COMMISSION STAFF WORKING DOCUMENT Better Regulation Guidelines
Date: 2015-05-19
Institutions: European Commission
Subjects: EU action, EU control, EU law, EU policy, EU programme, European Commission, impact study, operation of the Institutions

EUROPEAN 
COMMISSION 

Strasbourg, 19.5.2015  
SWD(2015) 111 final 

COMMISSION STAFF WORKING DOCUMENT 

Better Regulation Guidelines 

{COM(2015) 215 final} 
{SWD(2015) 110 final} 

EN 

   EN 

 
 
 
 
  
 
Table of Contents 

TABLE OF CONTENTS .................................................................................................... 1 

CHAPTER I BETTER REGULATION IN THE COMMISSION ..................................... 4 

1. 
Introduction ....................................................................................................... 4 
2.  What is Better Regulation?................................................................................ 5 
How to Regulate Better? -  The Essentials........................................................ 6 
3. 
The structure of the guidelines ........................................................................ 10 
4. 

CHAPTER II GUIDELINES ON PLANNING ................................................................ 11 

1.  When Can Policy Preparation Begin? ............................................................. 11 
2.  Who is involved in the validation process?..................................................... 12 
3.  What needs to be validated? ............................................................................ 13 

CHAPTER III GUIDELINES ON IMPACT ASSESSMENT.......................................... 16 

1. 
2. 
3. 
4. 

Introduction ..................................................................................................... 16 
The key questions and principles of Impact assessment ................................. 18 
Summing it all up: the impact assessment report ............................................ 31 
From impact assessment to policy-making ..................................................... 31 

CHAPTER 

IV  GUIDELINES  ON 

PREPARING 

PROPOSALS, 

IMPLEMENTATION, AND TRANSPOSITION .................................................... 33 

1. 
2. 

Introduction ..................................................................................................... 33 
Anticipate  implementation  problems  and  facilitate  transposition: 
Implementation plans ...................................................................................... 34 
Better drafting of legal acts ............................................................................. 35 
the  link  between  EU  Law  and  Member  State  transposing  measures: 
explanatory documents.................................................................................... 39 
5.  Monitoring implementation............................................................................. 41 

3. 
4. 

CHAPTER V GUIDELINES ON MONITORING........................................................... 42 

1. 
2. 

Introduction ..................................................................................................... 42 
The key questions and principles of Monitoring............................................. 43 

CHAPTER VI GUIDELINES ON EVALUATION AND FITNESS CHECKS.............. 48 

1. 
2. 
3. 
4. 
5. 

Introduction ..................................................................................................... 49 
Key principles and concepts............................................................................ 53 
Key questions an Evaluation must answer ...................................................... 55 
Summing it all up: the evaluation staff working document ............................ 61 
Using the evaluation results............................................................................. 62 

CHAPTER VII GUIDELINES ON STAKEHOLDER CONSULTATION..................... 63 

1. 
2. 
3. 

Introduction ..................................................................................................... 63 
Scope and definition of stakeholder consultation............................................ 64 
General  principles  and  minimum 
consultation...................................................................................................... 65 
4.  When is stakeholder consultation required?.................................................... 66 

stakeholder 

standards 

for 

 
 
5.  Who in the Commission services is responsible to set up consultation 

activities?......................................................................................................... 68 
How to prepare and conduct a Consultation - Three interacting phases ......... 69 
Quality control................................................................................................. 85 

6. 
7. 

CHAPTER  VIII  THE  CONTENT  OF  THE  BETTER  REGULATION 

TOOLBOX ................................................................................................................ 86 

GLOSSARY ...................................................................................................................... 89 

3 

 
 
 
 
 
Chapter I 
Better Regulation in the Commission 

1. 

INTRODUCTION 

European policies and legislation impact the lives of the Union’s 500 million inhabitants 
and  its  millions  of  companies.  A  substantial  body  of  legislation  now  exists  and  this 
legislation must continue to keep pace with evolving political, societal and technological 
developments. The European Commission has a key role in this regard given its right to 
initiate  new  legislation  and  its  responsibility  to  ensure  the  correct  application  of  Union 
law. EU action must lead to a simple, clear, stable and predictable regulatory framework 
for businesses, workers and citizens that continue to add value as problems evolve, new 
solutions emerge and political priorities change. 

The  European  Commission  is  determined,  therefore,  to  ensure  that  its  proposals  meet 
policy goals at minimum cost and deliver maximum benefits to citizens, businesses and 
workers while avoiding all unnecessary regulatory burdens. This is key to support growth 
and job creation – allowing the EU to ensure its competitiveness in the global economy - 
while maintaining social and environmental sustainability.  

Determining  when  and  how  EU  action  should  be  undertaken,  reviewed  or  repealed  is 
ultimately a political choice. The quality of these choices, however, can be improved if 
"better  regulation"  principles  and  practices  are  followed  when  preparing,  implementing 
and evaluating policies and measures. 

Box 1. How to apply these guidelines 

•  The  guidelines  and  associated  Better  Regulation  "Toolbox"  should  be  applied  in  a 
proportionate  manner  using  common  sense  bearing  in  mind  that  the  aim  is  not  to 
respect procedural requirements per se but to ensure that the Commission is equipped 
with relevant information on which to base its decisions in a timely manner. Similarly, 
the depth of analysis should also reflect the significance of the impacts or effects of 
the initiative or intervention.  

•  The main guidelines set out the mandatory requirements and obligations for each step 
in the policy cycle while the Toolbox provides additional guidance and advice which 
is not binding unless expressly stated to be so. 

•  There may be cases where it may not be possible or most appropriate to follow each 
step  in  the  guidelines.  For  example,  a  special  regime  applies  to  the  Commission's 
proposals  for  a  Council  decision  to  implement  social  partners'  agreements  under 
Article 155 TFEU due to the role and autonomy entrusted by the Treaty to the social 
partners. In other case, there may be a political imperative to move ahead quickly, an 
emergency that requires a rapid response or a need to abide to specific timeframes set 
in  legislation  which  cannot  be  simply  respected  on  the  basis  of  proper  planning.  In 
such well justified cases it may, for instance, be necessary to combine evaluation and 
impact  assessment,  adopt  ad  hoc  consultation  strategies  etc.  Such  cases  (and  the  
related approach) should be discussed as early as possible in the planning phase with 
the  Secretariat  General  and,  whenever  relevant,  spelled  out  in  the  draft  Roadmap 
which informs the political validation of each initiative. Whenever needed, the agreed 
approach  should  be  externally  communicated  together  with  a  justification  and  an 
explanation  of  the  efforts  made  to  respect  the  spirit  of  the  guidelines  (typically 
through the final roadmap).  

 
 
•  To  avoid  undue  delays  and  to  maximize  the  quality  of  outputs,  the  efficient 
application  of  these  guidelines  requires  a  constructive  and  timely  collaboration 
between  the  lead  service,  the  Secretariat  General  and  those  services  included  in 
interservice groups.  

•  The Secretariat General will attentively monitor the impact of the introduction of new 
procedural requirements. It will review their implementation and propose, if needed, 
how to eliminate any source of administrative burden or undue procedural delay  thus 
identified  by  2017.  Any  such  review  will  not  endanger  the  respect  of  the  better 
the  Commission 
regulation  principles 
Communication 'Better regulation for better results – An EU agenda'.1 

these  guidelines  and 

identified 

in 

in 

These guidelines explain what Better Regulation is and how it should be applied in the 
day to day practices of Commission officials preparing new initiatives and proposals or 
managing existing policies and legislation. The guidelines should be read by all officials 
involved  in  Better  Regulation  activities  and  managers  who  are  responsible  for  quality 
control  and  the  allocation  of  resources  within  Commission  departments.  Better 
Regulation cannot be implemented without dedicated financial and human resources and 
DGs  must  ensure  that  appropriate  centres  of  expertise  (or  functions)  and  training  are 
available to support the various aspects of Better Regulation. 

2. 

WHAT IS BETTER REGULATION? 

"Better  Regulation"  means  designing  EU  policies  and  laws  so  that  they  achieve  their 
objectives at minimum cost. Better Regulation is not about regulating or deregulating. It 
is a way of working to ensure that political decisions are prepared in an open, transparent 
manner,  informed  by  the  best  available  evidence  and  backed  by  the  comprehensive 
involvement  of  stakeholders.  This  is  necessary  to  ensure  that  the  Union's  interventions 
respect the overarching principles of subsidiary and proportionality i.e. acting only where 
necessary and in a way that does not go beyond what is needed to resolve the problem. 

Better  Regulation  covers  the  whole  policy  cycle  –  policy  design  and  preparation, 
adoption; 
implementation  (transposition,  complementary  non-regulatory  actions), 
application  (including  enforcement),  evaluation  and  revision.    For  each  phase  of  the 
policy  cycle,  there  are  a  number  of  Better  Regulation  principles,  objectives,  tools  and 
procedures  to  make  sure  that  the  EU  has  the  best  regulation  possible.  These  relate  to 
planning, impact assessment, stakeholder consultation, implementation and evaluation. 

1 COM(2015)215 

5 

 
                                                 
Figure 1. The EU Policy cycle 

The different phases are closely interrelated and to recognise better the connections and 
to  ensure  greater  coherence  the  previously  separate  guidance  documents  have  been 
brought together into a single streamlined and integrated Better Regulation guide. These 
guidelines replace the previous standalone guidelines which addressed separately impact 
assessment, evaluation, implementation and also include new guidance on planning and 
stakeholder consultation2.  

3. 

HOW TO REGULATE BETTER? -  THE ESSENTIALS 

3.1. 

Forward planning and political validation 

Good  regulation  starts  with  good  planning.  Work  should  focus  on  the  Commission's 
priorities as reflected in the President's political guidelines3 and the Commission's annual 
work programmes4. Good planning covers the initial consideration of an initiative within 
the  Commission  and  the  organisation  of  the  supporting  processes  –  the  evaluation  of 
policies  already  in  place,  the  assessment  of  problems  and  alternative  solutions  and  the 
active  engagement  with  stakeholders.  These  take  time  and  require  resources  to  deliver 
timely results. 

2   These  guidelines  confirm  and  further  define  the  general  rules  on  how  Commission  services  should 
consult set out in the 2002 Commission Communication "Towards a reinforced culture of consultation 
and dialogue - General principles and minimum standards for consultation of interested parties by the 
Commission"  COM(2002)  704  final,  complemented  by  COM(2012)  746  and  accompanying 
SWD(2012) 422 and by COM(2014) 368. 

3   http://ec.europa.eu/priorities/docs/pg_en.pdf  

4   http://ec.europa.eu/atwork/key-documents/index_en.htm  

6 

 
 
 
                                                 
The first step in the planning process is to define the scope of the planned initiative and 
seek political validation to develop the idea further. The main planning tools used in this 
process  are  Agenda  Planning5  and  Roadmaps.  The  details  on  which  initiatives  must  be 
uploaded in Agenda Planning are provided in the instructions of the Secretary General6 
which complement the Working Methods of the European Commission 2014-20197 and 
outlined in detail in Chapter II on Planning.   

Box 2. Scoping, political validation and interservice work  

•  Major  initiatives  must  be  accompanied  by  a  Roadmap  and  entered  into  Agenda 
Planning as soon as preparatory work starts - at least 12 months prior to adoption by 
the  College.  They  must  be  validated  by  the  lead  Commissioner,  relevant  Vice-
President  and  the  First  Vice-President  before  being  accepted  to  be  included  into  the 
Commissions'  planning.  The  political  validation  must  be  understood  as  giving  the 
green light to proceed with further preparatory work. It should not be interpreted as a 
decision on a particular initiative or course of action that prejudges the outcome of any 
impact assessment process, stakeholder consultation or later political discussion in the 
College. 

•  Roadmaps  explain  what  the  Commission  is  considering.  A  Roadmap  describes  the 
problem  to  be  tackled  and  the  objectives  to  be  achieved.  It  sets  out  why  EU  action 
may be needed and its value added. The policy options being considered are outlined. 
The Roadmap also justifies the absence of an impact assessment. It also announces the 
details  of  the  stakeholder  consultation  strategy  (see  later  chapter).  A  (different) 
Roadmap  is  also  prepared  for  each  evaluation  and  Fitness  Check.  This  specifies  the 
scope of the evaluation and presents the evaluation questions to be answered.  

•   An Inception Impact Assessment is a Roadmap for initiatives subject to an IA that 
sets out in greater detail the description of the problem, issues related to subsidiarity, 
the policy objectives and options as well as the likely impacts of each option. 

•  All  Roadmaps  and  Inception  Impact  Assessments  are  published  by  the  Secretariat-
General  on  the  Commission's  website8  so  that  stakeholders  are  informed  and  can 
provide  initial  feedback  (including  data  and  information  they  may  possess)  on  all 
aspects of the intended initiative and impact assessment.  

•  Evaluations,  impact  assessments,  stakeholder  consultations,  policy  proposals  and 
implementation  plans  must  be  prepared  collectively  by  the  services9  within  an 
interservice  group.  It  is  important  that  all  services  with  an  interest  participate 
actively in the interservice work from the outset, particularly those DGs with specific 
expertise (e.g. competitiveness, SME impacts, social impacts, environmental impacts 

5   Agenda Planning is the Commission's IT platform for managing the preparation of initiatives. 

6   https://myintracomm.ec.europa.eu/sg/comcab/pages/methods.aspx  

7   C(2014)9004; http://ec.europa.eu/transparency/regdoc/rep/3/2014/EN/3-2014-9004-EN-F1-1.Pdf  

8   http://ec.europa.eu/atwork/planning-and-preparing/work-programme/index_en.htm  

9      See also art 23 of the Rules of Procedures of the Commission 'Cooperation and coordination between 

departments':  
 http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1427880050708&uri=URISERV:o10004 

7 

 
                                                 
 
and scientific/analytical).  

3.2. 

Stakeholder consultation 

Stakeholder consultation is an essential element of policy preparation and review.  Good 
policy  development  is  built  on  openness.  Stakeholder  inputs  provide  feedback  and 
evidence for all types of evaluation, impact assessments and political decisions. Planning 
stakeholder  consultation  is  good  practice,  and  should  be  reflected  in  a  simple,  concise 
consultation  strategy  that  identifies  and  targets  relevant  stakeholders  in  order  to  collect 
all relevant evidence (comprising data/information) and views. 

It  is  important  to  consult  as  early  and  as  widely  as  possible  in  order  to  maximise  the 
usefulness of the consultation and to promote an inclusive approach where all interested 
parties have the opportunity to contribute to the timely development of effective policies. 
At  the  same  time,  consultation  is  an  ongoing  process  and  consulting  stakeholders 
throughout the whole policy cycle remains key. Consultation should allow for reasonable 
time  limits  to  stimulate  informed  and  effective  feedback  from  all  relevant  stakeholder 
groups,  and  should  ensure  that  feedback  is  given  to  respondents  about  how  their 
information  and  views  were  used.  Open  public  consultation  is  essential  for  impact 
assessments, evaluations and Fitness Checks. 

3.3. 

Evaluation/Fitness Checks 

Policy  preparation  should  be  supported  by  both  retrospective  performance  evaluations 
and forward looking impact assessments. Both look  at how a problem  is,  or should be, 
addressed (and its underlying causes) to achieve the desired objectives taking account of 
costs  and  benefits.  Both  are  based  on  an  integrated  approach  that  addresses  impacts 
across the environmental, social and economic pillars of sustainable development and so 
contribute to the mainstreaming of sustainability in policy making at the Union level.  

Evaluations gather evidence to assess how well a specific intervention has performed (or 
is  working),  taking  account  of  earlier  predictions  made  in  the  context  of  an  impact 
assessment  and  whether  there  were  unintended/unexpected  effects  which  were  not 
anticipated by the impact assessment or the act agreed by the Legislator. An evaluation 
also  draws  conclusions  on  whether  the  EU  intervention  continues  to  be  justified  or 
should be modified to improve its effectiveness, relevance and coherence or to eliminate 
excessive burdens or inconsistencies or simply be repealed.  

A  Fitness  Check  is  a  comprehensive  evaluation  of  a  policy  area  that  usually  addresses 
how several related legislative acts have contributed (or otherwise) to the attainment of 
policy  objectives.  Fitness  Checks  are  particularly  well-suited  to  identify  overlaps, 
inconsistencies synergies and the cumulative impacts of regulation. 

Box 2. Regulatory Fitness Programme (REFIT) 

Given  their  focus,  evaluations  and  Fitness  Checks  are  particularly  important  in  the 
context  of  the  tools  that  are  used  to  implement  the  Regulatory  Fitness  and 
Performance  programme  (REFIT):    a  rolling  programme  to  keep  the  entire  stock  of 
EU  legislation  under  review  and  ensure  that  it  is  'fit  for  purpose',  that  regulatory 
burdens are minimised and that all simplification options are identified and applied. 
Evaluations  and  Fitness  Checks  always  consider  efficiency  and  effectiveness  and 
identify  any  overly  burdensome  and  complex  aspects  of  EU  legislation  and  its 
implementation  in  the  Member  States  as  well  as  any  subsequent  implementing  or 

8 

 
delegated legislation adopted by the Commission. 

It is important to monitor the impacts flowing from the implementation and application 
of the legislation in order to allow both Member States and the Commission to undertake 
a meaningful evaluation of the intervention at a future point in time. If there is no useful 
monitoring information, it will be difficult to evaluate the intervention appropriately and 
to rectify any problems or improve the delivery of desired results. 

3.4. 

Impact assessment 

Impact  assessments  collect  evidence  (including  results  from  evaluations)  to  assess  if 
future legislative or non-legislative EU action is justified and how such action can best be 
designed to achieve desired policy objectives.  An impact assessment must identify and 
describe  the  problem  to  be  tackled,  establish  objectives,  formulate  policy  options  and 
assess the impacts of these options. The Commission's impact assessment system follows 
an integrated approach that assesses the environmental, social and economic impacts of a 
range of policy options thereby mainstreaming sustainability into Union policy making. 

3.5. 

Quality control 

Staff working documents are required to present the results of all impact assessments and 
evaluations/Fitness Checks.  

The  quality  of  these  staff  working  documents  is  checked  by  the  Regulatory  Scrutiny 
Board  (RSB)  who  will  assess  all  impact  assessments  and  all  major10  evaluations  and 
Fitness Checks. The Board issues opinions based on the requirements of these guidelines. 
DGs  are  expected  to  modify  their  reports  to  reflect  the  Board's  opinion.  In  the  case  of 
impact  assessments,  and  according  to  the  Commission  Working  Methods,  a  positive 
opinion  from  the  Board  is  necessary  before  a  formal  interservice  consultation  can  be 
launched. The formal interservice consultation should check how the Board's comments 
have  been  integrated  and  should  also  check  the  quality  of  the  drafting  of  the 
initiative/legal proposal (see Chapter IV). 

3.6. 

Implementation support and monitoring 

(so-called  "gold-plating")  or 

The  full  benefits  of  an  EU  intervention  will  only  be  delivered  if  the  policy  is 
implemented and applied appropriately. Similarly, burdens for business may be increased 
beyond  what  is  foreseen  by  the  legislation  if  the  Member  States  impose  unjustified 
additional  obligations 
legislation 
inefficiently.  That  is  why  it  is  essential  to  take  into  account  implementation  and 
enforcement issues when designing an EU intervention including the impact assessment 
process and associated stakeholder consultation. It is also important to identify ways to 
assist  Member  States  in  the  transposition  phase  (aligning  national  legislation  with  EU 
legislation)  by  preparing  so-called  'implementation  plans'  (in  the  form  of  SWD)  which 
should  also  be  subject  to  interservice  consultation  together  with  the  impact  assessment 
and  the  proposed  intervention.  Checks  on  transposition  and  assessments  of  compliance 
are also key tools used to monitor the correct application of EU legislation.  

implement 

the 

10   Major evaluations capture REFIT evaluations, Fitness Checks; major MFF programme evaluations and 

any other evaluations which the RSB may scrutinise based on the DGs rolling evaluation plan. 

9 

 
                                                 
4. 

THE STRUCTURE OF THE GUIDELINES 

The Better Regulation guidelines are structured into separate chapters which cover 

•  Chapter II: Planning 

•  Chapter III: Impact Assessment; 

•  Chapter IV: Implementation; 

•  Chapter V: Monitoring; 

•  Chapter VI: Evaluation and Fitness Checks;  

•  Chapter VII: Stakeholder consultation; and 

•  Chapter  VIII:  A  description  of  the  web-based  Toolbox  which  contains  more 

detailed guidance on: 

• 

• 

• 

• 

• 

Principles of Better Regulation;  

How to carry out an impact assessment; 

How to carry out an evaluation/Fitness Checks;  

How to consult;  

How to assess sectorial impacts; and 

•  Methods, models and costs and benefits. 

The  Secretariat-General  is  responsible  for  the  preparation  of  the  Better  regulation 
guidelines.  Questions  about  their  interpretation  or  application  can  be  obtained  from  the 
following units in the SG using the associated functional mailboxes. 

•  SG-C1: Evaluation, Fitness Checks: SG EVALUATION AND SIMPLIFICATION 

•  SG-C2: Impact Assessment: SG IMPACT ASSESSMENT GUIDELINES 

•  SG-C3: Implementation: SG IMPLEMENTATION PLANS; SG INFRACTIONS 

•  SG-C4: Planning & stakeholder consultation: SG PLANNING; SG STAKEHOLDER 

CONSULTATION  

Individual  DGs  and  services  with  particular  expertise  in  the  field  of  Better  Regulation 
may  also  make  additional  materials  available  to  those  preparing  evaluations,  Fitness 
Checks, Impact Assessments and stakeholder consultations via their respective web sites. 

10 

 
 
Chapter II 
Guidelines on Planning 

Key requirements 

•  Work  may  only  start  and  the  necessary  resources  attributed  if  an  initiative  has 
received political validation at the appropriate level and a valid entry exists in Agenda 
Planning, where applicable (cf. point 3 below). 

•  "Major"  new  initiatives  have  to  be  accompanied  by  a  Roadmap  or  Inception  IA  and 
require political validation from the lead Commissioner, Vice-President and First Vice 
President. 

•  A  valid  agenda  planning  entry  is  needed  in  order  to  launch  an  interservice 

consultation. 

1. 

WHEN CAN POLICY PREPARATION BEGIN? 

The  identification  and  delivery  of  the  political  priorities  of  the  Commission  are  carried 
out in the context of the Strategic Planning and Programming cycle11 and on the basis of 
the  political  priorities12  of  the  Commission  President  and  the  Commission  Work 
Programme (CWP)13. 

Effective  and  quality  EU  action  starts  with  good  and  timely  planning.  New  initiatives 
including  evaluation  work  must  receive  political  validation  before  concrete  work  can 
start and resources are allocated. Policy planning and implementation are always steered 
by the political level. The political validation must be understood as giving the green 
light  to  proceed  with  further  preparatory  work.  It  should  not  be  interpreted  as  a 
decision on a particular initiative or course of action that prejudges the outcome of 
any impact assessment process or later political discussion in the College. 

For each initiative or evaluation/Fitness Check you need to 

•  Categorize the future initiative; and  

•  Identify the level of political validation required (see point 3). 

To obtain validation you should, via the Agenda Planning entry and, if applicable, via the 
Roadmap/ Inception IA: 

•  Explain  why  you  consider  it  necessary  to  work  on  a  particular  initiative  (e.g.  an 
identified  policy  problem,  a  legal  obligation,  implementation  concerns,  evaluation 
recommendations,  political  commitment,  request  by  other  institutions,  citizens' 
initiative etc.); 

•  Explain why action may be needed at EU level; 

11  

 https://myintracomm.ec.europa.eu/corp/sg/en/spp/Pages/cycle.aspx 

12   http://ec.europa.eu/priorities/docs/pg_en.pdf  

13   http://ec.europa.eu/atwork/key-documents/index_en.htm 

 
 
                                                 
 
•  Describe how the initiative would contribute to established political priorities. 

The scope and format of evaluation roadmaps are further explained in the toolbox. 

Work may start and the necessary resources may be attributed only if political 
validation has been obtained from the appropriate level. 

Good  planning  also  implies  taking  into  account  from  the  very  beginning  the  various 
procedural  requirement  and  their  duration,  including  translations.  Once  validation 
obtained,  translations  should  be  factored  in  as  soon  as  possible,  so  as  to  ensure  the 
highest possible quality of documents translated.  

2. 

WHO IS INVOLVED IN THE VALIDATION PROCESS? 

The  lead  DG  encodes  new  initiatives  in  Agenda  Planning  and  seeks  the  necessary 
political validation by the responsible Commissioner(s) and (if major) Vice-President(s). 
New initiatives can be encoded and validated throughout the year. 

The Secretariat-General coordinates a comprehensive screening process for all initiatives 
that  have  received  political  validation  and  is  responsible  for  seeking  the  political 
validation  for  major  items  from  the  First  Vice-President,  who acts  in close cooperation 
with  the  President's  Cabinet.  The  Secretariat-General  is  also  in  charge  of  publishing 
approved  Roadmaps/Inception  IA  on  the  Commission  website  and  compiling  and 
publishing regular reports to other institutions about planned initiatives. 

12 

 
 
 
 
 
 
 
 
 
 
Figure 2:  Prioritisation and political validation levels 

Inter Service Group  

RM / 
Inception 
IA 
published 
& 
Forecast 
Report

Major initiatives  
of the CWP 

Validated by the 
College 

Major initiatives 
outside CWP 

Validated by the 
First VP 

DG's work 
programming 

Validated by the 
Commissioner 

'Other' initiatives 
to be added to AP 

Validated by the 
Commissioner 

Evaluations/FCs* 
outside REFIT 

Validated by the 
Director General 

Eval. RM
published 

*FC = Fitness Check 

DG's 
Management 
Plan 

(cid:214) Consult stakeholders  
(cid:214) Assess impacts 
(cid:214) Plan implementation  

Prepare initiative 

WHAT NEEDS TO BE VALIDATED? 

3. 
The  instructions  implementing  the  working  methods  of  the  Commission14  focus  on  the 
use  of  the  Agenda  Planning15  application,  which  is  designed  to  help  the  Commission 
screen  and  manage  the  flow  of  initiatives  in  line  with  the  Political  Guidelines.  The 
Agenda  Planning  entry  and  the  accompanying  Roadmap,  where  applicable,  provide  a 
first outline of the initiative and are essential for the political validation. 

