COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT Accompanying the document REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL for a Single Market Emergency Instrument REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009 and (EU) No 305/2011 as regards emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to a Single Market emergency and DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directives 2000/14/EC, 2006/42/EC, 2010/35/EU, 2013/29/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU and 2014/68/EU as regard emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to a Single Market emergency
Date: 2022-09-19
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EC conformity marking, European standard, crisis management, goods and services, harmonisation of standards, market approval, market supervision, security of supply, single market, technical specification

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   EUROPEAN COMMISSION  Brussels, 19.9.2022  SWD(2022) 290 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT  Accompanying the document REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL for a Single Market Emergency Instrument              REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL              amending Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009 and (EU) No 305/2011 as regards emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to a Single Market emergency              and DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL              amending Directives 2000/14/EC, 2006/42/EC, 2010/35/EU, 2013/29/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU and 2014/68/EU as regard emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to a Single Market emergency {COM(2022) 459 final} - {SEC(2022) 323 final} - {SWD(2022) 288 final} - {SWD(2022) 289 final}  
 
 
Executive Summary Sheet 

Impact Assessment for the Single Market Emergency Instrument 

What is the problem and why is it a problem at EU level? 
Recent crises, such as the COVID-19 pandemic or  Russia’s invasion of Ukraine,  have demonstrated 
how  fragile  the  Single  Market  can  be  in  case  of  unforeseen  disruptions  and,  at  the  same  time,  how 
much  the  European  economy  and  all  its stakeholders  rely  on  a  well-functioning  Single Market.  The 
impact  of  a  crisis  on  the  Single  Market  can  be  two-fold.  On  the  one  hand,  a  crisis  can  lead  to  the 
appearance  of  obstacles  to  free  movement  within  the  Single  Market,  thus  disrupting  its  normal 
functioning. On the other hand, a crisis can amplify the shortages of crisis-relevant goods and services 
if  the  Single  Market  is  fragmented  and  is  not  functioning.  As  a  result,  supply  chains  can  swiftly 
become interrupted, companies face difficulties in sourcing, supplying or selling goods and services. 
Consumer  access  to  key  products  and  services  becomes  disrupted.  Lack  of  information  and  legal 
clarity further exacerbate the impact of these disruptions. In addition to direct societal risks caused by 
the crisis, citizens, and in particular vulnerable groups, are confronted with strong negative economic 
impacts. 
The Impact Assessment will look at two separate but interrelated problems: 

1.  Obstacles to free movement of goods, services and persons in times of crisis 
2.  Shortages of crisis-relevant goods and services 

What should be achieved? 
The scope of this initiative is not to provide solutions to overcome a future crisis as a whole, but rather 
to enable a swift and flexible response to Single Market impacts of a crisis, notably in relation to free 
movement  obstacles  and  shortages  of  crisis-relevant  goods  and  services.  The  general  objective  of 
SMEI  is  to  enhance  the  Single  Market’s  vigilance  for  and  response  to  crises  as  well  as  its  smooth 
functioning  in  times  of  crisis.  To  this  end,  SMEI  will  equip  the  EU  with  a  well-calibrated  crisis 
toolbox  that  permits  a  rapid  and  effective  response  to  any  future  crisis  that  threatens  to  hamper  the 
functioning  of  the  Single  Market.  It  will  complement  other  existing  EU  mechanisms,  including 
through better coordination, transparency and speed. This initiative pursues two specific objectives: 
1. Minimise obstacles to free movement of goods, services and persons in times of crisis: The aim 
is to  provide  a toolbox  of solutions  consisting  of  vigilance,  coordination  and transparency  measures 
assuring more aligned and targeted Member States responses and providing needed transparency when 
it comes to obstacles to free movement. 
2. Address shortages and safeguard availability of crisis-relevant goods and services:  The aim is 
to facilitate quick and practical solutions to issues of supply in times of crisis and to provide adequate 
vigilance,  coordination  and  transparency  mechanisms  for  a  targeted  policy  response  by  enabling 
information exchange and close cooperation with industry/stakeholders for identifying crisis-relevant 
supply chain bottlenecks and capacity needs, and taking further action where necessary. 
What is the value added of action at the EU level (subsidiarity)? 
The economic activities across the Single Market are deeply integrated. The objective of ensuring the 
smooth and undisrupted functioning of the Single Market cannot be achieved by means of unilateral 
national measures. The EU added value of this instrument would be the joint ability of Commission 
and  Member  States  to  have  a  quick  and  structured  way  of  communication,  coordination  and 
information  exchange  when  the  Single  Market  is  put  under  strain,  and  to  be  able  to  take  necessary 
measures  in  a  transparent  way  –  reinforcing  or  speeding  up  existing  mechanisms  as  well  as  adding 
new exceptional and targeted emergency tools. 
B. Solutions 
What are the various options to achieve the objectives? Is there a preferred option or not? If not, 
why? 
The options establish a governance body and a framework for contingency planning, vigilance and emergency 
modes. Both Single Market vigilance mode and Single Market emergency mode would be activated according to 
specific criteria and triggering mechanisms. Certain measures in the toolbox would need additional activation. 

