Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL establishing a Single Market emergency instrument and repealing Council Regulation No (EC) 2679/98
Date: 2022-09-19
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: crisis management, free movement of goods, free movement of persons, freedom to provide services, goods and services, market approval, security of supply, single market

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   EUROPEAN COMMISSION  Brussels, 19.9.2022  COM(2022) 459 final 2022/0278 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL establishing a Single Market emergency instrument and repealing Council Regulation No (EC) 2679/98 (Text with EEA relevance) {SEC(2022) 323 final} - {SWD(2022) 288 final} - {SWD(2022) 289 final} - {SWD(2022) 290 final}  
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

The Single Market is one of the EU’s greatest assets and provides the backbone for the EU’s 
economic growth and wellbeing. Recent crises, such as the COVID-19 pandemic or Russia’s 
invasion  of  Ukraine,  have  demonstrated    some  vulnerability  of  the  Single  Market  and  its 
supply  chains    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.  In the 
future,  in  addition  to  geopolitical  instability,  climate  change  and  resulting  natural  disasters, 
biodiversity  loss,  and  global  economic  instability  may  lead  to  other,  new  emergency 
situations.  For  this  reason,  the  functioning  of  the  Single  Market  needs  to  be  guaranteed  in 
times of emergency. 

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 
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  proposal  therefore  aims  to  address 
two  separate  but  interrelated  problems:  obstacles  to  free  movement  of  goods,  services  and 
persons in times of crisis and shortages of crisis-relevant goods and services. 

In  close  cooperation  with  all  Member  States  and  other  existing  EU  crisis  instruments,  the 
Single Market Emergency Instrument (SMEI) will provide a strong agile governance structure 
as  well  as  a  targeted  toolbox  to  ensure  the  smooth  functioning  of  the  Single  Market  in  any 
type  of  future  crisis.  It  is  likely  that  not  all  of  the  tools  included  in  this  proposal  will  be 
needed simultaneously. The purpose is rather to brace the EU for the future and equip it with 
what  may  prove  to  be  necessary  in  a  given  crisis  situation  severely  affecting  the  Single 
Market. 
The European Council in its Conclusions of 1-2 October 20201 stated that the EU will draw 
the lessons from the COVID-19 pandemic and address remaining fragmentation, barriers and 
weaknesses  of  the  Single  Market  in  facing  emergency  situations.  In  the  Update  of  the 
Industrial Strategy Communication2, the Commission announced an instrument to ensure the 
free  movement  of  persons,  goods  and  services,  as  well  as  greater  transparency  and 
coordination in times of crisis. The initiative forms part of the Commission Work Programme 
for  20223.  The  European  Parliament  welcomed  the  Commission’s  plan  to  present  a  Single 
Market  Emergency  Instrument  and  called  on  the  Commission  to  develop  it  as  a  legally 
binding structural tool to ensure the free movement of persons, goods and services in case of 
future crises4. 

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single market (2021/2043(INI). 

https://www.consilium.europa.eu/media/45910/021020-euco-final-conclusions.pdf.  
COM(2021)350 final.  
https://ec.europa.eu/info/publications/2022-commission-work-programme-key-documents_en.  
European Parliament resolution of 17 February 2022 on tackling non-tariff and non-tax barriers in the 

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• 

Consistency with existing policy provisions in the policy area 

A  number  of  EU  legal  instruments  lay  down  provisions  which  are  relevant  for  the 
management  of  crises  in  general.  On  the  other  hand,  certain  EU  frameworks  and  recently 
adopted  Commission  proposals  lay  down  more  targeted  measures  which  focus  on  certain 
aspects  of  crisis  management  or  are  relevant  for  specific  sectors.  The  Single  Market 
Emergency  Instrument  will  apply  without  prejudice  to  the  provisions  put  forward  by  these 
targeted crisis management instruments, which are to be considered as lex specialis. Financial 
services,  medicinal  products,  medical  devices  or  other  medical  counter-measures  and  food 
safety products in particular are excluded from the scope of the initiative due to the existence 
of a dedicated crisis-relevant framework in these areas. 

Interplay with horizontal crisis response mechanisms 
The  integrated  political  crisis  response  mechanism  (IPCR)5  is  among  the  horizontal  crisis 
response mechanisms6. The Presidency of the Council of the EU uses the IPCR to facilitate 
information  sharing  and  political  coordination  among  the  Member  States  in  responding  to 
complex  crises.  The  IPCR  scrutinised  for  the  first  time  in  October  2015  the  refugee  and 
migration crisis and it has been instrumental in monitoring and supporting the response to the 
crisis,  reporting  to  Coreper,  the  Council  and  the  European  Council.  The  IPCR  operated  the 
Union  response  to  major  crises  caused  by  cyber-attacks,  natural  disasters,  or  hybrid  threats. 
More recently, the IPCR has also operated after the outbreak of the COVID-19 pandemic and 
the Russian brutal aggression on Ukraine. 

Another EU mechanism for general crisis response is the Union Civil Protection Mechanism 
and its Emergency Response Coordination Centre (ERCC)7. The ERCC is the Commission’s 
central  operational  24/7  hub  for  first  emergency  response,  the  establishment  of  strategic 
stockpiles  at  the  EU  level  for  emergency  response  (“rescEU”),  disaster  risk  assessments, 
scenario  building,  disaster  resilience  goals,  EU  wide  overview  of  natural  and  man-made 
disaster risks, other prevention and preparedness measures, such as training and exercises. 

Interplay with horizontal Single Market mechanisms 

When appropriate and necessary, coordination should be ensured between the Single Market 
Emergency  Instrument  and  the  activities  of  the  Single  Market  Enforcement  Task-Force 
(SMET). In particular, the Commission shall refer notified obstacles that significantly disrupt 
the free movement of goods and services of strategic goods and services for discussion/review 
to the Single Market Enforcement Task Force (SMET). 

• 

Consistency with other Union policies 

Interplay with measures targeting specific aspects of crisis management 

The above-mentioned horizontal crisis response mechanisms are supplemented by other more 
targeted  measures,  focusing  on  specific  aspects  of  the  Single  Market  such  as  the  free 
movement of goods, common rules on exports or public procurement. 

One such framework is the Regulation (EC) No. 2679/98 setting up a response mechanism to 
address  obstacles  to  the  free  movement  of  goods  attributable  to  a  Member  State  leading  to 

https://www.consilium.europa.eu/en/policies/ipcr-response-to-crises/. 
It was formally set up by Council Implementing Decision (EU) 2018/1993 of 11 December 2018 on the 

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EU Integrated Political Crisis Response, on the basis of previously existing arrangements. 
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Mechanism. 

Laid  down  by  the  Decision  (EU)  1313/2013  governing  the  functioning  of  the  Union  Civil  Protection 

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serious  disruptions  and  requiring  immediate  action  (‘The  Strawberry  Regulation’)8.  This 
Regulation  provides  for  a  mechanism  of  notification  as  well  as  a  system  of  information 
exchange between the Member States and the Commission. (See sections 8.1 and 8.2 for more 
details.) 
The  Regulation  on  common  rules  for  exports9  allows  the  Commission  to  subject  certain 
categories  of  products  to  an  extra-EU  export  surveillance  or  to  an  extra-EU  export 
authorisation. The Commission was subjecting certain vaccines and active substances used for 
the manufacture of such vaccines to export surveillance10 on this basis. 

Other economic measures include negotiated procedure and occasional joint procurement by 
the Commission on behalf of the Member States11. 

Interplay with sector-specific crisis measures 

Certain  EU  frameworks  lay  down  more  targeted  measures  which  focus  only  on  certain 
specific aspects of crisis management or only concern certain specific sectors. 

The  Commission  communication  “Contingency  plan  for  ensuring  food  supply  and  food 
security”12 draws lessons learnt during the COVID-19 pandemic and previous crises with the 
objective to step up coordination and crisis management including preparedness. To this end, 
the  contingency  plan  puts  forward  key  principles  to  be  followed  to  ensure  food  supply  and 
food security in the event of future crises. To ensure the implementation of the contingency 
plan and the key principles therein, the Commission in parallel established the European Food 
Security  Crisis  preparedness  and  response  Mechanism  (EFSCM),  a  group  composed  of 
Member  States  and  non-EU  countries  representatives  as  well  as  of  food  supply  chain 
stakeholders  chaired  by  the  Commission  to  strengthen  coordination,  exchange  data  and 
practices. The EFSCM was convened for the first time in March 2022 to discuss the impacts 
of the energy and input price increases and the consequences of Russia’s invasion of Ukraine 
for food security and supply. The market observatories and the civil dialogue groups are other 
fora that ensure transparency and the flow of information in the food sector. 
The  Commission  communication  “Contingency  plan  for  transport”13  has  the  objective  to 
ensure crisis preparedness and business continuity in the transport sector. The plan establishes 
a  “crisis  manual”  that  includes  a  toolbox  consisting  of  10  actions  aimed  at  mitigating  any 
negative impact on the transport sector, passengers and the internal market in the event of  a 
crisis.  These  include  among  others  measures  rendering  EU  transport  laws  fit  for  crisis 
situations,  ensuring  adequate  support  for  the  transport  sector,  ensuring  free  movement  of 
goods, services and people, sharing of transport information, testing transport contingency in 
real-life situations etc.14 

Council Regulation (EC) No 2679/98 of 7 December 1998 on the functioning of the internal market in 

Regulation (EU) 2015/479 of the European Parliament and of the Council of 11 March 2015. 
Commission Implementing Regulation (EU) 2021/2071 of 25 November 2021. 
They  can  be  adopted  on  the  basis  of  Directive  2014/24/EU  of  the  European  Parliament  and  of  the 

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relation to the free movement of goods among the Member States, OJ L 337, 12.12.1998, p. 8. 
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Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC. 
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COM(2021)689 final. 
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COM(2022)211 final. 
14 
Additional  measures  include:  managing  refugee  flows  and  repatriating  stranded  passengers  and 
transport  workers,  ensuring  minimum  connectivity  and  passenger  protection,  strengthening  transport  policy 
coordination  through  the  Network  of  National  Transport  Contact  Points,  strengthening  cybersecurity  and 
cooperation with international partners.  

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Regulation  (EU)  No  1308/2013  establishing  a  common  organisation  of  the  markets  in 
agricultural products15 (CMO Regulation) as well as the sister CMO Regulation for fisheries16 
provide  the  legal  basis  for  collecting  relevant  information  from  Member  States  to  improve 
market transparency17. 

Regulation (EU) No 2021/1139 1308/2013 establishing the European Maritime, Fisheries and 
Aquaculture Fund18 (EMFAF Regulation) provides the legal basis for supporting the fisheries 
and  aquaculture  sector  in  case  of  exceptional  events  causing  a  significant  disruption  of 
markets. 
Regulation  (EU)  2021/953  establishing  the  EU  Digital  COVID  Certificate19  sets  out  a 
common framework for the issuance, verification and acceptance of interoperable certificates 
for  COVID-19  vaccination,  test  or  recovery  certificates  to  facilitate  free  movement  of  EU 
citizens  and  their  family  members  during  the  COVID-19  pandemic.  Furthermore,  based  on 
Commission  proposals,  the  Council  adopted  specific  recommendations  on  the  coordinated 
approach  to  the  restriction  of  free  movement  in  response  to  COVID-19  pandemic20.  The 
Commission also announced in the 2020 citizenship report21 that it intends to review the 2009 
guidelines  on  free  movement  in  order  to  improve  legal  certainty  for  EU  citizens  exercising 
their free movement rights, and to ensure a more effective and uniform application of the free 
movement  legislation  across  the  EU.  The  reviewed  guidelines  should  address  among  others 
the  application  of  restrictive  measures  on  free  movement,  specifically  those  that  are  due  to 
public health concerns. 

Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis 
preparedness  and  management  for  medicinal  products  and  medical  devices  provides  a 
framework to monitor and mitigate potential and actual shortages of centrally and nationally 

15 
Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 
establishing a common organisation of the  markets in agricultural products and repealing Council Regulations 
(EEC)  No  922/72,  (EEC)  No  234/79,  (EC)  No  1037/2001  and  (EC)  No  1234/2007,  OJ  L  347,  20.12.2013,  p. 
671. 
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Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 December 2013 on 
the  common  organisation  of  the  markets  in  fishery  and  aquaculture  products,  amending  Council  Regulations 
(EC)  No 1184/2006  and  (EC)  No 1224/2009  and  repealing  Council  Regulation  (EC)  No 104/2000.  OJ  L  354, 
28.12.2013, p. 1. 
17 
Following  Russia’s  invasion  of  Ukraine,  the  obligation  for  Member  States  to  provide  monthly 
notifications of cereal stocks has been included in an amendment to Commission Implementing Regulation (EU) 
2017/1185 of 20 April 2017 laying down rules for the application of Regulations (EU) No 1307/2013 and (EU) 
No  1308/2013  of  the  European  Parliament  and  of  the  Council  as  regards  notifications  to  the  Commission  of 
information and documents and amending and repealing several Commission Regulations,  OJ L 171, 4.7.2017, 
p. 113. 
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Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 
establishing a common organisation of the  markets in agricultural products and repealing Council Regulations 
(EEC)  No  922/72,  (EEC)  No  234/79,  (EC)  No  1037/2001  and  (EC)  No  1234/2007,  OJ  L  347,  20.12.2013,  p. 
671. 
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Regulation  (EU) 2021/953  of  the  European  Parliament  and  of  the  Council  of  14 June  2021  on  a 
framework  for  the  issuance,  verification  and  acceptance  of  interoperable  COVID-19  vaccination,  test  and 
recovery  certificates  (EU  Digital  COVID  Certificate)  to  facilitate  free  movement  during  the  COVID-19 
pandemic, OJ L 211, 15.6.2021, p. 1. 
20 
Council  Recommendation  (EU)  2020/1475  of  13  October  2020  on  a  coordinated  approach  to  the 
restriction  of  free  movement  in  response  to  the  COVID-19  pandemic,  OJ  L  337,  14.10.2020,  p.  3  and  its 
subsequent updates.  
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COM(2020)730 final. 

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authorised medicinal products for human use considered as critical to address a given ‘public 
health emergency’ or ‘major event’ 22. 

Finally, the Commission  Decision of 16 September 2021 established the Health Emergency 
Preparedness  and  Response  Authority23  for  coordinated  action  at  Union  level  to  respond  to 
health  emergencies,  including  monitoring  the  needs,  swift  development,  manufacturing, 
procurement and equitable distribution of medical countermeasures. 

Interplay with ongoing initiatives 

In parallel, a number of initiatives, which have been recently proposed and are currently being 
discussed, concern aspects relevant for the crisis response and preparedness. These initiatives 
however have a limited scope covering specific types of crisis scenarios and are not intended 
to  set  up  a  general  horizontal  crisis-management  framework.  To  the  extent  these  initiatives 
include  a  sectoral  crisis  response  and  preparedness  framework,  that  framework  will  take 
precedence over the Single Market Emergency Instrument as lex specialis. 

The Commission proposal for a Regulation on serious cross-border threats to health, repealing 
'Cross-border  Health  Threats  Decision')24  aims  at 
Decision  No  1082/2013/EU  (the 
strengthening the EU's health security framework, and reinforcing the crisis preparedness and 
response role of key EU agencies with respect to serious cross-border health threats25. When 
the  preparedness  and  response  planning  and  reinforce 
adopted, 
epidemiological  surveillance  and  monitoring,  improve  data  reporting,  strengthen  EU 
interventions. 

it  will  strengthen 

The  Commission  proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council 
amending Regulation (EC) No 851/2004 established a European Centre for disease prevention 
and control26. 

The Commission proposal for a Council Regulation on a framework of measures for ensuring 
the  supply  of  crisis-relevant  medical  countermeasures  in  the  event  of  a  public  health 
emergency  at  Union  level27  provides  for  crisis  response  tools  such  as  joint  procurement, 
mandatory  information  requests  for  businesses  about  their  production  capacities,  and 
repurposing production lines in  case of public health crises once  a public health emergency 
would  be  declared.  The  declaration  of  an  EU  emergency  situation  would  trigger  increased 
coordination  and  allow  for  the  development,  stockpiling  and  procurement  of  crisis-relevant 
products.  The  proposal  covers  medical  countermeasures  defined  as  medicinal  products  for 
human use, medical devices and other goods or services that are necessary for the purpose of 
preparedness and response to serious cross-border threats to health. 
The  Commission  proposal  for  the  European  Chips  Act28  aims  to  strengthen  Europe’s 
semiconductor ecosystem. One important pillar of this strategy is to set up a mechanism for 
coordinated monitoring and response to shortages in the supply of semiconductors, aiming to 
anticipate  and  swiftly  respond  to  any  future  supply  chain  disruptions,  through  a  dedicated 

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Regulation  (EU)  2022/123  of  the  European  Parliament  and  of  the  Council  of  25  January  2022  on  a 
reinforced  role  for  the  European  Medicines  Agency  in  crisis  preparedness  and  management  for 
medicinal products and medical devices. OJ L 20, 31.1.2022, p.1 
C(2021)6712 final.  
COM(2020)727 final.  
The  term  of  “cross-border”  is  understood  as  covering  both  any  situation  affecting  more  than  one 
Member  State  (“across  borders”)  as  well  as  more  specifically  a  situation  affecting  regions  in  two  or 
more Member States sharing a common border (“border regions”).  
COM/2020/726 final 
COM(2021)577 final.  
COM(2022)46 final.  

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emergency  toolbox,  together  with  Member  States  and  international  partners.  The  planned 
mechanism is specific to a possible semiconductor crisis and will apply in an exclusive way if 
the crisis mode is activated. 
The Commission proposal for a Data Act29 will allow public sector bodies to access data held 
by the private sector that is necessary for exceptional circumstances, particularly to implement 
a  legal  mandate  if  data  are  not  otherwise  available  or  in  case  of  a  public  emergency  (i.e. 
exceptional situation negatively affecting the population of the Union, a Member State or part 
of  it,  with  a  risk  of  serious  and  lasting  repercussions  on  living  conditions  or  economic 
stability,  or  the  substantial  degradation  of  economic  assets  in  the  Union  or  the  relevant 
Member State(s)). 
The Commission proposal to amend the Schengen Borders Code30 aims to provide a common 
response at the internal borders in situations of threats affecting a majority of Member States. 
The  proposed  amendment  will  also  put  in  place  procedural  safeguards  in  case  of  unilateral 
reintroductions  of  internal  border  controls  and  provide  for  the  application  of  mitigating 
measures  and  specific  safeguards  for  cross-border  regions  in  cases  where  internal  border 
controls  are  reintroduced.  Such  controls  affect  in  particular  people  crossing  the  border  for 
their daily life (work, education, health care, family visits) as evidenced during the COVID-
19  pandemic.  The  proposal  promotes  increased  use  of  effective  alternative  measures  to 
address  the  identified  threats  to  internal  security  or  public  policy  instead  of  internal  border 
controls, for instance increased checks by police or other authorities in border regions, subject 
to  certain  conditions.  The  proposal  also  includes  the  possibility  for  the  Council  to  quickly 
adopt binding rules setting out temporary travel restrictions for third country nationals at the 
external borders in case of a threat to public health. It also clarifies which measures Member 
States can take to manage the EU's external borders effectively in a situation where migrants 
are instrumentalised by third countries for political purposes. 

The proposal for a Directive on the resilience of critical entities adopted by the Commission 
in December 202031 has the objective to enhance the resilience of entities providing services 
that  are  essential  for  the  maintenance  of  vital  societal  functions  or  important  economic 
activities  the  EU.  With  this  initiative,  the  aim  is  to  create  a  comprehensive  framework  to 
support Member States in ensuring that critical entities providing essential services are able to 
prevent, protect against, respond to, resist, mitigate, absorb, accommodate and recover from 
significant disruptive incidents such as natural hazards, accidents or terrorism. The Directive 
will cover eleven key sectors, including energy, transport, banking and health. 

The Joint communication of 18 May 2022 on the Defence Investment Gaps Analysis and Way 
Forward, identified several issues including the ability of the EU's Defence Technological and 
Industrial Base (as well as the global Defence Technological and Industrial Base) to address 
upcoming defence Member State procurement needs, and putting forward several measures. 

In the context of the General Product Safety Directive 2001/95/EC revision, the Commission 
intends  to  examine  the  questions  whether  and  to  what  extent,  or  by  what  modalities,  the 
production  issues  that  are  addressed  by  the  Omnibus  rules  as  regards  goods  covered  by 
various  harmonised  regimes  could  be  addressed  in  the  distinct  context  of  non-harmonised 
goods. 

Consistency with the EU’s external action 

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30 
31 

COM (2022)68 final.  
COM (2021)891 final.  
COM(2020)829 final. 

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The  European  External  Action  Service  will  support  the  High  Representative  in  her/his 
function,  as  Vice-President  of  the  Commission,  to  coordinate  the  Union’s  external  action 
within the Commission. Union delegations under the authority of the High Representative will 
exercise  their  functions  as  external  representatives  of  the  Union  and  assist,  as  relevant,  in 
external dialogues. 

Interplay with other instruments 

The  Commission  can  support  Member  States  in  designing  and  implementing  reforms  to 
anticipate, prepare and respond to impacts of natural or man-made crises on the Single Market 
through the Technical Support Instrument (TSI)32. 

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The proposal is based on Articles 114, 21 and 45 TFEU. 

Within the context of a crisis, the Single Market can be impacted both by the appearance of 
the  specific  disruptions  and  shortages  inherent  to  the  said  crisis,  as  well  as  by  the  possible 
intra-EU restrictions to the free movement of goods, services and persons, which may emerge 
in an attempt to address the said crisis. The general objective of the initiative is to lay down 
the  mechanisms  and  procedures,  which  would  allow  to  prepare  for  and  to  address  potential 
crises and disruptions to the proper functioning of the Single Market. Such measures are also 
aimed to minimise the intra-EU obstacles to the free movement in times of crisis. Whereas the 
measures concerning free movement of goods and freedom to provide services are covered by 
the  internal  market  legal  basis,  the  free  movement  of  persons’  provisions  require  the 
Regulation to rely additionally on Articles 21 and 45 TFEU. In the case of a crisis that affects 
the supply chains of the Single Market, measures have to be taken to address any identified 
shortages  and  to  safeguard  the  availability  of  crisis-critical  goods  and  services  across  the 
entire EU. 

A  number  of  measures  in  this  proposal  derogate  from  or  complement  existing  EU 
harmonisation legislation, based on the general internal market legal basis. Measures such as 
facilitating  the  ramping  up  of  production  capacities  for  crisis  relevant  goods  and  service 
activities, accelerating the permitting procedures, prioritising orders and the building-up and 
distributing  strategic  reserves  are  of  exceptional  nature  and  aim  at  ensuring  a  coherent 
response to future crises and to avoid the fragmentation of the Single Market. In cases where 
there  are  substantial  risks  to  the  functioning  of  the  Single  Market  or  in  cases  of  severe 
shortages or an exceptionally high demand of goods of strategic importance, measures at EU 
level aimed to ensure the availability of crisis-relevant products, such as strategic reserves or 
priority rated orders, may prove to be indispensable for the return to the normal functioning of 
the  Single  Market.  Such  measures  have  a  gradual,  stepped  approach,  whereby  the  resort  to 
more binding measures follows inaction of economic operators to tackle the crisis at stake. 

