EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2018) XXX  draft  
 
COMMISSION DIRECTIVE (EU) .../…  
of XXX  
amending, for the purposes 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 aluminium  
(Text with EEA relevance)   EN 1  EN COMMISSION DIRECTIVE (EU) .../…  
of XXX  
amending, for the purposes 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 aluminium  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regar d 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 of the European Parliament and of the Council lays down 
migration lim its for  aluminium from toys or components of toys . Currently, the limits 
for aluminium are 5  625 mg/kg for dry, brittle, powder -like or pliable toy material, 
1 406 mg/kg for liquid or sticky toy material and 70  000 mg/kg for scraped -off toy 
material.  
(2) The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) 
has reviewed the available data on the toxicity of aluminium, taking into account the 
different tolerable intake levels for aluminium established by the European Food 
Safety Auth ority in 20082 and by the Joint FAO/WHO Expert Committee on Food 
Additives in 20113. The SCHEER considered, in its ' Final opinion on t olerable intake 
of aluminium with regard to adapting the migration limits for aluminium in toys ', 
adopted on 28 September 2017 , a tolerable daily intake ( TDI) of 0,3 mg/kg body 
weight per day  as an appropriate base for revising the migration limits for aluminium 
from toys . 
(3) Since children are exposed to aluminium also through sources other than toys, only a 
certain percentage of the TDI should be allocated to the exposure from toys when 
calculating the limit s. The maximum con tribution from toys to the daily intake 
recommended by the Scientific Committee on Toxicity, Ecotoxicity and the 
Environment in its 2004 opinion4 is 10  %. In 2010 , this percentage was confirmed by 
the Scientific Committee on  Health and Environmental Risks in its opinion on 'Risk 
                                                 
1 OJ L 170, 30.6.2009, p. 1.  
2 European Food Safety Authority (EFSA) , Safety of aluminium from dietary intake - Scientific Opinion 
of the Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials (AFC) . 
Opinion adopted on 22 May 2008. The EFSA Journal (2008)  754, p. 1 -34. 
http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/754.pdf   
3 WHO (2011) Technical Report 966 – Evaluation of certain food additives and contaminants. 74th report 
of the Joint FAO/WHO Expert Committee on Food Additives. P. 16.  
 http://apps.who.int/iris/bitstream/10665/44788/1/WHO_TRS_966_eng.pdf   
4 Scientific Committee on Toxicity, Ecotoxicity and the Environment  (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/committees/sct/documents/out235_en.pdf   EN 2  EN from organic CMR substances in toys '5 and in its opinion on 'Evaluation of the 
migration limits for chemical elements in toys'6. 
(4) The SCHEER applied 10 % of the TDI , multiplied by the average weight of a child 
under three years of age (estimated at 7,5 kg) and divided by the daily quantity of toy 
material ingested. That quantity was estimated at 100 mg/day for dry, brittle, powder -
like or pliable toy material, 400  mg/day for liquid or sticky toy material and 8  mg/day 
for scraped -off toy material. On the basis of that calculation, the SCHEER proposed 
revised migration limits for aluminium from toys of 2  250 mg/kg for dry, brittle, 
powd er-like or pliable toy material, 560 mg/kg for liquid or sticky toy material and 
28 130 mg/kg for scraped -off toy material (‘ the proposed migration limits’).  
(5) Compliance with the proposed migration limit s can be verified with the test method 
set out in European standard EN 71 -3:2013+A 3:2018 , the reference of which has been 
published in the Official Journal of the European Union7. The proposed migration 
limit s can be easily enforced, since the y are several thousand times higher than the 
lowest concentrati on that can be reliably quantified with the test method set out in the 
standard8. 
(6) In order to  advise the Commission in the preparation of legislative proposals and 
policy initiatives  in the area of toy safety, the Commission established the Expert 
Group on  Toys Safety9. The mission of its subgroup Working Group on chemicals  in 
toys (subgroup Chemicals) is to provide advice to the Expert Group on Toys Safety 
with regard to chemical substances that may be used in toys.  
(7) The subgroup Chemicals considered, at it s meeting on 26 September 2017, that the 
migration limits proposed by SCHEER were appropriate . 
(8) Market surveillance data on aluminium in toys10, 11, 12, 13 from approximately  5 800 
tests has show ed compliance with the proposed migration limits  in almost all cases . 
Data from writing instrument manufacturers  on approximately 250 samples14 has 
suggested that a substantial part of th e writing materials are already complian t with 
those limits . 
(9) The Expert Group on Toys Safety  agreed , at its meeting on  19 December 2017 , that 
the migration limits for aluminium should be amended as proposed . 
                                                 
5 Scientific Committee on  Health and Environmental Risks  (SCHER). Opinion on " Risk from  organic 
CMR substances in toys ". Adopted on 18 May 2010.  
6 Scientific Committee on  Health and Environmental Risks  (SCHER). Opinion on "Evaluation of the 
migration limits for chemical elements in Toys". Adopted on 1 July 2010.  
7 OJ C 282, 10.08.2018, p.3 . 
8 See table E.5 in EN  71-3:2013+A 3:2018.  
9 See Register of Commission Expert Groups, Expert Group on Toys Safety  (E01360).  
 http://ec.europa.eu/tra nsparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=1360   
10 Nederlandse Voedsel - en Warenautoriteit, Geverfd houten speelgoed 2016. (Dutch Food and Product 
Authority, Painted wood en toys 2016) . 
https://www.inspectieresultaten.nvwa.nl/productonderzoek/geverfd -houten -speelgoed -0  
11 Finnish Customs Laboratory, Market surveillance data from Finland for aluminium . Submission to the 
subgroup 'Chemicals ' as EXP/WG/2017/039 in the follow -up to the meeting on 26 September 2017.  
12 Results of market surveillance in France.  Submission to the subgroup 'Chemicals' as a follow -up to the 
meeting on 26 September 2017.  
13 Results of market surveillance in Austria . Submission to the subgroup 'Chemicals' as a follow -up to the 
meeting on 26 September 2017.  
14 Data provided by the European Writing Manufacturers Association (EWIMA) . Submission to the 
subgroup 'Chemicals' as a follow -up to the meeting on 26 September 2017 . EN 3  EN (10) In light of the available scientific evidence , the opinion of the SCHEER, the data 
provided by the Member States and the writing materials industry  and the 
recommendation s from the Expert Group on Toys Safety and its subgroup chemicals, 
it is necessary to adapt the current migration l imits  for aluminium from toys or 
components of toys to technical and scientific developments  by replacing them with 
the proposed migration l imits . 
(11) Directive 2009/48/EC should therefore be amended accordingly.  
(12) 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, in the table, the entry for 
aluminium  is replaced by the following:  
Element  mg/kg  
in dry, brittle, powder -
like or pliable toy 
material  mg/kg  
in liquid or sticky toy 
material  mg/kg  
in scrap ed-off toy 
material  
‘Aluminium  2 250 560 28 130' 
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  + 1 day after publication in 
the OJ] . 
When Member States adopt those provisions, they shall contain a reference to this 
Directive or be acco mpanied 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 twentieth day following that of its publication in 
the Official Journal of the European Union . 
Article 4  
This Directive is addressed to the Member States.  EN 4  EN Done at Brussels,  
 For the Commission  
 The President  
 Jean-Claude Juncker