated the moment they are published, because amendments are rarely subject to impact assments during the negotiations between the co-legislators. The perceived partial implementation of the Interinstitutional Agreement in this regard is widely seen as problematic. The quality and objectivity of an impact assessment report is ultimately vouched for by the Regulatory Scrutiny Board (see 4.3.). Impact assessments are made public together with the Board opinion when the Commission proposal is adopted. The feedback mechanism on proposals allows the public to provide its views on its quality and objectivity. Resources and support for Commission staff In the Commission, policy teams responsible for individual initiatives are directly tasked with carrying out any accompanying impact assessment. Given existing safeguards on the objectivity of the analysis, this is considered a desirable feature that maximises the relevance of impact assessments for the policy process. It has, however, a cost as the quality of impact assessments (and evaluations) reflects the diverging levels of expertise and experience of Commission staff who do not typically undertake impact assessments (and evaluations) on a continuous basis. Individual members of staff are unlikely, therefore, to be experts in evaluation and impact assessment methodology. Some departments have support teams that can provide assistance. During the consultation activities supporting the stocktaking, these support units indicated that while there were guidance documents, individual policy officers often pointed out they were under too much time pressure to familiarise themselves sufficiently with these documents and that there was too little learning from the experience built up within the institution. Staff indicated a desire for more face-to-face meetings with experienced colleagues to learn from them, share best practice and nurture a common understanding of better regulation. For example, they suggested: –a very early kick-off meeting of the project team with the better regulation support units to discuss procedures, timelines, scope and methods; –an earlier upstream meeting with the Regulatory Scrutiny Board to seek guidance and avoid problems later down the line; –communities of practice to learn from the recent experience of colleagues in other directorates-general that have carried out similar projects and to share best practice between better regulation support units; –facilitating a more effective use of in-house analytical capacity such as that provided by JRC or Eurostat. Finally, the consultations showed that policy officers are of the opinion that they do not have the time to follow more than the basic training courses. Consequently, more specialised knowledge (for example, about quantification and subsidiarity) is not systematically acquired. 4.2.Evaluation The various consultation activities revealed several important issues about the Commission’s practices on evaluation. The results of these consultations were complemented by reports from the European Court of Auditors and the ‘Task force on subsidiarity and proportionality’. The Court found that the Commission had designed a system which is, as a whole, well-managed and quality-controlled. The OECD has recently reported that the use of evaluations has improved. The EU’s evaluation system scores highly in the OECD’s 2018 regulatory policy outlook (4th out of 39 jurisdictions) and has increased its rating since the previous rating in 2015. The opinion of respondents to the public consultation is mixed, being more or less equally spread between satisfied, neutral or dissatisfied. The Commission, the other EU institutions and consultative bodies use evaluations to learn to what exent EU policies and speding programmes are working and to gain new insights. Results are used to decide whether legislation and programmes should be revised, but evaluations are really useful when they are well timed, designed to address the key questions and of sufficient quality to provide credible and pertinent answers. Stakeholders have raised issues for all of these factors as described below. Time the evaluation appropriately The systematic evaluation of legislation and programmes as part of an integrated policy cycle was one of the principal changes introduced in May 2015. Common sense requires that we should know how legislation works before making proposals to revise it. Commission officials had mixed views about the ‘evaluate first’ principle. Some argued that it is intuitive and logical, as it closes the policy cycle. Others suggested deciding on the need for evaluations on a case-by-case basis. European institutions, and in particular the Council and the European Economic and Social Committee, firmly supported the principle. Progress is also being made in applying the ‘evaluate first’ principle. 78% of impact assessments for amendments of legislation in 2018 were also accompanied by an evaluation. This is up from 50% in 2016. Evaluating before taking further action is one thing. Evaluating when there are solid conclusions to draw is another matter. Many respondents thought that legislation was given insufficient time to work before initiating evaluations. Evidence from the literature suggests that evaluations carried out too early may not lead to conclusive results and need to be complemented at a later stage. They suggest that evaluations required by legislation should be carried out at a moment in the policy cycle when impacts have materialised and data are available to pursue a meaningful evaluation. Improvements can be made if there is a shared understanding between the European Parliament, the Council and the Commission on when to require an evaluation (as opposed to other implementation issues such as transposition reports). The European Court of Auditors also raised these issues in its 2018 audit on ex post reviews. A specific challenge in this regard concerns spending programmes for which many respondents thought that the evaluation could provide more insight and useful learning for subsequent programmes. A key concern is that end-of-programme evaluations come when the programmes of the next cycle of the multiannual financial framework have already been decided. Similar views have been expressed in the academic literature . Many respondents suggested reconsidering the timing of programme evaluations, but this is challenging given that, due to the need to have a seamless transition between budgetary periods, underlying projects funded by a given multiannual financial framework will not have been completed by the time the next framework has to be prepared. Mid-term evaluations of an ongoing programme that are used for preparing a new generation of programmes would be more useful when building also on the results of the preceding programme. Then evaluate well

