COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE EVALUATION of Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys
Date: 2020-11-19
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: European standard, dangerous substance, free movement of goods, health risk, market supervision, product safety, safety standard, technical standard, toy industry

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   EUROPEAN COMMISSION  Brussels, 19.11.2020  SWD(2020) 288 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE EVALUATION  of Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys  {SWD(2020) 287 final}  
 
 
Executive summary 

Toys  have  to  be  safe  when  children  play  with  them.  The  Toy  Safety  Directive  (Directive 
2009/48/EC) therefore lays down rules to make toys safe, including when they are exposed to 
children’s sometimes ‘unforeseeable’ behaviour. 

At the same time, the Directive ensures the successful functioning of the internal market for 
toys, worth almost EUR 20 billion a year. The toy industry is dynamic and innovative: around 
one third of the toys on the market each year have new features or are newly developed. 

The Toy Safety Directive has been adapted 12 times since its adoption, resulting most often in 
strict(er)  limit  values  for  hazardous  chemicals  that  might  be  present  in  toys,  such  as  for 
chromium  VI,  lead,  phenol  and  bisphenol  A.  There  is  a  focus  on  chemicals  because 
knowledge  about  their  toxicity  evolves  more  often  than  knowledge  about  other  hazards  in 
toys; chemicals are more often recognised to be more hazardous than previously known. 

This evaluation of the Toy Safety Directive assesses the functioning of the Directive since its 
entry into force. It is based on the following sources: 

  a 2015 external study evaluating the Directive; 
  online  questionnaires  addressed  to  Member  States  and  stakeholders  (a  public 
consultation and a specific consultation of economic operators on the costs caused by 
the Directive);  
the  Member  States’  reports  on  the  application  of  the  Directive  in  their  national 
territory; these are due every 5 years, covering 2009–2013 and 2014–2018; 

 

  a  study  on  the  Directive’s  costs  and  benefits,  supplied  by  the  Commission’s  Joint 

Research Centre (JRC); and  

  several  Commission  fitness  checks  and  related  studies  on  chemicals  legislation, 

insofar as they refer to toys;  

  a 2013 external report on the toy industry prepared on behalf of the Commission;  
  knowledge  and  experience  acquired  in  the  Directive’s  day-to-day  management, 

including from discussions with Member States and stakeholders. 

The  effectiveness  of  the  Toy  Safety  Directive  appears  to  have  improved  over  that  of  its 
predecessor Directive from 1988. This is due in particular to the clarified definition of ‘toy’, 
but  also  to  the  much  larger  number  of  particular  safety  requirements,  notably  on  chemicals 
restricted for use in toys. 

Despite  this,  the  Directive’s  effectiveness  is  deficient  in  several  points,  in  particular  on 
chemicals.  Although  specific  limit  values  can  be  set  for  any  chemicals  in  toys,  these  limit 
values only apply to toys for children under the age of 36 months, and to toys intended to be 
put in the mouth. Since a chemical’s toxicity does not vanish when a child reaches the age of 
36 months  or  just  because  a  toy  is  not  intended  to  be  put  in  the  mouth,  the  Directive’s 
effectiveness is limited in this regard. Furthermore, the prohibition in principle of chemicals 
that  are  carcinogenic,  mutagenic  or  toxic  for  reproduction  (CMR)  has  a  derogation  that 
tolerates their presence in concentrations too high to ensure effective protection according to 
current  scientific  knowledge.  Similarly,  the  limit  values  for  nitrosamines,  which  are  often 
carcinogenic, and for nitrosatable substances, which may generate nitrosamines, are too high. 
Finally,  the  tailor-made  labelling  requirements  for  specific  allergenic  fragrances  in  certain 

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experimental  toy  sets  cannot  be  easily  updated  when  the  lists  of  allergenic  fragrances  are 
amended. 

The Directive’s safety requirements for hazards other than chemical hazards have not led to 
any  major  discussion  with  Member  States  or  stakeholders  about  their  effectiveness,  so  it 
seems that they can be readily applied in practice. Only the applicability of the requirements 
for toys for children under 36 months, which manufacturers find indeed challenging, is under 
almost permanent discussion. Classifying a toy as being for older children avoids the costs for 
the  ‘extra  slice  of  safety’  that  children  under  36 months  deserve.  Market  surveillance 
authorities,  however,  quite  swiftly  find  consensus, 
if  not  agreement,  on  disputed 
classifications. 