• 

Subsidiarity (for non-exclusive competence) 

The economic activities across the Single Market are deeply integrated.  Interaction between 
companies,  service  providers,  clients,  consumers  and  workers  located  in  different  Member 
States that rely on their free movement rights, is increasingly common. The experience of past 
crises has shown that often the distribution of production capacities across the EU is uneven. 

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Regulation  (EU)  2021/240  of  the  European  Parliament  and  of  the  Council  of  10  February  2021 
establishing 
https://eur-lex.europa.eu/legal-
content/EN/ALL/?uri=CELEX:32021R0240. 

Instrument 

Technical 

Support 

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In parallel, in the case of a crisis, the demand for crisis-relevant goods or services across the 
EU  territory  may  also  be  uneven  as  some  EU  regions  are  disproportionally  vulnerable  and 
exposed  to  supply  chain  disruptions,  in  particular  the  EU  outermost  regions33  located 
thousands  of  kilometres  away  from  mainland  Europe  The  objective  of  ensuring  the  smooth 
and undisrupted functioning of the Single Market cannot be achieved by means of unilateral 
national  measures.  Moreover,  even  if  measures  adopted  by  the  Member  States  individually 
may  be  able  to  address  to  a  certain  extent  the  deficiencies  resulting  from  a  crisis  at  the 
national level, they are in fact more likely to further exacerbate the said crisis across the EU 
by adding further obstacles to the free movement and/or additional strain on products already 
impacted by shortages. 

The introduction of rules which govern the functioning of the Single Market is a competence 
shared  between  the  EU  and  the  Member  States.  A  significant  number  of  EU  frameworks 
governing various aspects are already in place and they contribute to the smooth operation of 
the Single Market by laying down coherent sets of rules which apply across all the territories 
of  the  Member  States.  However,  the  existing  EU  frameworks  generally  lay  down  rules 
concerning  the  day-to-day  functioning  of  the  Single  Market,  outside  of  any  specific  crisis 
scenarios. There is currently no horizontal set of rules and mechanisms which address aspects 
such  as  the  contingency  planning,  the  crisis  anticipation  and  monitoring  and  the  crisis 
response measures, which would apply in a coherent manner across economic sectors and the 
entire Single Market. 

The emergency instrument has the objective of ensuring a coordinated approach to anticipate, 
prepare for and respond to crises that have important effects across borders or specifically in 
border regions  or both  and threaten the functioning of the Single Market, and where no EU 
instrument  already  exists  or  where  the  existing  instruments  do  not  lay  down  crisis-relevant 
provisions. Putting in place contingency and vigilance measures across the Single Market can 
facilitate the coordination of the response measures in the case of a crisis. Furthermore, such 
measures  can  be  complemented  by  effective  and  efficient  coordination  and  cooperation 
between the Commission and Member States during the crisis in order to ensure that the most 
appropriate measures to address the crisis are taken. 

The  Single  Market  Emergency  Instrument  is  not  intended  to  lay  down  a  detailed  set  of  EU 
level  provisions  which  should  be  exclusively  relied  upon  in  the  case  of  crisis.  Instead,  the 
instrument  is  intended  to  lay  down  and  ensure  the  coherent  application  of  possible 
combinations between provisions taken at EU level together with rules on the coordination of 
the measures taken at the level of the Member States. In this respect, the measures which may 
be  taken  at  EU  level  on  the  basis  of  the  Single  Market  Emergency  Instrument  would  be 
coordinated  with  and complement the response  measures  adopted by the Member States.  In 
order  to  allow  for  such  coordination  and  complementarity,  the  Single  Market  Emergency 
Instrument sets out specific measures which the Member States should refrain from imposing 
once a Single Market emergency has been activated at EU level. 

In this context, the EU added value of this instrument would be to lay down the mechanisms 
for  a  swift  and  structured  way  of  communication  between  the  Commission  and  Member 
States,  coordination  and  information  exchange  when  the  Single  Market  is  put  under  strain, 

33 
The  EU  outermost  regions  -  Guadeloupe,  French  Guiana,  Martinique,  Mayotte,  Réunion  and  Saint-
Martin (France), the Azores and Madeira (Portugal) and the Canary Islands (Spain) - are located in the Atlantic 
and Indian Oceans, in the Caribbean basin and in South America. In accordance with  Article 349 TFEU these 
regions can benefit from specific measures and tailored EU legislation to help address the major challenges they 
face due to their location, remoteness, insularity, small size, vulnerability to climate change and extreme weather 
events.  

EN 

8 

  EN 

                                                 
 
and to  be able to  take necessary measures in  a transparent  and inclusive way  –  accelerating 
existing mechanisms as well as adding new targeted tools for crisis situations. It would also 
ensure transparency across the internal market, ensuring that businesses and citizens that rely 
on  their  free  movement  rights  have  at  their  disposal  appropriate  information  about  the 
applicable measures in all the Member States. This will increase legal certainty allowing them 
to take informed decisions. 

A  further  advantage  of  action  in  this  domain  would  be  to  equip  the  EU  with  the  resilience 
tools  needed  to  sustain  the  competitiveness  of  the  EU  industry  in  a  geopolitical  context  in 
which  our  international  partners  and  competitors  can  already  rely  on  legal  instruments 
allowing  for  a  structured  monitoring  of  supply  chain  disruptions  and  for  the  adoption  of 
possible response measures such as strategic reserves. 

• 

Proportionality 

The measures contained in this Regulation are carefully tailored in order to ensure that they 
do  not  go  beyond  what  is  necessary  for  the  achievement  of  its  objective  of  ensuring  the 
smooth  and  undisrupted  functioning  of  the  Single  Market.  The  measures  complement 
Member  States’  action  where  the  aims  of  the  Regulation  cannot  be  achieved  by  means  of 
unilateral  action  by  the  Member  States.  They  take  into  account  the  need  for  the  economic 
operators to be able to manage the normal business risks, to have their own contingency plans 
and  to  come  up  with  initiatives  for  resolving  supply  chain  issues.  This  is  catered  for  in 
particular  by  means  of  obligations  of  the  Commission  to  consult  the  economic  operators 
before  resorting  to  mandatory  Single  Market  emergency  measures  such  as  mandatory 
information requests and priority rated orders. 

• 

Choice of the instrument 

The  Single  Market  Emergency  Instrument  initiative  takes  the  form  of  a  Proposal  for  a 
Regulation  of  the  European  Parliament  and  of  the  Council.  Considering  that  in  the  case  of 
provisions  laid  down  in  a  Regulation,  there  is  no  need  for  the  Member  States  to  transpose 
them  into  their  respective  national  legislation,  this  specific  legal  instrument  would  allow  to 
ensure that the provisions are applied in a consistent manner. 

The  proposed  Regulation  will  introduce  procedures  which  are  complementary  to  the  Single 
Market  Transparency  Directive  or  the  Services  Directive  and  are  to  be  applied  in  the 
emergency  mode.  The  Regulation  clarifies  the  relationship  between  the  relevant  legal 
frameworks but without amending the respective legal frameworks. 

3. 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Ex-post evaluations/fitness checks of existing legislation 

The Regulation (EC) No. 2679/98 setting up a response mechanism to address obstacles to the 
free  movement  of  goods  attributable  to  a  Member  State  leading  to  serious  disruptions  and 
requiring immediate action (‘The Strawberry Regulation’) will be repealed. According to its 
evaluation  finalised in  October 2019 and supported by  an external  study, this mechanism is 
rarely  used  and  its  information  exchange  system  is  insufficient  as  it  is  too  slow  and 
outdated34. 

34 
Document SWD(2019)371 final of 8 October 2019. 

As  assessed  in  the  evaluation  supporting  study  and  the  evaluation  Commission  Staff  Working 

EN 

9 

  EN 

                                                 
• 

Stakeholder consultations 

As outlined in Annex 2 to the Impact Assessment accompanying this proposal,  stakeholder 
consultation  activities  were  conducted  between  October  2021  and  May  2022.  The 
consultation activities included: a call for evidence published on the “Have your say” portal 
and open from 13 April to 11 May 2022, a public consultation conducted via a questionnaire 
published on the same portal in the same period, a stakeholder workshop on 6 May 2022, a 
Member  State  survey  in  May  2022  and  targeted  consultations  conducted  by  means  of 
meetings with Member States and specific stakeholders. 

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  broad  crisis  preparedness  measures 
when  no  crisis  is  looming  on  the  horizon,  without  specifying  targeted  supply  chains.  While 
some  business  stakeholders  voiced  concerns  about  mandatory  measures  targeting  economic 
operators,  others  have  expressed  support  for  a  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 European standards, EU and national 
single points of information, emergency simulations for experts. 

 • 

Collection and use of expertise 

Evidence and data that were used for the development of the Impact Assessment included: 

– 

– 

– 

– 

– 

– 

“The  impact  of  COVID-19  on  the  Internal  Market”,  study  at  the  request  of  the  EP 
IMCO Committee; 

Evaluation  of  the  “Strawberry  Regulation”  (EC)  No  2679/98  and  its  supporting 
external study; 

Evaluation of the New Legislative Framework; 

Relevant  information  and/or  evidence  collected  in  the  context  of  preparation  of 
existing  or  proposed  EU  crisis  response  initiatives  and  mechanisms,  including 
through  consultation  activities  or  impact  assessment  studies  (e.g.  the  Data  Act, 
Single  Market  Information  Tool  (SMIT),  the  EU  Health  Security  Framework, 
Schengen  Borders  Code,  Contingency  plan  for  ensuring  food  supply  and  food 
security,  the  integrated  political  crisis  response  mechanism  (IPCR),  Contingency 
transport,  EU  Digital  COVID  Certificate  Regulation,  Council 
plan 
Recommendation  (EU)  2020/1475  on  a  coordinated  approach  to  the  restriction  of 
free movement in response to the COVID-19 pandemic and its adaptations); 

for 

Academic studies and literature on the effect of previous crises on the functioning of 
the Single Market, as well as existing position papers and other documents drawn up 
by relevant stakeholders; 

Newspaper articles and press materials. 

The Impact Assessment further relied on the information received from consultation activities 
as detailed in the synopsis report contained in Annex 2 of the Impact Assessment. 

The  evidence  base  of  the  report  is  strongly  limited  due  to  the  relatively  low  number  of 
responses  to  the  call  for  evidence  and  the  public  consultation,  and  the  lack  of  a  supporting 
study.  To  remedy  this  situation,  on  6  May  2022  the  Commission  conducted  a  stakeholder 

EN 

10 

  EN 

workshop  attended  by  a  large  number  of  stakeholders  and  conducted  a  series  of  targeted 
consultations, especially with Member States and stakeholders. 

 • 

Impact assessment 

In  line  with  its  ‘Better  Regulation’  policy,  the  Commission  conducted  an  Impact 
Assessment35.  The  Impact  Assessment  evaluated  three  policy  options  establishing  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 
(approach  1)  to  a  hybrid  approach  (approach  2)  to  a  more  comprehensive  legislative 
framework (approach 3). On the basis of this analysis, some or all approaches were retained 
for  each  building  block  and  were  combined  into  three  realistic  policy  options  reflecting 
different levels of political ambition and stakeholder support: 

Mode 

Building blocks 

Policy Option 1 

Policy Option 2 

Policy Option 3 

TRANSPARENCY 

COOPERATION 

SOLIDARITY 

All times 

1. 
governance, 
coordination  and 
cooperation 

All times 

crisis 

2. 
contingency 
planning 

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 

Approach 3 

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

-  Recommendation  to  MS  for  risk  assessment  & 
compendium of crisis response measures and 

-  Obligation  of  the  Commission  for  Union  level 
risk assessment 

-  Obligation  of  MS  to  train  their  relevant  crisis 
management staff regularly 

Vigilance 

3.  Single  Market 
vigilance 

Approach 2 

-  Recommendation 
the  Member  States  on 
information  gathering  concerning  identified  strategic 
supply chains 

to 

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

to 

Approach 3 

- Obligation to MS to 
gather 
information 
concerning  identified 
supply 
strategic 
chains 

and 

-  Obligation  of  the 
Commission  to  draw 
regularly 
up 
update 
list  with 
targets  for  strategic 
reserves 
- Obligations to MS36  
to  build  up  strategic 

35 

36

EN 

See the accompanying Staff Working Document SWD(2022)289. 

Subject to additional trigger 

11 

  EN 

 
 
                                                 
 
reserves  for  selected 
goods  of 
strategic 
importance  if  the  MS  
strategic  reserves  fall 
significantly  short  of 
the targets 

Emergency  4.  key  principles 
supportive 
and 
for 
measures 
free 
facilitating 
movement 
during 
emergency 

Approach 2 

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

Emergency  5. 

transparency 

Approach 3 

and 
administrative 
assistance  during 
emergency 

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 

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

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  

Emergency  7. 

public 

Approach 2 

procurement 
during 
emergency 

Emergency  8. 

measures 
impacting  crisis-
relevant 
supply 
during 
chains 
emergency mode 

New provision on joint procurement/common purchasing by the Commission 
for some or all Member States 

Approach 1 

Approach 2 

Guidance on  ramping up 
capacity; 
production 
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 
prioritise 
and 
accept 
orders 
Empowering  MS37 
to 
economic 
oblige 
operators 
to  ramp  up 
production  capacity  and 
to 
binding 
information  requests  to 
economic operators 

address 

Approach 3 
Obligations  of  MS38 
to  distribute  products 
previously 
stockpiled;  speeding 
up 
permitting 
procedures, 

Obligations 
of 
businesses  to  accept 
and  prioritise  orders; 
ramp  up  production 
capacity  and  provide 
crisis-relevant 
information 

The  Impact  Assessment  did  not  present  a  preferred  option,  instead  leaving  the  choice  of 
options for political decision. The measures chosen in the legal proposal correspond to Policy 

37

38

Subject to additional trigger 

Subject to additional trigger 

EN 

12 

  EN 

 
 
 
                                                                                                                                                         
 
 
 
 
Option 3 for all building blocks with the exception of building block 8. For building block 8, a 
combination of Policy Option 1 (for ramping up production), Policy Option 2 (for distribution 
of stockpiled products and for speeding up permitting procedures), and Policy Option 3 (for 
obligations  of  businesses  to  accept  and  prioritise  orders  and  to  provide  crisis-relevant 
information) has been chosen. 

On  15  June  2022,  the  Commission  submitted  the  Impact  Assessment  to  the  Regulatory 
Scrutiny Board (RSB). The RSB gave a negative opinion, noting in particular (1) the need to  
provide  clear  and  detailed  information  related  to  the  foreseen  Single  Market  emergency 
including a definition, the criteria and decision-mechanisms for establishing and terminating it 
and the measures which would be implemented during it; (2) the need to provide a thorough 
assessment  of  the  impacts  of  the  policy  options;  and  (3)  the  need  to  present    alternative 
combinations of relevant policy options, in addition to the policy approaches, and to link the 
comparison to the analysis of impacts. To address these findings, the Commission provided a 
clear  definition  of  a  Single  Market  emergency,  specified  the  criteria  and  decision  making 
mechanisms, explained the three modes of functioning of SMEI and specified which building 
block of SMEI would be activated under which mode. It further elaborated the assessment of 
impacts  to  cover  more  types  of  impacts  i.e.  economic  impacts  for  key  stakeholders 
(businesses, Member States and Commission), impacts on SMEs, impacts on competitiveness, 
competition,  international  trade,  and  differentiated  which  impact  would  occur  with  the 
immediate  effects  and  which  could  be  expected  under  the  vigilance  and  emergency  modes. 
Further,  the  Impact  Assessment  defined  three  alternative  policy  options  based  on  a 
combination of different approaches to some of the building blocks, provided an assessment 
of impacts of these options and extended the comparison of options to cover proportionality 
and subsidiarity. 

On 29 July 2022, the Commission submitted the revised Impact Assessment to the RSB. The 
RSB  then  gave  a  positive  opinion  with  comments.  These  comments  related  to  the  need  to 
further  explore  the  different  types  of  crisis  that  may  impact  the  functioning  of  the  Single 
Market,  to  more  clearly  set  out  the  interplay  with  possible  measures  taken  on  the  basis  of 
Article  4(2)  TFEU  and  to  sufficiently  justify  some  of  the  measures  proposed  from  the 
subsidiarity  and  proportionality  point  of  view.  To  address  these  comments,  indications  on 
effects of potential future crises were added, interplay with potential measures under Article 
4(2)  TFEU  was  better  explained  and  further  details  were  added  on  the  obligatory  measures 
foreseen under emergency mode. 

Further  information  on  how  the  RSB  recommendations  are  reflected  in  the  Impact 
Assessment report can be found in Annex 1, point 3, of the Impact Assessment. 

• 

Regulatory fitness and simplification 

According to the Commission’s Regulatory Fitness and Performance Programme (REFIT), all 
initiatives  with  the  objective  to  change  existing  EU  legislation  should  aim  to  simplify  and 
deliver stated policy objectives more efficiently (i.e. reducing unnecessary regulatory costs). 

The proposal provides a toolbox of measures to address Single Market emergency, consisting 
a  set  of  measures  applicable  at  all  times  as  well  as  certain  measures  only  applicable  in 
vigilance or emergency modes, to be separately activated. There are no administrative costs 
for  businesses  and  citizens  that  would  apply  with  immediate  effect  and  during  the  normal 
functioning of the Single Market. 

For  measures  likely  to  lead  to  strong  impacts  and  potential  costs  for  SMEs,  in  particular 
measures  such  as  mandatory  information  requests,  requests  to  ramp  up  production  and  to 
accept  priority-rated  orders,  during  the  additional  activation  of  such  measures  specific 

EN 

13 

  EN 

analysis and assessment will be done as to their impact and proportionality, in particular their 
impact  on  SMEs,  by  the  Commission.  This  assessment  will  be  part  of  the  process  of 
additional  activation  of  these  specific  measures  by  a  Commission  implementing  act 
(additional to the overall activation of the emergency mode). Depending on the nature of the 
crisis  and  the  concerned  strategic  supply  chains  and  crisis-relevant  products,  specific 
accommodations  will  be  provided  for  SMEs.  While  it  is  not  possible  to  except 
microenterprises  completely  from  the  scope  of  measures  such  as  mandatory  information 
requests,  as  these  enterprises  may  have  specific  unique  know-how  or  patents  of  critical 
importance in  a crisis,  specific  accommodations  will include simplified survey designs, less 
onerous reporting requirements, and longer deadlines for responses, to the extent possible in 
view of the need for urgency in the context of a specific crisis. 

The Regulation (EC) No. 2679/98 setting up a response mechanism to address obstacles to the 
free  movement  of  goods  attributable  to  a  Member  State  leading  to  serious  disruptions  and 
requiring immediate action (‘The Strawberry Regulation’) will be repealed. This will lead to 
the simplification of the legal framework. 

 • 

Fundamental rights 

This  Regulation  and  in  particular  the  priority  rated  orders  and  the  measures  facilitating  the 
repurposing  of  production  lines  as  well  as  the  measures  facilitating  the  expansion  of 
production  capacity  affect  the  freedom  to  conduct  business  set  out  in  Article  16  of  the  EU 
Charter of Fundamental Rights of the economic operators active on the Single Market during 
the Single Market emergency. Such restrictions have been carefully tailored and are balanced 
against the vital interests of the society. The provisions on priority rated orders provide for a 
number of safeguards for the economic operators subject to such orders, in order to balance 
the intensity of the restriction. 

The mandatory information requests to economic operators may also affect the protection of 
business  secrets  and  other  sensitive  information  of  economic  operators.  However,  the 
Regulation provides for safeguards and guarantees that such information requests will be only 
made  in  case  the  relevant  information  is  indispensable  for  resolving  the  Single  Market 
emergency and is not available on a voluntary basis or from publicly accessible sources, and 
the  obtained  information  is  handled  carefully,  ensuring  secrecy  and  non-disclosure  of 
sensitive business information, such restrictions are proportionate and justified. 

Finally the sanctions which are foreseen for breaches of the mandatory information requests 
to  economic  operators  and  the  priority  rated  orders  constitute  restrictions  to  the  right  to 
property set out in Article 17 of the EU Charter of Fundamental Rights. Given the fact that the 
amounts of fines have been set at appropriately dissuasive, but not excessive levels, and the 
period  of  their  application  is  limited  in  time,  with  a  possibility  to  contest  them  before  the 
CJEU, they amount to proportionate and justified restrictions of the right to property. 

The Regulation respects the right to an effective judicial remedy and to a fair trial as provided 
for  in  Article  47  of  the  Charter.  It  reiterates  the  right  of  economic  operators  subject  to 
information  requests  and  priority  rated  orders  to  defend  their  rights  before  the  CJEU  and 
provides  for  possibilities  of  contesting  such  requests  of  the  Commission  in  administrative 
procedures before that. 

4. 

BUDGETARY IMPLICATIONS 

The budgetary implications of the proposals would relate to three expenditure categories. The 
recurrent  costs  of  staff  within  the  Commission  would  be  in  principle  covered  under  the 
heading “Administrative expenditure” while costs for the foreseen training activities and the 

EN 

14 

  EN 

necessary extension of the IT tool used for the notification system would be covered under the 
Single Market Programme. Under the current set-up, the costs related to the emergency mode, 
namely  building  up  of  strategic  reserves,  the  secure  supply,  such  as  those  related  to 
procurement  of  goods  and  services  of  strategic  importance  and  crisis-relevant  goods,  or  to 
priority rated orders would be borne exclusively by the Member States and there would be no 
impact  on  Union  resources.  The  additional  management  costs  in  the  Commission  deriving 
from  the  occurrence  of  a  crisis,  which  are  unpredictable  by  nature,  would  be  covered  in 
principle via internal  redeployment of Union resources under the heading 1 “Single market, 
innovation and digital” and/or heading 7 “Administrative expenditure”. 

5. 

• 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements 

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. 

The European Anti-Fraud Office (OLAF) shall be consulted for all the contracts and financing 
agreements  issued  on  the  basis  of  this  Regulation,  to  ensure  that  antifraud  clauses  are 
appropriately integrated. 

• 

Detailed explanation of the specific provisions of the proposal 

The  SMEI  aims  to  establish  a  comprehensive  preparedness  and  crisis-response  architecture 
composed of the following main components: 

– 

– 

– 

– 

1. 

an advisory group; 

a framework for contingency planning; 

a framework for Single Market vigilance and 

a framework for Single Market emergencies. 

The advisory group 

The role of this group will be to advise the Commission on the appropriate measures 
for preventing or addressing the impact of the crisis on the Single Market. It can be 
involved  in  the  activation  and  in  determining  the  scope  of  the  Single  Market 
vigilance  and  emergency  modes  and  analyse  the  relevant  information  gathered  by 
voluntary or mandatory means, including from the economic operators. This central 
body will be composed of one representative of each Member State with expertise in 
Single Market matters as permanent members, and observers representing other crisis 
relevant  bodies  such  as  the  Integrated  Political  Crisis  Response  group  of  the 
Council, the  Health  Crisis  Board,  the  Health  Security  Committee,  European 
Semiconductor  Board,  European  Food  Security  Crisis  preparedness  and  response 
Expert Group, etc. The Commission will organise and chair the meetings. 