All  'major  initiatives'  need  to  be  entered  into  Agenda  Planning  at  the  latest  12  months 
before their planned adoption date and be accompanied by a Roadmap16 or an Inception 
IA.  The  implementing  instructions  identify  certain  types  of  acts  as  being  per  definition 
'major'.  However,  any  other  Commission  initiative  that  is  sensitive  or  important  should 
also  be  considered  as  'major'.  It  is  the  responsibility  of  each  DG  to  consider  carefully 
aspects  such  as  the  political  importance  and  sensitivity,  the  magnitude  of  the  expected 
impacts;  importance  for  other  policy  areas  and  prior  knowledge  about  divergent  or 
sensitive stakeholder views. 

14   https://myintracomm.ec.europa.eu/sg/comcab/pages/methods.aspx 

15   https://webgate.ec.europa.eu/agendap/agenda/protected/agendaItems/list.agenda 

16   Where Impact Assessments will follow-on directly from evaluations, DGs may, on a case by case basis 

and after discussion with the Secretariat General, consolidate the roadmap exercise into one. 

13 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
 
Different initiatives and validation requirements 

Major initiatives 

'Other' initiatives 

DG internal work plan 

Non-major 
evaluations 
and 
Fitness Check
s 

•  Delegated and 
implementing 
acts not 
having 
significant 
impacts 
•  Commission 

reports except 
for 
Evaluations or 
Fitness 
Checks 

Which 
acts? 

• 

Initiatives included in 
the CWP 
•  REFIT items 
•  New legislative 
proposals 

•  Recommendations for 
the negotiation of 
international 
agreements and 
proposals for their 
conclusion  

•  Policy communications 
•  Delegated and 

implementing acts 
having significant 
impacts 

•  Financing decisions 
having significant 
impacts 

•  Other Commission 
initiatives that are 
sensitive or important 

•  Commission decisions of 
and 

administrative 
routine nature 

• 

• 

Intermediate 
acts 

legislative 

Implementing  decisions 
under 
International 
Treaties 

•  Financing  decision  of  a 

routine nature 

• 

Information notes for the 
Commission 

•  Decisions 
delegated 
(empowerment 
delegations) 

granting 
powers 
and 

• 

Infringement, 
competition and state aid 
cases, 
defence 
trade 
enforcement 
cases, 
action 
under 
international trade rules 

•  Emergency 

procedures 

(duly justified) 

•  Any other initiative  

AP entry? 

Roadmap/ 
Inception 
IA needed? 

Political 
validation 
by 

ISG 
required 

Conditions 
to launch 
ISC 

Mandatory 

Mandatory 

Mandatory 

Not required 

Mandatory, signed off by 
the Commissioner(s). For 
initiatives that will 
undergo impact 
assessment, the Roadmap 
should be presented in the 
form of an Inception IA. 

Commissioner(s), VP(s) 
and the First VP, in close 
cooperation with 
President's Cabinet 

Yes 
(Important/sensitive cases 
chaired by SG) 

•  Only if complete AP 

• 

entry exists 
If impact assessment: 
positive opinion of the 
RSB 

•  Validation by the 
Commissioner(s), 
VP(s) and the First VP  

Not required 

Mandatory, 
signed off by the 
Director General 

Not required 

Commissioner 

Director General 
through the 
Management Plan 
endorsement 

Commissioner 

No 

Yes 

No 

•  Only if complete AP entry exists 
•  Validation by Commissioner(s), 

VP(s) and the First VP 

•  Validation by the 
Commissioner 

14 

 
 
  
If preparatory work for a possibly important or sensitive initiative is carried out only at 
internal  DG  level  and  outside  of  Agenda  Planning,  the  launch  of  the  ISC  may  not  be 
validated at political level, or the initiative may be blocked by any DG at the ISC stage, 
due to the lack of transparency and non-compliance with the implementing instructions.  

Methodological advice regarding the selection of the appropriate type of act can be asked 
via  SG  HELPDESK  PROCEDURES  and  concerning  the  inclusion  of  an  initiative  in 
Agenda Planning, either as "major" or "other" initiative, via SG PLANNING. GoPro and 
the Agenda Planning website also provide useful information in this regard17. 

17  

 https://myintracomm.ec.europa.eu/sg/planning/Pages/index.aspx 

15 

 
 
                                                 
Chapter III 
Guidelines on Impact Assessment 

Key requirements 

•  IAs  must  set  out  the  logical  reasoning  that  links  the  problem  (including  subsidiarity 
issues),  its  underlying  drivers,  the  objectives  and  a  range  of  policy  options  to  tackle 
the problem. They must present the likely impacts of the options, who will be affected 
by them and how. 

•  Stakeholders  must  be  able  to  provide  feedback  on  the  basis  of  an  Inception  Impact 
Assessment  which  describes  the  problem,  subsidiarity  related  issues,  objectives, 
policy options and an initial consideration of relevant impacts of these policy options. 

•  A 12-week internet-based public consultation covering all of the main elements of the 
IA  as  part  of  a  broader  consultation  strategy  to  target  relevant  stakeholders  and 
evidence. 

•  IAs  must  compare  the  policy  options  on  the  basis  of  their  economic,  social  and 
environmental  impacts  (quantified  as  far  as  possible)  and  present  these  in  the  IA 
Report. 

•  Certain  elements  must  be  included  in  the  final  IA  Report.  These  include:  (i)  a 
description  of  the  environmental,  social  and  economic  impacts  and  an  explicit 
statement if any of these are not considered significant; (ii) a clear description of who 
will  be  affected  by  the  initiative  and  how;  (iii)  impacts  on  SMEs;  (iv)  impacts  on 
competitiveness;  and  (v)  a  detailed  description  of  the  consultation  strategy  and  the 
results obtained from it. 

•  The  draft  IA  Report  must  be  presented  to  the  Regulatory  Scrutiny  Board  for  its 
scrutiny.  A  positive  opinion  of  the  Board  is  necessary  before  an  interservice 
consultation can proceed. 

•  The IA report must be complemented by a 2-page executive summary sheet available 

in all languages. 

1. 

INTRODUCTION 

Who Should Read These Guidelines? 

All  officials  involved  in  the  preparation  of  an  impact  assessment  (IA)  should  read 
these guidelines including officials and managers who are responsible for ensuring the 
quality of impact assessments in the lead DG.  

More detailed guidance is also available in a separate "tool box" which accompanies this 
guide. This is aimed at those directly involved in preparing the various elements of an IA. 
These  "tools"  contain  important  guidance  on  specific  issues  such  as  when  an  IA  is 
necessary,  on  the  identification  of  the  various  social,  environmental  and  economic 
impacts,  including  on  SMEs  and  competitiveness,  and  many  other  aspects  regarding 
methodological or other aspects in the preparation of an impact assessment. 

What is Impact Assessment and when is it required? 

Impact  assessment  is  about  gathering  and  analysing  evidence  to  support  policy 
making.  In this process, it verifies the existence of a  problem, identifies its underlying 

 
 
causes,  assesses  whether  EU  action  is  needed,  and  analyses  the  advantages  and 
disadvantages of available solutions.  

IA promotes more informed decision-making and contributes to Better Regulation 
which  delivers  the  full  benefits  of  policies  at  minimum  cost  while  respecting  the 
principles  of  subsidiarity  and  proportionality.  However,  IA  is  only  an  aid  to  policy-
making/decision-making and not a substitute for it.  

An  IA  is  required  for  Commission  initiatives  that  are  likely  to  have  significant 
economic, environmental or social impacts. 

Provided  that  the  above  conditions  are  fulfilled,  impact  assessments  should  be 
carried  out  for  both  legislative  and  non-legislative  initiatives  as  well  as  delegated  acts 
and  implementing  measures,  taking  into  account  the  principle  of  proportionate 
analysis.  When  the  above  conditions  are  not  met,  no  impact  assessment  is  needed 
regardless of the nature of the initiative18.  

What are the procedural steps? 

The  IA  work  is  led  by  the  Directorate-General(s)  responsible  for  the  relevant  policy 
initiative.  DGs  should  establish  as  early  as  possible  in  the  policy  planning/political 
validation process whether an IA is required on the basis of the associated Roadmap. 
If it is established that an IA will be carried out, the Roadmap should be developed 
and presented as an Inception IA.  

The Inception IA provides a first description of the problem and possible policy options 
along  with  an  overview  of  the  different  planned  stages  in  the  development  of  the 
initiative, including foreseen impact assessment work and consultation of stakeholders. If 
an  impact  assessment  will  not  be  carried  out,  this  should  equally  be  explained  in  the 
regular Roadmap.  

The subsequent preparation of an IA involves the following main steps:  

(1) 

(2) 

(3) 

The creation  of  an  interservice  group  (ISG) which will steer the IA process and 
collectively prepare the IA report. For those initiatives in the Commission's work 
programme  (or  other  important/sensitive  initiatives), the ISG will be established 
and chaired by the Secretariat-General; 

Finalisation of the Inception IA by the ISG and publication on the Commission's 
website,  allowing  stakeholders  to  be  informed  and  to  provide  feedback  and 
evidence  in  relation  to  the  problem,  possible  policy  options  and  their  likely 
impacts and subsidiarity considerations;  

The preparation of a consultation strategy by the ISG including a mandatory 12-
week internet-based open public consultation19. The consultation strategy should 
ensure that stakeholders' views are sought on all key impact assessment questions;  

18   See tool on when an impact assessment is necessary for more detail and cases when no IA is necessary 

such as when the Commission has no discretion over the policy content etc. 

19   Where the evaluation and IA are done "back to back" it is possible to conduct only one open public 

consultation as long as relevant stakeholders are consulted on all the main elements of the IA. 

17 

 
                                                 
(4) 

The  collection  and  analysis  of  all  relevant  evidence,  including  data,  scientific 
advice, other expert views, stakeholder input, etc; 

(5) 

Drafting of the IA Report; 

(6) 

(7) 

Submission  of  the  draft  IA  report  to  the  Regulatory  Scrutiny  Board  for  quality 
review,  followed  by  revision  to  take  account  of  its  recommendations  for 
improvement; 

Subject to a positive opinion by the Board, submission of the IA report to inter-
service consultation together with the accompanying policy initiative.   

The  IA  should  begin  as  early  as  possible  during  the  process  of  policy-development 
subject to the political validation requirements. The time needed to prepare an IA will 
vary from case to case. It should also be remembered that there is close link with ex-post 
evaluations  or  Fitness  Checks  of  existing  policy  frameworks  and  programmes,  whose 
results should be ready in time to feed meaningfully into the IA of a new proposal. The 
timing of the two processes may need to be carefully planned therefore. 

An  Impact  Assessment  Report  presents  the  final  results  of  the  IA  process  and 
accompanies  the  draft  proposal  through  the  Commission  decision-making  process.  The 
Commission's Regulatory Scrutiny Board (RSB) scrutinises the quality of all draft IAs 
and issues an opinion on the draft IA Report. A positive opinion by the RSB is required 
before an initiative can proceed. 

Following adoption, the final IA Report is published and transmitted to the co-legislators 
together with a 2-page executive summary sheet and the adopted initiative.  

2. 

THE KEY QUESTIONS AND PRINCIPLES OF IMPACT ASSESSMENT  

IA is a tool to help structure reflection and conduct analyses informing policy design. It 
is not a list of tasks to tick off. There is no recipe for the perfect IA. Given the widely 
differing nature of Commission initiatives, the best way to carry out an IA and present its 
results will vary from case to case.  

However,  all  impact  assessments  must  answer  a  set  of  key  questions  and  respect  a 
number  of  principles.  An  impact  assessment  should  comprehensive,  proportionate, 
evidence-based,  open  to  stakeholders'  views,  unbiased,  prepared  collectively  with 
relevant  Commission  services,  embedded  in  the  policy  cycle,  transparent  and  of  a  high 
quality20. 

The Questions An Impact Assessment Should Answer 

1.  What is the problem and why is it a problem?  

2.  Why should the EU act?  

3.  What should be achieved?  

20   See details in tool on Better Regulation principles. 

18 

 
                                                 
The Questions An Impact Assessment Should Answer 

4.  What are the various options to achieve the objectives?   

5. 

6. 

What  are  their  economic,  social  and  environmental  impacts  and  who  will  be 
affected?  

How  do  the  different  options  compare  in  terms  of  their  effectiveness  and 
efficiency (benefits and costs)?   

7.  How will monitoring and subsequent retrospective evaluation be organised?  

The  process  of  finding  answers  to  these  questions  is  necessarily  iterative.  The  IA 
process  should  start  from  broad  definitions  of  the  problem,  the  objectives  and  the 
possible  solutions  and  then  narrow  them  down  to  what  is  most  relevant.  The  questions 
are  also  interrelated.  Compliance  with  subsidiary  and  proportionality,  for  example,  can 
only  be  fully  verified  once  objectives  are  set  and  the  impacts  of  alternative  options 
assessed. The following should guide the IA process: 

(1)  When  making  choices  about  the  focus  and  depth  of  the  analysis,  the  IA  should 
concentrate  on  what  is  relevant  to  inform  decision-making,  leaving  out  what  is 
not.  

(2) 

(3) 

(4) 

(5) 

The results of any relevant evaluations of the existing policy framework should be 
used  as  the  starting  point  for  the  IA.  The  expertise  of  other  services  in  the 
Commission should also feed into the IA in order to consider and properly assess 
all relevant issues. 

The  most  appropriate  methods  should  be  identified  to  collect  data  and  analyse 
impacts. Where necessary, external studies may be contracted out to provide input 
on specific elements.   

A consultation strategy should be designed, keeping in mind the need to consult 
on  all  key  IA  issues.  The  IA  Report  should  corroborate  the  conclusions  of  the 
analysis  with  stakeholder  views  and  justify  any  significant  differences.  The 
synopsis  report  summarising  the  results  of  stakeholder  consultation  should  be 
integrated into the IA Report as a mandatory annex. 

Throughout  the  IA  Report,  conclusions  should  be  substantiated  with  evidence 
(e.g. data, estimations, scientific findings) together with appropriate citations and, 
if this is not possible, it should be explained why. Stakeholder views should also 
be referred to. 

2.1. 

Question 1: What is the problem and why is it a problem? 

An  IA  starts  by  verifying  the  existence  of  a  problem,  identifying  who  is  affected, 
estimating the problem's scale, analysing its causes and consequences, and assessing its 
likelihood to persist in the absence of (further) EU policy intervention. 

The  answer  to  this  question  should  give  policy-makers  the  information  needed  to 
decide whether there is a problem for which a policy response may be warranted. 

19 

 
Better regulation is about regulating only when necessary and in a proportionate manner. 
High quality policy proposals are built on a clear problem definition and understanding 
of the underlying factors and behaviours (so-called “problem drivers”). The first step of 
an IA, therefore, is to (i) verify the existence of a problem and identify who is affected; 
(ii) estimate the problem's scale and analyse its underlying causes and consequences; and 
(iii) identify the EU-dimension and assess the likelihood that the problem will persist. A 
key input to this assessment should be relevant evaluations or Fitness Checks of existing 
policy frameworks as well as stakeholder feed-back.  

A  problem  can  be  caused  by  several  factors,  such  as  the  existence  of  market  failures, 
behavioural biases, regulatory inefficiencies or the need to ensure respect of fundamental 
rights.  It  may  already  have  negative  consequences  or  simply  present  a  risk  of  negative 
occurrences. Developing a clear understanding of these underlying factors is important, 
using relevant internal and external expertise including scientific advice.  

It  is  equally  important  to  make  clear  in  in  the  analysis  how  individuals,  enterprises  or 
other actors are affected by the problem:  

•  How much does the "problem" affect their daily life?  

•  Whose behaviour would have to change for the situation to improve?  

Addressing these questions will ensure that the analysis stays concrete, focused, close to 
stakeholders'  concerns  and  mindful  of  the  practical  implications  of  any  initiative.  This 
will  facilitate  the  subsequent  identification  of  proportionate  policy  alternatives  and 
analysis of impacts. 

The problem description in the IA Report should be clear and specific. It should focus 
on  the  issues  to  be  addressed  by  the  initiative  under  consideration,  avoiding  lengthy 
presentations of general issues and/or Commission objectives in the relevant policy area.  

2.2. 

    Question 2: 

Why should the EU act? 

Having established the existence of a problem, its scale and the causes, the IA analysis 
should verify whether Member States alone could resolve it sufficiently and whether the 
EU has the competence to act (i.e. a legal basis), and would be best placed to do so.  

The answer to this question should give policy-makers the information needed to decide 
whether a policy response at the EU level is needed.  

The fact that the Union has the competence to address a problem (i.e. that there is a legal 
basis for it) does not automatically mean the EU is best placed to solve it. In areas that 
fall outside its exclusive competence, the Union must act in accordance with the principle 
of  subsidiarity21,  i.e.  act  only  where  Union  action  would  be  more  effective  than  action 
taken by the Member States at central, regional or local level. 

The  IA  should  verify  whether  EU  action  in  areas  outside  its  exclusive  competence  is 
compatible with the principle of subsidiarity. This is not to be taken for granted and it is 
important to remember that, pursuant to the Treaty of Lisbon, the respect of the principle 

21   See Article 5 of the Treaty on European Union. 

20 

 
                                                 
of  subsidiarity  is  closely  scrutinised  by  the  other  EU  institutions  and  by  national 
Parliaments  and  that  Union  acts  can  be  annulled  by  the  Court  for  non-respect  of  the 
principle22.  

When assessing whether or not the subsidiarity principle is respected the following key 
questions should be reviewed: whether the problem addressed has transnational aspects 
which cannot be adequately addressed by action by Member States and whether action at 
EU  level  would  produce  greater  benefits  compared  with  action  at  the  level  of  Member 
States due to its scale or effectiveness.  

This assessment is likely to be an iterative process. Preliminary analyses in the Inception 
IA  and  early  in  the  IA  process  should  clarify  the  legal  basis  and  indicate  whether 
advancing further at EU level would make sense. A final verification of compliance with 
the subsidiarity principle will only be possible once all relevant information is collected 
and  the  analysis  of  impacts  is  completed.  In  addition,  the  assessment  of  whether  an 
initiative is proportionate is clearly linked to the assessment of subsidiarity and the need 
to match the nature and intensity of a given measure to the identified problem. 

Assessing subsidiarity necessarily involves elements of political judgement, particularly 
when  evidence  is  inconclusive  and/or  stakeholder  views  diverge.  All  elements  should, 
therefore, be presented objectively in the IA Report, providing the basis for a political 
appreciation by the College. General statements and circular reasoning should be avoided 
in favour of concrete arguments, specific to the issues being analysed and substantiated 
with qualitative, and where possible, quantitative evidence. 

2.3. 

Question 3: What should be achieved? 

The IA should set out what EU policy should achieve. 

The objectives of policy action should be clearly identified, including the level of policy 
ambition  and  the  criteria  against  which  alternative  policy  options  would  be  compared 
and the success of any initiative assessed.  

For reasons of transparency and accountability, any EU policy intervention should have 
clear objectives. These should help in:  

•  Establishing  the  logical  chain  between  the  identified  problems  and  the  solutions 

considered;  

•  Clarifying the relationship between an initiative's specific goals and any horizontal EU 

objectives and any other agreed political goals in the area; 

•  Highlighting any trade-off between policy goals; 

•  Setting out the criteria for comparing the different policy options; 

•  Defining  indicators  to  measure  performance  and  progress  towards  the  declared 

objectives; 

22   http://ec.europa.eu/dgs/secretariat_general/relations/relations_other/npo/  

21 

 
                                                 
•  Establishing 

the  operational  monitoring  and  evaluation  framework  for 

the 

implemented policy measure.  

Objectives  should  be  as  S.M.A.R.T.23  as  possible.  Providing  general  objectives  is 
important  to  put  the  proposed  initiative  into  the  overall  context  of  the  Union's  policies 
and  to  assess  later  if  and  how  the  initiative  has  contributed.  However,  the  IA  Report 
should focus on the presentation of the more specific and operational objectives (for the 
preferred  option)  the  proposed  initiative  aims  to  achieve.  For  non-legislative  policy 
initiatives, it may be sufficient to set out the general and specific objectives, leaving the 
definition of more detailed operational objectives to the relevant follow-up initiatives.   

2.4. 

      Question 4:  What are the various options to achieve the objectives? 

There  are  different  ways  to  achieve  policy  objectives.  The  IA  should  allow  for  an 
informed  decision  about  which  one  to  pursue.  To  do  so,  available  options  should  be 
identified  and  screened  with  a  view  to  selecting  the  most  relevant  ones  for  further 
analysis and comparison. 

At the end of this process, the most relevant alternative policy options should have been 
identified for further examination in the impact analysis stage.  

It  is  important  to  consult  widely  about  alternatives,  think  outside  the  box  and  give  due 
consideration  to  all  different  options.  This  is  one  of  the  key  functions  of  an  impact 
assessment process. When well done, this is perhaps the impact assessment component 
most  appreciated  by  external  stakeholders.  When  badly  done,  it  tends  to  be  the  most 
criticised  and  significantly  undermines  the  credibility  of  the  whole  exercise  and  its 
usefulness for political decision making. Keeping an open mind is important even if, in 
many  cases,  the  IA  analysis  may  start  from  an  idea,  stakeholder  view  or  political 
statement, about what a policy proposal may look like. Often there is already an existing 
policy  framework  in  place  in  the  area  under  analysis  and  this  affects  the  breadth  of 
choices realistically available but initial ideas should be comprehensively tested in the IA 
process.  

However, existing policies may have fallen short of their objectives, proved too costly or 
no  longer  be  fit  for  purpose.  Also,  views  on  the  best  policy  typically  differ  (among 
stakeholders,  Member  States,  policy-makers,  Commission  services  and  experts).  In 
addition,  a  solid  justification  should  be  given  for  any  relevant  option  that  is  discarded 
early on. 

This should be done through an iterative process:  

(1) 

Start by considering the widest range of policy alternatives both in terms of 
content and instruments. Consider regulatory and non-regulatory means, less or 
more prescriptive measures, actions at national, EU and international level.  

When  identifying  options,  the  guiding  principle  should  be  whether  and  how  a  certain 
measure could influence the drivers of the problem and change the relevant behaviours in 
a way that would lead towards the desired objectives. The IA Report will need to show 

23   Specific, Measurable, Achievable, Relevant and Time-bound. 

22 

 
                                                 
that there is a clear logic between the problems, objectives and policy interventions under 
consideration. 

When designing the policy options, always consider: 

•  The  option  of  changing  nothing  (also  known  as  the  "baseline"):  The  “baseline 
scenario” should always be developed and used as the benchmark against which 
the  alternative  options  should  be  compared.  As  such,  it  should  take  account  of 
both national and EU policies in place and reflect possible developments of these 
in the absence of new EU-level action. It should also try to anticipate important 
technological or societal developments such as the pervasive role of the internet 
and other ICTs; 

•  The option of improving implementation and enforcement of existing legislation; 

or doing less / simplifying existing legislation; 

•  Options that take account of new technological developments. All new initiatives 
should be "digital and internet ready" and operate effectively both in the digital 
and the physical worlds24; 

•  Alternative policy approaches: e.g. different policy content / approaches to reach 

the objective; 

•  Alternative  policy  instruments:  e.g.  non-regulatory  alternatives;  self-  or  co-
international 

regulation25;  market-based  solutions,  regulatory  alternatives; 
standards26, and their mix; 

•  Alternative  scope:  for  instance,  is  the  "think  small  first"  principle  taken  into 
account;  are  micro-enterprises  excluded  from  the  scope  of  any  proposed 
legislation27. 

Consider  options  which  have  been  proposed  by  stakeholders28  and/or  are  likely  to  be 
proposed  during  the  legislative  process  but  do  not  discard  a  priori  options  with  little 
support or facing strong opposition29.  

24   Adaptive Governance and Internet inclusive Legislation 

25   See 

the  principles 

for  better 

self- 

and 

co-regulation 

at  https://ec.europa.eu/digital-

agenda/en/news/principles-better-self-and-co-regulation-and-establishment-community-practice 

26   The IA Report will need to recall the reasons for any divergence from international standards – where 
they  exists  –  as  well  as  from  regulation  with  similar  ambition  in  major  jurisdictions  whenever 
regulatory divergence may have a significant negative impact on trade and investment flows. Possible 
inconsistencies with obligations undertaken at the WTO or in international agreements should also be 
explained. 

27   Where micro-enterprises must be covered by legislative proposals for public policy reasons recourse to 
adapted  solutions  and  lighter  regimes  will  be  sought  concerning  all  forms  of  regulatory  burden 
including,  in  particular  regarding  administrative  requirements  –  see  COM(2011)  803  final  'Adapting 
EU regulation to the needs of micro-enterprises'.  

28   For  example,  from  stakeholders,  experts,  Member  States,  other  EU  institutions  and  third  country 

partners.  

23 

 
                                                 
(2) 

Screen  the  previously  identified  policy  alternatives.    In  many  cases,  little 
analysis  will  be  needed  to  justify  discarding  some  alternatives  (e.g.  those  not 
technically  feasible,  not  legally  viable,  difficult  to  implement,  disrespecting 
fundamental  rights  or  with  other  unacceptable  or  disproportionate  impacts). 
Options that clearly restrict the scope for national decision making over what is 
needed to achieve the objectives satisfactorily should also be abandoned early on 
(as they would fail to respect the principle of proportionality).  

(3) 

Having  screened  the  options,  the  most  relevant  ones  should  be  retained, 
together with the baseline, for further detailed examination.  

