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20.3.2012 Official
Journal
of
the
European
Union L
80/19
COMMISSION DECISION
of 1 March 2012
concerning the national provisions notified by the German Federal Government maintaining the
limit values for lead, barium, arsenic, antimony, mercury and nitrosamines and nitrosatable
substances in toys beyond the entry into application of Directive 2009/48/EC of the European
Parliament and of the Council on the safety of toys
(Only the German text is authentic)
(Text with EEA relevance)
(2012/160/EU)
THE EUROPEAN COMMISSION,
In the absence of a Decision by the Commission within
this period the national provisions referred to in para
graphs 4 (…) shall be deemed to have been approved.
Having regard to the Treaty on the Functioning of the European
Union, and in particular Article 114(4) and (6) thereof,
When justified by the complexity of the matter and in
the absence of danger for human health, the Commission
Whereas:
may notify the Member State concerned that the period
referred to in this paragraph may be extended for a
further period of up to six months.’
FACTS
(1) On
20
January
2011,
the
German
Federal
Government
requested the Commission, pursuant to Article 114(4)
The Directive
TFEU, the permission to retain the existing provisions
provided in German law for the five elements: lead,
(3) The
Directive
lays
down
rules
on
the
safety
of
toys
and
arsenic, mercury, barium and antimony, as well as for
on their free movement in the European Union.
nitrosamines and nitrosatable substances released from
According to Article 54, Member States shall bring
toy material, beyond the date of entry into force of
into force national provisions complying with this
Annex II, Part III, to Directive 2009/48/EC of the
Directive by 20 January 2011, and they shall apply
European Parliament and of the Council of 18 June
them as from 20 July 2011. Part III of Annex II to the
2009 on the safety of toys (
Directive will be applicable as from 20 July 2013.

1 ) (hereinafter ‘the Directive’).
Article 114(4) and (6) TFEU
(4) The
Directive
contains,
in
Annex
II,
Part
III,
point
8,
specific values for nitrosamines and nitrosatable
(2) Article
114(4)
and
(6)
TFEU
provides:
substances. These substances shall be prohibited for use
in toys intended for use by children under 36 months or
in other toys intended to be placed in the mouth if the
‘4. If, after the adoption by the Council or by the
migration of the substances is equal to or higher than
Commission of a harmonisation measure, a Member
0,05 mg/kg for nitrosamines and 1 mg/kg for nitro
State deems it necessary to maintain national provisions
satable substances. Point 13 of Part III of Annex II to
on grounds of major needs referred to in Article 36, or
the Directive contains specific migration limits for several
relating to the protection of the environment or the
elements, including lead, arsenic, mercury, barium and
working environment, it shall notify the Commission
antimony. Three different migration limits exist, related
of these provisions as well as the grounds for main
to the type of toy material: dry, brittle, powder-like or
taining them.
pliable toy material, liquid or sticky toy material and
scraped-off toy material. The following limits shall
respectively not be exceeded: 13,5, 3,4 and 160 mg/kg
(…)
for lead, 3,8, 0,9 and 47 mg/kg for arsenic, 7,5, 1,9 and
94 mg/kg for mercury, 4 500, 1 125 and 56 000 mg/kg
for barium, and 45, 11,3 and 560 mg/kg for antimony.
6. The
Commission
shall,
within
six
months
of
the
notifications (…), approve or reject the national
provisions involved after having verified whether or not
The German national provisions
they are a means of arbitrary discrimination or a
disguised restriction to trade between Member States
(5) The
German
Consumer
Goods
Ordinance
(Bedarfsgegen
and whether or not they shall constitute an obstacle to
stndeverordnung) sets requirements for nitrosamines and
the functioning of the internal market.
nitrosatable substances. These provisions were adopted in
2008, in the context of the absence of specific EU
( 1 ) OJ L 170, 30.6.2009, p. 1.
provisions on nitrosamines and nitrosatable substances

