EN
3.3.2012 Official
Journal
of
the
European
Union L
64/7
DIRECTIVES
COMMISSION DIRECTIVE 2012/7/EU
of 2 March 2012
amending, for the purpose of adaptation to technical progress, part III of Annex II to Directive
2009/48/EC of the European Parliament and of the Council relating to toy safety
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
additives (JEFCA) in 1989 and confirmed by JECFA in
2001. A safety factor of two was applied, resulting in a
tolerable weekly intake of 3.5 μg/kg and a tolerable daily
Having regard to the Treaty on the Functioning of the European
intake of 0.5 μg/kg.
Union,
(4) In
order
to
define
possible
exposure
scenarios
to
Having regard to Directive 2009/48/EC of the European
chemical substances, the quantity of toy material
Parliament and of the Council of 18 June 2009 on the safety
ingested was estimated by the RIVM at 8 mg per day
of toys ( 1 ), and in particular Article 46.1 (b) thereof,
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 the Scientific
Whereas:
Committee on Health and Environmental Risks (SCHER)
in its opinion entitled "Risks from organic CMR
substances in toys" adopted on the 18 May 2010.
(1) Directive
2009/48
sets
limit
values
for
cadmium,
based
on the recommendations of the Dutch National Institute
for Public Health and the Environment (RIVM) made in
(5) By
applying
5
%
of
the
tolerable
daily
intake,
multiplied
the 2008 report entitled "Chemicals in Toys. A general
by the weight of the child and divided by the quantity of
methodology for assessment of chemical safety of toys
toy material ingested, the following limit values for
with a focus on elements". The RIVM recommendations
cadmium were established: 23 mg/kg for scrapped-off
are based on the assumption that exposure of children to
material, 1.9 mg/kg for dry material and 0.5 mg/kg for
chemicals in toys may not exceed a certain level, called
liquid material.
“tolerable daily intake”. Since children are exposed to
chemicals via other sources than toys, only a percentage
of the tolerable daily intake should be allocated to toys.
(6) The
European
Food
Safety
Authority
(EFSA)
concluded
in
The Scientific Committee on Toxicity, Ecotoxicity and the
its opinion of 30 January 2009 that the tolerable weekly
Environment (CSTEE) recommended in its 2004 report
intake established by JEFCA in 1989 and confirmed by
that a maximum of 10 % of the tolerable daily intake
JECFA in 2001 was no longer appropriate in view of the
may be allocated to toys. However, for cadmium and
new developments related to the toxicology of cadmium.
other chemical substances which are particularly toxic,
The EFSA established a new tolerable weekly intake of
the recommended allocation should not exceed 5 % of
2.5 μg/kg, resulting in a tolerable daily intake of
the tolerable daily intake, in order to ensure that only
0.36 μg/kg.
traces that are compatible with good manufacturing
practice will be present
(7) Applying
5
%
of
the
new
tolerable
daily
intake,
multiplied by the weight of the child and divided by
(2)
According to the RIVM recommendations, the maximum
percentage of the tolerable daily intake should be
the quantity of toy material ingested results in the
multiplied by the weight of a child, estimated at 7.5 kg,
following limits for cadmium: 17 mg/kg for scrapped-
and divided by the quantity of toy material ingested, in
off material, 1.3 mg/kg for dry material and 0.3 mg/kg
order to obtain the limit values for the chemical
for liquid material.
substances listed in Directive 2009/48/EC.
(8) Directive
2009/48/EC
should
therefore
be
amended
(3) For
cadmium,
RIVM
used
the
tolerable
weekly
intake
of
accordingly.
7 μg/kg established by the Joint Food and Agriculture
Organisation of the United Nations and the World
Health Organisation Experts committee on food
(9) The
measures
provided
for
in
this
Directive
are
in
accordance with the opinion of the Toy Safety
( 1 ) OJ L 170, 30.6.2009, p. 1.
Committee.

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L 64/8
EN
Official Journal of the European Union
3.3.2012
HAS ADOPTED THIS DIRECTIVE:
2. Member
States
shall
communicate
to
the
Commission
the
text of the main provisions of national law which they adopt in
Article 1
the field covered by this Directive.
Part III of Annex II to Directive 2009/48/EC is amended in
Article 3
accordance with the Annex to this Directive.
This Directive shall enter into force on the twentieth day
Article 2
following that of its publication in the Official Journal of the
European Union.
1. Member
States
shall
adopt
and
publish,
by
20
January
2013 at the latest, the laws, regulations and administrative
Article 4
provisions necessary to comply with this Directive. They shall
forthwith communicate to the Commission the text of those
This Directive is addressed to the Member States.
provisions
They shall apply those provisions from 20 July 2013.
Done at Brussels, 2 March 2012.
When Member States adopt those provisions, they shall contain
For the Commission
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
The President
States shall determine how such reference is to be made.
José Manuel BARROSO
ANNEX
Part III of Annex II to Directive 2009/48/EC is amended as follows:
In point 13, the entry for cadmium is replaced by the following:
mg/kg
Element
in dry, brittle, power-like or
mg/kg
mg/kg
pliable toy material
in liquid or sticky toy material
in scrapped-off toy material
‘Cadmium 1,3 0,3 17’

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Document Outline

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