Several interest groups, the Regulatory Scrutiny Board and the General Secretariat of the Council observed that the Commission’s evaluations were of lower quality than its impact assessments. In the literature, it is acknowledged that a widespread practice of policy-related evaluations started somewhat later than impact assessments and need more time to mature further, particularly in terms of design and methodologies. The Board frequently raised issues with design and methodology. Commission departments grapple with several well-known practical evaluation challenges, including when to evaluate and how to best ensure ownership and independence. Timing obviously plays a role in the final quality of an evaluation, but data availability and data quality, more generally, are a strong concern for several interest groups. On quantification, a number of Commission officials thought that the lack of appropriate data is the most important problem affecting the quality of evaluations. Comparable EU-wide data are often not available, which makes it difficult to quantify impacts. Some of the literature reviewed made a similar point . The European Parliament Research Service suggested applying clear quality criteria, in particular for non-governmental data, together with a clear prioritisation for data collection. The Committee of the Regions sees a role for the newly created Network of Regional Hubs for EU Policy Implementation Review (RegHub) in gathering data on regional impacts to inform better the Commission’s evaluations and impact assessments. Some Commission officials think that the evaluation process is too long and that systematic data collection via well-defined monitoring (instead of ad hoc collection) would substantially shorten the evaluation process and improve the quality of the analysis. They noted that there is a trade-off between the pressure to reduce the administrative burden of systematic monitoring in the original proposal and the availability of evidence when it comes to the evaluation. Solutions may emerge when paragraphs 22 and 23 of the Interinstitutional Agreement on Better Law-Making will be implemented in a more consistent manner. This calls on the three institutions to consider including monitoring and evaluation provisions in each basic act of Union law. A good impact assessment forms the basis for a good evaluation because the impact assessment sets out problems, objectives and indicators to monitor and appraise the success of the policy. Subesequently, to avoid excessive administrative burden, legislative proposals need to establish adequate monitoring requirements and data collection verifying that the data is not already being colleted under some different legislative framework. The way in which evaluations are carried out and presented is another factor affecting their quality, but views on this appear to vary. Whether the Commission should conduct evaluations internally or involve external contractors or other institutions met with mixed views. Commission officials shared the view that conducting the evaluation internally allows in-house expertise to be built up and used more frequently. Some officials were also sceptical about the quality of the contractors’ work and the quality of service they provide. Similar views were expressed in the literature. In particular, various authors questioned the Commission’s capacity to conduct its own internal consultations, while others thought that external evaluations were more objective, which was important for spending programmes but less so when evaluating legislation. Some authors questioned the ability of external contractors to perform policy evaluations. A number of Commission officials thought that it was necessary to use external studies due to the limited capacity to cope with an increased workload and sometimes the need for specific (methodological) expertise. Some of the respondents to the public consultation argued that evaluations should be outsourced or conducted by the European Parliament and the Member States. Some Commission officials and respondents to the public consultation called for a flexible application of the rules and procedures to make evaluations more meaningful, given the wide variety of policy areas covered by evaluations. Others urged for additional codification, standardisation, formal oversight and requirements to ensure that the scientific evidence and analyses are of the highest quality. Additionally, respondents to the public consultation and the European Economic and Social Committee wanted evaluations to address more comprehensively the transposition of directives into national law and the manner in which they are implemented. Finally, evaluation lessons must be clearly communicated and brought to bear on policymaking. The requirement for an evaluation staff working document introduced in 2015 aims to present the results of the evaluation process in a self-standing and uniform format. Commission officials generally saw it as helpful in logically structuring the assessment, but they considered it unsuitable for communicating with the public, and some thought it redundant when there is a good evaluation report that has been prepared by external contractors. Analysis of empirical evidence shows that the links between impact assessments and evaluations were limited in the past. The European Court of Auditors reported that in legislation adopted by Council and European Parliament between 2014 and 2016 ex post reviews were not always used when preparing impact assessments. Several respondents to the public consultation also said that the evaluation results needed to be utilised better when performing impact assessments. 