•  "Straw  man"  options  (i.e.  clearly  more  costly  or  less  effective  alternatives 
retained only to highlight the benefits of the preferred option) should be avoided. 
They  do  not  strengthen  the  argument  for  any  preferred  option  but  rather 
undermine the credibility of the IA; 

•  If it is difficult to identify at least two credible alternatives on top of the baseline, 
make  an  extra  effort  to  think  'outside  of  the  box'  (e.g.  have  all  choices  been 
considered?).  If  there  are  no  other  alternatives,  the  focus  of  the  subsequent 
analysis should be on determining the detailed design of the retained option, for 
example,  by  considering  alternative  "sub-options"  for  some  of  the  individual 
elements of the proposal or different implementation modes; 

•  After a first assessment of impacts, it may be necessary to go back to the drawing 
board  and  experiment  with  modifications  to  the  original  alternatives  to  further 
improve  them.  This  will  typically  be  the  case  when  options  fail  to  meet  the 
objectives 
to 
disproportionate  negative  effects  (of  any  type,  for  instance,  on  fundamental 
rights,  SMEs,  competitiveness,  trade  partners,  regions,  developing  countries, 
etc.).  An  option  should  not  be  judged  inferior  before  having  reviewed  possible 
improvements and/or mitigating measures to reduce its negative impacts.  

in  a  satisfactory  way  or  when 

they  are 

likely 

lead 

to 

The  IA  Report  does  not  need  to  describe  this  process  in  detail.  It  should,  however, 
demonstrate  that  all  relevant  options  have  been  considered,  taking  into  account 
stakeholders’  views  and  justifying  why  some  options  were  discarded  without  a  full 
assessment  of  their  impacts.  A  sufficiently  detailed  description  of  the  alternatives 
retained should be provided.   

A  particularly  strong  justification  should  be  provided  when,  exceptionally,  only  one 
option is retained for full assessment against the baseline.    

2.5. 

 Question 5: What are the impacts of the different policy options and who 
will be affected? 

Once a set of policy options is selected, a robust assessment should be carried out of 
their economic, social and environmental impacts and of who will be affected.   

At the end of this process, policy-makers should know to what extent different policy 

29   If such options are exceptionally excluded early on, this should be clearly spelled out alongside a solid 

justification.  

24 

 
                                                                                                                                                 
options  would  meet  their  objectives,  with  what  benefits,  at  what  cost,  with  what 
implications for different stakeholders, and at what risk of unintended consequences.  

To support policy decisions that deliver the best balance between benefits and costs, the 
IA  analysis  must  assess  all  the  relevant  advantages  and  disadvantages  of  the  retained 
policy alternatives ("the options") against the reference of the baseline. Once again, it is 
best to do this through an iterative process that starts with a wide reach and then focusses, 
and  deepens,  the  analysis  on  the  most  relevant  impacts,  being  ready  to  go  back  and 
improve the retained options before finalizing.  

Using internal and external expertise along with stakeholders' knowledge is particularly 
helpful when analysing impacts. The consultation strategy, any external studies and the 
ISG work should be organised in a manner which allows views to be collected and results 
tested with regard to all elements of the impact analysis.    

2.5.1. 

Identify all potential impacts of the options.  

For all retained options, the impact assessment should specify how they would tackle the 
identified problems and meet the policy objectives.  

To do this, there is a need first to identify the changes that a proposal would imply for 
those  affected,  notably  those  who  would  have  to  comply  with  any  new  legislative 
requirement,  those  who  would  have  to  implement  and  enforce  it  and  those  who  are 
expected to be the final beneficiaries:  

•  What actions and measures would affected parties need to take (to comply or to 

enforce compliance)?;  

•  Would these realistically be taken (balance between compliance costs and costs 

for public authorities involved in ensuring compliance)?;  

•  Would this allow the objectives to be reached?  

Answering  these  questions  at  the  very  beginning  of  the  analysis  is  important  to  ensure 
that the technical assessment of the impacts remains concrete and closely related to the 
practical implications of the various policy options.    

Answering such questions will also highlight how different options can trigger different 
changes  and  thus  have  different  types  of  impacts.  A  wide  range  of  possible  impacts 
should  be  reviewed  across  the  economic,  social  and  environmental  policy  areas,  going 
beyond the most obvious consequences of the proposed policy. All potentially important 
impacts  should  be  identified  regardless  of  whether  or  not  it  will  be  possible  to  assess 
them  precisely.  It  is  important  not  to  "miss"  a  significant  impact  as  this  may  affect  the 
overall comparison of options or weaken the case for the Commission's proposal later on. 
The impact assessments should, in particular, examine the impact of the different options 
on  fundamental  rights,  when  such  an  assessment  is  relevant  and  address  the  potential 
exposure to fraud in the context of spending programmes. 

Potentially important indirect impacts should also be considered, i.e. positive or negative 
consequences  that  are  incidental  to  the  main  purpose  of  the  initiative  (such  as  those 
stemming from an increase in the accumulated costs borne by a party, evasive behaviour 
by those who need to comply, or positive spill-overs from one affected sector to another).  

25 

 
Both  positive  impacts  (i.e.  the  benefits)  as  well  as  negative  impacts  (i.e.  the  costs  or 
adverse  environmental  and  social  impacts)  should  be  identified.  A  positive  impact  for 
one party can be negative for another. It is therefore important to identify who would be 
specifically affected by each impact. 

It  is  also  likely  that  a  policy  option  will  require  some  sort  of  IT  system  or  network  to 
automate  business  processes,  publish/exchange  information,  deliver  online  services  via 
web-based Portals, etc. It means that the impact related to the implementation of new or 
the  adaptation  of  existing  ICT  solutions  should be assessed. The possibility  of  re-using 
what  exists  already  and  not  "reinvent  the  wheel"  should  not  be  overlooked.  A  "digital 
screening" and possible further ICT impact analysis may be needed (see the tool on ICT 
impacts in the BR toolbox). "  

At the end of this analysis, all potential impacts– positive or negative - should be mapped 
out according to their expected magnitude and likelihood and to the specific parties that 
would be affected. The following classifications can be used when describing identified 
impacts: 

•  Broad nature: economic, social and environmental. 

•  Specific  nature,  for  instance:  increases  (or  decreases)  in  compliance  costs,  i.e. 
those costs incurred by the relevant parties (businesses, citizens etc.) to comply 
with  any  new  legislative  requirement,  their  sub-components  (administrative 
burdens,  labour  costs;  equipment  costs  etc.)  and  the  administration  and 
enforcement  costs  incurred  by  the  responsible  authorities;  gains  (or  falls)  in 
market efficiency, competitiveness, innovation; impacts on health, quality of the 
environment,  combating  climate  change,  levels  of  education  and  training, 
fundamental rights, employment and skills, social inclusion, poverty etc.;  

•  Relation with the underlying initiative: direct impacts are those directly generated 
by  a  policy  measure.  Indirect  (or  second-round)  impacts  arise  as  a  result  of  the 
behavioural changes prompted by the direct impacts and often affect third parties 
and can be just as significant as direct impacts. 

•  Affected parties, groups or regions: businesses of different sizes (SMEs or not), 
citizens,  workers,  learners,  consumers,  public  administrations,  third  country 
actors,  developing  countries,  different  territories  and  regions  (less  developed  or 
prosperous regions, cities, rural areas, border regions, overseas territories etc.); 

•  Frequency  and  certainty:  long/short  term,  one-off,  recurrent;  certain  or  likely 

(risks).  

While all of the above classifications are useful in principle, each analysis should use the 
categories that are most appropriate for the initiative at hand. Importantly, the IA Report 
should always be transparent about the methodological choices made to assess impacts, 
the underlying reasons particularly where non-standard approaches are deployed).    

2.5.2. 

Select the significant impacts.  

The  choice  of  impacts  to  be  retained  for  deeper  assessment  should  be  clearly  justified, 
taking account of their: 

•  Expected overall magnitude; 

26 

 
•  Relevance for specific stakeholders (enterprises and in particular SMEs, trading 
partners, economic sectors, consumers, learners, workers, public administrations, 
regions, developing countries etc.);  

•  Importance for Commission horizontal objectives and policies.  

The expected significance of impacts should be assessed in terms of changes relative to 
the  baseline.  In  making  the  selection,  the  principle  of  proportionate  analysis  should  be 
applied.  However,  it  is  important  not  to  leave  out  anything  that  is  of  relevance  for 
political  decision-making.  The  choice  should  take  account  of  stakeholders'  views  and 
relevant expertise, including within the Interservice Group.  

2.5.3.  Assess the most significant impacts.  
All  relevant  impacts  should  be  assessed  quantitatively,  if  possible30,  as  well  as 
qualitatively. Similarly, impacts should be monetized whenever possible.  

When  quantifying,  spurious  precision  should  be  avoided  and  ranges  provided, 
complemented  by  qualitative  comments.  In  many  cases,  quantification  will  rely  on  a 
given set of assumptions. These should be clearly presented. Whenever an assumption is 
particularly important or uncertain, sensitivity analysis should be used to check whether 
changing it would lead to significantly different results31. 

There are several methods to quantify impacts, both in terms of overall methodological 
approach32  and  specific  techniques  for  individual  types  of  impacts.  For  each  case,  the 
most  appropriate  method  should  be  used.  The  choice  of  method  should  be  clearly 
justified and explained in the IA Report. 

There is no best method which would apply to all possible Commission initiatives. There 
is,  however,  an  obligation  to  make  the  most  sensible  methodological  choice  given  the 
specificities of the case at hand, the availability of data and the requirement to carry out a 
proportionate analysis. In all cases, methodological complexity is not an excuse for not 
presenting  the  practical  implications  of  different  options  for  affected  parties.  Similarly, 
the fact that it may not be possible to monetize, or quantify, some impacts does not mean 
they  should  not  be  taken  into  due  account.  All  significant  impacts  should  be  analysed 
regardless of the nature of the available methodology to do so. 

When quantitative analysis is not possible or proportionate, impacts should be assessed 
qualitatively. Also the qualitative analysis should be rigorous and thorough, focussing on 
the practical implications for affected parties. As for quantitative assessments, important 
underlying assumptions will have to be stated. The conclusions should rely on available 
theory  and  evidence33,  including  on  illustrative  examples,  while  also  referring  to 
stakeholder  views.  They  should  acknowledge  limits  and  clearly  distinguish  between 

30   I.e. if they are susceptible of being quantitatively estimated through a sound methodology and if the 

required data exists and can be collected at a proportionate cost.  

31   Ranges of outcomes or confidence interval should then be provided rather than precise results.  

32   For instance, general vs. partial equilibrium approaches, bottom up vs. top down methods.  

33   For  instance  regarding  a  subset  of  the  targeted  sector  /  Member  States  for  which  data  and  reliable 

analyses are available.  

27 

 
                                                 
facts,  expert  opinions  and  stakeholder  views.  If  a  broad  order  of  magnitudes  cannot  be 
given, a qualitative reasoning should be provided of why one option is considered likely 
to have larger (or smaller) impacts than another. 

In the case of both quantitative and qualitative analysis, it is important to remember that:  

•  Changes should be assessed relative to the baseline scenario. Normally, this will 
evolve  overtime  (for  instance  as  a  result  of  on-going  policies).  Therefore, 
changes should not simply be determined relative to the current situation but to 
how the latter would evolve in the absence of a new planned initiative; 

•  Different  impacts  are  likely  to  occur  at  different  times  (with  costs  often  being 
incurred early on and benefits emerging only  later). This should be reflected in 
the  assessment,  discounting  monetized  estimates  as  appropriate  when  these  are 
available; 

•  Impacts should be assessed from the point of view of society as a whole although 
distributional effects and cumulative burdens on individual parties should also be 
proportionately assessed and considered. Whenever impacts are aggregated, you 
should  make  sure  you  avoid  any  double-counting  (for  instance,  businesses 
transferring  increased  compliance  costs  on  consumer  prices,  public  authorities 
imposing fees to cover for the costs of enforcing a regulation).  

Assessing impacts can be particularly challenging at the EU level. First, data across the 
EU  may  not  be  available  or  comparable.  Secondly,  final  impacts  will  often  depend  on 
Member  States'  choices  at  the  implementation  stage  (or  on  future  delegated  and 
implementing  acts).  It  is  often  difficult,  therefore,  to  provide  accurate  estimates,  at  the 
impacts  such  as  compliance  or 
Commission  proposal  stage,  even  of  direct 
implementation costs. Nevertheless, "known unknowns" should not be cast aside in the 
analysis. On the contrary, they should be readily acknowledged. In case of lack of data or 
uncertainties,  the  qualitative  assessment  needs  to  be  strengthened  (e.g.  based  on 
theoretical approaches), while being transparent about the impact that such uncertainties 
may have on the comparison of options. 

At the end of this analysis, there should be a solid understanding of the extent to which 
each option achieves the objectives, with what benefits and at what costs at the aggregate 
level and for affected parties. Potentially disproportionate impacts (e.g. on fundamental 
rights,  SMEs,  competitiveness,  specific  communities,  workers'  health  and  safety, 
employment, poverty, regions or Member States, developing countries etc.) should have 
been  identified  along  with  any  significant  risk  of  unintended  consequences.  This  will 
help  compare  the  options  in  terms  of  their  coherence  with  horizontal  EU  objectives  as 
well as to identify potential mitigating measures for any preferred option.  

transparent  about  any 

The  IA  Report  should  summarize  the  results  of  the  impact  analysis  in  an  accessible 
manner.  It  should  be  clear  and 
limitations  (e.g.  data, 
methodological) and risks of unintended consequences. While the more technical aspects 
of the assessment are important, the final concrete impacts for individuals, enterprises or 
public  administrations,  and  where  possible  the  societal  or  geographical  distribution  of 
such  impacts,  should  be  kept  at  the  forefront  of  the  analysis  and  the  IA  Report. 
Aggregated costs and benefits should be clearly distinguished from distributional impacts 
and transfers. The choices made in the selection of relevant impacts and in the analytical 
methods should be clearly justified in the annexes. Data sources should be provided and 
underlying assumptions illustrated in relation to any quantification. 

28 

 
2.6. 

   Question 6: 

How do the options compare? 

Based  on  the  assessment  of  the  various  impacts  and  their  distribution  across  affected 
stakeholders,  the  IA  should  compare  the  different  options  with  regard  to  their 
effectiveness,  efficiency  and  coherence,  as  well  as  their  compliance  with  the 
proportionality principle. 

At  the  end  of  this  process,  the  IA  should  present  the  relevant  information  for  policy-
makers to make a choice and, where appropriate, suggest a preferred option.  

Having assessed the likely economic, social and environmental impacts, as well as their 
distribution  across  stakeholders,  the  IA  analysis  should  bring  together  the  results  in  a 
clear comparison of the options. This should facilitate the identification of the preferred 
option. 

Cost-benefit  analysis,  cost-effectiveness  analysis,  compliance  cost  analysis  and  multi-
criteria analysis are the most commonly used methods to do this. Choosing one (or a mix 
of  them)  depends  on  several  factors  including  the  number  and  nature  of  impacts  and 
objectives,  the  extent  to  which  benefits  and  costs  can  be  monetized  (or  quantified)  and 
the relevance of distributional concerns.  

The IA does not need to identify a preferred option, but it should attempt objectively to 
compare the options against common criteria, in particular: 

•  The  extent 

to  which  different  options  would  achieve 

the  objectives 

(effectiveness);  

•  The benefits versus the costs (efficiency);34  

•  The  coherence  of  each  option  with  the  overarching  objectives  of  EU  policies 

(coherence). 

The compliance of the options with the proportionality principle, and in particular of any 
preferred option, should also be considered by answering additional questions such as: 

•  Whether  the  option  goes  beyond  what  is  necessary  to  achieve  the  objectives 

satisfactorily?;  

•  Whether  the  scope  of  the  option  is  limited  to  those  aspects  that  Member  States 
cannot achieve satisfactorily on their own, and where the Union can do better?;  

•  Whether costs for the Union, national governments, regional or local authorities, 
economic  operators  or  citizens,  are  minimised  in  relation  to  the  objective  to  be 
achieved?; 

•  Whether the form of action (choice of instrument) is as simple as possible, and 
the  objective  and  effective 

coherent  with  satisfactory  achievement  of 
enforcement?  

34   Alternatively the extent to which objectives can be achieved for a given cost, a.k.a. cost effectiveness. 

29 

 
                                                 
When comparing the options, the underlying analysis and hypotheses should be kept in 
mind: the robustness of the comparison should be verified, sensitivities and limitations of 
the  analysis  highlighted,  trade-offs  between  objectives  flagged  and  uncertainties  that 
could significantly affect the result of the comparison referred to.  

The IA Report should present the results of this comparison in an accessible manner, for 
example  in  a  summary  table,  clearly  flowing  from  the  previous  analysis.  When  no 
preferred  option  is  indicated,  this  should  be  clearly  stated.  In  case  the  IA  leads  to  the 
conclusion that no proposal is warranted, this should be communicated in the IA Report 
that should still be published. 

2.7. 

Question 7:  How would actual impacts be monitored and evaluated?  

Having the entire policy cycle in mind, the IA should identify monitoring and ex-post 
evaluation  arrangements  to  track  whether  the  policy  measure  actually  delivers  the 
intended results and to inform any future revisions of the policy.  

At  the  end  of  this  process,  policy-makers  should  know  how  the  policy  will  be 
monitored and evaluated, allowing for future policy-adjustments whenever needed.  

Policy makers and stakeholders need to be able to check if policy implementation is ‘on 
track’, and the extent to which it is achieving its objectives, at what costs and with what 
benefits.  To  do  so,  one  should  start  from  a  clear  idea  of  how  the  situation  should  look 
like in the future if the initiative is successful. What will be different and for whom after 
a few years of implementation? How can this be verified?  

Actual  results  are  likely  to  differ  from  those  estimated  or  desired,  regardless  of  the 
quality of the IA and the proposed initiative. However, when a policy is not achieving its 
objectives,  or  the  costs  and  negative  impacts  are  more  significant  than  expected,  it  is 
important  to  know  if  this  is  the  result  of  unexpected  exogenous  factors,  problems  with 
the  design  of  the  policy,  amendments  introduced  during  the  legislative  process  (if 
relevant) or poor implementation.  

Monitoring and evaluation arrangements (including the definition of a set of indicators), 
provide valuable information in this regard. The IA should outline, therefore, what these 
arrangements will be. Core indicators should be defined for the main policy objectives in 
relation  to  the  preferred  option  where  one  is  stated.  Where  no  preferred  option  is 
presented  in  the  IA  Report,  monitoring  and  indicators  should  refer  to  the  specific 
objectives of the initiative.  

Indicators  must  allow  measuring  to  what  extent  the  objectives  of  the  policy  have  been 
achieved (and on potential negative impacts). Indicators on transposition, implementation 
and enforcement in Member States might also be useful.  

Underlying data should be easily available and the cost of data collection, proportionate. 
If lack of data was a significant concern for the IA, the IA Report should sketch out how 
this issue will be addressed for the future policy evaluation.  

According to the Commission's evaluation rules, all its activities have to be evaluated on 
a regular basis. For spending programmes evaluation is compulsory (including anti-fraud 
measures) and many other policy instruments also contain a review clause. Where, such a 
review is requested it should be based on an evaluation of the existing policy framework. 
Evaluations should be announced and described in advance, with a clear indication of the 

30 

 
timing, the main focus and purpose, who will be responsible for carrying them out, and to 
whom the results will be addressed.  

The  IA  Report  should  sketch  out  core  indicators  relating  to  the  operational  objectives 
and the main monitoring and evaluation provisions of the preferred option (including any 
relevant data collection aspects).   

3. 

SUMMING IT ALL UP: THE IMPACT ASSESSMENT REPORT  

The Impact Assessment Report should summarise and present the final results of the IA 
analysis. Annexes should be used for the more detailed / technical parts of the analysis. 
The Report should be presented as a Staff Working Document. 

As the previous pages have made clear, the IA Report is not the IA. The IA is an iterative 
process supporting the design of a policy proposal. The IA Report is a document through 
which  you  communicate  the  results  of  this  process  to  policy  makers  to  inform  their 
decision  and  to  stakeholders,  to  show  the  evidence  basis  on  which  a  Commission  has 
taken a decision.   

The IA Report should be transparent, objective and balanced.  

While  IA  analysis  can  be  complex,  the  IA  Report  should  be  written  with  non-expert 
readers in mind. In most cases, a main report of some 30-40 pages of text, accompanied 
by annexes for the more detailed technical parts of the analysis, should be sufficient.  

A reader should easily be able to understand what the problem being addressed is, why 
EU level action is appropriate, what the pros and cons of different courses of action are 
and  who  would  be  affected.  Stakeholder  views  and  how  these  have  been  considered 
should be transparently referred to throughout the IA Report. All external material used 
(studies, reports, scientific findings etc.) should also be systematically referenced. 

Certain elements must be included in the final IA Report. These include (i) a description 
of  the  environmental,  social  and  economic  impacts  and  an  explicit statement  if  any  of 
these are not considered significant; (ii) a clear description of who will be affected by the 
initiative  and  how;  (iii)  impacts  on  SMEs;  (iv)  impacts  on  competitiveness;  and  (v)  a 
detailed description of the consultation strategy and the results obtained from it. 

To allow for an easily accessible overview of the main findings of the IA, an executive 
summary sheet of a maximum of 2 pages should also be prepared. It should be presented 
as a separate Staff Working Document and be translated into all EU languages. 

4. 

FROM IMPACT ASSESSMENT TO POLICY-MAKING  

The  IA  process  should  have  allowed  for  the  identification  of  one  (or  more)  preferred 
options. When  developing the proposal, it is useful  to  double-check  a  number  of  key 
questions to ensure that the final proposal linked to the IA is fit for purpose and in line 
with better regulation principles.  

Policy-makers should cross-check that the final proposal would contribute positively to 
regulatory fitness in the EU.  

It is useful to test the preferred option for its regulatory fitness at the end of the process. 
This  is  not  necessary  when  the  impact  assessment  indicates  no  (further)  EU  policy 

31 

 
response  is  needed.  However,  it  should  always  be  done  when  a  legislative  option  has 
been chosen.  

Verifying regulatory fitness for a proposal requires checking issues some of which will 
have already been touched upon during the impact assessment process:  

•  Does the draft (legal) text fully comply with subsidiarity?; 

•  Is the proposal proportionate?;  

•  Is it in line with the Charter of Fundamental Rights?; 

•  Are  the  draft  legal  provisions  as  simple  and  clear  as  possible?  Do  they  avoid 
unnecessary deviations from international standards? Can they be made easier to 
implement?;  

•  Has  the  "Think  Small  First"  principle  been  applied?  Could  microenterprises  be 

exempted from the scope of the initiative, and if not, why?; 

•  Do the draft legal provisions take into account the challenges and opportunities 
offered  by  developments  in  ICTs  (e.g.  simplified  monitoring  and  information 
reporting)?;   

•  Without  affecting  the  overall  achievement  of  the  objectives,  is  there  scope  to 

modify some of the legal provisions so as to reduce: 

•  Expected compliance costs for SMEs and any other relevant stakeholder; 

•  Any negative impact on sectoral EU competitiveness; 

•  Any  potential  negative  impacts  on  international  trade,  developing 

countries etc.; 

•  Impact on human rights in the partner country in relation to its obligations 
arising  from  international  treaties  (for  proposals  with  an  external 
dimension); 

•  Any  other  impact  (including  social,  environment,  or  those  on  specific 

groups, territorial areas, Member States, innovation, etc.).   

•  Without affecting the overall cost of the proposal, are there still ways to modify 
some  of  the  proposed  legal  provision  so  as  to  increase  the  effectiveness  and 
coherence of the proposed text?  

For legislative initiatives, the Commission's political appreciation of its final proposal is 
set out in the Explanatory Memorandum, which describes how the proposal conforms 
to  the  subsidiarity,  proportionality  and  better  regulation  principles.  After  Commission 
adoption  of  the  concerned  policy  initiative,  the  IA  is  transmitted  to  the  European 
Parliament  and  to  the  Council  who  are  likely  to  discuss  its  content  and  quality.    The 
European  Parliament  and  the  Council  have  made  commitments  to  provide  additional 
analyses to support any substantive amendments they propose.  

32 

 
 
Chapter IV 
Guidelines on preparing proposals, implementation, and 
transposition 

Key requirements 

•  Implementation  Plans  (SWD)  must  accompany  proposals  for  major  Directives  and 
should describe implementation challenges and relevant support actions to be taken by 
the Commission. 

•  Use  available  guidance  to  prepare  high  quality  legal  text  and  explanatory 
memorandum.  The  need  for  Explanatory  Documents  relating  to  major  Directives 
must be justified in the proposal. 

•  A  compliance  assessment  of  EU  Directives  must  be  carried  out  in  two  stages:  (1) 
timely and systematic check whether Member States have transposed Union law; (2) a 
timely and systematic conformity check of national transposing measures against the 
relevant Union legislation. 

1. 

INTRODUCTION 

Who Should Read these Guidelines? 

All  officials 
implementation/application should read these guidelines.  

the  preparation  of  an 

involved 

in 

initiative  and 

its  subsequent 

Why is good implementation important? 

Effective application of EU law is essential if the European Union is to meet its policy 
objectives.  While  Member  States  are  responsible  for  the  timely  and  accurate 
transposition  of  directives  as  well  as  the  correct  application  of  the  entire  acquis35,  the 
Commission has to monitor the Member States’ efforts and ensure that their legislation 
complies with Union law. The Commission has three important roles: 

First,  during  the  preparation  of  a  new  initiative  where  issues  and  problems  related  to 
implementation and application should be anticipated and taken into account. Second, the 
Commission  should  prepare  well-drafted,  high  quality  legal  texts  that  are  easy  to 
understand and implement. Third, the Commission needs to have thorough and consistent 
information on implementation/application in the Member States. It needs rigorously to 
examine  national  implementing  measures  to  ensure  that  the  laws  of  the  Member  States 
are fully compliant with the Union acquis. 

The following aims to assist services to take implementation aspects better into account 
when  preparing  new  initiatives  and  to  help  them  in  identifying  ways  to  check  the 
implementation  of  EU  law.  This  chapter  complements  the  subsequent  chapter  which 
deals with how to monitor the application/effects of Union policies. 

35   Article 291 (1) TFEU.  

 
 
 
 
                                                 
2. 

