Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009 and (EU) No 305/2011 as regards emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to a Single Market emergency
Date: 2022-09-19
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: cable transport, crisis management, gas appliance, goods and services, harmonisation of standards, market approval, market supervision, protective equipment, security of supply, single market

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   EUROPEAN COMMISSION  Brussels, 19.9.2022  COM(2022) 461 final 2022/0279 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009 and (EU) No 305/2011 as regards emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to a Single Market emergency (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) package 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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3 
4 
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 

5 
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EU Integrated Political Crisis Response, on the basis of previously existing arrangements. 
7 
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 

8 
relation to the free movement of goods among the Member States, OJ L 337, 12.12.1998, p. 8. 
9 
10 
11 
Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC. 
12 
COM(2021)689 final. 
13 
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. 
16 
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. 
18 
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. 
19 
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.  
21 

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,  nor  to  introduce  emergency 
procedures  in  the  relevant  sectoral  Union  framework  regulating  the  design,  conformity 
assessment,  placing  on  the  market  and  market  surveillance  of  goods.  To  the  extent  these 
initiatives  include  a  sectoral  crisis  response  and  preparedness  framework,  the  fact  that  the 
sectoral  frameworks  considered  in  the  context  of  this  initiative,  which  lay  down  the 
harmonised  Union  level  rules  for  the  design,  conformity  assessment,  placing  on  the  market 
and  market  surveillance  of  goods  are  maximum  harmonisation  frameworks,  the  will  be  no 
overlap with any of the ongoing initiatives.  

None of the relevant ongoing initiatives lay down any sectoral emergency procedures, which 
are  to  be  incorporated  in  the  relevant  sectoral  harmonised  frameworks  regulating  the  free 
movement of goods.  

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 
adopted, 
the  preparedness  and  response  planning  and  reinforce 
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  establishing  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 

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25 

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27 

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.  

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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 
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 stage is triggered. 
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.  

28 
29 
30 
31 

COM(2022)46 final.  
COM (2022)68 final.  
COM (2021)891 final.  
COM(2020)829 final. 

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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 

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)  laid down by Regulation (EU) 2021/240  of 
the European Parliament and of the Council.   

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The proposal is based on Article 114 TFEU, which is the original legal basis for the adoption 
of  the  5  sectoral  frameworks,  which  this  proposal  aims  to  amend.  These  5  sectoral 
frameworks  are:  Regulation  (EU)  2016/424  on  cableway  installations;  Regulation  (EU) 
2016/425  on  personal  protective  equipment;  Regulation  (EU)  2016/426  on  gas  appliances; 
Regulation  (EU)  2019/1009  on  fertilising  products  and  Regulation  (EU)  305/2011  on 
construction products.  

The  EU  sectoral  frameworks,  which  are  considered  in  the  context  of  this  proposal  are  the 
ones, which are among the so-called “harmonised products”. What  is common among these 
sectoral  frameworks  is  that  they  lay  down  harmonised  rules  regarding  the  design, 
manufacture, conformity assessment and placing on the market of such products. Essentially, 
these sectoral frameworks introduce for each respective sector/product category the essential 
safety  requirements  which  the  products  should  meet  and  the  procedures  how  to  assess  the 
compliance  with  these  requirements.  These  rules  lay  down  full  harmonisation  and  therefore 
the Member States cannot derogate from these rules, even in a case of emergency, unless the 
respective framework provides for such a possibility.  

Another common feature of these frameworks is that they are more or less closely aligned to 
the general principles laid down in Decision No 768/2008/EC of the European Parliament and 
of the Council of 9 July 2008 on a common framework for the marketing of products32, which 
lays down reference provisions for the drawing up of Community legislation harmonising the 
conditions for the marketing of products.  

Other  EU  harmonised  frameworks,  which  follow  the  same  approach,  such  as  the  Medical 
devices  Regulation  (EU)  2017/745  and  the  In  vitro  diagnostic  medical  devices  Regulation 
(EU) 2017/746 already contain provisions allowing the Member States to derogate from the 
harmonised  procedures  in  certain  cases.  Therefore,  it  is  not  necessary  to  amend  those 
frameworks.  

32 

OJ L 218, 13.8.2008, p. 82. 

EN 

7 

  EN 

                                                 
• 

Subsidiarity (for non-exclusive competence)  

The  proposal  aims  to  amend  the  harmonised  rules  laid  down  by  a  number  of  EU  sectoral 
frameworks.  These  frameworks  do  not  provide  for  the  possibility  for  the  Member  States  to 
adopt  crisis-response  measures  in  derogation  of  the  harmonised  rules.  Considering  that  the 
Regulations,  which  this  proposal  aims  to  amend  are  maximum  harmonisation  frameworks, 
such amendments may only be done at EU level.  

• 

Proportionality 

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).  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. 

• 

Choice of the instrument 

The  proposal  aims  to  amend  5  Regulations  of  the  European  Parliament  and  of  the  Council 
and.  In  order  to  respect  the  principle  of  parallelism,  the  Proposal  shall  take  the  form  of  a 
Proposal  for  a  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. 

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 
outdated33. 

• 

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 

33 
Document SWD(2019)371 final of 8 October 2019. 

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

EN 

8 

  EN 

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

EN 

9 

  EN 

• 

Impact assessment 

In  line  with  its  ‘Better  Regulation’  policy,  the  Commission  conducted  an  Impact 
Assessment34.  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 

governance, 
1. 
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 

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

to 

Approach 3 

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

and 

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

-  Obligations 
tof 
MS35    to  build  up 
strategic  reserves  for 

34 

35

EN 

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

Subject to additional trigger 

10 

  EN 

 
 
                                                 
 
 
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  MS36 
to 
economic 
oblige 
operators 
to  ramp  up 
production  capacity  and 
to 
binding 
information  requests  to 
economic operators 

address 

Approach 3 
Obligations  of  MS37 
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 
Option 3 for all building blocks with the exception of building block 8. For building block 8, a 

36

37

Subject to additional trigger 

Subject to additional trigger 

EN 

11 

  EN 

 
 
 
                                                 
 
 
 
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  overall  SMEI  package  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.  The  current 
proposal  provides  for  emergency  procedures  for  the  conformity  assessment,  placing  on  the 
market,  adoption  of  common  specifications  and  market  surveillance.  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  part  of  the  overall  SMEI  package  and  likely  to  lead  to  strong  impacts  and 
potential  costs  for  SMEs,  in  particular  measures  such  as  mandatory  information  requests, 

EN 

12 

  EN 

requests  to  ramp  up  production  and  to  accept  priority-rated  orders,  during  the  additional 
activation of such measures specific 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 triggering 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. 

In the context of the overall SMEI package, the Regulation (EC) No. 2679/98 setting up an 
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 

The proposal does not have an impact on the exercise of their fundamental rights of citizens 
or businesses.  

4. 

BUDGETARY IMPLICATIONS 

The  measures  in  this  act  concern  targeted  amendments  of  existing  product  legislation.  The 
implementation and application thereof is the responsibility of the Member States. There will 
thus not be implications on the Union budget.   

5. 

• 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements 

There is no specific monitoring mechanism included to this proposal. The specific monitoring 
requirements are already contained in the EU sectoral frameworks, which are being amended 
by  this  proposal  and  the  amendments  do  not  have  an  impact  on  these  existing  monitoring, 
evaluation and reporting arrangements.  

• 

European Economic Area 

The proposed act is of relevance to the EEA and should therefore extend thereto.  

• 

Detailed explanation of the specific provisions of the proposal 

The amendments, which this Proposal aims to introduce cover the following aspects:  

(1) 

(2) 

Prioritisation  by  the  notified  bodies  of  the  conformity  assessment  of  products 
designated as crisis-relevant; 

Possibility  for  the  national  competent  authorities  to  issue  temporary  authorisations 
for  crisis  relevant  products,  which  have  not  undergone  the  standard  conformity 
assessment  procedures,  provided  that  the  products  comply  with  all  the  applicable 
essential requirements  and provided that the authorisation  is  limited to  the duration 
of the Single Market emergency and to the territory of the issuing Member State;  

EN 

13 

  EN 

(3) 

(4) 

Possibility  for  the  manufacturers  to  rely  on  relevant  international  and  national 
standards  during  an  emergency  if  no  harmonised  standards  are  available  and  if  the 
alternative standards ensure an equivalent level of safety;  

Possibility  for  the  Commission  to  adopt  via  delegated  acts  voluntary  or  mandatory 
common technical specifications for crisis-relevant products; 

(5) 

Prioritisation  of 

the  market  surveillance  activities  for  crisis-relevant  goods

EN 

14 

  EN 

2022/0279 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009 
and (EU) No 305/2011 as regards emergency procedures for the conformity assessment, 
adoption of common specifications and market surveillance due to a Single Market 
emergency 

(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 
Article 114 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 Committee38,  
Acting in accordance with the ordinary legislative procedure39, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

[insert  reference  to  SMEI  Regulation]  aims  to  ensure  the  normal  functioning  of  the 
Single  Market,  including  the  free  movement  of  goods,  services  and  persons  and 
guarantee the availability of crisis-relevant goods and services and goods and services 
of strategic importance to citizens, businesses and public authorities during a crisis. 

The  framework  established  by  [insert  reference  to  SMEI  Regulation]  lays  down 
measures, which should be deployed in a coherent, transparent, efficient, proportionate 
and  timely  manner,  so  as  to  prevent,  mitigate  and  minimise  the  impact  on  the 
functioning of the Single Market that a crisis may cause. 

[insert  reference  to  SMEI  Regulation]  lays  down  a  multi-layered  mechanism 
consisting  of  contingency  planning,  vigilance  mode  and  Single  Market  emergency 
mode. 

[insert  reference  to  SMEI  Regulation]  lays  down  rules  with  the  objective  of 
safeguarding the free movement of goods, services and persons in the Single Market 
and to ensure the availability of goods and services that are particularly important also 
in  times  of  crisis.  [insert  reference  to  SMEI  Regulation]  applies  to  both  goods  and 
services. 

