2006/347/EC: Commission Decision of  3 January 2006  on the national provisions notified by the Kingdom of Sweden under Article 95(4) of the EC Treaty concerning the maximum admissible content of cadmium in fertilisers  (notified under document number C(2005) 5532)   (Text with EEA relevance)
Date: 2006-01-03
Institutions: European Commission
Subjects: Sweden, cadmium, derogation from EU law, fertiliser, marketing, plant health legislation

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II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 3 January 2006

on the national provisions notified by the Kingdom of Sweden under Article 95(4) of the EC Treaty
concerning the maximum admissible content of cadmium in fertilisers

(notified under document number C(2005) 5532)

(Only the Swedish text is authentic)

(Text with EEA relevance)

(2006/347/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community, and in particular Article 95(6) thereof,

establishing the European

Whereas:

(1)

(2)

I. FACTS

1. Community legislation

Council Directive 76/116/EEC of 18 December 1975 on
the approximation of the laws of the Member States
relating to fertilisers (1),
laid down the requirements
that fertilisers must fulfil in order to be placed on the
market with the designation ‘EC fertilisers’.

to its composition,

Annex I to Directive 76/116/EEC set out the type desig-
nation and the corresponding requirements, e.g. with
respect
that each EC-designated
fertiliser must fulfil. EC-designated fertilisers included in
this list are grouped into categories, depending on the
content of
the elements
the primary nutrients,
nitrogen, phosphorus and potassium.

i.e.

(3)

According to Article 7 of Directive 76/116/EEC, Member
States were not permitted on grounds of composition,

(4)

(5)

(6)

identification, labelling or packaging, to prohibit, restrict
or hinder the marketing of fertilisers marked ‘EC fertiliser’
which comply with the provisions of this Directive.

Commission Decision 2002/399/EC of 24 May 2002 on
the national provisions notified by the Kingdom of
Sweden under Article 95(4) of the EC Treaty concerning
the maximum admissible content of cadmium in ferti-
lisers (2), granted a derogation to Directive 76/116/EEC,
by approving the Swedish provisions which prohibit the
placing on the Swedish market of fertilisers containing in
excess of 100 grams of
tonne of
phosphorus. This
applicable until
31 December 2005.

derogation was

cadmium per

Directive 76/116/EEC, as amended, has been replaced by
Regulation (EC) No 2003/2003 of
the European
Parliament and of
the Council of 13 October 2003
relating to fertilisers (3).

Article 35(2), of Regulation (EC) No 2003/2003 states
that derogations from Article 7 of Directive 76/116/EEC
that were granted by the Commission under Article 95(6)
of the Treaty shall be construed as derogations from
Article 5 of the present Regulation and shall continue
to produce their effects notwithstanding the entry into
force of this Regulation.

(1) OJ L 24, 30.1.1976, p. 21. Directive as last amended by the 2003

Act of Accession.

(2) OJ L 138, 28.5.2002, p. 24.
(3) OJ L 304, 21.11.2003, p. 1. Regulation as amended by Commission
Regulation (EC) No 2076/2004 (OJ L 359, 4.12.2004, p. 25).

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(7)

Recital 15 of Regulation (EC) No 2003/2003 announces
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
and will present it to the European Parliament and the
Council.

were fixed nationally at the date of accession and that
this derogation applies for the period from 1 January
1999 until 31 December 2001.

(8) Work is in progress to prepare a Commission proposal

on cadmium in fertilisers.

national

(12) On 7 December 2001, the Kingdom of Sweden notified
existing
from the
legislation,
provisions of Directive 76/116/EEC on the approxi-
mation of the laws of the Member States relating to
fertilisers.
Decision
2002/399/EC granted a prolongation of the derogation
from Directive 76/116/EEC until 31 December 2005.

consideration,

deviating

careful

After

2. The accession of Sweden

3. National provisions

(9)

shall,

the use

concerning

Sweden acceded to the European Union on 1 January
1995. The Act of Accession (4)
lays down transitional
provisions
and marketing of
cadmium in that State. Article 112(1) provides that
from the date of
four years
during a period of
accession, the provisions referred to in Annex XII of
the Act
in accordance with that Annex and
subject to the conditions set out therein, not apply to
Sweden. Article 112 of and point 4 of Annex XII to the
Act of Accession provide that Article 7 of Directive
76/116/EEC,
in so far as it concerns the cadmium
content of fertilisers, shall not apply to Sweden before
the provisions of Directive
1 January 1999 and that
reviewed in accordance with
76/116/EEC will be
Community procedures by 31 December 1998.

