EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2014) XXX  draft 
  
COMMISSION DIRECTIVE ../…/EU 
of XXX  
amending, for the purpose of adapting to technical progress, A nnex II to Directive 
2009/48/EC of the European Parliament and of the Council on th e safety of toys 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION DIRECTIVE ../…/EU 
of XXX  
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 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 2009/48/EC of the Eu ropean Parliament and of the Council of 18 
June 2009 on the safety of toys
1, and in particular Ar ticle 46(1)(b) thereof, 
Whereas: (1) Directive 2009/48/EC lays down migration limits for toys or components of toys, for a 
range of elements, including lead, in dry, liquid and scraped-off toy material. The 
limits for lead are 13,5 mg/kg, 3,4 mg/ kg and 160 mg/kg in each toy material, 
respectively.  
(2) Those limits were based on the recommendati ons of the Dutch National Institute for 
Public Health and the Environment (R IVM) made in th e 2008 report entitled 
‘Chemicals in Toys. A general methodology for assessment of chemical safety of toys 
with a focus on elements’.
2 The RIVM recommendations were based on the 
conclusion that exposure of children to elemen ts such as lead may not exceed a certain 
level, called ‘tolerable daily intake’. In  the report, a tolerable daily intake of 3,6 
microgram per kilogram body weight per day was determined for lead as the 
toxicological reference value. 
(3) Since children are exposed to elements, such as lead, also via othe r sources than toys, 
only a certain percentage of the toxicologi cal reference value s hould be allocated to 
toys. The Scientific Committee on Toxicit y, Ecotoxicity and E nvironment (CSTEE) 
recommended that 10% of the maximum tolera ble intake of certain elements such as 
lead should be allowed as th e maximum contribution from toys3. The Scientific 
Committee for Health and Environmenta l Risks (SCHER) concurred with the 
approach that the uptake of elements such as lead from toys should not exceed 10% of 
a toxicology-based reference value4. Furthermore, since lead is considered particularly 
toxic, its limits in Directive 2009/48/EC were set at levels half of those considered 
safe according to the criteria of the relevant Scientific Co mmittee, in order to ensure 
that only traces that are compatible with  good manufacturing pract ice will be present. 
                                                 
1 OJ L 170, 30.6.2009, p. 1.  
2 J.G.M. Van Engelen, et al. (2008) RIVM report 320003001/2008. 
  http://www.rivm.nl/biblioth eek/rapporten/320003001.pdf 
3 Scientific Committee on Toxicity, Ecotoxicity an d Environment (CSTEE), Opinion on the "Assessment 
of the bioavailability of certain elements in toys", adopted on 22 June 2004, p. 3. 
4 Scientific Committee on Health and Environmental Risks (SCHER), Opinion on the "Evaluation of the 
Migration Limits for Chemical Elements in Toys", adopted on 1 July 2010, p. 5.  
EN 3   EN Accordingly, the limits for lead were se t at 5% of the tolerable daily intake, 
determined as migration from lead in toys. 
(4) The European Food Safety Agency (EFSA) conc luded that for lead, as a toxic metal, 
there is no threshold below which the exposure to lead has no critical health effects. 
Even low-level exposure to lead is suscepti ble to cause neurotoxicity (i.e. damage to 
the nervous system and brain) , in particular learning defi cits. Therefore, according to 
the new scientific knowledge published by EF SA, the tolerable daily intake should no 
longer be used as the toxi cological reference value5. 
(5) According to EFSA, the new toxicological refe rence value to be used for establishing 
lead limits is the BMDL 01 (benchmark dose limit) rela ting to neuro-developmental 
effects. The BMDL 01 is the lower confidence limit (95% percentile) of the benchmark 
dose of a 1% extra risk of intellectual deficits in children measured by the Full Scale 
IQ score, i.e. a decrease in  IQ by 1 point on that scale6. The BMDL 01 is equivalent to a 
lead intake of 0,5 microgram pe r kilogram body weight per day. 
(6) The Committee for Risk Assessment (R AC) established under the European 
Chemicals Agency (ECHA) agre ed with EFSA that the BMDL 01 is the highest 
tolerable exposure for lead7. Since the current average blood lead levels in European 
children are up to 4 times higher than this highest tolerable exposure level, and since 
no threshold for the neuro-developmental e ffects can be established, any additional 
exposure must be avoided as far as possible8. 
(7) Applying the latest scientific developm ents to the methodology in the above-
mentioned RIVM report to calculate safe lim its for elements in toys, and applying the 
approach of Directive 2009/48/ EC to managing the risks of particularly toxic elements 
such as lead, the limits for lead in toys  laid down in Directive 2009/48/EC should be 
reviewed, and should be set at  a 5% allocation of the BMDL 01 for the protection of 
children's health. 
(8) Directive 2009/48/EC should therefore be amended accordingly. 
(9) The measures provided for in this Directiv e are in accordance with the opinion of the 
Toy Safety Committee, 
HAS ADOPTED THIS DIRECTIVE: 
 
 
Article 1 
In the table under point 13 of part III of Anne x II the entry for lead is replaced by the 
following: 
                                                 
5 EFSA CONTAM Panel (2013), Scientific Opinion on Lead in Food. (See footnote above ) p. 5. Applied 
in: SCHER (2011), Opinion on a Lead Standard in Drinking Water, adopted on 11 January 2011. 
6 EFSA CONTAM Panel (2013), Scientific Opinion on Lead in Food. (See footnote above.) p. 5, p. 98. 
7 ECHA (RAC) (2013), Opinion on an Annex XV dossier proposing restrictions on lead and its 
compounds in articles intended for consumer use,  adopted on 10 December 2013, ECHA/RAC/RES-O-
0000003487-67-04/F, p. 5.  
8 ECHA RAC (2013), Opinion on an Annex XV dossier proposing restrictions on lead and its compounds 
in articles intended for consumer use (see footnote 6, p. 5.  
EN 4   EN Element  mg/kg 
in dry, brittle, powder-
like or pliable toy 
material mg/kg 
in liquid or sticky toy 
material  mg/kg 
in scrapped-off toy 
material  
‘Lead 2,0 0,5 23’ 
 
Article 2 
1. Member States shall adopt and publish, by [… (Fill in date falling 18 months after 
publication in the OJ) ] at the latest, the laws, re gulations and administrative 
provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions. 
They shall apply those provisions from [… Fill in same date as in previous 
subparagraph) ]. 
When Member States adopt those provisions,  they shall contain a reference to this 
Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determin e how such reference is to be made. 
2. Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 
Article 3 
This Directive shall enter into force on the tw entieth day following that of its publication in 
the Official Journal of  the European Union . 
Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 The President