2. 

The framework for contingency planning 

In normal times where no sudden event is likely to have or is already having severe 
disruptive effects on the Single Market, market forces ensure the functioning of the 
businesses and the Single Market. The framework of contingency planning does not 
require an activation step and consists of: 

EN 

15 

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(a)  Arrangements  for  crisis  protocols  and  crisis  communication  and  training  and 
emergency simulations in view of ensuring timely cooperation and exchange of 
information between the Commission, Member States and relevant Union level 
bodies and organising trainings and rehearsals on potential scenarios of Single 
Market emergencies. 

(b)  Ad  hoc  alerts  for  early  warning  system  for  any  incidents  that  significantly/ 
seriously  disrupt  or  have  the  potential  to  significantly/seriously  disrupt  the 
functioning of the Single Market and in its supply chains of goods and services. 
In  determining  the  significance  or  the  seriousness  of  the  disruption,  pre-
determined  parameters  will  be  taken  into  account  such  as  the  number  of 
economic operators affected, geographical area or duration of the disruption. 

3. 

The framework for Single Market vigilance 

This  will  be  the  framework  for  impacts  of  significant  incidents  that  have  not  yet 
escalated into a full-blown Single Market emergency. It requires activation when an 
incident that has occurred has the potential to significantly disrupt the supply chains 
of goods and services of strategic importance that are dependent on non-diversifiable 
and non-substitutable inputs or which causes firsts signs of severe shortages of such 
goods and services. This framework includes a set of measures such as: 

(a)  Monitoring of the supply chains of goods and services of strategic importance 
that  have  been  identified  in  the  Union  level  risk  assessment  referred  in  the 
framework for contingency planning and whose supply could  be significantly 
disrupted due to the occurrence of an incident. Such monitoring will be carried 
out  by  the  Member  States  on  the  basis  of  voluntary  requests  for  information 
about  factors  impacting  the  availability  of  the  selected  goods  and  services  of 
strategic importance (such as production capacity, stocks, suppliers limitations, 
substitution,  demand  conditions, 
possibilities 
bottlenecks) to all actors along the relevant supply chain of goods and services 
of strategic importance and other relevant stakeholders established in Member 
States national territory. 

for  diversification  and 

(b)  Building-up  of  strategic  reserves,  which  is  a  measure  subject  to  additional 
activation  by  means  of  additional  Commission  implementing  acts.  The 
Commission  may  draw  up  lists  of  individual  and  non-binding  targets  for  the 
strategic reserves that the Member States should maintain. The Member States, 
acting jointly in a spirit of solidarity, shall deploy their best efforts to build up 
strategic reserves of the goods identified as being of strategic importance. The 
Commission  might,  in  exceptional  circumstances,  on  its  own  initiative  or  if 
asked by 14 Member States, assess the need to take further measures to build 
up  strategic  reserves  of  such  goods.  Following  such  assessment  supported  by 
objective data, the Commission may adopt  an implementing act  to  render the 
individual target for one or more Member States mandatory; 

(c)  Public  procurement:  i)  procurement  of  goods  and  services  of  strategic 
importance  by  the  Commission  on  behalf  of  Member  States  and  ii) 
procurement  of  goods  and  services  of  strategic  importance  by  the  Member 
States 

4. 

The framework for Single Market emergencies 

The  activation  of  the  Single  Market  emergency  will  immediately  activate  the 
application of a number of emergency-response measures, which include: 

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(a)  Measures  to  improve  transparency:  Member  States  obligations  to  notify  any 
draft  measures  relating  to  crisis-relevant  goods  and  services  and  goods  and 
services  of  strategic  importance  as  well  as  crisis-relevant  restrictions  of  free 
movement of persons, together with the reasons for those measures; 

(b)  Actions 

for 

re-establishing  and 

free  movement:  general 
requirements for free movement restrictions during a Single Market emergency 
(list of key principles) as well as provisions on prohibited restrictions. 

facilitating 

(c)  The  banning  of  restrictions  to  free  movement  rights  during  a  Single  Market 
emergency requiring Member States to refrain from, for example, introducing 
intra-EU  export  bans  of  crisis-relevant  goods  or  services  and  any  export 
restriction of products or services that 

– 

– 

– 

hamper their free movement; 

disrupt their supply chains and 

create or increase shortages in the Single Market; 

(d)  Public  procurement: 

the 
Commission on behalf of Member States and ii) procurement of crisis-relevant 
goods by the Member States 

i)  procurement  of  crisis-relevant  goods  by 

(e)  Actions to ensure the availability and supply of crisis-relevant goods 

– 

– 

– 

facilitating the expansion or repurposing of existing or the establishment 
of new production capacities for crisis-relevant goods; 

facilitating  the  expansion  of  existing  or  the  establishment  of  new 
capacities related to activities; 

the introduction of measures ensuring regulatory flexibility, including on 
permitting, aimed at facilitating the production and placing on the market 
of crisis-relevant goods 

(f)  Targeted and coordinated distribution of strategic reserves 

The  Commission  may  recommend  the  Member  States  to  distribute  Union 
strategic  reserves  and,  where  those  are  not  available  or  sufficient,  Member 
States strategic reserves in a targeted way, where there is concrete and reliable 
evidence  of  serious  disruptions  in  the  supply  chain  of  crisis-relevant  goods 
leading  to  dire  shortages  of  goods  of  strategic  importance,  including  in 
geographical  areas  particularly  vulnerable  to  such  disruptions  such  as  the  EU 
outermost regions 

(g)  Emergency measures of exceptional nature requiring additional activation:  

– 

information requests to economic operators 

The Commission shall, if necessary in case of severe shortages of crisis-
relevant  goods  or  services  or  an  immediate  threat  thereof  and  after 
consulting 
the  designated  Advisory  Group,  request  representative 
organisations of economic operators or, if necessary individual economic 
operators in crisis-relevant supply chains to provide targeted information 
to  the Commission  in  relation  to  their production capacities and  current 
supply chain disruptions. 

EN 

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The  Commission  shall  present  aggregate  information  based  on  any 
targeted  information  requests  to  economic  operators  or  representative 
organisations of economic operators to the designated Advisory Group. 

– 

priority rated orders 

In  the  first  stage,  the  Commission  may  invite  economic  operators  to 
accept  and  prioritise  an  order  of  inputs  for  production  of  crisis-relevant 
goods or orders for the  production  or supply  of  crisis-relevant  goods as 
final products. 

In the second stage, the Commission may, in exceptional circumstances, 
on  its  own  initiative  or  if  asked  by  14  Member  States,  assess  the 
necessity and proportionality of resorting to priority rated orders of such 
goods,  taking  into  account  the  position  of  the  economic  operator  and 
potential  affected  parties.  Following  such  assessment,  the  Commission 
may  address  an  implementing  act  requiring  an  economic  operator  to 
accept  and  prioritise  orders  of  inputs  for  the  production  or  supply  of 
crisis-relevant goods or orders of crisis-relevant goods as final products. 
Economic operators may, within 10 working days, decline to accept such 
obligation, and provide an explanation of duly justified reasons for doing 
so.  The  Commission  may  make  such  reasoned  explanation  or  parts 
thereof  public.  The  obligation,  if  accepted,  shall  take  precedence  over 
any performance obligation under private or public law. 

– 

The  Commission  shall  have  regard  to  the  circumstances  of  the  case, 
including  the  principles  of  necessity  and  proportionality.  The  priority 
rated  order  shall  be  placed  at  fair  and  reasonable  price;targeted 
amendments of harmonised product legislation 

(b) 

This measure will allow an accelerating placing on the market of the identified crisis-
relevant  goods  by  introducing  emergency  procedures    for  conformity  assessment, 
adoption of common technical specifications and market surveillance in the context 
emergency.
of 

Market 

Single 

a 

EN 

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2022/0278 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

establishing a Single Market emergency instrument and repealing Council Regulation 
No (EC) 2679/98 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Articles 114, 21 and 45 thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 
Having regard to the opinion of the European Economic and Social Committee39,  
Having regard to the opinion of the Committee of the Regions40,  

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

Past crises, especially the early days of the COVID-19 pandemic, have shown that the 
internal  market  (also  referred  to  as  the  Single  Market  and  its  supply  chains  can  be 
severely  affected  by  such  crises,  and  appropriate  crisis  management  tools  and 
coordination  mechanisms  are  either  lacking,  do  not  cover  all  aspects  of  the  Single 
market or do not allow for a timely response to such impacts. 

The  Union  was  not  sufficiently  prepared  to  ensure  efficient  manufacturing, 
procurement  and  distribution  of  crisis-relevant  non-medical  goods  such  as  personal 
protective equipment, especially in the early phase of the COVID-19 pandemic and the 
ad-hoc measures taken by the Commission in order to re-establish the functioning of 
the Single Market and to ensure the availability of crisis-relevant non-medical goods 
during the COVID-19 pandemic were necessarily reactive The pandemic also revealed 
insufficient  overview  of  manufacturing  capacities  across  the  Union  as  well  as 
vulnerabilities related to the global supply chains. 

Actions  by  the  Commission  were  delayed  by  several  weeks  due  to  the  lack  of  any 
Union  wide  contingency  planning  measures  and  ofclarity  as  to  which  part  of  the 
national  administration  to  contact  to  find  rapid  solutions  to  the  impact  on  the  Single 
Market  being  cause  by  the  crisis.  In  addition  it  became  clear  that  uncoordinated 
restrictive actions taken by the Member States would further aggravate the impacts of 
the  crisis  on  the  Single  market.  It  emerged  that  there  is  a  need  for  arrangements 
between  the  Member  States  and  Union  authorities  as  regards  contingency  planning, 
technical level coordination and cooperation and information exchange. 

39 
40 

OJ C , , p. . 
OJ C , , p. . 

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(4) 

(5) 

(6) 

(7) 

(8) 

Representative  organisations  of  economic  operators  have  suggested  that  economic 
operators  did  not  have  sufficient  information  on  the  crisis  response  measures  of  the 
Member States during the pandemics, partly due to not knowing where to obtain such 
information, partly due to language constraints and the administrative burden implied 
in  making  repeated  inquiries  in  all  the  Member  States,  especially  in  a  constantly 
changing  regulatory  environment.  This  prevented  them  from  making  informed 
business  decisions  as  to  what  extent  they  may  rely  on  their  free  movement  rights  or 
continue cross-border business operations during the crisis. It is necessary to improve 
the availability of information on national and Union level crisis response measures 

These recent events have also highlighted the need for the Union to be better prepared 
for possible future crises, especially  as we consider the continuing effects  of climate 
change  and  resulting  natural  disasters  as  well  as  global  economic  and  geopolitical 
instabilities.  Given  the  fact  that  it  is  not  known which  kind  of  crises  could  come  up 
next  and  produce  severe  impacts  on  the  Single  Market  and  its  supply  chains  in  the 
future,  it  is  necessary  to  provide  for  an  instrument  that  would  apply  with  regards  to 
impacts on the Single Market of a wide range of crises. 

The impact of a crisis on the Single Market can be two-fold. On the one hand, a crisis 
can  lead  to  obstacles  to  free  movement  within  the  Single  Market,  thus  disrupting  its 
normal functioning. On the other hand, a crisis can amplify shortages of crisis-relevant 
goods and services on the Single Market. The Regulation should address both types of 
impacts on the Single Market. 

Since any specific aspects of future crises that would impact the Single Market and its 
supply  chains  are  hard  to  predict,  this  Regulation  should  provide  for  a  general 
framework  for  anticipating,  preparing  for,  mitigating  and  minimising  the  negative 
impacts which any crisis may cause on the Single Market and its supply chains. . 

The  framework  of  measures  set  out  under  this  Regulation  should  be  deployed  in  a 
coherent, transparent, efficient, proportionate and timely manner, having due regard to 
the need to maintain vital societal functions, meaning including public security, safety, 
public order, or  public  health respecting,  the   responsibility  of the Member States to 
safeguard national security and their power to safeguard other essential state functions, 
including ensuring the territorial integrity of the State and maintaining law and order. 

(9) 

To this end, this Regulation provides: 

– 

– 

– 

the necessary means to ensure the continued functioning of the Single Market, 
the businesses that operate on the Single Market and its strategic supply chains, 
including the free circulation of goods, services and persons in times of crisis 
and the availability of crisis relevant goods and services to citizens, businesses 
and public authorities at the time of crisis; 

a  forum  for  adequate  coordination,  cooperation  and  exchange  of  information; 
and 

the means for the timely accessibility and availability of the information which 
is needed for a targeted response and adequate market behaviour by businesses 
and citizens during a crisis. 

(10)  Where  possible,  this  Regulation  should  allow  for  anticipation  of  events  and  crises, 
building  on  on-going  analysis  concerning  strategically  important  areas  of  the  Single 
Market economy and the Union’s continuous foresight work. 

EN 

20 

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(11)  This  Regulation should not  duplicate the existing framework for medicinal products, 
medical  devices  or  other  medical  counter-measures  under  the  EU  Health  Security 
Framework,  including  Regulation  (EU)  …/…  on  serious  cross-border  health  threats 
[SCBTH  Regulation  (COM/2020/727)],  Council  Regulation  (EU)  …/…  on  a 
framework  of  measures  for  ensuring  the  supply  of  crisis-relevant  medical  counter-
measures  [Emergency  Framework  Regulation  (COM/2021/577)],  Regulation  (EU) 
…/…  on  the  extended  mandate  of  the  ECDC  [ECDC  Regulation  (COM/2020/726)] 
and  Regulation  (EU)  2022/123  on  the  extended  mandate  of  the  EMA  [EMA 
Regulation].Therefore, medicinal products, medical devices or other medical counter-
measures,  when  they  have  been  placed  on  the  list  referred  to  in  Article  6(1)  of  the 
Emergency  Framework  Regulation,    shall  be  excluded  from  the  scope  of  this 
Regulation,  except  in  relation  to  the provisions relating to  free movement  during the 
Single  Market  emergency,  and  in  particular  those  designed  to  re-establish  and 
facilitate free movement as well as the notification mechanism.  

(12)  This  Regulation  should  complement  the  Integrated  Political  Crisis  Response 
mechanism  operated  by  the  Council  under  Council  Implementing  Decision  (EU) 
2018/1993 as regards its  work on Single Market  impacts of cross-sectoral crises that 
require political decision-making.  

(13)  This Regulation should be without prejudice to the Union Civil Protection Mechanism 
(‘UCPM’). This Regulation should be in complementarity with the UCPM and should 
support it, where neessary, as regards availability of critical goods and free movement 
of civil protection workers, including their equipment, for crises that fall into the remit 
of that mechanism. 

(14)  This Regulation should be without prejudice to  Articles 55 to 57 of Regulation (EC) 
No 178/2002 on the general plan on crisis management in the area of food and feed, 
implemented by Commission Decision (EU) 2019/300. 

(15)  The  Regulation  should  be  without  prejudice  to  the  European  Food  Security  Crisis 
preparedness and response Mechanism (EFSCM). Nevertheless, food products should 
be  governed  by  the  provisions  of  this  Regulation,  including  those  concerning  the 
notification  mechanism  and  concerning  restrictions  to  free  movement  rights  .  The 
measures  concerning  food  products  notified  under  this  Regulation  may  be  also 
reviewed for their compliance with any other relevant provisions of EU law. 

(16) 

In  order  to  account  for  the  exceptional  nature  of  and  potential  far-reaching 
consequences  for the fundamental  operation of the Singe Market  of a Single Market 
emergency,  implementing  powers  should  exceptionally  be  conferred  on  the  Council 
for the activation of Single Market emergency mode pursuant to Article 281(2) of the 
Treaty on the Functioning of the European Union. 

(17)  Article 21 TFEU lays down the right of EU citizens to move and reside freely within 
the territory of the Member States, subject to the limitations and conditions laid down 
in the Treaties and the measures adopted to give them effect. The detailed conditions 
and  limitations  are  laid  down  in  Directive  2004/38/EC.  This  Directive  sets  out  the 
general principles applicable to these limitations and the grounds that may be used to 
justify  such  measures.  These  grounds  are  public  policy,  public  security  or  public 
health. In this context, restrictions to freedom of movement can be justified if they are 
proportionate  and  non-discriminatory.  This  Regulation  is  not  intended  to provide  for 
additional grounds for the limitation of the right to free movement of persons beyond 
those provided for in Chapter VI of Directive 2004/38/EC.  

EN 

21 

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(18)  As regards the measures for re-establishing and facilitating free movement of persons 
and  any  other  measures  affecting  the  free  movement  of  persons  provided  under  this 
Regulation, they are based on Article 21 TFEU and complement Directive 2004/38/EC 
without  affecting  its  application  at  the  time  of  Single  Market  emergencies.  Such 
measures  should  not  result  in  authorising  or  justifying  restrictions  to  free  movement 
contrary to the Treaties or other provisions of Union law. 

(19)  Article  45  TFEU  lays  down  the  right  to  free  movement  of  workers,  subject  to  the 
limitations and conditions laid down in the Treaties and the measures adopted to give 
them  effect.  This  Regulation  contains  provisions  which  complement  the  existing 
measures  in  order  to  reinforce  free  movement  of  persons,  increase  transparency  and 
provide  administrative  assistance  during  Single  Market  emergencies.  Such  measures 
include setting up and making available of the single points of contact to workers and 
their representatives in the Member States and at Union level during the Single Market 
vigilance and emergency modes under this regulation. 

(20) 

If Member States adopt measures affecting free movement of goods or persons, goods 
or  the  freedom  to  provide  services  in  preparation  for  and  during  Single  Market 
emergencies, they should limit such measures to what is necessary and remove them 
as  soon  as  the  situation  allows  it.  Such  measures  should  respect  the  principles  of 
proportionality  and  non-discrimination  and  should  take  into  consideration  the 
particular situation of border regions. 

(21)  The activation of the Single Market emergency mode should trigger an obligation for 

the Member States to notify crisis-relevant free movement restrictions. 

(22)  When examining the compatibility of any notified draft or adopted measures with the 
principle  of  proportionality,  the  Commission  should  pay  due  regard  to  the  evolving 
crisis  situation  and  often  limited  information  that  is  at  the  disposal  of  the  Member 
States when they seek to reduce the emerging risks in the context of the crisis. Where 
justified and necessary in the circumstances, the Commission may consider based on 
any available information, including specialised or scientific information, the merits of 
Member  State  arguments  relying  on  the  precautionary  principle  as  a  reason  for 
adoption of free movement of persons restrictions. It is the task of the Commission to 
ensure  that  such  measures  comply  with  Union  law  and  do  not  create  unjustified 
obstacles to the functioning of the Single Market. The Commission should react to the 
notifications  of  Member  States  as  quickly  as  possible,  taking  into  account  the 
circumstances of the particular crisis, and at the latest within the time-limits set out by 
this Regulation. 

(23) 

In order to ensure that the specific Single Market emergency measures provided for in 
this Regulation are used only where this is indispensable for responding to a particular 
Single  Market  emergency,  such  measures  should  require  individual  activation  by 
means  of  Commission  implementing  acts,  which  indicate  the  reasons  for  such 
activation and the crisis-relevant goods or services that such measures apply to. 

(24)  Furthermore, in order to ensure the proportionality of the implementing acts and due 
respect  for  the  role  of  economic  operators  in  crisis  management,  the  Commission 
should  only  resort  to  the  activation  of  the  Single  Market  emergency  mode,  where 
economic  operators  are  not  able  to  provide  a  solution  on  a  voluntary  basis  within  a 
reasonable  time.  Why  this  is  the  case  should  be  indicated  in  each  such  act,  and  in 
relation to all particular aspects of a crisis. 

EN 

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(25) 

Information  requests  to  economic  operators  should  be  used  by  the  Commission  only 
where  the  information  which  is  necessary  for  responding  adequately  to  the  Single 
Market emergency, such as information necessary for procurement by the Commission 
on  behalf  of  the  Member  States  or  estimating  the  production  capacities  of 
manufacturers of crisis-relevant goods the supply chains of which have been disrupted, 
cannot  be  obtained  from  publicly  available  sources  or  as  a  result  of  information 
provided voluntarily.  

(26)  The  activation  of  the  Single  Market  emergency  mode,  where  needed,  should  also 
trigger  the  application  of  certain  crisis-response  procedures  which  introduce 
adjustments  to  the  rules  governing  the  design,  manufacture,  conformity  assessment 
and  the  placing  on  the  market  of  goods  subject  to  Union  harmonised  rules.  These 
crisis-response procedures should enable products, designated as crisis-relevant goods 
to  be  placed  swiftly  on  the  market  in  an  emergency  context.  The  conformity 
assessment bodies should prioritise the conformity assessment of crisis-relevant goods 
over  any  other  ongoing  applications  for  other  products.  On  the  other  hand,  in  cases, 
where  there  are  undue  delays  in  the  conformity  assessment  procedures,  the  national 
competent authorities should be able to issue authorisations for products, which have 
not undergone the applicable conformity assessment procedures to be placed on their 
respective market, provided that they comply with the applicable safety requirements. 
Such  authorisations  shall  be  only  valid  on  the  territory  of  the  issuing  Member  State 
and  limited  to  the  duration  of  the  Single  Market  emergency.  In  addition,  in  order  to 
facilitate the increase in supply of crisis-relevant products, certain flexibilities should 
be  introduced  with  respect  to  the  mechanism  of  presumption  of  conformity.  In  the 
context  of  a  Single  Market  emergency,  the  manufacturers  of  crisis-relevant  goods 
should be able to rely also on national and international standards, which provide an 
equivalent  level  of  protection  to  the  harmonised  European  standards.  In  cases  where 
the later do not exist or the compliance with them is rendered excessively difficult by 
the disruptions to the Single Market, the Commission should be able to issue common 
technical  specifications  of  voluntary  or  of  mandatory  application  in  order  to  provide 
ready-to-use technical solutions to the manufacturers.   

(27)  The  introduction  of  these  crisis-relevant  adjustments  to  the  relevant  sectorial  Union 
harmonised  rules  requires  targeted  adjustments  to  the  following  19  sectorial 
frameworks:  Directive  2000/14/EC,  Directive  2006/42/EU,  Directive  2010/35/EU, 
Directive  2013/29/EU,  Directive  2014/28/EU,  Directive  2014/29/EU,  Directive 
2014/30/EU,  Directive  2014/31/EU,  Directive  2014/32/EU,  Directive  2014/33/EU, 
Directive  2014/34/EU,  Directive  2014/35/EU,  Directive  2014/53/EU,  Directive 
2014/68/EU, Regulation (EU) 2016/424, Regulation (EU) 2016/425, Regulation (EU) 
2016/426, Regulation (EU) 2019/1009 and Regulation (EU) 305/2011. The activation 
of the emergency procedures should be conditional upon the activation of the Single 
Market emergency and should be limited to the products designated as crisis-relevant 
goods.  

(28) 

In cases where there are substantial risks to the functioning of the Single Market or in 
cases  of  severe  shortages  or  an  exceptionally  high  demand  of  goods  of  strategic 
importance, measures at Union level aimed to ensure the availability of crisis-relevant 
products, such as priority rated orders, may prove to be indispensable for the return to 
the normal functioning of the Single Market.  