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L 80/20
EN
Official Journal of the European Union
20.3.2012
in toys. The Consumer Goods Ordinance (Bedarfsgegen
(9) By
letter
of
24
June
2011
the
Commission
consulted
the
stndeverordnung) requires that for nitrosamines and nitro
other Member States on the notification received from
satable substances in toys made of natural or synthetic
the German Federal Government. The Commission also
rubber designed for children under 36 months and
published a notice regarding the notification in the
intended or likely to be placed in the mouth, the
Official Journal of the European Union ( 2 ) in order to
amount released as a result of migration must be so
inform other interested parties of the national provisions
small as not to be laboratory detectable. The abovemen
the German Federal Government intends to maintain as
tioned Ordinance currently requires the migration of
well as the grounds invoked to that effect.
nitrosamines and nitrosatable substances to be below
0,01 mg/kg for nitrosamines and below 0,1 mg/kg for
nitrosatable substances. The detailed provisions on nitro
(10) The
Commission
received
comments
from
The
Czech
samines and nitrosatable substances are laid down in
Republic, Poland, Sweden, and several concerned stake
Annex 4, point 1.b, and Annex 10, point 6, to the
holders.
Consumer Goods Ordinance (Bedarfsgegenstndeverord
nung), published on 23 December 1997, and most
recently amended by the Ordinance of 6 March 2007.
(11) The
Czech
Republic
considers
that
the
measures
notified
by Germany constitute a barrier to trade as it will
prevent economic operators complying with the
(6) The
Second
Equipment
and
Product
Safety
Act
Directive from placing toys on the German market.
Ordinance (Verordnung über die Sicherheit von Spielzeug
The Czech authorities support a higher level of
— 2. GPSGV) concerns in particular the following
protection for children from dangerous chemicals,
elements: lead, arsenic, mercury, barium and antimony.
however hold the opinion that such measures should
The limit values for the abovementioned elements
be taken at European level, within the framework of
contained in the Second Equipment and Product Safety
the Directive.
Act Ordinance (Verordnung über die Sicherheit von Spielzeug
— 2. GPSGV) are those laid down in Council Directive
88/378/EEC of 3 May 1988 on the approximation of the
(12) Poland
considers that the German measures are an
laws of the Member States concerning the safety of
obstacle to the free movement of toys within the EU
toys ( 1 ). These limits have been applicable in the EU
and therefore unacceptable. Poland holds the opinion
since 1990. The maximum daily bioavailability is
that one Member State can not, unilaterally, maintain
0,7 μg for lead, 0,1 μg for arsenic, 0,5 μg for mercury,
different safety requirements, and create obstacles to
25,0 μg for barium, and 0,2 μg for antimony. The
the functioning of the toy market.
detailed provisions on the abovementioned elements are
laid down in § 2 of the Second Equipment and Product
Safety Act Ordinance (Verordnung über die Sicherheit von
(13) Sweden considers the justifications put forward by
Spielzeug — 2. GPSGV).
Germany as convincing and supports the request.
PROCEDURE
(14) By
letter
to
the
Commission,
Toy
Industries
of
Europe,
the European association of writing materials manufac
(7) With
a
first
letter
of
its
Federal
Ministry
of
Economics
turers, the French association of toy manufacturers and
and Technology, received on 20 January 2011, the
the European Balloons Council shared their concerns
German Federal Government requested the Commission,
with regard to the obstacles the German measures, if
pursuant to Article 114(4) TFEU, the permission to retain
accepted, will create on the functioning of the toys
the existing provisions provided in German law for the
internal market.
five elements: lead, arsenic, mercury, barium and
antimony, as well as for nitrosamines and nitrosatable
substances released from toy material, beyond the date
of entry into force of Annex II, Part III, to the Directive.
(15) By
Decision of 4 August 2011
( 3 ), the Commission
A complete justification of the request has been sent by
informed the German Federal Government that,
the German Federal Government with letter from the
pursuant to Article 114(6), third subparagraph, TFEU,
Office of its Permanent Representative, dated 2 March
the period of 6 months referred to in its first
2011. The detailed justification contained several
subparagraph to approve or reject the national provisions
annexes including scientific studies on the health
concerning the five elements (lead, arsenic, mercury,
assessment of the abovementioned substances from the
barium and antimony), as well as for nitrosamines and
Bundesinstitut für Risikobewertung (hereinafter ‘BfR’),
nitrosatable substances, notified by Germany on 2 March
dated January 2011.
2011, pursuant to Article 114(4), is extended until

5 March 2012.
( 2 ) OJ C 159, 28.5.2011, p. 23.
(8) The
Commission
confirmed
receipt
of
the
request
with ( 3 ) Commission Decision 2011/510/EU of 4 August 2011 extending
letters dated 24 February 2011 and 14 March 2011 and
the period referred to in Article 114(6) of the Treaty on the Func
set the deadline for her reaction to 5 September 2011 in
tioning of the European Union in relation to national provisions
accordance with Article 114(6) TFEU.
maintaining the limit values for lead, barium, arsenic, antimony,
mercury and nitrosamines and nitrosatable substances in toys
notified by Germany pursuant to Article 114(4) (OJ L 214,
( 1 ) OJ L 187, 16.7.1988, p. 1.
19.8.2011, p. 15).

