REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Minimizing regulatory burden for SMEsAdapting EU regulation to the needs of micro-enterprises
Date: 2011-11-23
Institutions: European Commission
Subjects: action programme, derogation from EU law, legislation, micro-enterprise

EUROPEAN COMMISSION 

Brussels, 23.11.2011 
COM(2011) 803 final 

REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN 
PARLIAMENT 

Minimizing regulatory burden for SMEs 
Adapting EU regulation to the needs of micro-enterprises 

 
 
 
 
  
 
1. 

INTRODUCTION  

Small  and  medium-sized  enterprises  (SMEs)  play  a  key  role  in  shaping  Europe's  economy, 
accounting for 99 % of enterprises, of which 92 % are micro-enterprises.1 They provide more 
than two thirds of private sector employment and play a key role in economic growth. They 
have a crucial importance to the European economy as employers and sources of innovation. 
The  Commission  is  committed  to  support  their  development,  notably  through  the  "Small 
Business Act" with its "Think Small First" principle and by facilitating, amongst other things, 
access  to  EU  funding.  The  Commission's  Smart  Regulation  agenda  also  aims  to  help  small 
businesses by minimising the regulatory burden of legislation that is deemed necessary at EU 
level.  

The EU's growth strategy for the coming decade, Europe 2020, highlights the importance of 
improving the business environment, including through  smart  regulation,  to  make  European 
enterprises  more  competitive  at  the  global  scale.  However,  the  financial  crisis  is  having  a 
severe  impact  on  many  of  the  smallest  companies  in  the  EU  economy.  It  is,  therefore, 
essential  to  free  up  micro  enterprises  to  allow  them  pursue  their  business  goals  without 
unnecessary  regulation.  The  Commission  is  aware  that  the  smallest  firms  face  the  greatest 
costs  in  complying  with  regulations2.  Compliance  with  legislation  stemming  from  the 
regional,  national  or  European  level  will  always  be  more  burdensome  for  the  smaller 
enterprise. 

This paper outlines ways of taking the concept of "Think Small First" a step further to deliver 
rapid  results.  It  sets  out  how  the  Commission  will  strengthen  the  use  of  exemptions  or 
specific, lighter  legislative regimes for  SMEs or micro companies. It also explains how this 
will be followed up through the legislative process and implementation. 

Regulation is a necessary part of modern business life. It protects citizens and workers from 
safety  risks,  the  environment  from  pollution.  It  is  the  vehicle  through  which  public  policy 
aims  are  achieved.  The  steady  development  of  the  EU's  internal  market  brings  many  new 
opportunities for companies of all sizes but it also needs a minimum of regulation to function.  

The Commission welcomes the European Council interest in this issue, and looks forward to 
feedback  from  the  European  Parliament,  the  Council  and  other  stakeholders  on  this  report, 
which  will  help  to  take  this  important  work  forward.  The  Commission  also  hopes  the 
European  Parliament  and  the  Council  will  give  strong  support  to  its  legislative  proposals 
seeking to keep regulatory costs for SMEs and especially micro companies to a minimum.  

The  Commission  will  also  continue  to  work  with  Member  States  to  help  them  minimise 
regulatory burden and eliminate gold plating when implementing EU legislation. 

1 

2 

The definition of an SME covers all enterprises with less than 250 employees and equal to or less than 
either  €50  million  turnover  or  €43  million  balan ce  sheet  total.  Micro-enterprises  are  the  smallest 
category  of  SME,  with  less  than  ten  employees  and  a  turnover  or  balance  sheet  total  equal  to  or  less 
than €2 million. 
On average, where a big company spends one euro per employee to comply with a regulatory duty a 
medium-sized enterprise might have to spend around four Euros and a small business up to ten Euros 
(Report  from  the  Expert  Group  on  “Models  to  Reduce  the  Disproportionate  Regulatory  burden  on 
SMEs”, May 2007. )  

2 

 
 
 
                                                 
 
2. 

