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 the safety of toys and repealing Directive 2009/48/EC
Date: 2023-07-28
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EC conformity marking, European standard, child, free movement of goods, market approval, product safety, safety standard, technical standard, toy industry

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   EUROPEAN COMMISSION  Brussels, 28.7.2023  SWD(2023) 270 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 the safety of toys and repealing Directive 2009/48/EC     {COM(2023) 462 final} - {SEC(2023) 297 final} - {SWD(2023) 268 final} - {SWD(2023) 269 final}  
 
 
Executive Summary Sheet 

Impact assessment on a proposal for a regulation of the European Parliament and of the Council on the safety of 
toys 

A. Need for action 

What is the problem and why is it a problem at EU level? 
The evaluation of the Toy Safety Directive (TSD)1 (the Evaluation) identified a number of deficiencies in the TSD 
in ensuring a high level of protection of children from possible risks in toys, and in particular from risks posed by 
harmful chemicals. The Evaluation also concluded that there remain many non-compliant and unsafe toys on the 
EU market. 

What should be achieved?  

This  initiative  should  achieve  a  higher  level  of  protection  of  children  from  the  most  harmful  substances  and 
reduce the number of non-compliant and unsafe toys on the EU market. 

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

The TSD  harmonises  toy-safety  rules  across  Member  States  based  on  Article  114  TFEU.  Any  changes  to  the 
scope  or  requirements  of  such  a  directive  must  be  made  at  EU  level  to  avoid:  (i)  distorting  the  market;  (ii) 
creating barriers to the free movement of products; or (iii) undermining the protection of human health and well-
being.  

B. Solutions 

What are the various options to achieve the objectives? Is there a preferred option or not? If not, why? 
In addition to the baseline of no action, the impact assessment identifies three policy options (POs) to address 
the two problems identified, the first problem being the need to  better protect children from harmful chemicals, 
and the second problem being the many non-compliant/unsafe toys on the EU market.  

To strengthen the requirements to protect children from harmful chemicals:  

  PO1a would empower the Commission to add and amend limit values for chemicals in any toy; 
  PO1b  is  similar  to  PO1a  but  also  includes  generic  bans  for  the  most  harmful  chemicals  in  toys,  allowing 

derogations; 

  PO1c is similar to PO1b but would not allow derogations to the generic bans.  

To reduce the many non-compliant and unsafe toys: 

  PO2a  would extend the requirement for third-party conformity assessment to: (i) toys for children under the 

age of 3; (ii) toys to be put in the mouth; and (iii) toys which are chemical mixtures;  

  PO2b  would  require  the  compliance  documentation  to  accompany  the  product  digitally,  relying  on  the 
product passport under the Ecodesign for Sustainable Products Regulation (ESPR)2, and would also require 
this product passport to be presented at customs; 

  PO2c would combine the requirements of PO2a and PO2b. 

The preferred option is  PO1b  together with PO2b. PO1b would significantly improve children’s protection from 
harmful substances while limiting the negative impacts for industry by providing for derogations to generic bans. 
PO2b  would  ensure  that  toys  presented  at  customs  without  the  product  passport  would  be  automatically 
prevented  from  being  released  for  free  circulation.  In  addition,  there  would  be  significant  efficiency  gains  for 
market surveillance authorities when inspecting toys. Thus PO2b would have the potential to significantly reduce 
the  number  of  non-compliant  toys  on  the  EU  market.  Other  policy  options  that  included  third-party  conformity 
assessment were not considered to be as effective or efficient; it was assessed that they would increase costs 
for compliant manufacturers while not leading to a significant reduction of non-compliant toys.  

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/1852-Evaluation-of-the-Toy-

1  
Safety-Directive. 
2 Proposal for a Regulation of the European Parliament and of the Council establishing a framework for setting 
ecodesign  requirements  for  sustainable  products  and  repealing  Directive  2009/125/EC  of  30  March  2022, 
COM(2022) 142 final. 

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What are different stakeholders’ views? Who supports which option? 
Industry stakeholders supported PO1a but not PO1b, and strongly opposed PO1c. Industry was also opposed to 
PO2a,  but  supported  the  digitalisation  of  compliance  information  in  PO2b.  Member  States  expressed  clear 
support  for  strengthening  the  requirements  for  chemicals,  both  with  specific  limit  values  and  with  additional 
generic  prohibitions  for  certain  substances  (PO1a  and  PO1b).  They  supported  PO2b.  They  also  supported 
PO2a, but to a lesser extent. Consumers favoured  PO1b and PO1c. Consumers also favoured introducing the 
product  passport  (PO2b)  as  well  as  the  extension  of  the  requirement  for  third-party  conformity  assessment 
(PO2a and PO2c). 

