COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Better regulation: Joining forces to make better laws
Date: 2021-04-29
Institutions: European Commission, Secretariat-General
Subjects: EU Member State, EU strategy, application of the law, consumer protection, cross-border cooperation, drafting of EU law, goods and services, legislative procedure, national implementing measure, single market

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 29.4.2021  COM(2021) 219 final  COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Better regulation: Joining forces to make better laws  
 
 
COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE 
COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE 
OF THE REGIONS 

Better regulation: Joining forces to make better laws 

1.  SUPPORTING EU RECOVERY THROUGH BETTER REGULATION 

The  Commission’s  ‘better  regulation’  system  is  one  of  the  most  advanced  regulatory 
approaches in the world1. The continued improvement of the system over the last years 
has clearly helped us to achieve better results.  

It  systematically  assesses  the  economic,  social  and  environmental  impacts  of  policy 
action  and  ensures  a  consistently  high  quality  of  proposed  legislation.  Given  this 
Commission’s  ambitious  agenda  and  the  unprecedented  challenges  we  are  facing,  the 
need  for  strong  analysis  and  reliable  evidence  is  greater  than  ever.  Therefore,  we  are 
proposing a number of further improvements not least to ensure our policies support the 
recovery  and  resilience  of  the  EU  and  its  twin  transition  in  the  best  possible  way  the 
Commission will: 

 

Invite Member States, regions, and key stakeholders to help remove obstacles and 
red tape slowing down the building of 21st century infrastructure. This will help 
to  speed  up  investments  and  the  implementation  of  NextGenerationEU.  Better 
regulation will play a crucial role in this endeavour and the Fit for Future (F4F) 
Platform2, will support efforts  to  simplify and make EU laws better  adapted for 
tomorrow’s needs.  

 

By introducing a  ‘one in, one out’ approach  adapted to  the policymaking in  the 
EU,  strengthen  the  attention  of  policymakers  for  the  implications  and  costs  of 
applying legislation, especially for small and medium-sized enterprises (SMEs) 
  Mainstream  the United  Nations’ sustainable development  goals3 (SDGs) to  help 
ensure  that  every  legislative  proposal  contributes  to  the  2030  sustainable 
development  agenda;  and  ensure  that  the  ‘do  no  significant  harm’  principle  is 
applied across all policies in line with the European Green Deal oath;  
In  line  with  the  2030  Digital  Compass  Communication4,  better  regulation  will 
promote  the  ‘digital  by  default’  principle  in  forthcoming  EU  legislation  as  an 
important tool to support digital transformation; 

 

 

Integrating  strategic  foresight  into  policymaking  will  see  to  it  that  existing  and 
new EU legislation is fit for the future. 

Better regulation is a shared objective and responsibility of all EU institutions.  We will 
reach out to the European Parliament and the Council regarding their efforts to assess and 
monitor the impact of EU legislation and EU spending programmes. In addition, we will 

1   OECD (2018), OECD Regulatory Policy Outlook 2018 (OECD Publishing, Paris). 
2   https://ec.europa.eu/info/law/law-making-process/evaluating-and-improving-existing-laws/refit-

making-eu-law-simpler-less-costly-and-future-proof/fit-future-platform-f4f_en  

3   https://sdgs.un.org/goals 
4   Commission  Communication,  2030  Digital  Compass:  the  European  way  for  the  Digital  Decade, 

COM(2021) 118. 

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cooperate more closely with local, regional and national authorities, and social partners 
on EU policymaking. 

Another focus will be on improving our understanding of the needs for and impact of EU 
legislation within and outside the EU, including engagement with external partners5. To 
engage  individuals,  businesses  and  civil  society,  we  will  raise  awareness  of  our  public 
consultations  and  make  it  easier  to  navigate  and  participate  in  them.  Finally,  we  will 
address the shortcomings identified in our 2019 stocktaking of better regulation6. 

2.  A SHARED EFFORT 

Cooperation  among  EU  co-legislators,  with  Member  States  and  stakeholders,  including 
social partners, is key. We need to boost our joint efforts to improve the transparency of 
evidence-informed  policy,  raise  awareness  of  benefits  of  legislation  and  reduce  the 
burden of EU legislation. 

Assessing impacts7 and eliminating unnecessary costs8 

The Commission can only determine the expected impacts, including costs and savings, 
associated  with  its  own  legislative  proposals.  Amendments  made  to  proposals  in  the 
course of negotiations with the European Parliament and the Council may significantly 
alter the implications of EU legislation for people and businesses.  

We therefore reiterate our call on the European Parliament and the Council to live up to 
the  commitments  in  the  Interinstitutional  Agreement  on  Better  Law-Making9.  In 
particular,  we  urge  the  two  institutions  to  document  the  effect  of  their  amendments  in 
terms  of  anticipated  impacts.  A  relaunch  of  our  political  dialogue  will  facilitate  the 
exchange  of  ideas,  so  that  all  parties  can  deliver  on  their  commitments  under  the 
Interinstitutional Agreement. 

Member  States’  implementation  of  EU  legislation  can  also  significantly  influence  its 
impact  on  people  and  businesses.  We  would  ask  Member  States  to  provide  us  with 
feedback  on  our  estimates  of  the  benefits  and  costs  associated  with  specific  pieces  of 
legislation  after they have implemented them.  We will use this for our evaluations and 
subsequent revisions of the legislation. 

We  are  fully  aware  of  the  importance  of  SMEs  for  the  EU  economy  and  the  hardship 
they have endured due to the COVID-19 crisis. The EU SME envoy10 will help to screen 
EU  initiatives  to  identify  where  the  impact  on  SMEs  requires  special  attention.  The 
envoy will also help to shape the work programme of the Fit for Future Platform11, and, 

5   In line with policy coherence for development, Article 208 TFEU. 
6   Commission  Communication,  Better  regulation:  taking  stock  and  sustaining  our  commitment, 

COM(2019) 178. 

7   See Section 6. 
8   See Section 5. 
9   Interinstitutional Agreement between the European Parliament, the Council of the European Union and 

the European Commission of 13 April 2016 on Better Law-Making (OJ L 123, 12.5.2016, p. 1). 

10   Commission Communication, An SME strategy for a sustainable and digital Europe, COM(2020) 103. 
11   See Section 5.1. 

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together  with  the  Committee  of  the  Regions’  RegHubs12,  focus  activities  on  the 
legislation that is most problematic on the ground. 

Gathering evidence and making it accessible 

A  cornerstone  of  our  better  regulation  approach  is  to  learn  from  the  past  by  evaluating 
existing  legislation.  Monitoring  is  crucial  in  the  policy  cycle  and  requires  systematic 
collection  of  data.  Monitoring  and  review  clauses13  in  legislation  ensure  that  the 
necessary data is collected and evaluated. It is the joint responsibility of the co-legislators 
to  see  to  it  that  these  provisions  are  of  high  quality,  so  that  the  effectiveness  of  EU 
legislation in the Member States can be properly assessed. 

Scientific  evidence  is  another  cornerstone  of  better  regulation,  vital  to  establishing  an 
accurate  description  of  the  problem,  a  real  understanding  of  causality  and  therefore 
intervention  logic;  and  to  evaluate  impact.  High  quality  research  cannot  be  done 
overnight,  so  ensuring  pertinent  evidence  is  available  when  needed  requires  to  better 
anticipate  and  coordinate  the  needs  for  evidence.  It  also  means  better  mobilising  and 
engaging  the  research  community  in  the  regulatory  process  from  the  start,  as  many 
governments have done during the pandemic.  

The  Commission  as  well  as  the  European  Parliament  and  the  Council  have  various 
databases in which they collect the evidence used in the course of the legislative process. 
A joint effort to create a common evidence register14, the Joint Legislative Portal, would 
provide  anyone  interested  in  EU  policymaking  with  easy  access  to  all  the  evidence 
underpinning  a  given  policy  initiative.  Improved  cooperation  on  a  common  register 
would  integrate  different  efforts  and  allow  more  effective  communication  between 
policymakers at EU and national level. 

