COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council, and repealing Council Directive 87/357/EEC and Directive 2001/95/EC of the European Parliament and of the Council
Date: 2021-06-30
Institutions: Directorate-General for Justice and Consumers, European Commission
Subjects: European standard, consumer goods, harmonisation of standards, market supervision, product safety, safety standard, technical standard, traceability

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  EN 

   EUROPEAN COMMISSION  Brussels, 30.6.2021  SWD(2021) 169 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT  Accompanying the document Proposal for a Regulation of the European Parliament and of the Council  on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council, and repealing Council Directive 87/357/EEC and Directive 2001/95/EC of the European Parliament and of the Council                 {COM(2021) 346 final} - {SEC(2021) 280 final} - {SWD(2021) 168 final}  
 
 
Executive Summary Sheet  

Impact assessment on a Proposal to revise the General product safety directive 

A. Need for action 

What is the problem and why is it a problem at EU level?  

This Impact Assessment follows the Evaluation of the General Product Safety Directive (GPSD), carried 
out in parallel. Evaluation results show that GPSD is a valid instrument and overall met its objectives, but 
still  too  many  unsafe  products  circulate  on  the  EU  market,  creating  an  uneven  playing  field  for 
businesses  and  an  important  cost  for  society  and  consumers.  The  preventable  detriment  to  EU 
consumers and society from injuries/death caused by unsafe products is estimated at EUR 11.5 billion per 
year and the detriment to consumers  based on the value of unsafe products is estimated at  EUR 19.3 
billion. Specific problems in the GPSD relate to the following: the GPSD does not sufficiently address 
challenges linked to new technologies and the online sales; unsafe product recalls from consumers are 
not sufficiently effective, market surveillance provisions are not fully effective and coherent with rules 
relevant for harmonised products; and safety rules for food-imitating products are inconsistently applied 
across  the  EU.  Main  drivers  of  those  problems  are  market  and  regulatory  failures,  in  a  context  where 
online  sales  and  new  technologies  are  strongly  growing.  These  problems  are  expected  to  increase  over 
time, as consumer product sales will be more and more related to globalisation and digitalisation.   

What should be achieved? 

The initiative aims to achieve the general objectives of ensuring protection of EU consumers from unsafe 
products, while contributing to the proper functioning of the Single Market, in particular a level playing 
field for businesses. The specific objectives are to (1) ensure the EU legal framework provides for general 
safety  rules  for  all  consumer  products  and  safety  risks,  including  those  linked  to  new  technologies;  (2) 
address product safety challenges in the online sales channels; (3) make product recalls more effective and 
efficient to keep unsafe products away from consumers; (4) enhance market surveillance and ensure better 
alignment of rules for harmonised and non-harmonised consumer products  and (5) address  safety issues 
related to food imitating products.  

What is the value added of action at the EU level (subsidiarity)?  

Product safety is  a shared competence between Member States and the EU. The problems identified are 
widespread and have the same causes across the EU. The objective of product safety cannot be sufficiently 
achieved  by  the  Member  States  acting  alone,  given  the  need  for  a  very  high  degree  of  cooperation, 
interaction and coherent action of all the market surveillance authorities across the EU to ensure the same 
high level of protection of all EU consumers and enable level-playing field on the Single Market where 
goods  circulate  freely.  Absence  of  EU  action  would  also  significantly  increase  the  costs  of  market 
surveillance for Member States and administrative costs for businesses. 

B. Solutions 

What are the various options to achieve the objectives? Is there a preferred option or not? If not, 
why?  

Beyond the baseline scenario, the following policy options have been identified to address the objectives:  

Option 1: Improved implementation and enforcement of the existing legal framework, mainly through 
increased guidance and  promotion  of the current  tools  but without legal  revision of the GPSD (only the 
Food-Imitating Product Directive would be revised);  

Option 2: Targeted revision of the GPSD, as a Directive or Regulation, addressing the coverage of new 
risks  linked  to  new  technologies,  making  several  provisions  inspired  by  the  Product  Safety  Pledge 
provisions  legally  binding,  introducing  mandatory  requirements  for  product  recalls,  aligning  with  the 

 
 
market  surveillance  rules  for  harmonised  products  and  integrating  rules  for  food-imitating  products  into 
the GPSD. 

Option  3:  Full  revision  of  the  GPSD  in  the  form  of  a  Regulation  providing  for,  beyond  Option  2, 
clarifications of safety rules linked to software, additional obligations related to online sales and product 
recalls,  stronger  enforcement  powers  to  Member  States,  setting  an  arbitration  mechanism  for  disputes 
between them in relation with divergent risk assessments, and enhancing product traceability.  

Option  4:  Integration  of  the  legal  instruments  on  market  surveillance,  beyond  the  provisions  under 
Option 3. 

The substantive provisions of the Food-imitating Product Directive were considered to be revised under all 
options  1  to  4  with  two  possible  sub-options:  (a)  a  full  ban  of  food-imitating  products  per  se  and  (b) 
application of the risk-assessment approach to this category of products. 

The preferred option is Option 3 with the (b) sub-option for food imitating products. 

What are different stakeholders' views? Who supports which option? 

During  the  open  consultation  on  the  GPSD  Roadmap/Inception  Impact  assessment,  most  of  the 
stakeholders supported the GPSD legal revision, almost half of them being in favour of the full revision 
(Options  3+4).  In  the  open  public  consultation,  as  well  as  other  consultation  activities,  stakeholders 
provided  clear  support  to  specific  measures  under  Option  3.  Consumer  organisations  are  generally  in 
favour  of  Option  4.  Member  States  are  mostly  supporting  Option  3.  Businesses  highlight  the  need  for 
clear definition of responsibilities,  legal  certainty  and level-playing field  and seem  therefore to  favour  a 
legal revision of the GPSD (Option 2 and 3). 