4.3.Regulatory Scrutiny Board Providing the best possible basis for timely and sound policymaking requires the capacity to provide high quality, objective analyses of what works, what does not and why. Under Commission policy, a Regulatory Scrutiny Board (the Board) scrutinises the quality of such analyses and supports their improvement. This is in line with OECD best practices according to which regulatory oversight by a standing body close to the centre of government should play a key role in this context. The Board was set up by the President of the Commission as part of the overall May 2015 better regulation package. It has seven full-time members who do not have any policymaking responsibility. Each member serves for a period of 3 years. Three members are also recruited from outside the EU’s institutions. Together, these changes represent substantially stronger guarantees of the Board’s independence in exercising its scrutiny function compared to its predecessor, the Impact Assessment Board established in 2007. What does the Board do? The Board performs a quality check on impact assessments and evaluations to improve them and ultimately to improve the Commission’s proposals and the legislation adopted by the co-legislators. Box 2. The Board’s work in its own words ‘The Board evaluates the quality of an impact assessment report based on the Commission’s Better Regulation Guidelines and verifies whether the minimum standards are met. However, in doing so, the Board also takes into account the context of each initiative and the proportionality of the analysis, meaning that the depth of the analysis should match the importance of the initiative. It considers how an individual initiative fits within the wider sectoral regulatory environment, to what extent it responds to political orientations that have already been agreed by the relevant EU institutions, and whether there is a legal obligation to act. Timing constraints of the initiative are sometimes a factor when judging the availability of evidence, of prior evaluations and of comprehensive stakeholder consultations.’ The Board’s mandate is wider than that of its predecessor. The new Board looks at selected evaluations (and fitness checks) in addition to all impact assessments. It checks their quality before they are shared with the Commission’s departments in the interservice consultation and issues recommendations for their improvement. In 2017, the Board introduced positive and negative opinions for evaluations. Additionally, in late 2016 the Board began distinguishing between ‘positive opinions’ and ‘positive opinions with reservations’ for impact assessments. It also overhauled its system of indicators to monitor the quality of the reports submitted. The new system consists of 10 quality components for impact assessments and 6 quality components for evaluations. These allow the Board to track changes in the quality of an impact assessment or evaluation. What has the Board done? After replacing the Impact Assessment Board in May 2015, the Regulatory Scrutiny Board became fully staffed and operational within the following year. Each year the Board publishes reports on its own work that also provide insight into the wider application of better regulation. The following table and graphs present key statistics on the Board’s scrutiny activities since its creation. Table 4 Opinions issued by the Regulatory Scrutiny Board, 2015-2018 RSB opinion 2015 2016 2017 2018 Impact assessments First submission Positive 15 22 12 22 Positive with reservations 0 13 18 33 Negative 14 25 23 21 Second submission Positive 10 16 7 9 Positive with reservations 0 0 16 9 Negative 1*** 1 2 1** Evaluations First submission Positive - 7* 10 8 Negative - 7 3 Second submission Positive - - 4 1 Negative - 0 0

* In 2016, evaluations received opinions with comments, without ‘positive’ or ‘negative’. ** a third submission received a positive opinion with reservation *** no proposal was presented following the negative opinion In 2015, the Board's recommendations for impact assessments focused primarily on defining the problems to be tackled, considering and presenting stakeholders’ views and describing and assessing options. In 2016, the Board’s annual report flagged problem analysis and development of options as ‘common weaknesses’. In 2017, negative opinions were most often issued when the rationale for policy action was not convincing or the analysis of the baseline and options showed shortcomings. In 2018, the Board highlighted problem definition, use of evaluation, the design of options and their comparison as being initially the weakest part of impact assessments. Comparable statistics for evaluations were available for the first time in 2017. Coherence, presentation, relevance and EU value added were the most common issues raised when the Board issued negative opinions. The Board observed that often the evaluation questions were not appropriate or could not be answered. Additionally, they pointed out that often either data were not available or were not compared against a baseline or definition of success. What has the Board achieved? The Board acted as the Commission’s quality control body for the analysis supporting its political decisions. In principle, when the Board issues a negative opinion on an impact assessment, the policy process is put on hold until the quality of the underlying evidence reaches a sufficient level. This has been the norm. In three cases, however, the Commission took the political decision to go forward with an initiative despite the absence of a positive Board opinion vouching for the adequateness of the underlying impact assessment. In all of these cases, the Commission carried through on its commitment of May 2015 to explain publicly why. Initiatives were also typically adapted to address the weakenesses in the underlying evidence base. Box 3. An example of a proposal presented after a negative opinion by the Board •In the negative opinion on the impact assessment on the proposal for a framework for the free flow of non-personal data in the European Union, the Regulatory Scrutiny Board found that the report did not make the case for EU action and did not assess appropriately the proportionality of the options. The revised report received a second negative opinion from the Regulatory Scrutiny Board. The Board found that the report particularly failed to make the case for a new right for the portability of cloud services. The initiative was adopted by the College without the provisions establishing mandatory portability of cloud services, but with self-regulatory measures instead. The Board also managed to improve the quality of the draft impact assessments and evaluations submitted to it. Evidence of its success in doing so comes from several sources. First, the rate of negative opinions has been dropping for both impact assessments and evaluations. Secondly, the monitoring system established by the Board shows that the quality of the draft impact assessments and evaluations submitted is improving gradually. The quality components applied by the Board also show an improvement in quality following the Board’s scrutiny. The weakest impact assessments are improving the most. However, the Commission’s departments are less diligent in improving draft impact assessments that receive a positive opinion with reservations. Early meetings between the Board and the team drafting the impact assessment or evaluation significantly increased the quality of the submitted reports. Finally, consultation activities undertaken by the Board and by the Commission’s departments reveal that the Board is widely seen as adding value to the policymaking process