(29) 

In order to leverage the purchasing power and negotiating position of the Commission 
during  the  Single  Market  vigilance  mode  and  the  Single  Market  emergency  mode, 
Member States should be able to request the Commission to procure on their behalf. 

EN 

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(30)  Where there is a severe shortage of crisis-relevant products or services on the Single 
market during a Single Market emergency, and it is clear that the economic operators 
that  operate  on  the  Single  market  do  not  produce  any  such  goods,  but  would  in 
principle  be  able  to  repurpose  their  production  lines  or  would  have  insufficient 
capacity to provide the  goods or services needed, the Commission  should be able to 
recommend  to  the  Member  States  as  a  last  resort  to  take  measures  to  facilitate  or 
request the ramping up or repurposing of production capacity of manufacturers or the 
capacity  of  the  service  providers  to  provide  crisis-relevant  services.  In  doing  so  the 
Commission  would  inform  the  Member  States  as  to  the  severity  of  the  shortage  and 
the  type  of  the  crisis-relevant  goods  or  services  that  are  needed  and  would  provide 
support and advice in relation to the flexibilities in the EU acquis for such purposes. 

(31)  The  measures  ensuring  regulatory  flexibility  would  allow  the  Commission  to 
recommend  that  Member  States  accelerate  the  procedures  for  granting  permits  that 
would be necessary for enhancement of the capacity to produce crisis-relevant goods 
or provide crisis-relevant services. 

(32)  Additionally,  to  ensure  that  crisis-relevant  goods  are  available  during  the  Single 
Market emergency, the Commission may invite the economic operators that operate in 
crisis-relevant  supply  chains  to  prioritise  the  orders  of  inputs  necessary  for  the 
production  of  final  goods  that  are  crisis  relevant,  or  the  orders  of  such  final  goods 
themselves. Should an economic operator refuse to accept and prioritise such orders, 
following  objective  evidence  that  the  availability  of  crisis-relevant  goods  is 
indispensable, the Commission may decide to invite the economic operators concerned 
to  accept  and  prioritise  certain  orders,  the  fulfilment  of  which  will  then  take 
precedence over any other private or public law obligations. In the event of failure to 
accept, the operator in question should explain its legitimate reasons for declining the 
request. The Commission  may make such reasoned explanation or parts of it public, 
with due regard to business confidentiality. 

(33)  Furthermore,  to  ensure  availability  of  crisis-relevant  goods  during  the  Single  Market 
emergency, the Commission may recommend  that Member States distribute strategic 
reserves,  having  with  due  regard  to  the  principles  of  solidarity,  necessity  and 
proportionality. 

(34)  Where  the  activities  to  be  carried  out  pursuant  to  this  Regulation  involve  the 
processing  of  personal  data,  such  processing  should  comply  with  the  relevant  Union 
legislation  on  personal  data  protection,  namely  Regulation  (EU)  2018/1725  of  the 
European  Parliament  and  of  the  Council41  and  Regulation  (EU)  2016/679  of  the 
European Parliament and of the Council42. 

(35) 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Regulation, 
implementing  powers  should  be  conferred  on  the  Commission  as  regards  the 
possibility to adopt supportive measures for facilitating free movement of persons, for 
establishing  a  list  of  individual  targets  (quantities  and  deadlines)  for  those  strategic 
reserves that the Member States should maintain, so that the objectives of the initiative 
are  achieved.  Furthermore,  implementing  powers  should  be  conferred  on  the 

41 

42 

Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the 
protection of natural persons with regard to the  processing of personal data by the Union institutions, 
bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 
45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). 
Regulation  (EU)  2016/769  of  the  European  Parliament  and  of  the  Council  of  27  April  2016  on  the 
protection of natural persons with regard to the processing of personal data and on the free movement of 
such data, and repealing Directive 95/46/EC (OJ L 119, 4.5.2016, p. 1). 

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Commission as regards activating the vigilance mode and vigilance measures in order 
to  carefully  monitor  the  strategic  supply  chains  and  coordinate  the  building  up  of 
strategic  reserves  for  goods  and  services  of  strategic  importance.  Moreover, 
implementing powers should be conferred on the Commission as regards activation of 
specific  emergency  response  measures  at  the  time  of  a  Single  Market  emergency,  to 
allow  for  a  rapid  and  coordinated  response.  Those  powers  should  be  exercised  in 
accordance with Regulation (EU) No 182/2011 of the European Parliament and of the 
Council. 

(36)  This Regulation respects fundamental rights and observes the principles recognised in 
particular  by  the  Charter  of  Fundamental  Rights  of  the  European  Union  (the 
‘Charter’).  In  particular,  it  respects  the  right  to  privacy  of  the  economic  operators 
enshrined in Article 7 of the Charter, right to data protection set out in Article 8 of the 
Charter,  the  freedom  to  conduct  business  and  the  freedom  of  contract,  which  are 
protected by Article 16 of the Charter, the right to property, protected by Article 17 of 
the  Charter,  right  to  collective  bargaining  and  action  protected  by  Article  26  of  the 
Charter and the right to an effective judicial remedy and to a fair trial as provided for 
in  Article  47  of  the  Charter.  Since  the  objective  of  this  Regulation  cannot  be 
sufficiently achieved by  the Member States and can rather, by reason  of the scale or 
effects of the action, be better achieved at Union level, the Union may adopt measures 
in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In 
accordance  with  the  principle  of  proportionality  as  set  out  in  that  Article,  this 
Regulation  does  not  go  beyond  what  is  necessary  in  order  to  achieve  that  objective. 
The Regulation should not affect the autonomy of the social partners as recognised by 
the TFEU. 

(37)  The  Union  remains  fully  committed  to  international  solidarity  and  strongly  supports 
the  principle  that  any  measures  deemed  necessary  taken  under  this  Regulation, 
including those necessary to prevent or relieve critical shortages, are implemented in a 
manner  that  is  targeted,  transparent,  proportionate,  temporary  and  consistent  with 
WTO obligations. 

(38)  The  Union  framework  shall  include  interregional  elements  to  establish  coherent, 
multi-sectoral,  cross-border  Single  Market  vigilance  and  emergency  response 
measures, in particular considering the resources, capacities and vulnerabilities across 
neighbouring regions, specifically border regions. 

(39)  The Commission shall also where appropriate enter into consultations or cooperation, 
on behalf of the Union, with relevant third countries, with particular attention paid to 
developing countries, with a view to  seeking cooperative solutions to address supply 
chain  disruptions,  in  compliance  with  international  obligations.  This  shall  involve, 
where appropriate, coordination in relevant international fora. 

(40) 

In  order  to  put  in  place  a  framework  of  crisis  protocols  the  power  to  adopt  acts  in 
accordance  with  Article  290  TFEU  should  be  delegated  to  the  Commission  to 
supplement the regulatory framework set out in this Regulation by further specifying 
the modalities of cooperation of the Member States and Union authorities during the 
Single  Market  vigilance  and  emergency  modes,  secure  exchange  of  information  and 
risk and crisis communication. It is of particular importance that the Commission carry 
out  appropriate  consultations  during  its  preparatory  work,  including  at  expert  level, 
and that those consultations be conducted in accordance with the principles laid down 
in  the  Interinstitutional  Agreement  of  13  April  2016  on  Better  Law-Making  .  In 
particular,  to  ensure  equal  participation  in  the  preparation  of  delegated  acts,  the 

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European  Parliament  and  the  Council  receive  all  documents  at  the  same  time  as 
Member  States'  experts,  and  their  experts  systematically  have  access  to  meetings  of 
Commission expert groups dealing with the preparation of delegated acts. 

(41)  Council  Regulation  (EC)  2679/98  which  provides  for  a  mechanism  for  bilateral 
discussions of obstacles to the functioning of the Single Market has been rarely used 
and  is  outdated.  Its  evaluation  demonstrated  that  the  solutions  provided  by  that 
Regulation  are  not  able  to  cater  for  the  realities  of  complex  crises,  which  are  not 
limited to  incidents  happening  at  the borders of two neighbouring Member States.  It 
should therefore be repealed. 

HAVE ADOPTED THIS REGULATION: 

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Part I 
General Provisions 

TITLE I 
SCOPE 

Article 1 
Subject matter 

1. 

This  Regulation  establishes a framework of measures to  anticipate, prepare  for  and 
respond to impacts of crises on the Single Market, with the purpose of safeguarding 
the free movement of goods, services and persons and of ensuring the availability of 
goods and services of strategic importance and crisis-relevant goods and services in 
the Single Market. 

2. 

The measures referred to in paragraph 1 include: 

(a) 

an  advisory  group  to  advise  the  Commission  on  the  appropriate  measures  for 
anticipating,  preventing  or  responding  to  the  impact  of  a  crisis  on  the  Single 
Market; 

(b)  measures for obtaining, sharing and exchanging the relevant information; 

(c) 

contingency measures aiming at anticipation and planning; 

(d)  measures  for  addressing  Single  Market  impacts  of  significant  incidents  that 
have not yet resulted in a Single Market emergency (Single Market vigilance), 
including a set of vigilance measures and 

(e)  measures  for  addressing  Single  Market  emergencies,  including    a  set  of 

emergency response measures. 

Member States shall regularly exchange information on all matters falling within the 
scope of this Regulation among themselves and with the Commission. 

The  Commission  may  obtain  any  relevant  specialised  and/or  scientific  knowledge, 
which is necessary for the application of this Regulation. 

Article 2 
Scope of application 

The measures set out in this Regulation apply in relation to significant impacts of a 
crisis on the functioning of the Single Market and its supply chains. 

This Regulation shall not apply to the following: 

(a)  medicinal  products  as  defined  in  Article  2,  paragraph  2  of  Directive 

2001/83/EC; 

(b) 

 medical  devices  as  defined  in  Article  2,  point  (e),  of  Regulation  (EU) 
2022/123 of the European Parliament and of the Council43; 

Regulation  (EU)  2022/123  of  the  European  Parliament  and  of  the  Council  of  25 January  2022  on  a 
reinforced  role  for  the  European  Medicines  Agency  in  crisis  preparedness  and  management  for 
medicinal products and medical devices, OJ L 20, 31.1.2022, p. 12. 

3. 

4. 

1. 

2. 

43 

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(c) 

(d) 

(e) 

(f) 

 other medical countermeasures as defined in Article 3, point (8), of Regulation 
(EU)  …/…  on  Serious  Cross-Border  Threats  to  Health  [the  SCBTH 
Regulation]  44  and  included  in  the  list  established  in  accordance  with  Article 
6(1)  of  the  proposal  for]  Council  Regulation  (EU)  …/…  on  a  framework  of 
measures for ensuring the supply of crisis-relevant medical countermeasures 45; 

semiconductors as defined in Article 2(1) of the Regulation of the Council and 
of  the  European  Parliament  establishing  a  framework  of  measures  for 
strengthening Europe's semiconductor ecosystem (Chips Act)46;  

energy  products  as  defined 
in  Article  2,  paragraph  1,  of  Directive 
2003/96/EC47, electricity as defined in Article 2, paragraph 2 of that Directive 
and other products as referred to in Article 2, paragraph 3, of that Directive.  

financial  services,  such  as  banking,  credit,  insurance  and  re-insurance, 
occupational  or  personal  pensions,  securities,  investment  funds,  payment  and 
investment  advice,  including  the  services  listed  in  Annex  I  to  Directive 
2013/36,  as  well  as  settlement  and  clearing  activities  and  advisory, 
intermediation and other auxiliary financial services. 

By way of derogation from paragraph 2, points (a), (b) and (c), Articles 16 to 20 and 
Article 41 of this Regulation shall apply to the products referred to in those points. 

This  Regulation  is  without  prejudice  to  the  Union  Civil  Protection  Mechanism  set 
out in Decision 1313/13/EU and the general plan on crisis management in the area of 
food and feed in accordance with Regulation (EC) No 178/2002. 

This Regulation is without prejudice to Union competition rules (Articles 101 to 109 
TFEU and implementing regulations), including antitrust, merger and State aid rules. 

This Regulation is without prejudice to the Commission: 

(a) 

entering  into  consultations  or  cooperation,  on  behalf  of  the  Union,  with 
relevant third countries, with particular attention paid to developing countries, 
with a view to seeking cooperative solutions to avoid supply chain disruptions, 
in  compliance  with  international  obligations.  This  may  involve,  where 
appropriate, coordination in relevant international fora; or 

(b) 

assessing whether it is appropriate to impose restrictions to exports of goods in 
line with the international rights and obligations of the Union under Regulation 
(EU) 2015/479 of the European Parliament and of the Council  48. 

Any actions under this Regulation shall be consistent with Union’s obligations under 
international law  

This  Regulation  is  without  prejudice  to  the  responsibility  of  the  Member  States  to 
safeguard  national  security  or  their  power  to  safeguard  essential  state  functions, 
including ensuring the territorial integrity of the State and maintaining law and order. 

[reference to adopted Act to be inserted once available] 
[reference to adopted Act to be inserted once available] 
[reference to adopted Act to be inserted once available] 
OJ L 283, 31.10.2003, p. 51. 
OJ L 83, 27.3.2015, p. 34. 

3. 

4. 

5. 

6. 

7. 

8. 

44 
45 
46 
47 
48 

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Article 3 
Definitions 

For the purposes of this Regulation, the following definitions apply: 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

1. 

2. 

3. 

‘crisis’ means an exceptional unexpected and sudden, natural or man-made event of 
extraordinary nature and scale that takes place inside or outside of the Union; 

‘Single  Market  vigilance  mode’  means  a  framework  for  addressing  a  threat  of 
significant disruption of the supply of goods and services of strategic importance and 
which  has the potential to escalate into a Single Market  emergency  within the next 
six months; 

‘Single  Market  emergency’  means  a  wide-ranging  impact  of  a  crisis  on  the  Single 
Market  that  severely  disrupts  the  free  movement  on  the  Single  Market  or  the 
functioning  of  the  supply  chains  that  are  indispensable  in  the  maintenance  of  vital 
societal or economic activities in the Single Market; 

‘strategically  important  areas’  means  those  areas  with  critical  importance  to  the 
Union and its  Member  States, in  that they  are of systemic  and vital  importance  for 
public  security,  public  safety,  public  order  or  public  health,  and  the  disruption, 
failure,  loss  or  destruction  of  which  would  have  a  significant  impact  on  the 
functioning of the Single Market; 

‘goods  and  services  of  strategic  importance’  means  goods  and  services  that  are 
indispensable  for  ensuring  the  functioning  of  the  Single  Market  in  strategically 
important areas and which cannot be substituted or diversified; 

‘crisis-relevant goods and services’ means goods and services that are indispensable 
for responding to the crisis or for addressing the impacts of the crisis on the Single 
Market during a Single Market emergency ; 

‘strategic  reserves’  means  a  stock  of  goods  of  strategic  importance  for  which 
building a reserve may be necessary to prepare for a Single Market emergency, under 
the control of a Member State. 

TITLE II  
GOVERNANCE 

Article 4 
Advisory group 

An advisory group is established. 

The  advisory  group  shall  be  composed  of  one  representative  from  each  Member 
State.  Each  Member  State  shall  nominate  a  representative  and  an  alternate 
representative. 

The  Commission  shall  chair  the  advisory  group  and  ensure  its  secretariat.  The 
Commission may invite a representative of the European Parliament, representatives 
of  EFTA  States  that  are  contracting  parties  to  the  Agreement  on  the  European 
Economic Area49, representatives of economic operators, stakeholder organisations, 
social partners and experts, to attend meetings of the advisory group as observers. It 

49 

OJ L 1, 3.1.1994, p. 3. 

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shall  invite  the  representatives  of  other  crisis-relevant  bodies  at  Union  level  as 
observers to the relevant meetings of the advisory group. 

4. 

For  the  purpose  of  contingency  planning  under  Articles  6  to  8,  the  advisory  group 
shall assist and advise the Commission as regards the following tasks: 

(a) 

the 
proposing  arrangements 
Commission and the Member States at the time of the Single Market vigilance 
and  emergency modes that would be contained in the crisis protocols; 

for  administrative  cooperation  between 

(b) 

assessingment of significant incidents that the Member States have alerted the 
Commission to. 

5. 

For the purpose of  of the Single Market  vigilance mode as  referred to  in  Article 9, 
the advisory group shall assist the Commission in the following tasks: 

(a) 

establishing  whether  the  threat  referred  to  in  Article  3(2)  is  present,  and  the 
scope of such threat; 

(b)  gathering foresight, data analysis and market intelligence; 

(c) 

(d) 

(e) 

consulting  the  representatives  of  economic  operators,  including  SMEs,  and 
industry to collect market intelligence; 

analysing aggregated data received by other crisis-relevant bodies at Union and 
international level; 

facilitating exchanges and sharing of information, including with other relevant 
bodies and other crisis-relevant bodies at Union level, as well asthird countries, 
as  appropriate,  with  particular  attention  paid  to  developing  countries,  and 
international organisations; 

(f)  maintaining a repository of national and Union crisis measures that have been 
used  in  previous  crises  that  have  had  an  impact  on  the  Single  Market  and  its 
supply chains 

6. 

For the purposes of the Single Market emergency mode as referred to in Article 14, 
the advisory group shall assist the Commission in the following tasks: 

(a) 

(b) 

(c) 

analysing  crisis-relevant  information  gathered  by  Member  States  or  the 
Commission; 

establishing whether the criteria for activation or deactivation of the emergency 
mode have been fulfilled; 

advising  on  the  implementation  of  the  measures  chosen  to  respond  to  Single 
Market emergency at Union level; 

(d)  performing a review of national crisis measures; 

(e) 

facilitating  exchanges  and sharing of information, including with  other  crisis-
relevant bodies at Union level, as well as, as appropriate, third countries, with 
particular  attention  paid 
international 
organisations. 

to  developing  countries,  and 

7. 

The Commission  shall ensure the participation of all bodies at  Union level  that  are 
relevant  to  the  respective crisis.  The  advisory  group shall cooperate and  coordinate 
closely,  where  appropriate,  with  other  relevant  crisis-related  bodies  at  Union  level. 
The Commission shall ensure coordination with the measures implemented through 
other Union mechanisms, such as the Union Civil Protection Mechanism (UCPM) or 

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8. 

9. 

1. 

2. 

the  EU  Health  Security  Framework.  The  advisory  group  shall  ensure  information 
exchange with the Emergency Response Coordination Centre under the UCPM. 

The advisory group shall meet at least three times a  year. At its first meeting, on a 
proposal by and in agreement with the Commission, the advisory group shall adopt 
its rules of procedure. 

The advisory group may adopt opinions, recommendations or reports in the context 
of its tasks set out in paragraphs 4 to 6. 

Article 5 
Central liaison offices 

Member  States  shall  designate  central  liaison  offices  responsible  for  contacts, 
coordination  and  information  exchange  with  the  central  liaison  offices  of  other 
Member  States  and  Union  level  central  liaison  office  under  this  Regulation.  Such 
liaison  offices  shall  coordinate  and  compile  the  inputs  from  relevant  national 
competent authorities. 

The Commission shall designate a Union level central liaison office for contacts with 
the central  liaison  offices of the Member States during the Single Market  vigilance 
and emergency modes under this Regulation. The Union level central liaison office 
shall  ensure  the  coordination  and  information  exchange  with  the  central  liaison 
offices of the Member States for the management of the Single Market vigilance and 
emergency modes. 

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Part II  
Single Market contingency planning 

Article 6 
Crisis protocols 

1. 

The Commission taking into consideration the opinion of the advisory group and the 
input  of  relevant  Union  level  bodies,  is  empowered  after  consulting  the  Member 
States,  to  adopt  a  delegated  act  to  supplement  this  Regulation  with  a  framework 
setting out crisis protocols regarding crisis cooperation, exchange of information and 
crisis  communication  for  the  Single  Market  vigilance  and  emergency  modes,  in 
particular: 

(a) 

cooperation  between  national  and  Union  level  competent  authorities  for  the 
management of the Single Market vigilance and emergency modes in vigilance 
and emergency modes across the sectors of the Single Market; 

(b)  general modalities for secure exchange of information; 

(c) 

a  coordinated  approach  to  risk  and  crisis  communication  also  vis-à-vis  the 
public with a coordinating role for the Commission; 

(d) 

the management of the framework. 

2. 

The  Commission  and  the  Member  States  shall  put  in  place  detailed  administrative 
arrangements  for  ensuring  timely  cooperation  and  secure  exchange  of  information 
between  the  Commission,  the  relevant  Union-level  bodies  and  the  Member  States 
concerning: 

(a) 

(b) 

(c) 

(d) 

an  inventory  of  relevant  national  competent  authorities,  the    central  liaison 
offices  designated  in  accordance  with  Article  5  and  single  points  of  contact 
referred 
their  contact  details,  assigned  roles  and 
responsibilities  during  the  vigilance  and  emergency  modes  of  this  Regulation 
under national law; 

in  Article  21, 

to 

consultation  of  the  representatives  of  economic  operators  and  social  partners, 
including  SMEs,  on  their  initiatives  and  actions  to  mitigate  and  respond  to 
potential  supply  chain  disruptions  and  overcome  potential  shortages  of  goods 
and services in the Single Market;  

technical  level  cooperation  in  the  vigilance  and  emergency  modes  across  the 
sectors of the Single Market; 

risk  and  emergency  communication,  with  a  coordinating  role  for  the 
Commission, adequately taking into account already existing structures; 

3. 

In  order  to  ensure  the  operation  of  the  framework  referred  to  in  paragraph  1,  the 
Commission  may  conduct  stress  tests,  simulations  and  in-action  and  after-action 
reviews  with  Member  States,  and  propose  the  relevant  Union-level  bodies  and  the 
Member States to update the framework as necessary. 

Article 7 
Trainings and simulations 

The  Commission  shall  organise  the  training  on  crisis  coordination,  cooperation  and 
information  exchange  referred  to  in  Article  6  for  the  staff  of  the  designated  central  liaison 

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32 

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offices. It shall organise simulations involving the staff of the central liaison offices from all 
Member States based on potential scenarios of Single Market emergencies. 

1. 

2. 

3. 

Article 8 
Ad hoc alerts for early warning 

The  central  liaison  office  of  a  Member  State  shall  notify  the  Commission  and  the 
central liaison offices of other Member States without undue delay of any incidents 
that significantly disrupt or have the potential to significantly disrupt the functioning 
of the Single Market and its supply chains (significant incidents). 

The  central  liaison  offices  and  any  relevant  national  competent  authorities  shall,  in 
accordance  with  Union  law  and  national  legislation  that  complies  with  Union  law, 
treat  the  information  referred  to  in  paragraph  1  in  a  way  that  respects  its 
confidentiality,  protects  the  security  and  public  order  of  the  European  Union  or  its 
Member States, and protects  the security and commercial interests of the  economic 
operators concerned. 

In  order  to  determine  whether  the  disruption  or  potential  disruption  of  the 
functioning  of  the  Single  Market  and  its  supply  chains  of  goods  and  services  is 
significant and should be the object of an alert, the central liaison office of a Member 
State shall take the following into account: 

(a) 

the  number  of  economic  operators  affected  by  the  disruption  or  potential 
disruption; 

(b) 

the duration or anticipated duration of a disruption or potential disruption; 

(c) 

the  geographical  area;    the  proportion  of  the  Single  Market  affected  by  the  
disruption  or  potential  disruption;  the  impact  on  specific  geographical  areas 
particularly vulnerable or exposed to supply chain disruptions including the EU 
outermost regions; 

(d) 

the effect of the disruption or potential disruption on non-diversifiable and non-
substitutable inputs. 

