L 195/16
EN
Official Journal of the European Union
18.7.2013
COMMISSION REGULATION (EU) No 681/2013
of 17 July 2013
amending part III 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 COMMISSION,
these data contained important flaws. Therefore animal
experiments data, more reliable for deriving a tolerable
daily intake, were used.
Having regard to the Treaty on the Functioning of the European
Union,
(4) In
order
to
define
possible
exposure
scenarios
to
chemical substances, the quantity of toy material
Having regard to Directive 2009/48/EC of the European
ingested was estimated by the RIVM at 8 mg per day
Parliament and of the Council of 18 June 2009 on the safety
for scraped-off toy material, 100 mg for brittle toy
of toys (
material and 400 mg for liquid or sticky toy material.

1 ), and in particular Article 46(1)(b) thereof,
Those ingestion limits were supported by SCHER in its
opinion entitled ‘Risks from organic CMR substances in
toys’ adopted on 18 May 2010.
Whereas:
(5) By
applying
10
%
of
the
tolerable
daily
intake,
multiplied
(1) Directive
2009/48/EC
sets
limit
values
for
barium,
based
by the weight of the child and divided by the quantity of
on the recommendations of the Dutch National Institute
toy material ingested, the following limit values for
for Public Health and the Environment (RIVM) made in
barium were established: 56 000 mg/kg for scraped-off
the 2008 report entitled ‘Chemicals in Toys. A general
material, 4
500
mg/kg for dry material and
methodology for assessment of chemical safety of toys
1 125 mg/kg for liquid material.
with a focus on elements’. The RIVM recommendations
are based on the conclusion that exposure of children to
chemicals in toys may not exceed a certain level, called
(6) The
US
Agency
for
Toxic
Substances
and
Disease
‘tolerable daily intake’. Since children are exposed to
Registry published in 2007 an update of its report on
chemicals via other sources than toys, only a percentage
the toxicological profile for barium, where a tolerable
of the tolerable daily intake should be allocated to toys.
daily intake of 0,2 mg/kg body weight/day is proposed.
The Scientific Committee on Toxicity, Ecotoxicity and the
This update was made available after the finalisation of
Environment (CSTEE) recommended in its 2004 report
the RIVM report. Additionally, following discussions with
that a maximum of 10 % of the tolerable daily intake
stakeholders, it was considered that the IPCS report from
may be allocated to toys. This allocation has been
2001 was not appropriately taken into consideration by
endorsed by the Scientific Committee on Health and
RIVM.
Environmental Risks (SCHER) in its opinion entitled
‘Evaluation of the migration limits for chemical
elements in toys’ and adopted on 1 July 2010.
(7)
Taking this into account, the Commission sent a request
for an opinion to SCHER, asking for an additional
evaluation of the migration limits for barium, and recom
(2)
According to the RIVM recommendations, the maximum
mendations with regard to the tolerable daily intake to be
percentage of the tolerable daily intake should be
used, in the light of the IPCS and ATSDR (2007) docu
multiplied by the weight of a child, estimated at 7,5 kg,
ments.
and divided by the quantity of toy material ingested, in
order to obtain the limit values for the chemical
substances listed in Directive 2009/48/EC.
(8) In
its
opinion
adopted
on
22
March
2012,
SCHER
concluded that the available data on humans are not
appropriate in order to derive a tolerable daily intake.
(3) For
barium,
RIVM
used
a
tolerable
daily
intake
of
Good quality animal studies are more appropriate for
0,6 mg/kg body weight/day, following the approach of
deriving a tolerable daily intake for barium, which, in
the US Agency for Toxic Substances and Disease Registry
SCHER’s opinion, should be 0,2 mg/kg body weight/day.
(ATSDR) in its 2005 report on the toxicological profile
for barium, based on animal experiments data. Other
barium reviews, based on human data, were considered
(9) This
value
takes
into
account
the
gastrointestinal
by RIVM but not used for determining barium’s tolerable
absorption of barium. SCHER estimates that children
daily intake. Although human data are considered as a
aged 1 to 15 have a gastrointestinal absorption of
more appropriate basis for deriving a tolerable daily
30 %, while infants will absorb 60 %. However, SCHER
intake, RIVM considered that the studies providing
bases barium’s tolerable daily intake on the ‘worst case
scenario’ assumption according to which children will
( 1 ) OJ L 170, 30.6.2009, p. 1.
absorb 100 % of the barium they are exposed to.

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EN
18.7.2013 Official
Journal
of
the
European
Union L
195/17
(10) Applying 10
% of the new tolerable daily intake
(12) Directive 2009/48/EC should therefore be amended
multiplied by the weight of the child and divided by
accordingly.
the quantity of toy material ingested results in the
following limits for barium: 18 750 mg/kg for scraped-
(13) The
measures
provided
for
in
this
Regulation
are
in
off material, 1
500
mg/kg for dry material and
accordance with the opinion of the Toy Safety
375 mg/kg for liquid material.
Committee,
(11) In
order
to
ensure
the
best
possible
protection
of
health
HAS ADOPTED THIS REGULATION:
and life of humans, in particular children, it is necessary
Article 1
to apply those lower migration limits for barium within
the shortest possible delay. Therefore, the Directive
Part III of Annex II to Directive 2009/48/EC is amended in
should be amended by a Regulation which enters into
accordance with the Annex to this Regulation.
force on 20 July 2013, thus avoiding a longer period of
Article 2
transposition of a Directive during which different
migration limits would apply.
This Regulation shall enter into force on 20 July 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 July 2013.
For the Commission
The President
José Manuel BARROSO
ANNEX
In part III of Annex II to Directive 2009/48/EC, the entry for barium in point 13 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 scraped-off toy material
‘Barium 1
500 375 18
750’

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Document Outline

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