On  the  basis  of  analysis  of  problem  drivers  and  gaps  in  the  relevant  sector-specific  legislation,  eight  building 
blocks of measures were defined by grouping measures into blocks applying at different times (at all times, in 
vigilance  mode  and  in  emergency  mode).  For  each  building  block,  three  policy  approaches  were  analysed 
ranging from non-legislative measures to a hybrid approach to a more comprehensive legislative framework. On 
the basis of this analysis, some or all approaches were retained for each building block and were combined into 

1 

 
 
 
three realistic policy options reflecting different levels of political ambition and stakeholder support.  

Mode 

Building blocks 

All times 

All times 

1. governance, 
coordination and 
cooperation 

2. crisis 
contingency 
planning 

Vigilance 

3. Single Market 
vigilance 

Policy Option 1 
TRANSPARENCY 

Policy Option 2 
COOPERATION 

Policy Option 3 
SOLIDARITY 

Approach 2 
Formal  Advisory  Group as the technical-level  forum and obligation of the 
MS  to  share  information  within  the  group  in  anticipation  and  during  the 
crisis 

Approach 2 
Recommendation to the 
MS for risk assessment, 
training and drills & 
compendium of crisis 
response measures 

Approach 2 
-  Recommendation 
information 
strategic supply chains 

to 
gathering 

Approach 3 
- Recommendation to MS for risk assessment & 
compendium of crisis response measures and 
- Obligation to the Commission for Union level 
risk assessment 
- Obligation to MS  to train their relevant crisis 
management staff regularly 

the  Member  States  on 
identified 

concerning 

-  Recommendations  to  the  Member  States  for 
building up strategic reserves  of goods of strategic 
importance 

and 

strategic 

Approach 3 
-  Obligation  to  MS 
to gather information 
concerning 
identified 
supply chains 
-  Obligation  of  the 
Commission to draw 
regularly 
up 
list  with 
update 
targets  for  strategic 
reserves 
- Obligations to MS1  
to  build  up  strategic 
reserves  for  selected 
goods  of  strategic 
if 
importance 
the 
MS 
strategic 
fall 
reserves 
significantly short of 
the targets 

Emergency  4. key principles 

and supportive 
measures for 
facilitating free 
movement 
during 
emergency 

Emergency  5. transparency 
and 
administrative 
assistance during 
emergency 

Emergency  6. speeding up 
the placing of 
crisis-relevant 
products on the 
market during 
emergency 

Emergency  7. public 

procurement 
during 
emergency 

1 Subject to additional trigger 

Approach 2 
Reinforcing  key  principles  of  free  movement  of  crisis-relevant  goods  and 
services in binding rules where appropriate for effective crisis management 

Approach 3 
Binding  full-fledged  fast-track  notification  mechanism,  flash  peer  review 
and possibility to declare the notified measures incompatible with EU law; 
contact points and electronic platform 

Approach 2 
Targeted amendments of existing Single Market harmonisation legislation: 
faster  placing  of  crisis-relevant  products  on  the  market;  Commission  can 
adopt technical specifications; MS prioritise  market surveillance for crisis-
relevant products  