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Part III  
Single Market Vigilance 

TITLE I 
VIGILANCE MODE 

Article 9 
Activation 

1. 

2. 

1. 

2. 

3. 

1. 

2. 

Where  the  Commission,  taking  into  consideration  the  opinion  provided  by  the 
advisory group, considers that the threat referred to in Article 3(2) is present, it shall 
activate the vigilance mode for a maximum duration of six months by means of an 
implementing act. Such an implementing act shall contain the following: 

(a) 

an assessment of the potential impact of the crisis; 

(b) 

list of the goods and services of strategic importance concerned, and 

(c) 

 the vigilance measures to be taken. 

The implementing act referred to in paragraph 1 shall be adopted in accordance with 
the examination procedure referred to in Article 41(2).  

Article 10 
Extension and deactivation 

The  Commission,  if  it  considers  that  the  reasons  for  activating  the  vigilance  mode 
pursuant  to  Article  9(1)  remain  valid,  and  taking  into  consideration  the  opinion 
provided  by  the  advisory  group,  may  extend  the  vigilance  mode  for  a  maximum 
duration of six months by means of an implementing act. 

Where  the  Commission,  taking  into  consideration  the  opinion  provided  by  the 
advisory group, finds that the threat referred to in Article 3(2) is no longer present, 
with  respect  to  some  or  all  vigilance  measures  or  for  some  or  all  of  the  goods  and 
services,  it  shall  deactivate  the  vigilance  mode  in  full  or  in  part  by  means  of  an 
implementing act. 

Implementing acts referred to in paragraphs 1 and 2 shall be adopted in accordance 
with the examination procedure referred to in Article 42(2). 

TITLE II 
VIGILANCE MEASURES 

Article 11 
Monitoring 

When the vigilance mode  has been activated in accordance with Article  9, national 
competent  authorities  shall  monitor  the  supply  chains  of  goods  and  services  of 
strategic importance that have been identified in the implementing act activating the 
vigilance mode. 

The Commission shall provide for standardised and secure means for the collection 
and  processing  of  information  for  the  purpose  of  paragraph  1,  using  electronic 
means.    Without  prejudice  to  national  legislation  requiring  collected  information 

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3. 

4. 

5. 

6. 

7. 

1. 

2. 

including business secrets to be kept confidential, confidentiality with regard to the 
commercially sensitive informationand information affecting  the security and public 
order of the Union or its Member States shall be ensured. 

Member States shall set up and maintain an inventory of the most relevant economic 
operators  established  on  their  respective  national  territory  that  operate  along  the 
supply chains of goods and services of strategic importance that have been identified 
in the implementing act activating the vigilance mode. 

On  the  basis  of  the  inventory  set  up  pursuant  to  Article  6,  national  competent 
authorities shall address requests for voluntary provision of information to the most 
relevant  operators  along  the  supply  chains  of  goods  and  services  identified  in  the 
implementing  act  adopted  pursuant  to  Article  9  and  other  relevant  stakeholders 
established  in  their  respective  national  territory.  Such  requests  shall  in  particular 
states  which  information  about  factors  impacting  the  availability  of  the  identified 
goods  and  services  of  strategic 
is  requested.  Each  economic 
operator/stakeholder  that  voluntarily  provides  information  shall  do  so  on  an 
individual basis in line with the Union rules on competition governing the exchange 
of  information.  The  national  competent  authorities  shall  transmit  the  relevant 
findings  to  the  Commission  and  the  advisory  group  without  undue  delay  via  the 
respective central liaison office. 

importance 

National competent authorities shall have due regard to the administrative burden on 
economic operators and in particular SMEs, which may be associated with requests 
for information and ensure it is kept to a minimum. 

The Commission may ask the advisory group to discuss the findings and prospects of 
evolution based on the monitoring of supply chains of goods and services of strategic 
importance. 

On  the  basis  of  the  information  collected  through  the  activities  carried  out  in 
accordance  with  paragraph  1,  the  Commission  may  provide  a  report  of  the 
aggregated findings. 

Article 12 
Strategic reserves 

The  Commission  may,  among  the  goods  of  strategic  importance  listed  in  an 
implementing act  adopted pursuant to Article 9(1),, identify those for which it may 
be necessary to  build  a  reserve  in  order to  prepare for  a Single Market  emergency, 
taking  into  account  the  probability  and  impact  of  shortages.  The  Commission  shall 
inform the Member States thereof. 

Capacities which are a part of the rescEU reserve  in  accordance with  Article 12 of 
Decision No 1313/2013/EU are excluded from the application of this Article. 

The  Commission  may  require,  by  means  of  implementing  acts,  that  the  Member 
States  provide  information  on  the  goods  listed  in  an  implementing  act  adopted 
pursuant to Article 9(1), as regards all of the following: 

(a) 

the current stock in their territory;  

(b) 

any potential for further purchase;  

(c) 

any options for alternative supply; 

(d) 

further information that could ensure the availability of such goods.  

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3. 

4. 

5. 

6. 

The implementing act shall specify the goods for which information is to be given.  

Member  States  shall  report  to  the  Commission  the  levels  of  strategic  reserves  of 
goods  of  strategic  importance  held  by  them,  and  the  levels  of  other  stocks  of  such 
goods held on their territory. 

Taking  due  account  of  stocks  held  or  being  built  up  by  economic  operators  on 
theirterritory,  Member  States  shall  deploy  their  best  efforts  to  build  up  strategic 
reserves of the goods of strategic importance identified in accordance with paragraph 
1.  The  Commission  shall  provide  support  to  Member  States  to  coordinate  and 
streamline their efforts. 

Where the building of strategic reserves of goods of strategic importance identified 
pursuant  to  paragraph  1  can  be  rendered  more  effective  by  streamlining  among 
Member  States,  the  Commission  may  draw  up  and  regularly  update,  by  means  of 
implementing  acts,  a  list  of  individual  targets  regarding  the  quantities  and  the 
deadlines for those strategic reserves that the Member States should maintain. When 
setting the individual targets for each Member State, the Commission shall take into 
account: 

(a) 

(b) 

the probability and impact of shortages referred in paragraph 1; 

the  level  of  existing  stocks  of  the  economic  operators  and  strategic  reserves 
across  the  Union,  and  any  information  on  economic  operators’  ongoing 
activities to increase their stocks; 

(c) 

the costs for building and maintaining such strategic reserves. 

The Member States shall regularly inform the Commission about the current state of 
their  strategic  reserves.  Where  a  Member  State  has  reached  the  individual  targets 
referred to in paragraph 4, it shall inform the Commission if it has at its disposal any 
stocks of the goods in question in excess of their target. The Member States whose 
reserves have not reached the individual targets shall explain to the Commission the 
reasons  for  this  situation.  The  Commission  shall  facilitate  cooperation  between  the 
Member  States  which  have  already  reached  their  targets  and  the  other  Member 
States. 

Where the strategic reserves of a Member State continuously fall significantly short 
of  the  individual  targets  referred  to  in  paragraph  4  and  economic  operators  on  its 
territory  are not  able to  compensate that  shortfall, the Commission  may,  at  its own 
initiative  or  at  the  request  of  14  Member  States,  assess  the  need  to  take  further 
measures  to  build  up  strategic  reserves  of  goods  of  strategic  importance  identified 
pursuant to paragraph 1.  

Following  such  an  assessment,  where  the  Commission  establishes,  supported  by 
objective data, that 

(a) 

(b) 

(c) 

the  needs  for  the  good  in  question  remain  unchanged  or  have  increased 
compared to the situation at the time the target referred to in paragraph 4 was 
first set or last amended pursuant to paragraph 4,  

access  to  the  concerned  good  is  indispensable  to  ensure  preparedness  for  a 
Single Market emergency 

the  Member  State  concerned  has  not  provided  sufficient  evidence  to  explain 
the failure to meet the individual target, and  

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(d) 

exceptional  circumstances  exist,  in  that  the  failure  by  that  Member  State, 
considering  its  importance  to  the  supply  chain  concerned,  to  build  up  such 
strategic reserves  gravely  imperils  the Union’s preparedness  in  the face  of an 
impending threat of a Single Market emergency,  

the Commission may adopt an implementing act, requiring the Member State in question to 
build up its strategic reserves of the goods concerned by a set deadline. 

7. 

When acting under this Article, the Commission shall seek to ensure that the building 
up of strategic reserves does not create a disproportionate strain on the supply chains 
of the goods identified in accordance to paragraph 1, or on the fiscal capacity of the 
Member State concerned. 

The Commission shall take fully into account  any national security concerns raised 
by Member States. 

8. 

The implementing acts referred to in this Article shall be adopted in accordance with 
the examination procedure referred to in Article 42(2).  

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Part IV 
Single Market Emergency 

TITLE I 
EMERGENCY MODE 

Article 13 
Criteria for activation 

1. 

When assessing the severity of a disruption for the purposes of ascertaining whether 
the impact of a crisis on the Single Market qualifies as a Single Market emergency, 
the Commission shall, based on concrete and reliable evidence, taking into account at 
least the following indicators: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

the  crisis  has  caused  activation  of  any  relevant  Council  crisis  response 
mechanism,  Union  Civil  Protection  Mechanism  or  the  mechanisms  set  up 
within  the  EU  Health  Security  Framework,  including  [the  proposal  for] 
Regulation (EU) …/… on serious cross-border health threats and [the proposal 
for] Council Regulation (EU) …/… on a framework of measures for ensuring 
the supply of crisis-relevant medical countermeasures; 

an  estimation  of  the  number  of  economic  operations  or  users  relying  on  the 
disrupted sector or sectors of the Single Market for the provision of the goods 
or services concerned; 

the importance of the goods or services concerned for other sectors; 

the impacts in terms of degree and duration on economic and societal activities, 
the environment and public safety; 

the economic operators affected have not been able to provide a solution in a 
reasonable time to the particular aspects of the crisis on a voluntary basis. 

the market position of affected economic operators in the concerned sector or 
sectors; 

the  geographic  area  that  is  and  could  be  affected,  including  any  cross-border 
impacts  on  the  functioning  of  supply  chains  that  are  indispensable  in  the 
maintenance of vital societal or economic activities in the Single Market; 

the  importance  of  the  affected  economic  operator  in  maintaining  a  sufficient 
level of supply of the goods or services, taking into account the availability of 
alternative means for the provision of those goods or services; and 

(i) 

the absence of substitute goods, inputs or services. 

Article 14 
Activation 

1. 

The  Single  Market  Emergency  mode  may  be  activated  without  the  Single  Market 
vigilance  mode  having  previously  been  activated  with  regard  to  the  same  goods  or 
services.  Where  the  vigilance  mode  has  previously  been  activated,  the  emergency 
mode may replace it partially or entirely. 

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2. 

3. 

4. 

5. 

6. 

1. 

2. 

3. 

Where  the  Commission,  taking  into  consideration  the  opinion  provided  by  the 
advisory group, considers there is a Single Market emergency, it shall propose to the 
Council to activate the Single Market emergency mode. 

The Council may activate the Single Market emergency mode by means of a Council 
implementing  act.  The  duration  of  the  activation,  hall  be  specified  in  the 
implementing act, and shall be a maximum of six months. 

The  activation  of  the  Single  Market  emergency  mode  regarding  certain  goods  and 
services  does  not  prevent  the  activation  or  continued  application  of  the  vigilance 
mode and deployment of the measures laid down in Articles 11 and 12 regarding the 
same goods and services. 

As soon as  the Single  Market  emergency mode is  activated, the Commission shall, 
without  delay,  adopt  a  list  of  crisis-relevant  goods  and  services  by  means  of  an 
implementing act. The list may be amended by means of implementing acts. 

 The  Commission  implementing  act  referred  to  in  paragraph  5  shall  be  adopted  in 
accordance  with  the  examination  procedure  referred  to  in  Article  42(2).  On  duly 
justified  imperative  grounds  of  urgency  relating  to  the  impacts  of  the  crisis  on  the 
Single  Market,  the  Commission  shall  adopt  immediately  applicable  implementing 
acts in accordance with the procedure referred to in Article 42(3). 

Article 15 
Extension and deactivation 

Where the Commission considers, taking into consideration the opinion provided by 
the  advisory  group,  that  an  extension  of  the  Single  Market  emergency  mode  is 
necessary,  it  shall  propose  to  the  Council  to  extend  the  Single  Market  emergency 
mode. Subject to urgent and exceptional changes in circumstances, the Commission 
shall  endeavour  to  do  so  no  later  than  30  days  before  the  expiry  of  the  period  for 
which  the  Single  Market  emergency  mode  has  been  activated.  The  Council  may 
extend the Single Market emergency mode by no more than six months at a time by 
means of an implementing act. 

Where the advisory group has concrete and reliable evidence that the Single Market 
emergency  should  be  deactivated,  it  may  formulate  an  opinion  to  that  effect  and 
transmit it to the Commission. Where the Commission, taking into consideration the 
opinion  provided  by  the  advisory  group,  considers  a  Single  Market  emergency  no 
longer  exists,  it  shall  propose  to  the  Council  without  delay  the  deactivation  of  the 
Single Market emergency mode. 

The  measures  taken  in  accordance  with  Articles  24  to  33  and  pursuant  to  the 
emergency  procedures  introduced  in  the  respective  Union  legal  frameworks  by 
means of the amendments to sectorial product legislation set out in Regulation of the 
European  Parliament  and  of  the  Council  amending  Regulation  (EU)  2016/424, 
Regulation  (EU) 2016/425, Regulation  (EU) 2016/426,  Regulation  (EU) 2019/1009 
and  Regulation  (EU)  No  305/2011  and  introducing  emergency  procedures  for  the 
conformity assessment, adoption of common specifications and market surveillance 
in  the  context  of  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,    and2014/68/EU 
and  introducingas  regard  emergency  procedures  for  the  conformity  assessment, 

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adoption of common specifications and market surveillance in the context ofdue to a 
Single  Market  shall  cease  to  apply  upon  deactivation  of  the  duration  of  the  Single 
Market  emergency  mode.  The  Commission  shall  submit  to  the  Council  an 
assessment  on  the  effectiveness  of  the  measures  taken  in  addressing  the  Single 
Market emergency no later than three months after the expiry of the measures, on the 
basis of the information gathered via the monitoring mechanism foreseen by Article 
11. 

TITLE II 
 FREE MOVEMENT DURING THE SINGLE MARKET EMERGENCY 

Chapter I 
Measures for re-establishing and facilitating free movement 

Article 16 
General requirements for measures restricting free movement to address a Single Market 
emergency 

1. 

2. 

3. 

4. 

5. 

When  adopting  and  applying  national  measures  in  response  to  a  Single  Market 
emergency  and  the  underlying  crisis,  Member  States  shall  ensure  that  their  actions 
fully comply with the Treaty and Union law and, in particular, with the requirements 
laid down in this Article. 

Any restriction shall be limited in time and removed as soon as the situation allows 
it.  Additionally,  any  restriction  should  take  into  account  the  situation  of  border 
regions. 

Any  requirement  imposed  on  citizens  and  businesses  shall  not  create  an  undue  or 
unnecessary administrative burden. 

Member  States  shall  inform  citizens,  consumers,  businesses,  workers  and  their 
representatives about measures that affect their free movement rights in a clear and 
unambiguous manner. 

Member States shall ensure that all  affected stakeholders are informed of  measures 
restricting  free  movement  of  goods,  services  and  persons,  including  workers  and 
service  providers,  before  their  entry  into  force.  Member  States  shall  ensure  a 
continuous dialogue with stakeholders, including communication with social partners 
and international partners. 

 Article 17 
Prohibited restrictions of free movement rights during a Single Market emergency 

1. 

During the Single Market emergency mode and when responding to a Single Market 
emergency, Member States shall refrain from introducing any of the following: 

(a) 

(b) 

intraUnion  export  bans  or  other  measures  having  equivalent  effect  on  crisis-
relevant  goods  or  services  listed  in  an  implementing  act  adopted  pursuant  to 
Article 14, paragraph 5; 

restrictions on the intra-EU export of goods or provision or receipt of services, 
or    measures  having  equivalent  effect,  where  those  restrictions  do  any  of  the 
following 

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(c) 

(d) 

(i) disrupt supply chains of crisis-relevant goods and services that are listed in 
an implementing act adopted pursuant to Article 14, paragraph 5,   or 

(ii)  create  or  increase  shortages  of  such  goods  and  services  in  the  single 
market; 

discrimination  between  Member States  or between citizens, including in  their 
role  as  service  providers  or  workers,  based  directly  on  nationality  or,  in  the 
case of companies, the location of the registered office, central administration 
or principal place of business; 

restrictions  on  the  free  movement  of  persons  involved  in  the  production  of 
crisis-relevant goods that are listed in an implementing act adopted pursuant to 
Article 14, paragraph 5 and their parts or in provision of crisis-relevant services 
that are listed in an implementing act adopted pursuant to Article 14 paragraph 
5, or other measures having equivalent effect, that: 

(i) 
 cause shortages of necessary workforce on the Single Market and thus 
disrupt supply chains of crisis-relevant goods and services or create or increase 
shortages of such goods and services in the Single market or 

(ii) 

are directly discriminatory based on nationality of the person. 

2. 

During  the  Single  Market  emergency  mode  and  when  responding  to  the  Single 
Market emergency,  Member States shall refrain from any of the following, unless to 
do so is inherent to the nature of the crisis: 

3. 

4. 

(a) 

applying  more  generous  rules  to  goods  originating  from  a  neighbouring 
Member  State,  any  other  Member  State  or  a  group  of  Member  States,  as 
compared to goods originating from other Member States; 

(b) 

selectively refusing the entry of goods originating from specific other Member 
States to their territory; 

(c) 

introducing prohibitions of the operation of  freight transport; 

During the Single Market emergency mode and when responding to a Single Market 
emergency, Member States shall refrain from any of the following unless to do so is 
inherent to the nature of the crisis/Single Market emergency: 

(a) 

banning types of services or modes of service provision; 

(b)  blocking flows of passenger transport; 

During  the  Single  Market  emergency  mode  and  when  responding  to  the  Single 
Market emergency, Member States shall refrain from any of the following: 

(a) 

applying of more  generous rules to  travel  to  or  from one Member  State to  or 
from another Member State or group of Member States, as compared to travel 
to and from other Member States unless to do so is inherent to the nature of the 
crisis/Single Market emergency;  

(b)  denying, to beneficiaries of the right of free movement under Union law, of the 
right to enter the territory of their Member State of nationality or residence, the 
right  to  exit the  territory  of    Member  States  to  travel  to  the  Member  State  of 
nationality or residence, or the right to transit through a Member State in order 
to reach the Member State of nationality or residence; 

(c) 

prohibiting  of  business  travel  linked  to  the  research  and  development,  to 
production  of  crisis-related  goods  that  are  listed  in  an  implementing  act 

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41 

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adopted pursuant to Article 14, paragraph 5, or their placing on the market or to 
the related inspections; 

(d) 

(e) 

imposing prohibitions on travel, including travel for imperative family reasons, 
which are not appropriate for the achievement of any legitimate public interest 
purportedly pursued by such measures or which manifestly go beyond what is 
necessary to achieve that aim; 

restrictions  on  workers  and  service  providers  and 

imposing 
their 
representatives,  unless  to  do  so  in  inherent  to  the  nature  of  the  crisis/Single 
Market emergency and it does not manifestly go beyond what is necessary for 
that purpose. 

When a Single Market emergency has been activated in accordance with Article 14 
and  the  activities  exercised  by  the  service  providers,  business  representatives  and 
workers are not affected by the crisis in the Member State and safe travel is possible 
despite  the  crisis,  that  Member  State  shall  not  impose  travel  restrictions  on  such 
categories  of  persons  from  other  Member  States  that  would  prevent  them  from 
having access to their place of activity or workplace. 

When a Single Market emergency has been activated in accordance with Article 14 
and  exceptional  circumstances  resulting  from  the  crisis  do  not  allow  all  service 
providers, business representatives and workers from other Member States to  travel 
and to have unhindered access to their place of activity or workplace, but travelling is 
still possible, Member States shall not impose travel restrictions, on: 

(a)  Those service providers that provide crisis-relevant services that are listed in an 
implementing act adopted pursuant to Article 14(5), or business representatives 
or workers that are involved in production of crisis-relevant goods or provision 
of  crisis-relevant  services    that  are  listed  in  an  implementing  act  adopted 
pursuant  to  Article  14(5)  to  allow  them  to  have  access  to  the  place  of  their 
activities, if activities in the sector concerned are still allowed in the  Member 
State; 

(b) 

 civil protection workers to allow them to have unhindered access to their place 
of activity with their equipment in any of the Member States. 

When  taking  the  measures  referred  to  in  this  provision,  the  Member  States  shall 
ensure  full  compliance  with  the  Treaties  and  Union  law.  Nothing  in  this  provision 
shall be construed as authorising or justifying restrictions to free movement contrary 
to the Treaties or other provisions of Union law. 

Article 18  
Supportive measures 

During  the  Single  Market  emergency  mode,  the  Commission  may  provide  for 
supportive  measures  to  reinforce  free  movement  of  persons  referred  to  in  Article 
17(6)  and  17(7)  by  means  of  implementing  acts.  Those  implementing  acts  shall  be 
adopted in accordance with the examination procedure referred to in Article 422(2). 
On duly justified imperative grounds of urgency relating to the impacts of the crisis 
on  the  Single  Market,  the  Commission  shall  adopt  immediately  applicable 
implementing acts in accordance with the procedure referred to in Article 42(3). 

5. 

6. 

7. 

1. 

2. 

During the Single Market emergency mode, where the Commission establishes that 
Member  States  have  put  in  place  templates  for  attesting  that  the  individual  or 

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economic  operator  is  a  service  provider  that  provides  crisis-relevant  services,  a 
business  representative  or  worker  that  is  involved  in  production  of  crisis-relevant 
goods  or  provision  of  crisis-relevant  services  or  a  civil  protection  worker  and  it 
considers that the use of different templates by each Member States is an obstacle to 
the free movement at the time of a Single Market emergency, the Commission may 
issue, if it considers it necessary for supporting the free movement of such categories 
of  persons  and  their  equipment  during  the  ongoing  Single  Market  emergency, 
templates for attesting that they fulfil the relevant criteria for the application Article 
17(6) in all Member States by means of implementing acts. 

The  implementing  acts  referred  to  in  paragraphs  1  and  2  shall  be  adopted  in 
accordance  with  the  examination  procedure  referred  to  in  Article  42(2).  On  duly 
justified  imperative  grounds  of  urgency  relating  to  the  impacts  of  the  crisis  on  the 
Single  Market,  the  Commission  shall  adopt  immediately  applicable  implementing 
acts in accordance with the procedure referred to in Article 42(3). 

Chapter II 
Transparency and administrative assistance 

Article 19 
Notifications 

During the Single Market emergency, Member States shall notify to the Commission 
any  crisis-relevant  draft  measures  restricting  free  movement  of  goods  and  the 
freedom to provide services as well as crisis-relevant restrictions of free movement 
of persons, including workers together with the reasons for those measures. 