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EN
20.3.2012 Official
Journal
of
the
European
Union L
80/21
ASSESSMENT
(20) The Directive, adopted in 2009, replaced Directive
88/378/EEC and modernised the legal framework
Admissibility
applicable to chemicals, by taking into account the
latest scientific evidences available at the time of the
(16) The
Commission
considered,
in
its
Decision
of
4
August
revision.
2011, that the application submitted by Germany with a
view to obtaining authorisation to maintain its national
provisions on the five elements: lead, arsenic, mercury,
barium and antimony, as well as for nitrosamines and
nitrosatable substances is admissible.
(21) The
limit
values
for
arsenic,
lead,
antimony,
barium
and
mercury set out in the Directive are calculated as follows:
based on the recommendations of the Dutch National
Institute for Public Health and the Environment (RIVM)
made in the 2008 report entitled ‘Chemicals in Toys. A
Assessment of merits
general methodology for assessment of chemical safety of
toys with a focus on elements’, exposure of children to
(17) In
accordance
with
the
provisions
of
Article
114
of
the
chemicals in toys may not exceed a certain level, called
TFEU, the Commission has to assure that all conditions
‘tolerable daily intake’. Since children are exposed to
enabling a Member State to avail of the possibilities of
chemicals via other sources than toys, only a percentage
derogation provided for in this Article are met. The
of the tolerable daily intake should be allocated to toys.
Commission has to verify whether the provisions
The Scientific Committee on Toxicity, Ecotoxicity and the
notified are justified by the major needs of protection
Environment (CSTEE) recommended in its 2004 report
referred to in Article 36, or relating to the environment
that a maximum of 10 % of the tolerable daily intake
or working environment. In addition, the Commission
may be allocated to toys. However, for particularly toxic
has to verify whether or not these measures, when
substances (for example arsenic, lead, mercury) the
justified, are a means of arbitrary discrimination or a
Legislator decided that the recommended allocation
disguised restriction on trade between the Member
should not exceed 5 % of the tolerable daily intake, in
States, and whether or not they constitute an obstacle
order to ensure that only traces that are compatible with
to the functioning of the internal market.
good manufacturing practice will be present. In order to
obtain limit values, the maximum percentage of the
tolerable daily intake should be multiplied by the
weight of a child, estimated at 7,5 kg, and divided by
the quantity of toy material ingested, estimated by the
RIVM at 8 mg per day for scraped-off toy material,
100 mg for brittle toy material and 400 mg for liquid
(18) The
German
Federal
Government
has
based
its
request
or sticky toy material. Those ingestion limits were
on the need of protection of human health. In support of
supported by the Scientific Committee on Health and
this request, the German authorities provided detailed
Environmental Risks (SCHER) in its opinion entitled
justification including scientific studies on the health
‘Risks from organic CMR substances in toys’ adopted
assessment of the concerned substances from the BfR.
on 18 May 2010. As the tolerable daily intakes are
established by scientific studies, and science may
evolve, the Legislator has foreseen the possibility to
amend these limits when new scientific evidence is
made available.
Justification on grounds of major needs
Preliminary remarks
(19) The
limit
values
for
arsenic,
lead,
antimony,
barium
and
mercury set out in the Second Equipment and Product
(22) The
Directive establishes migration limits, while the
Safety Act Ordinance (Verordnung über die Sicherheit von
national values Germany wants to maintain are
Spielzeug — 2. GPSGV) are those laid down in Directive
expressed in bioavailability. Bioavailability is defined as
88/378/EEC, applicable in the EU since 1990. These
the amount of chemicals which actually comes out of a
limits were set out on the basis of scientific evidence
toy and can but may not necessarily be absorbed by the
available at that time, namely the scientific opinion of
human body. Migration is defined as the amount which
the Scientific Advisory Committee to examine the
actually comes out of a toy and is actually absorbed by
toxicity and ecotoxicity of chemical compounds from
the human body. The Commission acknowledges that the
1985, entitled Report EUR 12964(EN), Chapter III
bioavailability limits set out in 1990 were transformed in
‘Chemical properties of toys’. To set up limit values,
migration limits in standard EN 71-3 — Migration of
estimated food intakes for adults were used as a basis.
certain elements. However, calculations made for the
It was assumed that children, with an estimated body
purpose of this transformation were approximate. The
weight up to 12
kg, would have an intake of
tolerable daily intakes used are based on recommen
maximum 50 % of the adults’ intake, and that leaking
dations from 1985. A daily intake of 8 mg of toy
from toys should not contribute more than 10 %.
material was assumed, and adjustments were made to

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L 80/22
EN
Official Journal of the European Union
20.3.2012
minimise the exposure of children to toxic elements by
established by JECFA in 1989 is no longer appropriate.
lowering, for example, the migration limit for barium,
In addition, EFSA concluded that no tolerable daily intake
and to ensure analytical feasibility by increasing, for
can be established due to scientific uncertainties.
example, the migration limit for antimony and arsenic.
(28) The German authorities pointed out that EFSA
recommends reducing as far as possible exposure to
(23) The
Commission
notes
that
standards
are
not
mandatory,
arsenic, while the limit values for arsenic in scraped-off
but used on a voluntary basis by industry in the
materials in the Directive increased compared to the
framework on the conformity assessment procedures
limits contained in standard EN 71-3.
set out in the legislation. In addition, standard EN 71-3
is currently under revision in order to give presumption
of conformity with the new limits values established in
the Directive.
(29) Also, Germany underlines that toys are the most

significant contribution after food to the overall
exposure of children to arsenic.
(24) In
conclusion, different scientific considerations were
(30) In
conclusion,
Germany
requests
maintaining
national
taken into account when establishing the limits under
limits for arsenic.
the Directive and under standard EN 71-3. Those estab
lished under the Directive are based on a consistent and
transparent scientific-toxicological approach to ensure
safety, and can therefore be considered as more appro
Evaluation of the position of the German Federal
priate.
Government
(31) The
Commission
was
made
aware
of
the
2009
EFSA
study on arsenic, and considered it as new scientific
evidence which may trigger the revision of the arsenic
limit values. The study was sent to the SCHER
Arsenic — general information
committee. In its opinion ( 2 ), SCHER notes that EFSA
(25) Arsenic is a metal naturally occurring in the earth’s crust.
has not derived a tolerable daily intake, but used a
It occurs in inorganic and numerous organic forms that
risk-based value. SCHER concluded in previous
differ not only in their physical and chemical properties
opinions ( 3 ) that ‘arsenic shows a non-linear dose
but also in their occurrence and toxicity. Activities such
response regarding cancer’. Using the present legal limit
as mining, waste incineration and wood preservation are
for drinking water (10 μg/L) and the food exposure
the major source for arsenic in the environment.
defined by EFSA for the average consumer, SCHER
Drinking water and food (in particular seafood) are the
concludes that the daily human exposure to arsenic is
main source of human exposure. In toys, traces of
approximately 1 μg/kg body weight/day and does not
arsenic can be found due to the use of natural raw
increase tumour incidence. This value can be used as a
materials which may be naturally contaminated. Arsenic
pragmatic tolerable daily intake, and exposure of children
is highly toxic for humans, and can impair the central
via toys should not exceed 10 %.
nervous system, leading to a deterioration of the
cognitive functions. Elevated chronic intake of inorganic
arsenic may have carcinogenic effects.
(32) The
value
on
which
SCHER
concluded
corresponds
to
the tolerable daily intake recommended by RIVM and
used to calculate migration of arsenic from toys in the
Directive. Therefore, the Commission concluded that the
limit values for arsenic should not be amended, as no
(26) The
migration
limits
for
arsenic
in
the
Directive
are
based
new tolerable intake, which may question the level of
on the tolerable daily intake established by the Joint Food
protection granted by the Directive, was established.
and Agriculture Organisation/World Health Organisation
Expert Committee on Food Additives (JECFA) in 1989, as
recommended by RIVM.
(33) Furthermore,
the
Commission
would
like
to
stress
that
the German authorities justified their request to maintain
national levels for arsenic by referring to the range of
daily intake doses established in the 2009 EFSA study.
The position of the German Federal Government
The Commission notes that the measures notified do not
appear consistent with this justification. The limits
(27) To
support
their
request,
the
German
authorities
refer
to
the 2009 EFSA study ( 1 ) assessing the arsenic effects on
health. In EFSA’s opinion, the tolerable daily intake
( 2 ) SCHER, ‘Evaluation of the Migration Limits for Chemical Elements in
Toys’, adopted on 1 July 2010.
( 3 ) Delivered opinion on the Italian derogation for arsenic in drinking
( 1 ) EFSA Journal 2009; 7(10):1351.
water (SCHER 2010 c).