and improving impact assessments and evaluations. Nearly 90% of the respondents to the public consultation who were familiar with the Board think it adds value to the regulatory process. Commission officials view the regulatory scrutiny process (with a hearing at the Board) as providing excellent preparation for the negotiations with the European Parliament and the Council and as an opportunity to rehearse how to explain their proposal to non-experts. Evidence and the general views of stakeholders thus suggest the Board has been performing its tasks in a successful manner. However, some areas of concern remain. First, despite stronger assurances of independence and a high rate of negative opinions, views on the Board’s impartiality and independence remain mixed. Proposals to increase independence were most commonly voiced by stakeholders in the public consultation but also by the Council. The lattter wants the President of the Commission to establish a secretariat for the Board that is independent from the Commission and to recruit all members externally. However, Meuwese cautioned that true independence was most likely unattainable and perhaps undesirable, given the need to retain the relevance of the impact assessment to the policymaking process. Secondly, some Commission officials expressed concerns that the Board’s demands for additional analysis and information are not proportionate to the specific initiative. Additionally, some Commission staff expressed concern that the Board does not apply its standards consistently to all impact assessments (such as its demands for quantified information). Few professionals responding to the public consultation and academics find that external experts, such as economists and social scientists, could usefully support the Board on a case-by-case basis. Thirdly, the public is largely unaware of the Board’s activities. Among individuals responding to the public consultation , 320 (74%) out of 433 said that they were not familiar with the Board or barely so, compared to 64 (39%) out of 163 professionals. Finally, there are contrasting views on whether the Board should expand its activities. The academic literature and various stakeholders have suggested widening the role and responsibilities of the Board so that it becomes a body ensuring compliance with many more aspects of better regulation; for example, checking the quality of roadmaps, scrutinising more evaluations, checking delegated acts and the final content of legal proposals (in relation to the impact assessment) and sanctioning exceptions from better regulation requirements. Moreover, some academics expect that the Board will develop to ultimately serve the European Parliament, the Council and the Commission. Others see the Board moving to an oversight role in a manner similar to the Court of Justice, European Court of Auditors or the Ombudsman. The Commission’s proposal for each institution to be able to call for an independent panel to assess the impacts of amendments to the legislative proposal was discarded during the negotiation of the 2016 Interinstitutional Agreement on Better Law-Making 4.4.Subsidiarity and proportionality The Union must respect the powers given to it by the Member States. Protocols No.1 and No.2 of the Treaties create the mechanism to ensure this happens and they give national parliaments a key role in checking conformity with the subsidiarity principle. The Commission presents an assessment of subsidiarity and proportionality of its proposals both in the impact assessment report and in the explanatory memorandum accompanying the Commission’s legal proposal. The Commission does not translate the impact assessment into all official languages but does translate the explanatory memorandum. The Commission has established guidance on how to perform these assessments. However, most assessments of subsidiarity presented in impact assessments tend to be rather general and qualitative in nature. They appear at the beginning of the impact assessment report and do not use relevant analyses which come later in the report as part of the assessment of policy options. The assessment of subsidiarity is also separate from the assessment of the proportionality of the various policy options. This is confirmed by responses to the consultation that stated that current assessments are overly legalistic and formalistic and that assessments should be based on evidence. Professionals noted that harmonisation and cross-border activity were too often used to justify EU action. In this context, it was stated that 20 or more different national approaches do not necessarily imply a need for harmonisation, but could also be evidence that the Member States have successfully tackled the problem. Therefore, the ‘Task force on subsidiarity, proportionality and doing less more efficiently’ set up by President Juncker on 14 November 2017 included recommendations meant to improve the assessment of subsidiarity and proportionality in its final report. Box 4: Task force’s key recommendations on impact assessments Recommendation 1 A common method (“assessment grid”) should be used by the Union’s institutions and bodies and by national and regional parliaments to assess issues linked to the principles of subsidiarity (including EU added value), proportionality and the legal basis of new and existing legislation. This assessment method should capture the criteria contained in the Protocol on subsidiarity and proportionality originally attached to the Amsterdam Treaty and relevant jurisprudence of the European Court of Justice. [A proposed model assessment grid is annexed to this report] During the legislative process, the European Parliament and the Council should systematically review the subsidiarity and proportionality of draft legislation and the amendments they make using the common method. They should take full account of the Commission's assessment presented in its proposals as well as the (reasoned) opinions of national Parliaments and the European Committee of the Regions. Recommendation 5 The Commission should ensure that its impact assessments and evaluations systematically consider territorial impacts and assess them where they are significant for local and regional authorities. Local and regional authorities should help to identify such potential impacts in their consultation responses and feedback on roadmaps. The Commission should revise its better regulation guidelines and toolbox accordingly and address issues linked to the implementation and EU added value of legislation, and to ensure greater visibility of the Commission's assessments of subsidiarity, proportionality and relevant territorial impacts in its proposals and accompanying explanatory memoranda.