Involving people in EU policymaking 

We will step up efforts to publicise our public consultations15 to attract more participants 
and quality contributions. As announced in the ‘Stocktaking Communication’16, we will 
work more closely with  the Committee of Regions, the European Economic and Social 
Committee,  national  authorities,  social  partners  and  other  representative  associations  in 
order  to  raise  awareness  of  the  opportunities  to  contribute  to  the  Commission’s 
policymaking.  For  example,  we  will  ask  them  to  help  us  disseminate  our  ‘calls  for 
evidence’17  at  national  and  regional  levels.  The  Commission’s  Representations  in  the 
Member States and the EU Delegations will also support these efforts. 

12   Following  up  on  the  work  of  the  Task  Force  on  Subsidiarity,  Proportionality  and  ‘Doing  Less  More 
Efficiently’,  the  committee  of  the  Regions  introduced  the  RegHub  network.  This  is  a  network  of 
regions that looks at how legislation is implemented at local level, using targeted surveys. Across the 
EU, RegHub 2.0 has 46 local and regional members (‘regional hubs’), 10 observers and one associated 
body.  The  hubs  are  consulted  through  workshops,  interviews  and  questionnaires  to  collect  their 
experience with the implementation of selected EU policies. 

13   See Section 6.3. 
14   See Section 4. 
15   See Section 3. 
16  Commission  Communication,  Better  regulation:  taking  stock  and  sustaining  our  commitment, 

COM(2019) 178. 

17   See Section 3. 

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3.  BETTER COMMUNICATION WITH STAKEHOLDERS AND THE GENERAL PUBLIC 

Good  policymaking  involves  those  affected  by  the  decisions.  To  sustain  trust  in  the 
European  Union,  EU  policies  need  to  take  into  account  and  reflect  the  values  and 
concerns  of  citizens.  The  active  participation  of  stakeholders,  including  citizens,  is 
essential – especially in times of uncertainty. At the same time, consultations should not 
impose unnecessary burdens. Therefore, we want to make it easier for interested parties 
to provide input through our consultations. 

During  the  crisis,  stakeholders  have  indicated  that  it  has  been  difficult  for  them  to 
contribute  by  the  deadlines  set.  In  response,  the  Commission  has,  where  possible, 
extended public consultations and feedback opportunities for initiatives to be delivered in 
2020 or early 2021, by up to 6 weeks. Going forward, we will adopt a more streamlined, 
inclusive  and  simpler  system,  based  on  a  single  ‘call  for  evidence’18  and  clearer 
questionnaires, while respecting the prerogatives of social partners. 

A streamlined and more accessible system: calls for evidence 

The  Organisation  for  Economic  Cooperation  and  Development  (OECD)  considers  that 
the Commission has the best approach to consultation. Nonetheless, we want to improve 
our approach still further. 

Our current consultation system offers many opportunities to contribute to policymaking, 
including  feedback  periods  for  inception  impact  assessments  and  roadmaps19,  online 
public  consultations20,  targeted  consultations  and  periods  for  feedback  on  adopted 
legislative proposals and draft implementing and delegated acts.  

However, having multiple consultations on the same initiative can be burdensome and at 
times  strain  stakeholders’  resources.  This  is  why  we  are  now  proposing  to  make  the 
consultation  system  more  focused,  clearer  and  user-friendly.  We  will  consolidate  our 
public consultations into a single ‘call for evidence’ on our Have Your Say web portal21. 
We  will  combine  two  steps  that  have  until  now  come  one  after  the  other:  feedback 
periods on roadmaps / inception impact assessments, which will continue to be published 
on Have Your Say as calls for evidence, and public consultations based on questionnaires. 

Calls  for  evidence  will  consist  of  a  description  of  the  initiative  and,  where  relevant, 
include a link to the public consultation22. As a general rule23, they will all be available in 
all EU official languages24 and people will have 12 weeks to respond25. 

18   ‘Evidence’ refers to multiple sources of data, information, and knowledge, including quantitative data 
such as statistics and measurements, qualitative data such as opinions, stakeholder input, conclusions of 
evaluations, as well as scientific and expert advice. 

19   Currently,  evaluations  are  announced  by  roadmaps  and  impact  assessments  by  inception  impact 

assessments. 

20   The Commission carried out 417 public consultations between 2015 and 2018. 
21   https://ec.europa.eu/info/law/better-regulation/have-your-say_en  
22   Organisation of targeted consultations will remain in the remit of specific Directorates-General. 
23   Where necessary, a consultation in two steps will however be undertaken.  
24   Except  for  very  technical  initiatives  and  specialised  questionnaires,  where  such  an  effort  would  be 

disproportionate to the expected input.  

25   During the summer holidays, this period is usually extended to 14 weeks. 

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Facilitating stakeholders’ contributions 

Contributing to public consultations requires time and resources from those participating. 
We therefore want to facilitate the input from stakeholders as much as possible and make 
sure that we consult the public only when needed. 

Evaluation  will continue to  rely on the views of those affected but,  where possible, we 
will  consult  the  public  only  once  when  revising  existing  legislation  and  evaluating 
spending  programmes  at  mid-term,  instead  of  having  separate  consultations  for  the 
evaluation  and  the  impact  assessment.  We  will  also  avoid  public  consultations  on  very 
technical issues of little interest for the general public, where a targeted consultation of 
stakeholders is a better means of collecting the necessary evidence26. 

The  better  regulation  stocktaking  showed  that  public  consultation  questionnaires  are 
currently  often  long  and  too  technical  and  do  not  have  the  right  balance  between  open 
and  closed  questions27.  We  will  improve  the  structure,  content  and  language  of 
questionnaires to address these concerns. 

We will reach out further 

Have Your Say is the web portal through which stakeholders, including members of the 
public,  scientific  and  technical  experts,  can  contribute  to  initiatives  as  they  take  shape 
before  and  after  adoption  by  the  Commission.  The  launch  of  this  single  entry  point  in 
2017 was a significant milestone. July 2020 saw the launch of a new version with a more 
intuitive  user  experience  and  a  markedly  improved  search  function.  In  line  with  our 
Strategy for the Rights of Persons with Disabilities28, we are also making the portal more 
accessible to people with disabilities. 

However, we need to boost awareness around Have Your Say, to encourage more people 
—  including  those  without  in-depth  knowledge  of  EU  policymaking  and  the  scientific 
community — to contribute to our ‘calls for evidence’. Therefore, we will promote Have 
Your Say more widely29. We will make a new effort to engage with the scientific research 
community to encourage them to submit relevant scientific research at the beginning of 
the process.  

The Conference on the Future of Europe also presents an excellent opportunity to debate 
with citizens how to address Europe’s challenges and priorities. The Conference’s online 
deliberative  platform  is  a  new  approach  to  engage  with  people  on  issues  that  they  care 
about.  

26   Decisions will be taken on a case-by-case basis. 
27   REFIT  Platform  opinion  on  submissions  XXII.4.a  by  the  DIHK  and  XXII.4.b  by  a  citizen  on 

stakeholder consultation mechanisms (adopted 7 June 2017). 

28   Commission  Communication,  Union  of  Equality:  Strategy  for  the  Rights  of  Persons  with  Disabilities 

2021-2030, COM(2021) 101 final 
29   Including by means of social media 

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Respondents will hear back from us 

Respect to respondent’s contribution to public consultations requires that information is 
available  on  how  it  was  used  in  the  policymaking  process30.  Therefore,  we  will  keep 
them informed of the feedback we receive and what happens subsequently. 