ANTICIPATE  IMPLEMENTATION  PROBLEMS  AND  FACILITATE  TRANSPOSITION: 
IMPLEMENTATION PLANS

36

Good implementation starts with a good impact assessment and stakeholder consultation. 
For  each  policy  option,  the  analysis  should  explicitly  address  any  clearly  identifiable 
problems  or  issues  which  are  likely  to  be  encountered  with  its  implementation  and 
application  by  the  Member  States  or  other  local  or  regional  authorities  or  enforcement 
agencies. A key issue will be to assess the balance between the efforts of those who are 
will  be  directly  regulated  or  obliged  to  comply  with  a  new  initiative  and  the  efforts  of 
public  authorities  who  will  be  responsible  for  enforcement  in  terms  of  costs  and  other 
resource implications. The analysis should also build on any relevant evaluation that may 
have identified implementation problems associated with existing legislation. 

Box 1. Regulatory costs versus Enforcment costs for public authorities 

•  Legal  rules  have  to  be  monitored  and  enforced  to  be  effective.  Depending  on  the 
policy option chosen, enforcement may be very cheap or costly for public authorities. 

•  Abolishing  business  reporting  obligations  on  health  and  safety  measures  does  not 
remove  the  desirability  of  monitoring  health  and  safety  at  the  workplace.  This  will 
likely lead to more monitoring and inspection by public authorities; 

•  Speed limits enforced via police officers will be more costly than by using centralised 
speed  cameras  (entailing  one-off  capital  costs  and  recurring  maintenance  costs  and 
centralised administration issuance of fines); 

•  Enabling private actions for antitrust damages creates greater demand (and backlogs) 

and costs for the use of the legal system which falls on public authorities. 

In parallel, the consultation strategy should ensure that it targets the views of those public 
authorities  who  will  ultimately  be  responsible  for  the  effective  application  of  the 
initiative  and  associated  enforcement  activities.  This  will  ensure 
that  relevant 
implementation experience and expertise is collected and built into the initiative. 

The  Commission  should  also  support  Member  States  in  their  transposition  and 
implementation efforts by preparing implementation plans (IPs) for certain directives and 
regulations.  The  preparation  of  an  IP  aims  at  facilitating  the  timely  and  effective 
application  of  law,  fully  recognising  the  responsibility  for  the  latter  rests  with  the 
Member States37. 

When is an implementation plan needed? 

An IP should be prepared when the implementation of the legal act concerned, because of 
its nature or complexity, could benefit or be facilitated by supportive measures.  

IPs would normally be required for framework directives; directives with a large scope 
containing a large number of legal obligations; directives aimed at the full harmonisation 
of  a  policy  area,  and  directives  having  a  significant  impact  on  or  amending  various 
branches of the national legal order. In contrast, IPs would normally not be required for 

36   This  guidance  replaces  the  guidance  provided  by  the  Annexe  II  of  the  Note  dated  7/01/2013 

(Ares(2013) 12012). 

37   Article 288 TFEU 

34 

 
  
                                                 
directives  with  a  limited  or  very  technical  scope  or  which  do  not  require  transposition 
measures38, directives containing only one or a very limited number of legal obligations 
and  directives  amending  only  one  or  a  very  limited  number  of  legal  obligations  of  an 
existing directive.  

Concerning  regulations,  an  IP  would  be  recommended  in  case  the  implementation 
requirements are similar to those of a directive and supporting measures to facilitate the 
application  by  Member  States  would  be  beneficial.  The  DGs  are  responsible  for 
identifying  where  an  IP  for  regulations  concerning  their  particular  sectors  would  be 
necessary. 

Inter-service Consultation on the implementation plan 

The preparation of an IP should be flagged in agenda planning before launching an ISC. 
If no IP is planned, this should be justified in Agenda Planning. The SG will verify and if 
necessary discuss justifications. The IP should be prepared as a staff working document 
and  accompany  the  proposal  in  inter-service  consultation  and  as  background  to  the 
discussions  in  the  institutions.  If  the  proposal  evolves  significantly  in  the  legislative 
process, the IP will need to be updated. More guidance is provided in the Toolbox. 

What should an implementation plan contain? 

The  preparation  of  the  Implementation  Plan  should  start  with  an  assessment  of  the 
challenges which the Member States will face in applying the legislation. On the basis of 
the assessment, The IP should set out the various types of support which the Commission 
services will provide to the Member States to assist them in their implementation of the 
legislation.  It  should  also  set  out  the  monitoring  arrangements  designed  to  ensure  the 
availability  of  strong  data  and  other  evidence  to  track  progress  and  report  on  the 
performance  of  the  measure.  A  template  for  such  an  implementation  is  provided  in  the 
tool box. 

3. 

BETTER DRAFTING OF LEGAL ACTS 

Union  legislation  should  be  well  drafted  in  order  to  ensure  it  adequately  reflects  the 
intention  of  the  legislator  and  can  achieve  its  regulatory  aim.    Respect  for  the 
requirements of legislative drafting plays an important role in achieving the goal of legal 
certainty. If legislation is clear it can be implemented effectively, citizens and economic 
actors can know their rights and obligations and the courts can enforce them.  

Where can legislative drafting rules be found? 

The  importance  of  good  legislative  drafting  has  been  recognised  for  many  years  in  the 
different  institutions.  The  Interinstitutional  Agreements  on  the  quality  of  drafting  of 
legislation39  and  on  the  use  of  codification40  and  recast41  techniques  have  established a 
common approach.  

38   For example, Directives updating provisions related to (inter-) institutional issues such as comitology. 

39   Interinstitutional Agreement of 22 December 1998 on common guidelines for the quality of drafting of 

Community legislation (OJ C 73, 17.3.1999, p.1). 

40   Interinstitutional  Agreement  of  20  December  1994  on  an  accelerated  working  method  for  official 

codification of legislative texts (OJ C102, 4.4.1996, p.2). 

35 

 
                                                 
The  Joint  Practical  Guide  for  persons  involved  in  the  drafting  of  European  Union 
legislation42  builds  upon  the  agreed  principles.  In  addition,  the  Quality  of  Legislation 
team in the Legal Service has developed the Drafters' Assistance Package (DAP)43 which 
offers guidance, step by step, on how to draft legal acts and is based on the Joint Practical 
Guide. It even provides useful links and suggested wording. In practice, if your draft is of 
high quality it is less likely to be altered later in the legislative procedure. 

DAP only covers the legal act itself and does not deal with other related documents, such 
as  the  impact  assessment  or  the  explanatory  memorandum.  DAP  is  integrated  into  the 
Legiswrite models but can also be accessed as a stand-alone wiki. 

Box 1. How to prepare a good quality legal act – some important steps 

•  Use the correct LegisWrite model whenever you draft a legal act; 

•  Follow  the  rules  in  the  Joint  Practical  Guide  and  check  in  DAP  whenever  you  have 

questions as to how a provision should be drafted; 

•  Bear in mind that your text may need to be translated into other languages; 

•  Check that references are accurate. 

What is the Recast technique? 

Recast is a tool for the simplification of Union legislation. It is a technique which makes 
it possible to amend an earlier act (which itself may have already been amended) while 
immediately  codifying  the  new  amendments  with  the  existing  provisions  of  the  earlier 
act.  It  results  in  a  new  legal  act  which  incorporates  both  the  amendments  and  the 
unchanged provisions. The new legal act replaces the earlier one which is repealed.  

The  recast  of  legislative  acts  is  governed  by  specific  rules  laid  down  in  the 
Interinstitutional Agreement on a more structured use of the recasting technique for legal 
acts. The Agreement sets the "rules of the game" necessary for preserving both the right 
of initiative of the Commission and the right of the legislator to make amendments to the 
Commission's proposal in a recast exercise.  

Advice should always be sought from the Legal Service when determining whether 
recast is appropriate in a given case. In particular, the Quality of Legislation Team can 
offer guidance and practical assistance44 and should be contacted at an early stage. More 
information is also available in DAP. 

 What is Codification? 

41   Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique 

for legal acts (OJ C77, 28.3.2001, p.1). 

42   Joint  Practical  Guide  of  the  European  Parliament,  the  Council  and  the  Commission  for  persons 
legislation 

involved 
http://www.cc.cec/wikis/display/dap/Legislative+drafting+resources  

European 

drafting 

Union 

the 

of 

in 

43   http://www.cc.cec/wikis/display/dap/Home     

44   SJ juristes-reviseurs@ec.europa.eu  

36 

 
 
                                                                                                                                                 
Codification  brings  together  all  of  the  provisions  of  an  existing  legal  act  and  all  of  its 
amendments in a new legal act replacing the earlier one, which is repealed.  

It is governed by the Interinstitutional Agreement on an accelerated working method for 
official codification of legislative texts.  

Codification – which passes through the full legislative process - should not be confused 
with the unofficial consolidation carried out by the Publications Office which results in 
texts which are not legally binding.  

Codification is carried out on the basis of initiatives undertaken in cooperation between 
the  Legal  Service  and  the  operational  DGs,  with  the  Legal  Service  acting  as  lead  DG.   
The  Legal  Service  is  therefore  responsible  for  the  preparation  of  the  proposal  for  a 
codification  and  for  following  up  the  procedure  leading  to  the  adoption  of  the  new, 
codified  act.  The  distinctive  feature  of  codification  is  that,  in  contrast  to  recast,  no 
substantive changes may be made to the earlier act.  

Other issues to consider when preparing proposals for legislation 

The  Commission  is  committed  to  the  use  of  common  commencement  dates  for  EU 
regulations  and  decisions  affecting  businesses  generally.  Proposed  Decisions, 
Regulations and delegated regulations should, where possible, stipulate a commencement 
date of 1  January or 1 July in a given year to help simplify the actions of affected parties. 

Sunset clauses may be used to prevent obsolete legal provisions from remaining in force. 
They terminate or repeal some or all provisions of a legal text after a specific date unless 
further legislative action is taken to extend them. As such, they can be used to direct an 
assessment of the continuing need for legislation and may be particularly relevant where 
"emergency"  legislation  is  adopted,  for  example,  in  respond  to  a  particular  crisis  or 
unexpected issue etc.  

Box 2. Example of a sunset clauses 

•  The EU Agency on Network and Information security was initially established with a 

time limited mandate. 

Legislative proposals should also foresee when, how and on what basis legislation will 
be  evaluated  in  the  future.  The  next  chapter  describes  how  monitoring  arrangements 
should  be  conceived  at  the  design  stage  of  a  new  initiative  in  order  to  support  such 
evaluations. 

The explanatory memorandum45 

The purpose of the explanatory memorandum is to explain the Commission's proposal. It 
is  required  for  all  legislative  proposals  non-legislative  proposals  for  adoption  by  the 
Council or by the EP and the Council46. It is transmitted to the other Institutions together 
with  the  accompanying  proposal  and  is  available  to  the  public.  The  explanatory 

45   See tool on how to draft an explanatory memorandum for more detail. 

46   A simpler explanatory memorandum also exists for delegated acts which are not directly covered by 

this guideline although elements of the guide and tool may still be relevant. 

37 

 
                                                 
memorandum is, however, not published in the Official Journal and will not become part 
of the act to be adopted.  

The  explanatory  memorandum  should  be  used  to  communicate  the  following  issues 
which are important for the Commission's Better Regulation Agenda:  

•  Legal  basis:  Explain  the  legal  basis  of  the  proposal.  Where  several  feasible  options 

exist, justify the choice on the basis of objective criteria.  

•  Subsidiarity  (for  non-exclusive  competence):  Explain  the  Union  dimension  of  the 
problem. Describe why the objectives of the proposal cannot be adequately achieved 
by the Member States (necessity test). Explain why action at EU level, by reason of its 
scale  or  effects,  would  produce  clear  benefits  as  opposed  to  action  at  Member  State 
level (effectiveness test). 

•  Proportionality:  Explain  the  scope  of  the  proposal  and  why  it  is  considered 
proportionate  (i.e.  not  going  beyond  what  it  necessary  to  achieve  the  objectives). 
Explain  the  choice  of  instrument  and  why  it  is  considered  the  most  suitable  act  for 
achieving the objective.  

•  Summarise results of any ex-post evaluations/Fitness Checks and clarify the link to 

the identified problem(s) addressed by the proposal. 

•  Describe the results of the stakeholder consultations undertaken including the views 

of respondents and how these were taken into account in the proposal.  

•  A short summary on the external expertise on which the Commission has relied upon 

(approach, range, advice received and used, public available information). 

•  Impact assessment:  

•  Where  the  initiative  is  not  supported  by  an  impact  assessment,  explain  the 

reasons why with reference to the associated Roadmap and toolbox47.  

•  In  addition,  a  justification  must  be  given  where  the  impact  assessment  is  not 

supported by a positive opinion from the Regulatory Scrutiny Board.  

•  Explain  which  policy  alternatives  were  examined,  how  they  compare  and  why 

the final proposal was considered to be the preferred policy choice.  

•  Describe the main economic, social and environmental impacts of the preferred 

option, who would be affected and how; 

•  Where  the  final  policy  proposal  deviates  from  the  options  assessed  in  the  IA, 

clarify the likely impacts of such a change. 

•  Regulatory fitness and simplification:  

47   See tool on when an IA is necessary. 

38 

 
                                                 
•  Mention,  with  quantified  estimates  wherever  possible,  the  extent  to  which  the 
proposal will reduce regulatory burden or simplify the existing legal framework.  

•  Outline whether and how the proposal exempts micro-enterprises (and reasons if 
no  exemption  is  proposed)  or  provides  a  lighter  regulatory  regime  for  SMEs 
generally including how it minimizes compliance costs for SMEs.  

•  The  possible  negative  impacts  on  sectoral  EU  competitiveness  or  international 

trade should also be specified; 

•  Explain  how  the  initiative  is  "digital  and  internet  ready"  so  that  initiatives  are 
appropriate for both the digital and physical worlds (see the tool on ICT impacts 
in the BR toolbox). 

•  Implementation  plans,  monitoring,  evaluation  and  reporting  arrangements: 
Refer  to  the  implementation  planning  associated  with  the  measure,  including  to  the 
monitoring,  evaluation  and  reporting  framework  to  be  applied  to  assist  with  its 
implementation and application and to report on its performance. 

•  Explanatory  documents  (for  directives):  Explain 

if 

the  proposal  requires 

Explanatory Documents on the transposition and why (see later section). 

4. 

THE  LINK  BETWEEN EU LAW  AND MEMBER STATE  TRANSPOSING  MEASURES: 
EXPLANATORY DOCUMENTS

48

Why  is  it  important  to  make  the  link  between  EU  law  and  national  transposition 
measures?  

The  Commission  is  the  guardian  of  the  Treaties.  That  means  that  it  has  to  monitor  the 
application of EU law and should be able to identify clearly how Member State measures 
link with EU legislation49.  

The  European  institutions  have  agreed  on  a  set  of  joint  political  declarations,  which 
indicate how the Commission can be provided with this information on the transposition 
of  directives.  The  Member  States  undertake  to  accompany  the  notification  of 
transposition  measures  with  one  or  more  so-called  'explanatory  documents',  which  can 
take  the  form  of  correlation  tables  or  other  documents  serving  the  same  purpose.  The 
Commission  must  first  justify  the  need  for,  and  the  proportionality  of,  providing  such 
documents on a case by case basis, when presenting its proposals. 

When is it justified to ask for explanatory documents? 

The Commission lead service should justify the request for explanatory documents. The 
key question to be answered is whether the document is necessary for the Commission to 
carry out its task of overseeing the transposition of directives. 

The Commission should weigh up the following: 

48   This guidance replaces the guidance provided in the Note dated 20/12/2011 (Ares(2011) 1386838. 

49   The policy is contained in a (1) joint political declaration between the Commission and the Member 
State (OJ 2011/C 369/02); and (2) a joint declaration between the EP, Council and Commission (OJ 
2011/C 369/03). 

39 

 
  
                                                 
•  The  complexity  of  the  directive  concerned  –  the  more  complex,  the  more  likely  an 

explanatory document is needed; 

•  The complexity of the area concerned in view of its transposition into the legal order 

of the member States;  

•  Possible  additional  administrative  burden  –  is  the  request  proportionate  to  the 

legislative imitative being prepared? 

The Commission must be sure that the document is essential in order for it to carry out its 
task  of  overseeing  the  application  of  Union  law.  To  facilitate  this  assessment,  the 
Commission services should consider the following. 

Explanatory documents would normally not be required if the notification of individual 
transposition measures itself is largely self-explanatory. This usually applies to: 

•  Directives containing only one or a very limited number of legal obligations; 

•  Directives  amending  only  one  or  a  very  limited  number  of  legal  obligations  of  an 

existing Directive; 

•  Directives  concerning  well  delimited  and  not  heavily  regulated  domains  at  national 

level. 

By contrast, explanatory documents are usually needed for: 

•  Framework directives; 

•  Directives with a large scope containing a large number of legal obligations; 

•  Directives aimed at full harmonisation of a policy area; 

•  Directives  having  a  significant  impact  or  amending  various  branches  of  the  national 

legal order. 

It should be noted that the Commission has also committed itself vis-à-vis the European 
Parliament to justify also all cases in which it will not request explanatory documents (in 
addition  to  the  scenario  of  positive  requests  as  contained  in  the  political  declarations). 
Although such justification may be shorter than those requiring explanatory documents, 
they should also be based on the considerations as mentioned above. 

Justification for Explanatory Documents in Commission Proposals 

For  all  new  proposals  for  Directives,  including  delegated  acts,  a  justification  should  be 
prepared as part of the explanatory memorandum. 

In cases where the services propose to request explanatory documents, a standard recital 
should directly be included in the proposed directive: 

"In  accordance  with  the  Joint  Political  Declaration  of  Member  States  and  the 
Commission on explanatory documents of 28 September 2011, Member States have 
undertaken  to  accompany,  in  justified  cases,  the  notification  of  their  transposition 
measures  with  one  or  more  documents  explaining  the  relationship  between  the 

40 

 
components  of  a  directive  and  the  corresponding  parts  of  national  transposition 
instruments." 

For  all  directives  to  be  adopted  through  comitology,  the  justification  for  explanatory 
documents should be provided orally to the Member States during committee discussions 
(this can then be reflected in the summary record of the committee meeting).  

MONITORING IMPLEMENTATION 

5. 
Compliance assessment50 

The Commission is committed to more systematic monitoring of the implementation of 
directives.51  This  is  done,  inter  alia,  by  conducting  compliance  assessments  of  both 
transposition and conformity. Compliance assessment is two-staged: 

First,  the  services  carry  out  a  transposition  check,  assessing  the  status  of  the 
transposition  of  the  directive  concerned.    If  directives  are  not  completely  transposed, 
services  propose  to  launch  an  infringement  procedure  under  Article  258  or,  where  a 
legislative Directive is concerned, in conjunction with Article 260(3) TFEU52. 

Once  the  transposition  check  is  finalised  and  once  possible  ensuing  infringement 
procedures for failure to communicate transposition measures have been closed, services 
should immediately start the second stage of the compliance assessment, the conformity 
check without excluding the possibility of launching conformity checks on parts of the 
Directive  that  have  already  been  transposed  completely.  This  check  aims  at  getting  a 
meaningful  picture  of  the  conformity  of  the  legislation  of  the  Member  State  with  the 
Directive. 

Monitoring application  

Good implementation also involves the monitoring of the application of legislation on the 
ground.  This  is  to  ensure  that  the  intervention  performs  as  intended  and  to  provide 
information so that corrective action can be taken if it is not performing or if there have 
been unintended consequences etc.  

The  Commission  may  decide  that  a  "soft"  policy  instrument  is  preferable  to  a  pure 
legislative  approach  (although  thiese  may  be  combined).  This  may  include  voluntary 
agreements or other forms of self-co-regulatory action which are described more fully in 
the  tool  on  policy  instruments.  In  such  cases,  there  will  also  be  a  need  to  monitor  the 
performance  of  such  approaches  against  the  policy/legislative  principles  underpinning 
them25, the commitments made by the parties and the objectives of the initiative.  

The  next  chapter  deals  in  more  detail  with  monitoring  the  effects  over  time  associated 
with a given intervention. 

50   This term covers transposition and conformity check 

51   COM (2012) 746 final.  

52   See  Commission  Communication,  Implementation  of  Article  260(3)  of  the  Treaty,  OJ  C12/02  of  15 

Jan. 2011, para. 7.  

41 

 
 
                                                 
Chapter V 
Guidelines on monitoring 

Key requirements 

•  Make sure it will be possible to assess the performance of an initiative while avoiding 

unnecessary or duplicative requests for data and information. 

•  Impact assessment to set out the future monitoring and evaluation arrangements which 

should identify data needs and data. 

•  Establish  monitoring  arrangements  and  indicators  that  will  generate  the  necessary 
information  for  subsequent  evaluation  of  the  performance  of  the  intervention  while 
minimising data collection costs. 

•  Ensure  that  monitoring  arrangements  initially  sketched  out  in  the  impact  assessment 
are  updated  to  reflect  the  actual  proposal  presented  by  the  Commission  and  what  is 
finally agreed by the Legislator. 

1. 

INTRODUCTION 

Who Should Read These Guidelines? 

All  officials  involved  in  the  preparation  of  an  impact  assessment  (IA)  and  related 
Commission  proposals  and  Implementing  Plans  should  read  these  guidelines 
including  officials  and  managers  who  are  responsible  for  ensuring  the  quality  of 
monitoring  systems  in  place  in  the  lead  DG.  The  guidelines  are  recommended  also  to 
those involved in the Strategic Planning and Programming cycle, in particular those who 
prepare Management Plans, and those involved in subsequent evaluations to allow them 
to understand how a monitoring system is set up. 

This chapter concentrates on monitoring during the application of the intervention on the 
ground.53  More  detailed  guidance  is  also  available  in  the  separate  "toolbox"  which 
accompanies this guide.  

What is monitoring and when is it required? 

Monitoring generates evidence on an intervention’s activities and impacts over time in a 
continuous and systematic way. A monitoring system is a necessary and integral part of 
Better Regulation helping to: 

•  Identify whether a policy is being applied on the ground as expected;  

•  Addressing any implementation problems of an intervention; and/or 

•  Identifying  whether  further  action  is  required  to  ensure  that  it  can  achieve  its 

intended objectives. 

53   Clearly, issues such as the timely and correct transposition of Union legislation into national rules and 
their appropriate enforcement will also influence the observed performance of the intervention. These 
aspects are dealt with in the preceding chapter. 

 
 
                                                 
Good monitoring generates factual data to improve the quality of future evaluation and 
impact assessment. It provides time series data that, under normal circumstances, will be 
more reliable in explaining behavior than one-off data collection exercises. 

The  monitoring  (and  evaluation)  arrangements  should  first  be  outlined  in  the  impact 
assessment and revised, if necessary, following adoption of the intervention by the Co-
legislator.  This  will  allow  more  efficient  evidence  gathering  to  be  integrated  into  the 
intervention  and  permit  the  maximum  exploitation  of  existing  sources  thereby 
minimising  costs  for  those  involved  in  providing,  collecting,  storing  and  disseminating 
evidence. 

In principle, part of the evaluation should assess the adequacy of the monitoring system 
in place. 

2. 

THE KEY QUESTIONS AND PRINCIPLES OF MONITORING  

Monitoring needs to consider the objectives of the intervention and what evidence need 
to be collected to track its progress and performance. This is linked to understanding both 
the logic of the intervention and how the evidence collected will be used. Consideration 
needs  to  be  given  to  the  frequency  and  method  of  collection,  different  sources  of 
evidence  taking  into  account  what  is  already  available  and  cost  for  different  parties 
involved. This leads to a series of questions. 

The key questions a monitoring system must address 

1  What evidence needs to be collected? 

2  When and how should evidence be collected? 

3  Who will collect the evidence and from whom? 

In answering these questions several governing principles need to be followed.  

Governing principles 

Comprehensive:  the  monitoring  system  put  in  place  must  cover  the  objectives  of  the 
intervention. Whilst high level monitoring of key indicators linked to general objectives 
is  likely  to  exist  already,  new  monitoring  arrangements  may  need  to  be  identified  for 
specific  or  operational  objectives.  Although  monitoring  systems  generally  collect 
objective  (e.g.  factual,  quantitative)  evidence,  it  is  also  possible  to  put  in  place 
monitoring  of  subjective  (e.g.  opinion  based,  qualitative)  evidence  such  as  periodic 
opinion polls or surveys. 

Proportionate:  the  system  put  in  place  needs  to  reflect  the  importance  placed  on 
different  aspects  of  the  intervention.  Collection  of  evidence  comes  at  a  cost  and  care 
should be taken to challenge the necessity of each (new) monitoring requirement being 
considered.  

Minimise  overlap:  The  EU,  Member  States,  Agencies,  international  organisations 
collect  a  lot  of  evidence.  It  is  important  to  know  what  we  have  already  and  when  and 
how it is collected. This should help to avoid duplication and the creation of unnecessary 
data collection burdens by concentrating only on the gaps which need to be filled. 

43 

 
Timeliness:  Whilst the monitoring system should be set up as soon as possible after the 
intervention  is  agreed,  this  does  not  mean  that  all  evidence  needs  to  be  collected  from 
that point onwards. Not all evidence needs to be collected at the same time – sometimes 
it  is  better  to  collect  evidence  as  it  happens,  other  times  it  can  be  done  later. 
Consideration also needs to be given to when the evidence will be used – different legal 
requirements may play a role not just in deciding what is needed, but also the when it is 
collected.  

Accessibility: in principle, all evidence gathered should be made available to the general 
public.  Unless  data  includes  confidential  elements,  it  is  recommended  that  it  is  made 
available  via  the  EU  Open  Data  Portal54  which  provides  a  single  point  of  access  to  a 
growing  range  of  data  produced  by  the  institutions  and  other  bodies  of  the  European 
Union. Such information has a significant potential not just to increase transparency but 
also,  through  its  re-use,  to  create  new  products  and  services  and  efficiency  gains  in 
administrations.  Facilitating  access  to  public  data  will  also  foster  the  participation  of 
citizens in policy making processes. 

As mentioned above, monitoring plays a key role in providing part of the evidence base. 
Good  monitoring  is  in  particular  important  for  evaluation,  which  cannot  be  undertaken 
satisfactorily  without  relevant  information/evidence  to  assess  the  performance  of  the 
intervention55.  

Early planning of data needs 

Considering the evidence required early at the impact assessment stage (or policy design 
stage) brings a number of advantages: 

•  The optimal evidence requirements can be identified more readily which increases the 

chances it will be available throughout the policy lifecycle; 

•  Requirements  can  be  designed  into  the  intervention  so  that  evidence  is  delivered 
routinely so that the costs/impacts for providers and handlers can be clearly assessed; 

•  Baselines and counterfactual data can be collected. 