New  provision  on 
Commission for some or all Member States 

joint  procurement/common  purchasing  by 

the 

Approach 2 

2 

 
 
 
 
 
                                                           
 
Emergency  8. measures 

Approach 1 

Approach 2 

impacting crisis-
relevant supply 
chains during 
emergency mode 

Guidance on  ramping 
up production capacity; 
speeding up permitting 
procedures; accepting 
and prioritising orders of 
crisis relevant goods 
Recommendations to 
businesses to share 
crisis-relevant 
information 

Recommendations to 
MS for the distribution 
of stockpiled products;  
speeding up permitting 
procedures; 
encouraging economic 
operators to accept and 
prioritise orders 
Empowering MS2 to 
oblige economic 
operators to ramp up 
production capacity and 
to address binding 
information requests to 
economic operators 

Approach 3 
Obligations to MS3 
to distribute products 
previously 
stockpiled; speeding 
up permitting 
procedures,  
Obligations to 
businesses to accept 
and prioritise orders; 
ramp up production 
capacity and provide 
crisis-relevant 
information 

The Impact Assessment does not present a preferred option.  
What are different stakeholders' views? Who supports which option? 
Stakeholders largely agree with the need to ensure free movement as well as greater transparency and 
coordination in times of crisis. Most experiences described by stakeholders came from the COVID-19 
crisis. When it comes to ensuring availability of crisis-relevant goods, Member States have expressed 
support  for  measures  such  as  coordination  of  public  procurement,  fast-track  conformity  assessment 
and improved market surveillance. A number of Member States have voiced concern about including 
measures  to  ensure  general  crisis  preparedness  and  to  address  difficulties  in  supply  chains.  Some 
business  stakeholders  have  expressed  support  for  a  clear  definition  of  an  emergency,  greater 
coordination and transparency, measures to ensure free movement of workers, fast-track notifications 
of national measures, fast track procedures for development and publishing of harmonised standards, 
EU  and  national  single  points  of  information,  emergency  drills  for  experts.  However,  some  voiced 
concerns about mandatory measures targeting economic operators. 
C. Impacts of the options 
What are the benefits of the options (if any, otherwise of main ones)? 
Option  1  is  expected to  bring  economic  benefits  for  companies,  in  particular  during  an  emergency, 
due to better EU-level crisis response leading to less obstacles to free movement and better availability 
of crisis-relevant products. Measures easing free movement will have a significant positive impact on 
workers  because  they  will  lead  to  securing  employment  by  ensuring  higher  cross-border  trade  and 
fewer disruptions in economic activity during crises. Cross-border workers and outermost regions will 
particularly benefit of this option. Measures to ensure better availability of crisis-relevant products will 
result  in  direct  social  benefits,  as  they  will  improve  crisis-specific  response  of  the  EU,  thereby 
contributing to better quality of life of citizens in times of crisis. However due to the voluntary nature 
of the measures in blocks 2, 3 and 8 under this Option, the ability to ensure the availability of such 
crisis-relevant products would be severely limited. 
Option  2  will  bring  further  benefits  compared  with  Option  1,  thanks  to  a  better  EU-level  crisis 
response.  Particularly,  the  binding  measures  in  block  8  would  provide  additional  social  benefits. 
Member  States’  capability  to  require economic  operators  crisis-relevant  information  and  to  ramp  up 
production of crisis-relevant products could address the demand for such products during the crisis at 
stake  and  thus  result  in  a  substantively  better  overall  EU  crisis  response,  leading  to  a  direct  social 
impact in terms of improving living conditions and quality of life. 
Option  3  is  expected  to  bring  even  larger  economic  benefits  for  companies,  in  particular  during  an 
emergency,  as  compared  to  Option  2.  Such  benefits  could  be  harvested  thanks  to  making  available 
stronger measures that allow to further improve EU-level crisis response thus leading to significantly 
better availability of crisis-relevant products and less obstacles to free movement. Furthermore, having 
a  harmonised  EU  wide  tool  avoids  the  situation  where  Member  States  may  introduce  individual 

2 Subject to additional trigger 
3 Subject to additional trigger 

3 

 
 
 
 
 
 
