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28.4.2012 Official
Journal
of
the
European
Union L
116/29
DECISIONS
COMMISSION DECISION
of 18 April 2012
extending the period referred to in Article 114(6) of the Treaty on the Functioning of the European
Union in relation to national provisions concerning the maximum admissible content of cadmium
in fertilisers notified by the Kingdom of Sweden pursuant to Article 114(5) of the TFEU
(notified under document C(2012) 2461)
(Only the Swedish text is authentic)
(Text with EEA relevance)
(2012/230/EU)
THE EUROPEAN COMMISSION,
involved after having verified whether or not they are a
means of arbitrary discrimination or a disguised
restriction on trade between Member States and
Having regard to the Treaty on the Functioning of the European
whether or not they shall constitute an obstacle to the
Union, and in particular Article 114(6) thereof,
functioning of the internal market.
Whereas:
In the absence of a decision by the Commission within
this period the national provisions referred to in para
I. FACTS
graphs … 5 shall be deemed to have been approved.
(1) On
17
October
2011,
the
Kingdom
of
Sweden
notified
the Commission, pursuant to Article 114(5) of the Treaty
When justified by the complexity of the matter and in
on the Functioning of the European Union (TFEU), of its
the absence of danger for human health, the Commission
intention to introduce national provisions to lower the
may notify the Member State concerned that the period
content of cadmium allowed in phosphorous fertilisers to
referred to in this paragraph may be extended for a
a maximum level of 46 grams of cadmium per tonne of
further period of up to six months.’
phosphorous (equivalent to 20 mg Cd/kg P 2 O 5 ). Those
measures would derogate from Regulation (EC)
No 2003/2003 of the European Parliament and of the
2. EU legislation
Council of 13 October 2003 relating to fertilisers ( 1 ) and
would lower the maximum level of 100 grams of
(3) Council
Directive
76/116/EEC
of
18
December
1975
on
cadmium per tonne of phosphorous (equivalent to
the approximation of the laws of the Member States
44 mg Cd/kg P 2 O 5 ) for which a derogation has already
relating to fertilisers ( 2 ), laid down the requirements
been granted to the Kingdom of Sweden.
that fertilisers must fulfil in order to be placed on the
market with the designation ‘EC fertiliser’.
1. Article 114(5) and (6) TFEU
(4) Annex
I
to
Directive
76/116/EEC
set
out
the
type
desig
(2)
Article 114, paragraphs (5) and (6) TFEU provide:
nation and the corresponding requirements, e.g. with
respect to its composition, that each fertiliser had to
‘5. … if, after the adoption of a harmonisation
fulfil to be eligible for designation as ‘EC fertiliser’.
measure by the European Parliament and the Council,
Type designations in this list were grouped into
by the Council or by the Commission, a Member State
categories, depending on the content of the primary
deems it necessary to introduce national provisions based
nutrients, i.e. the elements nitrogen, phosphorus and
on new scientific evidence relating to the protection of
potassium.
the environment or the working environment on
grounds of a problem specific to that Member State
arising after the adoption of the harmonisation
(5) According
to
Article
7
of
Directive
76/116/EEC
( 3 ),
measure, it shall notify the Commission of the
Member States were not permitted on grounds of
envisaged provisions as well as the grounds for intro
composition, identification, labelling or packaging, to
ducing them.
prohibit, restrict or hinder the marketing of fertilisers
marked ‘EC fertiliser’ which complied with the provisions
of the Directive.
6. The
Commission
shall,
within
six
months
of
the
notifications … approve or reject the national provisions
( 2 ) OJ L 24, 30.1.1976, p. 21, replaced by Regulation (EC) No
2003/2003.
( 1 ) OJ L 304, 21.11.2003, p. 1.
( 3 ) Replaced by Article 5 of Regulation (EC) No 2003/2003.