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EN
20.3.2012 Official
Journal
of
the
European
Union L
80/23
notified are derived from estimated food intakes estab
but also enters the environment through several
lished in 1985, not from the doses recommended by
industrial applications. Antimony is used to make
EFSA in 2009.
certain types of semi-conductor devices, such as diodes
and infrared detectors. Antimony alloys are also used in
batteries, low-friction metals, type metal and cable
(34) The
German
authorities
further
stated
that
the
limits
for
sheathing, among other products. Antimony
arsenic in scraped-off materials (47 mg/kg of material)
compounds are used to make flame-proofing materials
increased compared to the limits established in
and paints. Inhalation of antimony can cause irritation of
standard EN 71-3.
the eyes, skin and lungs. Prolonged exposure can cause
lung diseases, heart problems, diarrhoea, severe vomiting
and ulcers. In toys, antimony can be used as a flame
retardant.
(35) The Commission considers that different scientific
considerations were taken into account when establishing
the limits under the Directive and under standard EN 71-
3. Those established under the Directive are based on a
The position of the German Federal Government
consistent and transparent scientific-toxicological
approach to ensure safety, and can therefore be
(40) The
German
authorities
noted
an
increase
in
the
limit
considered as more appropriate.
values for antinomy in scrapped-off toy materials, as
established in the Directive, when compared to the
limits contained in standard EN 71-3. Although
(36) The migration limits for arsenic in scraped-off toy
Germany agrees that no adverse effects on human
material are based on the tolerable daily intake recom
health are expected from the limits set out in the
mended by RIVM in 2007, and on the assumption that
Directive, this increase is considered as unnecessary.
contribution from toys should not exceed 5 %. This
Therefore Germany requests maintaining national limits.
percentage was multiplied by the estimated weight of a
child (7,5 kg), and divided by the estimated quantity of
toy material ingested (8 mg/kg for scraped off materials).
The migration limits for arsenic in standard EN 71-3
Evaluation of the position of the German Federal
were derived from the bioavailability limits established
Government
in Directive 88/378/EEC, based on estimated food
(41) As previously stated, the Commission holds the opinion
intakes established in 1985. The calculation method
that the limit values established under the Directive are
applied did not take into account the weight of the
more appropriate, since they are based on a consistent
child nor the differences between toy materials, as does
and transparent scientific-toxicological approach to
the Directive. Thus, the Commission considers the limit
assure safety.
values established in the Directive as more appropriate.
(37) Germany further
underlines that toys are the most
(42) The
migration
limits
for
antimony
in
scraped-off
toy
significant contribution after food to the overall
material are based on the tolerable daily intake derived
exposure of children to arsenic. The Commission notes
by the WHO ( 2 ) in 2003 and recommended by RIVM in
that, based on scientific data available ( 1 ), soils and
2007, and on the assumption that contribution from
treated wood are the most significant contribution after
toys should not exceed 10 %. This percentage was
food to the overall exposure of children to arsenic.
multiplied by the estimated weight of a child (7,5 kg),
However, regardless of the actual contributions from
and divided by the estimated quantity of toy material
different compartments to the overall exposure, the
ingested (8
mg/kg for scraped-off materials). The
Legislator considered that contribution from toys
migration limits for antimony in standard EN 71-3
should not exceed 5 % of the overall exposure, in order
were derived from the bioavailability limits established
to assure safety.
in Directive 88/378/EEC, based on estimated food
intakes established in 1985. The calculation method
applied did not take into account the weight of the
(38) In the light of the above considerations, the Commission
child nor the differences between toy materials, as does
is of the opinion that the measures notified by Germany
the Directive. Thus, the Commission considers the limit
with regard to arsenic can not be considered as justified
values established in the Directive to be more appro
on grounds of major need of protection of human
priate.
health.
Antimony — general information
(43) In addition, the Commission acknowledges that

Germany, in the justification brought forward, admits
(39) Antimony
is
a
semi-metallic
chemical
element
which
can
that no adverse effect on human health is expected
exist in two forms, namely metallic and non-metallic
from the limit values for antimony as established in
form. Antimony occurs naturally in the environment,
the Directive. The Commission notes furthermore that
Germany did not provide any evidence demonstrating
( 1 ) RIVM, Agency for toxic substances and Disease Registry (ATSDR)
2007.
( 2 ) WHO (2003) Antimony in Drinking-water.