As a general rule, we will publish a summary report on each public consultation within 
eight weeks of its closure31. The synopsis reports accompanying all impact assessments 
and  evaluations  will  provide  an  overview  and  analysis  of  all  consultation  activities. 
Contributions  from  different  types  of  stakeholders  (local,  regional  and  national 
authorities,  associations,  civil  society,  businesses  of  different  sizes,  the  scientific 
community and individuals) will be better distinguished from each other. The insights we 
have  gained  from  the  consultations  will  be  better  reflected  in  impact  assessments  and 
evaluations. 

Notifications  on  new  developments  of  each  initiative,  such  as  the  publication  of  the 
Commission’s  proposal  or  the  adoption  of  the  final  legislation  following  negotiations 
between  the  European  Parliament  and  the  Council  and  the  Commission,  will  keep 
stakeholders informed throughout the process32.  

4. 

INCREASED TRANSPARENCY  

Transparency  is  fundamental  to  ensuring  that  people  can  play  an  active  part  in  the 
policymaking  process  and  hold  the  EU  institutions  accountable  for  their  decisions.  In 
addition, access to scientific evidence is also key to address global challenges.  

In  line  with  the  Commission’s  digital  strategy  goals33,  we  will  improve  access  to  the 
evidence  behind  every  legislative  proposal.  The  objective  is  to  ensure  that,  for  any 
legislative act, all related published studies, evaluations, datasets, etc. will be easy to find 
and access.  

We  will  improve  our  various  evidence  registers34  and  portals,  such  as  the  EU 
Publications35, EUR-Lex36 and Have Your Say, and the links between them. In addition, 

30   In  the  2019  stocktaking,  nearly  40%  of  the  respondents  to  the  public  consultation  were  (very) 
dissatisfied with the way the Commission reports on the result of its public consultations and feedback, 
and  what it does  with this information. The  REFIT Platform also asked  for  more  transparency  in the 
feedback provided (REFIT Platform opinion on submissions XXII.4.a). These observations  were also 
confirmed by the European Court of Auditors, which recommended that the Commission improve the 
way it reacts to evidence collected in its consultation activities (ECA, Special report no 14/2019: ‘Have 
your say!’: Commission’s public consultations engage citizens, but fall short of outreach activities). 
31   This only applies to public consultations. The 8-week timeframe is indicative for public consultations 
with large number of responses. Respondents’ feedback on legislative proposals is published online at 
the time of submission on Have Your Say. 

32   The Commission is committed to protecting respondents’ personal data and to respecting their privacy. 
A  single  privacy  statement  covers  all  public  consultations  published  on  Have  Your  Say,  in  line  with 
Regulation (EU) 2018/1725 of the European Parliament and of the Council. 

33   Communication  to  the  Commission,  European  Commission  digital  strategy:  a  digitally  transformed, 

user-focused and data-driven Commission, C(2018) 7118. 

34   The  process  has  already  started  for  the  register  of  Commission  documents  and  the  interinstitutional 

studies’ database. 

35   https://op.europa.eu/en/web/general-publications/publications  
36   https://eur-lex.europa.eu/ 

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we will gradually make internal databases and repositories publicly accessible37, in line 
with  our  data  transparency  policy38.  We  will  reach  out  to  the  European Parliament and 
the Council to set up a common evidence register, the Joint Legislative Portal, that will 
allow anyone interested in EU policymaking to find easily all the evidence underpinning 
a given initiative. 

Opening up scientific evidence39 to public scrutiny is also essential to strengthen public 
trust. We have already made MIDAS40 (the Commission’s repository of models) publicly 
available, so that anyone interested can understand the methods and assumptions used in 
our analysis.  

5.  NEW INSTRUMENTS FOR FURTHER SIMPLIFICATION AND BURDEN REDUCTION 

EU legislation is there to bring benefits by making a concrete and positive contribution to 
the  lives  of  its  citizens,  facilitating  businesses  and  helping  face  current  and  future 
challenges.  This  can  come  with  costs,  but  these  must  remain  reasonable  and 
proportionate. 

The  ultimate  shape  of  the  legislation  is  the  result  of  political  negotiations  and 
compromises that tend to make it more complex and costly. Moreover, some legislation 
does not  perform as  expected  when implemented on the  ground.  The overall impact  of 
legislation  depends  on  these  three  layers  (Commission  proposals,  final  negotiated 
legislative acts and implementation at national, regional and local level). 

The Commission has a long-standing policy of improving existing EU laws (see Box 1). 
The aim of the regulatory fitness and performance (REFIT) programme41 is to maximise 
benefits for people, businesses and society at large while removing red tape and reducing 
costs. It also aims to make EU laws simpler and easier to understand. 

We will now strengthen the burden reduction effort  further through a  ‘one in,  one out’ 
approach  whereby,  when  introducing  new  burdens,  we  systematically  and  proactively 
seek  to  reduce  burdens  imposed  by  existing  legislation.  To  support  the  work  on 
simplifying legislation, the Commission has set up the Fit for Future Platform to receive 
advice on ways to ensure that EU legislation is easy to comply with, efficient and fit for 
the future. 

Box 1: Timeline of Commission’s efforts in administrative burden reduction 

A history of EU regulatory burden reduction efforts 

The  Commission  has  a  long  history  of  reducing  regulatory  burden,  starting  in  2002.  The  approach  to 
burden  reduction  has  evolved  over  the  years,  with  experience  gathered  particularly  from  the  2007-2012 

37   Subject to intellectual property right and confidentiality provisions.  
38   Communication on Data, Information and Knowledge Management, C(2016)6626/F1 and Commission 

Communication, A European strategy for data, COM(2020) 66 final 

39   Moreover, scientific evidence is already made publicly available through various dedicated portals, e.g. 
of  the  EU  scientific  assessment  bodies  (such  as  European  Food  Safety  Authority,  or  European 
Medicines Agency). 

40   https://web.jrc.ec.europa.eu/policy-model-inventory/ 
41   https://ec.europa.eu/info/law/law-making-process/evaluating-and-improving-existing-laws/refit-

making-eu-law-simpler-and-less-costly_en  

7 

 
                                                 
administrative burden reduction action programme. 
Back then, it was found that a purely cost-reduction approach had significant drawbacks42, so in 2012 the 
Commission launched the REFIT programme, which focuses on balancing costs with (quantified or other) 
benefits when legislation is revised. This ensures that the original reasons for legislation, i.e. the benefits, 
are part of the equation. The ‘one in, one out’ approach will complement the REFIT programme by paying 
special attention to cumulative costs for individuals and businesses in a given policy area and by covering 
new initiatives. 

2002 — The ‘better regulation’ programme was a first step in simplifying and improving EU legislation. 
It  introduced  obligatory  impact  assessments  and  stakeholder  consultations  for  new  initiatives 
proposed by the Commission. 

2005  —  A  rolling  simplification  programme  was  launched;  it  covered  164  measures  in  2005-2009  and 

became part of the Commission’s annual work programme. 

2007 — The Commission launched the administrative burden reduction action programme; a high‑ level 

group was set up to advise on its implementation. 

2012 — By the end of the action programme, the Commission had reached its target of cutting by 25% the 
administrative  burden  for  businesses  stemming  from  EU  legislation  (estimated  annual  savings: 
€30.8 billion). The ‘Top 10’ consultation on the most burdensome EU laws for SMEs was carried 
out.  

2012 — The REFIT programme was launched. 

2015  —  The  Commission  published  a  study  (ABRplus)  to  examine  how  12  measures  from  the  action 
programme had been applied and to what extent the promised benefits had been achieved. 

2015 — The Commission set up a high-level group to advise it on how to simplify legislation (the REFIT 

Platform). 

2017 — The Commission strengthened REFIT by mainstreaming simplification and burden reduction in 

every evaluation and revision of existing legislation. 
2018 — The Commission published the first Annual Burden Survey43.  