WHAT HAS BEEN DONE 

The  Commission  is  taking  action  to  produce  SME  friendly  legislative  proposals,  like  that 
exempting micro-entities from unnecessary legal requirements in accounting directives. It is 
fully committed to assessing the impacts of new or revised legislation on SMEs through  its 
well  developed  impact  assessment  process;  it  also  regularly  evaluates  whether  legislation  is 
delivering  what  it  was  intended  to  do.  Through  the  Small  Business  Act  (SBA)3  and  Single 
market  Act  (SMA)4  it  is  taking  steps  to  facilitate  access  to  finance  for  SMEs,  one  of  the 
biggest challenges they face in the current crisis. Extensive simplification measures are being 
applied to help SMEs take part in EU funded programmes. The latest Commission proposal 
on  Cohesion  Policy,  for  example,  introduced  a  core  set  of  common  rules  for  the  five  funds 
concerned5,  including  simplified  reimbursement  methods,  which  will  significantly  simplify 
the conditions for access to EU funds for SMEs.  

The  Commission  has  run  two  exercises  to  improve  existing  legislation.  First,  a  major 
Simplification  Programme  to  streamline,  update  and  consolidate  EU  law:  around  200 
proposals  have  been  adopted  that  bring  substantial  benefits  for  businesses.  Second,  the 
Administrative  Burden  Reduction  Programme:  Commission  proposals  representing  a  33% 
reduction of the targeted burdens, well beyond the 25% objective, have been tabled. The co-
legislator has adopted proposals amounting to a 22% reduction. Member States have started to 
implement some of these measures.  

A  report  on  the  best  practices  of  Member  States  in  implementing  EU  law  in  the  least 
burdensome way is being prepared by the High Level Group of independent stakeholders on 
administrative burdens chaired by Dr E. Stoiber. More information on the results of all of this 
work can be found in the Smart Regulation Communication.6 

3. 

FURTHER  EMPHASISING  THE  NEED  TO  "THINK  SMALL  FIRST"  WHEN  PREPARING 
NEW PROPOSALS  

Following  a  proposal  from  President  Barroso,  welcomed  by  the  European  Council  in  June 
2011, the Commission has started a new screening of the EU legislative acquis to implement 
the  "Think  Small  First"  principle  and  to  identify  possible  further  exemptions  or  burden 
reductions for SMEs, in particular micro-enterprises. 

The screening of the acquis is being carried out but SME stakeholders' involvement is vital in 
order  to  identify  those  cases  that  can  make  a  real  difference.  SMEs  and  micros  need  to  be 
better involved in this exercise as they have expressed concerns that exemptions should not 
lead to disadvantages for their situation. For this reason, better and more specific consultation 
mechanisms for SMEs and micro companies are being established. 

First  results  of  the  screening  process  show  that  clear-cut  criteria  for  identifying  legislation 
from which micro companies can be exempted are difficult to identify on a general basis. It is 

3 

4 

5  

6 

Review  of  the  "Small  Business  Act"  for  Europe,  Commission  communication  -  COM(2011)78  (23 
February 2011). 
Single Market Act - Twelve levers to boost growth and strengthen confidence - "Working together to 
create new growth", Commission communication - COM (2011) 206 (13 April 2011). 
The  European  Regional  Development  Fund  (ERDF),  the  Cohesion  Fund  (CF),  the  European  Social 
Fund  (ESF),  the  European  Agricultural  Fund  for  Rural  Development  (EAFDR)  and  the  European 
Maritime and Fisheries Fund (EMFF) 
Smart  Regulation  in  the  European  Union,  Commission  communication  -  COM(2010)543  (8  October 
2010). 

3 

 
 
 
                                                 
acknowledged  by  SMEs  and  their  representatives  that  SMEs  cannot  expect  to  be  above  the 
law.  Much  legislation  will  remain  applicable  to  SMEs  and  micros,  covering  fundamental 
public  policy  obligations,  for  example,  product  safety  standards  that  are  integral  to  trading 
throughout the single market. Exemptions or lighter provisions for smaller businesses will not 
undermine  overall  public  policy  objectives  pursued  through  the  relevant  regulations,  for 
example in public and workplace health and safety, food safety or environmental protection. 
Their  aim  should  be  to  reduce  the  disproportionate  burden  of  delivering  these  objectives. 
There are instances when lightening the burden for smaller operators, while in itself attractive, 
could  produce  broader  negative  repercussions  which  could  outweigh  any  benefits.  In  such 
cases  the  priority  attached  to  the  impact  on  smaller  operators  should  play  a  key  role  in  the 
design of the whole instrument. The key issue is to apply the “Think Small First” principle to 
avoid unnecessary burdens on SMEs.  