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L 80/24
EN
Official Journal of the European Union
20.3.2012
that the Directive does not offer an appropriate level of
important flaws. Therefore animal experiments data,
protection to children, nor that the German measures
more reliable for deriving a tolerable daily intake, were
would assure a higher level of protection.
used.
(44) In the light of the above considerations, the Commission
(48) The WHO assessment, based on human data,
is of the opinion that the measures notified by Germany
recommends a lower tolerable daily intake. The
with regard to antimony can not be considered as
Commission recognises that this assessment, likely to
justified on grounds of major need of protection of
offer a higher level of protection to children, may not
human health.
have been appropriately considered by RIVM.
Barium — general information
(49) Thus,
the
Commission
sent
a
request
for
an
opinion
to
the SCHER committee, asking for an additional
(45) Barium is present in the earth’s crust, mostly as barium
evaluation of the migration limits for barium, and recom
sulphate and barium carbonate. These forms are
mendations with regard to the tolerable daily intake to be
insoluble in water. Other barium salt such as barium
used, in the light of the WHO assessment document. The
chloride and barium nitrate, however, readily dissolves
opinion is expected to be delivered in March 2012.
in water. Barium is present surface water and drinking
water (natural occurrence). The barium content in
drinking water depends on regional geochemical
conditions. Food also contains barium. Ingestion of
barium can cause increased blood pressure, stomach irri
(50) Based
on the outcome of the SCHER opinion, the
tation, and muscle weakness, damage to the liver, kidney,
Commission may proceed, if deemed necessary, to the
heart, and spleen. Barium has few industrial applications.
revision of the migration limits for barium as established
As barium naturally occurs in the environment, traces of
in the Directive.
barium can be found in toys when manufactured with
natural raw materials.
(51) In the light on the above considerations, the Commission
is of the opinion that the measures notified by Germany
The position of the German Federal Government
with regard to barium are considered as justified on
grounds of major need of protection of human health.
(46) The
German
authorities
consider
that
there
are
uncer
tainties with regard to the tolerable daily intake used
for calculating migration limits for barium in the
Directive. RIVM used a tolerable daily intake of
600 μg/kg body weight/day, based on animal
Lead — general information
experiments data (Engelen et al. 2008). According to

Germany, the use of this tolerable daily intake resulted
(52) Lead
is a particularly
toxic metal which
takes both
in higher migration limits for barium in scraped-off
organic and inorganic form. Given that lead is considered
materials, compared to those set out in standard EN
as a non-threshold toxic substance for neurotoxic effects
71-3. Germany considers the choice of RIVM to be ques
and given the specific vulnerability of children, their
tionable, since WHO ( 1 ) determined considerably lower
exposure to lead should be reduced to the maximum
tolerable daily intakes. Thus Germany requests main
extent possible. The exposure to lead can cause damage
taining national limits with regard to barium.
to a child’s central nervous system, thus adversely
impacting his/her development. Lead exposure mainly
arises from food products (cereals, vegetables and tap
water being the major contributors to lead exposure).
Another important exposure source is the environment,
Evaluation of the position of the German Federal
in particular house dust. An additional exposure source is
Government
the contact with consumer products, including toys.
Given the high exposure from food and environment,
(47) The
Commission
notes
that
there
are
uncertainties
with
limit values for lead in toys were set out in such way
regard to the tolerable daily intake for barium. Although
that exposure from toys does not exceed a certain
human data are considered as a more appropriate basis
amount of all exposure sources. Lead may be found in
for deriving a tolerable daily intake, RIVM considered
toys paints and softened plastic. Children are exposed to
that the studies providing these data contained
lead through ingestion, in particular through hand-to-
mouth or mouthing behaviour. As paint deteriorates, it
( 1 ) World Health Organisation, 2001. Barium and barium compounds.
peels, pulverises and then can be ingested or remains on
Concise International chemical assessment document.
the hands and fingers from where it can be ingested or

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EN
20.3.2012 Official
Journal
of
the
European
Union L
80/25
inhaled. Considering lead toxicological characteristic, the
(58) By
comparison
to
the
migration
limits
of
mercury
in
dermal exposure does not seem to represent any health
scraped-off materials as established in the Directive
risk ( 1 ).
(94 mg/kg), Germany concludes to an increase which
contradicts the European objective of reduction of
human exposure to mercury.
The position of the German Federal Government
(53) The
German
authorities
refer
to
the
2010
EFSA
study
carrying out a comprehensive assessment on lead. In
(59) Thus,
Germany
requests
maintaining
national
measures,
EFSA’s opinion, there is no scientifically justified
regardless of the fact that Germany expects no damage to
threshold dose for the adverse effects of lead on
health from the values established in the Directive.
human health. Therefore Germany considers that the
migration limits for lead, as established in the Directive,
are no longer scientifically based and request maintaining
national measures.
Evaluation of the position of the German Federal
Government
(60) As previously
explained, the Commission holds the
Evaluation of the position of the German Federal
opinion that limit values established under the Directive
Government
can be considered more appropriate since they are based