Such  notification  shall  not  prevent  Member  States  from  adopting  the  measures  in 
question in case immediate action is needed due to reasons occasioned by serious and 
unforeseeable  circumstances.  Member  States  shall  notify  the  adopted  measure 
immediately  together  with  a  justification  for  the  need  to  immediately  adopt  the 
measure. 

Member  States  shall  provide  to  the  Commission  a  statement  of  the  reasons  which 
make the enactment of such measure justified and proportionate, where those reasons 
have  not  already  been  made  clear  in  the  notified  measure.  Member States  shall 
communicate to the Commission the full text of the national legislative or regulatory 
provisions which contain or are modified by the measure. 

Member  States  shall  use  the  information  system  set  up  for  notifications  under 
Directive  (EU)  2015/1535  of  the  European  Parliament  and  of  the  Council50 for 
notifications under this Article. 

The  Commission  shall  communicate  the  notified  measures  to  the  other  Member 
States without delay and shall share them at the same time with the advisory group. 

If the advisory group chooses to deliver an opinion on a notified measure, it shall do 
so  within  four  working  days  from  the  date  of  receipt  by  the  Commission  of  the 
notification concerning that measure. 

The  Commission  shall  ensure  that  citizens  and  businesses  are  informed  of  the 
notified  measures,  unless  Member  States  request  that  the  measures  remain 
confidential, or the Commission deems disclosure of those measures would affect the 

3. 

1. 

2. 

3. 

4. 

5. 

6. 

50 

OJ L 241, 17.9.2015, p. 1. 

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7. 

8. 

9. 

10. 

11. 

12. 

13. 

14. 

security and public order of the European Union or its Member States, as well as of 
the decisions and Member States’ comments adopted in accordance with this Article. 

Member States shall postpone the adoption of a notified draft measure for 10  days 
from  the  date  of  receipt  by  the  Commission  of  the  notification  referred  to  in  this 
Article. 

Within  10  days  from  the  date  of  receipt  of  the  notification,  the  Commission  shall 
examine the compatibility of any draft or adopted measure with Union law, including 
Articles 16 and 17 of this Regulation as well as the principles of proportionality and 
non-discrimination, and may provide comments on the notified measure when there 
are immediately obvious and serious grounds to believe that it does not comply with 
Union  law.  Such  comments  shall  be  taken  into  account  by  the  notifying  Member 
State.  In  exceptional  circumstances,  in  particular  to  receive  scientific  advice, 
evidence or technical expertise in the context of an evolving situation, the period of 
10  days  may  be  extended  by  the  Commission.  The  Commission  shall  set  out  the 
reasons justifying any such extension, shall set a new deadline  and shall inform the 
Member  States  about  the  new  deadline  and  the  reasons  for  the  extension  without 
delay. 

Member States may also provide comments to the Member State which has notified a 
measure; that Member State shall take such comments into account. 

The  notifying  Member State  shall  communicate  the  measures  it  intends  to  adopt  in 
order to comply with the comments delivered in accordance with paragraph 8 to the 
Commission within 10 days after receiving them.  

If the Commission finds that the measures communicated by the notifying Member 
State are still not in accordance with Union law, it may issue within 30 days of that 
communication, a decision requiring that Member State to refrain from adopting the 
notified draft  measure.  The notifying Member State shall communicate the adopted 
text of a notified draft measure to the Commission without delay. 

If the Commission finds that an already adopted measure that has been notified to it, 
is not in accordance with Union law, it may issue within 30 days of that notification a 
decision requiring the Member State to abolish it. The notifying Member State shall 
communicate the text  of a  revised measure in  case it modifies the notified adopted 
measure without delay. 

 The  period  of  30  days  referred  to  in  paragraphs  11  and  12  may  be  exceptionally 
extended by the Commission in order to take account of a change of circumstances, 
in  particular  to  receive  scientific  advice,  evidence  or  technical  expertise  in  the 
context of an evolving situation. The Commission shall set out the reasons justifying 
any such extension and shall set a new deadline and shall inform the Member States 
about the new deadline and the reasons for the extension without delay.  

The  Commission  decisions  referred  to  in  paragraphs  11  and  12    shall  be  based  on 
available  information  and  may  be  issued  when  there  are  immediately  obvious  and 
serious grounds to believe that the notified measures do not comply with Union law, 
including Article 16 or 17 of this Regulation, the principle of proportionality or the 
principle  of  non-discrimination.  The  adoption  of  those  decisions  shall  be  without 
prejudice  to  the  possibility  for  the  Commission  to  adopt  measures  at  a  later  stage, 
including  the  launching  of  an  infringement  procedure  on  the  basis  of  Article  258 
TFEU. 

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15. 

16. 

Information supplied under this Article shall not be confidential except at the express 
request  of  the  notifying  Member State.  Any  such  request  shall  relate  to  draft 
measures and shall be justified. 

The  Commission  shall  publish  the  text  of  the  measures  adopted  by  the  Member 
States in the context of the Single market emergency that restrict free movement of 
goods, services and the persons, including workers, which have been communicated 
by means of the notifications referred to in this Article  as well as via other sources.  
The text of the measures shall be published within one working day of its receipt by 
means of an electronic platform managed by the Commission. 

Article 20 
Link to other notification mechanisms 

Where  a  Member  State  is  required  to  notify  a  measure  under  Article  19  of  this 
Regulation  and  under  Article  5(1)  of  Directive  (EU)  2015/153551,  a  notification 
made  under  this  Regulation  shall  be  deemed  to  have  satisfied  also  the  notification 
obligation set out in Article 5(1) of Directive (EU) 2015/1535. 

Where  a  Member  State  is  required  to  notify  a  measure  under  Article  19  of  this 
Regulation  and  under  Articles  15(7)  or  39(5)  of  Directive  2006/123/EC  of  the 
European Parliament and of the Council52, a notification made under this Regulation 
shall be deemed to have satisfied also the notification obligations set out in Directive 
2006/123/EC. Similarly the Commission Decisions referred to in Article 19(11) and 
19(12) of this Regulation are deemed to be a Decision taken under Article 15(7) of 
Directive 2006/123/EC for the purposes of that Directive. 

Where  a  Member  State  is  required  to  notify  a  measure  under  Article  19  of  this 
Regulation  and  to  inform  the  Commission  in  accordance  with  Article  59(5)  of 
Directive  2005/36/EC  of  the  European  Parliament  and  of  the  Council53,  that 
notification shall be deemed to have satisfied also the information obligation set out 
in Article 59(5) of Directive 2005/36/EC. 

Article 21 
Single points of contact in the Member States 

Member  States  shall  operate  national  single  points  of  contact  that  shall  provide 
citizens, consumers, economic operators and workers and their representatives with 
the following assistance: 

(a) 

(b) 

assistance in requesting and obtaining information about national restrictions of 
the free movement of goods, services, persons and workers that are related to 
an activated Single Market emergency; 

assistance  in  the  performance  of  any  national  level  crisis  procedures  and 
formalities  that  have  been  put  in  place  due  to  the  activated  Single  Market 
emergency. 

Member  States  shall  ensure  that  it  is  possible  for  citizens,  consumers,  economic 
operators and workers and their representatives to receive, at their request and via the 
respective single points of contact, information from the competent authorities on the 

OJ L 241, 17.9.2015, p. 1 
OJ L 376, 27.12.2006, p. 36. 
OJ L 255, 30.9.2005, p. 22. 

1. 

2. 

3. 

1. 

2. 

51 
52 
53 

EN 

45 

  EN 

                                                 
way  in  which  the  respective  national  crisis  response  measures  are  generally 
interpreted and applied. Where appropriate, such information shall include a step-by-
step  guide.  The  information  shall  be  provided  in  clear,  understandable  and 
intelligible  language.  It  shall  be  easily  accessible  at  a  distance  and  by  electronic 
means and shall be kept up to date. 

Article 22 
Union level single point of contact 

1. 

2. 

The Commission shall set up and operate a Union level single point of contact. 

The Union level single point of contact shall provide citizens, consumers, economic 
operators, workers and their representatives with the following assistance: 

(a) 

(b) 

assistance in requesting and obtaining information as regards Union level crisis 
response measures that are relevant to the activated Single Market emergency 
or which affect the exercise of the free movement of goods, services, persons 
and workers; 

assistance in the performance of any crisis procedures and formalities that have 
been  put  in  place  at  the  Union  level  due  to  the  activated  Single  Market 
emergency; 

(c) 

putting  together  a  list  with  all  national  crisis  measures  and  national  contact 
points. 

TITLE III 
SINGLE MARKET EMERGENCY RESPONSE MEASURES 

Chapter I 
Targeted information requests and availability of crisis-relevant 
goods and services 

Article 23 
Requirement of dual activation 

1. 

2. 

1. 

Binding  measures  included  in  this  Chapter  may  be  adopted  by  the  Commission  by 
means of implementing acts in accordance with Articles 24(2), first subparagraph of 
Article 26 and Article 27(2) may be adopted only after a Single Market Emergency 
has  been  activated  by  means  of  a  Council  implementing  act  in  accordance  with 
Article 14.  

An implementing act introducing a measure included in this Chapter shall clearly and 
specifically list the crisis-relevant goods and services to which such measure applies. 
That measure shall apply only for the duration of the emergency mode. 

Article 24 
Information requests to economic operators 

Where  there  is  a  severe  crisis-related  shortages  or  an  immediate  threat  thereof,  the 
Commission may invite  representative organisations or economic operators in crisis-
relevant  supply  chains  to  transmit  on  a  voluntary  basis,  within  a  set  time  limit, 
specific  information  to  the  Commission  on  the  production  capacities  and  possible 

EN 

46 

  EN 

2. 

existing stocks of crisis-relevant goods and components thereof in Union production 
facilities and third country facilities which it operates, contracts or purchases supply 
from, as well as information on any relevant supply chain disruptions within a given 
deadline. 

If  the  addressees  do  not  transmit  the  information  requested  in  accordance  with 
paragraph  1  within  the  time-limit  and  do  not  provide  a  valid  justification  for  not 
doing so, the Commission may, by means of an implementing act, require that they 
transmit the information, indicating in the implementing act why it is proportionate 
and  necessary  to  do  so,  specifying  the  crisis-relevant  goods  and  services  and 
addressees concerned by the information request, and the information that is sought, 
providing where necessary a template with the questions that may be addressed to the 
economic operators. 

3. 

The information requests referred to in paragraph 1 may concern the following: 

4. 

5. 

(a) 

targeted information to the Commission in relation to the production capacities 
and  possible  existing  stocks  of  the  crisis-relevant  goods  and  components 
thereof  in  production  facilities  located  in  the  Union  and  production  facilities 
located in a third country which the organisation or the operator referred to in 
paragraph  1    operates,  contracts  or  purchases  supply  from,  while  fully 
respecting  trade  and  business  secrets  and  requiring  them  to  transmit  to  the 
Commission a schedule of the expected production output for the following 3 
months  for  production  facility  located  in  the  Union  as  well  as  any  relevant 
supply chain disruptions; 

(b)  other  information  necessary  for  assessing  the  nature  or  magnitude  of  a  given 

supply chain disruption or shortage. 

Following  the  activation  of  the  mandatory  information  requests  to  economic 
operators by means of an implementing act, the Commission shall address a formal 
decision to each of those representative organisations or economic operators in crisis-
relevant supply chains that have been identified in the implementing act, requesting 
them to provide the information specified in the implementing act. The Commission 
shall rely, where possible, on the relevant and available contact lists of the economic 
operators  active  in  the  selected  supply  chains  of  crisis-relevant  goods  and  services, 
compiled  by  the  Member  States.  The  Commission  may  obtain  the  necessary 
information on the relevant economic operators from the Member States. 

The Commission Decisions containing individual information requests shall contain 
a  reference  to  the  implementing  act  referred  to  in  paragraph  2  on  which  they  are 
based and to the situations of severe crisis-related shortages or an immediate threat 
thereof which has given rise to them. Any information request shall be duly justified 
and proportionate in terms of the volume, nature and granularity of the data, as well 
as  the  frequency  of  access  to  the  data  requested,  and  shall  be  necessary  for  the 
management of the emergency or for compiling relevant official statistics. A request 
shall set out a reasonable time limit within which the information is to be provided. It 
shall take into account the effort required to collect and make the data available by 
the economic operator or representative organisation. The formal decision shall also 
contain  safeguards  for  protection  of  data  in  accordance  with  Article  39  of  this 
Regulation,  safeguards  for  non-disclosure  of  sensitive  business 
information 
contained  in  the  reply  in  accordance  with  Article  25,  and  information  on  the 
possibility of contesting it before the Court of Justice of the European Union in line 

EN 

47 

  EN 

6. 

7. 

8. 

1. 

2. 

3. 

4. 

5. 

with relevant Union law and the fines provided for in Article 28 for failure to comply 
and the timeline for a reply. 

The  owners  of  the  economic  operators  or  their  representatives  and,  in  the  case  of 
legal  persons,  companies  or  firms,  or  associations  having  no  legal  personality,  the 
persons authorised to represent them by law or by their constitution may supply the 
information  requested  on  behalf  of  the  economic  operator  or  the  association  of 
economic operators concerned. Each economic operator or association of economic 
operators shall provide the requested information on an individual basis in line with 
the  Union  rules  on  competition  governing  the  exchange  of  information.  Lawyers 
duly  authorised  to  act  may  supply  the  information  on  behalf  of  their  clients.  The 
latter  shall  remain  fully  responsible  if  the  information  supplied  is  incomplete, 
incorrect or misleading. 

The  Court  of  Justice  of  the  European  Union  shall  have  unlimited  jurisdiction  to 
review  decisions  whereby  the  Commission  has  imposed  a  mandatory  information 
request to an economic operator. 

The implementing acts referred to in paragraph 2 shall be adopted in accordance with 
the  committee  procedure  referred  to  in  Article  42(2).  On  duly  justified  imperative 
grounds  of  urgency  relating  to  the  impacts  of  the  crisis  on  the  Single  Market,  the 
Commission  shall  adopt  immediately  applicable  implementing  acts  in  accordance 
with the procedure referred to in Article 42(3). 

Article 25 
Confidentiality and processing of the information 

Information  received  as  a  result  of  the  application  of  this  Regulation  shall  be  used 
only for the purpose for which it was requested. 

Member States and the Commission shall ensure the protection of trade and business 
secrets  and  other  sensitive  and  confidential  information  acquired  and  generated  in 
application of this Regulation, including recommendations and measures to be taken, 
in accordance with Union and the respective national law. 

Member States and the Commission shall ensure that classified information provided 
or  exchanged  under  this  Regulation  is  not  downgraded  or  declassified  without  the 
prior written consent of the originator. 

The Commission may present to the advisory group referred to in Article 4 aggregate 
information based on any information collected pursuant to Article 24. 

The  Commission  shall  not  share  any  information  in  a  way  that  can  lead  to  the 
identification of an individual operator when the sharing of the information results in 
potential  commercial  or  reputational  damage  to  this  operator  or  in  divulging  any 
trade secrets. 

Article 26 
Targeted amendments to harmonised product legislation 

When  the  Single  Market  emergency  mode  has  been  activated  by  means  of  a  Council 
implementing  act  adopted  pursuant  to  Article  14,  and  there  is  a  shortage  of  crisis  relevant 
goods  the  Commission  may  activate  by  means  of  implementing  acts  the  emergency 
procedures included in the Union legal frameworks amended by [Regulation of the European 
Parliament  and  of  the  Council  amending  Regulation  (EU)  2016/424,  Regulation  (EU) 

EN 

48 

  EN 

2016/425,  Regulation  (EU)  2016/426,  Regulation  (EU)  2019/1009  and  Regulation  (EU)  No 
305/2011 and introducing emergency procedures for the conformity assessment, adoption of 
common specifications and market surveillance in the context of 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, 
2014/53/EU,  
2014/31/EU, 
and2014/68/EU  and  introducingas  regard  emergency  procedures  for  the  conformity 
assessment, adoption of common specifications and market surveillance in the context ofdue 
to  a  Single  Market]  as  regards  crisis-relevant  goods,  indicating  which  crisis-relevant  goods 
and emergency procedures are subject to the activation, providing reasons for such activation 
and its proportionality, and indicating the duration of such activation . 

2014/34/EU, 

2014/33/EU, 

2014/35/EU, 

2014/32/EU, 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred  to  in  Article  42(2).  On  duly  justified  imperative  grounds  of  urgency  relating  to  the 
impacts  of  the  crisis  on  the  Single  Market,  the  Commission  shall  adopt  immediately 
applicable implementing acts in accordance with the procedure referred to in Article 42(3). 

1. 

2. 

3. 

4. 

Article 27 
Priority rated orders 

The  Commission  may  invite  one  or  more  economic  operators  in  crisis-relevant 
supply chains established in the Union to accept and prioritise certain orders for the 
production or supply of crisis-relevant goods (‘priority rated order’). 

If  an  economic  operator  does  not  accept  and  prioritise  priority  rated  orders,  the 
Commission may, at its own initiative or at the request of 14 Member States, assess 
the  necessity  and  proportionality  of  resorting  to  priority  rated  orders  in  such  cases, 
the Commission shall give  the economic operator concerned as well as any parties 
demonstrably  affected  by  the  potential  priority  rated  order,  the  opportunity  to  state 
their  position  within  a  reasonable  time  limit  set  by  the  Commission  in  light  of  the 
circumstances  of  the  case.  In  exceptional  circumstances,  following  such  an 
assessment,  the  Commission  may  address  an  implementing  act  to  the  economic 
operator  concerned,  requiring  it  to  either  accept  and  prioritise  the  priority  rated 
orders  specified  in  the  implementing  act  or  explain  why  it  is  not  possible  or 
appropriate for that operator to do so. The Commission’s decision shall be based on 
objective  data  showing  that  such  prioritisation  is  indispensable  to  ensure  the 
maintenance of vital societal economic activities in the Single Market 

Where  the  economic  operator  to  which  the  decision  referred  to  in  paragraph  2  is 
addressed accepts the requirement to accept and prioritise the orders specified in the 
decision,  that  obligation  shall  take  precedence  over  any  performance  obligation 
under private or public law. 

Where  the  economic  operator  to  which  the  decision  referred  to  in  paragraph  2  is 
addressed  declines  to  accept  the  requirement  to  accept  and  prioritise  the  orders 
specified in the decision, it shall provide to the Commission, within 10 days from the 
notification of the decision, a reasoned explanation setting out duly justified reasons 
why it is not possible or appropriate, in light of the objectives of this provision, for it 
to comply with the requirement. Such reasons include the inability of the operator to 
perform  the  priority  rated  order  on  account  of  insufficient  production  capacity  or  a 
serious  risk  that  accepting  the  order  would  entail  particular  hardship  or  economic 
burden for the operator, or other considerations of comparable gravity.  

EN 

49 

  EN 

5. 

6. 

7. 

8. 

The Commission may make such reasoned explanation or parts of it public, with due 
regard to business confidentiality. 

When  an  economic  operator  established  in  the  Union  is  subject  to  a  measure  of  a  
third  country  which  entails  a  priority  rated  order,  it  shall  inform  the  Commission 
thereof. 

The Commission shall take the decision referred to in paragraph 2 in accordance with 
applicable Union law, including the principles of necessity and proportionality,  and 
the Union’s obligations under international law. The decision shall in particular take 
into  account  the  legitimate  interests  of  the  economic  operator  concerned  and  any 
available  information  concerning  the  cost  and  effort  required  for  any  change  in 
production sequence. It shall state the legal basis for its adoption, fix the time limits 
within  which  the  priority  rated  order  is  to  be  performed  and,  where  applicable, 
specify the product and quantity. It shall state the fines provided for in Article 28 for 
failure to comply with the decision.  The priority rated order shall be placed at a fair 
and reasonable price. 

Where an economic operator accepts and prioritises a priority rated order, it shall not 
be liable for any breach of contractual obligations governed by the law of a Member 
State  that  is  required  to  comply  with  the  priority  rated  order.  Liability  shall  be 
excluded only to  the  extent  the violation of contractual obligations is  necessary  for 
compliance with the required prioritisation. 

The implementing acts referred to in paragraph 2 shall be adopted in accordance with 
the examination procedure referred to in Article 42(2). On duly justified imperative 
grounds  of  urgency  relating  to  the  impacts  of  the  crisis  on  the  Single  Market,  the 
Commission  shall  adopt  immediately  applicable  implementing  acts  in  accordance 
with the procedure referred to in Article 42(3). 

Article 28 
Fines to operators for failure to comply with the obligation to reply to mandatory information 
requests or to comply with priority rated orders 

1. 

The  Commission  may,  by  means  of  a  decision,  where  deemed  necessary  and 
proportionate, impose fines: 

(a)  where  a  representative  organisation  of  economic  operators  or  an  economic 
operator,  intentionally  or  through  gross  negligence,  supplies  incorrect, 
incomplete or misleading information in  response to  a request  made pursuant 
to  Article  24,  or  does  not  supply  the  information  within  the  prescribed  time 
limit; 

(b)  where  an  economic  operator,  intentionally  or  through  gross  negligence,  does 
not  comply  with  the  obligation  to  inform  the  Commission  of  a  third  country 
obligation pursuant to Article 27 or fails to explain why it has not accepted a 
priority rated order; 

(c)  where  an  economic  operator,  intentionally  or  through  gross  negligence,  does 
not comply with an obligation which it has accepted to prioritise certain orders 
of crisis-relevant goods (‘priority rated order’) pursuant to Article 27 

2. 

Fines imposed in the cases referred to in paragraph 1 (a) and (b) shall not exceed 200 
000 EUR. 

EN 

50 

  EN 

3. 

4. 

5. 

Fines imposed in the cases referred to in paragraph 1 (c) shall not exceed 1 % of the 
average daily turnover in the preceding business year for each working day of non-
compliance  with  the  obligation  pursuant  to  Article  27  (priority  rated  orders) 
calculated  from  the  date  established  in  the  decision  not  exceeding  1%  of  total 
turnover in the preceding business year. 

In  fixing  the  amount  of  the  fine,  regard  shall  be  had  to  the  size  and  economic 
resources of the economic operator concerned, to the nature, gravity and duration of 
the  infringement,  taking  due  account  of  the  principles  of  proportionality  and 
appropriateness. 

The  Court  of  Justice  of  the  European  Union  shall  have  unlimited  jurisdiction  to 
review decisions whereby the Commission has fixed a fine. It may cancel, reduce or 
increase the fine imposed. 

Article 29 
Limitation period for the imposition of fines  

1. 

The  Commission  power  to  impose  fines  in  accordance  with  Article  30  shall  be 
subject to the following limitation periods: 

(a) 

(b) 

two  years  in  the  case  of  infringements  of  provisions  concerning  requests  of 
information pursuant to Article 24; 

three years in the case infringements of provisions concerning the obligation to 
prioritise the production of crisis-relevant goods pursuant to Article 26(2). 

The time shall begin to run on the day on which the Commission becomes aware of 
the  infringement.  However,  in  case  of  continuous  or  repeated  infringements,  time 
shall begin to run on the day on which the infringement ceases 

Any  action  taken  by  the  Commission  or  the  competent  authorities  of  the  Member 
States for the purposes of ensuring compliance with the provisions of this Regulation 
shall interrupt the limitation period. 