A not insignificant volume of cost comes from completing or keeping paperwork and records, 
or from being inspected to demonstrate compliance. Such costs can be abolished in whole or 
in part or often be made easier for small firms. Where laws are focussed on processes, such as 
those relating, for example, to hygiene standards, take-back obligations or similar provisions, 
the  Commission  is  working  to  develop  tailored  approaches  which  are  simpler  and  prevent 
businesses having to scour long rulebooks for the parts that apply to them. 

Examples  of  preliminary  results  of  the  ongoing  screening  exercise  are  given  in  the  non-
exhaustive lists in annexes 1 and 2.  

The screening exercise shows an important range of legislation with existing exemptions. A 
distinction  should  be  made  between  different  cases.    In  some  cases,  SMEs  are  completely 
excluded from the scope of the legislation. In other instances, legislation applies to SMEs but 
exemptions are granted based on the size of the enterprise. Finally, legislation is applicable to 
SMEs but with lighter requirements.  

Whilst the general objective is to exempt small businesses, these exemptions are defined on a 
case-by-case  basis  with  the  different  thresholds  taking  full  account  of  the  specific  nature  of 
the sector and the overall objective of the legislation. 

3.1. 

Legislation excluding small businesses from its scope 

In  some  cases,  small  businesses  are  not  covered  by  EU  legislation,  for  example  by  the 
application of the de minimis principle. 

3.2. 

Exemptions already applied or foreseen in EU legislation:  

• 

• 

Partial exemption: for example, fishing vessels below 15 meters which operate 
exclusively in the territorial waters may be exempted from the obligation to be 
fitted  with  a  vessel  monitoring  system;  micro  companies  are  exempted  from 
installing tachographs in lorries that travel within a limited radian; 

Extended transition periods: for example, the longer adaptation period allowed 
for SMEs to install health and safety signs in the workplace; and a transitional 
period  of  two  years  allowing  SMEs  in  the  construction  sector  to  adapt  to  the 
legislation on the use of work equipment. 

4 

 
 
 
 
• 

Temporary  exemptions:  micro  companies  are  exempted  for  a  limited  period 
from  certain  legislative  provisions  such  as  temporarily  exempting  self-
employed  persons  performing  mobile  road  transport  activities  which  were 
exempted from from working time directives until March 2009 ;  

3.3. 

Tailor-made legislation: 

• 

• 

• 

the  Commission, 

In certain domains, requirements should not be the same for the biggest and the 
in  accordance  with 
smallest  companies.  Therefore 
stakeholders'  wishes,  is  preparing  legislation  on  accounting  law  that  will 
clearly distinguish the obligations for each category of businesses (big, middle, 
small and micro). A further example of this is the ongoing reform of EU data 
protection rules, which is examining ways of alleviating some of the burden of 
legislation for micro-enterprises and SMEs, by introducing lighter obligations 
wherever possible, without prejudicing the protection of fundamental rights. 

The  modernisation  of  the  Transparency  Directive    will  alleviate  some  of  the 
obligations linked to listing and make capital markets more attractive to SMEs.  

In  addition  to  the  core  set  of  common  rules  for  the  five  relevant  funds 
introduced  by  the  recent  Commission  proposal  on  Cohesion  Policy,  further 
simplification  is  planned  for  the  forthcoming  EU  research  and  innovation 
programme, Horizon 2020, particularly to increase the participation of SMEs. 

4. 

STRENGTHENING  THE  APPLICATION  OF  THE  SME  TEST  PARTICULARLY  FOR 
MICRO-ENTERPRISES 

In  order  to  strengthen  the  focus  on  exemptions  and  tailor-made  legislation  for  micro-
enterprises  and  SMEs,  the  Commission  has  started  to  work  to  reverse  the  burden  of  proof. 
From  January  2012  the  Commission's  preparation  of  all  future  legislative  proposals  will  be 
based on the premise that in particular micro-entities should be excluded from the scope of 
the  proposed  legislation  unless  the  proportionality  of  their  being  covered  can  be 
demonstrated.  This  demonstration  is  a  new  element  to  be  included  in  the  SME  test.  Thus 
modified, the test will de facto reverse the burden of proof and focus the preparation of EU 
law on the specific situation of SMEs and micro companies.  

