COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a Council Directive amending, for the purpose of adapting to technical progress, Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards lead
Date: 2016-09-09
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: European standard, lead, product safety, safety standard, technical standard, technological change, toxic substance, toy industry

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   EUROPEAN COMMISSION  Brussels, 9.9.2016  SWD(2016) 289 final   COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT  Accompanying the document Proposal for a Council Directive amending, for the purpose of adapting to technical progress, Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards lead {COM(2016) 560 final} {SWD(2016) 290 final}  
 
 
Executive Summary Sheet 

Impact assessment accompanying the document Proposal for a Council Directive amending, for the purpose of 
adapting to technical progress, Annex II to Directive 2009/48/EC of the European Parliament and of the Council 
on the safety of toys, as regards lead 

A. Need for action 

Why? What is the problem being addressed? 
Lead  is  particularly  toxic.  According  to  the  European  Food  Safety  Authority  (EFSA)  in  2010,  lead  has  no  safe 
threshold  in  humans.  The  3  limits  for  lead  in  toys,  of  2009  (Toy  Safety  Directive  2009/48/EC;  TSD),  therefore 
have to be strengthened. 
Market monitoring studies in 2010 and 2011 in Germany (almost 2 500 samples) showed that most toys already 
complied with strengthened limits, except finger paints, colour pencil leads and water paint tablets, possibly due 
to contaminated raw material. These results were confirmed by Sweden. 

What is this initiative expected to achieve? 
This initiative will adapt the lead limits in the TSD to latest scientific knowledge. It will thus maintain 
 

the high level of protection of children regarding a possible presence of lead in toys: All children in the EU 
under 14 years of age (73 million), but primarily children under 3 (16 million) who are most vulnerable and 
who particularly mouth toys and ingest toy material. 
the Single Market for toys, since the TSD applies throughout the EU. 

 

What is the value added of action at the EU level? 
This  initiative  will  maintain  a  high  level  of  protection,  block  possible  action  of  single  Member  States  (MS)  to 
establish national limits, and eliminate the existing diverging limit in Germany. 

B. Solutions 

What  legislative  and  non-legislative  policy  options  have  been  considered?  Is  there  a  preferred 
choice or not? Why? 
Baseline  option:  No  strengthening  of  the  3  limits  in  the  TSD.  Other  options:  Voluntary  agreements  with(in) 
industry  to  reduce  lead  in  toys,  labelling  of  contaminated  toys,  strengthening  all  3 limits,  strengthening  with 
exemptions  for  certain  toys  or  (certain  parts  of)  industry.  Preferred  option:  strengthening  all  3  limits:  In 
agreement with science, best protection of children, equal treatment of economic operators. 

Who supports which option? 
Strengthening all 3 limits was supported by 17 MS, 9 MS favoured strengthening but with less strict limits (2 MS 
not  represented),  as  did  industry.  -  Options  with  exemptions  were  discarded  because  of  the  health  risks  for 
children and unequal treatment of economic operators. 

C. Impacts of the preferred option 

What are the benefits of the preferred option (if any, otherwise main ones)? 
Health benefits of the preferred option: EUR 836 million for avoiding behavioural and attention problems (ADHD) 
and EUR 1 176 million for avoiding reduced intelligence in children. (No adding up!) 
Economic benefits can be anticipated for test laboratories: More testing of toys and toy raw materials. 

What are the costs of the preferred option (if any, otherwise main ones)? 
The preferred option could lead to 662 lost jobs, equivalent to EUR 8,5 million, and to a loss of EUR 89 million of 
production value: Thus total up to EUR 97,5 million. 

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

Only the industry producing toys with contaminated raw materials could be affected (6,5 % of all toy sales in the 
EU). The EU toy industry consists of over 99 % SMEs. 

Will there be significant impacts on national budgets and administrations? 
No. 

Will there be other significant impacts?  
No. 

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When will the policy be reviewed?  
Upon new scientific knowledge. 

D. Follow up 

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