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L 116/30
EN
Official Journal of the European Union
28.4.2012
(6) Commission
Decision
2002/399/EC
of
24
May
2002
on
cadmium allowed in phosphorous fertilisers from the
the national provisions notified by the Kingdom of
current maximum level of 100 grams of cadmium per
Sweden under Article 95(4) of the EC Treaty concerning
tonne of phosphorus to a level of 46 grams of cadmium
the maximum admissible content of cadmium in ferti
per tonne of phosphorus (46 mg Cd/kg P, equivalent to
lisers ( 1 ), granted a derogation from Directive
20 mg Cd/kg P 2 O 5 ).
76/116/EEC, by approving the Swedish provisions
which prohibited the placing on the Swedish market of
fertilisers containing in excess of 100 grams of cadmium
II. PROCEDURE
per tonne of phosphorus. This derogation was applicable
until 31 December 2005.
(13) By letter of 17 May 2011 the Kingdom of Sweden
notified the Commission that, pursuant to Article 114(5)
TFEU, it requests approval to introduce national
(7) Directive
76/116/EEC
has
been
replaced
by
Regulation
provisions to lower the content of cadmium allowed in
(EC) No 2003/2003 relating to fertilisers.
phosphorous fertilisers to a maximum concentration of
46 grams per tonne of phosphorus. The Swedish auth
orities thus request to lower the cadmium content
(8) Article
35(2)
of
Regulation
(EC)
No
2003/2003
states
that derogations from Article 7 of Directive 76/116/EEC
allowed by the derogation provided by Decision
that were granted by the Commission under former
2006/347/EC.
Article 95(6) of the EC Treaty shall be construed as
derogations from Article 5 of that Regulation and shall
continue to produce their effects notwithstanding the
(14) By
letter
of
17
October
2011,
the
Swedish
authorities
entry into force of the Regulation.
sent additional information to the Commission to
provide the text of the national legislation in force
reflecting the amendments introduced by Ordinances
(9) Recital
15
of
Regulation
(EC)
No
2003/2003
announces
2008:255 and 2009:654 ( 4 ).
that the Commission will address the issue of uninten
tional cadmium content in mineral fertilisers and will,
where appropriate, draw up a proposal for a Regulation
(15) By letter of 14 November 2011, the Commission
and will present it to the European Parliament and the
informed the Swedish authorities that the six-month
Council. The Commission has conducted extensive
period for its examination according to Article 114(6)
preparatory work but due to the complexity of the
started on 18 October 2011.
various factors to be taken into account has not yet
adopted a proposal.
(16) By
letter
of
17
October
2011,
the
Commission
informed
the other Member States about the request received from
(10) Since
the
Swedish
derogation
was
granted
only
until
Sweden. The Commission also published a notice
31 December 2005, Sweden requested in June 2005
regarding the request in the Official Journal of the
an extension of the existing derogation. Commission
European Union ( 5 ) in order to inform other interested
Decision 2006/347/EC of 3 January 2006 on the
parties of the national measures that Sweden intends to
national provisions notified by the Kingdom of Sweden
introduce as well as the grounds invoked to that effect. In
under Article 95(4) of the EC Treaty concerning the
reaction, Latvia supported the Swedish request. No other
maximum admissible content of cadmium in fertilisers ( 2 )
comments were received by the Commission.
allows the Swedish authorities to maintain the national
measures until harmonised measures on cadmium in
fertilisers are applied at EU level.
III. ASSESSMENT
3. National provisions
1. Consideration of admissibility

(17) Article
114(5)
TFEU
concerns
cases
in
which
national
(11) ‘The
Chemicals
Products
(Handling,
Import
and
Export
Prohibitions) Ordinance’ (1998:944)
(
provisions are notified in relation to an EU harmon

3 ) contains
provisions relating, inter alia, to the maximum
isation measure, where the national measures are to be
permissible cadmium content in fertilisers, including
introduced after the harmonisation measure has been
EC-designated fertilisers. Section 3, paragraph 1,
adopted and enforced and where the new national
provides that fertilisers covered by customs tariffs
measure would be incompatible with the EU harmon
numbers 25.10, 28.09, 28.35, 31.03 and 31.05
isation measure. The national provisions were notified
containing in excess of 100 grams of cadmium per
in relation to Regulation (EC) No 2003/2003, which
tonne of phosphorous may not be offered for sale or
was adopted on the basis of former Article 95 of the
transferred.
EC Treaty, and which sets harmonised rules regarding the

composition, identification, labelling and packaging of EC
fertilisers. According to Article 5 of that Regulation,
(12) The envisaged national measure notified under
Member States are not allowed to introduce obstacles
Article 114(5) TFEU would lower the content of
to the free movement of fertilisers based on any of
those grounds.
( 1 ) OJ L 138, 28.5.2002, p. 24.
( 2 ) OJ L 129, 17.5.2006, p. 19.
( 4 ) Swedish Code of Statutes (SFS Svensk Frfattningssamling) of 4 June
( 3 ) Swedish Code of Statutes (SFS Svensk Frfattningssamling) of
2009.
14 July 1998.
( 5 ) OJ C 309, 21.10.2011, p. 8 and OJ C 339, 19.11.2011, p. 24.