However,  the  final  arrangements  can  only  be  established  once  the  content  of  the 
intervention is clear i.e. following adoption by the Legislator. 

2.1. 

Question 1: What evidence needs to be collected? 

Consideration should be given to what evidence need to be gathered to give reliable and 
consistent measurement against the objectives of a given intervention.  

54   For more information see: http://open-data.europa.eu/en/data/  

55   Monitoring information is also relevant for a DG's Management Plan and the Commission's strategic 
planning and programming cycle. It provides an overview of all inputs that contribute to EU policies 
and  the  results  and  impacts  of  those  policies.  It  also  presents  the  elements  of  the  performance 
framework to which the work of the DG contributes. The Annual Activity Report gives an account of 
progress  made  towards  key  policy  objectives  and  core  activities  of  a  DG  taking  into  account  the 
corresponding resources used each year. To enhance performance reporting on both spending and non-
spending activities, DGs now include output, result and impact indicators for all activities which need 
to be accompanied by good monitoring arrangements to assess the impact of EU policies on society. 

44 

 
                                                 
A good monitoring system will cover all parts of the implementation and application of 
an intervention.  

The first step in defining a monitoring system is to carefully consider the objectives of 
the  intervention  and  the  reporting  requirements  that  have  been  set.  Different  reports 
contain different kinds of evidence, serving different purposes, particularly depending on 
the time they are written in the policy cycle.  

In relation to an evaluation, evidence can be collected and help to assess: 

•  Whether  the  intervention  logic  underpinning  the  original  initiative  at  the  impact 

assessment stage remains valid;  

•  Whether  the  foreseen  steps/milestones  necessary  for  delivering  the  policy  objectives 
have been completed successfully or progress against specified targets is on track; 

•  The  numbers  and  characteristics  of  those  who  might  be  affected  by  a  given 
intervention  –  such  information  being  useful  in  future  stakeholder  consultation 
strategies; 

•  The  costs  and  benefits  to  society.  This  could  cover  a  wide  range,  from  individual 
stakeholders  to  particular  interest  groups  such  as  public  authorities,  businesses  by 
sector, NGOs etc.; 

•  The wider impacts of the intervention. 

Box 1. Implementation reports and evaluation 

Implementation  reports  are  generally  focussed  on  the  Member  States'  implementation 
measures.  They  often  have  a  wider  scope  than  pure  legal  compliance  reports  but 
nonetheless build on existing conformity/compliance checking. They do not constitute a 
full  evaluation  as  they  do  not  look  into  how  and  why  the  intervention  has  performed. 
They describe the state of play based on limited monitoring data and provide information 
on progress against agreed timetables or objectives. 

In  some  cases,  the  requirement  to  prepare  implementation  reports  may  be  repeated 
(typically  3-5  years).  However,  consideration  should  be  given  to  the  advantages  of 
undertaking a full evaluation of the measure, rather than preparing a further (and limited) 
report on implementation. 

2.2. 

Question 2: When and how should evidence be collected? 

Once it is clear what evidence is needed, careful consideration needs to be given to the 
timing and process of its collection. 

To  set  up  a  good  monitoring  system  a  clear  link  needs  to  be  established  between 
objectives  and  indicators  bearing  in  mind  the  arrangements  needed  to  collect  the 
necessary new evidence in time to meet reporting requirements.  

It is important to know what and when is already being collected to avoid asking for the 
same data several times or creating new burden by asking  for extra  data  when existing 
data cover broadly the same ground.  

Monitoring/reporting  requirements  can  create  administrative  burdens  which  should  be 
kept  to  what  is  absolutely  necessary.  Smart  use  of  technology  can  reduce  costs  – 
electronic  data  capture  at  the  point  of  origin  is  cheaper  than  periodic  interviews  or 

45 

 
surveys. Over the longer term, systematic monitoring systems can be more efficient than 
one-off exercises and provide information on trends.  

For every initiative checks on existing tools, systems, practices, standards etc. should be 
made to identify what can be reused – to avoid reinventing the wheel or developing new 
systems for every policy area. As much as possible all these systems and solutions should 
be "open", i.e. favouring the use of open standards and of open data.  

Timing  of  the  evidence  gathering  needs  to  be  considered  vis-à-vis  progress  of 
intervention's  implementation  and  reporting  requirements.  The  desired  outcome  of  a 
policy intervention may not materialise for many years and this should be reflected in the 
monitoring arrangements. Where it takes too long to capture the final policy outcome or 
where  it  will  not  be  possible  the  outcome  it  may  be  necessary  to  monitor  against 
intermediate or proxy outcomes. Again, these should be identified early in the design of 
the initiative. 

Careful  planning  for  future  data  collection  is  also  important  to  ensure  that  possible 
ethical/privacy issues are identified and fully addressed, that the costs of data provision 
are  transparently  presented  and  that  arrangements  to  ensure  data  quality  assurance, 
storage and transmission are planned for.  

Indicators 

A good monitoring system links objectives with their relevant indicators. 

−  Output indicators: These relate to the specific deliverables of the intervention such 
as a new database for collecting monitoring results or a new CEN standard etc.). 

−  Outcome/Result indicators: These match the immediate effects of the intervention 

with particular reference to the direct addressees. 

−  Impact indicators: These relate to the intended outcome of the intervention in terms 
of  impact  on  the  wider  economy/society  beyond  those  directly  affected  by  the 
intervention. 

The  Common  tool  on  monitoring  and  indicators  sets  out  in  more  detail  how  to  define 
objectives and indicators which link the impact assessment and evaluation phases of the 
policy cycle. 

Each indicator should be clearly defined. Even slight differences in definition can have 
important implications both in terms of accuracy/reliability and data collection costs. A 
clear  definition,  including  the  unit  of  measurement,  is  particularly  important  as  data 
need to be aggregated at the EU level. Aggregation of data can also become problematic 
if the definition is not provided or if indicators are not calculated on a consistent basis.  

The  frequency  of  measurements  has  implications  for  the  overall  costs  of  data 
collection.  As regards sources of data – it is always advisable to exploit existing data 
sources as much as possible in order to reduce costs.  

The  baseline  allows  for  assessment  of  the  progress  made.  If  we  don't  know  where  we 
started, we can't say how much progress has been made. Targets are not always set for 
initiatives,  but  if  they  are,  they  should  have  a  deadline  for  attainment  and  a  numerical 
value. 

46 

 
Table 1: Indicators56 

Indicator 

Definition 

Unit of 
measurement

Source 
of data 

Frequency of 
measurement

Baseline  Target 

2.3. 

Question 3: Who will collect the evidence and from whom? 

Consideration should be given to who will have responsibility for gathering data and who 
will be responsible for providing it. 

Evidence should be gathered at appropriate level with consideration to cumulative burden 
it could trigger. 

There should be a clear understanding of what evidence needs to be collected and what 
existing data and data collection paths already exist. In the EU context, this requires an 
understanding  of  the  different  systems  in  the  Member  States'.  In  principle,  evidence 
should  be  collected  centrally,  at  a  Member  State  level  or  through  a  national  or  EU 
coordinating body.  

Evidence providers will vary according to the intervention and the indicator. Sometimes 
evidence is needed from individual stakeholder (e.g. businesses or citizens); sometimes it 
can  come  from  a  collective  body  (e.g.  business  or  consumer  organisation, 
local/regional/national  level).  Every  effort  should  be  made  not  to  impose  excessive 
burdens on the stakeholder in terms of monitoring requirements. 

56   Indicators should be presented by their level, e.g input, result and impact indicators. 

47 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Chapter VI 
Guidelines on evaluation and Fitness Checks 

Key requirements 

•  Evaluations must be followed by an Interservice Steering Group (ISG) composed of a 
minimum of three members, including a representative from the lead DG's evaluation 
function.  For  Fitness  Checks  a  representative  from  the  Secretariat  General  must  be 
included in the ISG. 

•  An evaluation roadmap summarising the design, purpose and scope of the upcoming 
evaluation must be published for all evaluations and Fitness Checks and stakeholders 
must be able to provide feedback on it. 

•  All  evaluations  must  follow  a  clearly  defined,  robust  methodology  intended  to 
produce  objective  findings.  As  a  minimum,  evaluations  must  assess  effectiveness, 
efficiency, relevance, coherence and EU added value or explain why this is not done 
in the evaluation roadmap.  

•  Evaluations  and  Fitness  Checks  must  assess  all  significant  economic,  social  and 
environmental  impacts  of  EU  interventions  (with  particular  emphasis  on  those 
identified in a previous IA). 

•  As  part  of  a  broader  consultation  strategy  to  target  relevant  stakeholders  and  collect 
evidence, a 12-week internet-based public consultation should generally be conducted, 
covering all of the main elements of the evaluation. 

•  A SWD must be prepared for all evaluations. This SWD must contain information and 
annexes  as  indicated  in  the  toolbox  and  be  complemented  by  a  2  page  executive 
summary available in FR, DE and EN. 

•  The following files related to the evaluation must be published centrally: 

(1) 

(2) 

(3) 

The evaluation roadmap;  

(if  applicable)  Terms  of  Reference,  final  contractors'  report  and  associated 
Quality Assessment;  

The  Staff  Working  Document  and  its  executive  summary  (in  FR,  DE  and 
EN); 

(4) 

(if applicable) The Regulatory Scrutiny Board opinion. 

•  At the end of an evaluation, appropriate follow up actions must be identified and fed 

into the decision making cycle.  

•  Evaluation  findings  must  pinpoint  areas  where  there  is  potential  to  reduce 

inefficiencies, including regulatory burden and simplify the intervention.   

48 

 
 
 
 
 
1. 

INTRODUCTION 

Who Should Read these Guidelines? 

All officials involved in the preparation of an evaluation or a Fitness Check should 
read  these  guidelines57  including  officials  and  managers  in  the  evaluation  function  of 
the lead DG.  

These  guidelines  apply  to  evaluations  (i.e.  Fitness  Checks,  final,  ex-post  and  interim 
evaluations)  of  EU  policies  and  interventions  governed  by  legal  instruments,  including 
the Financial Regulation and its Implementing Rules. 

It may not be necessary to apply them fully when evaluating: 

•  Individual  intervention  projects,  groups  of  projects  or  sub-activities  where  their 
findings  will  feed  into  an  overarching  evaluation.  This  is  particularly  relevant  for 
external  programmes  where 
from  evaluations  of  country 
findings  coming 
programmes, specific delivery methods/tools or elements of certain themes feed into 
major evaluations including legal instruments; 

•  The  internal  administrative  policies  of  the  Commission  (Translation,  Interpretation, 
Human Resources and Security, the Publications Office and certain areas of Eurostat). 
For these a more proportionate approach should be applied. 

Such  evaluations  should  nonetheless  follow  the  definition,  concepts  and  principles  of 
evaluation  presented  here.  Where  a  Directorate  General  has doubts about the  degree  of 
application,  they  should  agree  the  approach  with  the  Secretariat  General,  preferably 
during the annual discussions establishing the evaluation plan. 

What is evaluation?  

Evaluation  is  defined  as  an  evidence-based  judgement  of  the  extent  to  which  an 
intervention has: 

-  Been effective and efficient,  

-  Been relevant given the needs and its objectives, 

-  Been coherent both internally and with other EU policy interventions and 

-  Achieved EU added-value.  

Evaluation  is  a  tool  to  help  the  Commission  assess  the  actual  performance  of  EU 
interventions  compared  to  initial  expectations.  By  evaluating,  the  Commission  takes  a 
critical look at whether EU activities are fit for purpose and deliver, at minimum cost, the 
desired  changes  to  European  businesses  and  citizens  and  contribute  to  the  EU's  global 
role. Evaluation also provides a key opportunity to engage stakeholders and the general 
public, encouraging feedback on how EU interventions are perceived.  

Evaluation  is  not  an  assessment  of  what  has  happened;  it  also  considers  why 
something has occurred (the role of the EU intervention) and, if possible, how much has 
changed  as  a  consequence.  It  should  look  at  the  wider  perspective  and  provide  an 
independent and objective judgement of the situation based on the evidence available.  

57   The  guidelines  set  out  the  key  requirements  and  obligations  for  evaluation  and  replace  the  previous 

(2004) guidelines and (2007) standards. 

49 

 
 
                                                 
Evaluation  looks  for  evidence  of  causality  –  i.e.  did  the  intervention  bring  about  the 
expected changes or were there other unintended or unexpected changes. Beyond listing 
outputs and describing changes, evaluations should seek to link changes in a situation to 
the EU intervention. To be most effective, such evaluation should be carried out once the 
intervention has been implemented and sufficient time has passed to allow for changes to 
be identified and/or measured.  

An  evaluation  should  also  assess  the  strength  of  the  evidence  obtained,  and  the 
implications  for  the  robustness  of  the  conclusions  reached.  Although  there  are  many 
useful  activities  which  may  cover  some  of  these  elements  (e.g.  reports  particularly 
implementing  reports,  monitoring  exercises,  audit,  studies  including  cumulative  cost 
assessments) it is unlikely that any of these sources will contain sufficient information to 
qualify as an evaluation. 

What is a Fitness Check?  

Traditionally, Commission evaluations have been conducted on individual interventions, 
but  the  increased  focus  on  the  performance  has  led  to  the  creation  of  a  new  type  of 
evaluation - the Fitness Check58.  

A Fitness Check is like an evaluation of an individual intervention except that it covers a 
group  of  measures  which  have  some  relationship  with  each  other  which  justifies  their 
being evaluated together (normally a common set of objectives).  

A Fitness Check assesses whether the framework59 for a given sector is fit for purpose by 
assessing the performance of the relevant framework with respect to its policy objectives. 
A  Fitness  Check  should  pay  particular  attention  to  identifying  any  synergies  (e.g. 
improved  performance,  simplification,  lower  costs,  reduced  burdens)  or  inefficiencies 
(e.g. excessive burdens, overlaps, gaps, inconsistencies and/or obsolete measures) within 
the  group  of  measures  which  may  have  appeared  over  time,  and  help  to  identify  the 
cumulative impact of the interventions covered, covering both costs and benefits.  

The  evaluation  of  individual  interventions  and  Fitness  Checks  of  policy  areas  are 
complementary  and  mutually  reinforcing  tools.  While  evaluations  of  individual 
initiatives provide more details on particular elements, they do not always show the full 
picture and a more strategic and global view is often required. Fitness checks can group 
together  into  one  exercise  evaluations  that  would  otherwise  have  been  undertaken 
separately,  and  potentially  less  coherently.  Fitness  Checks  can  provide  economies  of 
scale  and  place  a  greater  focus  on  overall  objectives  and  performance.  Their  particular 
strength is in addressing the cumulative effects of the applicable framework - these are 
not addressed via evaluations of individual initiatives and the cumulative effects do not 
necessarily correspond to the sum of effects identified through evaluations of individual 
measures.  

58   The concept of a Fitness Check was introduced in COM (2010) 543 final – Smart Regulation in the 

European Union 

59   Such  a  framework  may  be  purely  regulatory,  but  is  often  a  mix  of  regulatory  and  non-regulatory 
actions and in some instances it can be wholly non-regulatory e.g. consisting of EU level strategies, 
guidance documents etc. 

50 

 
 
                                                 
Why do we evaluate? 

Evaluation  at  the  Commission  serves  several  purposes.  Although  the  importance  may 
differ, most evaluation results will contribute to:  

–  Timely  and  relevant  advice  to  decision-making  and  input  to  political  priority-
setting:  Evaluation  supports  decision-making,  contributing  to  strategic  planning  and 
to  the  design  of  future  interventions.  The  Commission  applies  the  "Evaluate  First" 
principle  to  make  sure  any  policy  decisions  take  into  due  account  the  lessons  from 
past  EU  Action.  Thus  for  instance,  lessons  learned  from  evaluation  should  be 
available and feed into IA work from the very beginning.  

–  Organisational  learning:  The  results  of  an  evaluation  can  be  used  to  improve  the 
quality  of  an  on-going  intervention.  Evaluations  should  identify  not  just  areas  for 
improvement  but  also  encourage  the  sharing  of  (good  and  bad)  practices  and 
achievements.  Evaluation  also  provides  the  opportunity  to  look  for  the  "unintended" 
and/or "unexpected" effects of EU action. 

–  Transparency  and  accountability:  All  stakeholders  and  the  general  public  have  a 

right to know what the EU has done and achieved.  

–  Efficient  resource  allocation:  Evaluation  results  contribute  to  a  more  efficient 
allocation  of  resources  between  interventions,  between  the  separate  elements  of  a 
specific programme or activity, or between activities. 

What are the requirements to evaluate? 

Evaluations are an essential step to manage and revise the existing body of EU legislation 
and policy and should precede impact assessment60. 

The Commission is committed to evaluate in a proportionate way all EU spending  and 
non-spending  activities  intended  to  have  an  impact  on  society  or  the  economy61.  A 
commitment to evaluation is included in Article 318 of the Treaty on the Functioning of 
the  European  Union  (TFEU).  Further  sector-specific  evaluation  requirements  are  also 
explicitly  included  in  the  EU  Treaties  in  the  area  of  justice,  freedom  and  security; 
common  security  and  defence  policy;  research,  technological  development  and  space; 
industry;  employment;  social  policy  and  public  health.  More  specific  requirements  are 
often written into individual legal acts. 

These  commitments  are  all  brought  together  under  the  Commission's  Internal  Control 
Standard 1462. 

Evaluation is required where: 

60   See  section  "Applying  Smart  Regulation  instruments",  Instructions  of  the  Secretary  General 
at: 

the  European  Commission  2014-2019  Working  Methods 

implementing 
https://myintracomm.ec.europa.eu/sg/comcab/pages/methods.aspx. 

available 

61   SEC (2007)213 Responding to Strategic Needs: Reinforcing the use of evaluation 

62   The internal control standards are available at: 

http://ec.europa.eu/budget/biblio/documents/control/control_en.cfm#ci_risk. 

51 

 
                                                 
•  The legal basis of the relevant intervention so requires (e.g. a  "review" clause where 
to  permit 

sufficient  operational/implementation  experience  has  accumulated 
evaluation and/or specific evaluation requirements);  

•  Indicated  by  the  Financial  Regulation  and  Rules  of  Application  (i.e.  for  all 
programmes and activities entailing significant overall spending (over €5 million);  

•  Indicated by Council Regulation (EU) 2015/323 on the financial regulation applicable 

to the 11th European Development Fund. 

Where  a  DG  has  doubts  about  the  degree  of  application,  they  should  contact  the 
Secretariat General. 

What are the procedural steps? 

The  time  needed  to  prepare  an  evaluation  will  vary  from  case  to  case.  Sufficient  time 
needs to be allocated to ensure that the evaluation can be conducted according to these 
guidelines and, where necessary, the Commission can report to the European Parliament 
and Council by the date set in the legal base. Where an evaluation is linked to a (review) 
clause that also provides an opportunity to present new proposals by a certain date, care 
must be taken to ensure that the planning allocates appropriate time for any subsequent 
impact assessment.  

The key steps in an evaluation are63: 

1.  Establish an inter-service steering group (ISG) to steer the evaluation, finalise 
the  roadmap,  help  establish  the  Terms  of  Reference  and  complete  the  Quality 
Assessment on the final report by any contractors. The ISG must be involved in 
all  the  key  steps  of  the  evaluation  and  be  composed  of  a  minimum  of  three 
members, including a representative from the lead DG's evaluation function. For 
Fitness Checks it must include a member representing the Secretariat General. 

2.  Draft  the  evaluation  roadmap  which  summarises  the  evaluation  design, 
including clear statements on the subject, purpose and scope of the evaluation, the 
issues to be addressed and the evidence that will be gathered. Publication of the 
roadmap  will  provide  greater  transparency  and  enable  stakeholders  to  provide 
their feedback. 

3.  Prepare a consultation strategy with the ISG, complying with the requirements 
set  out  in  Chapter  VII,  including  a  12  week  internet  based  public  open 
consultation64.  

63   Further  more  detailed  information  on  each  individual  step  is  provided  in  the  toolbox  Chapter  

"Evaluation and Fitness Checks". 

64   Without prejudice to the cases identified in box 1 and the general rules set out in COM(2002) 704, the 
consultation strategy should include a 12 week internet-based open public consultation at some point 
over the lifetime of the evaluation. Where the evaluation and IA are done "back to back" it is possible 
to conduct only one open public consultation as long as relevant stakeholders are consulted on all the 
main elements of the IA. Where the evaluation is of an activity conducted outside the EU or where the 
internet  is  not  a  practical  support  tool,  including  for  duly  justified  confidentiality  reasons,  this 
mandatory  open  public  consultation  may  be  waived  as  long  as  the  consultation  strategy  envisages 
appropriate tools to reach the relevant stakeholders. Before applying derogations, the DG must contact 
the Secretariat General. 

52 

 
 
                                                 
4.  Prepare  the  Staff  Working  Document  and  a  short  executive  summary 
presenting  the  findings  of  the  evaluation  process.  Depending  on  the  approach 
followed  this  will  either  draw  completely  on  the  work  of  a  contractor  or  bring 
together  the  work  of  the  Commission  Services  and  contractors.  For  "major"65 
evaluations,  the  draft  evaluation  SWD  must  be  submitted  to  the  RSB  and  its 
comments must be incorporated; 

5.  Launch the Inter Service Consultation for the SWD; 

6.  Publish  the  Staff  Working  Document  and  any  supporting  contractors'  report 
centrally and, where required by legal article, transmit these to the Parliament 
and the Council in a short report; 

7.  Disseminate the evaluation findings and encourage active discussion and debate 

on the findings with stakeholders; 

8.  Identify  any  appropriate  follow-up  actions  to  put  into  practice  the  lessons 
learned and feed the evaluation findings into the next step of the decision making 
cycle. Some of this information may already be included in the report to the co-
legislators. 

2. 

KEY PRINCIPLES AND CONCEPTS 

What are the principles? 

All evaluations should be of high quality and respect certain principles: 

Comprehensive:  The  definition  of  evaluation  deliberately  targets  five  criteria  – 
effectiveness, efficiency, relevance, coherence and EU added value66.  Other criteria may 
also be added as appropriate. 

Proportionate:  The  scope  and  analysis  conducted  must  be  tailored  to  the  particular 
intervention, its maturity and the data available67. For some criteria new data will need to 
be collected, analysed and compared with other findings; for others, a short summary can 
be  presented  based  on  existing  reports  and  information  or  providing  a  standard 
explanation (e.g. in areas where the EU has exclusive competence).  

Independent  and  Objective:  Robust  and  reliable  results  can  be  delivered  only  by 
independent and objective evaluations. An evaluation can be considered as independent 
when  evaluators:  (i)  carry  out  their  tasks  without  influence  or  pressure  from  the 
organisation; (ii) are given full access to all relevant information required; and (iii) have 
full autonomy in conducting and reporting their findings.  

65    Major evaluations capture REFIT evaluations, Fitness Checks; major MFF programme evaluations and 

any other evaluations which the RSB may scrutinise based on the DGs rolling evaluation plan. 

66    See Tool  "Identifying the evaluation criteria and questions" of the toolbox. 

67 

In  general  it  is  recommended  to  evaluate  only  once  sufficient  time  has  elapsed  from  the 
implementation of the intervention to allow at least 3 years of reasonably full data to be collected.   

53 

 
                                                 
Transparent  Judgement68:  Evaluators  must  make  judgements  based  on  the  evidence 
(good or bad) and analysis available. These judgements should be as specific as possible 
and  judgement  criteria  for  each  evaluation  question  (success  factors,  related  indicators, 
required evidence and information) should be clearly identified during the design of the 
evaluation. 

Evidence-based: Evaluations are based on the best available evidence (factual, opinion 
based etc.), which should be drawn from a diverse and appropriate range of methods and 
sources (triangulation). Not all sources of evidence are equally robust and consideration 
must be given as to when and how the evidence was collected and whether there is any 
bias  or  uncertainty  in  it.  Where  possible,  sensitivity  and/or  scenario  analysis  should  be 
conducted to help test robustness of the analysis69. Any limitations to the evidence used 
and  the  methodology  applied,  particularly  in  terms  of  their  ability  to  support  the 
conclusions, must be clearly explained.  

What are the concepts? 

Deciding when and how to evaluate requires careful consideration. There is no "one size 
fits  all"  rule,  reflecting  the  Commission's  decision  to  decentralise  evaluation  and  the 
different intervention life-cycles that exist. All interventions follow their own cycle and 
timeline for the desired results to manifest themselves. Often trade-offs need to be made 
between  when  and  how  to  conduct  the  evaluation  (in  order  to  feed  further  decision 
making process) and the amount of reliable data which is available.  

The  starting  point  for  an  evaluation  is  to  consider  the  intervention  logic  of  the 
policy/programme under review. 

Evaluations  look  back  at  the  performance  of  the  (completed  or  on-going)  intervention 
and  critically  compare  what  has  actually  happened  to  the  earlier  estimates  and 
assumptions of what was expected to happen. 

The evaluation design must thus be informed by any previous relevant impact assessment 
covering  the  intervention  being  evaluated.  Where  the  impact  assessment  has  paid 
particular attention to certain stakeholder groups, or categories of impacts, the subsequent 
evaluation  must  perform  the  corresponding  complementary  retrospective  analysis  or 
explain why this has not been possible70.  

Evaluations thus need to deconstruct the expected chain of events by using a simplified 
model of causality – showing how an intervention was triggered by a certain set of needs 
or  problems  occurring  within  a  certain  context  and  how  it  was  designed,  with  the 
intention of producing the desired changes.  

68   The  requirement  to  provide  judgements  can  be  a  critical  factor  distinguishing  an  evaluation  from  a 

study. 

69   See tool "Useful analytical methods to compare options or assess performance" of the toolbox. 

70   Care needs to be taken to consider how expected impacts may have altered as a result of changes to the 
proposal introduced during the adoption process, which may have been assessed in impact assessment 
work conducted by the co-legislators.    

54 

 
                                                 
Such  "cause  and  effect"  relationships  are  challenging  to  prove,  particularly  when 
evaluating  EU  policies  which  operate  in  a  complex  environment  influenced  by  a  wide 
range of factors falling both within and outside the scope of the EU intervention. 