(5) 

In order to complement, ensure consistency and to further enhance the effectiveness of 
such measures, it is appropriate to ensure that referred to in [insert reference to SMEI 

38 
39 

OJ C , , p. . 
Position of the European Parliament of xxx (not yet published in the Official Journal) and Decision of 
the Council of xxx. 

EN 

15 

  EN 

                                                 
(6) 

(7) 

(8) 

(9) 

Regulation]  may  be  swiftly  placed  on  the  Union  market  in  order  to  contribute  to 
addressing and mitigating the disruptions. 

A  number  of  Union  sectoral  legal  acts  lay  down  harmonised  rules  regarding  the 
design,  manufacture,  conformity  assessment  and  placing  on  the  market  of  certain 
products. Such legal acts include Regulations (EU) 2016/42440, (EU) 2016/42541, (EU) 
2016/42642,  (EU)  2019/100943  and  (EU)  No  305/201144  of  the  European  Parliament 
and of the Council. Those legal acts are based on the principles of the new approach to 
technical harmonisation. Moreover, Regulations (EU) 2016/424, (EU) 2016/425, (EU) 
2016/426 and (EU) 2019/1009 are also aligned to the reference provisions laid down 
by Decision No 768/2008/EC of the European Parliament and of the Council 45. 

Neither  the  reference  provisions  laid  down  by  Decision  No  768/2008/EC,  nor  the 
specific provisions laid down by the sectoral nionU harmonisation legislation provide 
for  procedures  designed  to  apply  in  crisis.  It  is  appropriate  to  introduce  targeted 
adjustments  to  those  Regulations,  aimed  at  preparing  and  responding  to  impacts  of 
crises  affecting  products  that  have  been  designated  as  crisis-relevant  goods  and 
covered by those Regulations. 

Experience from the recent crises that have affected the Single Market has shown that 
the  procedures  laid  down  in  the  sectoral  legislation  are  not  designed  to  cater  for  the 
needs of crisis-response scenarios and do not offer the necessary regulatory flexibility. 
It  is  therefore  appropriate  to  provide  for  a  legal  basis  for  such  crisis-response 
procedures as a complement to the measures adopted under [insert reference to SMEI 
Regulation]. 

In order to overcome the potential effects of disruptions on the Single Market and in 
order  to  ensure  that  crisis-relevant  goods  are  placed  on  the  market  swiftly,  it  is 
appropriate  to  provide  for  a  requirement  for  the  conformity  assessment  bodies  to 
prioritise  the  conformity  assessment  applications  of  such  products  over  any  pending 
applications concerning products, which have not been designated as crisis-relevant. 

(10)  To  that  end,  emergency  procedures  should  be  laid  down  in  Regulations  (EU) 
2016/424,  (EU)  2016/425,  (EU)  2016/426,  (EU)  2019/1009  and  (EU)  No  305/2011. 
Those  procedures  should  be  available  only  following  the  activation  of  the  Single 
Market emergency mode in accordance with [insert reference to SMEI Regulation].  

(11)  Furthermore,  in  cases  where  the  disruptions  might  affect  the  conformity  assessment 
bodies or in cases where the testing capacities for such crisis-relevant products would 
not  be  sufficient,  it  is  appropriate  to  provide  for  the  possibility  for  the  national 
competent  authorities  to  exceptionally  and  temporarily  authorise  the  placing  on  the 
market  of  products,  which  have  not  undergone  the  usual  conformity  assessment 
procedures required by the respective EU sectoral legislation. 

(12)  As  regards  products  falling  within  the  scope  of  those  Regulations  that  have  been 
designated as crisis-relevant goods, the national competent authorities should be able, 
in the context of an ongoing Single Market emergency, to derogate from the obligation 
to carry out those conformity assessment procedures laid down in those  Regulations, 

40 
41 
42 
43 
44 
45 

OJ L 81, 31.3.2016, p. 1. 
OJ L 81, 31.3.2016, p. 51.  
OJ L 81, 31.3.2016, p. 99.  
OJ L 170, 25.6.2019, p. 1.  
OJ L 88, 4.4.2011, p. 5. 
OJ L 218, 13.8.2008, p. 82. 

EN 

16 

  EN 

                                                 
 
in those cases where the involvement of a notified body is mandatory and should be 
able to issue authorisations for those products, provided that they comply with all the 
applicable  essential  safety  requirements.  Compliance  with 
those  substantive 
requirements  may  be  demonstrated  by  various  means,  which  may  include  testing 
performed by the national authorities of samples provided by the manufacturer having 
applied  for  an  authorisation.  The  specific  procedures,  which  were  followed  to 
demonstrate  the  compliance  and  their  results  should  be  clearly  described  in  the 
authorisation issued by the national competent authority.  

(13)  Where a Single Market emergency entails an exponential increase in the demand for 
certain products and in order to support the efforts of economic operators to meet such 
demand,  it  is  appropriate  to  provide  technical  references,  which  may  be  used  by  the 
manufacturers  to  design  and  produce  crisis-relevant  goods,  which  comply  with  the 
applicable essential health and safety requirements. 

(14)  A number of sectoral Union harmonisation legislation provide for the possibility for a 
manufacturer  to  benefit  from  a  presumption  of  conformity  if  their  product  complies 
with a harmonised European standard. However, in cases where such standards do not 
exist  or  the  compliance  with  them  might  be  rendered  excessively  difficult  by  the 
disruptions  caused  by  the  crisis,  it  is  appropriate  to  provide  for  alternative 
mechanisms. 

(15)  With respect to Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and, (EU) 
2019/1009, the competent national authorities should be able to presume that products 
manufactured  in  accordance  with  national  or  international  standards  within  the 
meaning  of  Regulation  (EU)  No  1025/201246  ensuring  an  equivalent  level  of 
protection  to  that  offered  by  the  harmonised  European  standards  comply  with  the 
relevant essential health and safety requirements. 

(16)  Furthermore,  with  respect  to  Regulations  (EU)  2016/424,  (EU)  2016/425,  (EU) 
2016/426,  (EU) 2019/1009  and (EU) No 305/2011, the Commission should  have the 
possibility to adopt by means of implementing acts common specifications, on which 
the manufacturers may rely in order to benefit from a presumption of conformity with 
the  applicable  essential  requirements.  The  implementing  act  laying  down  such 
common specifications should remain applicable for the duration of the Single Market 
emergency.  

(17)  With  respect  to  Regulations  (EU)  2016/424,  (EU)  2016/425,  (EU)  2016/426,  (EU) 
2019/1009  and  (EU)  No  305/2011,  in  exceptional  and  duly  justified  circumstances, 
notably  in  order  to  ensure  the  interoperability  among  products  or  systems,  the 
Commission  should  be  able  to  adopt  by  means  of  implementing  acts  common 
specifications  laying  down  mandatory  technical  specifications,  with  which  the 
manufacturers  will  be  required  to  comply.  The  implementing  act  laying  down  such 
common specifications should remain applicable for the duration of the Single Market 
emergency. 

(18) 

In order to ensure that the level of safety provided by the harmonised products is not 
compromised, it is necessary to provide for rules for enhanced market surveillance, in 
particular with respect to goods designated as crisis-relevant and including by enabling 
closer cooperation and mutual support among the market surveillance authorities. 

46 

OJ L 316, 14.11.2012, p. 12. 

EN 

17 

  EN 

                                                 
(19) 

In  accordance  with  its  established  practice,  the  Commission  would  systematically 
consult the relevant sectoral experts in the context of the early preparation of all draft 
implementing acts laying down common specifications. 

(20)  Regulations  (EU)  2016/424,  (EU)  2016/425,  (EU)  2016/426,  (EU)  2019/1009  and 

(EU) No 305/2011 should therefore be amended accordingly, 

(21) 

In  order  for  this  Regulation  to  apply  from  the  same  date  as  [SMEI  Regulation],  its 
application should be deferred, 

HAVE ADOPTED THIS REGULATION: 

Article 1 
Amendments to Regulation (EU) 2016/424 

In Regulation (EU) 2016/424, the following Chapter VIa is inserted: 

‘CHAPTER Via 
EMERGENCY PROCEDURES 

Article 43a 
Application of emergency procedures 

1. 

2. 

3. 

4. 

1. 

2. 

3. 

Articles 43b to 43g shall only apply if the Commission has adopted an implementing 
act  pursuant  to  Article  23  of  [the  SMEI  Regulation]  activating  Article  26  of  [the 
SMEI Regulation] with respect to this Regulation.   

Articles  43b  to  43g  shall  apply  exclusively  to  subsystems  and  safety  components, 
which have been designated as crisis-relevant goods in the implementing act referred 
to in paragraph 1 of this Article. 

Articles  43b  to  43g,  except  as  regards  provisions  concerning  the  powers  of  the 
Commission, shall apply during the Single Market emergency mode.  

However, Article 43c(2), second subparagraph, and Article 43c(5) shall apply during 
the Single Market emergency mode and after its deactivation or expiry. 

The  Commission  shall  be  empowered  to  lay  down  by  means  of  implementing  acts 
rules  regarding  the  follow-up  actions  to  be  taken  with  respect  to  subsystems  and 
safety  components  placed  on  the  market  in  accordance  with  Articles  43c  to  43f. 
Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 44(3). 

Article 43b 
Prioritisation of the conformity assessment of crisis-relevant subsystems and safety 
components 

This Article shall apply to all subsystems and safety components designated as crisis-
relevant goods, which are subject to conformity assessment procedures in accordance 
with Article 18 requiring mandatory involvement of a notified body. 

The  notified  bodies  shall  process  all  applications  for  conformity  assessment  of 
subsystems and safety components designated as crisis-relevant goods as a matter of 
priority. 

All  pending  applications  for  conformity  assessment  of  subsystems  and  safety 
components  designated  as  crisis-relevant  goods  shall  be  processed  as  a  matter  of 
priority,  ahead  of  any  other  applications  for  conformity  assessment  of  subsystems 
and  safety  components,  which  have  not  been  designated  as  crisis-relevant  goods. 