C. Impacts of the preferred option 

impact  assessment  considers 

What are the benefits of the preferred option (if any, otherwise main ones)? 
The 
that  PO1b  would  have  considerable  health  benefits  (between 
EUR 240 million  and  EUR  1.2  billion  per  year)  in  terms  of  avoided  health  damage  for  endocrine 
disruptors alone. PO2b would lead to significant efficiency gains for market surveillance authorities. Moving to 
digital information could lead to savings of between EUR 2.62 million and EUR 3.93 million (EUR 3.275 
million  on  average)  per  year  for  industry.  PO2b  would  also  lead  to  savings  for  industry  in  dealing  with 
inspections  by market surveillance authorities that could range from  EUR  13  million  to  EUR  20  million  per 
year. Both options combined would improve the protection of children and reduce the number of non-compliant 
and  unsafe  toys;  thus  improving  the  functioning  of  the  single  market  and  the  competitiveness  of  industry.The 
savings  from  moving  to  digital  information  of  between  EUR  2.62  million  and  EUR  3.93  million  per  year  were 
considered as administrative savings within the scope of the ‘one in, one out’ approach. 

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

The generic prohibition could affect a significant number of toy models that would need to be subject to product 
adaptations  or  which  could  no  longer  be  made  available,  but  derogations  would  limit  this  impact.  PO1b  could 
result in total incremental  one-off adjustment costs associated  with  product  redesign  and  redevelopment  of 
an  additional  EUR  23.5  to  EUR  396.66  million.  Yearly  testing  costs  could  increase  compared  to  the 
baseline  by  around  EUR  7.31-11.70  million.  In  terms  of  products  that  could  no  longer  be  made  available, 
based on EU industry turnover, this option could affect EUR 249-367 million worth of products3. This is not 
expected  to  lead  to  a  direct  market  contraction  of  that  size  due  to  manufacturers  shifting  resources  and 
production to alternative toys as well as consumers buying alternative toys. The costs of requesting derogations 
could range between EUR 100 000 to EUR 300 000 per year. PO2b could lead to EUR  18  million  of  one-off 
administrative  costs  and  subsequent  costs  of  EUR  10.5  million  per  year  for  industry.  These  costs, 
together  with the costs for requesting derogations were accounted for as administrative burden to be offset as 
part of the ‘one in, one out’ approach.  

What are the impacts on SMEs and competitiveness? 

PO2b would allow SMEs to reap the benefits of the digital age. It would also potentially reduce the burden faced 
by  both  SMEs  and  larger  companies.  PO1b  and  PO2b  would  have  synergistic  impacts  in  improving 
competitiveness. Although PO1b would impose costs on industry to comply with new requirements on chemical 
substances,  it  would  be  accompanied  by  effective  measures  under  PO2b  to  significantly  reduce  unfair 
competition from non-compliant toys. This would help preserve the competitiveness of compliant businesses in 
the  toy  industry.  Without  PO2b,  PO1b  could  lead  to  more  rogue  traders  benefiting  from  selling  non-compliant 
(and often cheaper) toys. 

Will there be significant impacts on national budgets and administrations? 
Although  Member  States  may  face  some  adaptation  costs  to  adjust  to  the  product  passport,  these  should  be 
already  incurred  within  the  ESPR.  Having  the  compliance  information  readily  available  will  lead  to  significant 
efficiency gains and savings for market surveillance authorities. 

Will there be other significant impacts? 
No other significant impacts have been identified. 

3 Based on provisional EU industry turnover of EUR 6.56 billion for 2020.  

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Proportionality? 
The preferred option does not exceed what it is needed to achieve the objectives. The most harmful substances 
will be subject to generic bans in toys, but derogations will be possible. The product passport will lead to initial 
costs  but  also  generate  savings  for  industry  and  efficiency  gains  for  authorities.  It  will  significantly  reduce  the 
number of non-compliant toys on the EU market thereby strengthening the competitiveness of industry. 

When will the policy be reviewed? 
The new regulation will be evaluated after 5 years. 

D. Follow-up 

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