From the same date the Commission will also ensure that, in cases where micro enterprises 
must be covered by its legislative proposals for wider public policy reasons, its proposals will 
be  substantiated  via  the  introduction  of  a  micro-entities  dimension  in  the  "SME  test"  which 
forms part of the regular Impact Assessment. In these cases, recourse to adapted solutions 
and lighter regimes will be sought. As the arguments and reasons for lighter regimes become 
more  visible,  it  should  also  be  easier  to  trace  the  position  of  SMEs  and  micro  companies 
throughout the decision making process. 

To  achieve  this  major  shift  in  policy  and  to  make  sure  that  it  is  followed  through  to  the 
implementation  phase,  the  Commission  will  establish  a  scoreboard,  updated  on  a  yearly 
basis, which will show: 

• 

All exemptions and lighter regimes for SMEs and micro companies proposed 
by  the  Commission  as  well  as  other  proposals  where  the  impact  on  smaller 
operators has been identified as a major factor; 

5 

 
 
• 

• 

the  way  they  change  during  the  co-decision  process  and  the  final  outcome  of 
the legislation as adopted by the European Parliament and Council ; 

the subsequent implementation by each Member State of these provisions, with 
a particular emphasis on highlighting "gold plating" where this is done at the 
national or regional level. 

This will allow all interested parties to identify where progress is made – or where different 
stages in the EU legislative cycle backtrack on simplification, etc.  

5. 

AN ACTION PLAN TO INVOLVE SMES BETTER IN LAW-MAKING AND IN EVALUATING 
THE PROGRESS MADE  

The Commission will provide SMEs with better tailored opportunities to give their views and 
help to shape decisions targeting their needs. It will discuss with them their preferred way to 
mitigate  the  regulatory  burden  in  different  types  of  situations  or  domains.  The  Commission 
will  consult  them  in  an  appropriate  way  on  their  perceptions  of  the  expected  results  of  the 
different  measures.  In  the  field  of  social  policy  the  Commission  will  use  the  consultation 
process  with  the  European  social  partners  provided  under  Article  154  of  the  Treaty,  before 
issuing  a  proposal.  In  addition,  the  Commission  is  reviewing  its  consultation  process  as  a 
follow-up  to  the  Smart  Regulation  Communication  and  intends  to  make  the  following 
changes: 

1. 

2. 

3. 

4. 

5. 

6. 

The  Commission  will  strengthen  the  involvement  and  consultation  of  small 
businesses in better law-making. 

Specific  SME  Panel  consultations,  within  the  Enterprise  Europe  Network,  will  be 
used  more  often  to  provide  direct  input  from  SMEs  to  the  Commission's  impact 
assessment  process  and  for  a  range  of  other  purposes:  for  instance,  an  on-going 
consultation  invites  SMEs  to  report  on  the  most  burdensome  obstacles  they  are 
facing in the Internal Market.  

Dedicated conferences with SMEs and micro companies in the Member States, with 
the  Commission  listening  and  collecting  problems  presented  by  SMEs  and  micro 
companies, are currently being tested and will be rolled out on a larger scale in the 
framework of the Smart Regulation Agenda and the Small Business Act. 

The Small Business Act Review introduces a new governance structure to ensure that 
SMEs’ views are considered in the uptake and effective implementation of the Act. 
In the newly established network of national SME Envoys and the SME Assembly, 
the European and national SME organisations will report on and evaluate the uptake 
of the Small Business Act and promote the exchange of good practices, typically on 
how to ensure SME-friendly legislation and to avoid unnecessary regulatory burden.  

The  network  of  national  SME  Envoys  will  have  the  opportunity  to  provide  their 
views on where exemptions or lighter regimes are most needed and how they should 
be  framed.  The  Commission's  SME  Envoy  will  liaise  with  SME  stakeholders  and 
make  sure  SME  interests  are  taken  into  account  in  the  Commission's  business-
relevant proposals.  

A  dedicated  webpage,  will  be  created  to  identify  the  top  10  EU  legislative  acts 
considered  to  place  burdens  on  micro  companies  and  SMEs.  This  will  be  used  to 
make focused and tailor-made revisions of these legislative acts. 

6 

 
The  financing  of  these  actions  and  initiatives  will  be  covered  by  existing  or  planned 
programmes  consistently  with  the  current  Multi-Annual  Financial  Framework  and  the 
proposals for the new framework 2014-2020. 