C. Impacts of the preferred option 

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

Option  3  is  expected  to  lead  to  major  benefits  to  consumers  and  society.  The  consumer  detriment  is 
estimated  today,  based  on  the  value  of  unsafe  products,  to  be  around  EUR  19.3  billion.  This  should 
decrease by approximately EUR 1.0 billion in the first year of implementation of the preferred option 
and  decrease  by  approximately  EUR  5.5  billion  over  the  next  decade.  Option  3  should  also  reduce 
consumer detriment related to ineffective recalls by more than EUR 400 million per year. Moreover, the 
current detriment suffered by EU consumers and society due to preventable product-related accidents is 
estimated at EUR 11.5 billion per year. The current cost of health care for product-related injuries in 
the EU is approximately EUR 6.7 billion per year (hospitalisation accounting for about EUR 6.1 billion). 
These  costs  should  also  be  reduced  by  measures  under  Option  3  resulting  in  lower  number  of  unsafe 
products  (this  impact  could  not  be  quantified  due  to  lack  of  injury  data  to  estimate  trends).  Estimated 
savings  of  costs,  caused  by  reducing  the  differences  in  the  national  implementation  and  legal 
fragmentation,  is  estimated  to  amount  to  EUR  59  million  annually  for  businesses  and  to  EUR  0.7 
million  per  year  for  market  surveillance  authorities.  Reduced  number  of  unsafe  products,  including 
those containing hazardous chemicals, would have also positive environmental impacts. 

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

Total  costs  for  businesses  in  the  EU27  in  the  first  year  of  implementation  of  Option  3  are  estimated  at 
EUR 196.6 million (one-off and recurrent costs), equivalent to 0.02% of turnover of EU companies for 
manufacturing,  wholesale  and  retail  of  non-harmonised  products.  In  the  following  years,  the  recurrent 
costs  would  amount  to  EUR  177.8  million  for  EU  businesses.  These  costs  are  linked  to  the  increased 
obligations for businesses mainly for online sales, sales of new technology products and recalls of unsafe 
products  and  to  the  alignment  of  the  market  surveillance  rules  with  those  for  harmonised  products. 
Market  surveillance  authorities  in  Member  States  would  face  total  additional  recurrent  costs  under 
Option  3  of  approximatively  EUR  6.7  million  annually  due  to  the  increased  powers  in  the  market 

 
 
surveillance of unsafe products and only relatively moderate one-off adaptation and implementation costs. 
There are no negative environmental or social impacts. 

What are the impacts on SMEs and competitiveness? 

SMEs and micro-SMEs are not exempted from any of the obligations foreseen under the preferred option. 
EU  product  safety  legislation  does  not  allow  for  "lighter"  regimes  for  SMEs  since  a  consumer  product 
must  be  safe  whatever  the  characteristics  of  its  supply  chain,  to  meet  the  general  objective  of  product 
safety and consumer protection. Total costs for EU SMEs in the first year of implementation of Option 3 
are  estimated  at  EUR  111.1  million  (one-off  and  recurrent  costs).  In  the  following  years,  the  recurrent 
costs would amount to around EUR 100 million for EU SMEs. Estimated savings of costs, caused by 
reducing  the  differences  in  the  national  implementation  and  legal  fragmentation,  would  amount  to 
EUR 34 million for EU SMEs. The most affected business sectors would be online sales, producers of 
some  new  technology  sectors  but  without  having  a  major  impact  on  their  competitiveness  through 
harmonised EU requirements. 

Will there be significant impacts on national budgets and administrations? 

Member  States  would  face  total  additional  recurrent  costs  under  Option  3  of  around  EUR  6.7  million 
annually  but  these  should  be  compensated  by  reduced  health  care  costs  due  to  decrease  of  unsafe 
products  on  the  market.  Also,  cost  savings  of  around  EUR  0.7  million  per  year  would  arise  due  to 
harmonisation of market surveillance rules for Member States. This harmonisation will also facilitate 
the  implementation  of  the  initiative  by  Member  States,  since  they  are  already  familiar  with  rules  for 
harmonised products. 

Will there be other significant impacts? 

Option 3 would have positive impacts on fundamental rights by ensuring a higher level of the consumer 
protection  and  environmental  protection  due  to  a  decrease  of  unsafe  products  on  the  EU  market. 
Additional requirements for businesses do not affect the fundamental freedom to conduct a business and 
appear to be proportionate to the general objective pursued. Option 3 should also create simplification and 
reduction  of  administrative  burden  by  streamlining  the  standardisation  procedure  and  reducing  legal 
uncertainty (lack of clarity of certain substantive rules) and fragmentation (diverging market surveillance 
rules for different categories of products). 

Proportionality?  

Option  3  appears  conform  to  the  principle  of  proportionality  given  that  the  size  of  the  identified 
problem  is  significant  (high  presence  of  unsafe  consumer  products  on  the  EU  market  and  related  high 
consumer  detriment)  and  the  costs  associated  with  this  option  are  limited.  Overall,  the  balance  of  this 
option  is  positive  as  it  brings  positive  impacts  for  consumers  and  society  and  costs  for  business 
remain  low  in  percentage  of  their  turnover.  In  addition,  the  choice  of  Regulation  as  Union  action  is 
coherent  with  satisfactory  achievement  of  the  objective  to  ensure  level-playing  field  and  effective  and 
even enforcement at national level. 

D. Follow up 

When will the policy be reviewed?  

In addition to regular monitoring, an evaluation of the effectiveness, efficiency, relevance, coherence and 
EU  added  value  of  this  legislative  intervention  is  proposed  5  years  after  implementation  by  Member 
States, based on predetermined core progress indicators.