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EN
28.4.2012 Official
Journal
of
the
European
Union L
116/31
(18) Furthermore,
Article
114(5)
TFEU
requires
that
the
notifi
2. Recourse to Article 114(6), third subparagraph
cation of the intended national measures must be based
TFEU
on new scientific evidence relating to the protection of
the environment or the working environment on
2.1. Justification based on the complexity of the matter
grounds of a problem specific to the notifying Member
State arising after the adoption of the harmonisation
(23) To
support
its
request,
Sweden
has
conducted
a
new
risk
measure and must be accompanied by a description of
assessment which was finalised in January 2011, in
the grounds for introducing the intended national
which it compares the predicted no effect concentrations
measures.
(PNECs) for organisms representative for various environ
mental compartments with the cadmium concentrations
in the Swedish environment. In their notification,
reference is also made to certain studies made available
in the framework of the previous requests submitted to
(19) In
support
of
the
request
for
a
lower
limit
on
cadmium
the Commission in accordance with Article 114(4) of the
in phosphate fertilisers the Swedish authorities have
Treaty and to the EU risk assessment on cadmium and
submitted a national risk assessment and some studies.
cadmium oxide.
This assessment takes into account the general EU risk
assessment of cadmium and cadmium oxide produced in
2007 in accordance with Council Regulation (EEC)
No 793/93 ( 1 ), a scientific opinion from the European
Food Safety Authority on cadmium in food (
(24) The
PNEC
for
fresh
water
is
dependent
on
hardness.

2 ), as well
as old and new data relating to the assessment of the
Since Sweden has very soft fresh waters, toxicity for
risks to human health and the environment from
aquatic organisms is expected to occur at lower
cadmium in fertilisers in Sweden. The Swedish risk
cadmium concentration compared to other parts of
assessment is published on the internet (
Europe. The Swedish authorities, therefore, consider

3 ).
that it is likely that aquatic organisms in Swedish
waters are in general more sensitive to additional
cadmium compared to waters in Central and Southern
Europe.
(20) According
to the Swedish authorities, the new risk
assessment shows the need to reduce exposure to
cadmium to protect the health of the Swedish population
in the long term. Exposure depends on the intake of
cadmium via food, mainly from plants and therefore it
(25) Results
of
monitoring
programmes
in
Swedish
surface
is necessary to reduce the risk of high levels of cadmium
waters in 2006 and 2009 show that about 1 % of the
in crops. Arable soils are in general more acidic in
lakes and 7 % of the coastal waters show higher
Sweden than in Central Europe and this specific
cadmium concentrations than the PNEC values. A
situation makes cadmium more readily available for
review conducted in 2008 concluded that emission
plants.
reduction measures have for most metals led to
significant decreased concentrations in aquatic organisms,
but for cadmium the situation is less clear. A tendency of
increasing effects on the immune system in fish (eelpout)
during the last years seems to correlate with increasing
(21) Furthermore,
lowering
the
national
limit
of
100
grams
of
concentrations of cadmium in fish. A further report has
cadmium per tonne phosphorous to 46 grams of
been produced in 2011 with the aim to describe future
cadmium per tonne phosphorous is a measure intended
trends of cadmium in arable soils and crops to estimate
to reduce the accumulation of cadmium in soils and also
concentrations in 100 years and results have been used
risks to aquatic organisms living in extreme soft waters
in a worst case modelling to estimate the risk to aquatic
as occur in Sweden.
organisms inhabiting waters close to fields fertilised
during 100 years ahead.
(22) In the light of the foregoing, the Commission considers
that the application submitted by the Kingdom of
(26) The Swedish authorities conclude in their assessment that
Sweden with a view to obtaining approval to lower the
there might be an increased risk for aquatic organisms
content of cadmium in fertilisers to a maximum level of
living in extremely soft waters (below hardness 5 mg
46 grams of cadmium per tonne of phosphorus is
CaCO
admissible.
3 /l) in the longer term. But this is only likely in
small brooks with low dilution of the drainage water
from the agricultural soil. No other risk to the
( 1 ) EU RAR, ECB 2007: European Union Risk Assessment Report
environment resulting from the use of cadmium in ferti
cadmium oxide and cadmium metal, Volume 72 European
lisers has been identified by the Swedish authorities.
Commission, Joint Research Centre, Institute of Health and
Consumer Protection.
( 2 ) EFSA 2009: Scientific Opinion of the Panel on contaminants in the
Food Chain on a request from the European Commission on
cadmium in food. The EFSA Journal (2009) 980, 1-139.
(27) In the light of the complexity of the relations of
( 3 ) Available at: http://ec.europa.eu/enterprise/sectors/chemicals/
documents/specific-chemicals/fertilisers/cadmium/risk-assessment_en.
cadmium input via phosphate fertilisers, possible
htm
accumulation and risks to the environment, as already

