EN EN
EUROPEAN
COMMISSION
Brussels, XXX
[…](2012) XXX draft
COMMISSION DIRECTIVE ../…/EU
of XXX
[…]
amending, for the purpose of adaptation to technical progress, Appendix C 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 ENCOMMISSION DIRECTIVE ../…/EU
[…]
of XXX
amending , for the purpose of adaptation to technical progress, Appendix C 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)
THE EUROPEAN COMMI SSION,
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 toy s1,and in particular Article 46(2) thereof ,
Whereas:
(1) Directive 2009/48/EC establishes general requi rements for substances which are 
classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 
December 2008 on classification, labelling and packaging of substa nces and mixtures, 
amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending 
Regulation (EC) No 1907/20062. Such substances may not be used in toy s, in 
components of to ysor in micro -structurally distinct parts of toys, except if 
inaccessib le to children, permitted bya Commission decision or contained in 
individual concentrations equal to or smaller than the relevant concentrations 
established for the classification of mixtures containing them as CMR s. To further 
protect children's health, specific limit value s for such substances can be set out, when 
appropriate, for toys intended for use by  children under three years old or other toys 
intended to be placed in the mouth.
(2) The substance bisphenol A is a high volume chemical that is widely used in the 
production of a large variety of consumer products . Bisphenol A is used as a monomer 
in the manufacture of poly carbonate plastics. Polycarbonate plastics are used, amongst 
  
1OJ L 170, 30.6.2009 , p. 1. 
2OJ L 353, 31.12.2008, p. 1.EN 3 ENothers, in the manufacture of to ys. Moreover, bisphenol A has been found in plastic 
materials in children’s books.
(3) Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the 
Member States concerning the safet y of toys3governed the essential safet y 
requirements for chemical properties of toy s until 19 July 2013. European standard EN 
71-9 provides a migration limit of 0.1 mg/l for bisphenol A. European standards EN 
71-10 and EN 71 -11 provide the relevant test methods. The limits and methods for 
bisphenol A set out in EN 71 -9, EN 71 -10 and EN 71 -11 are used b y the toy industr y 
as a reference to ensure that there is no unsafe exposure from bisphenol A in toy s. Yet, 
those standards do not constitute harmonised standards.
(4) Bisphenol A is classified under Re gulation (EC) No 1272/2008 as toxic for
reproduction categ ory 2. In the absence of an y specific requirements, bisphenol A can 
be contained in toy s in concentrations equal to or smaller than the relevant 
concentration established for theclassification of mixtures containing it asCMR s, 
namely  5% as from 20 July  2013 and 3% as from 1 June 2015 respectively. It cannot 
be excluded that that concentration may lead to increased exposure of small children to 
bisphenol A, compared to the migration limit of 0.1 mg/l for bisphenol A set b y 
European standards EN 71 -9, EN 71 -10 and EN 71 -11.
(5) Bisphenol A was comprehensivel y ev aluated in 200 3 and 2008 under Council 
Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the 
risks of existing substances4. The final risk assessment report, e ntitled "Updated 
European Union Risk Assessment Report 4,4’ -isopropy lidenediphenol (bisphenol -A)",
found, among other things, that bisphenol A has endocrine modulating activity in a 
number of in vitro and in vivo screening assay s and concluded that further research 
was need ed to resolve the uncertainties surrounding the potential for bisphenol A to 
produce adverse effects on development at low doses .Nevertheless, a high level of 
protection of children against risks caused by chemical substances in toy s, in the light 
of the particular needs of children, who are a vulnerable group of consumers, warrants 
incorporating the migration limit of 0.1 mg/l for bisphenol A into Directive 
2009/48/EC.
(6) The effects of bisphenol A are under evaluation in scientific fora including the 
Europe an Food Safet y Authority. The migration limit laid down by this Directive 
should be reviewed if relevant new scientific information becomes available in the 
future.
(7) Directive 2009/48/EC should therefore be amended accordingl y.
(8) The measures provided for in this Directive are in accordance with the opinion of the 
Committee,
  
3OJ L 187, 16.7.1988, p. 1.
4OJ L 84, 5.4.1993, p. 1.EN 4 ENHAS ADOPTED THIS DI RECTIVE:
Article 1
Appendix C of Annex II to Directive 2009/48/EC is amended in accordance with the Annex 
tothis Directive.
Article 2
1. Member States shall adopt and p ublish, by  […(Fill in date falling 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 pro visions.
They shall appl y 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 b y 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 dayfollowing 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
José Manuel BARROSO
ANNEX
Appendix C of Annex II to Directive 2009/48/EC is amended as follows:
The following entry is introduced:EN 5 EN"Substance CAS No Limit value 
Bisphenol A 80-05-7 0.1 mg/l (migration limit) in accordance with 
the methods laid down in EN 7 1-10 and EN 
71-11"