2020  —The  Commission  set  up  the  Fit  for  Future  Platform  to  support  the  work  on  simplification  and 

burden reduction. 

2021  —  The  Commission  complemented  REFIT  with  the  ‘one  in,  one  out’  approach  to  keep  recurrent 

burdens in check. 

5.1.

‘One in, one out’ approach 

In her political Guidelines, President von der Leyen committed to make Europe greener, 
more digital and more resilient, so that we are ready to face the challenges of our times 
and to benefit from the opportunities of technological progress.  

The  Commission  is  more  committed  than  ever  to  designing  policies  and  proposals  that 
make  life  easier  for  people  and  businesses.  We  need  to  ensure  that  regulation  achieves 
benefits,  is  targeted,  easy  to  comply  with  and  does  not  add  unnecessary  regulatory 
burdens. 

The  ‘one  in,  one  out’  approach  (see  Box  2)  involves  offsetting  new  burdens  resulting 
from  the  Commission’s  legislative  proposals  by  equivalently  reducing  existing  burdens 
in  the  same  policy  area.  In  addition,  the  approach  will  widen  the  focus  from  burdens 

42   Generally, it was concluded (SWD(2017) 675) that, due to issues of data availability, transparency and 
reliability,  estimating  administrative  burdens  in  Member  States  was  a  costly  and  complex  exercise. 
Although  the  burden  reduction  objective  was  based  on  extensive  data  gathering,  it  could  not  clearly 
demonstrate its benefits for businesses on the ground. 

43   The Annual Burden Survey  is a Commission annual report providing an overview of the Commission’s 

burden reduction efforts.  

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stemming  from  specific  legislative  acts  to  the  accumulation  of  burdens  in  each  policy 
area and thus give a better overview of costs across policy areas every year. 

Experience in the Member States has shown44 that the introduction of approaches such as 
‘one in, one out’ prompts policymakers to look beyond policy objectives. It draws their 
attention to the practicalities of implementing policies. With the introduction of the ‘one 
in, one out’ approach, we want to strengthen a policymaking culture that not only ensures 
that we achieve our policy objectives, but also pays closer attention to how we do so. In 
this  respect,  we  will  look  into  simplifying  the  processes  leading  to  the  expected  policy 
results  while  considering  the  use  of  digital  solutions  to  foster  smoother  and  less  costly 
policy implementation. 

With  this  change,  we  should  not  only  reduce  the  burden  imposed  by  legislation,  but 
generally improve the quality of specific legislation and so the entire body of legislation. 
This will result in a better focus on legislative  efficiency, avoiding burdens that are not 
strictly necessary for the achievement of policy objectives. 

Under  the  REFIT  programme,  we  already  screen  existing  legislation  systematically  for 
opportunities  to  simplify  and  reduce  burdens  while  preserving  the  attained  benefits,  by 
means of e.g. looking for digital solutions.  

Several  Member  States  have  already  applied  the  ‘one  in,  one  out’  approach  in  various 
ways45.  The  Commission  needs  to  tailor  it  to  the  characteristics  of  the  EU  legal  and 
administrative  context,  with  EU  legislation  often  interacting  with  Member  State 
legislation. To this end, we are using experiences from Member States and stakeholders 
as  well  as  regular  peer  reviews  on  how  best  to  measure  the  costs  of  legislation  and 
improve its overall quality. 

We will not apply the approach mechanically, for example by proposing the withdrawal 
of an existing legislative act for every newly proposed act. Instead, we will seek to offset 
the burdens placed on people and businesses in some legislative proposals with savings 
in  others  in  the  same  policy  area.  We  will  report  on  the  annual  implementation  of  the 
‘one in, one out’ approach in the Annual Burden Survey.  

The Commission will pilot the ‘one in, one out’ approach already in the second half of 
2021 and will start implementing it with the Commission Work Programme 2022, which 
is already under preparation.  

Keeping burdens in check and quantifying them is not an end in itself. The Commission 
will  continue  to  propose  new  legislation  with  the  primary  goal  of  bringing  long-term 
economic, social and environmental benefits to people and businesses. The main test will 
remain  whether  the  benefits  outweigh  the  costs,  in  line  with  the  good  practice  in  our 
internationally  recognised  ‘better  regulation’  system.  The  principles  of  subsidiarity  and 
proportionality  will  be  applied  as  usual.  Hence,  the  implementation  of  the  ‘one  in,  one 
out’ approach will by no means lead to a lowering of the EU’s high economic, social and 
environmental standards and objectives, nor prevent the adoption of new initiatives with 
clear added value effectively pursuing policy priorities. 

44   In  2020,  the  Commission  held  two  workshops  with  Member  States  and  with  European  regulatory 

oversight bodies to collect national experiences with ‘one in, one out’ approaches. 

45   For  an  overview,  see,  for  example:  One-In,  X-Out:  regulatory  offsetting  in  selected  OECD  countries 

(OECD regulatory policy working paper). 

9 

 
                                                 
To comply with these standards and profit from resulting benefits, businesses often have 
to invest in upgrading production lines, reducing damage to the environment, improving 
public health or raising the level of consumer or worker protection. While businesses do 
not  always  directly  benefit  from  these  changes,  they  may  take  advantage  from  new 
business opportunities, gain a competitive advantage or have indirect benefits, such as a 
level playing field in the single market. 

Where investment needs are particularly high and reflect important policy objectives, the 
EU  and/or  Member  States  offer  specific  instruments  to  accompany  the  necessary 
adaptations46.  These  instruments  help  to  make  EU  economies  and  societies  more 
sustainable, resilient and better prepared for the challenges and opportunities of the green 
and digital transitions, leaving no-one behind. For example, new legislation may require 
investment in our resilience in the face of growing economic or environmental impacts, 
dependencies and related risks, including systemic risks.  

Finally,  legislation  at  EU  level  usually  aims  to  overcome  regulatory  fragmentation  in 
different  Member  States  by  replacing  27  national  different  systems.  Those  efficiency 
gains will be taken into account as ‘outs’.  

To  minimise  the  burden  linked  to  the  achievement  of  EU  policy  objectives  and 
implement  the  ‘one  in,  one  out’  approach,  the  expected  costs  of  complying  with  EU 
legislation  will  be  quantified  more  transparently  and  systematically  presented  in  the 
impact  assessments.  They  will  be  scrutinised  by  the  Regulatory  Scrutiny  Board  and 
communicated to the European Parliament and the Council as part of the Commission’s 
proposals  to  inform  the  political  debate.  Costs  incurred  by  enterprises  and  citizens  for 
information,  registration,  monitoring  and  control  will  be  offset  by  removing  equivalent 
existing burdens in the same policy area. 

For  costs  that  will  be  offset  as  part  of  the  ‘one  in,  one  out’  approach,  the  following 
arrangements will be introduced to make the system more flexible: 

 

 

 

flexibility  within  the  reporting  period  –  if  an  ‘out’  cannot  be  identified  in  the 
same year’s work programme, it will be reported in the next year; 

‘trading’  in  certain  exceptional  circumstances  across  policy  areas  –  if  the 
proposed legislation that imposes costs (‘in’) is deemed to be necessary, but it is 
not possible to find an ‘out’ in the same area, the Commission can decide to take 
the ‘out’ from a different policy area; and 

exemptions  in  certain  exceptional  circumstances  –  if  there  is  political  will  to 
regulate but  it is  not  possible to  identify an offset  in  the same area (for instance 
regulation in emerging policy areas where it is necessary to fill a regulatory gap), 
the  Commission  can  decide  to  exempt  the  regulation  from  the  ‘one  in,  one  out’ 
approach. 

Box 2: Practical implementation of the ‘one in, one out’ approach 

Outline of the ‘one in, one out’ approach in the Commission  

(operational  and  methodological  details  will  be  provided  in  the  revised  better  regulation  guidelines  and 

46   For instance through the Recovery and Resilience Facility, the cohesion policy and agricultural funds, 

and the Just Transition Mechanism. 

