Better Regulation TOOLBOX

1 TOOLBOXB etter RegulationNovember 2021 Better Regulation TOOLBOX November 2021 edition Better re gulation TOOLBOX 2021 Euro pean Commission 2 Better Regulation TOOLBOX This TOOLBOX complements the Better Regulation guidelines presented in SWD(2021) 305 final It is presented here in the form of a single document and structured around various chapters containing individual tools. It is also available and intended to be used as a series of web-based tools which are downloadable from the Commission's Better Regulation website. In general, the TOOLBOX presents guidance, tips and best practice. Users are not expected to read and apply each individual tool but to use the TOOLBOX selectively and with common sense. However, some aspects of the TOOLBOX must be applied because they are linked to the requirements of the Better Regulation guidelines, the Commission s working methods or political commitments given by the Commission.

2 These are explained in the first Tool #1 on principles, procedures and exceptions. Questions about this TOOLBOX can be sent to unit A2 of Directorate responsible for strategy, Better Regulation and corporate governance in the Secretariat-General The Better Regulation TOOLBOX is used internally in the Commission and therefore contains references to internal procedures as well as intranet pages that are not publically available. Better re gulation TOOLBOX 2021 Euro pean Commission 3 Table of contents Chapter 1 General principles of Better Regulation .. 7 TOOL #1. Principles, procedures & exceptions .. 8 TOOL #2. The regulatory fitness programme (REFIT) and the Fit for Future Platform .. 11 TOOL #3. Role of the Regulatory Scrutiny Board .. 14 TOOL #4. Evidence-informed policymaking .. 20 TOOL #5. Legal basis, subsidiarity and proportionality .. 30 TOOL #6.

3 Planning and validation of initiatives .. 37 Chapter 2 How to carry out an impact assessment .. 7 TOOL #7. What is an impact assessment and when it is necessary .. 42 TOOL #8. What steps should be followed for an impact assessment? .. 48 TOOL #9. Spending programmes, financial instruments and budgetary guarantee .. 55 TOOL #10. Treaty-based social partner consultations and initiatives .. 62 TOOL #11. Format of the impact assessment report .. 65 TOOL #12. How to apply proportionality to impact assessments .. 81 TOOL #13. How to analyse problems .. 86 TOOL #14. Risk assessment and 99 TOOL #15. How to set objectives .. 108 TOOL #16. How to identify policy options .. 111 TOOL #17. The choice of policy instruments .. 120 Chapter 3 Identifying impacts in evaluations, fitness checks and impact assessments .. 133 TOOL #18. Identification of 134 TOOL #19. Sustainable development goals .. 150 TOOL #20. Strategic foresight for impact assessments and evaluations.

4 155 TOOL #21. Sectoral competitiveness .. 159 TOOL #22. Research and innovation .. 170 TOOL #23. The SME test .. 181 Better re gulation TOOLBOX 2021 Euro pean Commission 4 TOOL #24. Competition .. 193 TOOL #25. Internal market .. 201 TOOL #26. Prevention of fraud .. 211 TOOL #27. External trade and investment .. 218 TOOL #28. Digital-ready 228 TOOL #29. Fundamental rights, including the promotion of equality .. 242 TOOL #30. Employment, working conditions, income distribution, social protection and inclusion .. 249 TOOL #31. Education and training, culture and youth (ETCY) .. 267 TOOL #32. Health impacts .. 280 TOOL #33. Consumers .. 291 TOOL #34. Territorial impacts .. 297 TOOL #35. Developing 305 TOOL #36. Environmental impacts .. 313 TOOL #37. Customs enforcement of sectoral prohibitions and restrictions at EU borders .. 324 Chapter 4 Compliance, implementation and preparing proposal .. 331 TOOL #38.

5 Compliance promotion and verification tools .. 332 TOOL #39. Compliance assessment: explanatory documents, transposition and conformity checks .. 336 TOOL #40. Drafting the explanatory memorandum .. 341 TOOL #41. Guidance documents containing legal interpretation of EU law .. 348 TOOL #42. Delegated and implementing acts .. 351 Chapter 5 Monitoring the application of an intervention .. 355 TOOL #43. Monitoring arrangements and indicators .. 356 TOOL #44. Legal provisions on monitoring and evaluation .. 366 Chapter 6 How to carry out an evaluation and fitness check .. 373 TOOL #45. What is an evaluation and when it is required .. 374 TOOL #46. Designing the evaluation .. 384 TOOL #47. Evaluation criteria and questions .. 400 TOOL #48. Conducting the evaluation .. 412 TOOL #49. Format of the evaluation report .. 417 TOOL #50. Back-to-back evaluations and impact assessments .. 434 Chapter 7 Stakeholder consultation.