EN 

18 

  EN 

This  requirement  applies  with  respect  to all  applications for conformity  assessment 
of  subsystems  and  safety  components  designated  as  crisis-relevant  goods, 
irrespective  of  whether  they  have  been  lodged  before  or  after  the  activation  of  the 
emergency procedures pursuant to Article 43a.  

The prioritisation of applications for conformity assessment of subsystems and safety 
components pursuant to paragraph 3 shall not give rise to any additional costs for the 
manufacturers, who have lodged those applications. 

The notified bodies shall deploy their best efforts to increase their testing capacities 
for subsystems and safety components designated as crisis-relevant goods in respect 
of which they have been notified. 

Article 43c 
Derogation from the conformity assessment procedures requiring mandatory 
involvement of a notified body 

By  way  of  derogation  from  Article  18,  any  competent  national  authority  may 
authorise, on a duly justified request, the placing on the market or the incorporation 
into a cableway installation within the territory of the Member State concerned, of a 
specific subsystem or safety component which has been designated as crisis-relevant 
good  and  for which the  conformity  assessment  procedures  requiring the  mandatory 
involvement of a notified body, referred to in Article 18 have not been carried out by 
a  notified  body  but  for  which  the  compliance  with  all  the  applicable  essential 
requirements has been demonstrated. 

The  manufacturer  of  a  subsystem  or  safety  component  subject  to  the  authorisation 
procedure referred to in paragraph 1 shall declare on his sole responsibility that the 
subsystem or safety component concerned complies with all the applicable essential 
requirements set out in Annex II and shall be responsible for the fulfilment of all the 
conformity assessment procedures indicated by the national competent authority.  

The  manufacturer  shall  also  deploy  all  reasonable  measures  to  ensure  that  the 
subsystem or safety component, which has been granted an authorisation pursuant to 
paragraph  1,  does  not  leave  the  territory  of  the  Member  State,  which  issued  the 
authorisation. 

Any authorisation issued by a national competent authority pursuant to paragraph 1 
shall  set  out  the  conditions  and  requirements  under  which  the  subsystem  or  safety 
component may be placed on the market or incorporated into a cableway installation, 
including: 

a description of the procedures,  by means of which compliance with the applicable 
essential requirements was successfully demonstrated; 

specific  requirements  regarding  the  traceability  of  the  subsystem  or  safety 
component concerned; 

an end date of validity of the authorisation, which cannot go beyond the last day of 
the period for which the Single Market emergency mode has been activated; 

any  specific  requirements  regarding  the  need  to  ensure  the  continuous  conformity 
assessment with respect to the subsystem or safety component concerned; 

measures to be taken with respect to the subsystem or safety component  concerned 
upon  expiry  of  the  authorisation  in  order  to  ensure  that  the  subsystem  or  safety 

4. 

5. 

1. 

2. 

3. 

(a) 

(b) 

(c) 

(d) 

(e) 

EN 

19 

  EN 

4. 

5. 

6. 

7. 

8. 

component concerned is brought back in compliance with all the requirements of this 
Regulation. 

By way of derogation from Article 43a(3), first subparagraph, where appropriate, the 
national competent authority may amend the conditions of the authorisation referred 
to  in  paragraph  3also  after  the  deactivation  or  expiry  of  the  Single  Market 
Emergency mode.  

By way of derogation from Articles 7 and 20, subsystems or safety components, for 
which  an  authorisation  has  been  granted  in  accordance  with  paragraph  1  of  this 
Article,  shall  not  leave  the  territory  of  the  Member  State  which  has  issued  the 
authorisation and shall not bear the CE marking.  

The market surveillance authorities of the Member State, whose competent authority 
has  granted  an  authorisation  pursuant  to  paragraph  1,  shall  be  entitled  to  take  all 
corrective  and  restrictive  measures  at  national  level  provided  for  under  this 
Regulation with respect to such subsystems or safety components.  

Member  States  shall  inform  the  Commission  and  the  other  Member  States  of  any 
decision to authorise the placing on the market of subsystems or safety components 
in accordance with paragraph 1. 

The application of Articles 43a to 43g and the use of the authorisation procedure set 
out  in  paragraph  1  of  this  Article  does  not  affect  the  application  of  the  relevant 
conformity  assessment  procedures  laid  down  in  Article  18  on  the  territory  of  the 
Member State concerned. 

Article 43d 
Presumption of conformity based on national and international standards 

Member States shall take all appropriate measures to ensure that, for the purposes of placing 
on  the  market,  their  competent  authorities  consider  that  subsystems  and  safety  components, 
which comply with the relevant international standards or any national standards in force in 
the  Member  State  of  manufacture,  ensuring  the  safety  level  required  by  the  essential 
requirements  set  out  in  Annex  II,  comply  with  those  essential  requirements  in  either  of  the 
following cases: 

(a) 

(b) 

where  no  reference  to  harmonised  standards  covering  the  relevant  essential 
requirements set out in Annex II is published in the Official Journal of the European 
Union in accordance with Regulation (EU) No 1025/2012; 

Where 

severe  disruptions  in  the  functioning  of  the  Single  Market,  which  were  taken  into 
consideration  when  activating  the  Single  Market  emergency  mode  in  accordance 
with Article 15(4) of [the SMEI Regulation], significantly restrict the possibilities of 
manufacturers  to  make  use  of  the  harmonised  standards  covering  the  relevant 
essential requirements set out in Annex II to this Regulation and already published in 
the Official Journal of the European Union in accordance with Regulation (EU) No 
1025/2012. 

Article 43e 
Adoption of common specifications conferring a presumption of conformity 

1. 

Where  subsystems  and  safety  components,  have  been  designated  as  crisis-relevant 
goods,  the  Commission  is  empowered  to  adopt  implementing  acts  establishing 

EN 

20 

  EN 

common  specifications  for  such  subsystems  and  safety  components  to  cover  the 
essential requirements set out in Annex II in either of the following cases: 

where  no  reference  to  harmonised  standards  covering  the  relevant  essential 
requirements set out in Annex II is published in the Official Journal of the European 
Union in accordance with Regulation (EU) No 1025/2012; 

where  severe  disruptions  in  the  functioning  of  the  Single  Market,  which  led  to  the 
activation  of  the  Single  Market  emergency  mode  in  accordance  with  Article  14  of 
[the  SMEI  Regulation],  significantly  restrict  the  possibilities  of  manufacturers  to 
make  use  of  the  harmonised  standards  covering  the  relevant  essential  requirements 
set out in Annex II to this Regulation and already published in the Official Journal of 
the European Union in accordance with Regulation (EU) No 1025/2012. 

The  implementing  acts  referred  to  in  paragraph  1  of  this  Article  shall  be  adopted 
following  a  consultation  of  the  sectoral  experts  and  in  accordance  with  the 
examination procedure referred to in Article 44(3) and they shall apply to subsystems 
or safety components placed on the market until the last day of the period for which 
the  Single  Market  emergency  mode  remains  active.  In  the  early  preparation  of  the 
draft implementing act establishing the common specification, the Commission shall 
gather  the  views  of  relevant  bodies  or  expert  groups  established  under  relevant 
sectoral Union legislation. Based on that consultation, the Commission shall prepare 
the draft implementing act. 

Without  prejudice  to  Article  17,  subsystems  and  safety  components  which  are  in 
conformity  with  common  specifications  adopted  pursuant  to  paragraph  2  of  this 
Article shall be presumed to be in conformity with the essential requirements set out 
in Annex II covered by those common specifications or parts thereof. 

By  way  of  derogation  from  Article  43a(3),  first  subparagraph,  unless  there  is 
sufficient reason to believe that the subsystems or safety components covered by the 
common specifications referred to in paragraph 1 of this Article present a risk to the 
health or safety of persons, the subsystems or safety components in compliance with 
the  said  common  specifications  which  have  been  placed  on  the  market  shall  be 
deemed compliant with this Regulation after the expiry or repeal of an implementing 
act  adopted  pursuant  to  paragraph  2  of  this  Article  and  after  the  expiry  or 
deactivation  of  the  Single  Market  Emergency  mode  in  accordance  with  [the  SMEI 
Regulation].  

When  a  Member  State  considers  that  a  common  specification  referred  to  in 
paragraph  1  does  not  entirely  satisfy  the  essential  requirements  which  it  aims  to 
cover and which are set out in Annex II, it shall inform the Commission thereof with 
a  detailed  explanation  and  the  Commission  shall  assess  that  information  and,  if 
appropriate,  amend  or  withdraw  the  implementing  act  establishing  the  common 
specification in question. 

Article 43f 
Adoption of mandatory common specifications 

In  exceptional  and  duly  justified  cases,  the  Commission  is  empowered  to  adopt 
implementing  acts  establishing  mandatory  common  specifications  to  cover  the 
essential  requirements  set  out  in  Annex  II  for  subsystems  or  safety  components, 
which have been designated as crisis-relevant goods. 

The implementing acts establishing mandatory common specifications, referred to in 
paragraph 1 of this Article shall be adopted following a consultation of the sectoral 

(a) 

(b) 

2. 

3. 

4. 

5. 

1. 

2. 

EN 

21 

  EN 

3. 

experts  and  in  accordance  with  the  examination  procedure  referred  to  in  Article 
44(3).  They  shall  apply  to  subsystems  or  safety  components  placed  on  the  market 
until the last day of the period for which the Single Market emergency mode remains 
active.  In  the  early  preparation  of  the  draft  implementing  act  establishing  the 
common specification, the Commission shall gather the views of relevant bodies or 
expert  groups  established  under  relevant  sectoral  Union  legislation.  Based  on  that 
consultation, the Commission shall prepare the draft implementing act. 

By  way  of  derogation  from  Article  43a(3),  first  subparagraph,  unless  there  is 
sufficient reason to believe that the subsystems or safety components covered by the 
common specifications referred to in paragraph 1 of this Article present a risk to the 
health or safety of persons, the subsystems or safety components in compliance with 
those common specifications which have been placed on the market shall be deemed 
compliant  with  this  Regulation  after  the  expiry  or  repeal  of  an  implementing  act 
adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of 
the Single Market Emergency mode in accordance with [the SMEI Regulation].  