In order to minimise the regulatory burden on SMEs and micro-enterprises, the Commission 
calls upon the Member States to make sure that they apply the same principles set out above 
and, in particular, that they: 

• 

• 

involve the small business community closely in law-making right from the start; 

take  the  “Think  Small  First”  principle  a  step  further  by  applying  it  systematically  in 
national  law-making  and  considering  lighter  requirements  and  exemptions  on  a  case-
by-case basis where appropriate; and 

•  apply  the  “SME  Test”  in  impact  assessments  and  strengthen  the  micro  enterprise-

dimension of the Test. 

The  national  SME  Envoy  should  have  a  key  role  in  his/her  country  to  monitor  the 
implementation of these actions in close cooperation with SME organisations.  

6. 

CONCLUSION 

The Commission has set out concrete actions in this report to minimise the regulatory burdens 
on  SMEs,  in  particular  for  micro  enterprises.  The  Council  and  European  Parliament  are 
invited to support this approach and to use the Commission Scoreboard to track exemptions 
and  lighter  requirements  for  micro  enterprises  through  the  co-decision  and  implementation 
process. The Commission calls upon the Member States to apply the “Think Small First” and 
to  commit  to  the  full  and  speedy  implementation  of  the  principles  and  actions  applicable  at 
Member State level.  

7 

 
Annex 1 – Existing legislation with exemptions or lighter regime 

Legislation 

1  Regulation  (EC)  No  1370/2007 
of  the  European  Parliament  and 
of  the  Council  of  23  October 
2007 
passenger 
public 
transport services by rail and by 
road  and 
repealing  Council 
Regulations  (EEC)  No  1191/69 
and 1107/70 

on 

2  Council  Directive  92/58/EEC  of 
24  June  1992  on  the  minimum 
requirements for the provision of 
safety  and/or  health  signs  at 
work (ninth individual Directive 
within the meaning of Article 16 
(1) of Directive 89/391/EEC) 

3  Directive  2007/46/EC  of 

the 
European  Parliament  and  of  the 
Council  of  5  September  2007 
establishing a framework for the 
approval  of  motor  vehicles  and 
their  trailers,  and  of  systems, 
components 
separate 
technical units intended for such 
vehicles 

and 

4  Regulation  (EC)  No  1221/2009 
of  the  European  Parliament  and 
of  the  Council  of  25 November 
2009 
voluntary 
the 
participation  by  organisations  in 
a  Community  eco-management 
and audit scheme (EMAS) 

on 

5  Directive  2002/14/EC  of 

the 
European  Parliament  and  of  the 
Council  of  11  March  2002 
establishing 
general 
framework  for  informing  and 
consulting  employees 
the 
European Community 

in 

a 

6  Council  Directive  2010/18/EU 
of  8  March  2010  implementing 
framework 
the 
revised 
leave 
agreement  on  parental 
by 
concluded 
BUSINESSEUROPE, 
UEAPME,  CEEP  and  ETUC 
and 
Directive 
96/34/EC 

repealing 

Exemption or lighter regime 
Where  contracts  are  awarded  to  SMEs  operating  a 
fleet  of  less  than  23  vehicles,  the  thresholds  above 
which  the  contract  must  be  opened  to  competitive 
tender  can  be  doubled,  making 
the  public 
procurement procedure simpler and less burdensome. 

specify 

categories 

Member  States  may 
of 
undertakings  (by  size  or  activity)  which  may  be 
allowed to replace totally, partially or temporarily the 
obligation  to  have  the  illuminated  signs,  and/or 
acoustic  signals  provided  they  use  other  means 
delivering with the same level of protection. 

Companies  that  manufacture  in  small  quantities  can 
apply  to  their  approval  body  to  have  reduced 
requirements  (NB  :  under  preparation  is  a  further 
exemption  to  exempt  small  series  producers  from 
certain  technical  requirements  in  the  motor  vehicle 
type approval legislation). 

SMEs  may  not  be  required  to  report  on  an  annual 
basis in order to be registered for EMAS. 

The  Directive  applies  to  undertakings  employing  at 
least 50 employees and to establishments with at least 
20 employees. 

Member States may authorise special arrangements to 
meet the operational and organisational requirements 
of small undertakings. 