(10) Article 2 of the Act of Accession provides that ‘from the
date of accession, the provisions of the original Treaties
and the Acts adopted by the institutions before accession
shall be binding on the new Member States and shall
apply in those States under the conditions laid down
in those Treaties and in this Act’. Article 168 of the
‘the new Member
Act of Accession stipulates
States shall put into effect the measures necessary for
them to comply, from the date of accession, with the
provisions of directives and decisions within the meaning
of Article 189 (now Article 249) of the EC Treaty (…),
unless a time limit is provided for in the list of Annex
XIX or in any other provisions of this Act’.

that

subsequently

(11) Directive 98/97/EC of the European Parliament and of
Council (5)
the
amended Directive
76/116/EEC as
the marketing in Austria,
Finland and Sweden of fertilisers containing cadmium.
inter alia, Sweden may prohibit
Article 1 provides that,
fertilisers containing
the marketing on its territory of
that which
cadmium at concentrations in excess of

regards

(13)

(14)

(15)

(16)

Ordinance’
inter

(1998:944) (6)
to
alia,

‘The Chemicals Products (Handling, Import and Export
contains
Prohibitions)
the maximum
provisions
relating,
permissible cadmium content
including
EC-designated fertilisers. Section 3, paragraph 3, of the
Ordinance, provides that fertilisers covered by customs
tariffs numbers 25.10, 28.09, 28.35, 31.03 and 31.05
containing in excess of 100 grams of cadmium per tonne
of phosphorous may not be offered for sale or trans-
ferred.

in fertilisers,

the

The provisions relating to the maximum permissible
cadmium content in fertilisers have been in force since
‘The Cadmium
1985 following
Ordinance’
Products
Chemicals
Ordinance’
codifies different provisions
relating to the protection of the environment, including
Cadmium Ordinance’
‘The
those
(1985:839).

adoption of
‘The

(1985:839).
(1998:944)

contained

in

II. PROCEDURE

the Kingdom of Sweden
By letter of 29 June 2005,
notified the Commission that,
in accordance with
article 95(4) of the EC Treaty, it intends to continue to
from 1 January 2006 national provisions
apply
in fertilisers. The
concerning the cadmium content
Swedish authorities request an extension of the current
derogation provided by Decision 2002/399/EC.

By letter of 29 July 2005, the Commission informed the
Swedish authorities that it had received the notification
under Article 95(4) and that the six-month period for its
examination according to Article 95(6) started on 30
June 2005, the day following the one when the notifi-
cation was received.

(4) OJ C 241, 29.8.1994, p. 41 and p. 316.
(5) OJ L 18, 23.1.1999, p. 60.

(6) Swedish Code of Statutes

(SFS Svensk Författningssamling) of

14 July 1998.

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(17)

By letter of 10 August 2005, the Commission informed
the other Member States about the request received from
Sweden. The Commission also published a notice
regarding the request
the
European Union (7)
in order to inform other interested
parties of the national measures that Sweden intends to
maintain.

in the Official

Journal of

III. ASSESSMENT

1. Consideration of admissibility

(18) Article 95(4) of the Treaty provides that,

if, after the
adoption by the Council or by the Commission of a
it
harmonisation measure,
necessary to maintain national provisions on grounds
of major needs referred to in Article 30, or relating to
the protection of the environment or the working envir-
onment,
these
provisions as well as the grounds for maintaining them.

shall notify the Commission of

a Member State deems

it

the

cadmium content of

the Act of
the European Union. As indicated above,
Accession lays down transitional provisions allowing
Sweden to continue to apply its national provisions
concerning
to
products covered by Directive 76/116/EEC for a period
of
four years. By Directive 98/97/EC Sweden was
authorised to continue to apply the above national
provisions
2001. Decision
31 December
2002/399/EC extended the derogation until December
2005.