Article 43g 
Prioritisation of market surveillance activities and mutual assistance among authorities 

1. 

2. 

Member States shall prioritise the market surveillance activities for  subsystems and 
safety components designated as crisis-relevant goods. 

The  market  surveillance  authorities  of  the  Member  States  shall  deploy  their  best 
efforts to provide assistance to other market surveillance authorities during a Single 
Market  emergency,  including  by  mobilising  and  dispatching  expert  teams  to 
temporarily  reinforce  the  staff  of  market  surveillance  authorities  requesting 
assistance  or  by  providing  logistical  support  such  as  reinforcement  of  the  testing 
capacity for subsystems and safety components designated as crisis-relevant goods. 

Article 2 
Amendments to Regulation (EU) 2016/425 

In Regulation (EU) 2016/425, the following Chapter VIa is inserted: 

‘CHAPTER VIa 
EMERGENCY PROCEDURES 

Article 41a 
Application of emergency procedures  

1. 

2. 

3. 

4. 

Articles 41b to 41g shall only apply if the Commission has adopted an implementing 
act  pursuant  to  Article  23  of  [the  SMEI  Regulation]  activating  Article  26  of  [the 
SMEI Regulation] with respect to this Regulation.   

rticles  41b  to  41g  shall  apply  exclusively  to  PPE,  which  has  been  designated  as 
crisis-relevant goods in the implementing act referred to in paragraph 1. 

Articles  41b  to  41g,  except  as  regards  provisions  concerning  the  powers  of  the 
Commission, shall apply during the Single Market emergency mode. 

However, Article 41c(2), second subparagraph, and Article 41c(5) shall apply during 
the Single Market emergency mode and after its deactivation or expiry. 

The  Commission  shall  be  empowered  to  lay  down  by  means  of  implementing  acts 
rules regarding the follow-up actions to be taken with respect to PPE placed on the 

EN 

22 

  EN 

1. 

2. 

3. 

4. 

5. 

1. 

2. 

market  in  accordance  with  Articles  41c  to  41f.  These  implementing  acts  shall  be 
adopted in accordance with the examination procedure referred to in Article 44(3). 

Article 41b 
Prioritisation of the conformity assessment of crisis-relevant PPE 

This Article shall apply to PPE designated as crisis-relevant goods, which are subject 
to  conformity  assessment  procedures  in  accordance  with  Article  19  requiring 
mandatory involvement of a notified body. 

The notified bodies shall process all applications for conformity assessment of PPE 
designated as crisis-relevant goods as a matter of priority. 

All pending applications for conformity assessment of such  PPE shall be processed 
as a matter of priority, ahead of any other applications for conformity assessment of 
PPE, which has not been designated as crisis-relevant goods. This requirement applie 
with  respect  to  all  applications  for  conformity  assessment  of  PPE  designated  as 
crisis-relevant  good,  irrespective  of  whether  they  have  been  lodged  before  or  after 
the activation of the emergency procedures pursuant to Article 41a.  

The  prioritisation  of  applications  for  conformity  assessment  of  PPE  pursuant  to 
paragraph  3  shall  not  give  rise  to  any  additional  costs  for  the  manufacturers,  who 
have lodged those applications. 

The notified bodies shall deploy their best efforts to increase their testing capacities 
for  PPE  designated  as  crisis-relevant  goods  in  respect  to  which  they  have  been 
notified. 

Article 41c 
Derogation from the conformity assessment procedures requiring mandatory 
involvement of a notified body 

By  way  of  derogation  from  Article  19,  any  competent  national  authority  may 
authorise, on a duly justified request, the placing on the market within the territory of 
the Member State concerned, of a specific PPE which has been designated as crisis-
relevant good for which the conformity assessment procedures  requiring mandatory 
involvement of a notified body referred to in that Article have not been carried out by 
a notified body but for which the compliance with all the applicable essential health 
and safety requirements has been demonstrated. 

The  manufacturer  of  a  PPE  subject  to  the  authorisation  procedure  referred  to  in 
paragraph 1 shall declare on his sole responsibility that the PPE concerned complies 
with  all  the  applicable  essential  health  and  safety  requirements  and  shall  be 
responsible for the fulfilment of all the conformity assessment procedures indicated 
by the national competent authority.  

The manufacturer shall also deploy all reasonable measures to ensure that the PPE, 
which has been granted an authorisation pursuant to paragraph 1 does not leave the 
territory of the Member State, which issued the authorisation. 

3. 

(a) 

Any authorisation issued by a national competent authority pursuant to paragraph 1 
shall set out the conditions and requirements under which the PPE may be placed on 
the market, including: 

a  description  of  the  procedures,  by  means  of  which  the  compliance  with  the 
applicable essential health and safety requirements was successfully demonstrated; 

(b) 

specific requirements regarding the traceability of the PPE concerned; 

EN 

23 

  EN 

(c) 

(d) 

(e) 

4. 

5. 

6. 

7. 

8. 

an end date of validity of the authorisation, which cannot go beyond the last day of 
the period for which the Single Market emergency mode has been activated; 

any  specific  requirements  regarding  the  need  to  ensure  the  continuous  conformity 
assessment with respect to the PPE concerned; 

measures  to  be  taken  with  respect  to  the  PPE  concerned  upon  expiry  of  the 
authorisation  in  order  to  ensure  that  the  PPE  concerned  is  brought  back  in 
compliance with all the requirements of this Regulation. 

By way of derogation from Article 41a(3), first subparagraph, where appropriate, the 
national competent authority may amend the conditions of the authorisation referred 
to  in  paragraph  3  of  this  Article  also  after  the  deactivation  or  expiry  of  the  Single 
Market Emergency mode.  

By way of derogation  from Articles 7  and 17, PPE, for which an  authorisation  has 
been  granted  in  accordance  with  paragraph  1  of  this  Article,  shall  not  leave  the 
territory of the Member State which has issued the authorisation and shall not  bear 
the CE marking.  

The market surveillance authorities of the Member State, whose competent authority 
has  granted  an  authorisation  pursuant  to  paragraph  1,  shall  be  entitled  to  take  all 
corrective  and  restrictive  measures  at  national  level  provided  for  under  this 
Regulation with respect to such PPE.  

Member  States  shall  inform  the  Commission  and  the  other  Member  States  of  any 
decision to authorise the placing on the market of PPE in accordance with paragraph 
1. 

The application of Articles 41a to 41g and the use of the authorisation procedure set 
out  in  paragraph  1  of  this  Article  does  not  affect  the  application  of  the  relevant 
conformity  assessment  procedures  laid  down  in  Article  19  on  the  territory  of  the 
Member State concerned. 

Article 41d 
Presumption of conformity based on national and international standards 

Member States shall take all appropriate measures to ensure that, for the purposes of placing 
on  the  market,  their  competent  authorities  consider  that  the  PPE,  which  complies  with  the 
relevant  international  standards  or  any  national  standards  in  force  in  the  Member  State  of 
manufacture, ensuring the safety level required by the essential health and safety requirements 
set out in Annex II, complies with those essential health and safety requirements in either of 
the following cases: 

(a) 

(b) 

where  no  reference  to  harmonised  standards  covering  the  relevant  essential  health 
and safety requirements set out in Annex II is published in the Official Journal of the 
European Union in accordance with Regulation (EU) No 1025/2012; 

where severe disruptions in the functioning of the Single Market, which were taken 
into consideration when activating the Single Market emergency mode in accordance 
with Article 15(4) of [the SMEI Regulation], significantly restrict the possibilities of 
manufacturers  to  make  use  of  the  harmonised  standards  covering  the  relevant 
essential  health  and  safety  requirements  set  out  in  Annex  II  to  this  Regulation  and 
already published in the Official Journal of the European Union in accordance with 
Regulation (EU) No 1025/2012. 

EN 

24 

  EN 

1. 

(a) 

(b) 

2. 

3. 

4. 

5. 

Article 41e 
Adoption of common specifications conferring a presumption of conformity 

Where  PPE,  have  been  designated  as  crisis-relevant  goods,  the  Commission  is 
empowered to adopt implementing acts establishing common specifications for such 
PPE to cover the essential health and safety requirements set out in Annex II in either 
of the following cases: 

where  no  reference  to  harmonised  standards  covering  the  relevant  essential  health 
and safety requirements set out in Annex II is published in the Official Journal of the 
European Union in accordance with Regulation (EU) No 1025/2012; 

where  severe  disruptions  in  the  functioning  of  the  Single  Market,  which  led  to  the 
activation  Single  Market  emergency  mode  significantly  restrict  the  possibilities  of 
manufacturers  to  make  use  of  the  harmonised  standards  covering  the  relevant 
essential  health  and  safety  requirements  set  out  in  Annex  II  to  this  Regulation  and 
already published in the Official Journal of the European Union in accordance with 
Regulation (EU) No 1025/2012. 

The  implementing  acts  referred  to  in  paragraph  1  of  this  Article  shall  be  adopted 
following  a  consultation  of  the  sectoral  experts  and  in  accordance  with  the 
examination procedure referred to  in  Article  44(3). They shall remain applicable to 
PPE placed on the market until the last day of the period for which the Single Market 
emergency mode remains active. In the early preparation of the draft implementing 
act establishing the common specification, the Commission shall gather the views of 
relevant  bodies  or  expert  groups  established  under  relevant  sectoral  Union 
legislation.  Based  on  that  consultation,  the  Commission  shall  prepare  the  draft 
implementing act. 

Without  prejudice  to  Article  14,  PPE  which  are  in  conformity  with  common 
specifications adopted pursuant to paragraph 2 of this Article shall be presumed to be 
in  conformity  with  the  essential  health  and  safety  requirements  set  out  in  Annex II 
covered by those common specifications or parts thereof. 