on a consistent and transparent scientific-toxicological
(54) The
Commission
acknowledges
that
the
migration
limits
approach to assure safety.
for lead as established in the Directive no longer offer an
appropriate level of protection for children. The tolerable
daily intake used for calculating the limits was questioned
by EFSA and JECFA in 2010, after the revision of the toy
(61) The
migration
limits for mercury
in scraped-off
toy
safety legislation. Taking this into account, the
material are based on the tolerable daily intake recom
Commission already undertook the revision of the above
mended by RIVM in 2007, and on the assumption that
mentioned limits.
the contribution from toys should not exceed 10 %. This
percentage was multiplied by the estimated weight of a
child (7,5 kg), and divided by the estimated quantity of
toy material ingested (8 mg/kg for scraped-off materials).
(55) In the light of the above considerations, the Commission
The migration limits for mercury in standard EN 71-3
is of the opinion that the measures notified by Germany
were derived from the bioavailability limits established in
with regard to lead are considered as justified on grounds
Directive 88/378/EEC, based on estimated food intakes
of major need of protection of human health.
established in 1985. The calculation method applied did
not take into account the weight of the child nor the
differences between toy materials, as does the Directive.
Therefore, the Commission considers the limit values
Mercury — general information
established in the Directive to be more appropriate.
(56) Mercury is a naturally occurring element in the Earth’s
crust. The main source of exposure to mercury occurs
from dental amalgam. Other sources are drinking water
and consumption of fish and other marine organisms.
(62) In addition, the Commission acknowledges that
Mercury is also used in fluorescent tubes, batteries and
Germany, in the justification brought forward, admits
thermometers. Exposure to mercury at critical levels can
that no adverse effect on human health is expected
cause tremors, emotional changes, insomnia, neur
from the limit values for mercury as established in the
omuscular changes, headaches, disturbances in
Directive. In addition, the Commission notes that
sensations, changes in nerve responses. At higher
Germany did not provide any evidence demonstrating
exposures there may be kidney effects, respiratory
that German measures notified would assure a higher
failure and death.
level of protection.
The position of the German Federal Government
(63) In accordance to the European strategy concerning
mercury (
(57) Germany
notes
that
the
bioavailability
limits
for
mercury

2 ), measures have been taken in order to
established in Directive 88/378/EEC, and consequently in
reduce mercury exposure, specifically in the areas
the national measures notified, are 0,5 μg/day, trans
generating major exposure. With regard to toys,
formed, in standard EN 71-3, in migration limits of
mercury is used in batteries, which must be inaccessible
60 mg/kg.
to children. Therefore, due to the inaccessibility of the

batteries, children are not exposed to mercury via toys.
Germany did not provide any exposure data supporting
( 1 ) RIVM (2006) Chemicals in Toys — A general methodology for
the contrary. Also, as acknowledged by Germany in the
assessment of chemical safety of toys with a focus on elements of
the migration of heavy elements. Revised Final Version, 12 October
2006, Section II.10.7, p. 184.
( 2 ) COM(2010) 723 final.

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L 80/26
EN
Official Journal of the European Union
20.3.2012
justifications put forward, in recent years, no Member
toys made of synthetic and natural rubber and intended
State notified to the Commission measures against toys
for children under 3, as the exposure parameters are
containing mercury found on the market.
assumed to be different.
(68) SCCP
assumed
the
children
are
exposed
to
balloons
for
5
(64) In the light of the above considerations, the Commission
hours/year. Germany notes that the mouthing behaviour
is of the opinion that the measures notified by Germany
of children under 3 is assumed to be 3 hours/day. The
with regard to mercury, though based on public health
German authorities concludes that exposure of children
considerations, are considered as not justified on grounds
under 3 to rubber toys is much higher than exposure to
of major need of protection of human health.
balloons only.
Nitrosamines and nitrosatable substances — general
(69) Germany
further
considers
that
children
are
exposed
to
information
nitrosamines and nitrosatable substances via all toys

made of rubber, regardless of their intended use. Point
(65) Nitrosamines are a class of chemical compounds
8 of Annex II, Part III, to the Directive addresses, in
produced under certain conditions (acidic pH, high
Germany’s opinion, only toys for children under 3 and
temperature, presence of certain reducing agents) in a
other toys intended to be placed in the mouth. Thus,
variety of compartments (consumer products, biological
Germany invites the Commission to consider enlarging
systems, air, etc.), when nitrites react with the so-called
the scope of the Directive in order to include toys which
nitrosatable substances. Nitrosamines have been detected
are not intended but likely to be put in the mouth,
as contaminants in a number of products including
regardless of the age of the users.
foods, beer, tobacco products, rubber products, and
cosmetics. The two most common nitrosamines, N-nitro
sodimethylamine (NDMA) and N-nitrosodiethylamine
(NDEA) are classified as carcinogens: NDMA is classified
(70) In
addition,
the
German
authorities
note
that,
according
in the EU as a carcinogen 1B (‘presumed to have carci
to the technological state of the art, the formation of
nogenic potential for humans’) ( 1 ). NDEA is classified by
nitrosamines and nitrosatable substances during the
the International Agency for Research on Cancer (IARC)
manufacture of natural or synthetic rubber can largely
as a carcinogen category 2A (‘probably carcinogenic to
be avoided by using appropriate vulcanisation acceler
humans’) ( 2 ). In toys, nitrosamines can be found in
ators.
rubber toys and finger paints.
(71) In
the
light
of
the
above
justifications,
Germany
requests
maintaining national measures related to nitrosamines
(66) Directive 88/378/EEC does not contain specific
provisions on nitrosamines and nitrosatable substances.
and nitrosatable substances in toys for children under
Migration limits were introduced in the Directive for toys
3, intended or likely to be put in the mouth, and
intended for children under 3 and other toys intended to
made of synthetic or natural rubber.
be placed in the mouth, applicable as from 20 July 2013.
The limits are based on the Scientific Committee on
Consumer products (SCCP) opinion from 2007, related
to the presence and release of nitrosamines and nitro
Evaluation of the position of the German Federal
satable compounds from rubber balloons.
Government
(72) The
Commission
notes
that
the
German
measures
related
to nitrosamines and nitrosatable substances were adopted
in 2008. At that time, the risk on human health due to
exposure of small children to nitrosamines and nitro
The position of the German Federal Government
satable substances in rubber toys was not addressed by
(67) Germany
agrees
that
the
limits
set
out
by
the
SCCP
with
Directive 88/378/EEC. This risk was confirmed by the
regard to balloons are to be considered as posing a
SCCP in 2007, and addressed by the Legislator within
negligible risk. However, the German authorities
the revision of the abovementioned Directive.
consider that these limits can not be extended to all
( 1 ) According to Regulation (EC) No 1272/2008, of the European
Parliament and of the Council of 16 December 2008 on classifi
(73) Point 8 of Annex II, Part III, to the Directive prohibits the
cation, labelling and packaging of substances and mixtures,
use of nitrosamines and nitrosatable substances in toys
amending and repealing Directives 67/548/EEC and 1999/45/EC,
intended for children under 3 and other toys intended to
and amending Regulation (EC) No 1907/2006 (OJ L 353,
the placed in the mouth, when the migration of
31.12.2008, p. 1).
( 2 ) IARC Monographs on the Evaluation of Carcinogenic Risks to
substances is equal or higher that 0,05 mg/kg for nitro
Humans, volume 17.
samines and 1 mg/kg for nitrosatable substances.