Toy  safety  standards  that  the  Commission  has  referenced  in  the  Official  Journal  appear  to 
have  been  effective  in  supporting  children’s  safety.  There  have  been  no  major  incidents 
involving  toys  complying  with  such  standards.  Also,  only  very  rarely  did  Member  States 
object to a standard as insufficient. 

The  Directive’s  effectiveness  with  regard  to  the  internal  market  was  highly  rated  by  all 
stakeholders, although some differences in interpretation and national deviations are still to be 
resolved.  In  practice,  the  market  has  flourished  since  the  Directive  started  to  apply  fully  in 
mid-2013, as demonstrated by the remarkable 60% increase in intra-EU exports of toys since 
2012/2013. 

In contrast, the effectiveness of market surveillance under the Directive, which lays down just 
a  general  obligation  to  carry  out  surveillance,  is  limited.  Market  surveillance  authorities 
inspect just a few tens of thousands of toys every year, even though the market might consist 
of  billions.  Moreover,  when  authorities  select  toy  samples  for  inspection,  they  find 
approximately one in every three samples as non-compliant with the Directive. However, an 
improvement  in  market  surveillance  can  be  expected  from  the  Regulation  on  Market 
Surveillance  and  Compliance  of  Products,  applicable  as  of  2021,  with  its  binding,  detailed 
EU-wide rules. 

In  terms  of  efficiency,  the  Toy  Safety  Directive  is  generally  considered  to  provide  an 
appropriate  balance  between  costs  and  benefits.  The  Directive,  which  is  stricter  than  its 
predecessor,  imposed  one-off  costs  on  manufacturers  in  particular  to  adapt  to  the  new 
manufacturing, testing  and documentation requirements. These costs amounted to  about  2% 
of  annual  turnover,  and  are  recovered  over  3  years  or  less  on  average.  The  Directive  also 
generates higher costs at cruising speed due to its higher number of requirements (about 7% 
higher  than  in  the  predecessor  Directive)  and  its  regular  adaptations  (about  1%  of  annual 
turnover).    Despite  the  higher  costs,  the  number  of  toy  companies  in  the  EU  increased  by 
some 10% within 5 years from mid-2013, when all the requirements of the new Toy Safety 
Directive became applicable in the Member States. 

Quantifying the benefits of the Directive is very challenging. On the one hand, this is due to 
the non-availability of data for key indicators such as the reduction of accidents and injuries 
involving  toys,  but  it  is  also  due  to  many  confounding  factors,  such  as  manufacturers’ 
decisions to automate production processes or to move to low-wage countries to save costs, 
which  might  lead  to  lower  toy  prices  (or  higher  profits  for  manufacturers).  Qualitatively 

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speaking,  benefits  have  been  identified  in  particular  in  ensuring  legal  certainty  and  a  level 
playing field in the internal market, and are considered to outweigh the costs. 

The  Toy  Safety  Directive’s  relevance  is  generally  recognised  with  regard  to  the  safety  of 
toys,  in  particular  given  that  dangerous  toys  continue  to  appear  on  the  market;  however, 
technical  and  scientific  developments  are  not  taken  up  sufficiently  quickly.  With  regard  to 
trade  across  the  EU,  the  Directive  is  acknowledged  as  successfully  enabling  the  free 
movement  of  toys.  As  the  Directive  is  focused  on  the  protection  of  (physical)  health  and 
safety, it does not cover internet-connected toys, which may also harm children’s privacy and 
security. Specific action on internet-connected devices, including toys, is being taken instead 
under the Radio Equipment Directive. 

The Toy Safety Directive provides for only a general reporting obligation for Member States. 
It does not identify the indicators and related data needs for future monitoring and evaluation 
that could help draw a detailed picture of the Directive's effects or identify impediments to its 
functioning. As a consequence, the available data  are often incomplete or not representative 
and,  therefore,  not  always  comparable.  Future  data  collection  and  monitoring  on  toy  safety 
could  thus  be better harmonised to  ensure consistency in  the  Member States’ reports and to 
enable meaningful comparisons between the data collected. 

The coherence of the Directive with other EU or national legislation appears to be ensured, 
with  the  exception  of  the  stricter  limit  values  for  the  (carcinogenic)  nitrosamines  and 
nitrosatable  substances  in  one  Member  State,  which  the  Commission  has  however 
acknowledged as being justified. 

Finally,  the  EU  added  value  of  the  Toy  Safety  Directive,  stemming  from  it  being  a 
‘maximum harmonisation’ directive, is clearly acknowledged. This EU added value is visible 
in particular in its harmonising effect on health and safety requirements for toys and the large, 
seamless market for toys that it creates throughout the EU. 

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