By  way  of  derogation  from  Article  41a(3),  first  subparagraph,  unless  there  is 
sufficient  reason  to  believe  that  the  PPE  covered  by  the  common  specifications 
referred  to  in  paragraph  1  of  this  Article  present  a  risk  to  the  health  or  safety  of 
persons,  the  PPE  in  compliance  with  those  common  specifications  which  has  been 
placed on the market shall be deemed compliant with this Regulation after the expiry 
or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and 
after the expiry or deactivation of the Single Market Emergency mode in accordance 
with [the SMEI Regulation].  

When  a  Member  State  considers  that  a  common  specification  referred  to  in 
paragraph  1  does  not  entirely  satisfy  the  essential  health  and  safety  requirements 
which  it  aims  to  cover  and  which  are  set  out  in  Annex  II,  it  shall  inform  the 
Commission thereof with a detailed explanation and the Commission shall assess that 
information  and,  if  appropriate,  amend  or  withdraw  the  implementing  act 
establishing the common specification in question. 

Article 41f 
Adoption of mandatory common specifications 

1. 

In  duly  justified  cases,  the  Commission  is  empowered  to  adopt  implementing  acts 
establishing  mandatory  common  specifications  to  cover  the  essential  health  and 

EN 

25 

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2. 

3. 

safety requirements set out in Annex II for PPE, which has been designated as crisis-
relevant goods. 

The implementing acts establishing mandatory common specifications, referred to in 
paragraph 1 of this Article, shall be adopted following a consultation of the sectoral 
experts  and  in  accordance  with  the  examination  procedure  referred  to  in  Article 
44(3). They shall apply to PPE placed on the market until the last day of the period 
for  which  the  Single  Market  emergency  mode  remains  active.  In  the  early 
preparation of the draft implementing act establishing the common specification, the 
Commission  shall  gather  the  views  of  relevant  bodies  or  expert  groups  established 
under  relevant  sectoral  Union 
the 
Commission shall prepare the draft implementing act. 

legislation.  Based  on 

that  consultation, 

By  way  of  derogation  from  Article  41a(3),  first  subparagraph,  unless  there  is 
sufficient  reason  to  believe  that  the  PPE  covered  by  the  mandatory  common 
specifications referred to in paragraph 1 of this Article present a risk to the health or 
safety  of  persons,  the  PPE  in  compliance  with  those  common  specifications  which 
has been placed on the market shall be deemed compliant with this Regulation after 
the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this 
Article and after the expiry or deactivation of the Single Market Emergency mode in 
accordance with [the SMEI Regulation].  

Article 41g 
Prioritisation of market surveillance activities and mutual assistance among authorities 

1. 

2. 

Member States shall prioritise the market surveillance  activities for PPE designated 
as crisis-relevant goods. 

The  market  surveillance  authorities  of  the  Member  States  shall  deploy  their  best 
efforts to provide assistance to other market surveillance authorities during a Single 
Market  emergency,  including  by  mobilising  and  dispatching  expert  teams  to 
temporarily  reinforce  the  staff  of  market  surveillance  authorities  requesting 
assistance  or  by  providing  logistical  support  such  as  reinforcement  of  the  testing 
capacity for PPE designated as crisis-relevant goods.’ 

Article 3 
Amendments to Regulation (EU) 2016/426 

In Regulation (EU) 2016/426, the following Chapter VIa is inserted after Chapter VI: 

‘CHAPTER VIa 
EMERGENCY PROCEDURES 

Article 40a 
Applicationof emergency procedures 

1. 

2. 

3. 

Articles 40b to 40g shall only apply if the Commission has adopted an implementing 
act  pursuant  to  Article  23  of  [the  SMEI  Regulation]  activating  Article  26  of  [the 
SMEI Regulation] with respect to this Regulation.   

Articles 40b to 40g shall apply exclusively to appliances and fittings, which has been 
designated as crisis-relevant goods in the implementing act referred to in paragraph 1 
of this Article. 

Articles  40b  to  40g,  except  as  regards  provisions  concerning  the  powers  of  the 
Commission, shall apply during the Single Market emergency mode remains active. 

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26 

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However, Article 40c(2), second subparagraph, and Article 40c(5) shall apply during 
the Single Market emergency mode and after its deactivation or expiry. 

The  Commission  shall  be  empowered  to  lay  down  by  means  of  implementing  acts 
rules  regarding  the  follow-up  actions  to  be  taken  with  respect  to  appliances  and 
fittings  placed  on  the  market  in  accordance  with  Articles  40c  to  40f.  Those 
implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 42(3). 

Article 40b 
Prioritisation of the conformity assessment of crisis-relevant appliances and fittings 

This  Article  shall  apply  to  all  appliances  and  fittings  designated  as  crisis-relevant 
goods,  which  are  subject  to  conformity  assessment  procedures  in  accordance  with 
Article 14 requiring mandatory involvement of a notified body. 

The  notified  bodies  shall  process  all  applications  for  conformity  assessment  of 
appliances and fittings designated as crisis-relevant goods as a matter of priority. 

All  pending  applications  for  conformity  assessment  of  appliances  and  fittings 
designated as crisis-relevant goods shall be processed as a matter of priority, ahead 
of any other applications for appliances and fittings, which have not been designated 
as crisis-relevant goods. This requirement applies with respect to all applications for 
conformity assessment of appliances and fittings designated as crisis-relevant goods, 
irrespective  of  whether  they  have  been  lodged  before  or  after  the  activation  of  the 
emergency procedures pursuant to Article 41a.  

The  prioritisation  of  applications  for  conformity  assessment  of  appliances  and 
fittings  pursuant  to  paragraph  3  shall  not  give  rise  to  any  additional  costs  for  the 
manufacturers, who have lodged those applications. 

The notified bodies shall deploy their best efforts to increase their testing capacities 
for  appliances  and  fittings  designated  as  crisis-relevant  goods  in  respect  to  which 
they have been notified. 

4. 

1. 

2. 

3. 

4. 

5. 

Article 40c 
Derogation from conformity assessment procedures requiring mandatory involvement 
of a notified bod 

1. 

2. 

By  way  of  derogation  from  Article  14,  any  competent  national  authority  may 
authorise,  on  a  duly  justified  request,  the  placing  on  the  market  or  putting  into 
service within the territory of the Member State concerned, of a specific appliance or 
fitting  which  has  been  designated  as  crisis-relevant  good  and  for  which  the 
conformity assessment procedures requiring the mandatory involvement of a notified 
body, referred to in Article 14, have not been carried out by a notified body but for 
which  the  compliance  with  all  the  applicable  essential  requirements  has  been 
demonstrated. 

The manufacturer of an appliance or a fitting subject to the authorisation procedure 
referred to in paragraph 1 shall declare on his sole responsibility that the appliance or 
the fitting concerned complies with all the applicable essential requirements set out 
in  Annex  I  and  shall  be  responsible  for  the  fulfilment  of  all  the  conformity 
assessment procedures indicated by the national competent authority.  

The  manufacturer  shall  also  deploy  all  reasonable  measures  to  ensure  that  the 
appliance or fitting, which has been granted an authorisation pursuant to paragraph 1 
does not leave the territory of the Member State, which issued the authorisation. 

EN 

27 

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3. 

(a) 

(b) 

(c) 

(d) 

(e) 

4. 

5. 

6. 

7. 

8. 

Any authorisation issued by a national competent authority pursuant to paragraph 1 
shall  set  out  the  conditions  and  requirements  under  which  the  appliance  or  fitting 
may be placed on the market, including: 

a description of the procedures, by means of which compliance with the applicable 
essential requirements was successfully demonstrated; 

specific  requirements  regarding  the  traceability  of  the  subsystem  or  safety 
component concerned; 

an end date of validity of the authorisation, which cannot go beyond the last day of 
the period for which the Single Market emergency mode has been activated; 

any  specific  requirements  regarding  the  need  to  ensure  the  continuous  conformity 
assessment with respect to the subsystem or safety component concerned; 

measures to be taken with respect to the appliance or fitting concerned upon expiry 
of  the  authorisation  in  order  to  ensure  that  the  appliance  or  fitting  concerned  is 
brought back in compliance with all the requirements of this Regulation. 

By way of derogation from Article 40a(3), first subparagraph, where appropriate, the 
national competent authority may amend the conditions of the authorisation referred 
to  in  paragraph  3  also  after  the  deactivation  or  expiry  of  the  Single  Market 
Emergency mode.  

By  way  of  derogation  from  Articles  6  and  17,  appliances  or  fittings,  for  which  an 
authorisation has been granted in accordance with paragraph 1  of this Article, shall 
not  leave  the  territory  of  the  Member  State  which  has  issued  the  authorisation  and 
shall not bear the CE marking.  

The market surveillance authorities of the Member State, whose competent authority 
has  granted  an  authorisation  pursuant  to  paragraph  1  shall  be  entitled  to  take  all 
corrective  and  restrictive  measures  at  national  level  provided  for  under  this 
Regulation with respect to such appliances or fittings.  

Member  States  shall  inform  the  Commission  and  the  other  Member  States  of  any 
decision to authorise the placing on the market of appliances or fittings in accordance 
with paragraph 1. 

The application of Articles 40a to 40g and the use of the authorisation procedure set 
out  in  paragraph  1  of  this  Article  does  not  affect  the  application  of  the  relevant 
conformity  assessment  procedures  laid  down  in  Article  14  on  the  territory  of  the 
Member State concerned. 

Article 40d 
Presumption of conformity based on national and international standards 

Member States shall take all appropriate measures to ensure that, for the purposes of placing 
on the market or putting into service, their competent authorities consider that appliances and 
fittings, which comply with relevant international standards or any national standards in force 
in  the  Member  State  of  manufacture,  ensuring  the  safety  level  required  by  the  essential 
requirements  set  out  in  Annex  I,  comply  with  those  essential  requirements  in  either  of  the 
following cases: 

(a) 

where  no  reference  to  harmonised  standards  covering  the  relevant  essential  safety 
requirements set out in Annex I is published in the Official Journal of the European 
Union in accordance with Regulation (EU) No 1025/2012; 

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28 

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(b) 

1. 