8 

 
 
 
Legislation 

7  Council  Directive  2001/23/EC 
of  12  March  2001  on 
the 
approximation of the laws of the 
Member  States  relating  to  the 
safeguarding 
employees' 
of 
rights in the event of transfers of 
undertakings, businesses or parts 
of undertakings or businesses 

8  Directive  2006/32/EC  of 

the 
European  Parliament  and  of  the 
Council  of  5  April  2006  on 
energy  end-use  efficiency  and 
energy services 

9  Directive  2004/8/EC  of 

the 
European  Parliament  and  of  the 
Council of 11 February 2004 on 
the  promotion  of  cogeneration 
based  on  a  useful  heat  demand 
in the internal energy market 
10  Council  Directive  2006/112/EC 
of  28  November  2006  on  the 
common  system  of  value  added 
tax 

11  Directive  2006/66/EC  of 

the 
European  Parliament  and  of  the 
Council of 6 September 2006 on 
batteries  and  accumulators  and 
waste batteries and accumulators
12  Council  Directive  97/81/EC  of 
15  December  1997  concerning 
the  Framework  Agreement  on 
part-time  work  concluded  by 
UNICE, CEEP and the ETUC 
13  Council  Regulation  (EC)  No 
1224/2009  of  20  November 
2009  establishing  a  Community 
for  ensuring 
control  system 
compliance with the rules of the 
common fisheries policy 
14  Directive  94/25/EC  of 

the 
European  Parliament  and  of  the 
Council  of  16  June  1994  on  the 
approximation  of 
laws, 
regulations  and  administrative 
provisions of the Member States 
relating to recreational craft 

the 

Exemption or lighter regime 
to 
Member  States  may 
undertakings  or  businesses  which,  in  terms  of  the 
number  of  employees,  meet  the  conditions  for  the 
election  or  nomination  of  a  collegiate  body 
representing the employees. 

the  obligations 

limit 

Member  States  may  exclude  small  distributors  from 
the  obligations  to  support  energy  savings  in  end-use 
consumption  and  to  provide  advanced  metering  and 
informative billing. 

The directive opens the possibility for Member States 
to give better treatment to high-efficiency small scale 
cogeneration as regards access to the grid. 

Member  States  are  allowed  to  implement  simplified 
VAT  charging  and  collection  schemes  for  small 
enterprises such as flat-rate VAT schemes. 

Member States may exempt producers which, relative 
to  the  size  of  the  national  market,  sell  very  small 
quantities  of  batteries  or  accumulators  from  the 
obligation  to  make  a  financial  contribution  to  waste 
treatment and recycling requirements. 
Member States may exclude wholly or partly from the 
terms of this legislation part-time workers who work 
on a casual basis. 

Exemption  for  fishing  vessels  below  15  meters  are 
exempted  from  the  obligation  to  be  fitted  with  a 
vessel monitoring system, because these would entail 
disproportionate costs. 

Longer transitional periods were granted to SMEs to 
adapt 
to  new 
requirements of the directive.  

their  production 

(small  crafts) 

9 

 
 
Legislation 

15  Regulation (EC) No 852/2004 of 
the  European  Parliament  and  of 
the Council of 29 April 2004 on 
the hygiene of foodstuffs 

16  Directive  2003/87/EC  of 

the 
European  Parliament  and  of  the 
Council  of  13  October  2003 
for 
a 
establishing 
emission 
greenhouse 
gas 
the 
allowance 
Community 

trading  within 

scheme 

17  Directive  2003/71/EC  of 

the 
European  Parliament  and  of  the 
Council of 4 November 2003 on 
the  prospectus  to  be  published 
when  securities  are  offered  to 
the public or admitted to trading 
the 
European  Parliament  and  of  the 
Council  of  12  December  2006 
technical 
laying 
requirements 
inland 
waterway vessels 

down 

for 

18  2006/87/EC  Directive  of 

19  Directive  2000/59/EC  of 

the 
European  Parliament  and  of  the 
Council  of  27  November  2000 
on  port  reception  facilities  for 
ship-generated  waste  and  cargo 
residues 

20  Regulation (EC) No 443/2009 of 
the  European  Parliament  and  of 
the  Council  of  23  April  2009 
setting  emission  performance 
standards for new passenger cars 
as  part  of 
the  Community's 
integrated  approach  to  reduce 
CO2  emissions  from  light-duty 
vehicles 

is 

Exemption or lighter regime 
Food  business  operators  are  responsible  for  food 
hygiene.  Implementation  of  HACCP-methodology 
(Hazard  Analysis  and  Control  of  Critical  Points),  a 
required. 
food  safety  management  system, 
However, SME can adapt aspects of the legislation to 
their  situation  (e.g.  reduction  of  frequency  of  auto-
control)  Primary  producers  and  retailers  may  replace 
implementation  of  HACCP  by  implementation  of 
sectoral guides of good practices. 
The Emissions Trading Scheme legislation includes a 
capacity threshold to exclude small installations from 
the  Emissions  Trading  Scheme  or  to  submit  them  to 
equivalent  measures  and  simplified  monitoring  and 
reporting 
emissions 
installations. 

requirements 

low 

for 

Exemptions regarding the prospectus to be published 
when  securities  are  offered  to  the  public  or  admitted 
to  trading  are  provided  for  offers  below  2.5  Mio 
EUR. 

