EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
[…](2012) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending part III of Annex II to Directive 2009/48/EC of the European Parliament and 
of the Council  on the safety of toys 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending part III of Annex II to Directive 2 009/48/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, and in particular Article 46(1) (b) thereof, 
Whereas: (1) Directive 2009/48/EC sets limit values fo r barium, based on the recommendations of 
the Dutch National Institute for Public Hea lth and the Environment (RIVM) made in 
the 2008 report entitled "Chemicals in Toys. A general methodology for assessment of chemical safety of toys with a focus on elements". The RIVM recommendations are based on the conclusion that exposure of child ren to chemicals in toys may not exceed 
a certain level, called "tolerable daily inta ke". Since children are exposed to chemicals 
via other sources than toys, only a percentage  of the tolerable daily intake should be 
allocated to toys. The Scientific Co mmittee on Toxicity, Ecotoxicity and the 
Environment (CSTEE) recommended in its 2004 report that a ma ximum of 10 % of 
the tolerable daily intake may be allocated to toys. This alloca tion has been endorsed 
by the Scientific Committee on Health and Environmental Risks (SCHER) committee in its opinion entitled "Evaluation of the mi gration limits for chemical elements in 
toys" and adopted on 1 July 2010. 
(2) According to the RIVM recommendations, th e maximum percentage of the tolerable 
daily intake should be multiplied by the weight of a child, estimated at 7,5 kg, and divided by the quantity of toy material ingested, in order to obtain the limit values for 
the chemical substances list ed in Directive 2009/48/EC. 
(3) For barium, RIVM used a tolerable da ily intake of 0.6 mg /kg body weight/day, 
following the approach of the US Agency fo r Toxic Substances and Disease Registry 
(ATSDR) in its 2005 report on th e toxicological profile for barium, based on animal 
experiments data. Other barium reviews, based on human data, we re considered by 
RIVM but not used for determining barium 's tolerable daily intake. Although human 
data are considered as a more appropriate basis for deriving a to lerable daily intake, 
RIVM considered that the studies providi ng these data contained important flaws. 
Therefore animal experiments data, more reli able for deriving a tolerable daily intake, 
were used. 
(4) In order to define possible exposure scenario s to chemical substances, the quantity of 
toy material ingested was estimated by the RIVM at 8 mg per day for scraped-off toy material, 100 mg for brittle toy material and 400 mg for liquid or sticky toy material. Those ingestion limits were supported by SCHE R in its opinion entitled "Risks from 
organic CMR substances in toys" adopted on 18 May 2010.   
EN 3   EN (5) By applying 10 % of the tolerable daily intake, multiplied by the weight of the child 
and divided by the quantity of toy material ingested, the following limit values for barium were established: 56 000 mg/kg fo r scrapped-off material, 4500mg/kg for dry 
material and 1125 mg/kg for liquid material.  
(6) The US Agency for Toxic Substances a nd Disease Registry published in 2007 an 
update of its report on the toxicological pr ofile for barium, where a tolerable daily 
intake of 0.2 mg/kg body weight/day is pr oposed. This update was made available 
after the finalisation of the RIVM report.  Additionally, following discussions with 
stakeholders, it was considered that the IP CS report from 2001 was not appropriately 
taken into consideration by RIVM.  
(7) Taking this into account, the Commission se nt a request for an opinion to the SCHER 
committee, asking for an additional evaluati on of the migration limits for barium, and 
recommendations with regard to the tolerable da ily intake to be used, in the light of the 
IPCS and ATSDR (2007) documents. 
(8) In its opinion adopted on the 22 March 20 12, SCHER concluded that the available 
data on humans are not appropriate in order to derive a tolerable daily intake. Good 
quality animal studies are more appropriate for deriving a tolerable daily intake for barium, which, in SCHER's opinion, shoul d be 0.2 mg /kg body weight/day.  
(9) This value takes into account the gastro intestinal absorpti on of barium. SCHER 
estimates that children aged 1 to15 have a gastrointestinal absorption of 30 %, while 
infants will absorb 60 %. However, SCHER ba sis barium's tolerable daily intake on 
the "worst case scenario" a ssumption according to which children will absorb 100% of 
the barium they are exposed to.  
(10) Applying 10 % of the new tolerable daily inta ke multiplied by the weight of the child 
and divided by the quantity of toy material i ngested results in the following limits for 
barium: 18750 mg/kg for scrapped-off materi al, 1500 mg/kg for dry material and 375 
mg/kg for liquid material. 
(11) In order to ensure the best possible prot ection of health and life of humans, in 
particular children, it is necessary to appl y those lower migration limits for Barium 
within the shortest possibl e delay. Therefore, the Dire ctive should be amended by a 
Regulation which enters into force on 20 July 2013, thus avoiding a longer period of 
transposition of a Directiv e during which different migration limits would apply. 
(12) Directive 2009/48/EC should therefore be amended accordingly.  
(13) The measures provided for in this Regula tion are in accordance with the opinion of 
the Committee, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Part III of Annex II to Directiv e 2009/48/EC is amended in accord ance with the Annex to this 
Regulation.  
Article 2 
This Regulation shall ente r into force on 20 July 2013.  
EN 4   EN This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels,  
 For the Commission 
 The President      On behalf of the President    [Position]  
EN 5   EN ANNEX  
In part III of Annex II, the entry for bari um in point 13 is replaced by the following: 
Element  mg/kg 
in dry, brittle, power-
like or pliable toy material mg/kg 
in liquid or sticky toy 
material  mg/kg 
in scrapped-off toy 
material  
'Barium 1500 375 18750'