When  evaluating  EU  legislation,  it  is  particularly  difficult  to  identify  a  robust  counter-
factual  situation  (i.e.  what  the  situation  would  be  if  EU  laws  had  not  been  adopted), 
making absolute quantitative analysis problematic. Often, EU evaluations have to rely on 
qualitative,  reasoned  arguments  (backed  by  the  appropriate  evidence)  about  the  likely 
contribution of an EU intervention to the changes observed.  

Figure  1  illustrates  how  the  different  components  of  evaluation  are  linked  together  to 
present the expected intervention logic71.  

Figure 1: The different components of the "intervention logic"  

3. 

KEY QUESTIONS AN EVALUATION MUST ANSWER 

The questions an evaluation must answer 

1.  What is the current situation? 

2.  How effective has the EU intervention been?  

3.  How efficient has the EU intervention been?  

4.  How relevant is the EU intervention?  

5.  How coherent is the EU intervention internally and with other (EU) actions?   

71   Further  guidance  on  how  to  create  an  intervention  logic  is  provided  in  the  Tool  "Designing  the 

Evaluation". 

55 

 
 
 
                                                 
The questions an evaluation must answer 

6.  What is the EU added value of the intervention?  

All evaluations must answer the above listed questions72, following a process which 
complies  with  the  principles  identified  in  the  previous  section.  Depending  on  the 
subject  being  evaluated,  further  evaluation  criteria  may  be  added  e.g.,  sustainability, 
utility etc.73  

3.1. 

Question 1:  What is the current situation? 

An evaluation starts by finding out how the situation has evolved since the intervention 
began, how the intervention has been implemented and/or applied, what has happened/is 
happening to different stakeholders.  

The answer to this question should give all readers an overview of the current situation 
and explain key issues or external factors that may be referred to later when answering 
the remaining questions.  

The  first  step  of  an  evaluation  is  to  understand  the  background,  context  and  current 
situation of an intervention. Developing a clear understanding of the current situation and 
its underlying factors involves answering the following set of questions: 

•  What is the origin of the intervention and what were its objectives? 

•  Where things are – what progress has been made over time?  

•  What is the current situation for different stakeholders and how are they affected by 
the intervention?  This  should include  consideration of  how  different  elements of the 
intervention or different options have worked in practice. 

Addressing  these  questions  will  ensure  that  the  evaluation  stays  concrete  and  focussed, 
remaining close to stakeholders' concerns. 

3.2. 

Question 2:   How effective has the EU intervention been? 

The  evaluation  should  analyse  the  progress  made  towards  achieving  the  objectives  of 
the intervention, looking for evidence of why, whether or how these changes are linked 
to the EU intervention. 

The  answer  to  this  question  should  go  further  than  showing  if  the  intervention  is  on 
track. It should seek to identify the factors driving or hindering progress and how they 

72   The  evaluation  of  a  single  intervention  may  on  an  exceptional  basis  omit  one  or  two  of  the  five 
evaluation  criteria.  Clear  justification  for  such  omission  must  then  be  provided  in  the  evaluation 
roadmap and repeated in the final evaluation report. Fitness Checks always consider the five criteria.  

73   Further  information  is  provided  in  Tool  "Identifying  the  evaluation  criteria  and  questions"  of  the 

toolbox. 

56 

 
 
                                                 
are linked (or not) to the EU intervention.  

Effectiveness  analysis  considers  how  successful  EU  action  has  been  in  achieving  or 
progressing  towards  its  objectives.  The  evaluation  should  form  an  opinion  on  the 
progress made to date and the role of the EU action in delivering the observed changes. If 
the objectives (general, specific, operational) have not been achieved or things are not on 
track, an assessment should be made of the extent to which progress has fallen short of 
the target and what factors have influenced why something was successful or why it has 
not yet been achieved. Consideration should also be given to whether the objectives can 
still be achieved on time or with what delay. The analysis should also try to identify if 
any unexpected or unintended effects have occurred. 

Typical examples of effectiveness questions  
- 
- 
- 
- 
- 
- 
- 

To what extent have the objectives been achieved?  
What have been the (quantitative and qualitative) effects of the intervention? 
To what extent do the observed effects correspond to the objectives?  
To what extent can these changes/effects be credited to the intervention?  
What factors influenced the achievements observed?  
To what extent did different factors influence the achievements observed? 

For spending programmes, did anti-fraud measures allow for the prevention and 
timely detection of fraud? 

3.3. 

Question 3:  How efficient has the EU intervention been? 

The  evaluation  should  always  look  closely  at  both  the  costs  and  benefits  of  the  EU 
intervention as they accrue to different stakeholders, identifying what factors are driving 
these costs/benefits and how these factors relate to the EU intervention.  

The  answer  to  this  question  should  provide  evidence  on  the  actual  costs  and  benefits, 
making it clear what can be linked to the EU intervention and what cannot. Efficiency 
analysis is a key input to policy making, helping both policy makers and stakeholders to 
draw conclusions on whether the costs of the EU intervention are proportionate to the 
benefits.    

Efficiency considers the relationship between the resources used by an intervention and 
the  changes  generated  by  the  intervention  (which  may  be  positive  or  negative). 
Differences  in  the  way  an  intervention  is  approached  and  conducted  can  have  a 
significant  influence  on  the  effects,  making  it  interesting  to  consider  whether  other 
choices  (e.g.  as  demonstrated  via  different  MS)  achieved  the  same  benefits  at  less  cost 
(or greater benefits at the same cost).  

Efficiency  analysis  can  differ  depending  on  the  type  of  intervention  being  evaluated. 
Typical efficiency analysis will include an examination of administrative and regulatory 
burden74 and look at aspects of simplification – these are important for ALL evaluations, 
but  particularly  those  identified  under  the  REFIT  programme.  Where  appropriate, 

74   For definition of regulatory burden please refer to the Tool "What key impacts must be considered" of 

the toolbox. 

57 

 
 
                                                 
evaluation  findings  should  pin-point  areas  where  there  is  potential  to  reduce 
inefficiencies particularly regulatory burden and simplify the intervention.  

The  full  efforts  to  support  and  perform  an  intervention  can  be  broken  into  different 
categories such as: staff, purchases made, time and/or money spent, fixed costs, running 
costs,  etc.75  These  costs  can  be  associated  to  different  aspects  of  an  intervention  and 
judged against the benefits achieved.  

Good evaluations should make strong efforts to go beyond a qualitative description of the 
different  costs  and  benefits  of  the  EU  intervention  and  seek  to  quantify  them.  While 
assessing costs and benefits may be (methodologically) easier for spending programmes, 
such assessment in policy areas may be a challenge since obtaining robust, good quality 
data  is  difficult,  particularly  across  28  Member  States  which  may  have  implemented 
legislation in a variety of different manners. 

Typical examples of efficiency questions  
- 
- 

To what extent has the intervention been cost effective? 
To what extent are the costs involved justified, given the changes/effects which have 
been achieved? 
To what extent are the costs proportionate to the benefits achieved? What factors 
are influencing any particular discrepancies? 

- 

-  What factors influenced the efficiency with which the achievements observed was 

- 

- 

attained? 
How affordable were the costs borne by different stakeholder groups, given the 
benefits they received? 
If there are significant differences in costs (or benefits) between Member States, 
what is causing them? 

3.4. 

Question 4:   How relevant is the EU intervention? 

The evaluation must look at the objectives of the EU intervention being evaluated and 
see how well they (still) match the (current) needs and problems.   

The  answer  to  this  question  should  identify  if  there  is  any  mismatch  between  the 
objectives  of  the  intervention  and  the  (current)  needs  or  problems.  This  is  key 
information  that  will  assist  policy  makers in deciding whether to continue, change or 
stop an intervention. 

Relevance  looks  at  the  relationship  between  the  needs  and  problems  in  society  and  the 
objectives of the intervention. Things change over time - certain objectives may be met 
or  superseded;  needs  and  problems  change,  new  ones  arise.  Relevance  analysis  is  very 
important – because if an intervention does not help to address present needs or problems 
then  it  does  not  matter  how  effective,  efficient  or  coherent  it  is  –  it  is  no  longer 
appropriate.  This is why there is a strong link between relevance analysis and the criteria 

75   Further information is provided in Tool "Typology of costs and benefits" of the toolbox. 

58 

 
 
                                                 
of EU added value – which assesses whether action continues to be justified at the EU 
level. 

- 

- 

Typical examples of relevance questions  
- 
- 

To what extent is the intervention still relevant? 
To what extent have the (original) objectives proven to have been appropriate for 
the intervention in question?  
How well do the (original) objectives (still) correspond to the needs within the EU? 

How well adapted is the intervention to subsequent technological or scientific 
advances? (N.B. Could include issues related to the specify policy here e.g. social, 
environmental) 

- 

How relevant is the EU intervention to EU citizens? 

3.5. 

Question 5:  How coherent is the EU intervention internally and with other 
(EU) actions? 

The evaluation should look at how well the intervention works: i) internally and ii) with 
other EU interventions. 

The answer to this question should provide evidence of where and how EU interventions 
are  working  well  together  (e.g.  to  achieve  common  objectives  or  as  complementary 
actions) or point to areas where there are tensions (e.g. objectives which are potentially 
contradictory, or approaches which are causing inefficiencies).  

No policy exists in a vacuum. There are many different actors involved in many different 
interventions,  both  inside  and  outside  the  EU.  Even  small  changes  in  how  one 
intervention  is  designed  or  implemented  can  trigger  improvements  or  inconsistencies 
with other on-going actions. The evaluation of coherence involves looking at a how well 
or not different actions work together. 

Checking internal coherence means looking at how the various internal components of an 
EU  intervention  operate  together  to  achieve  its  objectives.  Similar  issues  can  arise 
externally at different levels: for example, between interventions within the same policy 
field  (e.g.  a  specific  intervention  on  drinking  water  and  wider  EU  water  policy)  or  in 
areas  which  may  have  to  work  together  (e.g.  water  policy  and  chemicals  policy,  or 
chemicals  and  health  and  safety).  At  its  widest,  external  coherence  can  look  at 
compliance  with  international  agreements/declarations  (for  example  EU  labour  market 
initiatives might be looking into coherence with ILO conventions).  

The focus on coherence may vary depending on the type of evaluation and is particularly 
important  in  Fitness  Checks,  where  coherence  analysis  will  look  for  evidence  of 
synergies or inconsistencies between actions in a related field which are expected to work 
together. Even when evaluating an individual intervention, it can be important to check 
coherence with (a limited number of) other interventions.  

Typical examples of coherence questions  
- 

To what extent is this intervention coherent with other interventions which have 
similar objectives?  

59 

 
 
- 
- 
- 

To what extent is the intervention coherent internally? 
To what extent is the intervention coherent with wider EU policy? 
To what extent is the intervention coherent with international obligations? 

3.6. 

Question 6:  What is the EU added value of the intervention?  

The  evaluation  should  consider  arguments  about  the  value  resulting  from  EU 
interventions that is additional to the value that would have resulted from interventions 
initiated at regional or national levels by both public authorities and the private sector. 

The  answer  to  this  question  should,  where  applicable,  respond  to  the  subsidiarity 
analysis conducted in any related IA. For spending programmes, EU added value may 
result from different factors e.g. co-ordination gains, improved legal certainty, greater 
effectiveness or complementarity. The analysis of  EU  added value  is often  limited to 
the qualitative, given the stated difficulties to identify a counter-factual. 

EU-added  value76  looks  for  changes  which  it  can  reasonably  be  argued  are  due  to  EU 
intervention,  rather  than  any  other  factors.  In  many  ways,  the  evaluation  of  EU  added 
value  brings  together  the  findings  of  the  other  criteria,  presenting  the  arguments  on 
causality and drawing conclusions, based on the evidence to hand, about the performance 
of the EU intervention and whether it is still justified.  

The sources and nature of this additional value vary from intervention to intervention. It 
is, in particular, useful to distinguish the European added value of an EU policy measure 
in general (like an EU regulation to foster the single market) and that of an EU spending 
programme per se. In both cases, European added value may be the results of different 
factors: coordination gains, legal certainty, greater effectiveness, complementarities etc. 
In  all  cases,  measurement  is  a  challenge  and  the  final  judgement  on  whether  expected 
added  value  would  justify  an  EU  intervention  is  ultimately  the  result  of  a  political 
process.  

In areas where the EU has exclusive competence, the appropriate answer to the question 
of EU added value may simply involve re-stating the reasons why the EU has exclusive 
competence  or  may  already  be  answered  by  the  efficiency  and  effectiveness  analysis. 
Sometimes  it  may  be  necessary  to  question  if  the  assumption  of  exclusive  competence 
still holds or whether the needs have changed (see also common tool on subsidiarity/EU 
added value). In such instances, the evaluation may focus more strongly on consideration 
of the relevance and efficiency of the intervention.  

Where  there  is  little  evidence  of  the  EU  added  value  of  an  intervention,  consideration 
should be given to its repeal. 

Typical examples of EU added value questions  
-  What is the additional value resulting from the EU intervention(s), compared to 

what could be achieved by Member States at national and/or regional levels?  

76   For further information see SEC(2011) 867 final "The added value of the EU budget". 

60 

 
 
                                                 
- 

To what extent do the issues addressed by the intervention continue to require 
action at EU level? 

-  What would be the most likely consequences of stopping or withdrawing the 

existing EU intervention? 

4. 

SUMMING IT ALL UP: THE EVALUATION STAFF WORKING DOCUMENT 

The  evaluation  Staff  Working  Document  (SWD)  summarises  and  presents  the  final 
results of the evaluation process. It draws on work conducted: 

•  Exclusively by external contractors (via one or more reports) 

•  And/or the Commission Services.  

The lead DG must take a position on the robustness of the process and findings, stating if 
necessary, where there are any disagreements and why.  

The mandatory format for the evaluation SWD is provided in the Toolbox77.  

The evaluation SWD will communicate the results and conclusions of the evaluation: (i) 
to  policy  makers,  helping  to  inform  their  decision  making  and  (ii)  to  stakeholders, 
showing  the  method,  evidence  base  and  analysis  used  for  the  evaluation.  It  will  draw 
together  all  the  different  steps  of  the  evaluation  process  –  answering  the  commitments 
made  in  the  evaluation  roadmap  or  explaining  why  this  has  not  been  possible, 
summarising and critiquing the method applied, the evidence collected and the analysis 
conducted,  drawn  from  a  wide  range  of  sources.  The  evaluation  SWD  should  be 
transparent,  objective  and  balanced.  Non-expert  readers  should  be  able  to  follow  the 
arguments.  

The process followed for the evaluation will influence the length of the evaluation SWD. 
Where the full body of work described in the evaluation roadmap has been outsourced to 
contractors,  who  have  written  up  their  process  and  findings  as  a  separate  report,  the 
evaluation SWD should be no more than 15-20 pages excluding annexes. For all Fitness 
Checks  and  those  evaluations  which  have  had  either  limited  or  no  support  from 
contractors the main document is likely to be longer (50 pages maximum) as it will have 
to present the process, evidence and analysis in more detail.  

In  all  instances,  stakeholder  views  and  how  these  have  been  considered  should  be 
transparently referred to throughout the evaluation SWD (and any supporting contractor's 
report) as well as summarised in an Annex. All external material used (reports, scientific 
findings etc.) should also be systematically referenced. To allow for an easily accessible 
overview  of  the  headline  findings  from  the  evaluation,  a  short  executive  summary 
(recommended length three pages) must also be prepared and translated into EN, FR and 
DE. 

For  major  evaluations,  the  Regulatory  Scrutiny  Board  (RSB)  will  review  the  draft 
evaluation  SWD  and  the  related  inter-service  consultation  cannot  start  before  the  RSB 
has  issued  its  opinion.  The  package  to  be  sent  to  the  RSB  will  include  the  draft 

77   For further information see Tool "Staff Working Document for evaluation". 

61 

 
 
                                                 
evaluation SWD and associated executive summary, the minutes of the last ISG meeting 
and where applicable the relevant contractors' report and associated Quality Assessment 
by the ISG.  

5. 

USING THE EVALUATION RESULTS 

Evaluation  results  should  be  assessed  and,  where  relevant,  be  complemented  by  follow 
up actions to ensure maximum use of the results. Active discussion and debate on these 
findings should be encouraged. 

5.1. 

Disseminating the evaluation findings 

Evaluation  is  an  opportunity  to  assess  the  performance  of  an  EU  intervention  and  feed 
any  lessons  learned  into  the  next  round  of  decision  making  in  a  timely  manner.  By 
conducting evaluations in a transparent manner the Commission is providing an account 
of  its  actions  to  all  interested  stakeholders  and  EU  citizens.  To  maximise  transparency 
and ease access: 

•  Any related contractors report must be published in the EU bookshop 

•  The  final  evaluation  Staff  Working  Document,  alongside  the  final  evaluation 
roadmap,  consultation  strategy  and  related  consultation  documents,  Terms  of 
Reference  and  associated  final  contractors  report  (if  applicable)  and  the  opinion 
of the Regulatory Scrutiny Board (if applicable) must be published centrally  

Further dissemination activities tailored to the needs of the different audiences who may 
wish to know about the evaluation and what it has concluded should also be considered78.  

5.2. 

Identifying the follow-up actions 

Evaluation  is  not  the  end  of  the  process.  Completing  the  evaluation  Staff  Working 
Document  and  disseminating  the  evaluation  findings  should  stimulate  discussion  and 
lead to the identification of appropriate follow-up actions to put into practice the lessons 
learned  and  feed  the  evaluation  findings  into  the  next  cycle  of  decision  making.  The 
evaluation  results  must  feed  into  the  Annual  Activity  Reports  and  related  follow  up 
actions must be identified in the Annual Management Plans of the Commission Services. 

Follow-up  can  take  many  forms,  such  as  impact  assessment  or  improving  guidance  or 
further monitoring. Identifying and sharing planned follow-up actions is part of accepting 
responsibility and accountability for EU actions and ensures transparency. It should also 
mean that evaluation findings are used and not simply filed on a shelf.  

In many instances the immediate dissemination/follow-up to an evaluation is identified in 
the legal base of the intervention and takes the form of a Commission Report to Council 
and  the  European  Parliament  on  the  findings  of  the  evaluation.  In  this  instance,  the 
Commission Report should be a short document, presenting the headline findings of the 
evaluation and presenting next steps (in varying detail depending on what is appropriate). 
The executive summary for the evaluation Staff Working Document could be the starting 
point for this report. 

78   Further information on dissemination can be found in Tool "Disseminating the evaluation findings". 

62 

 
                                                 
Chapter VII 
Guidelines on Stakeholder Consultation 

Key requirements 

•  A  simple  consultation  strategy  identifying  and  targeting  relevant  stakeholders  and 
evidence must be developed for each initiative, evaluation or Fitness Check and Green 
Paper. 

•  The  consultation  strategy  and  consultation  documents  must  be  discussed  and  agreed 
by  the  Inter  Service  Group  (ISG)  or,  if  no  ISG  is  established,  by  the  Secretariat 
General and any other associated service. 

•  Without  prejudice  to  the  exptional  circumstances  outlined  in  box  1,  a  12-week 
internet-based  public  consultation  must  be  part  of  the  consultation  strategy  for 
initiatives subject to impact assessments, evaluation and Fitness Checks as well as for 
Green Papers. 

•  Key  elements  of 

the  consultation 

strategy 

should  be  outlined 

in 

the 

Roadmap/Inception IA. 

•  Stakeholders  must  be  able  to  provide  feedback  on  each  Roadmap  (including  for 
evaluations)  or  Inception  Impact  Assessment,  on  legislative  and  policy  proposals 
adopted by the College and for draft implementing and delegated acts79.  

•  Any consultation activity (but not the provision of feedback opportunities) must fulfil 
the Commission's minimum standards for consultation, as outlined in these guidelines. 

•  A report outlining the overall results of the consultation work and providing feedback 
(synopsis report) must be published on the consultation website and, where applicable, 
added  as  an  annex  to  the  impact  assessment/evaluation  report.    Such  a  report  would 
also provide an occasion to summarise relevant feedbacks received in parallel.   

1. 

INTRODUCTION 

Who should read these guidelines? 

All officials involved in the preparation of legislative or policy proposals or in their 
evaluation  should  read  these  guidelines  including  officials  and  managers  who  are 
responsible for ensuring the quality of stakeholder consultation in the lead DG.  

More detailed guidance is also available in a separate "tool box" which accompanies this 
guide.  This  is  aimed  at  those  directly  involved  in  preparing  the  various  steps  of 
stakeholder consultation. 

Why does the Commission consult stakeholders? 

The  initial  design,  evaluation  and  revision  of  policy  interventions  benefits  from 
considering  the  input  and  views  provided  by  stakeholders,  including  those  who  will  be 
directly  impacted  by  the  policy  but  also  those  who  are  involved  in  ensuring  its  correct 
application. Stakeholder consultation can also improve the evidence-base underpinning a 

79   For delegated and implementing acts certain exceptions apply, see section 4.1.  

 
 
                                                 
given policy initiative. Early consultation can avoid problems later and promote greater 
acceptance of the policy initiative/ intervention.  

In addition, the Commission has a duty to identify and promote in its policy proposals the 
general public interest of the Union as opposed to special interests of particular Member 
States or groups or parts of society – hence the need to consult widely. 

Box 1. Treaty provisions 
•  According  to  Article  11  of  the  Treaty  on  European  Union80,  ‘the  European 
Commission  shall  carry  out  broad  consultations  with  parties  concerned  in  order  to 
ensure that the Union’s actions are coherent and transparent’.  

•  Protocol No. 2 on the application of the principles of subsidiarity and proportionality 
annexed  to  the  Treaty  stipulates  that  ‘before  proposing  legislative  acts,  the 
Commission shall consult widely’.   

2. 

SCOPE AND DEFINITION OF STAKEHOLDER CONSULTATION 

Consultation is a formal process by which the Commission collects input and views from 
stakeholders about its policies.  

Consultation  is  a  continuous  process  and  formal  stakeholder  consultations  complement 
the  Commission's  broader  interaction  with  stakeholders  (e.g.  meetings  or  exchanges  or 
through existing permanent platforms for dialogue81). 

The  term  'stakeholder  consultation'  applies  to  all  consultations  with  stakeholders  in  the 
process  of  preparation  of  a  policy  initiative  or  the  implementation  of  an  existing 
intervention.  

It does not apply to: 

• 

Inter-institutional  consultations  (e.g.  reports  from  the  EP,  opinions  from  national 
parliaments etc.), 

•  Specific  frameworks  for  consultation  provided  for  in  the  Treaties  or  in  primary 

legislation, such as  

- 

- 

the  consultation  of  the  consultative  committees  in  the  context  of  the  legislative 
process (Articles 304 and 307 TEU), 
the consultation of social partners (Articles 154-155 TFEU)82, 

-  consultations in the area of environment (Regulation (EC) N° 1367/2006). 

•  Opinions provided by Committees under Comitology, 

•  Opinions provided by expert groups involved in the preparation of Delegated Acts, 

80   http://europa.eu/about-eu/basic-information/decision-making/treaties/index_en.htm  

81   E.g.  Action  Platform  on  Diet,  Physical  Activity  and  Health  (DG  SANTE),  Technical  Platform  for 

Cooperation on the Environment (DG ENV). 

82   However,  if  after  a  social  partner  consultation,  which  did  not  lead  to  an  agreement,  a  Commission 
proposal is foreseen, the stakeholder consultation guidelines apply. More details can be found in the 
'Better Regulation Toolbox'. 

64 

 
                                                 
•  Stakeholder  consultation  preceding 

the  submission  of  draft  Delegated  and 

Implementing Acts prepared by any EU agency or body to the Commission, 

• 

Input from citizens in the context of the 'European Citizen Initiative' (Article 11 [4] 
of the TEU). 

3. 

GENERAL  PRINCIPLES  AND  MINIMUM  STANDARDS  FOR  STAKEHOLDER 
CONSULTATION 

Stakeholder  consultation  is  governed  by  four  principles  and  five  minimum  standards 
taking  proportionality  into  account.83  They  are  complemented  and  further  defined  by 
these guidelines. 

Box 2: General principles and minimum standards for consultation 

Relations with stakeholders are governed by four general principles: 

(1) Participation: Adopt an inclusive approach by consulting as widely as possible; 

(2) Openness  and  Accountability:  Make  the  consultation  process  and  how  it  has  affected 

policy making transparent to those involved and to the general public; 

(3) Effectiveness: Consult at a time where stakeholder views can still make a difference, respect 

proportionality and specific restraints; 

(4) Coherence:  Ensure  consistency  of  consultation  processes  across  all  services  as  well  as 

evaluation, review and quality control. 

These principles are complemented by five Minimum Standards that all consultations have to 
respect: 

A.  Clear  content  of  the  consultation  process  ('Clarity'):  All  communication  and  the 
consultation document itself should be clear, concise and include all necessary information 
to facilitate responses; 

B.  Consultation  of  target  groups  ('Targeting'):  When  defining  the  target  group(s)  in  a 
consultation  process,  the  Commission  should  ensure  that  all  relevant  parties  have  an 
opportunity to express their opinions;  

C.  Publication:  The  Commission  should  ensure  adequate  awareness-raising  publicity  and 
adapt  its  communication  channels  to  meet  the  needs  of  all  target  audiences.  Without 
excluding other communication tools, (open public) consultations should be published on 
the internet and announced at the "single access point"84; 

D.  Time limits for participation ('Consultation period'): The Commission should provide 

sufficient time for planning and responses to invitations and written contributions; 

E.  Acknowledgement  of  feedback  ('Feedback'):  Receipt  of  contributions  should  be 
acknowledged  and  contributions  published.  Publication  of  contributions  on  the  "single 
access  point"  replaces  a  separate  acknowledgment  if  published  within  15  working  days. 
Results  of  (open  public)  consultations  should  be  published  and  displayed  on  websites 

83   These general rules on how Commission services should consult are set out in the 2002 Commission 
Communication "Towards a reinforced culture of consultation and dialogue - General principles and 
minimum standards for consultation of interested parties by the Commission"; COM(2002) 704 final, 
complemented by COM(2012) 746 and accompanying SWD(2012) 422 and by COM(2014) 368. 