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L 116/32
EN
Official Journal of the European Union
28.4.2012
demonstrated during the evaluation of similar requests
European soils at a limit of 46 mg Cd/kg P. SCHER
for derogation from Austria, Finland, and the Czech
confirms that such estimate is still defendable including
Republic, as well as the earlier requests from Sweden,
for Swedish agricultural soils and notes that the deri
the Commission requested the Scientific Committee on
vation was based on a ‘stand-still principle’, not on a
Health and Environmental Risks (SCHER) for an opinion
risk assessment as performed by the Swedish authorities
on the overall quality of the Swedish risk assessment, any
in their current justification.
significant deficiencies, the appropriateness of the
scenarios studied and the assumptions made, as well as
the reliability and validity of the conclusions concerning
the identified risks for the environment.
(30) Although,
in
its
opinion
of
27
February
2012,
SCHER
considers that the risk assessment report prepared by the
Swedish authorities is of good scientific quality and
contains new and relevant data, some uncertainties
remain regarding certain key assumptions used by the
(28) The
SCHER
adopted
its
opinion
on
27
February
2012
( 1 ).
Swedish authorities to conclude that there is a risk to
SCHER concluded that the risk assessment report
aquatic organisms in small brooks in Sweden. This will
prepared by the Swedish authorities is of good scientific
need further clarification from the Swedish authorities to
quality and that in general the scenarios studied are
allow the Commission to take a final position.
appropriate and most parameter values used in the
scenarios are acceptable. However, SCHER considers
that a number of statements and/or assumptions in the
report are not supported by sufficient evidence. For
example, the observations given in the fish monitoring
studies assume a cause-effect relationship which is not
2.2. Absence of danger to human health
proven. Another example is the important (central to the
(31) In
their
justification,
the
Swedish
authorities
identify
risks
risk assessment) assumption of a 1/2 dilution factor used
for sensitive groups of the population (diabetics, people
to calculate the cadmium concentration in the surface
suffering from osteoporosis or iron deficiency). These
waters of brooks. No scientific evidence or justification
risks are caused by long-term exposure to cadmium
is given to support this factor. SCHER also notes that for
through the diet. Therefore, there is no danger to
some scenarios rather worst-case conditions were used.
human health linked to a decision to extend the
For example, the calculations for phosphate applications
assessment of the Swedish situation for an additional
on agricultural soils use application rates that are actually
period of six months. This additional period will allow
valid for less than 25 % of Swedish soils. The calculations
the Commission to take into account further clarifi
of the water surface concentrations in the brooks after
cations to be provided by the Swedish authorities in
drainage seem problematic and the proposed levels do
order to take a final decision.
not correspond with the measured concentrations given
elsewhere in the report. The PNECs used in the Swedish
risk assessment are those suggested in the EU RAR on
cadmium and as such can be supported by SCHER. The
presented risk characterisation ratios (RCR) are thus
solely dependent on the exposure assessment, i.e. the
(32) Based on the above, the Commission considers that the
predicted cadmium concentrations in Swedish surface
conditions laid down in Article 114(6), third subpara
waters. The latter are dependent on the – unsubstantiated
graph, are met in order for it to have recourse to the
– soil/brook dilution factor. SCHER does not agree either
possibility of extending the six-month period within
with the assumption that there is no adsorption of
which it has to approve or reject the national provisions
cadmium in the soil. This will occur only if the soil is
notified by Sweden.
already heavily contaminated and no net adsorption
occurs at steady state, which is not the situation in
Sweden. The Swedish report also assumes that there is
no cadmium adsorption in soil occurring deeper than
30 cm, which is also not the case. Consequently,
IV. CONCLUSION
SCHER does not support the results presented by the
Swedish authorities for brooks, which is the only envi
(33) In
the
light
of
the
foregoing,
it
can
be
concluded
that
the
ronmental compartment for which the Swedish auth
request of the Kingdom of Sweden for introducing
orities had identified risks.
national provisions derogating from Regulation (EC)
No 2003/2003 is admissible.
(29) Nonetheless,
SCHER recalls
the earlier
assessment of
(34) However, in view of the complexity of the matter and of
CSTEE in 2002, which estimated that cadmium concen
the absence of danger for human health by adopting the
trations in soil are expected not to increase in most
present Decision, the Commission considers it justified to
extend the period referred to in Article 114(6), first para
( 1 ) http://ec.europa.eu/health/scientific_committees/environmental_risks/
graph, TFEU for a further period expiring on 18 October
docs/scher_o_156.pdf
2012,

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EN
28.4.2012 Official
Journal
of
the
European
Union L
116/33
HAS ADOPTED THIS DECISION:
Article 1
Pursuant to Article 114(6), third paragraph, TFEU, the period to approve or reject the envisaged national
provisions on cadmium in fertilisers notified by the Kingdom of Sweden on 17 October 2011 pursuant to
Article 114(5) TFEU is extended until 18 October 2012.
Article 2
This Decision is addressed to the Kingdom of Sweden.
Done at Brussels, 18 April 2012.
For the Commission
Antonio TAJANI
Vice-President

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