(a) 

(b) 

2. 

3. 

4. 

5. 

severe  disruptions  in  the  functioning  of  the  Single  Market,  which  were  taken  into 
consideration  when  activating  the  Single  Market  emergency  mode  in  accordance 
with Article 15(4) of [the SMEI Regulation], significantly restrict the possibilities of 
manufacturers  to  make  use  of  the  harmonised  standards  covering  the  relevant 
essential  health  and  safety  requirements  set  out  in  Annex  I  to  this  Regulation  and 
already published in the Official Journal of the European Union in accordance with 
Regulation (EU) No 1025/2012. 

Article 40e 
Adoption of common specifications conferring a presumption of conformity 

Where  appliances  or  fittings  have  been  designated  as  crisis-relevant  goods,  the 
Commission  is  empowered  to  adopt  implementing  acts  establishing  common 
specifications for such appliances  or fittings  to  cover the essential requirements set 
out in Annex I in either of the following cases: 

where  no  reference  to  harmonised  standards  covering  the  relevant  essential 
requirements set out in Annex I is published in the Official Journal of the European 
Union in accordance with Regulation (EU) No 1025/2012; 

where  severe  disruptions  in  the  functioning  of  the  Single  Market,  which  led  to  the 
activation of the Single Market emergency mode in accordance with Article 15(4) of 
[the  SMEI  Regulation],  significantly  restrict  the  possibilities  of  manufacturers  to 
make  use  of  the  harmonised  standards  covering  the  relevant  essential  requirements 
set out in Annex I in this Regulation and already published in the Official Journal of 
the European Union in accordance with Regulation (EU) No 1025/2012. 

The  implementing  acts  referred  to  in  paragraph  1  of  this  Article  shall  be  adopted 
following  a  consultation  of  the  sectoral  experts  and  in  accordance  with  the 
examination  procedure  referred  to  in  Article  42(3).  They  shall  apply  to  appliances 
and fittings placed on the market no longer than until the last day of the period for 
which the Single Market emergency mode remains active. In the early preparation of 
the  draft  implementing  act  establishing  the  common  specification,  the  Commission 
shall gather the views of relevant bodies or expert groups established under relevant 
sectoral Union legislation. Based on that consultation, the Commission shall prepare 
the draft implementing act. 

Without prejudice to Article 13, appliances or fittings which are in conformity with 
common  specifications  adopted  pursuant  to  paragraph  2  of  this  Article  shall  be 
presumed  to  be  in  conformity  with  the  essential  requirements  set  out  in  Annex I 
covered by those common specifications or parts thereof. 

By  way  of  derogation  from  Article  40a(3),  first  subparagraph,  unless  there  is 
sufficient  reason  to  believe  that  the  appliances  or  fittings  covered  by  the  common 
specifications referred to in paragraph 1 of this Article present a risk to the health or 
safety  of  persons,  the  appliances  or  fittings  in  compliance  with  those  common 
specifications which have been placed on the market shall be deemed compliant with 
this Regulation after the expiry or repeal of an implementing act adopted pursuant to 
paragraph 2 of this Article and after the expiry or deactivation of the Single Market 
Emergency mode in accordance with [the SMEI Regulation].  

When  a  Member  State  considers  that  a  common  specification  referred  to  in 
paragraph  1  does  not  entirely  satisfy  the  essential  requirements  which  it  aims  to 
cover and which are set out in Annex I, it shall inform the Commission thereof with a 
detailed  explanation  and  the  Commission  shall  assess  that  information  and,  if 

EN 

29 

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1. 

2. 

3. 

appropriate,  amend  or  withdraw  the  implementing  act  establishing  the  common 
specification in question. 

Article 40f 
Adoption of mandatory common specifications 

In  duly  justified  cases,  the  Commission  is  empowered  to  adopt  implementing  acts 
establishing  mandatory  common  specifications  to  cover  the  essential  requirements 
set  out  in  Annex  I  for  appliances  or  fittings,  which  have  been  designated  as  crisis-
relevant goods. 

The implementing acts establishing mandatory common specifications, referred to in 
paragraph 1 of this Article, shall be adopted following a consultation of the sectoral 
experts and in accordance with the examination procedure referred to in Article 42(3) 
and they shall apply to appliances or fittings placed on the market at the latest until 
the last day of the period for which the Single Market emergency remains active. In 
the  early  preparation  of  the  draft  implementing  act  establishing  the  common 
specification,  the  Commission  shall  gather  the  views  of  relevant  bodies  or  expert 
groups  established  under  relevant  sectoral  Union  legislation.  Based  on  that 
consultation, the Commission shall prepare the draft implementing act. 

By  way  of  derogation  from  Article  40a(3),  first  subparagraph,  unless  there  is 
sufficient  reason  to  believe  that  the  appliances  or  fittings  covered  by  the  common 
specifications referred to in paragraph 1 of this Article present a risk to the health or 
safety  of  persons,  the  appliances  or  fittings  in  compliance  with  those  common 
specifications which have been placed on the market shall be deemed compliant with 
this Regulation after the expiry or repeal of an implementing act adopted pursuant to 
paragraph 2 of this Article and after the expiry or deactivation of the Single Market 
Emergency mode in accordance with [the SMEI Regulation]. 

Article 40g 
Prioritisation of market surveillance activities and mutual assistance among authorities 

1. 

2. 

The  Member  States  shall  prioritise  the  market  surveillance  activities  for  appliances 
and fittings designated as crisis-relevant goods. 

The  market  surveillance  authorities  of  the  Member  States  shall  deploy  their  best 
efforts to provide assistance to other market surveillance authorities during a Single 
Market  emergency,  including  by  mobilising  and  dispatching  expert  teams  to 
temporarily  reinforce  the  staff  of  market  surveillance  authorities  requesting 
assistance  or  by  providing  logistical  support  such  as  reinforcement  of  the  testing 
capacity for appliances and fittings designated as crisis-relevant goods. 

Article 4 
Amendments to Regulation (EU) 2019/1009 

In Regulation (EU) 2019/1009, the following Chapter Va is inserted: 

CHAPTER Va 
EMERGENCY PROCEDURES 

Article 41a 
Applicationof emergency procedures 

EN 

30 

  EN 

1. 

2. 

3. 

4. 

1. 

2. 

3. 

4. 

5. 

1. 

Articles 41b to 41g shall only apply if the Commission has adopted an implementing 
act  pursuant  to  Article  23  of  [the  SMEI  Regulation]  activating  Article  26  of  [the 
SMEI Regulation] with respect to this Regulation.   

Articles  41b  to  41g  shall  apply  exclusively  to  fertilising  products,  which  has  been 
designated as crisis-relevant goods in the implementing act referred to in paragraph 1 
of this Article. 

Articles  41b  to  41g,  except  as  regards  provisions  concerning  the  powers  of  the 
Commission, shall apply during the Single Market emergency mode. 

However, Article 41c(2), second subparagraph, and Article 41c(5) shall apply during 
the Single Market emergency mode and after its deactivation or expiry. 

The  Commission  shall  be  empowered  to  lay  down  by  means  of  implementing  acts 
rules regarding the follow-up actions to be taken with respect to fertilising products 
placed  on  the  market  in  accordance  with  Articles  41c  to  41f.  Those  implementing 
acts  shall  be  adopted  in  accordance  with  the  examination  procedure  referred  to  in 
Article 45(3). 

Article 41b 
Prioritisation of the conformity assessment of crisis-relevant fertilising products 

This  Article  shall  apply  to  fertilising  products  designated  as  crisis-relevant  goods, 
which are subject to conformity assessment procedures in accordance with Article 15 
requiring mandatory involvement of a notified body. 

The  notified  bodies  shall  process  all  applications  for  conformity  assessment  of 
fertilising products designated as crisis-relevant goods as a matter of priority. 

All pending applications for conformity assessment of fertilising products designated 
as crisis-relevant goods shall be processed as a matter of priority, ahead of any other 
applications  for  conformity  assessment of  fertilising products, which have not  been 
designated as crisis-relevant goods. This requirement is applicable with respect to all 
applications  for  conformity  assessment  of  fertilising  products  designated  as  crisis-
relevant  goods,  irrespective  of  whether  they  have  been  lodged  before  or  after  the 
activation of the emergency procedures pursuant to Article 41a.  

The  prioritisation  of  applications  for  conformity  assessment  of  fertilising  products 
pursuant  to  paragraph  3  shall  not  give  rise  to  any  additional  costs  for  the 
manufacturers, who have lodged those applications. 

The notified bodies shall deploy their best efforts to increase their testing capacities 
for  fertilising  products  designated  as  crisis-relevant  goods  in  respect  of  which  they 
have been notified. 

Article 41c 
Derogation from the conformity assessment procedures requiring mandatory 
involvement of a notified body 

By  way  of  derogation  from  Article  15,  any  competent  national  authority  may 
authorise, on a duly justified request, the placing on the market within the territory of 
the  Member  State  concerned,  of  a  specific  fertilising  product  which  has  been 
designated  as  crisis-relevant  good  and  for  which  the  conformity  assessment 
procedures  requiring  the  mandatory  involvement  of  a  notified  body  referred  to  in 
Article 15 have not been carried out by a notified body but for which the compliance 
with the requirements set out in Annexes I and II has been demonstrated. 

EN 

31 

  EN 

2. 

3. 

(a) 

(b) 

(c) 

(d) 

(e) 

4. 

5. 

6. 

7. 

8. 

The  manufacturer  of  a  fertilising  product  subject  to  the  authorisation  procedure 
referred to in paragraph 1 shall declare on his sole responsibility that the  fertilising 
product  concerned  complies  with  the  requirements  set  out  in  Annexes  I  and  II  and 
shall  be  responsible  for  the  fulfilment  of  all  the  conformity  assessment  procedures 
indicated by the national competent authority.  