On 23 October 2018, the Commission already set out in broad terms how it would respond to the task force. In particular, it committed to incorporate the ‘grid’ for assessing subsidiarity and proportionality in its better regulation guidance and to use the grid to present its findings in impact assessments, evaluations and explanatory memoranda. To avoid a piecemeal approach, this should be done concomitantly with any revision / update of better regulation guidelines and tools the next Commission may opt for. It will then need to be decided whether the assessment grid should be annexed to the impact assessment report or attached to the explanatory memorandum accompanying the Commission’s proposal (whether or not there is an impact assessment). Since the memorandum is translated in all languages, it would offer a wider coverage and reach but would imply additional translation costs. 5.Keeping the existing stock of legislation fit for purpose Legislation should remain fit for purpose and deliver the results that EU lawmakers intended and people expected. The Commission focuses on tackling unnecessary costs and eliminating administrative burdens without compromising policy objectives. Making legislation simpler and less burdensome also improves implementation and enforcement, and ultimately delivers better results. To pursue these objectives, the Juncker Commission progressively mainstreamed the REFIT programme, supported it with the establishment of the REFIT Platform, and communicated more extensively on its results. 5.1.The REFIT programme REFIT is the programme for the Commission’s actions to ensure existing legislation is simple,efficient and fit for purpose. Strengthened in the May 2015 better regulation package, the REFIT programme was mainstreamed in 2017. The Commission now seeks to achieve REFIT goals whenever any existing law is due to be reviewed. The exact operational implications of this were explained in an appropriately revised version of the better regulation tool. In addition, all evaluations now seek to identify elements for simplification and burden reduction. While the Commission has repeatedly stressed that REFIT is not deregulatory and does not undermine existing policy objectives by removing unnecessary costs, responses from some NGOs and individuals to the stocktaking exercise continue to criticise the Commission’s approach for putting at risk social, environmental, consumer and employment objectives. National authorities in the stocktaking consultation supported the Commission’s efforts to review and simplify legislation. The European Parliament suggested that the Commission’s work programme should identify REFIT evaluations/initiatives that could be agreed in the political declaration on priority initiatives pursuant to the Interinstitutional Agreement on Better Law-Making. The Committee of the Regions considers that REFIT provides an essential focus to assess whether implementation is practical and feasible. The Committee also suggested involving the REFIT Platform more closely in evaluations. Commission officials recognised that the REFIT programme is important for communication purposes to emphasise the European Union’s focus on tackling unnecessary costs and to stress the value the Union places on engaging with its people. The challenges of quantifying regulatory burdens is an aspect of REFIT that several officials underlined.. 5.2.REFIT Platform The Commission established the REFIT Platform in May 2015. The key purpose of this expert group chaired by the Commission’s First Vice President is to provide the REFIT process with bottom-up input by collecting and considering stakeholders’ views on possible improvements to legislation. The Platform issues recommendations to the Commission, which committed itself to explain systematically how it intended to follow up on these. The Platform comprises two groups. The first is made up of experts from different parts of civil society, while the second group has an expert from each Member State government. It met for the first time in January 2016, following the formal process to appoint its members. By 31 December 2018 the Platform had received 684 submissions from various parts of civil society. The Platform responded to all of these submissions and adopted 89 opinions covering 129 of the submissions. Table 5 REFIT Platform-related activities. Numbers 2015 2016 2017 2018 Feedback on the ‘Lighten the Load’ website and ‘Have Your Say’ portal 294* 212 64 112 Platform opinions - 24 45 20 *Includes 34 submissions sent to the Commission in 2014 before the Platform existed. Business associations and EU citizens accounted for almost three quarters of all 684 submissions. Public authorities (including local and regional authorities) accounted for approximately 5% of submissions. The 268 submissions from individuals resulted in only five opinions of the Platform. This is because they were largely covering other aspects or issues than those in the remit of the REFIT platform. Individual submissions covered many policy areas but the area most covered was agriculture (30) followed by financial services (13), education (13) and the internal market (12). Box 5. Organisations making submissions to the REFIT Platform Box 6. Policy areas covered by the submissions to the REFIT Platform The consultation activities revealed mixed opinions from external stakeholders and Commission staff. Stakeholders want a wider mandate and better reporting on the follow-up to opinions. A number of Commission officials find the Platform provides little added value to what they already know but requires relatively disproportionate resources. However, some Commission officials recognised that better ways to gather evidence from regional and local levels (perhaps via the Committee of the Regions) and from closer links with stakeholders through dedicated conferences would be beneficial. Industrial organisations pointed to the need to raise awareness about the Platform to increase submissions on potentially problematic legislation. The Commission is also urged to publish information on measures that are implemented following each Platform opinion. There should also be better guidelines on how to create a good submission to the Platform and more focus on reducing costs and burdens for SMEs.