10 

 
                                                 
toolbox)  

Objectives at EU level: 

  keep to a minimum the burdens for individuals and businesses resulting from EU legislation; 

  greater awareness among policymakers of the costs and benefits of EU legislation; and  

  comparable estimates of costs across policy areas. 

Scope: 

 

Initiatives,  both  new  and  revisions,  that  generate  significant  costs  or  remove  them  and  are 
accompanied by an impact assessment; 

  Pilot phase in the second half of 2021; All relevant Commission legislative proposals47, starting with 

the 2022 Commission Work Programme;  

  Where an initiative imposes some burdens and removes others, these will be accounted as ‘ins’ (new 

costs) and ‘outs’ (cost savings) respectively; 

  All  compliance  costs48  (i.e.  adjustment  and  administrative  costs)  will  be  analysed  and  quantified  in 

the impact assessments, where this is feasible and proportionate.  

o  Administrative costs will be offset. 

o  Adjustment costs will be transparently and systematically presented in impact assessments to 
the extent this is feasible and proportionate. Other measures will be undertaken with a view 
to compensate those costs to the greatest extent possible.  

  All compliance costs  will be scrutinised by the  Regulatory Scrutiny Board, made publicly available 

and be subject to discussions in the legislative process. 

Reporting: 

  Reporting will be done in the Annual Burden Survey. 

 

In  urgent  cases  where  an  initiative  is  adopted  by  the  Commission  without  an  impact  assessment, 
information on the associated costs will be provided after the publication of the legislative proposal, 
so that it can be included in ‘one in, one out’. 

5.2.

  Fit for Future Platform 

The Commission greatly appreciates Member States’, social partners’ and stakeholders’ 
input (advice and hands-on experience) to help establish where legislation is no longer fit 
for  purpose,  imposes  unnecessary  burdens,  requires  further-going  intervention  to  attain 
the envisaged objectives or can be simplified. Some additional legislation may be in need 
of an update in the light of the COVID-19 crisis and its consequences. 

Until  2019,  the  REFIT  Platform  supported  the  Commission’s  efforts  to  improve  EU 
legislation  in  the  context  of  the  REFIT  programme49.  The  Platform  provided  valuable 

47   Amendments  introduced  by  the  European  Parliament  or  the  Council  are  taken  into  account  at  the 

evaluation stage, after legislation has been implemented in the Member States. 

48   Adjustment  costs  encompass  those  investments  and  expenses  that  businesses,  citizens,  civil  society 
organizations have to bear in order to adjust their activity to the requirements contained in a legal rule. 
Administrative  costs  are  resulting  from  administrative  activities  performed  to  comply  with 
administrative  obligations  included  in  legal  rules  (e.g.  reporting  obligations  for  monitoring  and 
statistical purposes, labelling  and non-labelling information for third parties, registration, certification 
of products or processes). 

49   Commission Communication, EU Regulatory Fitness, COM(2012) 746. 

11 

 
                                                 
information on the practical implementation and impact of the legislation50. Nevertheless, 
its work had limited visibility and its potential was not always fully exploited; this led the 
Commission to launch the Fit for Future Platform in May 202051. 

The Fit for Future Platform continues the search for simplification and burden reduction 
potential. It also checks existing legislation in the light of emerging worldwide trends and 
challenges.  In  this  way,  it  helps  the  Commission  to  ensure  that  EU  policies  are 
future-proof,  innovation  friendly,  identify  opportunities  for  digitalisation  and  to  pay 
particular attention to ‘legislative density’52. 

large  businesses, 

The Fit for Future Platform brings together the expertise of public administrations, social 
partners,  small  and 
technical  experts  and  consumer,  health, 
environmental and other non-governmental organisations in regular meetings to improve 
existing EU legislation. The Committee of the Regions and the European Economic and 
Social  Committee  play  a  prominent  role  by  taking  part  in  the  Platform’s  government 
group and the stakeholder group, respectively. The Committee of Region’s RegHub 2.0 
will be systematically involved in the Platform. 

To ensure that its work produces timely, visible and useful outcomes, the Platform works 
on the basis of an annual  work programme.  Its  work programme for 202153 focuses on 
identifying  potential  for  digitalisation,  supporting  efficient  labelling,  authorisation  and 
reporting  obligations,  and  improving  the  quality  of  legislation  to  avoid  overlaps  and 
inconsistencies, while ensuring that it remains future-proof.  

The annual work programme is established by the Platform members and benefits from 
input  from  the  SME  Envoys  Network  (represented  by  the  EU  SME  envoy),  Member 
States, the Economic and Social Committee, the Committee of the Regions and RegHub 
2.0. 

6.  IMPROVING OUR TOOLKIT 

Over 20 years since the first impact assessments and evaluations were conducted54, these 
tools have become an integral part of the Commission’s policymaking process. However, 
these  efforts  should  not  be  limited  to  initial  Commission  proposals,  but  should  also  be 
applied  to  the  legislation  as  it  is  adopted  at  the  end  of  the  negotiation  process.  The 
European  Parliament  and  the  Council  committed  to  do  so  in  the  2016  Interinstitutional 
Agreement on Better Law-Making. 

50   Commission  Communication,  Better  regulation:  taking  stock  and  sustaining  our  commitment, 

COM(2019) 178. 

51   Commission  Decision  C(2020) 2977  of  11  May  2020  establishing  the  Fit  for  Future  Platform  (OJ 

C 163, 12.5.2020, p. 3). 

52   This  relates  to  the  question  as  to  whether  it  is  sufficient  to  establish  principles  and  objectives,  or 
whether  detailed  technical  prescriptions  are  needed  as  to  how  to  achieve  those  objectives.  This  may 
influence  the  degree  of  discretion  for  national,  regional  and  local  authorities  when  implementing  the 
legislation  (see  the  work  of  the  Task  Force  on  Subsidiarity,  Proportionality  and  ‘Doing  Less  More 
Efficiently’). 

53   https://ec.europa.eu/info/law/law-making-process/evaluating-and-improving-existing-laws/refit-

making-eu-law-simpler-less-costly-and-future-proof/fit-future-platform-f4f/annual-work-
programme_en 

54   Sectoral impact assessments were prepared in the Commission as of 1990s. 

12 

 
                                                 
For  our  part,  we  are  planning  the  following  improvements  to  evaluations  and  impact 
assessments. We are looking forward to learning how our institutional partners intend to 
reinforce their efforts, in particular in view of their commitments in the Interinstitutional 
Agreement. 

6.1.

Integrating strategic foresight in policymaking 

In  addition  to  navigating  the  challenges  of  today,  the  COVID-19  pandemic  has  shown 
that  the  EU  must  do  more  to  anticipate  the  challenges  of  tomorrow.  We  need  well-
designed  policies  to  strengthen  the  EU’s  resilience,  seize  opportunities  in  strategic 
sectors and address our vulnerabilities in line with the EU’s overarching goals. We want 
to  make  sure  that  EU  policies  are  fit  for  the  future,  for  instance  in  terms  of  taking  on 
board 
change, 
hyperconnectivity  and  the  significant  demographic  trends  and  others,  as  well  as  using 
horizon scanning exercises to identify possible future developments in specific fields.  

emerging  megatrends55, 

technological 

accelerating 

such 

as 

In  this  context,  strategic  and  science-based  foresight  will  play  a  key  role  in  helping  to 
‘future-proof’ EU policymaking, by ensuring that decisions taken today are grounded in a 
longer-term perspective, including ensuring contribution to long-term commitments such 
as  the  sustainable  development  goals.  It  will  also  bring  a  dynamic  perspective  of 
synergies and trade-offs among EU policy goals, thereby supporting the coherence of EU 
policies.  