The  manufacturer  shall  also  deploy  all  reasonable  measures  to  ensure  that  the 
fertilising product, which has been granted an authorisation pursuant to paragraph 1 
does not leave the territory of the Member State, which issued the authorisation. 

Any authorisation issued by a national competent authority pursuant to paragraph 1 
shall  set  out  the  conditions  and  requirements  under  which  the  fertilising  products 
may be placed on the market, including: 

a description of the procedures, by means of which compliance with the applicable 
essential requirements was successfully demonstrated; 

specific requirements regarding the traceability of the fertilising product concerned; 

an end date of validity of the authorisation, which cannot go beyond the last day of 
the period for which the Single Market emergency mode has been activated; 

any  specific  requirements  regarding  the  need  to  ensure  the  continuous  conformity 
assessment with respect to the fertilising product; 

measures to be taken with respect to the fertilising product concerned upon expiry of 
the authorisation in order to ensure that the fertilising product concerned is brought 
back in compliance with all the requirements of this Regulation. 

By way of derogation from Article 41a(3), first subparagraph, where appropriate, the 
national competent authority may amend the conditions of the authorisation referred 
to  in  paragraph  3of  this  Articcle  also  after  the  deactivation  or  expiry  of  the  Single 
Market Emergency mode.  

By  way  of  derogation  from  Articles  3  and  18,  fertilising  products,  for  which  an 
authorisation  has  been  granted  in  accordance  with  paragraph  1  of  this  Article  shall 
not  leave  the  territory  of  the  Member  State  which  has  issued  the  authorisation  and 
shall not bear the CE marking.  

The market surveillance authorities of the Member State, whose competent authority 
has  granted  an  authorisation  pursuant  to  paragraph  1,  shall  be  entitled  to  take  all 
corrective  and  restrictive  measures  at  national  level  provided  for  under  this 
Regulation with respect to such fertilising products.  

Member  States  shall  inform  the  Commission  and  the  other  Member  States  of  any 
decision to authorise the placing on the market of fertilising products in accordance 
with paragraph 1. 

The application of Articles 41a to 41g and the use of the authorisation procedure set 
out  in  paragraph  1  of  this  Article  does  not  affect  the  application  of  the  relevant 
conformity  assessment  procedures  laid  down  in  Article  15  on  the  territory  of  the 
Member State concerned. 

Article 41d 
Presumption of conformity based on national and international standards 

Where  severe  disruptions  in  the  functioning  of  the  Single  Market,  which  were  taken  into 
consideration when activating the Single Market emergency mode in accordance with Article 

EN 

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15(4)  of  [the  SMEI  Regulation]  significantly  restrict  the  possibilities  of  manufacturers  to 
make use of the harmonised standards covering the relevant requirements set out in Annex I, 
II  or  III  or  tests  referred  to  in  Article  13(2)  of  this  Regulation  and  already  published  in  the 
Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012, 
the  Member  States  shall  take  all  appropriate  measures  to  ensure  that,  for  the  purposes  of 
placing  on the market,  their competent  authorities  consider as complying  with  requirements 
set out in Annex I, II or III of this Regulation fertilising products which comply with relevant 
international  standards  or  any  relevant  national  standards  in  force  in  the  Member  State  of 
manufacture, ensuring a safety level equivalent to that required by the requirements set out in 
Annex I, II or III. 

Article 41e 
Adoption of common specifications conferring a presumption of conformity 

1. 

2. 

3. 

4. 

5. 

Where  EU  fertilising  products,  have  been  designated  as  crisis-relevant  goods,  the 
Commission  is  empowered  to  adopt  implementing  acts  establishing  common 
specifications for such EU fertilising products for the requirements set out in Annex 
I,  II  or  III  or  tests  referred  to  in  Article  13(2)  where  severe  disruptions  in  the 
functioning  of  the  Single  Market,  which  led  to  the  activation  of  [were  taken  into 
consideration  when]  the  Single  Market  emergency  mode  significantly  restrict  the 
possibilities of manufacturers to make use of the harmonised standards covering the 
relevant requirements set out in Annex I, II or III or tests referred to in Article 13(2) 
of  this  Regulation  and  already  published  in  the  Official  Journal  of  the  European 
Union in accordance with Regulation (EU) No 1025/2012. 

The  implementing  acts  referred  to  in  paragraph  1  of  this  Article  shall  be  adopted 
following  a  consultation  of  the  sectoral  experts  and  in  accordance  with  the 
examination procedure referred to in Article 45(3). They shall apply to EUfertilising 
products  placed  on  the  market  until  the  last  day  of  the  period  for  which  the  Single 
Market emergency mode remains active in accordance with [the SMEI Regulation]. 
In  the  early  preparation  of  the  draft  implementing  acts  establishing  the  common 
specification,  the  Commission  shall  gather  the  views  of  relevant  bodies  or  expert 
groups  established  under  relevant  sectoral  Union  legislation.  Based  on  that 
consultation, the Commission shall prepare the draft implementing act. 

Without prejudice to Article 13, EU fertilising products which are in conformity with 
common  specifications  adopted  pursuant  to  paragraph  2  of  this  Article  shall  be 
presumed to be in conformity with the requirements set out in Annex I, II or III [or 
tests  referred  to  in  Article  13(2)]  covered  by  those  common  specifications  or  parts 
thereof. 

By  way  of  derogation  from  Article  41a(3),  first  subparagraph,  unless  there  is 
sufficient  reason  to  believe  that  the  fertilising  products  covered  by  the  common 
specifications referred to in paragraph 1 of this Article present a risk to the health or 
safety  of  persons,  the  fertilising  products  in  compliance  with  those  common 
specifications which have been placed on the market shall be deemed compliant with 
this Regulation after the expiry or repeal of an implementing act adopted pursuant to 
paragraph 2 of this Article and after the expiry or deactivation of the Single Market 
Emergency mode in accordance with [the SMEI Regulation].  

When  a  Member  State  considers  that  a  common  specification  referred  to  in 
paragraph 1 does not entirely satisfy the requirements set out in Annexes I and II, it 
shall inform the Commission thereof with a detailed explanationand the Commission 

EN 

33 

  EN 

shall  assess 
implementing act establishing the common specification in question. 

information  and, 

if  appropriate,  amend  or  withdraw 

that 

the 

1. 

2. 

3. 

Article 41f 
Adoption of mandatory common specifications 

In  duly  justified  cases,  the  Commission  is  empowered  to  adopt  implementing  acts 
establishing  mandatory  common  specifications  for  EU  fertilising  products  to  cover 
the requirements  set  out in  Annexes  I  and  II  which have been designated as  crisis-
relevant goods. 

The  implementing  acts  referred  to  in  paragraph  1  shall  be  adopted  following  a 
consultation  of  the  sectoral  experts  and  in  accordance  with  the  examination 
procedure referred to in Article 45(3) and they shall apply to EU fertilising products 
placed  on  the  market  until  the  last  day  of  the  period  for  which  the  Single  Market 
emergency mode remains active. In the early preparation of the draft implementing 
act establishing the common specification, the Commission shall gather the views of 
relevant  bodies  or  expert  groups  established  under  relevant  sectoral  Union 
legislation.  Based  on  that  consultation,  the  Commission  shall  prepare  the  draft 
implementing act. 

By  way  of  derogation  from  Article  41a(3),  first  subparagraph,  unless  there  is 
sufficient reason to believe that the EU fertilising products covered by the mandatory  
common specifications referred to in paragraph 1 of this Article present a risk to the 
health or safety of persons, the fertilising products in compliance with those common 
specifications which have been placed on the market shall be deemed compliant with 
this Regulation after the expiry or repeal of an implementing act adopted pursuant to 
paragraph 2 of this Article and after the expiry or deactivation of the Single Market 
Emergency mode in accordance with [the SMEI Regulation].  

Article 41g 
Prioritisation of market surveillance activities and mutual assistance among authorities 

1. 

2. 

Member  States  shall  prioritise  the  market  surveillance  activities  for  fertilising 
products designated as crisis-relevant goods. 

The  market  surveillance  authorities  of  the  Member  States  shall  deploy  their  best 
efforts to provide assistance to other market surveillance authorities during a Single 
Market  emergency,  including  by  mobilising  and  dispatching  expert  teams  to 
temporarily  reinforce  the  staff  of  market  surveillance  authorities  requesting 
assistance  or  by  providing  logistical  support  such  as  reinforcement  of  the  testing 
capacity for fertilising products designated as crisis-relevant goods.’ 

Article 5 
Amendments to Regulation (EU) No 305/2011 

In Regulation (EU) 305/2011 is amended as follows: 

the following Chapter VIIIa is inserted: 

‘‘CHAPTER VIIIa 
EMERGENCY PROCEDURES 

Article 59a 

Application of emergency procedures  

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1. 

2. 

3. 

4. 

Articles 59b to 59f shall only apply if the Commission has adopted an implementing 
act  pursuant  to  Article  23  of  [the  SMEI  Regulation]  activating  Article  26  of  [the 
SMEI Regulation] with respect to this Regulation.   

Articles 59b to 59f shall apply exclusively to construction products, which have been 
designated as crisis-relevant goods in the implementing act referred to in paragraph 1 
of this Article. 

Articles  59b  to  59f,  except  as  regards  provisions  concerning  the  powers  of  the 
Commission, shall apply during the Single Market emergency mode. 

However, Article 59c(2), second subparagraph, and Article 59c(5) shall apply during 
the Single Market emergency mode and after its deactivation or expiry. 

The  Commission  shall  be  empowered  to  lay  down  by  means  of  implementing  acts 
rules  regarding  the  follow-up  actions  to  be  taken  with  respect  to  construction 
products  placed  on  the  market  in  accordance  with  Articles  59b  to  59f.  These 
implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 64(2a) 

Article 59b 

Prioritisation of the assessment and verification of constancy of performance of crisis-
relevant construction products 

1. 

2. 

3. 

4. 

5. 

This Article shall apply to construction products designated as crisis-relevant goods, 
which are subject to third party tasks of notified bodies related to the assessment and 
verification of constancy of performance, in accordance with Article 28(1). 