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EN
20.3.2012 Official
Journal
of
the
European
Union L
80/27
(74) These
limits
are
based
on
the
values
considered
by
SCCP,
legislation notified pursuant to Article 114(4). Thus such
when evaluating exposure to balloons, as posing a
request can not be considered as admissible pursuant to
negligible risk to health. Due to the lack of realistic
Article 114(4).
data necessary for evaluating exposure to rubber toys,
acknowledged by Germany in the justifications put
forward, the limit values recommended for balloons
were extended to other types of toys likely to contain
nitrosamines or nitrosatable substances.
(80) However
the
Commission
considers
that
the
Directive

addresses appropriately the categories of toys likely to
release nitrosamines and nitrosatable substances. All
toys intended for children under 3 are concerned, as
these children have a pronounced mouthing behaviour
(75) In the absence of precise data, the Commission agrees
(i.e. tendency to put all products into the mouth, even
that, with regard to toys intended to be placed in the
when this is not intended). Toys for older children are
mouth, data on children’s mouthing behaviour is more
concerned only when intended to be placed in the
relevant than data on exposure to balloons for assuming
mouth, as the mouthing behaviour is less relevant than
exposure parameters.
for children under 3. The Commission is aware that
children under 3 can be in contact with toys intended
for older children. However this risk can be addressed by
other means, less restrictive, such as appropriate
(76) The
Commission
also
agrees
that,
taking
into
account
the
warnings indicating the toys are not suitable for
technological state of the art, the formation of nitro
children under 3. The Directive contains provisions for
samines and nitrosatable substances during the manu
such warnings.
facture of natural of synthetic rubber can largely be
avoided by using appropriate vulcanisation accelerators.
The SCCP reached the same conclusions in its 2007
opinion. In addition, it is proven to be technically
Absence of arbitrary discrimination
feasible for the manufacture of rubber teats and
soothers, where migration of nitrosamines and nitro
(81) Article
114(6)
requires
the
Commission
to
verify
that
the
satable substances shall not exceed 0,01 and respectively
national provisions notified pursuant to Article 114(4)
0,1 mg/kg ( 1 ).
are not a means of arbitrary discrimination. The
absence of discrimination, according to the jurisprudence
of the Court of Justice, means that no different treatment
should be given to similar situations, nor similar
treatment to different situations.
(77) In addition, the Commission notes that a specific

standard is being developed by the European
Committee for Standardisation (CEN) for testing the
presence of nitrosamines and nitrosatable substances in
toys. The Commission is aware that the limits for nitro
(82) Since
the measures related to mercury,
arsenic, and
samines in finger paints are going to be lowered from
antimony are not justified by the need to protect the
0,05 mg/kg to 0,01 mg/kg within the development of
human health, the Commission does not have to verify
this standard, in order to better take into account
whether this condition is satisfied.
children’s exposure. The Commission will ask CEN to
consider data on small children’s mouthing behaviour
for all toys covered by point 8 of Annex II, Part III, to
the Directive.
(83) The
German
national
measures
related
to
lead,
barium,
nitrosamines and nitrosatable substances in toys apply
without distinction to all products, whether manu
factured in Germany or imported from other Member
(78) In the light of the above considerations, the Commission
States. Therefore, there is no evidence that the German
is of the opinion that the measures notified by Germany
measures have been used as a means of arbitrary
with regard to nitrosamines and nitrosatable substances
discrimination between economic operators in the EU.
in toys for children under 3 and made of synthetic or
natural rubber are considered as justified on grounds of
major need of protection of human health.
Absence of a disguised restriction on trade
(84) National
measures
derogating
from
the
provisions
of
a
(79) As
regards
extending
the
scope
of
these
provisions
to
European directive normally constitute a barrier to trade.
toys which are not intended but likely to be placed in
Products which can be legally placed on the market in
the mouth, the Commission notes that such requirement
the rest of the EU cannot be placed on the concerned
is neither in force in Germany, nor part of the national
Member State’s market. Article 114(6) intends to prevent
that national measures notified under Article 114(4) are
applied for inappropriate reasons, and in reality
( 1 ) Commission Directive 93/11/EEC of 15 March 1993 concerning the
release of the N-nitrosamines and N-nitrosatable substances from
constitute economic measures intended to indirectly
elastomer or rubber teats and soothers (OJ L 93, 17.4.1993, p. 37).
protect national production.

