EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2017) XXX  draft  
  
COMMISSION DIRECTIVE (EU) .../…  
of XXX  
amending, for the purpose of adaptation to technical and scientific developments, point 
13 of part III of Annex II to Directive 2009/48/EC of the European Parliament and of 
the Council on the safety of toys, as regards chromium VI  
(Text with EEA relevance)   EN 2   EN COMMISSION DIRECTIVE (EU) .../…  
of XXX  
amending, for the purpose of adaptation to technical and scientific developments, point 
13 of part III of Annex II to Directive 2009/48/EC of the European Parliament and of 
the Council on the safety of toys, as regards chromium VI  
(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 European Parliament and of the Council of 
18 June 2009 on the safety of toys1, and in particular Article 46( 1)(b) thereof,  
Whereas:  
(1) Directive 2009/48/EC sets a limit value for chromium VI  in scraped -off toy material 
such as paints on toys, hard and soft polymers, wood, textiles, and others. The current 
limit value (0,2 mg/kg) is based on a tolerable daily intake of 0,0053  µg of chromium 
VI per kg  bodyweight per day proposed by the Office of Environmental Health Hazard 
Assessment (OEHHA) of the California Environmental Protection Agency2. 
(2) At the request of the  European Commission, the Scientific Committee on Health and 
Environmental Risks (SCHER) assessed in 2015 the relevance  of the oral cancer 
potency of chromium VI. In its opinion on "Chromium VI in toys" adopted on 
22 January 20153, SCHER reported to have reviewed, among others, the OEHHA 
technical support document for the Public Health Goal for chromium VI in drinking 
wate r4  and a US -National Toxicology Program (NTP) study5. The SCHER considered 
0,0002 µg of chromium VI per kg bodyweight per day, derived by the OEHHA as 
being associated with one additional cancer case in a million, as an appropriate 
tolerable daily intake . 
(3) Since children are also exposed to chromium VI through sources other than toys, only 
a certain percentage  of the tolerable daily intake should be taken as the basis when 
                                                 
1 OJ L 170, 30.6.2009, p. 1.  
2 OEHHA (1999). Public health goal for chromium in drinking water. Pesticide and Environmental 
Toxicology Section Office of Environmental Health Hazard. Assessment Californ ia Environmental 
Protection Agency. Dated February 1999. Cited in: Chemicals in Toys. A general methodology for 
assessment of chemical safety of toys with a focus on elements RIVM report 320003001/2008. National 
Institute for Public Health and the Environm ent (RIVM) of The Netherlands. p. 114 , Table 8 -1. 
3  Scientific Committee on Health and Environmental Risks (SCHER) , Opinion on "Chromium VI in 
toys". Adopted on 22 January 2015.  
 http://ec.europa.eu/health/sites/health/files/scientific_committees/environmental_risks/docs/scher_o_16
7.pdf  
4 OEHHA (2011). Public h ealth goals for chemicals in drinking water. Hexavalent chromium (Cr VI). 
http://oehha.ca.gov/water/phg/072911Cr6PHG.html   
5 National Toxicology Program (2008). Toxicology and Carcinogenesis S tudies of Sodium Dichromate 
Dihydrate (CAS No. 7789 -12-0) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP TR 
546, NIEHS, Research Triangle Park, NC. NIH Publication No. 08 -5887.  EN 3   EN calculating the limit value  for chromium VI .  The maximum contribution from toys to 
the daily intake of chromium VI recommended by the Scientific Committee on 
Toxicity, Ecotoxicity and the Environment  in its 2004 opinion6 is 10  %. 
(4) In addition, for chromium VI and other chemical substances which are particularly 
toxic,  Directi ve 2009/48/EC suggests in its recital 22 to set limit values at half of those 
considered safe by the relevant Scientific Committee, in order to ensure that only 
traces that are compatible with good manufacturing practice will be present.  
(5) Applying 10  % of t he tolerable daily intake, multiplied by the average weight of a 
child  under three years  of age , estimated at 7,5  kg, divided by the daily quantity of 
scraped -off toy material ingested , estimated at 8 mg/day,  and multiplied by ½  led the 
SCHER to propose , in its above -mentioned opinion on "Chromium VI in toys" ,  
0,0094 mg/kg as a revised limit value for chromium VI in scraped -off toy material . 
(6) Compliance with the proposed limit value can, however , not be verified with the test 
method in European standard EN 71 -3:2013+A1:2014, the reference of which has 
been published in the Official Journal of the European Union7. The proposed limit 
value is almost six times lower than the lowest concentration that can be reliably 
measured with th e test method  in the standard , which is 0,053 mg/kg . 
(7) In those circumstances,  the subgroup "Chemicals" of the Expert Group on Toys Safety 
established by the Commission8 recommended at its meeting on 14 October 2016 to  
lower the limit value for chromium VI  from the current 0,2  mg/kg to 0,053 mg/kg.  The 
subgroup "Chemicals" equally recommended to review available test methods for 
chromium VI every two years to possibly identify a test method that can reliably 
measure  even lower concentrations, until the limit value  proposed by SCHER has been 
reached.  
(8) The European Committee for Standardization  (CEN) is currently reviewing the test 
method in standard EN 71 -3 with regard  to improving the detection of chromium VI . 
A revised test method is expected to  be available soon al lowing to reliably measure 
concentrations down to 0,0025 mg/kg. It would then be possible to strengthen further 
the limit value for chromium VI  in scraped -off toy material . 
(9) Directive 2009/48/EC should therefore be amended accordingly.  
(10) The measures provided for in this Directive are in accordance with the opinion of the 
Toy Safety Committee , 
HAS ADOPTED THIS DIRECTIVE:  
Article 1  
In point 13 of Part III of Annex II to Directive 2009/48/EC, the entry for chromium  VI is 
replaced by the foll owing entry : 
Element  mg/kg  
in dry, brittle, mg/kg  
in liquid or sticky toy mg/kg  
in scraped -off toy 
                                                 
6 Scientific Committee on Toxicity, Ecotoxicity and the Environme nt (CSTEE) . Opinion  on "Assessment 
of the bioavailability of certain elements in toys". Adopted on 22 June 2004.  
 http://ec.europa.eu/health/archive/ph_risk/c ommittees/sct/documents/out235_en.pdf   
7 OJ C 378, 13.11.2015, p.  1. 
8 See Register of Commission Expert Groups, Expert Group on Toys Safety  (E01360).  
 http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=1360   EN 4   EN powder -like or 
pliable toy material  material  material  
”Chromium (VI)  0,02 0,005  0,053”  
Article  2 
1. Member States shall adopt and publish, by [18 months after publication in the OJ]  at 
the latest, the laws, regulations 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  [18 months after publication in the OJ + 
1 day]. 
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 determine  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 twentiet h 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  
 Jean-Claude Juncker