As strategic foresight informs major policy initiatives, it will become an integral part of 
the  Commission’s  better  regulation  agenda.  In  policy  areas  subject  to  rapid  structural 
change, impact assessments, fitness checks and major evaluations will take account to the 
extent possible of major trends, such as those identified in the 2020 Strategic Foresight 
Report56  as  well  as  in  its  following  editions.  Public  consultations  could  also  include 
foresight-related  questions,  in  order  to  capture  stakeholders’  perspective  in  the  given 
policy area. The Regulatory Scrutiny Board will take the more prominent role of strategic 
foresight  into  account  when  scrutinising  the  Commission’s  impact  assessments,  fitness 
checks and major evaluations. Additionally, strategic foresight will feed into the process 
of assessing how EU laws remain fit for the future and enable innovations that are in line 
with EU policy objectives. Finally, evaluations and fitness checks will consider the long-
term relevance of policies in the light of possible future developments. 

6.2.

  More comprehensive and transparent impact assessments 

Publishing the rationale behind all relevant proposals 

Impact assessments are carried out for initiatives where policy alternatives are available, 
where expected impacts can be clearly identified beforehand and where these impacts are 
significant  for  society.  However,  sometimes  the  need  for  urgent  legislative  action  does 
not leave time for all the steps set out in the Commission’s better regulation guidelines. 

During the COVID-19 crisis, the Commission has had to propose a number of initiatives 
as  a  matter  of  urgency.  Most  were  decisions  or  acts  that  would  not  have  required  an 
impact  assessment  in  any  case.  Others  would  normally  have  been  subject  to  public 

55   https://ec.europa.eu/knowledge4policy/foresight/tool/megatrends-hub_en  
56   Commission Communication, 2020 Strategic Foresight Report  — charting the course towards a more 

resilient Europe, COM(2020) 493. 

13 

 
 
                                                 
consultations  and  impact  assessments,  but  time  was  too  short.  The  explanatory 
memoranda set out the underlying rationale for the proposals, but the impacts could not 
be fully assessed in advance due to the lack of time and the rapidly evolving situation. 

We  will  continue  to  explain  the  absence  of  an  impact  assessment  in  the  explanatory 
memorandum for the relevant legislative proposals (i.e. those without RSB scrutiny). In 
such cases57, the analysis and all supporting evidence will be set out in a staff working 
document published with the proposal or at the latest within 3 months of its publication. 
This document will set out clearly how and when the act will subsequently be evaluated. 

Improved analysis and reporting of impacts 

The  recovery  from  the  current  crisis  will  see  paradigm  shifts  in  policymaking  and 
investments on an unprecedented scale that will shape the world for the next generation. 
It  is  essential  to  go  about  this  strategically,  so  that  we  not  only  recover,  but  also 
fast-forward  the  twin  transition  and  make  the  world  a  better,  more  resilient  and  equal 
place  than  it  was  before.  Hence,  all  our  legislative  proposals  should  contribute  to 
overarching goals. 

To ensure this, we will identify relevant UN sustainable development  goals (SDGs) for 
each proposal and examine how the initiative will support their achievement58. Links to 
the SDGs will be included throughout evaluations and impact assessments.  

To  reflect  the  ambitious  goals  of  the  von  der  Leyen  Commission,  we  will  improve 
analysis and reporting of some types of impact, in particular those relating to the green 
and  digital  transitions  and  their  socially  just  and  fair  dimension59.  We  will  pay  greater 
attention  to  the  gender  equality  dimension  as  well  as  equality  for  all60,  to  give  it 
consistent  consideration  in  all  stages  of  policymaking.  Territorial  impact  assessments61 
and rural proofing62 will be strengthened, so that the needs and specificities of different 
EU territories are better taken into account, for instance of urban/rural areas, cross-border 
areas63  and  outermost  regions64  to  facilitate  a  more  symmetric  recovery  and  cohesion 
across  the  Union.  At  the  same  time,  we  will  strive  to  better  consider  the  external 
implications of internal policies and their significant impacts on third countries; its actors 
will be better considered. Where relevant,  these impacts  will be analysed  in  the impact 
assessments  and  presented  in  the  explanatory  memoranda  accompanying  Commission 
proposals. 

57   That  is,  when  an  IA  should  have  been  prepared  according  to  the  provisions  of  the  better  regulation 

guidelines but was not following a discretional decision by the Commission. 

58   The principle of proportionate analysis will apply; thus impacts will be quantified to the extent feasible. 
59   See  Commission  Communication,  The  European  Pillar  of  Social  Rights  Action  Plan, 

COM(2021) 102 final 

60   In line with Article 8 and Article 10 TFEU. 
61   Following  up  on  Commission  Communication,  The  principles  of  subsidiarity  and  proportionality: 
Strengthening  their  role  in  EU  policymaking,  COM(2018) 703:  Territorial  Impact  Assessment 
Necessity Checks will be introduced as part of tools so that Commission services can identify when it is 
relevant to conduct territorial impacts assessments 

62   Commission Communication, The Future of Food and Farming, COM(2017) 713 final 
63   Commission Communication , Boosting growth and cohesion in EU border regions COM(217)534 final 
64   In its Communication:  A stronger and renewed strategic partnership with  the EU's outermost regions, 
COM(2017) 623 final, the Commission committed itself to ensuring  that the concerns and interests of 
the  outermost  regions  are  taken  into  due  consideration  as  relevant  in  impact  assessments  and  policy 
evaluations. 

14 

 
                                                 
In addition, impact assessments must reflect the various effects of the COVID-19 crisis. 
In particular, the problem definition, the analysis of subsidiarity and proportionality, the 
baseline  and  the  assessment  of  policy  options  should  take  account  of  the  changed 
circumstances,  including  longer-term  effects  identified  by  foresight  and  the  need  to 
strengthen resilience. 

SMEs  have  been  severely  affected  by  the  crisis.  Careful  assessment  of  the  impacts  of 
Commission  proposals  on  SMEs  will  ensure  that  action  is  targeted,  achieves  its 
objectives  and  does  not  add  unnecessary  costs.  A  more  systematic  and  proportionate 
application of the ‘SME test’65 will help achieve this aim. 

Finally,  we  intend  to  revamp  the  executive  summaries  of  impact  assessments  to  make 
them  an  attractive  read  for  a  wider  audience.  We  will  also  ensure  that  explanatory 
memoranda  describe  clearly  the  basic  reasoning  behind  the  legislative  proposals  in 
question. 

Subsidiarity assessment grid 

Better  regulation  is  partly  about  acting  at  EU  level  only  when,  and  to  the  extent, 
necessary. The principles of subsidiarity and proportionality are  cornerstones of the EU 
treaties, and are systematically applied to the Commission’s legislative proposals. 

The Task Force on Subsidiarity, Proportionality and ‘Doing Less More Efficiently’ and 
the  better  regulation  stocktaking  have  highlighted  that  the  Commission  needs  to 
communicate better why it deems action at EU level to be necessary in particular cases. 
The Committee of the Regions has developed a set of standard questions on subsidiarity 
and proportionality66 to allow for a common understanding of those principles. 

In line with previous commitments67, we will publish a subsidiarity assessment grid with 
every politically sensitive or important proposal accompanied by an impact assessment68. 
This should make it easier for the political institutions to understand which aspects of the 
need for and form of EU action are controversial. This is meant to focus the discussion 
on those points. 

Twin transition 

The  European  Green  Deal  committed  the  Commission  to  improve  the  way  in  which 
better  regulation  addresses  and  supports  sustainability.  Better  regulation  is  also  an 
important tool to support progress towards a common vision and appropriate actions for 
the EU to succeed in the digital decade. It will support digital transformation and the ‘do 
no significant harm’ principle in the following way: 

-  Stakeholder  consultations  explicitly  cover  environmental  and  digital  aspects 

where this is relevant; 

65   Better Regulation Toolbox 2017, Tool #22. 
66   https://portal.cor.europa.eu/subsidiarity/Pages/Subsidiarityandproportionalityanalysiskit.aspx 
67   Commission  Communication,  The  principles  of  subsidiarity  and  proportionality:  Strengthening  their 

role in the EU’s policymaking, COM(2018) 703. 