The stakeholder group of the Platform has generally taken a more proactive role in setting priorities and leading the work on individual opinions . Experts from the national administrations have preferred not to specify priorities in the absence of clear instructions from their governments . The Platform’s government group has also set clear limits on the number of opinions it is willing to address at any one time (between 5 and 15) and to ensure a clear demarcation between the work of the Council and that of the Platform. Government responses to the consultation activities clearly support extending the mandate of the Platform into the next Commission and raising the awareness of its work. This is perhaps illustrated by the fact that 40% of the individuals who responded to the consultation did not know whether the REFIT Platform was effective in identifying legislation that can be simplified. They indicated that information is not readily available and is not advertised. The process followed is also difficult to understand. The European Economic and Social Committee indicated that it would like a stronger representation in the Platform to reflect the interests of its constituents. It would also like the Platform to address cross-cutting topics to improve the quality of legislation in addition to tackling unnecessary costs, and this may include identifying the need for new legislation. The literature review also highlighted the Platform’s narrow focus on reducing unnecessary regulatory costs . A dedicated stocktaking exercise undertaken by the REFIT Platform has resulted in an opinion on Future prospects. It indicates that the Platform itself is satisfied with its contribution to the REFIT agenda and proposes to continue in its current form, with a Stakeholder group and a Government group. The Stakeholder group and the Government group suggest improvements, which are detailed in the opinion.The Committee of the Regions annexed its views to the opinion. It considers that to better achieve its goals, the REFIT Platform should be adapted in terms of approach and structure to review existing legislation also from the perspective of subsidiarity, proportionality, legislative density and the role of local and regional authorities. Stakeholders want the Platform to be more productive, to gather more ideas for simplification and for concrete changes to flow more quickly from those ideas. The Task force on subsidiarity and proportionality recommended that the Commission’s REFIT Platform be adapted to review legislation from the perspective of subsidiarity, proportionality, legislative density and the role of local and regional authorities. The Task force noted that the composition of the Platform might also need to change to include a greater presence from local and regional authorities. Stronger links to the work and networks of the Committee of the Regions could also be considered. The Commission echoed these views in its Communication on the principles of subsidiarity and proportionality published on 23 October 2018. 5.3.Communicating REFIT activities The Commission’s work programmes flag its key REFIT initiatives. The Commission has also begun to report annually on its efforts to simplify legislation, and every year publishes online a REFIT Scoreboard that monitors simplification initiatives throughout their life cycle. The Scoreboard provides a comprehensive overview of the REFIT results achieved under each of the Juncker Commission’s political priorities. The Commission’s follow-up to the REFIT Platform opinion is explained in the Commission’s annual work programme and in the follow –up report. To improve transparency, since July 2017 impact assessments have also included an annex detailing quantified estimates of costs and benefits. Consultations have, however, raised various issues about the usefulness, and awareness of the REFIT Scoreboard in its current version. National authorities thought that the Scoreboard could not yet be considered truly user-friendly. They also asked for clear quantitative measurement of reductions in unnecessary costs and suggested that the REFIT Scoreboard could help monitor, visualise and communicate progress better than today. Following the European Court of Auditors recommendation for clarification of the REFIT concept the Commission has clarified in its annual burden survey the scope of REFIT and improved its internal and external communication to stakeholders. Many Commission staff were of the opinion that the REFIT Scoreboard was burdensome because it requires constant updating. Officials who were interviewed suggested using more qualitative examples or case studies to illustrate impacts of legislation. 5.4.Considering alternative approaches to simplification and burden reduction The (Competitiveness) Council has asked the Commission on several occasions to introduce a system of targets to tackle the perceived excessive burden of regulatory costs associated with European Union legislation. Paragraph 48 of the Interinstitutional Agreement on Better Law-Making also calls on the Commission to look at the feasibility of establishing objectives for burden reduction. Box 7. Council’s request for targets to reduce regulatory costs ·Council conclusions of December 2014 (Doc 16000/14): ‘…call on the Commission to develop and put in place - on the basis of input from Member States and stakeholders - reduction targets in particularly burdensome areas, especially for SMEs, within the REFIT Programme, which would not require baseline measurement and should consider at the same time the costs and benefits of regulation.’ ·Council conclusions of 26 May 2016 on better regulation to strengthen competitiveness which ‘urge the Commission to rapidly proceed on [..] the introduction of reduction targets in 2017, whilst always taking into account a high level of protection of consumers, health, the environment and employees and the importance of a fully functioning Single Market.’ ·Council conclusions of 12 November 2018 ((Doc. 14137/18) on the European Court of Auditors’ Special Report No 16/2018 "Ex-post review of EU legislation: a well-established system, but incomplete". ‘…RECALLS the Council Conclusions of March 2018, which underline the importance of concrete targets for the reduction of unnecessary regulatory burdens, whilst respecting existing protection standards and without undermining the underlying objectives of the legislation.’ The Commission has thus considered alternative approaches and explained its own approach in its Communication of October 2017. The Commission looks to simplify legislation on a case-by-case basis, using evidence gathered from evaluations and impact assessments and including consultation of stakeholders. To avoid adversely affecting underlying policy objectives and to ensure democratic accountability and transparency, it is essential that a political decision on which costs are legitimate to achieve policy goals and which instead should be eliminated is based on evidence from a case-to-case assessment that responds to the concerns of stakeholders and people. Up-front targets would not offer such fundamental guarantees and would present formidable methodological challenges at the European level. When revising legislation, the Commission thus investigates whether it can be simplified and any unnecessary costs removed. To provide a transparent measure of the impact of the proposed measures and a more easily verifiable objective, the Commission tries to quantify the reduction in regulatory costs implied by any such measure. However, ths is not always possible due to data and methodological challenges. In addition, to preserve the meaningfulness of any quantitative objective to reduce burdens in proposed legislation, quantitative estimates need to be modified whenever needed due to co-legislators amendments and Member States transposition and implementation choices. 