6 437 Better re gulation TOOLBOX 2021 Euro pean Commission 5 TOOL #51. Consulting stakeholders .. 438 TOOL #52. Consultation strategy .. 454 TOOL #53. Conducting consultation activities .. 463 TOOL #54. Analysing data and informing policymaking .. 470 TOOL #55. Horizontal matters publication of responses, data protection, access to documents and transparency register .. 484 Chapter 8 Methodologies for analysing impacts in impact assessments, evaluations and fitness checks .. 493 TOOL #56. Typology of costs and 497 TOOL #57. Methods to assess costs and benefits .. 503 TOOL #58. EU Standard Cost Model .. 516 TOOL #59. Cost estimates and the one in, one out approach .. 526 TOOL #60. 534 TOOL #61. Simulation models .. 540 TOOL #62. Multi-criteria decision analysis .. 546 TOOL #63. Cost-benefit analysis .. 550 TOOL #64. Discount 554 TOOL #65. Uncertainty and sensitivity analysis .. 560 TOOL #66. Life cycle assessment.

7 565 TOOL #67. Data identification for evaluation and impact assessment .. 571 TOOL #68. Methods for evaluating causal effects .. 579 TOOL #69. Emerging methods and policy instruments .. 593 Better re gulation TOOLBOX 2021 Euro pean Commission 6 Better re gulation TOOLBOX 2021 Euro pean Commission 7 Chapter 1 General principles of Better Regulation TOOL #1. Principles, procedures & exceptions .. 8 TOOL #2. The regulatory fitness programme (REFIT) and the Fit for Future Platform .. 11 TOOL #3. Role of the Regulatory Scrutiny Board .. 14 TOOL #4. Evidence-informed policymaking .. 20 TOOL #5. Legal basis, subsidiarity and proportionality .. 30 TOOL #6. Planning and validation of initiatives .. 37 Better re gulation TOOLBOX 2021 Euro pean Commission 8 TOOL #1. PRINCIPLES, PROCEDURES & EXCEPTIONS 1. COMMON Better Regulation PRINCIPLES AND PROCEDURES Through its Better Regulation policy, the Commission has committed to design, deliver and support the implementation of high quality policies.

8 Better Regulation covers the whole EU policy cycle planning, design, adoption, implementation, evaluation and revision. All EU interventions legislative or non-legislative, policy initiatives or spending programmes aim to achieve certain objectives through one or several means, in line with the goals and responsibilities set by the EU Treaty. The European Parliament, Council and the Commission concluded an Interinstitutional Agreement on Better Law-Making in 2016. The three institutions recognised their joint responsibility to deliver high-quality legislation: In areas where it has the greatest added value for European citizens and strengthen the competitiveness and sustainability of the Union's economy; Which delivers the Union's policy objectives in the simplest, most efficient and effective way possible; Which avoids overregulation and unnecessary administrative burdens for citizens, administrations and businesses and particularly SMEs; and Which is designed to facilitate its transposition and practical application.

9 Better Regulation is governed within the Commission by a set of common principles and follow established processes. These principles have developed over the years, based on progress in standards, methods and data sources and were also inspired by international work such as the 2012 OECD regulatory policy recommendations1 and later work developed in the OECD. They apply to all DGs and services involved in the preparation, implementation or evaluation of EU interventions and associated stakeholder consultations. The application of these principles and procedures will help to provide a rigorous evidence base to inform decision-making and contribute to making Commission initiatives more effective, coherent, relevant and efficient. It should also enhance transparency, participation, learning and accountability. Box 1. Key dimensions of Better Regulation Embedded in the planning and policy cycle Evidence from all preparatory and analytical work, including stakeholder consultations, should feed into the policy development process.

10 Lessons from implementation and evaluations form part of the evaluate first approach to policy development. Of high quality The Commission's impact assessments, stakeholder consultations, fitness checks and evaluations should conform to the requirements of the Better Regulation guidelines; the Regulatory Scrutiny Board provides an independent check. Evidence-based Better Regulation instruments should be based on the best available evidence. They should provide a transparent explanation of why some evidence may not be available and why it is appropriate to act in the absence of evidence. Evidence refers to multiple sources of data, information and knowledge, including quantitative data such as statistics and measurements, qualitative data such as 1 Recommendation of the Council on Regulatory Policy and Governance - OECD Better re gulation TOOLBOX 2021 Euro pean Commission 9 opinions, stakeholder input, conclusions of evaluations, as well as scientific and expert advice.