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 laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on products and amending Regulations (EU) No 305/2011, (EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2017/1369 of the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC, 2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council
Date: 2017-12-19
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: approximation of laws, import (EU), market approval, market supervision, marketing standard, product quality, product safety, quality standard, single market, surveillance concerning imports

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 19.12.2017  SWD(2017) 467 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 laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on products and amending Regulations (EU) No 305/2011, (EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2017/1369 of the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC, 2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council {COM(2017) 795 final} - {SWD(2017) 466 final} - {SWD(2017) 468 final} - {SWD(2017) 469 final} - {SWD(2017) 470 final}  
 
 
Executive Summary Sheet 

Impact assessment on Proposal for a Regulation of the European Parliament and of the Council on laying 
down  rules  and  procedures  for  compliance  with  and  enforcement  of  Union  harmonisation  legislation  on 
products 

Why? What is the problem being addressed?  

A. Need for action 

The  value  of  products subject  to EU  harmonised  rules  amounts  to  more  than  2 400  billion  euro  per  year 
representing 69% of the overall value of manufacturing products in the EU. The existence of non-compliant 
products  exposes  citizens  to  potentially  dangerous  products,  puts  the  environment  at  risk  and  distorts 
competition. The root causes are limited knowledge of rules, low deterrence, and major inefficiencies in the 
enforcement systems. The problem is expected to increase due to growing online sales and imports from 
third countries.  

What is this initiative expected to achieve?  

This  initiative  aims  to  reduce  the  number  of  non-compliant  products  in  the  Single  Market,  by  (1) 
Reinforcing  cooperation  procedures  (2)  Increasing  operational  enforcement  capacity,  improving  efficiency 
and  availability  of  resources;  (3)  Strengthening  the  enforcement  toolbox;  (4)  Promoting  compliance  and 
accessibility of compliance information.   

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

Enforcement of Union harmonisation legislation is the responsibility of Member States that are constrained 
by jurisdictional boundaries. Coordination of activities is necessary to ensure consistent enforcement across 
the EU and efficiently tackle non-compliance.  

B. Solutions 

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

The options considered are: (1) Baseline; (2) Improvement of existing tools and cooperation mechanisms; 
(3)  in addition  increased  deterrence  effect  to  enforcement  tools and  stepped up  EU  coordination  and (4) 
further  added-on  centralised  EU  level  enforcement  in  certain  cases.  The  preferred  option  includes  a 
mechanism  for  mutual  assistance  among  authorities,  an  EU  Product  Compliance  Network  to  coordinate, 
help  implementing  joint  enforcement  activities  and  peer  review  Member  States'  performance,  common 
powers  for  authorities,  more  systematic  publication  of  restrictive  measures,  recovery  of  control  costs  in 
case  of  non-compliant  products  and  obligation  of  manufacturers  to  designate  a  person  responsible  for 
compliance information in the EU and an extended advice role of Product Contact Points, digital publication 
of compliance information and a web-portal for voluntary measures. 
Who supports which option?  

Stakeholders concur on the need for much stronger coordination, more and efficient use of resources and 
more effective tools to improve the enforcement framework for controls within the Single Market and for 
imports into the EU.  

C. Impacts of the preferred option 

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

The  initiative  would  result  in  more  effective  enforcement  against  non-compliant  products  throughout  the 
Single Market and more efficient checking of imports. Product users' would be better protected from undue 
environmental, public and occupational health and safety risks. Businesses would benefit from compliance 
assistance, a more level playing field and reduced unfair competition.  

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

Some  economic  operators  may  face  adjustments  to  provide  compliance  information  digitally  or  appoint  a 
responsible  person  in  the  EU.  Costs  to  the  Commission/EU  budget  would  relate  in  particular  to  the 
establishment of an EU Product Compliance Network (€18 million per year). No negative environmental or 
social impacts are anticipated.  

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

The  proposal  would  help  businesses,  including  SMEs,  reduce  negative  effects  from  unfair  competition  or 
inconsistencies.  

Will there be significant impacts on national budgets and administrations?  

Member States would have to adjust to new procedures, but they would also save costs due to streamlined 

1 

 
cooperation procedures.  

Will there be other significant impacts?  

In  the  fine-tuning  of  national  authority  powers  and  enforcement  measures,  due  respect  for  fundamental 
rights and the principles of legality and proportionality will need to be ensured.  

When will the policy be reviewed? 

D. Follow up 

In  addition  to  regular  monitoring,  an  evaluation  of  the  functioning  of  the  new  legislative  framework  is 
expected after around 5 years of implementation.  

2