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L 80/28
EN
Official Journal of the European Union
20.3.2012
(85) Since
the measures related to mercury, arsenic and
(90) Since
the measures related to mercury, arsenic and
antimony are not justified by the need to protect the
antimony are not justified by the need to protect the
human health, the Commission does not have to verify
human health, the Commission does not have to verify
whether this condition is satisfied.
whether this condition is satisfied.
(91) With
regard
to
lead
and
barium,
the
Commission
notes
that manufacturers, when applying the provisions of the
(86) With regard to lead, the Commission agrees that the limit
Directive, will be able to market toys in all Member
values established in the Directive do no longer offer an
States, except for Germany. Manufacturers are not
appropriate level of protection, since the scientific back
likely to develop two sets of different toys, but align
ground for setting the values evolved. Consequently, the
on the derogating provisions in order to have toys
Commission undertook a revision of these measures.
which can be marketed in all Member States. The
Thus, the Commission considers that the German
Commission further notes that the German limits for
request is based on a real concern with regard to
lead and barium are those that have been applicable in
children’s health, and does not constitute a disguised
the EU since 1990 on the basis of Directive 88/378/EEC,
restriction on trade between Member States.
and therefore can be technically met by manufacturers.
Toy manufacturers have confirmed this assumption when
expressing their position on the German measures. The
Commission has therefore reasons to consider that the
(87) With
regard
to
barium,
the
Commission
agrees
that
the
effect on the functioning of the internal market is
WHO assessment was not appropriately considered by
proportionate in relation to the objective of protecting
RIVM when recommending a tolerable daily intake.
children’s health.
Thus, uncertainties exist with regard to the level of
protection offered by the Directive. The Commission
asked clarifications to SCHER and will consider, as
(92) With
regard
to
nitrosamines
and
nitrosatable
substances,
soon as SCHER has adopted its opinion, the revision of
the Commission concludes similarly. The German
the limits if necessary. Therefore, the Commission
measures on nitrosamines and nitrosatable substances
considers that the German request is based on a real
are applicable in Germany since 2008. Manufacturers
concerns with regard to children’s health, and does not
did not, to the Commission’s knowledge, develop two
constitute a disguised restriction on trade between
sets of different toys, but aligned to the German
Member States.
provisions in order to have toys which can be
marketed in all Member States. With the entry into appli
cation of the Directive, less strict that the German
measures, the Commission expects manufacturers to
align on the strictest provisions in order to have toys
(88) With regard to nitrosamines and nitrosatable substances,
which can be marketed in all Member States. The
the Commission agrees that exposure parameters with
Commission further notes that meeting the German
regard to children’s mouthing behaviour where not
limits is technically feasible, as manufacturers comply
appropriately considered when establishing limit values
with them since 2008. The Commission has therefore
in the Directive. The Commission will require CEN to
reasons to consider that the effect on the functioning
consider these parameters to lower the limit values
of the internal market is proportionate in relation to
within the standardisation process. Thus, the
the objective of protecting children’s health.
Commission considers that the German request is
based on a real concern with regard to children’s
health, and do not constitute a disguised restriction on
CONCLUSION
trade between Member States.
(93) In the light of the above considerations, the Commission
concludes that the national provisions notified by
Germany with regard to mercury, arsenic and antimony
are not justified on grounds of major need of protection
Absence of obstacles to the functioning of the internal
of human health. Therefore, the Commission considers
market
that those national provisions notified can not be
(89) Article
114(6)
prohibits
the
approval
of
any
national
approved.
measure likely to affect the functioning of the internal
market. However, this requirement can not be interpreted
as prohibiting the approval of all measures likely to affect
(94) With regard to the national measures notified by
the functioning of the internal market. All measures
Germany in relation to lead and barium, the Commission
derogating from a harmonisation measure constitute a
concludes that these measures are considered as justified
measure that is likely to affect the functioning of the
by the need to protect human health, and that they do
internal market. Thus, the Commission considers that
not constitute either a means of arbitrary discrimination,
the concept of obstacle to the functioning of the
a disguised restriction on trade between Member States,
internal market as referred to in Article 114(6) has to
or a disproportionate obstacle to the functioning of the
be understood as a disproportionate effect in relation to
internal market. The Commission has therefore reasons
the pursued objective, in order to preserve the useful
to consider that the national measures notified can be
character of the procedure.
approved, subject to a limitation in time.

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EN
20.3.2012 Official
Journal
of
the
European
Union L
80/29
(95) With
regard
to
the
national
measures
notified
in
relation
The German measures related to barium and notified pursuant
to nitrosamines and nitrosatable substances, the
to Article 114(4) of the TFEU are approved until the date of
Commission concludes that these measures are justified
entry into force of EU provisions setting new limits for barium
by the need to protect the human health, and that they
in toys or 21 July 2013, whichever comes first.
do not constitute either a means of arbitrary discrimi
nation, a disguised restriction on trade between Member
States or a disproportionate obstacle to the functioning
The German measures related to nitrosamines and nitrosatable
of the internal market. The Commission has reason to
substances notified pursuant to Article 114(4) of the TFEU are
consider that the national provisions notified can be
approved.
approved,
Article 2
HAS ADOPTED THIS DECISION:
This Decision is addressed to the Federal Republic of Germany.
Article 1
The German measures related to antimony, arsenic and mercury
notified pursuant to Article 114(4) of the TFEU are not
Done at Brussels, 1 March 2012.
approved.
The German measures related to lead and notified pursuant to
For the Commission
Article 114(4) of the TFEU are approved until the date of entry
into force of EU provisions setting new limits for lead in toys or
Antonio TAJANI
21 July 2013, whichever comes first.
Vice-President

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