68   Except for areas of EU’s exclusive competence where subsidiarity does not apply. 

15 

 
                                                 
-  The assessment of the preferred option in impact assessments will be expanded to 
cover  the  analysis  of  the  ‘do  no  significant  harm’  and  ‘digital  by  default’ 
principles.  

-  All  relevant  evaluations  will  contain  a  specific  question  about  whether 
environmental  impacts  could  be  further  minimised  and  whether  more  could  be 
done for a successful digital transformation. 

-  The  explanatory  memorandum  accompanying  all  legislative  proposals  will 
explain  how  each  initiative  upholds  the  ‘do  no  significant  harm’  principle  and 
contributes to achieving the European way for a digital society and economy. 

In  so  doing,  the  Commission  will  ensure  it  abides  by  the  obligations  set  under  the 
European  Climate  Law  and  delivers  on  the  targets  and  principles  set  out  in  the  2030 
Digital Compass Communication. 

6.3.

  Enhancing evaluations to improve use of their findings 

A  large  majority  of  the  Commission’s  legislative  proposals  are  revisions  of  existing 
legislation, including for spending programmes. For them to produce the best results, we 
need  to  check  whether  EU  policies  and  funding  programmes  have  delivered  results  as 
intended and remain relevant and fit for purpose. This is how we learn. 

Therefore, we will stay strongly committed to the ‘evaluate first’ principle. Already, over 
80% of the Commission’s impact assessments supporting legislative revisions are based 
on an evaluation. 

More useful monitoring and review clauses 

Clearly,  an  EU  legislative  act  can  be  evaluated  only  with  the  involvement  of  those 
affected and only after it has been fully implemented by the Member States. Therefore, 
sufficient time has to pass before the Commission can gather enough data and evidence 
to assess the effectiveness of the legislation. 

However,  the  co-legislators  often  introduce  amendments  through  which  legislation 
contains unclear requirements regarding the type of review to  be conducted or imposes 
deadlines for evaluating (parts of) legislation that expire before there is enough practical 
experience  and  information  on  its  implementation  and  effects.  The  European  Court  of 
Auditors raised this issue when it assessed the EU’s evaluation policy69. Our legislative 
proposals will include review clauses that are in line with the auditors’ recommendations, 
but the end-result remains largely in the hands of the co-legislators. 

To make review clauses more consistent, the Commission proposes to our co-legislators 
that we distinguish more clearly between implementation reports and evaluations70. The 
former  would  cover  progress  in  transposing,  implementing  and  applying  legislation, 
including  any  problems  encountered  in  that  context.  The  latter  would  evaluate  the 

69   European  Court  of  Auditors,  Special  Report  No  16/2018:  Ex-post  review  of  EU  legislation:  a 

well-established system, but incomplete. 

70   This  is  to  avoid  inventing  divergent  categories,  e.g. ‘assessing  the  experience  of  implementing’, 
‘carrying  out  a  review  of  implementation’,  ‘monitoring  the  application  of  Regulation  …  [by]  in 
particular  examining 
the 
implementation’,  ‘report  on 
implementation and impact’, ‘review of all elements’, ‘review of the functioning and effectiveness’. 

its  effectiveness’,  ‘evaluation  of 

the 

16 

 
                                                 
legislation  (including  spending  programmes)  a  few  years  after 
the  start  of 
implementation, evaluating its effects in the light of the established evaluation criteria71.  

Evaluations and subsequent  impact  assessments rely heavily on the quality, availability 
and  the  reuse  of  data72.  Hence,  it  is  crucial  to  monitor  the  performance  of  legislative 
provisions  on  the  ground.  At  the  same  time,  such  monitoring  and  the  related  reporting 
obligations place administrative burdens on businesses and public authorities. Therefore, 
there needs to be a balance between only gathering what is strictly necessary and having 
enough data available for future evaluations. For this reason, we call on the co-legislators 
to safeguard that all legislation contains monitoring and reporting clauses that guarantee 
sufficient relevant data to evaluate it. 

To work towards consistent review clauses and practicable monitoring clauses, we invite 
the  European  Parliament  and  the  Council  to  develop  common  definitions  and  identify 
best  practices  through  our  regular  dialogue  in  the  context  of  the  Interinstitutional 
Agreement on Better Law-Making.  

In response to the COVID-19 crisis, national statistical authorities have taken temporary 
measures  to  reduce  reporting  burdens  on  businesses,  for  example  by  adapting  some 
questionnaires  and  information  submission  modes.  At  the  same  time,  Eurostat  and  the 
national statistical authorities have continued to provide high-quality statistics needed to 
inform recovery efforts and day-to-day monitoring of the performance of EU laws. 

Improving evaluations and fitness checks to better inform policymaking 

Evaluations are most instructive when they generate a robust evidence base on successes 
and shortcomings, while also identifying areas for improvement with respect to emerging 
trends and challenges. Importantly, they should say more about why pieces of legislation 
have or have not delivered as expected. 

Evaluations  therefore  need  to  report  accurately  evidence-based  findings  on  how 
legislation has performed and derive conclusions that clearly link back to the assessment. 
We  will  report  more  clearly  any  unintended  consequences  or  underperformance  of  EU 
laws  (as  compared  to  the  envisaged  objectives),  so  that  evaluations  can  better  inform 
policymaking. 

In the context of the ‘one in, one out’ approach, evaluations will verify initially estimated 
costs  and  benefits  against  actual  outcomes,  following  co-legislators’  amendments  and 
national implementation. Fitness checks of entire policy areas (rather than evaluations of 
specific  legislative  acts)  are  particularly  useful  in  this  regard.  Apart  from  assessing  the 
extent to which a policy initiative is achieving its objectives, they look at the cumulative 
impacts of legislation, overlaps and inconsistencies, and so give a more complete picture 
of  the  benefits  brought  to  and  burdens  borne  by  businesses,  individuals  and  public 
administrations.  Fitness  checks  of  horizontal  issues,  such  as  reporting  obligations  have 
already  been  conducted  in  a  limited  number  of  policy  areas  (e.g.  environment, 
agriculture)  and  they  have  identified  significant  potential  to  simplify  the  requirements 
and reduce reporting costs. We will endeavour to conduct more of such horizontal fitness 
checks  in  the  future,  as  they  proved  very  useful,  despite  requiring  substantial 
organisational efforts. 

71   Effectiveness, efficiency, relevance, coherence and EU added value. 
72   In line with the Commission’s Digital Strategy and A European strategy for data. 

17 

 
                                                 
Fitness checks and major evaluations are scrutinised by the Regulatory Scrutiny Board, 
providing the quality check to the assessment of how legislation is performing. 

Finally, as with impact assessments, we will make executive summaries more accessible 
and more informative on how legislation has performed. 

6.4.

  A strong Regulatory Scrutiny Board 

Within the Commission, the Regulatory Scrutiny Board assesses the quality of the impact 
assessments,  major  evaluations  and  fitness  checks  that  inform  (but  do  not  replace) 
political  decision-making.  The  Board  cannot  and  does  not  question  the  political 
objectives  and  choices  presented  in  the  reports  accompanying  draft  proposals,  but 
considers the quality of evidence, analysis and the logic of intervention. In its advisory 
role, the Board will continue to offer advice regarding the application and interpretation 
of the better regulation guidelines, as amended following this Communication, including 
on the application of exemptions. 