5.5.Results of simplification efforts The current Commission has presented more than 150 new initiatives focused on simplifying legislation. As there is a diverse range of costs varying between the different initatives, these quantification estimates cannot be added together to provide a single figure. In addition, the extent to which the Commission’s simplification proposals actually deliver tangible benefits for regulated entities depends on the subsequent decisions of the European Parliament and the Council when legislating and Member States when transposing and implementing. The Commission has reported annually on the results it has achieved. The following box extracts from these reports some illustrative examples. Box 8. Examples of regulatory simplification entered into force in 2018. Value added tax (VAT) for cross-border business to consumer e-commerce ). In 2017 the Commission introduced a one-stop shop by which traders that sell goods online to their customers can deal with their VAT obligations through one easy-to-use online portal. The online traders will no longer have to register for VAT in each of the Member States in which they sell goods. The Commission estimated that the one-stop shop will generate an overall saving of €2.3 billion for businesses and €7 billion increase in VAT revenues for Member States. A single digital gateway to provide information, procedures, assistance and problem-solving services. In 2017 the Commission proposed a single digital gateway to ensure centralised access to EU citizens and businesses to information they need to exercise their EU rights. The gateway will integrate several networks and services from national and EU level. It will provide a user-friendly interface in all official EU languages. The single digital gateway could reduce by 60 % the 1.5 million hours that people currently spend researching online before going abroad and businesses could save between EUR 11 and EUR 55 billion annually. Consumer protection cooperation: In 2016 the Commission proposed to modernise cooperation mechanisms to reduce the harm caused to consumers by cross-border infringements. The regulation will ensure a swifter protection of consumers, saving time and resources for Member States and businesses. Thanks to additional cooperation powers, the authorities can act faster and save costs to jointly stop widespread online infringements. Businesses operating in all or a large majority of Member States will have the possibility to negotiate commitments at EU-level, which will make it simpler, faster and cheaper to resolve consumer issues. European Structural and Investment Funds. The Commission proposed in 2016 a regulation with concrete simplification provisions to make the use of the Funds simpler for beneficiaries and authorities and financial rules more flexible. Overall, this means reducing the implementation costs of EU rules as well the number of errors contributing to optimise the impact of the Multi-annual Financial Framework 2014-2020.

Nearly a third of all respondents to the public consultation indicated their satisfaction with the Commission’s efforts to simplify existing EU laws and reduce costs where possible. However, some 40% were not satisfied. Combined with the evidence presented above, this suggests that while the Commission’s efforts to simplify and reduce unnecessary burdens have delivered results, these are neither well communicated nor generally regarded as sufficient. The changes introduced under this Commission have gone in the right direction but there is scope to do better. It is worth considering how to speed up the adoption of simplification measures and increase their visibility. Improving quantification of costs and benefits in evaluations would also help. In principle, each evaluation should assess the extent to which policy objectives have been met and assess the economic efficiency of the policy . However, according to the literature, many evaluations do not generate sufficiently convincing evidence that policies are being delivered in the most effective and efficient manner. Assessing this in quantified terms is not always methodologically possible. Finally, and perhaps more importantly, while regulatory costs are often justified for each individual piece of legislation, their combined impact can have undesired effects that deserve to be better addressed. The report of the ‘Task force on subsidiarity and proportionality’ pointed to the combined effects of legislation (including delegated acts and implementing acts) which may not be impact assessed or evaluated well enough. The task force recommends that the Commission’s REFIT programme be adapted to review legislation from the perspective of subsidiarity, proportionality, legislative density and the role of local and regional authorities. Consideration on how to do this could also encompass an enhanced role for the REFIT Platform. 6.Better regulation as a shared Effort In May 2015, the Commission presented a comprehensive better regulation package, including a proposal for a new interinstitutional agreement on better regulation. The previous agreement on better law-making dated back to 2003, and was considered in need of revision, given the developments in the better regulation agenda. A new interinstitutional agreement also reflects recognition of the need for a renewed commitment on the part of all three institutions involved in the legislative process (the European Parliament, Council and Commission) in order for better law-making efforts to succeed. Following negotiations, the three institutions came to an agreement on the substance of the interinstitutional agreement on 8 December 2015. The new Interinstitutional Agreement on Better Law-Making was signed on 13 April 2016 and entered into force the same day. The Interinstitutional Agreement stipulates that a political meeting is to be held annually to take stock of progress in implementing the Agreement. The first meeting took place in Strasbourg in December 2017 in the margins of the European Parliament’s plenary session. Since then the three institutions have held regular discussions at technical level in the Interinstitutional Coordination Group chaired by the European Parliament. The Secretariat of the European Parliament prepared an overview on the implementation of the Agreement for the Parliament’s Conference of Presidents in June 2017. The European Parliament adopted an own-initiative report on the interpretation and implementation of the Agreement. The Council has presented regular reports on the work it has undertaken to implement the Agreement. The Agreement contains a number of commitments and follow-up activities. Progress on each of these varies. 