COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on the mutual recognition on goods lawfully marketed in another Member State
Date: 2017-12-19
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EU Member State, administrative cooperation, exchange of information, free movement of goods, goods and services, market approval, mutual recognition principle, single market, technical rule

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   EUROPEAN COMMISSION  Brussels, 19.12.2017  SWD(2017) 472 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT  Accompanying the document Proposal for a Regulation of the European Parliament and of the Council  on the mutual recognition on goods lawfully marketed in another Member State {COM(2017) 796 final} - {SWD(2017) 471 final} - {SWD(2017) 475 final} - {SWD(2017) 476 final} - {SWD(2017) 477 final}  
 
 
Impact assessment on Proposal for a Regulation of the European Parliament and of the Council on mutual 
recognition on goods 

Executive Summary Sheet 

Why? What is the problem being addressed?  

A. Need for action 

The  Evaluation  has  concluded  that  mutual  recognition  does  not  function  as  it  should,  due  to  the  lack  of 
awareness,  the  legal  uncertainty  and  the  lack  of  efficient  communication  and  cooperation  among 
stakeholders. Economic operators don’t benefit fully from their existing rights. National authorities lose time 
and  resources.  Consumers  face  higher  prices  and  lower  choices.  Absent  any  action  at  EU  level,  it  is 
expected for the problem to remain. 

What is this initiative expected to achieve?  

While  the  expected  benefits  cannot  be  estimated  with  accuracy,  a  recent  study  on  "The  Costs  of  Non-
Europe in the Single Market" shows that a reduction of trade barriers could lead to an increase of intra-EU 
trade  of  more  than  100  billion  EUR  per  year.  The  concept  of  trade  barriers  in  this  study  is  broader  than 
mutual recognition only, but it provides an estimation of the expected benefits.  

What is the value added of action at the EU level?  

Having  a  common  set  of  rules  guarantees  equal  treatment  and  allows  a  coherent  application  of  mutual 
recognition.  Action  by  Member  States  alone  would  dismantle  the  principle  in  28  different  and  potentially 
contradicting national procedures.   

What legislative and non-legislative policy options have been considered? Is there a preferred 
choice or not? Why?  

B. Solutions 

The policy options assessed were: 
  Option 2 - Soft law  
  Option 3 - Minimum legislative changes  
  Option 4 - Comprehensive legislative  
  Option 5 - Voluntary prior authorisation to marketing 
The preferred option is option 4 complemented by option 2. 

Who supports which option?  

Option 2 was supported by all, if complemented by other tools.  

Option 3 was considered potentially effective by all but to a less extent than other options.  

Option 4 was considered by all as the most effective.  

There was a consensus against option 5. 

C. Impacts of the preferred option 

What are the benefits of the preferred option (if any, otherwise main ones)?  

Option 4 combined with option 2 will increase awareness and knowledge about mutual recognition, while 
bringing legal certainty on the application of the principle and improving administrative cooperation among 
Member States.  

What are the costs of the preferred option (if any, otherwise main ones)?  

Costs  for  companies  are  minimal.  Member  States  and  the  Commission  will  bear  certain  necessary  costs, 
estimated  as  follows:  organisation  and  coordination  of  awareness  and  training  events  (500  000  Euro), 
exchange  of  officials' scheme  (170  000  Euro  per  year),  the  fast  track  appeal  procedure  (3-4  Commission 
FTEs, 225 000-300 000 Euro per year), increased administrative cooperation (1 200 000 Euro per year).  

How will businesses, SMEs and micro-enterprises be affected?  

Micro and SMEs will be positively impacted by the initiative without incurring any additional costs.  

Will there be significant impacts on national budgets and administrations?  

Product Contact Points may be affected as appropriate resources will be needed for the entrusted tasks.  

Will there be other significant impacts?  

There will be bigger market opportunities for companies, in particular the innovative ones.   

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When will the policy be reviewed?  

D. Follow up 

The Commission would report to the European Parliament and to the Council five years after the entry into 
force of the new regulation and every five years thereafter. 

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