The interruption of the limitation period shall apply for all the parties which are held 
responsible for the participation in the infringement. 

Each interruption shall start the time running afresh. However, the limitation period 
shall  expire  at  the  latest  on  the  day  in  which  a  period  equal  to  twice  the  limitation 
period has elapsed without the Commission having imposed a fine. That period shall 
be extended by the time during which the limitation period is suspended because the 
decision of the Commission is the subject of proceedings pending before the Court of 
Justice of the European Union. 

Article 30 

Limitation periods for enforcement of fines 

The power of the Commission to enforce decisions taken pursuant to Article 28 shall 
be subject to a limitation period of five years.  

Time shall begin to run on the day on which the decision becomes final.  

The limitation period for the enforcement of fines shall be interrupted:  

2. 

3. 

4. 

5. 

1. 

2. 

3. 

EN 

51 

  EN 

(4) 

(5) 

1. 

2. 

3. 

4. 

(a) 

by notification of a decision varying the original amount of the fine or refusing 
an application for variation;  

(b)  by any action of the Commission or of a Member State, acting at the request of 

the Commission, designed to enforce payment of the fine.  

Each interruption shall start time running afresh.  

The limitation period for the enforcement of fines shall be suspended for so long as:  

(a) 

(b) 

time to pay is allowed;  

enforcement  of  payment  is  suspended  pursuant  to  a  decision  of  the  Court  of 
Justice of the European Union. 

Article 31 
Right to be heard for the imposition of fines  

Before  adopting  a  decision  pursuant  to  Article  28,  the  Commission  shall  give  the 
economic operator or representative organisations of economic operators concerned 
the opportunity of being heard on: 

(a) 

preliminary  findings  of  the  Commission,  including  any  matter  to  which  the 
Commission has taken objections; 

(b)  measures  that  the  Commission  may  intend  to  take  in  view  of  the  preliminary 

findings pursuant to point (a) of this paragraph. 

Undertakings and representative organisations of economic operators concerned may 
submit  their  observations  to  the  Commission’s  preliminary  findings  within  a  time 
limit which shall be fixed by the Commission in its preliminary findings and which 
may not be less than 21 days. 

The  Commission  shall  base  its  decisions  only  on  objections  on  which  economic 
operators  and  representative  organisations  of  economic  operators  concerned  have 
been able to comment. 

The  rights  of  defence  of  the  economic  operator  or  representative  organisations  of 
economic  operators  concerned  shall  be  fully  respected  in  any  proceedings.  The 
economic operator or representative organisations of economic operators concerned 
shall  be  entitled  to  have  access  to  the  Commission's  file  under  the  terms  of  a 
negotiated disclosure, subject to the legitimate interest of economic operators in the 
protection of their business secrets. The right of access to the file shall not extend to 
confidential information and internal documents of the Commission or the authorities 
of  the  Member  States.  In  particular,  the  right  of  access  shall  not  extend  to 
correspondence between the Commission and the authorities of the Member States. 
Nothing  in  this  paragraph  shall  prevent  the  Commission  from  disclosing  and  using 
information necessary to prove an infringement. 

Chapter II 

Other measures for ensuring availability of crisis-relevant 
goods and services 

EN 

52 

  EN 

 
 
Article 32 

Coordinated distribution of strategic reserves  

Where the strategic reserves constituted by the Member States in accordance with Article 12 
prove  to  be  insufficient  to  meet  the  needs  related  to  the  Single  Market  emergency,  the 
Commission,  taking  into  consideration  the  opinion  provided  by  the  advisory  group,  may 
recommend to the Member States to distribute the strategic reserves in a targeted way, where 
possible, having regard to the need not to further aggravate disruptions on the Single Market, 
including  in  geographical  areas  particularly  affected  by  such  disruptions  and  in  accordance 
with  the  principles  of  necessity,  proportionality  and  solidarity  and  establishing  the  most 
efficient use of reserves with a view to ending the  Single Market emergency. 

Article 33 

 Measures to ensure the availability and supply of crisis-relevant goods and services 

1. 

The Commission may, when it considers that there is  a risk of a shortage of crisis-
relevant  goods,  recommend  that  Member  States  implement  specific  measures  to 
ensure the efficient re-organisation of supply chains and production lines and to use 
existing  stocks  to  increase  the  availability  and  supply  of  crisis-relevant  goods  and 
services, as quickly as possible. 

2. 

In particular, the measures referred to in paragraph 1 may include measures:  

(a) 

(b) 

facilitating  the  expansion  or  repurposing  of  existing  or  the  establishment  of 
new production capacities for crisis-relevant goods; 

facilitating  the  expansion  of  existing  or  the  establishment  of  new  capacities 
related to service activities;  

(c) 

aiming at accelerating permitting of crisis-relevant goods. 

EN 

53 

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Part V 
Procurement 

CHAPTER I 
PROCUREMENT OF GOODS AND SERVICES OF STRATEGIC IMPORTANCE AND 
CRISIS-RELEVANT GOODS BY THE COMMISSION ON BEHALF OF MEMBER 
STATES DURING VIGILANCE AND EMERGENCY MODES 

Article 34 
Request of Member States to the Commission to procure goods and services on their behalf 

1. 

2. 

3. 

1. 

2. 

3. 

4. 

Two or more Member States may request that the Commission launch a procurement 
on  behalf  of  the  Member  States  that  wish  to  be  represented  by  the  Commission 
(ʽparticipating Member Statesʼ), for the purchasing of goods and services of strategic 
importance listed in an implementing act adopted pursuant to Article 9(1) or crisis-
relevant goods and services listed in an implementing act adopted pursuant to Article 
14(5). 

The Commission shall assess the utility, necessity and proportionality of the request. 
Where the Commission intends not to follow the request, it shall inform the Member 
States concerned and the advisory group referred to in Article 4 and give reasons for 
its refusal. 

Where  the  Commission  agrees  to  procure  on  behalf  of  the  Member  States,  it  shall 
draw up a proposal for a framework agreement to be concluded with the participating 
Member States allowing the Commission to procure on their behalf. This agreement 
shall  lay  down  the  detailed  conditions  for  the  procurement  on  behalf  of  the 
participating Member States referred to in paragraph 1. 

Article 35 
Establishment and implementation of the negotiating mandate of the Commission 

The agreement [referred to in Article 34(3) shall establish a negotiating mandate for 
the Commission to act as a central purchasing body for  relevant goods and services 
of  strategic  importance  or  crisis-relevant  goods  and  services  on  behalf  of  the 
participating Member States through the conclusion of new contracts. 

In accordance with the agreement, the Commission may be entitled, on behalf of the 
participating  Member  States,  to  enter  into  contracts  with  economic  operators, 
including  individual  producers  of  goods  and  services  of  strategic  importance  or 
crisis-relevant  goods  and  services,  concerning  the  purchase  of  such  goods  or 
services. 

Representatives  of  the  Commission  or  experts  nominated  by  the  Commission  may 
carry  out  on-site  visits  at  the  locations  of  production  facilities  of  relevant  goods  of 
strategic importance or crisis-relevant goods. 

The  Commission  shall  carry  out  the  procurement  procedures  and  conclude  the 
resulting  contracts  with  economic  operators  on  behalf  of  the  participating  Member 
States. 

EN 

54 

  EN 

Article 36 
Modalities of procurement by the Commission on behalf of the Member States 

1. 

2. 

Procurement  under  this  Regulation  shall  be  carried  out  by  the  Commission  in 
accordance  with  the  rules  set  out  in  Regulation  (EU,  Euratom)  2018/1046  of  the 
European Parliament and of the Council54 for its own procurement. 

The  contracts  may  include  a  clause  stating  that  a  Member  State  which  has  not 
participated in the procurement procedure may become a party to the contract after it 
has been signed, laying out in detail the procedure for doing so and its effects. 

CHAPTER II 
JOINT PROCUREMENT DURING VIGILANCE AND EMERGENCY MODES 

Article 37 
Joint procurement procedure 

Where it is  necessary to carry  out  a joint  procurement between the Commission  and one or 
more  contracting  authorities  from  Member  States  in  accordance  with  the  rules  set  out  in 
Article 165(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the 
Council, the Member States may acquire, rent or lease fully the capacities jointly procured. 

CHAPTER III 
PROCUREMENT BY THE MEMBER STATES DURING THE EMERGENCY MODE 

Article 38 
Consultation and coordination regarding individual procurement by the Member States 

When the Single Market emergency mode has been activated pursuant to Article 14, Member 
States  shall  consult  each  other  and  the  Commission  and  coordinate  their  actions  with  the 
Commission and the representatives of the other Member States in the advisory group prior to 
launching  procurement  of  crisis-relevant  goods  and  services  listed  in  an  implementing  act 
adopted pursuant to Article 14(5) in accordance with Directive 2014/24/EU of the European 
Parliament and of the Council55. 

Article 39 
Ban of individual procurement action by participating Member States 

Where  the  Single  Market  emergency  mode  has  been  activated  pursuant  to  Article  16  and 
procurement by the Commission on behalf of Member States has been launched in accordance 
with Articles 34 to 36, the contracting authorities of the participating Member States shall not 
procure goods or services covered by such procurement by other means. 

54 

55 

Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on 
the  financial  rules  applicable  to  the  general  budget  of  the  Union,  amending  Regulations  (EU)  No 
1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No  1309/2013, (EU) 
No  1316/2013,  (EU)  No  223/2014,  (EU)  No  283/2014,  and  Decision  No  541/2014/EU  and  repealing 
Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). 
Directive  2014/24/EU  of  the  European  Parliament  and  of  the  Council  of  26 February  2014  on  public 
procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65).. 

EN 

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Part VI 
Final provisions 

Article 40 
Personal data protection 

1. 

2. 

3. 

This  Regulation  shall  be  without  prejudice  to  the  obligations  of  Member  States 
relating to their processing of personal data under Regulation (EU) No 2016/679 and 
Directive 2002/58/EC on privacy and electronic communications, or the obligations 
of  the  Commission  and,  where  appropriate,  other  Union  institutions  and  bodies, 
relating  to  their  processing  of  personal  data  under  Regulation  (EU)  No  2018/1725, 
when fulfilling their responsibilities. 

Personal data shall not be processed or communicated except in cases where this is 
strictly necessary to the purposes of this Regulation. In such cases, the conditions of 
Regulation  (EU)  No  2016/679  and  Regulation  (EU)  No  2018/1725  shall  apply  as 
appropriate. 

Where  processing  of  personal  data  is  not  strictly  necessary  to  the  fulfilment  of  the 
mechanisms  established  in  this  Regulation,  personal  data  shall  be  rendered 
anonymous in such a manner that the data subject is not identifiable. 

Article 41  

Digital tools 

The  Commission  and  the  Member  States  may  set  up  interoperable  digital  tools  or  IT 
infrastructures supporting the objectives of this Regulation. Such tools or infrastructures may 
be developed outside the duration of the Single Market Emergency.  

The Commission shall, by means of implementing acts, set out the technical aspects of such 
tools  or  infrastructures.  Those  implementing  acts  shall  be  adopted  in  accordance  with  the 
examination procedure referred to in Article 42(2). 

Article 42 
Committee 

1. 

2. 

3. 

1. 

The  Commission  shall  be  assisted  by  a  Single  Market  Emergency  Instrument 
Committee. That committee shall be a committee within the meaning of Regulation 
(EU) No 182/2011. 

Where  reference  is  made  to  this  paragraph,  Article  5  of  Regulation  (EU) 
No 182/2011 shall apply. 

Where  reference  is  made  to  this  paragraph,  Article  8  of  Regulation  (EU) 
No 182/2011, in conjunction with Article 5 thereof, shall apply. 

Article 43 
Delegated acts 

The  power  to  adopt  delegated  acts  is  conferred  on  the  Commission  subject  to  the 
conditions laid down in this Article. 

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2. 

3. 

4. 

5. 

1. 

2. 

The power to adopt delegated acts referred to in Article 6 shall be conferred on the 
Commission for a period of five years from date of entry into force of this Directive 
or any other date set by the co-legislators. 

The delegation of power referred to in Article 6 may be revoked at any time by the 
European Parliament or by the Council. A decision to revoke shall put an end to the 
delegation  of  the  power  specified  in  that  decision.  It  shall  take  effect  the  day 
following  the  publication  of  the  decision  in  the  Official  Journal  of  the  European 
Union  or  at  a  later  date  specified  therein.  It  shall  not  affect  the  validity  of  any 
delegated acts already in force. 

Before adopting a delegated act, the Commission shall consult experts designated by 
each  Member  State 
the 
in  accordance  with 
Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 

the  principles 

laid  down 

in 

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council. 

Article 4 
Report and review 

By [OP: please insert date = five years from the entry into force of this Regulation] 
and  every  five  years  thereafter,  the  Commission  shall  present  a  report  to  the 
European  Parliament  and  the  Council  on  the  functioning  of  the    contingency 
planning,  vigilance  and  Single  Market  emergency  response  system  suggesting  any 
improvements if necessary, accompanied, where appropriate, by relevant legislative 
proposals. 

This report shall include an evaluation of the work of the advisory  group under the 
emergency framework established by this Regulation, and its relation to the work of 
other relevant Union level crisis management bodies. 

Council Regulation (EC) 2679/98 is repealed with effect from [date]. 

Article 45 
Repeal 

Article 46 
Entry into force 

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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LEGISLATIVE FINANCIAL STATEMENT 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE 

1.1. 

Title of the proposal/initiative 

Regulation  of  the  European  Parliament  and  of  the  Council  for  a  Single  Market 
Emergency Instrument 

1.2. 

Policy area(s) concerned 

Internal Market; free movement of goods, services and persons 

1.3. 

The proposal/initiative relates to: 

X a new action 
 a new action following a pilot project/preparatory action56 

 the extension of an existing action 

 a merger or redirection of one or more actions towards another/a new action 

1.4. 

Objective(s) 

1.4.1.  General objective(s) 

The general objective of Single Market Emergency Instrument (SMEI) is to enhance 
the Single Market’s vigilance for, response to and 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, complementing other existing EU mechanisms, 
including  through  better  coordination,  transparency  and  speed.  The  objective  is  to 
strengthen  the  functioning  of  the  Single  Market  and  provide  quick  and  practical 
solutions to issues of free movement of goods, services and persons and of supply in 
times of crisis. 

1.4.2. 

Specific objective(s) 

Specific objective No 1 

Minimise  obstacles  to  free  movement  of  goods,  services  and  persons  in  times  of 
crisis 

The specific objective 1 is to minimise obstacles to free movement of goods, services 
and persons in times of crisis by providing a toolbox of solutions to ensure a well-
coordinated  EU-level  vigilance  and  response  to  crises  affecting  the  Single  Market. 
To this end, it is expected to provide a toolbox of solutions consisting of vigilance, 
coordination and transparency measures assuring more aligned and targeted Member 
State responses and providing needed transparency when it comes to obstacles to free 
movement. 

Specific objective No 2 

Address shortages and safeguard availability of crisis-relevant goods and services 

56 

As referred to in Article 58(2)(a) or (b) of the Financial Regulation. 

EN 

58 

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This specific objective aims at facilitating quick and practical solutions to issues of 
supply  in  times  of  crisis.  To  this  end,  it  is  expected  to  provide  adequate  vigilance, 
coordination and transparency mechanisms for a targeted policy response and for all 
Single Market players by enabling information exchange and close cooperation with 
industry/stakeholders  for  identifying  crisis-relevant  supply  chain  bottlenecks  and 
capacity needs and taking further action when necessary to ensure the availability of 
crisis-relevant goods and services in an emergency. 

1.4.3.  Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

The  inititave  will  ensure  access  to  the  Single  Market  during  times  of  crisis  for 
citizens  and  businesses  and  will  provide  support  for  the  identified  supply  chains 
ensuring  the  functioning  of  the  Single  Market  and  better  overall  EU-level  crisis 
response  thanks  to  the  availability  of  crisis-relevant  products  needed  in  the  crisis 
response, and will also generate indirect social benefits in terms of improving living 
conditions and quality of life of citizens and saving lives, depending on the type of 
crisis. 

The  initiative  is  expected  to  contribute  to  the  achievement  of  the  United  Nations 
Sustainable Development Goals (SDGs), in particular SDG #1 No poverty, SDG #8 
Decent work and economic growth, SDG #9 Industry, innovation and infrastructure, 
SDG #10 Reduced inequalities and SDG #16 Peace, justice and strong institutions. 

Businesses  will  be  positively  affected,  in  particularly  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  in  the  toolbox  that  would  have  a 
direct  positive effect  on businesses include key principles to  ensure free movement 
transparency  and  administrative  assistance  during 
and  supporting  measures, 
emergency,  public  procurement  during  emergency  and  measures  to  place  products 
faster  on  the  market  during  emergency,  and  speeding  up  permitting  during 
emergency. Businesses however could also face costs and their operations could be 
impacted,  notably  due  to  measures  to  support  supply  chains  during  emergency,  in 
particular information requests to companies, obligations to ramp up production and 
to accept priority-rated orders. 

Citizens would benefit from the overall better EU-level crisis response thanks to the 
presence  of  the  coordination  mechanisms  as  well  as  the  toolbox  to  ensure  less 
obstacles  to  free  movement  and  better  availability  of  crisis-relevant  products.  They 
would  further  directly  benefit  from  key  principles  to  ensure  free  movement,  in 
particular as it concerns free movement of persons, in their capacity as workers and 
consumers.  They  could  also  directly  benefit  from  distribution  of  previously 
stockpiled crisis-relevant products of strategic importance. There are no direct costs 
to citizens. 

Member  States  would  benefit  from  overall  better  EU-level  crisis  response  and 
directly  benefit  from  the  existence  of  a  dedicated  governance  body  ensuring 
coordination  during  a  crisis  with  impact  on  the  Single  Market.  There  would  be 
administrative  and  compliance  costs  for  Member  States  for  a  range  of  measures 
foreseen  under 
including  for  contingency  planning,  gathering 
information  on  supply  chains,  participation  in  match-making  and  constitution  of 
strategic  reserves  under  vigilance  mode,  as  well  as  in  emergency  mode  for 
compliance  with  key  principles  for  free  movement,  measures  on  transparency  and 

toolbox, 

the 

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administrative  assistance,  compliance  with  measures  on  placing  crisis-relevant 
products  on  the  market,  participation  in  public  procurement  during  emergency  and 
measures impacting crisis-relevant supply chains during emergency. 

For  the  Commission,  we  consider  that  the  activity  of  developing  new  guidance, 
recommendations  and  coordinating  obligatory  measures  forms  part  of  the  normal 
activities.  The  Commission  would  nevertheless  incur  additional  specific  costs,  in 
particular  for  the  organisation  of  the  SMEI  Advisory  Group  meetings,  organising 
trainings  and  emergency  symulation  for  national  experts,  organising  match-making 
between companies, analysis  of notifications under transparency  and administrative 
assistance. 

1.4.4. 

Indicators of performance 

Specify the indicators for monitoring progress and achievements. 

The  Commission  will  carry  out  an  evaluation  of  the  effectiveness,  efficiency, 
coherence, proportionality and subsidiarity 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 in that 
evaluation  report  how  to  improve  the  Single  Market  Emergency  Instrument.  This 
review  mechanism  is  similar  to  the  review  mechanisms  included  with  the 
Commission  proposal  for  a  Council  Regulation  on  a  framework  of  measures  for 
ensuring  the  supply  of  crisis-relevant  medical  countermeasures  in  the  event  of  a 
public health emergency at Union level  as well as with the Commission proposal for 
a  Regulation  of  the  European  Parliament  and  of  the  Council  establishing  a 
framework of measures for strengthening Europe's semiconductor ecosystem (Chips 
Act) . 

Member  States  and  representative  organisations  of  economic  operators  will  be 
obliged  to  provide  the  Commission  with  the  information  necessary  for  the 
preparation of that report. 

The  Commission  and  Member  States  will  regularly  monitor  the  application  of  the 
legal  acts,  in  particular  the  effectiveness  of  the  measures  facilitating  the  free 
movement  of  goods,  persons  and  services  during  the  crisis  on  the  persons  and 
businesses  concerned  as  well  as  the  functioning  of  the  Single  Market,  and  the 
impacts of the information requests and monitoring, building and distribution of the 
strategic  reserves  and  other  measures  increasing  the  availability  of  products  and 
services on the Single Market to economic operators and their representatives. 

1.5. 

Grounds for the proposal/initiative 

1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for 

roll-out of the implementation of the initiative 

N/A as the application of the instrument depends on the emergence of a crisis which 
by its nature cannot be foreseen. 

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60 

  EN 

1.5.2.  Added  value  of  Union  involvement  (it  may  result  from  different  factors,  e.g. 
coordination gains, legal certainty, greater effectiveness or complementarities). For 
the purposes of this point 'added value of Union involvement' is the value resulting 
from  Union  intervention  which  is  additional  to  the  value  that  would  have  been 
otherwise created by Member States alone. 

Reasons  for  action  at  European  level  (ex-ante):  the  economic  activities  across  the 
Single  Market  are  deeply  integrated.  Interaction  between  companies,  service 
providers,  clients,  consumers  and  workers  located  in  different  Member  States  that 
rely  on  their  free  movement  rights,  is  increasingly  common.  The  experience  of  the 
past  crisis  has  shown  that  often  the  distribution  of  production  capacities  across  the 
EU is uneven (e.g. with the production lines of certain products primarily located in a 
few Member States such as PPE). In parallel, in the case of a crisis, the demand for 
crisis-relevant  goods  or  services  across  the  EU  territory  may  also  be  uneven.  The 
objective of  ensuring the smooth  and undisrupted functioning of the Single Market 
cannot  be  achieved  by  means  of  unilateral  national  measures.  Moreover,  even  if 
measures  adopted  by  the  Member  States  individually  may  be  able  to  address  to  a 
certain extent the deficiencies resulting from a crisis at the national level, they are in 
fact more likely to further exacerbate the said crisis across the EU by adding further 
obstacles to the free movement and/or additional strain on products already impacted 
by shortages. 

Expected  generated  Union  added  value  (ex-post):  the  introduction  of  rules  which 
govern the functioning of the Single Market is a competence shared between the EU 
and the Member States. A significant number of EU frameworks governing various 
aspects are already in place and they contribute to the smooth operation of the Single 
Market by laying down coherent sets of rules which apply across all the territories of 
the Member States. 

However, the existing EU frameworks generally lay down rules concerning the day-
to-day functioning of the Single Market, outside of any specific crisis scenarios. This 
being  said,  some  proposals  which  have  been  recently  adopted  by  the  Commission 
contain  certain  crisis-relevant  provisions.  However,  there  is  currently  no  horizontal 
set of rules and mechanisms which address aspects such as the contingency planning, 
the  crisis  monitoring  and  the  crisis  response  measures,  which  would  apply  in  a 
coherent manner across economic sectors and across the entire Single Market. 