84   "Your Voice in Europe": http://ec.europa.eu/yourvoice/. 

65 

 
                                                 
linked to the "single access point" on the internet and adequate feedback given on how the 
results of the consultation have been taken into account. 

4. 

WHEN IS STAKEHOLDER CONSULTATION REQUIRED? 

Stakeholders  should  always  be  consulted  when  preparing  a  Commission  legislative  or 
policy initiative or when performing an evaluation or Fitness Check. 

According  to  the  working  methods  of  the  Commission  2014-201985  and  accompanying 
instructions  to  the  services,  stakeholder  consultations  can  in  principle  take  place 
throughout  the  whole  policy  cycle.  However,  stakeholder  consultations  can  only  be 
launched  for  initiatives  which  have  received  political  validation  by  the  appropriate 
political level (cf. Chapter II on Planning). 

As part of promoting greater transparency, stakeholders should be consulted or be able to 
provide feedback on the following86. 

Box 3: Mandatory consultation and feedback requirements 

Mandatory open, internet-based public consultation (minimum 12 weeks)87: 

•  Initiatives  with  impact  assessments.  Consultation  is  on  the  basis  of  consultation  documents 

including questionnaires, background information, the Inception IA etc.; 

•  Evaluations. Consultation is on the basis of consultation documents including questionnaires 

and background information, the Roadmap, etc.; 

•  Fitness  Checks.  Consultation  is  on  the  basis  of  consultation  documents,  including 

questionnaires, background information, Roadmaps, etc.; 

•  Green Papers. 

Stakeholders must be able to give feedback on: 

•  Roadmaps  for  Evaluations  and  Fitness  Checks  roadmaps  (4  weeks),  and  Roadmap  and 
Inception Impact Assessments (suggested timeline for feedback to be provided on a case by 
case basis taking in to account the expected timing of any subsequent consultation); 

•  Draft Delegated Acts and Implementing Acts (4 weeks)88; 

•  Legislative  or  policy  proposals  adopted  by  the  College  and,  where  applicable,  the 

accompanying impact assessments (8 weeks). 

85   C(2014)9004. 

86   For  more  details  see  "Summary  of  documents  on  which  stakeholders  are  consulted  or  can  provide 
feedback" in the Better Regulation toolbox. Consultation involves a more structured engagement with 
stakeholders  where  the  consultation  principles  and  standards  apply;  whereas  the  feedback  process 
allows  stakeholders  to  provide  comments  on  a  particular  document  which  will  be  considered  in  the 
further elaboration of the document or initiative. 

87   Without prejudice to the exceptional cases referred to in box 1 and in full respect of the general rules 
set out in COM(2002) 704. Accordingly, where several consultation steps are mandated as part of a 
process to elaborate an initiative, it is not  necessary to conduct  multiple 12-week consultations each 
time. 

88   Certain exceptions apply, see section 4.1. 

66 

 
                                                 
4.1. 

Delegated Acts and Implementing Acts 

The opportunity to provide feedback on delegated acts will apply with a limited number 
of  exceptions.  For  implementing  acts,  the  opportunity  to  provide  feedback  must  be 
considered  for  acts  adopted  under  committee  control.  However,  several  categories  of 
exemptions  apply  and  due  to  the  varied  nature  of  implementing  acts  the  final  decision 
should be made on a case-by-case basis. Delegated and implementing acts are now, as a 
general rule, included in Agenda Planning. When introducing the Agenda Planning entry, 
an  indication  should  be  given  whether  the  opportunity  for  stakeholders  to  comment  on 
the  draft  text  is  foreseen.  This  is  in  order  to  facilitate  the  preparation  of  a  forward 
planning to inform  stakeholders of the Commission's future intentions to seek feedback 
on particular delegated acts and implementing acts.  

In  certain  cases,  the  Commission  will  not  consult  on  draft  delegated  and  implementing 
acts. These cases and the reasons are summarised in the table below: 

Exceptions to the 4-week public consultation on Delegated/Implementing Acts89: 

Type 

Reason 

Examples 

No  (or  limited)  margin  of 
discretion  

Lack 
alternatives 

of 

policy 

Extensive  consultation 
on  the  draft  text  has 
already  taken  place  in  a 
dedicated framework 

Drafts  have  been  prepared  by 
an  EU  agency  or  body  and 
have  been  subject 
to  full 
consultation  before 
public 
being 
the 
submitted 
Commission and for which the 
Commission does not have the 
intention 
significantly 
modify them 

to 

to 

Urgency 
measures 

/ 

emergency 

Time  limitations  do  not 
allow 
additional 
consultation period  

an 
implementing 
Acts 
international  standards  into 
EU  law  without  any  (or 
limited) discretion. 

Corrigenda 

Acts  based  on  regulatory 
standards 
technical 
submitted  by  the  European 
Banking  Authority  or  by 
European  Securities  and 
Markets Authority  

e.g. 

Acts  under 
the  urgency 
procedure  or  other  urgent 
temporary 
acts, 
exceptional 
support 
measures in the  agricultural 
field, 
urgent/emergency 
addressing 
measures 
threats  to  public,  animal  or 
plant health.  

Budgetary  procedures 

and  Lack 

of 

policy  Decisions 

on 

work 

89   The table refers to delegated and implementing acts. This does not prejudge in any way the choice of 
instrument;  certain  types  of  acts  such  as  those  linked  to  budgetary  procedures  and  programme 
management or individual authorisation decisions, can, by their nature, only be implementing acts. 

67 

 
 
                                                 
Type 

Reason 

Examples 

measures, 
management decisions 

programme 

Individual 
authorisation 
decisions  /  acts  /  decisions 
based  on  the  assessment  of 
compliance 
legal 
requirements 

with 

alternatives 
implementation 
agreements 
decided on 

/ 
of 
already 

Lack 
of 
impact, routine acts 

significant 

Temporary  risk  management 
decisions 

/ 

of 

policy 
Lack 
no 
alternatives 
significant 
direct 
impacts  /  no  deviation 
from  the  advice  of  risk 
assessors 

programmes  and  selection 
and award decisions  

Marketing  authorisations  in 
the  pharmaceutical  field  or 
comparable  authorisations, 
inclusions,  amendments  in 
the PDO&PGI register, (de) 
control 
classification  of 
bodies  

 Temporary 
measures  

food 

safety 

Based  on  scientific  opinions 
from  an  agency  or  scientific 
committee  on  which  a  public 
consultation has already taken 
place  where  the  Commission 
follows the agency findings 

Extensive  consultation 
the  substance  has 
on 
already  taken  place  in  a 
dedicated framework 

Areas  in  which  agencies 
such as EFSA have given a 
scientific advise   

Other  duly  justified  reasons, 
eg.:   

•  Involving  business  secrets 

or security threats  

or 

Public  consultation  not 
not 
possible 
appropriate,  eg.  due  to 
legal  restrictions 
  or 
practical constraints. 

•  Influence on markets 

confidential 
Acts  with 
the 
in 
content  (such  as 
aviation  safety  or  space 
area, Galileo)  

to 

Acts 
the 
relating 
common organisation of the 
markets 
agricultural 
products,  measures  relating 
to  aid  to  certain  Member 
States  

in 

Authorisations  to  Member 
to  own 
States 
resource calculations 

relating 

5. 

IN  THE  COMMISSION  SERVICES 

WHO 
CONSULTATION ACTIVITIES? 

IS  RESPONSIBLE  TO  SET  UP 

The  responsibility  for  running  stakeholder  consultations  is  decentralised  to  the 
Commission  service  responsible  for  the  respective  initiative.  Commission  services 
choose  consultation  tools  and  methods  on  the  basis  of  consultation  objectives,  target 
groups and available resources, taking into account the key mandatory requirements set 
out in these guidelines.  

68 

 
 
 
 
Consultation strategies and consultation documents must be discussed and agreed by the 
inter-service group (ISG) established for the policy initiative90. The inter-service group 
ensures  that  the  consultation  strategy  and  the  various  consultation  activities  are  in  line 
with  the  relevant  requirements  and  monitors  the  quality  of  consultation  activities, 
including where parts of them are outsourced. If no ISG is set up for a given initiative, 
the responsible Directorate General must consult and seek approval from the Secretariat 
General. The Secretariat General is responsible for launching all public consultations on 
the 'Your voice in Europe' website91. 

In some cases, external consultants can support or even conduct the consultation work, 
but  the  lead  service  remains  accountable  for  setting  the  scope  and  objectives  of  the 
consultation,  its  process,  outcome  as  well  as  compliance  with  the  Minimum  Standards 
and requirements92. 

6. 

HOW  TO  PREPARE  AND  CONDUCT  A  CONSULTATION  -  THREE  INTERACTING 
PHASES 

The consultation process can be structured into three interacting phases: 

(1) Establishing the consultation strategy; 

(2) Conducting consultation work; 

(3) Informing policy making. 

Each phase consists of several consecutive steps which provide the framework for a high 
quality, transparent stakeholder consultation. 

6.1. 

Phase 1 - Establishing a consultation strategy 

Effective and useful consultation starts with a good planning of all consultation work that 
is to be conducted in the course of preparing an initiative (consultation strategy). 

Consultation  is  not  a  one-off  event,  but  a  dynamic,  on-going  process  that  may  vary  in 
terms  of  objectives,  target  groups,  methods  and  tools  used  and  timing.  It  is  important, 
therefore, to plan carefully and design a consultation strategy which: 

•  Covers all consultation activities that will be carried out; 

• 

identifies  the  most  appropriate  consultation  methods,  tools  and  communication 
methods to announce the consultation; 

•  provides  all  relevant  and  interested  stakeholder  groups  with  the  opportunity  to 

express their views; 

•  endeavours to receive relevant input of highest possible quality; 

90   See figure 2 in chapter II (Planning) for which initiatives an ISG should always be set up. 

91   See  the  Better  Regulation  toolbox  for  more  detail  on  the  procedure  for  approval  of  consultation 

documents and for the launch of public consultations. 

92   The  Secretariat  General  organises  training  sessions  on  stakeholder  consultation  under  the  'Ariane' 

training programme, which are highly recommended to staff involved in consultation activities. 

69 

 
                                                 
•  defines  the  required  time  and  resources  to  carry  out  the  different  consultation 

activities; 

• 

remains  proportionate  to  the  expected  scope  and  impact  of  the  initiative  it 
supports and to the consultation objectives. 

Box 4. The interacting phases and key steps of the consultation process 

  ?? 

Quality assessment of the effectiveness of the consultation process 

A  consultation  strategy  is  always  case-specific  and  should  be  defined  early  in  the 
planning  process  of  the  initiative,  impact  assessment,  evaluation  or  Fitness  Check.  The 
consultation strategy may need to be adjusted throughout the policy preparation phase, in 
order  to  take  into  account  policy  developments  or  conclusions  drawn  from  the 
application of other better regulation tools. 

The consultation strategy should be outlined in the Roadmap, Inception IA or Evaluation 
Roadmap  to  provide  advanced  information  to  stakeholders  on  upcoming  consultation 
activities, allowing them to prepare well or select consultations they want to participate 
in.  The  consultation  strategy  must,  therefore,  be  discussed  and  endorsed  by  the  ISG  or 
associated services (cf. point 5 of this chapter) when finalising the Roadmap or Inception 
IA. 

The consultation strategy93 should cover the following elements: 

Step 1: 

Set consultation objectives; 

Step 2: 

Identify or "map" stakeholders; 

Step 3: 

Determine consultation methods, tools and ensure accessibility; 

Step 4:   Create a consultation webpage. 

93   For details see tool on stakeholder consultation in the Better Regulation toolbox. 

70 

 
                                                 
6.1.1. 

Step 1: Set consultation objectives  

The  first  step  in  designing  the  consultation  strategy  is  to  define  the  consultation 
objectives: 

•  What is the goal of conducting the consultation? 

•  What proposal or initiative, or what aspects of it are to be consulted on? 

Based on the stage in the policy development process, the consultation objectives can be, 
for  example,  to  gather  new  ideas94,  collect  views  and  opinions95,  gather  factual 
information, data and knowledge96; and test existing ideas and analysis97. 

Issues to consider when defining consultation objectives 

•  The  context,  scope  and  expected  impacts  of  the  initiative  and  the  stage  in  the  policy 

development process. 

•  The consultation background of the initiative under preparation: 

•  consultations that have already taken place; 

•  future consultations that will take place after the current one and their respective 

objectives.  

This should help identifying the information already available and the additional elements sought 
from the stakeholder consultation.  

•  The scope of the consultation:  

•  What items or aspects are the focus of a consultation at a particular stage of the 

procedure? 

•  Where is it still possible to influence the outcome of the policy preparation, what 

items or aspects have already been decided? 

•  The difference between collecting views or opinions (subjective) and collecting data or facts 

(objective). 

Clear  communication  of  the  objectives  on  the  consultation  web  page  and  in  the  relevant 
consultation  documents:  transparency  about  the  objectives  of  each  consultation  activity  allows 
stakeholders  to  identify  quickly  and  at  minimum  effort  if  the  content  of  a  consultation  affects 
them or not, and its expected outcome will avoid mismatched expectations from the responding 
target groups and obtain the input that is being sought.  

94   For example, identifying issues at stake, additional policy options, and possible (indirect) impacts. 

95   For  example, opinions of respondents  on a  given  topic, on  the  suggested  EU  level  involvement  in  a 

given policy area, or views on the implementation arrangements for selected policy options. 

96   For example, examples/evidence/data/experience that would help to estimate or indicate the magnitude 
and scale of identified problems and their potential effects on the performance of existing policy 

97   For  example,  clarify  whether  the  identified  issues  are  perceived  in  the  same  way  by  relevant 
stakeholders/whether they are considered as priority for them, clarify possible impacts of a proposal, 
verify assumptions/hypothesis, validate existing information or analysis, as a form of external quality 
control; receive critical feedback on analysis or on suggested ways forward. 

71 

 
                                                 
The scope of consultation will differ depending on the nature of the initiative, the timing 
and  the  context.  For  initiatives  accompanied  by  Impact  Assessments  as  well  as  for 
Evaluations and Fitness Checks, the scope must at least cover the following aspects: 

Mandatory scope of consultations on Impact Assessments, Evaluations and 
Fitness Checks98 

Initiatives accompanied by Impact Assessments99: 

Stakeholders must be consulted on all IA elements in the IA process. The key issues which must 
be addressed are therefore:  

•  The problem to be tackled;  

•  The issue of subsidiarity and the EU dimension to the problem,  

•  The available policy options; and  

•  The impacts of the policy options. 

Evaluations and Fitness Checks100: 

It is essential to consult on the mandatory evaluation criteria, which are:  

•  Effectiveness of the intervention;  

•  Efficiency of the intervention in relation to resources used; 

•  The  relevance  of  the  intervention  in  relation  to  the  identified  needs/problem  it  aims  to 

address;  

•  Coherence  of  the  intervention  with  other  interventions  which  share  common  objective; 

and  

•  The EU added value resulting from the intervention compared to what could be achieved 

by Member State action only. 

6.1.2. 

Step 2: Map Stakeholders 

An important element of any consultation strategy is to identify or map the stakeholder 
groups  that  should  be  consulted.  This  will  help  determine  the  most  appropriate 
consultation  methods  and  tools.  Where  available  and  useful,  modern  ICT  tools  to  help 
catalogue, identify and reach stakeholder groups in a comprehensive manner. 

98   Where the evaluation and IA are done "back to back" it is possible to conduct only one open public 
consultation as long as relevant stakeholders are consulted on all the main elements of the IA. Where 
the evaluation is of an activity conducted outside the EU or where the internet is not a practical support 
tool,  this  mandatory  open  public  consultation  may  be  waived  as  long  as  the  consultation  strategy 
envisages  appropriate  tools  to  reach  the  relevant  stakeholders.  Before  applying  derogations,  the  DG 
must contact the Secretariat General. 

99   For details, see chapter III on Impact Assessments. 

100   For details, see chapter VI on Evaluations and Fitness Checks. 

72 

 
 
 
                                                 
The basic rule is to consult broadly and transparently among stakeholders who might be 
concerned by the initiative, seeking the whole spectrum of views in order to avoid bias or 
skewed conclusions ("capture") promoted by specific constituencies. 

A successful stakeholder mapping involves101: 

1.  Identification  of  stakeholder  categories  relevant  for  or  interested  in  the 

concerned policy area(s), 

2.  Sorting stakeholder categories according to the level of interest in or influence 

on the concrete initiative that is to be consulted upon. 

Identification of stakeholder categories relevant for or interested in the policy area 

The key issue is to identify which stakeholder categories are relevant for the concerned 
policy area(s). 

Services  should  build  up  knowledge  on  who  has  an  interest  in  the  policy  area.  They 
should  also  identify  the  persons  and  groups  with  expertise  or  technical  knowledge  in  a 
given field and keep track of inputs made in earlier consultation exercises or less formal 
contacts and exchanges. Member States could also be invited to provide a list of interest 
groups for the concerned policy area within their countries. 

Existing contacts (e.g. in mailing or distribution lists), subscriptions in the 'Commission 
at work notifications' and the 'Transparency register' or the track record of participants in 
previous consultations could be used as a starting point. Also advisory or expert groups 
or standing groups of stakeholders, established by Directorates General around a specific 
policy  area  could  be  considered,  in  particular  for  targeted  consultations.  Interservice 
Group  members  could  also  suggest  new  contacts.  Due  attention  should  be  paid  to  data 
protection issues102. 

Stakeholders categories (non-exhaustive list): 

Citizen/individual 

Industry/business/workers' 
organisations 

EU  platform,  network,  or 
association 

•  Multi-national/global 
•  National 
•  Small and Medium-sized Enterprises 
•  Business organisation 
•  Trade Union 
•  Chamber of commerce 

•  Representing for-profit interests 
•  Representing not-for-profit interests 
•  Representing professions/crafts 

Organisation/association 

•  National organisation representing for-profit interests 
•  National  organisation 
representing  not-for-profit 

101   See the tool on stakeholder consultations for guidance on stakeholder mapping. 

102   For information on data protection rules see the Better Regulation toolbox. 

73 

 
 
 
 
                                                 
interests,  

•  National organisation representing professions/crafts 
•  International/ Inter-governmental organisation 

•  EU institution 
•  National government  
•  National Parliament 
•  Regional/ local/municipal authority 
•  National competent authorities/agencies 

•  Think-tank 
•  Professional consultancy 
•  Law firm 

•  University 
•  School & education establishment 
•  Research institute 

Public authority 

Consultancy 

Research/academia 

Other 

Sorting stakeholder categories according to the level of interest in or influence on the 
concrete initiative 

Understanding the stakeholder type to which stakeholders belong helps identifying their 
potential level of interest or influence on the concrete initiative which is to be consulted 
upon.  In  turn,  this  supports  the  selection  of  the  most  appropriate  consultation  methods 
and tools. 

Box 5: Stakeholder types 

The Minimum Standards define three stakeholder types, those: 

•  Affected by the policy; 

•  Who will have to implement it; 

•  Who have a stated interest in the policy. 

It  is  useful  to  distinguish  between  stakeholder  categories,  which  the  concrete  initiative 
may affect (both directly and indirectly) in a significantly different way, e.g. consumers 
versus industry; those who will benefit versus those who will have to pay/to change their 
actions/behaviour etc.. 

Differentiation  within  a  specific  stakeholder  category  should  also  be  examined.  For 
example, businesses can be affected by the concrete initiative differently, depending on 
their size (e.g. micro, small or medium-sized business), location (including those in third 
countries),  type  of  activity,  whether  they  are  public  or  private,  incumbent  operators  or 
new entrants. 

For a successful stakeholder mapping, the following aspects should be considered: 

•  Identify  target  groups  that  run  the  risk  of  being  excluded:  There might  be 
differences between stakeholder groups regarding their access to consultations or 
availability  of  resources  they  can  dedicate  to  participation  in  consultations.  For 

74 

 
 
 
example, for rural areas with limited internet access, using different tools than an 
internet-based consultation can ensure wider participation. 

•  Seek  balance  and  comprehensive  coverage: 

social,  economic  and 
environmental  bodies;  large  and  small  organisations  or  companies;  wider 
constituencies  (e.g.  religious  communities)  and  specific  target  groups  (e.g. 
women, the elderly, the unemployed, ethnic minorities), organisations in the EU 
and  those  in  non-member  countries  (e.g.  candidate,  associated  or  developing 
countries or major trading partners of the EU). It should also be recognised that 
similar  stakeholder  groups  in  different  Member  States  may  operate  under 
different  conditions,  (such  as  for  instance  the  local  business  environment  and 
market or regulatory conditions) and may not always have similar interests.  

• 

Identify if you have the need: 

–  For specific experience, expertise or technical knowledge; or 

–  To involve non-organised interests, as  opposed  to organised  interested 

parties at European or Member States level. 

•  Avoid  'regulatory  capture':  The  same  businesses/representative  organisations 
should not always be exclusively consulted, as this increases the risk of listening 
to a narrow range of interests.  

•  Use  clear  and  transparent  criteria  for  selection  of  participants:  For  targeted 
consultations like meetings, conferences or other types of stakeholder events with 
limited capacity, a pre-selection of participants in the consultation event may be 
necessary. 

Step 3: Determine consultation methods, tools & ensure accessibility 

6.1.3. 
The most appropriate consultation methods and tools103 depend on the objectives of the 
consultation,  the  identified  stakeholders,  the  nature  of  the  initiative  as  well  as  required 
time and resources. 

A  consultation  strategy  can  foresee  several  consultation  activities,  using  different 
consultation  methods  and  tools,  serving  different  purposes  at  different  stages  of  the 
policy  development  process  and  targeting  different  stakeholder  categories.  Not  all 
stakeholders must be addressed in every consultation activity. 

Anticipate how contributions will be analysed in relation to the choice of the consultation 
method and designing the consultation tools; 

The overall result of the consultation will be the sum of various inputs received, at 
various  moments,  through  different  methods  and  tools  and  from  all  participating 
stakeholders, all of which will inform the ultimate decision. 

103   See the Better Regulation toolbox' for an overview of possible consultation methods and tools. 

75 

 
 
                                                 
Consultation methods 

There  is  a  general  choice  between  open  public  or  targeted  consultations,  depending  on 
the  consultation  objectives  and  target  group(s)  identified  through  the  stakeholder 
mapping: 

•  Open  public  consultation  reaches  a  wide  spectrum  of  respondents  without, 
however,  ensuring  full  representativeness.    The  relevance  of  opinions  collected 
needs,  therefore,  to  be  thoroughly  assessed104.  Open  public  consultations  can 
foster transparency and accountability and ensure broadest public validation and 
support for an initiative. 

•  Targeted consultations allow more focused interactions or dialogue and may tap 
expertise  more  efficiently,  in  particular  when  dealing  with  a  very  specific  or 
technical subject. Privileged access for some stakeholders should be avoided. 

Consultation tools 

The  choice  of  the  consultation  method  will  determine  the  consultation  tools.  The 
consultation  tools  most  commonly  used  are  written  consultations  via  consultation 
documents or questionnaires as well as direct interactions with stakeholders via meetings, 
conferences, hearings or other events105. 

The selection of the most appropriate consultation tool should take into account  

•  Proportionality; 

•  The  degree  of  interactivity  needed  (e.g.  written  consultation  versus  stakeholder 

events/ online discussion fora/ other internet based tools); 

•  Accessibility considerations (language regime, disability etc.)106; and 

•  Timing requirements. 

In  practice,  effective  consultation  often  requires  a  combination  of  written  consultation 
tools (used for both open public and targeted consultations) and more direct interactions 
with stakeholders. 

If the consultation should provide statistically representative results, then particular tools 
should be foreseen, such as surveys (e.g. Eurobarometer). 

104   Average response rates have been rather low in the past which requires efforts to raise stakeholders' 

awareness about the public consultation. 

105   Specific  tools  exist  to  reach  particular  groups,  such  as  SMEs:  the  Small  Business  Act  Follow-Up 
meetings  with  stakeholders  or  SME  Panel  Consultations  run  by  DG  GROW,  or,  platforms  of  the 
Committee of the Regions and the Economic and Social Committee etc. 

106   See tool on stakeholder consultation for more detail. 

76 

 
 
                                                 
Mandatory timeframes for consultation and feedback 

Mandatory  open, 
consultation: 

internet-based  public 

How long?  When? 

•  Initiatives with impact assessments 

•  Evaluations 

•  Fitness Checks 

•  Green Papers 

Decision on case-by-case basis 

Minimum 12 
weeks107 

After 
Commission 

adoption 

by 

the 

Stakeholders  must  be  enabled  to  give 
feedback on: 

How long?  When? 

•  Roadmaps for Evaluations and Fitness 

checks 

4 weeks 

After publication 

•  Roadmaps, Inception Impact 

Assessments 

Indication to 
be provided 

After publication 

•  Draft Delegated Acts108 

4 weeks 

•  Draft Implementing Acts109 

4 weeks 

After conclusion of the Inter-
Service-Consultation in parallel 
with Member State experts. 

After conclusion of the Inter-
Service-Consultation and before 
the vote in the Comitology 
Committee 

•  Legislative or policy proposals adopted 
by the College and, where applicable, 
the accompanying impact assessments 

8 weeks 

After adoption by the 
Commission 

6.1.4. 

Step 4 - Create a consultation webpage  

Establish  a  consultation  webpage  on  the  DG's  websites  for  the  policy  initiative  under 
preparation  and  publish  the  consultation  strategy,  including  the  planned  dates  of  the 
various  consultation  activities,  as  soon  as  known.  Dates  for  consultations  will  also  be 
included in the Commissions' Consultation Planning Calendar, compiled by the SG based 
on information received from the DGs and to be published on 'Your Voice in Europe'. 

Add  and  up-date  all  information  about  the  various  consultation  activities  linked  to  a 
given initiative. Communication relating to a consultation should be clear and concise. 

Specific sub-pages for the various consultation work should be created (e.g. open public 
consultation, stakeholder conference etc.). 

107  Without  prejudice  to  the  exceptional  cases  referred  to  in  box  1  and  the  general  rules  set  out  in 

COM(2002) 704.  

