EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2015) XXX  draft  
  
COMMISSION DIRECTIVE (EU) .../…  
of XXX  
amending, for the purpose of adopting specific limit values for chemicals used in toys, 
Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the 
Council on the safety of toys, as regards bisphenol A  
(Text with EEA relevance)   EN 2   EN COMMISSION DIRECTIVE (EU) .../…  
of XXX  
amending , for the purpose of adopting specific limit values for chemicals used in toys, 
Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the 
Council on the safety of toys, as regards bisphenol A  
(Text with EEA relevance)  
THE EUROPEA N 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(2) thereof,  
Whereas : 
(1) Directive 2009/48/EC establishes certain requirements for chemical substances which 
are classified as carcinogenic, mutagenic or toxic for reproduction under Regulation 
(EC) No 1272/2008 of the European Parliament and of the Council2. Appendix C to 
Annex  II to Directive 2009/48/EC lays down  specific limit values for chemicals used 
in toys intended for use by children under 36 months or in other toys intended to be 
placed in the mouth  
(2) The specific limit value for b isphenol A ( CAS number 80-05-7) is 0,1 mg/l (migration 
limit) . European standards EN 71 -10:2005 (sample preparation) and EN 71 -11:2005  
(measurement)  provide the relevant test methods . 
(3) EN 71 -10:2005  requires that 10 cm2 of a toy material be extracted with 100 ml of 
water during one  hour. Compli ance with the specific limit value of 0,1 mg/l thus 
means that during this extraction  a maximum of 0,01 mg bisphenol A may migrate out 
of the toy material.  
(4) In order to provide it with advice in the preparation of legislative proposals and policy 
initiatives in the area of toy safety, the Commission established the Expert Group on 
Toys Safety. The mission of its subgroup "Chemicals" is to provide such advice with 
regard to chemical substances which may be used in toys.  The subgroup "Chemicals" 
of the Expert Group on Toys Safety considered at its meeting o n 1 October 2015 that 
applying the specific limit value and the test methods set out above  leads to an 
exposure of 3 microgram per kilogram body weight per day  in a child of 10 kg body  
weight mouth ing a toy during 3 hours  daily.  
(5) New data on bisphenol A and refined methodologies led the Panel on Food Contact 
Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) of the European 
Food Safety A uthority  (EFSA) to set a "temporary" tolerable daily  intake ( TDI) for 
                                                 
1 OJ L 170, 30.6.2009, p. 1.  
2 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006  (OJ L 353, 31.12.2008, 
p. 1). EN 3   EN bisphenol A  at 4 microgram per kilogram body weight per day3. The CEF Panel 
designated the TDI as temporary, pending the outcome of the long -term study in rats 
involving prenatal as well as postnatal exposure to bisphenol A, currently bei ng 
undertaken by N ational Toxicology Programme of the United States Food and Drug 
Administration . 
(6) In the light of the above, the subgroup "Chemicals" of the Expert Group on Toys 
Safety recommended at its meeting of 1 October 2015 that bisphenol A be limited in 
toys to 0,04 mg/l (migration limit)  when tested in accordance with EN 71 -10:2005  and 
EN 71 -11:2005 , assuming  a child's body weight of 10 kg, a daily mouthing time of 
three  hours , a mouthed toy surface of 10 cm2 and an allocation of 10 % of th e 
temporary TDI to the exposure of a child to bisphenol A from toys.  The Expert Group 
on Toys Safety supported this recommendation at its meeting of 14 January 2016.  
(7) While Commission Regulation (EU) No 10/20114 sets down  a specific  migration limit 
for bisphenol A as a monomer for use in certain food contact materials , as well as a 
prohibition to use bisphenol A for the manufacture of polyc arbonate infant feeding 
bottles,  the basic assumptions for deriving that migration limit and laying down the 
prohibi tion are different from those for the migration limit for bisphenol A in toys.  
(8) In the light of available scientific evidence and considering the differences between 
toys and materials which come into contact with food, the currently applicable specific 
limit value for bisphenol A in toys  is too high and should be revised . 
(9) The effects of bisphenol A are under review in scientific fora. While it may be 
necessary to review t he migration limit if relevant new scientific information becomes 
available in the futu re, the limit reflecting current scientific knowledge should be laid 
down in order to ensure adequate protection of children . 
(10) Appendix C to Annex II to Directive 2009/48/EC should therefore be amended 
accordingly.  
(11) The measures provided for in this Directiv e are in accordance with the opinion of the 
Toy Safety Committee  established under  Article 47 of Directive 2009/48/EC,  
HAS ADOPTED THIS DIRECTIVE:  
Article 1  
In Appendix C to Annex II to Directive 2009/48/EC , in the table, the entry for bisphenol A  is 
replaced by the following : 
'Bisphenol A  80-05-7 0,04 mg/l (migration limit) in accordance 
with the methods laid down in EN 71 -
10:2005  and EN 71 -11:2005.'.  
 
 
                                                 
3 EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)  (2015) 
Scientific Opinion on the risks to public health related to the presence of bisphenol A (BPA) in 
foodstuffs: PART II - Toxicological assessment and risk characterisation. EFSA Journal 
2015;13(1):3978 , p. 196.  
 http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/3978part2.pdf .  
4 Commission Regulation (EU) No  10/2011 of  14 January 2011 on plastic materials and articles intended 
to come into contact with food  (OJ L 12, 15.1.2011, p.1 ). EN 4   EN Article 2  
1. Member States shall adopt and publish, by [ Fill in date falling 18 mon ths 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 [ Fill in a date which is one day later than the 
date set out  in the first  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 
publicat ion. 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 shal l 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.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean-Claude Juncker