The emergency instrument would only be deployed with the objective of ensuring a 
coordinated  approach  to  respond  to  crises  that  have  important  cross-border  effects 
and  threaten  the  functioning  of  the  Single  Market,  and  where  no  EU  instrument 
already  exists  or  where  the  existing  instruments  do  not  lay  down  crisis-relevant 
provisions.  Putting  in  place  contingency  and  vigilance  measures  across  the  Single 
Market can facilitate the coordination of the response measures in the case of a crisis. 
Furthermore,  such  measures  can  be  complemented  by  effective  and  efficient 
coordination  and  cooperation  amongst  the  Commission  and  Member  States  during 
the crisis in order to ensure that the most appropriate measures to address the crisis 
are taken. 

The Single Market Emergency Instrument is not intended to lay down a detailed set 
of EU level provisions which should be exclusively relied upon in the case of crisis. 
Instead, the instrument is intended to lay down and ensure the coherent application of 
possible  combinations  between  provisions  taken  at  EU  level  together  with  rules  on 
the  coordination  of  the  measures  taken  at  the  level  of  the  Member  States.  In  this 

EN 

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respect, the emergency measures which may be taken at EU level on the basis of the 
Single  Market  Emergency  Instrument  would  be  coordinated  with  and  complement 
the emergency response measures adopted by the Member States. In order to allow 
for  such  coordination  and  complementarity, 
the  Single  Market  Emergency 
Instrument would set out specific measures which the Member States should refrain 
from imposing once a Single Market emergency has been activated at EU level. 

In  this  context,  the  EU  added  value  of  this  instrument  would  be  to  lay  down  the 
mechanisms  for  a  swift  and  structured  way  of  communication  between  the 
Commission  and  Member  States,  coordination  and  information  exchange  when  the 
Single  Market  is  put  under  strain,  and  to  be  able  to  take  necessary  measures  in  a 
transparent way – speeding up existing mechanisms as well as adding new targeted 
tools for emergency situations. It would also ensure transparency across the internal 
market, ensuring that businesses and citizens that rely on their free movement rights 
have at  their disposal  appropriate information  about  the applicable measures across 
all  the  Member  States.  This  will  increase  legal  certainty  allowing  them  to  take 
informed decisions. 

A  further  advantage  of  action  in  this  domain  would  be  to  equip  the  EU  with  the 
resilience  tools  needed  to  sustain  the  competitiveness  of  the  EU  industry  in  a 
geopolitical context in which our international competitors can already rely on legal 
instruments allowing for a structured monitoring of supply chain disruptions and for 
the adoption of possible response measures such as strategic reserves. 

1.5.3.  Lessons learned from similar experiences in the past 

In recent years, the world has been witnessing a sequence of crises from the COVID-
19 pandemic to  Russia’s invasion of  Ukraine. These will not  be the last crises that 
the world will have to weather. In addition to geopolitical instability, climate change 
and resulting natural disasters, biodiversity loss, and global economic instability may 
lead  to  other,  new  emergency  situations.  Unfortunately,  there  is  no  crystal  ball  at 
hand to predict the exact time and form of the next crisis. 

As  recent  crises  have  shown,  a  fully-operational  Single  Market  and  smooth 
cooperation of Member States on Single Market  issues can considerably  strengthen 
the  EU’s  resilience  and  crisis  response.  Therefore,  the  Single  Market  Emergency 
Instrument,  for  which  this  Impact  Assessment  analyses  different  policy  options, 
should provide a blueprint for an EU reaction on Single Market matters in a future 
crisis.  It  should  take  into  account  the  lessons  learned  from  past  emergencies  and 
extrapolate them to possible future emergencies. 

the 

lessons  from 

The European Council in its Conclusions of 1-2 October 2020 stated that the EU will 
draw 
the  COVID-19  pandemic  and  address  remaining 
fragmentation,  barriers  and  weaknesses  of  the  Single  Market  in  facing  emergency 
situations. In the Update of the Industrial Strategy Communication, the Commission 
announced  an  instrument  to  ensure  the  free  movement  of  persons,  goods  and 
services,  as  well  as  greater  transparency  and  coordination  in  times  of  crisis.  The 
initiative  forms  part  of  the  Commission  Work  Programme  for  2022.  The  European 
Parliament welcomed the Commission’s plan to present a Single Market Emergency 
Instrument and called on the Commission to develop it as a legally binding structural 
tool  to  ensure  the  free  movement  of  persons,  goods  and  services  in  case  of  future 
crises. 

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1.5.4.  Compatibility  with  the  Multiannual  Financial  Framework  and  possible  synergies 

with other appropriate instruments 

The proposal is a political priority of the European Commission and delivers on the 
commitment  to  ensure  the  smooth  functioning  of  the  Single  Market.  The  initiative 
presents  synergies  with  various  instruments,  for  instance  with  horizontal  crisis 
response mechanisms (integrated political crisis  response mechanism  -  IPCR); with 
measures targeting specific aspects of crisis management (Council Regulation (EC) 
No 2679/98 of 7 December 1998 on the functioning of the internal market in relation 
to the free movement of goods among the Member States, Regulation (EU) 2015/479 
of the European Parliament and of the Council of 11 March 2015 on common rules 
for exports); with sector-specific crisis measures (the European Food Security Crisis 
preparedness  and  response  Mechanism  –  EFSCM;  Regulation  (EU)  2021/953 
establishing  the  EU  Digital  COVID  Certificate;  Regulation  (EU)  123/2022 
reinforcing  the  role  for  the  European  Medicines  Agency  in  crisis  preparedness  and 
management  for  medicinal  products  and  medical  devices;  Commission  Decision  of 
16  September  2021  establishing  the  Health  Emergency  Preparedness  and  Response 
Authority;  Regulation  (EU)  No  1308/2013  establishing  a  common  organisation  of 
the  markets  in  agricultural  products    (CMO  Regulation)  as  well  as  the  sister  CMO 
Regulation  for  fisheries;  Commission  communication  “Contingency  plan  for 
transport”). 

In  parallel,  a  number  of  initiatives,  which  have  been  recently  proposed  and  are 
currently  being  discussed,  concern  aspects  relevant  for  the  crisis  response  and 
preparedness. These initiatives however have a limited scope covering specific types 
of  crisis  scenarios  and  are  not  intended  to  set  up  a  general  horizontal  crisis-
management  framework.  To  the  extent  these  initiatives  include  a  sectoral  crisis 
response and preparedness framework, that framework will take precedence over the 
Single Market Emergency Instrument as lex specialis: 

- the Commission proposal for a Regulation on serious cross-border threats to health 

- the Commission proposal  amending Regulation (EC) No 851/2004 establishing a 
European Centre for disease prevention and control 

- the Commission proposal for a Council Regulation on a framework of measures for 
ensuring  the  supply  of  crisis-relevant  medical  countermeasures  in  the  event  of  a 
public health emergency at Union level 

- the Commission proposal for the European Chips Act 

- the Commission proposal for a Data Act 

- the Commission proposal to amend the Schengen Borders Code 

- the Commission proposal for a Directive on the resilience of critical entities 

1.5.5.  Assessment  of  the  different  available  financing  options,  including  scope  for 

redeployment 

For recurrent expenditures, which derive from staff costs within the Commission for 
the foreseen training activities and the necessary extension of the IT tool used for the 
notification system, the source of financing could be identified via redeployment of 
Union resources under the Single Market Programme. 

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1.6. 

Duration and financial impact of the proposal/initiative 

Comment:  considering  the  nature  of  the  initiative,  which  is  closely  linked  to  the 
occurrence of a crisis of unpredictable nature and scale, the duration of the initiative 
cannot be indicated. 

 limited duration 

–    in effect from [DD/MM]YYYY to [DD/MM]YYYY 

–    Financial  impact  from  YYYY  to  YYYY  for  commitment  appropriations  and 

from YYYY to YYYY for payment appropriations. 

 unlimited duration 

–  Implementation with a start-up period from YYYY to YYYY, 

–  followed by full-scale operation. 

1.7.  Management mode(s) planned57 

X Direct management by the Commission 

–  X by its departments, including by its staff in the Union delegations; 

–    by the executive agencies 

 Shared management with the Member States 

 Indirect management by entrusting budget implementation tasks to: 

–   third countries or the bodies they have designated; 

–   international organisations and their agencies (to be specified); 

–   the EIB and the European Investment Fund; 

–   bodies referred to in Articles 70 and 71 of the Financial Regulation; 

–   public law bodies; 

–   bodies governed by private law with a public service mission to the extent that 

they provide adequate financial guarantees; 

–   bodies governed by the private law of a Member State that are entrusted with 
the  implementation  of  a  public-private  partnership  and  that  provide  adequate 
financial guarantees; 

–    persons  entrusted  with  the  implementation  of  specific  actions  in  the  CFSP 

pursuant to Title V of the TEU, and identified in the relevant basic act. 

– 

If more than one management mode is indicated, please provide details in the ‘Comments’ section. 

Comments 

The  standard  rules  for  monitoring  the  Commission  expenditures  for  the  implementation  of 
this Regulation apply. 

57 

Details of management modes and references to the Financial Regulation may be found on the 
BudgWeb site: 
https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx  

EN 

64 

  EN 

                                                 
2. 

MANAGEMENT MEASURES 

2.1.  Monitoring and reporting rules 

Specify frequency and conditions. 

The management mode  for this initiative is  direct  management  by the Commission 
and its responsibilities in implanting it will pertain to its departments. 

Report by Commission to the Council in five years from the entry into force of this 
Regulation  and  every  five  years  after  that  on  the  functioning  of  the    contingency 
planning,  vigilance  and  Single  Market  emergency  response  system  suggesting  any 
improvements if necessary. 

This  review  shall  include  an  evaluation  of  the  work  of  the  Advisory  Board 
established under this Regulation under the emergency framework established by this 
Regulation,  and  its  relation  to  the  work  of  other  relevant  Union  level  crisis 
management bodies. 

Member  States  shall  be  consulted  and  their  views  and  recommendations  on  the 
implementation  of  the  emergency  framework  reflected  in  the  final  report.  The 
Commission shall, if appropriate, present proposals based on that report in order to 
amend this Regulation or make further proposals. 

2.2.  Management and control system(s) 

2.2.1.  Estimation and justification of the cost-effectiveness of the controls (ratio of "control 
costs ÷ value of the related funds managed"), and assessment of the expected levels 
of risk of error (at payment & at closure) 

 The  controls  are  part  of  the  Commission’s  internal  control  system.  These  new 
activities will generate non-significant additional costs of control at DG level. 

2.3.  Measures to prevent fraud and irregularities 

Specify existing or envisaged prevention and protection measures, e.g. from the Anti-Fraud Strategy. 

The  Commission  shall  ensure  that,  when  actions  financed  under  this  Decision  are 
implemented, the financial interests of the Union are protected by the application of 
preventive  measures  against  fraud,  corruption  and  any  other  illegal  activities,  by 
effective checks and by the recovery of the amounts unduly paid and, if irregularities 
are detected, by effective, proportional and dissuasive penalties. 

The measures implemented by the Commission will be subject to the ex-ante and ex-
post controls in accordance with the Financial Regulation. Contracts and agreements 
financing 
the 
Commission,  including  OLAF  and  the  Court  of  Auditors  to  conduct  audits,  and 
investigations in accordance with Regulation (EU, Euratom) No 883/2013, including 
on-the-spot checks and inspections. 

this  Regulation  will  expressly  entitle 

implementation  of 

the 

EN 

65 

  EN 

3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE 

3.1.1. 

Justification  of  the  management  mode(s),  the  funding  implementation  mechanism(s),  the  payment  modalities  and  the  control  strategy 
proposed 

Direct management, as per article 62.1(a) of the Financial Regulation, is the preferable mode as the actions will be implemented by the 
European Commission, which will ensure the coordination with the Member States and the various stakeholders.Information concerning 
the risks identified and the internal control system(s) set up to mitigate them 

3.2. 

Heading(s) of the multiannual financial framework and expenditure budget line(s) affected 

  Existing budget lines 

In order of multiannual financial framework headings and budget lines. 

Budget line 

Heading of 
multiannual 
financial 
framework 

Number  

Type of  
expenditure 

Diff./Non-
diff.58 

Contribution  

from 
EFTA 
countries
59 

from 
candidate 
countries60 

from third 
countries 

within the 
meaning of 
Article 21(2)(b) of 
the Financial 
Regulation  

1 

1 

03.010101  -  Support  expenditure  for 
the Single Market Programme 

Non-diff. 

YES 

TBD61 

TBD60 

NO 

- 

and 
03.020101 
development of the internal market of 
goods and services 

Operation 

diff. 

YES 

TBD60 

TBD60 

NO 

58 
59 
60 
61 

Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations. 
EFTA: European Free Trade Association.  
Candidate countries and, where applicable, potential candidates from the Western Balkans. 
Association agreements in the Single Market Programme currently under finalisation 

EN 

66 

EN 

 
 
 
 
 
                                                 
3.3. 

Estimated financial impact of the proposal on appropriations 

3.3.1. 

Summary of estimated impact on operational appropriations 

–    The proposal/initiative does not require the use of operational appropriations 

–   The proposal/initiative requires the use of operational appropriations, as explained below: 

Heading of multiannual financial  

framework  

1 

Single Market, Innovation and Digital 

DG: GROW 

 Operational appropriations  

Year 
2024 

Year 
2025 

Year 
2026 

Year 
2027 

Following 
years 

TOTAL 

EUR million (to three decimal places) 

Budget 
line  03.020101  -  Operation  and 
development  of  the  internal  market  of  goods 
and services 

Commitments 

Payments 

(1a) 

(2a) 

0,250 

0,025 

0,025 

0,025 

0,125 

0,150 

0,025 

0,025 

Appropriations  of  an  administrative  nature  financed  from  the 
envelope of specific programmes62 

Budget  line  03.010101  -  Support  expenditure 
for the Single Market Programme 

(3) 

0,038 

0,028 

0,028 

0,028 

TOTAL appropriations 
for DG GROW 

Commitments 

Payments 

=1a+1b 
+3 

=2a+2b 

+3 

0,288 

0,053 

0,053 

0,053 

0,163 

0,178 

0,053 

0,053 

0,325 

0,325 

0,122 

0,447 

0,447 

 TOTAL operational appropriations  

Commitments 

(4) 

0,250 

0,025 

0,025 

0,025 

0,325 

62 

Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research. 

EN 

67 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

Payments 

(5) 

(6) 

0,125 

0,150 

0,025 

0,025 

0,038 

0,028 

0,028 

0,028 

TOTAL appropriations  
under HEADING 1 
of the multiannual financial framework 

Commitments 

=4+ 6 

0,288 

0,053 

0,053 

0,053 

Payments 

=5+ 6 

0,163 

0,178 

0,053 

0,053 

  TOTAL  operational  appropriations  (all 
operational headings) 

Commitments 

Payments 

 TOTAL appropriations of an administrative nature financed 
from  the  envelope  for  specific  programmes  (all  operational 
headings) 

(4) 

(5) 

(6) 

0,250 

0,125 

0,025 

0,150 

0,025 

0,025 

0,025 

0,025 

0,038 

0,028 

0,028 

0,028 

TOTAL appropriations  
under HEADINGS 1 to 6 
of the multiannual financial framework 
(Reference amount) 

Commitments 

=4+ 6 

0,288 

0,053 

0,053 

0,053 

Payments 

=5+ 6 

0,163 

0,178 

0,053 

0,053 

0,325 

0,122 

0,447 

0,447 

0,325 

0,325 

0,122 

0,447 

0,447 

EN 

68 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Heading of multiannual financial  
framework  

7 

‘Administrative expenditure’ 

This section should be filled in using the 'budget data of an administrative nature' to be firstly introduced in the Annex to the Legislative 
Financial Statement (Annex V to the internal rules), which is uploaded to DECIDE for interservice consultation purposes. 

Year 
2024 

Year 
2025 

Year 
2026 

Year 
2027 

TOTAL 

EUR million (to three decimal places) 

DG: GROW 

 Human resources  
 Other administrative expenditure  

 0,628 

 0,628 

 0,628 

 0,628 

0,030 

0,030 

0,030 

0,030 

TOTAL DG GROW 

Appropriations  

0,658 

0,658 

0,658 

0,658 

2,512 

0,120 

2,632 

TOTAL appropriations 
under HEADING 7 
of the multiannual financial framework  

(Total  commitments  = 
Total payments) 

0,658 

0,658 

0,658 

0,658 

2,632 

Year 
2024 

Year 
2025 

Year 
2026 

Year 
2027 

Following years 

TOTAL 

EUR million (to three decimal places) 

TOTAL appropriations  
under HEADINGS 1 to 7 
of the multiannual financial framework  

Commitments 

0,946 

0,711 

0,711 

0,711 

Payments 

0,821 

0,836 

0,711 

0,711 

3,079 

3,079 

EN 

69 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.3.2.  Estimated output funded with operational appropriations   

Comment: considering the nature of the initiative and the inherent character of unexpected, unpredictable crisis, this estimation is not 
possible at the moment. 

Year 
N 

Year 
N+1 

Year 
N+2 

Year 
N+3 

OUTPUTS 

Commitment appropriations in EUR million (to three decimal places) 

Enter as many years as necessary to show the 
duration of the impact (see point 1.6) 

TOTAL 

o
N

Cost 

o
N

Cost 

o
N

Cost 

o
N

Cost 

o
N

Cost  N

o

Cost 

o
N

Cost 

Total 
No 

Total 
cost 

Indicate 
objectives and 
outputs 

 

Type63 

Avera
ge 
cost 

SPECIFIC OBJECTIVE No 164… 

- Output 

- Output 

- Output 

Subtotal for specific objective No 1 

SPECIFIC OBJECTIVE No 2 ... 

- Output 

Subtotal for specific objective No 2 

TOTALS 

63 
64 

Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.). 
As described in point 1.4.2. ‘Specific objective(s)…’  

EN 

70 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.3.3. 

Summary of estimated impact on administrative appropriations 

–    The  proposal/initiative  does  not  require  the  use  of  appropriations  of  an 

administrative nature 

–   The proposal/initiative requires the use of appropriations of an administrative 

nature, as explained below: 

EUR million (to three decimal places) 

Year 
2023 

Year 
2024 

Year 
2025 

Year 
2026 

TOTAL 

HEADING 7 
of the multiannual 
financial framework 

Human resources  

0,628 

0,628 

0,628 

0,628 

2,512 

Other administrative 
expenditure  

Subtotal HEADING 7 
of the multiannual 
financial framework  

Outside HEADING 765  
of the multiannual 
financial framework 

Human resources  

Other expenditure  
of an administrative 
nature 

Subtotal  
outside HEADING 7 
of the multiannual 
financial framework  

0,030 

0,030 

0,030 

0,030 

0,120 

0,658 

0,658 

0,658 

0,658 

2,632 

0,038 

0,028 

0,028 

0,028 

0,122 

0,038 

0,028 

0,028 

0,028 

0,122 

TOTAL 

0,696 

0,686 

0,686 

0,686 

2,754 

The  appropriations  required  for  human  resources  and  other  expenditure  of  an  administrative  nature  will  be  met  by 
appropriations from the DG that are already assigned to management of the action and/or have been redeployed within the 
DG,  together  if  necessary  with  any  additional  allocation  which  may  be  granted  to  the  managing  DG  under  the  annual 
allocation procedure and in the light of budgetary constraints. 

65 

Technical  and/or  administrative  assistance  and  expenditure  in  support  of  the  implementation  of  EU programmes 
and/or actions (former ‘BA’ lines), indirect research, direct research. 

EN 

71 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.3.3.1.  Estimated requirements of human resources 

–    The proposal/initiative does not require the use of human resources. 

–    The  proposal/initiative  requires  the  use  of  human  resources,  as  explained 

below: 

Estimate to be expressed in full time equivalent units 

20 01 02 01 (Headquarters and Commission’s Representation 
Offices) 

20 01 02 03 (Delegations) 

01 01 01 01  (Indirect research) 

 01 01 01 11 (Direct research) 

Other budget lines (specify) 

20 02 01 (AC, END, INT from the ‘global envelope’) 

20 02 03 (AC, AL, END, INT and JPD in the delegations) 

XX 01  xx yy zz  66 

- at Headquarters 

- in Delegations  

01 01 01 02 (AC, END, INT - Indirect research) 

 01 01 01 12 (AC, END, INT - Direct research) 

Other budget lines (specify) 

TOTAL 

XX is the policy area or budget title concerned. 

Year 
2024 

Year 
2025 

Year 
2026 

Year 
2027 

4 

4 

4 

4 

4 

4 

4 

4 

The human resources required will be met by staff from the DG who are already assigned to management of the 
action  and/or  have  been  redeployed  within  the  DG,  together  if  necessary  with  any  additional  allocation  which 
may  be  granted  to  the  managing  DG  under  the  annual  allocation  procedure  and  in  the  light  of  budgetary 
constraints. 

Description of tasks to be carried out: 

Officials and temporary staff 

1 FTE for the secretariat of the advisory board 

External staff 

66 

Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines). 

EN 

72 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.3.4.  Compatibility with the current multiannual financial framework 

The proposal/initiative: 

–   can be fully financed through redeployment within the relevant heading of the 

Multiannual Financial Framework (MFF). 

In case of activation of the Emergency mode, redeployment will be considered first within the Single 
Market Programme. 

–    requires use of the unallocated margin under the relevant heading of the MFF 

and/or use of the special instruments as defined in the MFF Regulation. 

Explain  what  is  required,  specifying  the  headings  and  budget  lines  concerned,  the  corresponding 
amounts, and the instruments proposed to be used. 

–    requires a revision of the MFF. 

Explain what is required, specifying the headings and budget lines concerned and the corresponding 
amounts. 

3.3.5.  Third-party contributions 

The proposal/initiative: 

–   does not provide for co-financing by third parties 

–    provides for the co-financing by third parties estimated below: 

Appropriations in EUR million (to three decimal places) 

Year 
N67 

Year 
N+1 

Year 
N+2 

Year 
N+3 

Enter as many years as necessary 
to show the duration of the 
impact (see point 1.6) 

Total 

Specify  the  co-financing 
body  

TOTAL appropriations 
co-financed  

67 

Year N is the year in which implementation  of the proposal/initiative starts. Please replace "N" by the 
expected first year of implementation (for instance: 2021). The same for the following years. 

EN 

73 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.4. 

Estimated impact on revenue 

–    The proposal/initiative has no financial impact on revenue. 

–   The proposal/initiative has the following financial impact: 

– 

– 

– 

 

 

on own resources 

on other revenue 

please indicate, if the revenue is assigned to expenditure lines  

Appropriations 
available for 
the current 
financial year 

Budget revenue line: 

Article 4 2 9 - Other non-
assigned fines and penalty 
payments 

     EUR million (to three decimal places) 

Impact of the proposal/initiative68 

Year 
2024 

Year 
2025 

Year 
2026 

p.m. 

p.m. 

p.m. 

Year 
2027 

p.m. 

Enter as many years as necessary to show 
the duration of the impact (see point 1.6) 

For assigned revenue, specify the budget expenditure line(s) affected. 

Other  remarks  (e.g.  method/formula  used  for  calculating  the  impact  on  revenue  or  any  other 
information). 

The  potential  assigned  revenues  cannot  be  evaluated  at  this  stage  as  there  is  not 
certainty that any fine will materialise. 

68 

As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be  net 
amounts, i.e. gross amounts after deduction of 20 % for collection costs. 

EN 

74 

  EN