108   Certain exceptions apply, see section 4.1. 

109   Certain exceptions apply, see section 4.1. 

77 

 
 
                                                 
The  link  to  an  open  public  consultation  webpage  will  be  posted  on  the  'Your  voice  in 
Europe' website which is available in all official EU languages. 

In  order  to  ensure  consistency  and  user-friendly  access  to  information,  the  standard 
consultation page template should be used110. A vade mecum with explanatory notes on 
how  to  prepare  the  standard  consultation  page  is  available  on  the  internal  Commission 
website111. 

6.2. 

Phase 2 – Conduct the consultation work 

Once  the  consultation  strategy  has  been  endorsed  by  the  ISG  (Phase  1),  the  various 
consultation activities can be launched. For each consultation activity, the following steps 
should be followed:  

•  Step 5:  

Announce and communicate; 

•  Step 6:  

Run consultation; 

•  Step 7:  

Inform on contributions; 

•  Step 8:  

Analyse content. 

6.2.1. 

Step 5 – Announce and communicate 

Announce  the  launch  of  a  planned  consultation  activity  on  the  dedicated  website  and 
ensure that the advertisement chosen is adapted to all target audiences. Services should 
use  those  communication  channels  which  are  most  appropriate  to  reach  the  relevant 
target groups. 

The consultation target group(s) should be clearly specified in the consultation document 
and on the consultation web page. 

110   For further information, please see the Better Regulation toolbox.  

111   https://myintracomm.ec.europa.eu/corp/sg/en/stakeholder/Pages/template.aspx .  

78 

 
 
                                                 
Box 6. Ways to publicise the consultation 

•  Press conference, including issuing a press release and/or the possibility of a more in-

depth briefing for journalists; 

•  Mid-day express and newsletters; 

•  Speeches delivered during relevant events; 

•  Placing  announcements  in  relevant  publications;  adding  links  on  web  sites  and 

proposing articles for either general and/or more specialized media; 

•  Commission's blogs and social media; 

•  Commission Representation in the Member States could also be a distribution point, 

as well as DG COMM which can provide useful input and resources; 

•  Other  'intermediaries'  through  which  information  can  be  spread  are  the  Permanent 
Representations  to  the  EU  and  the  Member  States’  expert  groups;  invite  Member 
States to publicise on national/regional/local websites; 

•  If an open public consultation is launched, certain stakeholders will be automatically 
alerted  via  their  registration  with  the  Transparency  Register  or  the  Notifications 
system of the Commission112. 

•  Contacting interested parties or organizations113 

6.2.2. 

Step 6 – Run the consultation and provide acknowledgment 

The practical organisation and facilitation of the consultation needs full attention. There 
should  be  sufficient  staff  foreseen  to  reply  to  questions,  solve  technical  problems  and 
process the contributions. 

Consultation documents 

All  consultation  documents  need  to  be  endorsed  by  the  ISG  or,  for  open  public 
consultations for initiatives for which no ISG exists, by the Secretariat-General. 

The quality of consultation documents determines the quality of contributions and 
thus the quality of input to policy making. 

It  is  good  practice  to  test  consultation  documents  (e.g.  presentations,  surveys  or 
questionnaires)  with  some  test  persons  who  were  not  involved  in  the  drafting.  These 
should be as closely as possible resembling the actual target audience of the consultation 
or sub-groups of this target-audience.  

The  purpose  of  this  testing  is  to  find  out  whether  the  target  group  will  find  the 
consultation  documents  easy  to  understand  and  practical  to  use.  Test  persons  can  for 
instance be colleagues in other units, other DGs or stakeholder groups who can give their 

112   https://webgate.ec.europa.eu/notifications/homePage.do?locale=en  

113   Organisations  representing  the  interest  of  SMEs  can  be  alerted  also  through  the  Small  Business  Act 

Follow-Up meetings managed by DG GROW. 

79 

 
 
                                                 
personal  critical  feedback  on  how  to  improve  the  documents  further,  e.g  the  European 
Enterprise Network if the consultation targets also individual SMEs. 

Stakeholder identification and Transparency Register 

It  is  important  to  mention  clearly  in  the  consultation  notice  that  the  identity  of 
stakeholders and their interests should be mentioned in order to ensure consideration of 
the contribution114. You should make sure that the personal and background information 
requested by respondents before they can reply will allow you analysing replies by any of 
the stakeholder categories you target (e.g. if individual SMEs cannot identify themselves 
as such in their reply, you will not be able to analyse their replies separately). 

Organisations,  networks,  platforms  or  self-employed  individuals  engaged  in  activities 
aiming  at  influencing  the  EU  decision  making  process  are  expected  to  register  in  the 
Transparency  Register.  During  the  analysis  of  replies  to  a  consultation,  contributions 
from  respondents  who  choose  not  to  register  will  be  treated  as  individual  contributions 
(unless  the  contributors  are  recognized  as  representative  stakeholders  through  Treaty 
provisions115). 

Acknowledgement of receipt 

Written contributions can be provided under different forms such as (e-)mail, web tools 
or  social  media.  Whenever  stakeholders  provide  written  contributions  to  any  type  of 
consultation,  it  is  best  practise  to  send  an  acknowledgement  of  receipt  and  provide 
information as to when the contributions are likely to be published. If contributions are 
sent  by  e-mail  or  using  social  media  platforms,  these  same  channels  can  be  used  to 
acknowledge  receipt.  To  minimize  work,  individual  or  collective  acknowledgments  of 
receipt could be automatically generated at the entry point. 

In  case  contributions  are  published  within  15  days  after  closure  of  the  consultation 
activity,  the  publication  will  replace  a  separate  acknowledgment  of  receipt.  If  the  15-
days' limit cannot be respected, reasons for the delay should be explained on the website 
and a new deadline should be indicated. 

6.2.3. 

Step 7 – Inform about contributions 

The  careful  and  transparent  treatment  of  contributions  received  in  the  course  of  a 
consultation  is  crucial  and  establishes  a  good  basis  for  preserving  constructive 
cooperation and fruitful relations with stakeholders. 

Publication of contributions on the webpage 

After  a  consultation  has  ended,  the  contributions  made  by  stakeholders  should  be 
published.  Contributions  should  be  published  in  the  languages  in  which  they  were 
submitted and/or the language used for the consultation activity.  

Written contributions should be made public on the dedicated consultation webpage. In 
the  case  of  stakeholder  consultation  events  (meetings,  hearings,  conferences,  etc.), 
summary  minutes  and  speeches  or  presentations  provided  during  the  event  should  be 
made public on the consultation webpage. 

114   See also box 5 under step 4, bullet on Transparency Register 

115   European Social Dialogue, Art. 154-155 TFEU 

80 

 
                                                 
According  to  the  relevant  data  protection  rules116,  respondents  have  the  following 
options: 

•  Publication of the contribution with personal information;  

•  Anonymised  publication  of  the  contribution  (without  the  name/  name  of  the 

organization);  

•  No publication but use of the contribution for statistical and analytical purposes. 

Inform on key issues of the contributions 

It is good practice to prepare and publish on the consultation website a short document 
summarising  the  key  issues  raised  in  each  of  the  separate  stakeholder  consultations 
foreseen  in  the  consultation  strategy  (e.g.  informal  report,  minutes  of  a  stakeholder 
meeting,  list  or  table  of  contributions).  This  is  particularly  useful  where  consultation 
activities are spread out over a longer period of time and will facilitate the preparation of 
the final synopsis report which should summarise the results of all consultation activities 
undertaken. 

The  summary  documents  of  consultation  activities  help  increase  transparency  and 
provide  the  basis  for  further  analysis  and  feedback  to  stakeholders  on  how  the 
consultation has informed policy making. 

Summarise contributions 

Give  a  concise  and  balanced  overview  of  contributions  received  during  a  specific 
consultation activity  

Give factual information on input 
received 

•  Who contributed? 

•  Whom are they representing? 

•  What aspects are addressed? 

•  What are their views and concerns? 

•  Which  communication  channels  were  used  for 

contributions? 

Stay neutral 

•  Document the input as received:  

Avoid  qualifying 
feedback 

it, 

taking  position  or  giving 

Aggregate at an appropriate level   •  Cluster information 

Inform on the process 

Add Disclaimer 

• 

Inform  on  what  was  done  so  far  in  terms  of 
consultation activities and on the next steps  

•  Emphasise  that  the  contributions  received  cannot  be 
regarded  as  the  official  position  of  the  Commission 
the 
and 
Commission. 

thus  does  not  bind 

its  services  and 

116   See Better Regulation toolbox. 

81 

 
 
                                                 
6.2.4. 

Step 8 - Analyse content 

Once consultation work is completed, the input received for each consultation needs to 
be thoroughly analysed. 

Keep in mind that responses to consultations are generally not statistically representative 
of the target population: Ratios can generate a false perception of representativeness and 
can thus lead to wrong conclusions. If you need statistically representative input, use an 
appropriate consultation method (e.g. surveys).  

The way of presenting results should be objective and unbiased. 

A  brief  descriptive  overview  of  contributions  should  be  complemented  by  a  qualitative 
assessment. 

Brief descriptive overview of the profile of respondents 

Based  on  simple  descriptive  data,  an  overview  of  the  profiles  of  respondents  can,  for 
example, provide information on:  

•  The distribution of respondents across Member States and/or third countries; 

•  The distribution of respondents by stakeholder category; 

•  The distribution across any other dimension (e.g. clustering by sector) that might 
be  relevant  for  the  specific  consultation  or  where  similar  trends  in  replies  or 
particular concerns can be observed. 

Analysis based on substance/content of responses (qualitative) 

Examine content of contributions:  

•  Do the contributions respond to the questions/expectations? 

•  Compare  the  input  with  the  objectives  of  the  consultation,  as  defined  in  the 

consultation strategy and identify replies unrelated to the consultation topic. 

•  Distinguish  between  information  (data/facts)  and  subjective  opinions  and  views 
provided by respondents. Where possible, the source and reliability of data/facts 
needs to be verified. 

•  Are there views that strongly diverge from the mainstream view? 

•  Do  the  contributors  match  up  with  the  list  of  stakeholder  target  groups?  If  not,  is 

additional consultation necessary? 

Provide a qualitative appreciation of the responses and the respondents:  

•  Respondents´ involvement and interest in the policy, 

•  the way they benefit or are impacted by the policy 

•  if they reply on their behalf or if they represent some specific interests, 

82 

 
•  to  which  extent  and  how  their  contribution  has  been  consolidated  (i.e.  stakeholder 
organisations  should  as  a  good  practice  describe  how  they  organised  their  internal 
consultation and come up with a consolidated reply). 

Presentation of the analysis 

(i) Analysis on the basis of the different stakeholder categories  

This approach would be appropriate when consulting many different stakeholder groups 
with differing and potentially conflicting views on a few issues: 

•  Distinguish  the  main  stakeholder  categories  –  the  brief  descriptive  overview 

builds already the basis for this. 

•  Distinguish  within  the  main  stakeholder  categories  e.g.  if  similar  response 
profiles can be identified (geographical-Member State group 1 and Member State 
group 2; 
industry-producer, 
citizens–students 
intermediary, distributor etc.) 

citizens–retired; 

and 

or 

•  Once broken down by stakeholder category, identify the nature of the responses, 

e.g.:  

•  Do they support/oppose/suggest modifications to a certain policy measure?  

•  Do they provide new ideas? Do they suggest an alternative approach? 

•  Do they provide further information/facts of the impact of a policy measure?  

•  Can the information/facts ne considered objective? How reliable is the provided 

information/facts (identify source and reliability) 

The relative importance of this analysis should result from the consultation objectives in 
the consultation strategy (Phase 1). 

(ii) Analysis on the basis of the different consultation topics  

This approach would be suitable when many issues are discussed and fewer stakeholders 
with potentially less differing or conflicting views consulted. 

• 

Identify the main issues that stem from the replies to the consultation  

•  Distinguish between the views of main stakeholder categories, for each of these 
issues and identify the nature of responses (e.g. facts vs opinions). The questions 
could be structured as indicated under (i).  

6.3. 

Phase 3 – Inform policy making and provide feedback 

The contributions received through the various consultations carried out in the context of 
the consultation strategy feed into the further work in relation to the policy initiative. It is 
up  to  the  competent  Services  to  provide  information  on  the  outcome  of  the  overall 
consultation work, the conclusions that may result and any other related issues.  

83 

 
6.3.1. 

Step 9 – Synopsis of entire consultation results 

Adequate  feedback  should  be  provided  to  stakeholders.  It  is  critical  for  those 
participating  in  stakeholder  consultations  to  know  how,  and  to  what  extent,  their  input 
has been taken into account and to understand why certain suggestions could not be taken 
up in the policy formulation. Providing effective feedback will contribute to the overall 
transparency  of 
the  Commission's 
the  Commission's  policy-making,  enhance 
accountability  and  credibility,  and  potentially  solicit  better  responses  to  future 
consultations. 

Synopsis report 

At  the  end  of  the  consultation  work,  an  overall  synopsis  report  should  be  drawn  up 
covering the results of the different consultation activities that took place. 

The synopsis report must consist of the following elements: 

•  Documentation  of  each  consultation  activity  undertaken  on  the  same  initiative 
including,  if  applicable,  reasoning  as  to  how  and  why  the  consultation  strategy 
outlined in the Roadmap / Inception IA has been altered, 

• 

Information  on  which  stakeholder  groups  participated,  which  interests  they 
represented and whether all identified stakeholder groups have been reached, 

•  Description  of  the  results  of  each  consultation  activity,  if  different  consultation 
activities have been undertaken on the same consultation scope, a comparison of 
their results including interdependencies, consistencies or contradictions, 

•  For  ad  hoc  contributions  received  outside  the  formal  consultation  context,  a 
description of the origin of the contributions received including identification of 
the type of stakeholder and their represented interests, 

•  Feedback on how the results of the consultation have fed into policy making. 

The synopsis report should not exceed 10 pages and be made available in all languages in 
which the consultation was published on the consultation website. 

The synopsis report should accompany the initiative through Inter Service Consultation 
to adoption of the initiative by the Commission. If the consultation has taken place in the 
context of an Impact Assessment or Evaluation, the synopsis report is also annexed to the 
IA or Evaluation report. 

Explanatory memorandum 

For legislative proposals, the explanatory memorandum should reflect how far the main 
contributions  have  been  taken  into  account  in  the  draft  policy  initiative  and  if  not, 
substantiated why not. 

Give the reasons for the options chosen: 

•  Report  why  certain  options  were  discarded  (especially  when  those  were  widely 

supported by the respondents); 

•  Highlight the link between respondents'/participants' input, impact assessment or any 

other factor that justifies the options the Commission proposes. 

84 

 
7. 

QUALITY CONTROL 

Internal quality assessment of the consultation process 

With  the  view  to  improve  future  consultations,  it  is  good  practice  to  carry  out  a 
proportionate  internal  quality  assessment  of  the  consultation  process.  The  conclusions 
should be shared with the services involved in the inter service group or, in case no ISG 
has been established, with the services associated for the initiative, including the SG. 

Assessment of the effectiveness of the consultation strategy 

An end-of-process survey addressed to all consulted parties could help gauge the depth of 
stakeholder satisfaction with the process, as well as with the final outputs and outcomes. 
This could also help to identify best practices, learn from past experiences and to reap the 
benefits  of  a  well-organised  consultation  process.  A  summary  of  the  outcome  of  this 
survey should be published on the consultation webpage established for the initiative. 

The assessment of the consultation strategy should help answer three questions: 

(1) 

(2) 

Did the consultation strategy work? (E.g. did it reach its target groups, did it 
meet its objectives, how effective and efficient were the different tools, and 
how relevant were the responses collected and what was their impact? 

Did the process work? (E.g. what worked well and less well, how satisfied 
were stakeholders participating in the consultation, which are the lessons to 
be drawn for the future? 

(3)  What impact did the process have? (E.g. on participants, on the outcome, on 

policy makers?) 

85 

 
 
Chapter VIII 
The content of the Better Regulation Toolbox 

The  different  chapters  in  this  Better  Regulation  guideline  are  complemented  by  the 
following tools117 which provide more detailed information. 

General principles of Better Regulation 

Principles of Better regulation 

Evidence gathering 

Subsidiarity and proportionality 

How to carry out an impact assessment 

When is an impact necessary? 

What steps should I follow for an IA? 

IA for spending programmes and financial instruments 

IA requirements for social partner agreements 

Format of the IA report 

How to undertake a proportionate IA? 

Stakeholder consultation in the context of an IA 

How to analyse problems 

Risk assessment and management 

How to set objectives 

How to identify policy options 

The choice of policy instrument 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

How to identify impacts in Impact Assessments, evaluations and Fitness Checks 

16 

17 

18 

19 

20 

21 

22 

23 

24 

Identification/Screening of Impacts 

Impacts on sectoral competitiveness 

Impacts on Research and Innovation 

The SME test 

Impacts on Competition 

Impacts on the Internal market 

Impacts on external trade and investment 

Impacts on ICT, the digital economy and society 

Fundamental Rights & Human Rights 

117   http://ec.europa.eu/smart-regulation/index_en.htm 

 
 
 
                                                 
25 

26 

27 

28 

29 

30 

31 

32 

33 

34 

Impacts on Employment, working conditions, income distribution and inequality 

Impacts on education, culture and youth 

Impacts on health 

Impacts on consumers 

Territorial impacts 

Impacts on developing countries 

Impacts on resource efficiency 

Implementation, transposition and preparing proposals 

The Implementation Plan 

Transposition checks 

Drafting the explanatory memorandum 

35 

Monitoring arrangements and indicators 

Monitoring implementation 

Evaluations and Fitness Checks 

36 

37 

38 

39 

40 

41 

42 

43 

44 

45 

46 

47 

48 

49 

What is an evaluation and when is it required? 

Preparing for an evaluation 

Planning: The (5 year) rolling evaluation plan 

Setting up an inter-service steering group 

Establishing an evaluation roadmap 

Designing the Evaluation 

Identifying the evaluation criteria and questions 

What key impacts must be considered? 

Stakeholder consultation in the context of Evaluation 

Conducting the evaluation 

Completing the Quality Assessment 

The Evaluation Staff Working Document 

Disseminating the evaluation findings 

Follow up action plans 

50 

Stakeholder consultation tools 

Stakeholder consultation 

Methods, models and costs and benefits 

51 

52 

53 

54 

Typology of costs and benefits 

Methods to assess costs and benefits 

The Standard Cost Model for estimating administrative costs 

The use discount rates 

87 

 
55 

56 

57 

58 

59 

Useful  analytical  methods  to  compare  policy  options  or  assess  performance  of 
existing interventions 

The use of analytical models in IA or evaluation 

Multi-criteria analysis 

Life Cycle analysis 

Use of visual aids 

88 

 
Glossary 

Term 

Meaning 

Agenda Planning 

Application 

Consultation 

Consultation Strategy 

Evaluation / Evaluation report 

Fitness check / Fitness check 
report 

Gold-plating 

Impact 

Agenda planning (AP) is the Commission's tool for managing and 
tracking the most important initiatives which proceed to adoption by 
the College. AP entries provide information about timing and content, 
adoption procedure, a link to Roadmaps (where applicable) and 
indicate whether an Impact assessment (IA) and/or Implementation 
Plan (IP) is being prepared. 

Application means actually putting the requirements of legislation into 
daily practice after it has entered into force. EU Regulations apply 
directly from their date of entry into force, the rules laid down in EU 
Directives will apply only from the date of entry into force  of the 
national legislation which has transposed the EU Directive into 
national law. Application covers transposition and implementation. 

Consultation describes a process of gathering feedback, comments, 
evidence or other input on a particular intervention from other entities 
either from within the Commission (interservice consultation) or from 
outside the Commission (stakeholder consultation). 

A Consultation strategy sets out one or more approaches to ascertain 
the views of stakeholders about a given issue. The strategy identifies 
relevant stakeholders for a new initiative under preparation by the 
Commission and defines the appropriate methods, tools and timing of 
consultation activities. For example, web-based public consultation 
may be complemented by approaches such as workshops, meetings, 
letters etc. The Roadmap informs about the Consultation strategy. 

Evaluation is an assessment of the effectiveness, efficiency, 
coherence, relevance and EU added-value of one single EU 
intervention. The Roadmap informs about evaluation work and timing. 
An evaluation report (SWD) is prepared by the lead service and 
presents the findings and conclusions about the evaluation. The 
quality of major evaluation reports is checked by the Regulatory 
Scrutiny Board against the requirements of the relevant guidelines 
prior to publication and/or transmission to the Legislator as part of a 
formal report from the Commission. 

A Fitness check is an evaluation of the effectiveness, efficiency, 
coherence, relevance and EU added-value of a number of related EU 
interventions in a policy area/business sector. It identifies excessive 
burdens, inconsistencies and obsolete or ineffective measures and 
helps to identify the cumulative impact of legislation. 
A Fitness check report (SWD) is prepared by the lead service which 
presents the findings of the Fitness check. The quality of major 
Fitness check reports is checked by the Regulatory Scrutiny Board 
against the requirements of the relevant guidelines prior to publication 
and/or transmission to the Legislator as part of a formal report from 
the Commission. 

Gold-plating describes a process by which a Member State which has 
to transpose EU Directives into its national law, or has to implement 
EU legislation, uses the opportunity to impose additional 
requirements, obligations or standards on the addresses of its national 
law that go beyond the requirements or standards foreseen in the 
transposed EU legislation.  

In an impact assessment process, the term impact describes all the 
changes which are expected to happen due to the implementation and 
application of a given policy option/intervention. Such impacts may 
occur over different timescales, affect different actors and be relevant 

 
 
at different scales (local, regional, national and EU). In an evaluation 
context, impact refers to the changes associated with a particular 
intervention which occur over the longer term. 

Impact Assessment is an integrated process to assess and to compare 
the merits of a range of policy options designed to address a well-
defined problem. It is an aid to political decision making not a 
substitute for it. The Roadmap informs whether an impact assessment 
is planned or justifies why no impact assessment is carried out. 
An impact assessment report is a SWD prepared by the lead service 
which presents the findings of the impact assessment process. It 
supports decision making inside of the Commission and is transmitted 
to the Legislator following adoption by the College of the relevant 
initiative. The quality of each IA report is checked by the Regulatory 
Scrutiny Board against the requirements of the relevant guidelines.  

Implementation describes the process of making sure that the 
provisions of EU legislation can fully enter into application. For EU 
Directives, this is done via transposition of its requirements into 
national law, for other EU interventions such as Regulations or 
Decisions other measures may be necessary (e.g. in the case of 
Regulations, aligning other legislation that is not directly touched 
upon but affected indirectly by the Regulation with the definitions and 
requirement of the Regulation). Whilst EU legislation must be 
transposed correctly it must also be applied appropriately to deliver 
the desired policy objectives. 

An implementation plan is a SWD that is prepared to support the 
implementation by the Commission and the Member States of certain 
new Directives and Regulations. It accompanies any impact 
assessment and the proposal itself. It identifies implementation needs 
and actions required of different entities to ensure a timely, effective 
and consistent implementation. The Roadmap informs if an 
Implementation plan is established. 

The inception Impact Assessment is the initial description of the 
problem, its underlying drivers, the policy objectives, policy options 
and the economic, social, environmental impacts of those policy 
options. It provides a comprehensive basis for stakeholders to provide 
feedback, information and opinions. 

An interservice group is a group of Commission representatives from 
more than one DG or service who discusses priority cross-cutting 
issues and steers and monitors elements of the policy making process 
that require the interaction of more than one DG or other Commission 
service. Interservice steering groups are required for the preparation of 
major initiatives, entailing impact assessments, stakeholder 
consultations, evaluations and Fitness Checks. 

An initiative is a policy instrument prepared at EU level to address a 
specific  problem  or  societal  need.  An  impact  assessment  will  assess 
options to inform the policy content of the initiative. 

Intervention  is  used  as  umbrella  terms  to  describe  a  wide 
range  of  EU  activities  including:  expenditure  and  non-
expenditure  measures,  legislation,  action  plans,  networks 
and agencies. 

The intervention logic is the logical link between the problem that 
needs to be tackled (or the objective that needs to be pursued), the 
underlying drivers of the problem, and the available policy options (or 
the EU actions actually taken) to address the problem or achieve the 

90 

Impact Assessment / Impact 
Assessment report 

Implementation 

Implementation Plan 

Inception Impact Assessment 

Interservice (steering) group 

Initiative 

Intervention 

Intervention logic 

 
 
Monitoring 

REFIT 

Regulatory Scrutiny Board 

Roadmap 

SME 

Stakeholder 

Transposition 

objective. This intervention logic is used in both prospective Impact 
Assessments and retrospective evaluations. 

Monitoring describes the process of tracking the implementation and 
application of EU legislation by the Commission or the progress of 
spending programmes. 

REFIT is the European Commission's Regulatory Fitness and 
Performance programme launched in December 2012. Under REFIT, 
action is taken to make EU law simpler, lighter, more efficient and 
less costly, thus contributing to a clear, stable, least burdensome and 
most predictable regulatory framework supporting growth and jobs. 

A body inside the Commission which scrutinises draft impact 
assessment reports and major retrospective evaluations and issues 
opinions with a view to improving their quality or providing guidance 
for the future. 

A roadmap is a tool to substantiate the political validation of an 
initiative the Commission is preparing and, to inform stakeholders 
about planned consultation work, impact assessments, evaluations, 
Fitness Checks. It is published at an early stage by the Secretariat 
General on the Commission's web site and helps stakeholders prepare 
timely and effective inputs to the policy making process. 

SME is the abbreviation for micro, small and medium-sized 
enterprises (SMEs). SMEs are defined in Commission 
Recommendation 2003/361 as enterprises which employ fewer than 
250 persons and which have an annual turnover not exceeding EUR 
50 million, and/or an annual balance sheet total not exceeding EUR 43 
million. 

Stakeholder is any individual or entity impacted, addressed or 
otherwise concerned by an EU intervention. 

Transposition describes the process of incorporating the rights and 
obligations set out in an EU Directive into national legislation, thereby 
giving legal force to the provisions of the Directive. The Commission 
may take action if a Member State fails to transpose EU legislation 
and /or to communicate to the Commission what measures it has 
taken. In case of no or partial transposition, the Commission can open 
formal infringement proceedings and eventually refer the Member 
State to the European Court of Justice.  

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