The  notified  bodies  shall  process  requests  for  third  party  tasks  related  to  the 
assessment  and  verification  of  constancy  of  performance  of  construction  products 
designated as crisis-relevant goods as a matter of priority. 

All  pending  applications  for  the  performance  of  third  party  tasks  related  to  the 
assessment  and  verification  of  constancy  of  performance  of  construction  products 
designated as crisis-relevant goods shall be processed as a matter of priority, ahead 
of  any  other  applications  regarding  construction  products,  which  have  not  been 
designated  as  crisis-relevant  goods.  This  requirement  applies  with  respect  to  all 
applications  for  third  party  tasks  related  to  the  assessment  and  verification  of 
constancy  of  performance  of  construction  products  designated  as  crisis-relevant 
goods, irrespective of whether they have been lodged before or after the activation of 
the emergency procedures pursuant to Article 59a.  

The prioritisation  of applications for third party tasks  related to  the assessment and 
verification  of  constancy  of  performance  of  construction  products  pursuant  to 
paragraph 3 shall not give rise to any additional costs for the manufacturerswho have 
lodged those applications. 

The  notified  bodies  shall  deploy  their  best  efforts  to  increase  their  respective 
assessment and verification capacities regarding construction products designated as 
crisis-relevant goods. 

Article 59c 
Derogation from the third party assessment procedures for assessment and verification 
of constancy of performance 

1. 

By  way  of  derogation  from  Article  28(1),  the  competent  national  authority  may 
exceptionally authorise, on a duly justified request, the placing on the market within 

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the territory of the Member State concerned, of a specific construction product which 
has  been  designated  as  crisis-relevant  good  for  which  the  required  third-party 
assessment  and  verification  of  constancy  of  performance  procedures  referred  to  in 
that Article have not been carried out by a notified body. 

The  manufacturer  of  a  construction  product  subject  to  the  authorisation  procedure 
referred to in paragraph 1 shall declare on his sole responsibility that the construction 
product concerned achieves the declared performance and shall be responsible for the 
fulfilment  of  all  the  procedures  for  the  assessment  and  verification  of  constancy  of 
performance indicated by the national competent authority.  

The  manufacturer  shall  also  deploy  all  reasonable  measures  to  ensure  that  the 
construction product, which has been granted an authorisation pursuant to paragraph 
1 does not leave the territory of the Member State, which issued the authorisation. 

Any authorisation issued by a national competent authority pursuant to paragraph 1 
shall set out the conditions and requirements under which the construction products 
may be placed on the market, including: 

a  description  of  the  procedures,  to  be  followed  in  order  to  demonstrate  that  the 
construction  product  achieves  the  declared  performance  and  complies  with  this 
Regulation, as applicable; 

the  specific  requirements  regarding  the  safety  as  well  as  the  traceability,  including 
labelling, of the concerned construction product; 

an end date of validity of the authorisation, which cannot go beyond the last day of 
the period for which the Single Market emergency mode has been activated; 

any specific requirements regarding the continuous performance of third party tasks 
related to the assessment and verification of constancy of performance with respect 
to the concerned construction product; 

measures to be taken with respect to the construction product concerned upon expiry 
of  the  authorisation  in  order  to  ensure  that  the  construction  product  concerned  is 
brought back in compliance with all the requirements of this Regulation. 

By way of derogation from Article 54a(3), first subparagraph, where appropriate, the 
national  competent  authority  may  amend  the  conditions  of  the  authorisation  issued 
referred to in paragraph 3 of this Article, also after the deactivation or expiry of the 
Single Market Emergency mode. 

Construction  products,  for  which  an  authorisation  has  been  granted  in  accordance 
with  paragraph  1  of  this  Article  shall  not  leave  the  territory  of  the  Member  State 
which has issued the authorisation and shall not bear the CE marking.  

The market surveillance authorities of the Member State, whose competent authority 
has  granted  an  authorisation  pursuant  to  paragraph  1,  shall  be  entitled  to  take  all 
corrective  and  restrictive  measures  at  national  level  provided  for  under  this 
Regulation with respect to such construction products.  

Member  States  shall  inform  the  Commission  s  of  any  decision  to  authorise  the 
placing on the market of construction products in accordance with paragraph 1. 

The application of Articles 59a to 59f and the use of the authorisation procedure set 
out  in  paragraph  1  of  this  Article  does  not  affect  the  application  of  the  relevant 
procedures for the assessment and verification of constancy of performance required 
by Article 28 on the territory of the Member State concerned. 

2. 

3. 

(a) 

(b) 

(c) 

(d) 

(e) 

4. 

5. 

6. 

7. 

8. 

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1. 

(a) 

(b) 

2. 

3. 

4. 

5. 

Article 59d 
Adoption of common specifications enabling performance assessment 

Where  construction  products,  have  been  designated  as  crisis-relevant  goods,  the 
Commission  is  empowered  to  adopt  implementing  acts  establishing  common 
specifications to cover the methods and the criteria for  assessing the performance of 
those products in relation to their essential characteristics in either of the following 
cases: 

where  no  reference  to  harmonised  standards  covering  the  relevant  methods  and 
criteria for assessing the performance of those products in relation to their essential 
characteristics  is  published  in  the  Official  Journal  of  the  European  Union  in 
accordance with Article 17(5); 

where the severe disruptions in the functioning of the Single Market, which led to the 
activation  of  the  Single  Market  emergency  mode  significantly  restrict 
the 
possibilities of manufacturers to make use of the harmonised standards, providing the 
relevant  methods  and  criteria  for  assessing  the  performance  of  those  product  in 
relation  to  their  essential  characteristics,  and  already  published  in  the  Official 
Journal of the European Union in accordance with Article 17(5). 

The  implementing  acts  referred  to  in  paragraph  1  of  this  Article  shall  be  adopted 
following  a  consultation  of  the  Standing  Committee  on  Construction  and  in 
accordance with the examination procedure referred to in Article 64(2a). They shall 
apply to  construction products placed on the market until the last day of the period 
for  which  the  Single  Market  emergency  mode  remains  active.  In  the  early 
preparation of the draft implementing act establishing the common specification, the 
Commission  shall  gather  the  views  of  relevant  bodies  or  expert  groups  established 
under  relevant  sectoral  Union 
the 
Commission shall prepare the draft implementing act. 

legislation.  Based  on 

that  consultation, 

Without  prejudice to  Articles 4  and 6, the methods and the criteria provided in  the 
common specifications adopted pursuant to paragraph 1 of this Article, may be used 
for  assessing  and  declaring  the  performance  of  construction  products  covered  by 
those common specifications in relation to their essential characteristics.   

By  way  of  derogation  from  Article  59a(3),  first  subparagraph,  declaration  of 
performance in compliance with the common specifications referred to in paragraph 
1  of  this  Article  regarding  construction  products  which  have  been  placed  on  the 
market shall not be affected by the subsequent expiry or repeal of the implementing 
act,  which  has  laid  down  those  common  specifications,  unless  there  is  sufficient 
reason to believe that construction products covered by those common specifications 
present a risk or do not achieve the declared performance.  

When  a  Member  State  considers  that  a  common  specification  referred  to  in 
paragraph  1  is  incorrect  in  terms  of  criteria  and  methods  for  the  assessment  of 
performance  in  relation  to  essential  characteristics,  it  shall  inform  the  Commission 
thereof with a detailed explanation and the Commission shall assess that information 
and, if appropriate, amend or withdraw the implementing at establishing the common 
specification in question 

Article 59e 
Adoption of mandatory common specifications 

1. 

In  duly  justified  cases,  the  Commission  is  empowered  to  adopt  implementing  acts 
establishing mandatory common specifications to cover the methods and the criteria 

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2. 

3. 

for assessing the performance of construction products which have been designated 
as crisis-relevant goods. 

The  implementing  acts  referred  to  in  paragraph  1  of  this  Article  shall  be  adopted 
following  a  consultation  of  the  Standing  Committee  on  Construction  and  in 
accordance with the examination procedure referred to in Article 64(2a). They shall 
apply to  construction products placed on the market until the last day of the period 
for  which  the  Single  Market  emergency  remains  active.  In  the  early  preparation  of 
the draft implementing acts establishing the common specifications, the Commission 
shall gather the views of relevant bodies or expert groups established under relevant 
sectoral Union legislation. Based on that consultation, the Commission shall prepare 
the draft implementing act. 

By  way  of  derogation  from  Article  59a(3),  first  subparagraph,  unless  there  is 
sufficient reason to believe that the construction products covered by the mandatory 
common specifications referred to in paragraph 1 of this Article present a risk to the 
health  or  safety  of  persons,  the  construction  products  in  compliance  with  those 
common  specifications  which  have  been  placed  on  the  market  shall  be  deemed 
compliant  with  this  Regulation  after  the  expiry  or  repeal  of  an  implementing  act 
adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of 
the Single Market Emergency mode in accordance with [the SMEI Regulation].  

Article 59f 
Prioritisation of market surveillance activities and mutual assistance among authorities 

1. 

2. 

Member  States  shall  prioritise  the  market  surveillance  activities  for  construction 
products designated as crisis-relevant goods. 

The  market  surveillance  authorities  of  the  Member  States  shall  deploy  their  best 
efforts to provide assistance to other market surveillance authorities during a Single 
Market  emergency,  including  by  mobilising  and  dispatching  expert  teams  to 
temporarily  reinforce  the  staff  of  market  surveillance  authorities  requesting 
assistance  or  by  providing  logistical  support  such  as  reinforcement  of  the  testing 
capacity for construction products designated as crisis-relevant goods.’ 

(2) In Article 64, the following paragraph 2a is inserted: 

‘2a.  Where  reference  is  made  to  this  paragraph,  Article  5  of  Regulation  (EU)  No 
182/2011 shall apply.’ 

Article 6 
Entry into force 

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. 

It shall apply from [OP- please insert the date identical to that of the entry into application of 
the SMEI Regulation]. 

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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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