                                                           
 
national measures fragmenting the Single Market. It is also expected to provide higher social benefits. 
The measures impacting crisis-relevant supply chains during emergency (block 8) would all serve as 
exceptional  measures  that  could  however  be  decisive  in  ensuring  the  availability  of  crisis-relevant 
products in case of a dire need in a crisis. This in turn allows a much better overall EU crisis response, 
leading to an even stronger direct social impact in terms of improving living conditions and quality of 
life and, depending on the crisis, saving lives of citizens.  
What are the costs of the options (if any, otherwise of main ones)? 
Option  1  does  not  entail  costs  for  companies,  as  all  measures  that  could  have  a  negative  impact  in 
terms of costs are voluntary. There are some direct costs for the Commission and the Member States 
such as administrative costs linked to organisation and participation in the Advisory Group meetings 
as  well  as  compliance  costs  linked  to  measures  in  blocks  4  and  5  during  an  emergency  such  as 
compliance with key principles and notifications.  
Option 2 could entail some costs for companies linked to measures applicable during an emergency 
mode  as  compared  to  Option  1.  Such  costs  are  compliance  costs  for  information  requests  and 
opportunity costs linked to the obligation to ramp up or repurpose production. Also, additionally to the 
costs  of  Option  1,  there  would  be  costs  for  Member  States  for  trainings  and  drills,  as  well  as  costs 
linked to the measures in block 8 such as information requests and ramping up production. Additional 
costs will be also for the Commission in particular linked to the measures under block 2 such as risk 
assessment and trainings and drills. 
Option 3 For companies, in addition to costs under Option 2, there could be opportunity costs linked 
to measures in emergency mode such as priority rated orders. For Member States, compared to Option 
2, there could be additional costs linked to measures in vigilance mode such as constitution of strategic 
reserves  (block  3)  and  measures  in  emergency  mode  such  as  distribution  of  strategic  reserves  and 
speeding  up  permitting  (block  8).  Overall,  the  absence  of  harmonised  rules  and  cooperation  would 
lead to a fragmentation of the Single Market, causing costs for companies. 
What are the impacts on SMEs and competitiveness? 
The initiative is considered relevant for SMEs. As all companies, SMEs will benefit from the overall 
better EU-level crisis response due to less obstacles to free movement and better availability of crisis-
relevant  products.  Overall,  no  costs  for  SMEs  are  expected  under  Option  1.  SMEs  could  be 
particularly negatively affected by the mandatory information requests under  Options 2 and 3. SMEs 
could particularly benefit from the obligation to ramp up production with appropriate financial support 
under  Options  2  and  3.  SMEs could further benefit from  measures  to  speed  up  permitting and from 
priority-rated orders under Option 3. 
Under Option 1, there would be better transparency and legal certainty as well as lower costs for EU 
companies  due  to  easing  of  free  movement  and  measures  to  ensure  transparency,  thus  improving 
competitiveness. Additional impact under Option 2 compared to Option 1 is expected to be small as 
the direct measures will concern only a very limited number of companies. Under Option 3 there could 
be a significant positive effect on competitiveness compared to Option 2 as it would have a significant 
effect on the companies concerned and would ensure a better overall crisis response. 
Will there be significant impacts on national budgets and administrations? 
Member  States  will  incur  recurrent  costs  linked  to  the  Advisory  Group  meetings  and  specific  costs 
during vigilance and emergency modes linked to specific measures activated in those modes. 
Will there be other significant impacts? 
No other significant impacts have been identified. 
Proportionality? 
The proposed actions address the objectives of the initiative and do not go beyond what is necessary to 
ensure the resilience and functioning of the Single Market in times of crisis. Stakeholders and Member 
States have expressed doubts about whether in particular the measures impacting crisis-relevant supply 
chains during emergency under Option 3 comply with the principle of proportionality. 
D. Follow up 
The Commission will carry out an evaluation of the effectiveness, efficiency, coherence, relevance and 
EU added value of this legislative initiative and present a report on the main findings to the European 
Parliament,  the  Council,  the  European  Economic  and  Social  Committee,  and  the  Committee  of  the 
Regions five years after the date of application of the legislative acts. The Commission may propose 
based on the evaluation report how to improve the Single Market Emergency Instrument. 

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