If the  Board finds that an impact  assessment or  evaluation  does not  meet  the standards 
established in the better regulation guidelines, it issues a negative opinion. The report in 
question  then  has  to  be  revised.  If  the  Board  issues  two  negative  opinions  on  a  given 
impact assessment, only the Vice-President for Interinstitutional Relations and Foresight 
can  submit  the  initiative  to  the  College  of  Commissioners  for  possible  adoption.  No 
regulatory oversight body in the Member States is given this degree of influence. 

President  von  der  Leyen  revised  the  decision  setting  up  the  Board73  to  ensure 
uninterrupted functioning of the Board when mandate of its members end as well as to 
strengthen its outreach activities, so that its role is better known by the public.  

The Board can now also engage in independent  outreach activities. It will seek to raise 
awareness of its work outside the EU’s political institutions and thereby strengthen trust 
in  the  quality  of  the  Commission’s  work.  In  addition,  it  will  engage  more  with  similar 
bodies in the Member States to nurture a common approach to better regulation.  

Finally,  the  Board  will  play  a  prominent  role  in  scrutinising  impact  assessments  and 
evaluations  in  the  light  of  the  ‘one  in,  one  out’  approach,  strategic  foresight  and 
appropriate consideration of the various effects of the COVID-19 crisis. 

7.  THE KEY ROLE OF ENFORCEMENT 

The EU is built on commonly agreed rules. For these rules to work, Member States must 
fully implement and enforce them in a timely fashion. They then need to ensure that the 
rules  are  correctly  applied  and  enforced,  because  non-enforcement  bears  costs  for 
citizens and businesses74. 

In  its  role  as  guardian  of  the  Treaties,  the  Commission  assists  Member  States  in 
implementing  EU  law  and  pursues  serious  breaches  of  EU  rules.  The  Commission  and 
the Member States thus share responsibility for the enforcement of EU law. 

73   Decision C(2019) 5565 of 17 July 2019 and P(2020) 2 of 23 January 2020. 
74   E.g. the total costs for society of current environmental implementation gaps alone are around EUR 55 
billion  annually.  COWI  study  for  the  European  Commission,  ‘Costs  of  not  implementing  EU 
environmental law’ (2019)  

18 

 
                                                 
The effective application, implementation and enforcement of EU law is a priority for the 
von  der  Leyen  Commission.  As  announced  in  President  von  der  Leyen’s  political 
guidelines,  we  will  continue  to  guide  and  support  Member  States  in  their  efforts  to 
transpose directives, implement regulations and apply EU rules properly. Our compliance 
checks  verify  how  Member  States  translate  EU  legislation  into  national  legislation.  To 
ensure effective dialogue in the transposition phase, we depend on the Member States for 
clear and precise information on national legislation. 

In its Communication on identifying  and addressing barriers to  the single market75, the 
Commission highlighted that ‘gold plating’ often translates into additional regulatory or 
administrative burden for consumers and businesses, with a particular impact on SMEs. 
However,  compliance  checks  cannot  accurately  identify  all  national  provisions  that  go 
beyond  what  EU  legislation  requires.  Neither  can  the  Commission  in  some  cases 
precisely  gauge  how  much  of  the  regulatory  burden  stems  from  Member  States  adding 
elements  of  national  importance  when  implementing  EU  rules.  In  line  with  the 
Interinstitutional  Agreement  on  Better  Law-Making76,  the  Commission  reiterates  its 
request  to  Member States to  report when they  choose to  add elements  that do not stem 
from EU legislation. 

Going  forward,  the  Commission  intends  to  carry  out  a  stocktaking  of  its  oversight  and 
enforcement activities, to ensure that they remain fit for making EU law work in practice. 

8.  CONCLUSIONS 

Given  the  opportunities  and  challenges  that  lie  ahead  in  the  recovery  from  the  most 
recent  crisis,  it  is  more  important  than  ever  to  legislate  as  efficiently  as  possible. 
Therefore, while the Commission already has one of the best ‘better regulation’ systems 
in  the world,  we  — the  European Parliament,  the Council and the Commission  — still 
need  to  do  more.  This  is  particularly  true  for  the  assessment  of  major  amendments 
introduced in the course of negotiations or in final legislative texts. 

First, we need to ensure that the European Union institutions, local, regional and national 
authorities,  social  partners,  business,  civil  society,  the  scientific  community  and  the 
general public work together on high-quality EU policymaking. For our part, we will be 
improving  the  way  we  consult  and  communicate  with  stakeholders  and  increase 
transparency. In particular, we will raise people’s awareness of the  Have Your Say web 
portal  and  ensure  that  anyone  can  navigate  the  consultations  on  it,  even  without  prior 
knowledge. 

We are stepping up efforts to simplify legislation and reduce its burden by establishing 
the  ‘one  in,  one  out’  approach  and  using  the  advice  of  the  Fit  for  Future  Platform. 
Moreover,  we  will  be  developing  our  better  regulation  toolbox  to  make  better  use  of 
foresight,  mainstream  the  sustainable  development  goals  and  better  take  into  account 
sustainability  and  the  importance  of  digitalisation.  We  will  keep  our  approach  under 
review to  ensure that it  delivers as intended. To  that  effect,  we will take  stock in  2023 
how  the  ‘one  in,  one  out’  approach  has  been  applied  and  we  will  review  its 
implementation. 

75   Commission Communication, Identifying and addressing barriers to the single market, COM(2020) 93. 
76   See paragraph 43 of the Agreement. 

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The best way to progress in making better laws (and thus to deliver better results) is by 
working closely together over the coming years. In this way, we can ensure that the EU 
becomes stronger and more resilient during this Commission’s term in office. 

The Commission will: 

 

 

engage  with  the  European  Parliament  and  the  Council  on  the  full  implementation  of  the 
Interinstitutional  Agreement  on  Better  Law-Making,  including  on  improving  the  quality  of  EU 
legislation to ensure that it is clear, readable and understandable; 

simplify  its  consultation  process  to  fewer  steps  by  introducing  a  single  call  for  evidence, 
improving questionnaires and consulting only once when revising a piece of legislation; 

  make the improved Have Your Say web portal more widely known; 

 

provide feedback to consultations swiftly and offer follow-up updates; more accurately reflect the 
input of local, regional and national authorities; 

  make evidence underpinning every legislative proposal easily accessible by interlinking databases 

and repositories better and gradually opening them up to the public; 

 

 

introduce the ‘one in, one out’ approach to further minimise burdens when legislation is proposed 
and consider the cumulative impact of legislation on people and business; 

take into account the opinions of the Fit for Future Platform — a high-level expert group assisting 
the Commission by providing opinions on how to make EU legislation simpler, more efficient and 
innovation- and future-proof; 

  make foresight an integral part of policymaking and the better regulation agenda by incorporating 

it in impact assessments and evaluations; 

 

 

 

 

for politically sensitive and important initiatives for which it has not been possible to prepare an 
impact assessment, publish rationale and evidence within 3 months; 

ensure that better regulation supports the implementation of the ‘do no significant harm’ and the 
‘digital by default’ principles across all policies; 

improve the analysis and reporting of proposals’ impacts (e.g. on sustainable development goals, 
SMEs, sustainability, equality, subsidiarity and proportionality); 

distinguish more clearly between implementation reports and evaluations, and invite the European 
Parliament  and  the  Council  to  develop  common  definitions  and  identify  best  practices  for 
consistent review and monitoring clauses in EU legislation; 

  make  evaluations  more  useful  for  improving  policies  and  make  more  frequent  use  of  fitness 

checks to identify simplification and burden reduction opportunities; 

 

 

improve  the  quality  and  availability  of  monitoring  frameworks  and  data  to  enable  stronger 
evaluations; 

rely  on  the  Regulatory  Scrutiny  Board  to  scrutinise  impact  assessments,  evaluations  and  fitness 
checks in the light of the ‘one in, one out’ approach and foresight; and 

 

carry out a stocktaking of its oversight and enforcement activities. 

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