The  directive  includes  possible  derogations  for  ships 
travelling  only  in  the  interior  waters  of  one  Member 
State.  These  derogations  can  be  used  in  cases  of 
equipment  operating  on  navigable  waterways  not 
linked by inland waterway to the waterways of other 
Member States, or for craft having a dead weight not 
exceeding 350 tonnes. 
A  current  exemption  regime  exists  for  ships  with 
regular port calls. 

Small volume and niche manufacturers may apply for 
lower targets. 

10 

 
 
Legislation 

21  Regulation (EU) No 510/2011 of 
the  European  Parliament  and  of 
the  Council  of  11 May  2011 
setting  emission  performance 
standards 
light 
commercial  vehicles  as  part  of 
the  Union's  integrated  approach 
to  reduce  CO2  emissions  from 
light-duty vehicles 

new 

for 

Exemption or lighter regime 
Small volume and niche manufacturers may apply for 
lower targets. 

11 

 
 
Annex 2 – Possible future exemptions or lighter regime7 

States 

deciding 

instance  by 

Exemption or lighter regime 
Data  controllers  (such  as  public  authorities, 
enterprises etc) currently have the obligation to 
notify  their  data  processing  operations  to 
national  data  protection  authorities,  unless 
there  are  grounds  for  being  exempted.  The 
Directive  leaves  considerable  discretion  to 
Member 
possible 
in 
exemptions  to  the  obligation.  Due  to  this,  the 
situation  varies  a  lot  from  Member  State  to 
Member State. 
The  upcoming  reform  package  will  examine 
ways  of  effectively  simplifying  the  regulatory 
increasing 
for 
environment, 
harmonisation  and  proposing 
to  abolish 
notification  obligations  except  in  cases  of 
higher risk processing. 
the  systematic 
to  replace 
The  possibility 
documentation  of  risk  assessment  for  micro 
enterprises dealing with low risk activities by a 
proportionate  risk-based  approach  could  be 
examined  in  the  light  of  consultation  with  the 
social  partners  and  after  the  assessment  of  the 
impact of current obligations.  
The  opportunity  of  the  amendment  of  this 
directive  could  be  taken  to  introduce  a  risk-
based  approach,  which  would  result  in  less 
burdensome 
in 
accordance with the general approach foreseen 
for all occupational health and safety.  

for  SMEs, 

obligations 

The  introduction  of  a  risk  based  approach 
should  be  considered,  which  would  result  in 
less  burdensome  obligations  for  SMEs,  in 
accordance with the general approach foreseen 
for all occupational health and safety. 

1 

2 

3 

4 

Legislation 
Directive  95/46/EC  of  the 
European  Parliament  and  of 
the  Council  of  24  October 
1995  on  the  protection  of 
individuals  with  regard  to 
the  processing  of  personal 
data 
free 
the 
and  on 
movement of such data 

of 

introduction 

Directive 
Council 
89/391/EEC of 12 June 1989 
on 
of 
the 
encourage 
to 
measures 
improvements  in  the  safety 
and  health  of  workers  at 
work 
to  Directive 
Amendment 
2004/37/EC of the European 
Parliament 
the 
and 
Council of 29 April 2004 on 
the  protection  of  workers 
from  the  risks  related  to 
exposure  to  carcinogens  or 
mutagens at work 
for  a  EP  and 
Proposal 
Council  Directive  on 
the 
minimum  health  and  safety 
requirements  on  ergonomics 
at  work  particularly 
to 
work-related 
prevent 
disorders 
musculoskeletal 
(WRMSD) 
display 
screen  vision  conditions  and 
repealing  Council  Directive 
90/269/EEC  and  Council 
Directive 90/270/EEC 

and 

7  

Proposals  for  new  or  amended  EU  regulation  are  subject  to  consultation  and  impact 
assessment which contributes to the final decision on the policy to be adopted. 