6.1.Joint Declaration on the EUs legislative priorities In line with the Interinstitutional Agreement, in 2016 and 2017, the European Parliament, the Council and the European Commission agreed on two Joint Declarations on the EU’s legislative priorities. They highlighted 89 initiatives for which priority treatment in the legislative process was needed. This represents a common commitment by the three institutions to ensure substantial progress and, where possible, delivery before the European elections in May 2019. The European Commission has adopted all the proposals announced in the Joint Declarations. Of these 69 have been agreed or formally adopted. 20 initiatives remain pending. 6.2.Delegated acts “Omnibus” alignment proposal Many Union legislative acts still allow the Commission to use the regulatory procedure with scrutiny to introduce measures to implement Union law. Under paragraph 27 of the Interinstitutional Agreement on Better Law-Making, the Commission presented a proposal on 14 December 2016 to align these provisions with the requirements of the Lisbon Treaty on delegated acts and implementing acts. Discussions advanced slowly because of the technical nature of the proposal and diverging views of the European Parliament and the Council. The co-legislators managed to find agreement on the alignment of the empowerments in over 60 legislative acts, and the remaining acts will be revisited in the new parliamentary term. Delineation criteria (to distinguish delegated acts from implementing acts) In September 2017, the three institutions entered into negotiations under paragraph 28 of the Interinstitutional Agreement to establish non-binding criteria to improve the application of Articles 290 and 291 TFEU and to distinguish between the use of delegated acts and implementing acts. The European Parliament, Council and Commission reached agreement on the new criteria, and these are currently being endorsed in each institution. In practice, the choice of empowerment in legislative negotiations remains difficult because of political disagreements between the European Parliament and the Council. These difficulties may be eased with the growing awareness of the delineation criteria and other aspects of the Agreement. Interinstitutional register for delegated acts Under paragraph 29 of the Agreement, the three institutions established a joint register on delegated acts on 12 December 2017. It is a real success and has proved to be a useful tool to share information on delegated acts between the three institutions and the public. 6.3.Impact assessment The Commission has committed to carry out impact assessments to support its legislative and non-legislative initiatives that have significant economic, environmental or social impacts. This includes initiatives in the Commission work programme or in the joint declaration on annual interinstitutional programming. Not all legislative proposals require an impact assessment, because political discretion is limited or because the impacts are not significant (e.g. proposals to codify legislation). When the Commission does not present an impact assessment, it explains why in the explanatory memorandum accompanying the proposal. See Section 2.1 for further details. The European Parliament and the Council are committed to taking full account of the Commission's impact assessments. The co-legislators have also committed to assess the impacts of their substantial amendments where this is appropriate in a given legislative procedure. Each year the Council prepares a report on impact assessments and how the Council uses them in its work . It has also established guidance for working party chairs on how to handle examination of the Commission’s impact assessments. The General Secretariat of the Council indicates that the use of impact assessments is increasingly widespread in the Council and that in many areas they facilitate discussions and make it easier to reach political agreement. The impact assessment and the explanatory memorandum also provide basic information to assess conformity with the principles of subsidiarity and proportionality if challenges are made before the Court. The Council has made less progress in conducting its own assessments of the impacts linked to its substantial amendments. In January 2018, it established a pilot programme to outsource such assessments to external consultants but no assessment has yet been made. Moreover, the Council prefers to ask the Commission first before considering undertaking its own assessment. There is also a natural tendency of the rotating presidency to avoid any risk of delay on a legislative file during its six-month tenure. In contrast, the European Parliament has invested more heavily in creating its own expertise and capacity to assess substantial amendments. Since 2003, when the co-legislators first committed to make such assessments, the Parliament has made some 68 assessments. At the start of each legislative procedure, the European Parliament also routinely appraises the Commission’s impact assessment against the requirements of the Commission’s better regulation guidelines and the opinions of the Regulatory Scrutiny Board. The Parliament is also performing more retrospective evaluations of legislation that help inform its position on new Commission proposals.

6.4. ‘Gold-plating’ of national transposing legislation The Agreement calls on Member States to identify aspects of national law that are ‘gold-plated’ and to inform the public. To facilitate transparency, the Commission has adapted its IT platforms to enable Member States to provide information about “gold-plating”. Up until the end of 2018, there have been only three notifications from two Member States (add footnote with reference). At the political stocktaking meeting in December 2017, the three institutions agreed to remind the Member States about the gold-plating provisions. 6.5.Other issues There has been little or no tripartite discussion between the three institutions about the implementation of paragraphs 22 and 23 of the Agreement, which concern review clauses and the inclusion of monitoring and evaluation provisions in basic acts of Union law. The Commission has presented two annual burden surveys pursuant to paragraph 48 of the Agreement, and these are discussed in the chapter 5 above on the Union’s efforts to simplify legislation.. 7.Conclusions The costs of better regulation The benefits of better regulation are clear. We wish to deliver high quality effective legislation through informed decision-making. However, there are also significant financial and human resource costs associated with operating an effective better regulation policy. There are clearly trade-offs of making further improvements in a world of limited resources. It is not possible to estimate the costs associated with the changes introduced in 2015, but one can estimate the absolute costs a