12 

 
 
                                                 
5 

6 

7 

8 

9 

10 

Legislation 
Proposal  for  a  Directive  of 
the European Parliament and 
the 
the  Council  on 
of 
conditions  of  entry  and 
residence  of 
third-country 
nationals for the purposes of 
seasonal employment 
Directive  96/71/EC  of  the 
European  Parliament  and  of 
the Council of 16 December 
1996  concerning  the  posting 
of workers in the framework 
of the provision of services 
Directive  2009/45/EC  of  the 
European  Parliament  and  of 
the  Council  of  6  May  2009 
on safety rules and standards 
for passenger ships 
Council 
Directive 
92/29/EEC  of  31  March 
1992 on the minimum safety 
and  health  requirements  for 
improved  medical  treatment 
on board vessels 
Directive  2002/44/EC  of  the 
European  Parliament  and  of 
the Council of 25 June 2002 
on  the  minimum  health  and 
requirements 
safety 
regarding  the  exposure  of 
workers  to  the  risks  arising 
agents 
physical 
from 
(vibration) 
Directive  2002/96/EC  of  the 
European  Parliament  and  of 
the  Council  of  27  January 
2003 on waste electrical and 
electronic 
equipment 
(WEEE) 

Exemption or lighter regime 
Micros  and  perhaps  also  SMEs  could  be 
exempted 
to 
seasonal  workers,  so  that  small  farmers  can 
again  recruit  seasonal  workers,  as  before,  on 
lighter conditions. 

requirements 

related 

from 

drawing 

guidelines 
on 
this  Directive, 

the 
up 
In 
the 
implementation 
of 
Commission  will  consider  whether 
is 
possible  to  have  a  lighter  regime  for  smaller 
companies. 

it 

The  current  revision  of  this  directive  could  be 
an  opportunity  to  deal  with  some  excessive 
provisions, not adapted to take account of small 
ships. 

Vessels  must  be  equipped  with  minimum 
medical  supply  and  equipment.  Beyond  a 
specific threshold, a medical doctor is required. 
When  revising  this    directive  the  Commission 
will consider the pros and cons of proposing  a 
higher threshold for smaller vessels.  
The Commission in the context of the planned 
evaluation  of  this  Directive  and  as  part  of  the 
process  will  invite  comments  on  its  impact  on 
SMEs.  

If  the  recast  of  this  piece  of  legislation  would 
include  a  new  take  back  obligation  for  very 
small WEEE at distributors, as proposed by the 
European  parliament,  the  exemption  options 
from  such  a  take  back  obligation  could  be 
included  for  shops  operating  on  a  very  small 
surface area. 

13 

 
 
11 

12 

13 

Legislation 
Directive  2008/98/EC  of  the 
European  Parliament  and  of 
the Council of 19 November 
2008 on waste 

of 

with 

Directive  2006/24/EC  of  the 
European  Parliament  and  of 
the  Council  of  15  March 
2006 on the retention of data 
generated  or  processed  in 
connection 
the 
publicly 
provision 
available 
electronic 
communications  services  or 
of  public  communications 
networks 
Proposal  for  a  Directive  of 
the European Parliament and 
of  the  Council  on  public 
procurement 

Exemption or lighter regime 
Low  risk  SMEs  that  carry  waste  could  be 
subject  to  a  simplified  registration  procedure. 
To this end, the competent national authorities 
should  make  the  full  use  of  the  last  paragraph 
of  article  26  of  the  WFD,  which  provides  a 
possibility  to  obtain  the  relevant  information 
necessary  for  registration  of  such  SMEs  from 
the  existing  national  records.  This  could  be 
applied to low risk SMEs which pose minimal 
risk  in  terms  of  harm  to  the  environment  or 
human health. 
The  forthcoming  revision  of  this  directive 
could  present  an  opportunity  to  consider  to 
which  companies  the  obligation  to  retain  data 
should  apply.  The  size  of  the  company  might 
be amongst the criteria. 

of 

revision 

forthcoming 

The 
public 
procurement  rules  of  Directives  2004/17/EC 
and 2004/18/EC could foresee an alleviation of 
the  requirements  for  submission  of  certificates 
and  other  means  of  proof 
in  view  of 
participating to public procurement procedures. 
In  particular,  the  certificates  and  other  means 
of  proof  could  be  replaced  by  declarations 
(self-certifications). 

14