fertilisers

until

(23) As required by Article 95(4), as interpreted in the light of
Articles 2 and 168 of the Act of Accession, Sweden
notified the Commission of the actual wording of the
national provisions adopted before the accession to the
intends to maintain, accom-
European Union that
panying the request by an explanation of the reasons
which,
justify the maintenance of those
provisions.

in its opinion,

it

(19)

The notification submitted by the Swedish authorities on
29 June 2005 intends to obtain authorisation to extend,
beyond 31 December 2005,
the current derogation
provided in Decision 2002/399/EC. This Decision
allows Sweden to maintain the application of national
concerning the
provisions
composition of EC-denominated fertilisers contained in
Regulation (EC) No 2003/2003.

incompatible with those

(24)

The reasons provided by the Swedish authorities are
those already submitted in the past and that lead the
Commission, in Decision 2002/399/EC, to grant a dero-
gation until 31 December 2005. This period was granted
on the assumption that harmonised legislation would be
in place by end 2005. Although work is in progress,
legislation would not be adopted at Community level
before the end of the year.

(20) As already indicated, Article 5 of Regulation (EC) No
2003/2003 prevents Member States from restricting the
marketing of EC-denominated fertilisers because of their
composition, but the rules governing composition do not
set any limit value for cadmium content. This means that
pursuant to Article 5 of Regulation (EC) No 2003/2003,
EC-denominated
the
requirements of that Regulation can be placed on the
market regardless of their cadmium content.

complying

fertilisers

with

(25)

The notification submitted by Sweden on 29 June 2005
in order to obtain approval
for maintaining national
provisions derogating from the provisions of Regulation
(EC) No 2003/2003 is
therefore to be considered
admissible under Article 95(4) as interpreted in the
light of Articles 2 and 168 of the Act of Accession.

(21)

In the light of the abovementioned, it is clear that the
national provisions notified by Sweden, in so far as they
prohibit the placing on the market of EC-denominated
fertilisers with a cadmium content exceeding 100 grams
per tonne of phosphorus, are more restrictive than those
contained in Regulation (EC) No 2003/2003.

2. Assessment of merits

(26)

the
In accordance with Article 95 of
Commission has
the conditions
to ensure that all
enabling a Member State to avail itself of the possibilities
of derogation provided for in this article are fulfilled.

the Treaty,

(22)

The national provisions notified by the Swedish autho-
rities were adopted in 1985 before Sweden acceded to

(7) OJ C 197, 12.8.2005, p. 6.

(27)

In particular, the Commission has to assess whether the
provisions notified by the Member State are justified on
grounds of major needs referred to in Article 30 of the
Treaty, or relating to the protection of the environment
or the working environment.

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(28)

(29)

that

to Article 95(6) of

the Treaty,
In addition, pursuant
where it considers
the national provisions are
justified, the Commission must check whether or not
those national provisions are a means of arbitrary discri-
mination or a disguised restriction on trade between
Member States and whether or not they constitute an
obstacle to the functioning of the internal market.

Sweden has based its request on the need of protection
of human health and the environment. Cadmium in ferti-
lisers is deemed to pose a threat to the environment and
human health. In support of its request, Sweden makes
reference to the conclusions of a Swedish study published
in October 2000 (8) which contains an assessment of the
risks posed by cadmium-containing fertilisers.

2.1. Justification on grounds of major needs

(30) As regards the general

information on cadmium, from
it can be
the scientific data available up to now,
concluded that cadmium metal and cadmium oxide in
general can be considered to pose serious risks to health.
In particular, cadmium oxide has been classified as a
carcinogen, mutagen or substance toxic for reproduction,
category 2. It is also generally agreed that cadmium in
fertilisers
source of
the most
cadmium input to soil and to the food chain.

is by far

important

(31) As regards cadmium in fertilisers,

the most relevant
the risk assessment carried out by

information of
Sweden can be summarised as follows:

— concerning surface water, the Swedish risk assessment
report states that ‘the chosen PNEC (9) value implies
that in most rivers in southern Sweden, certain biota
would already be affected by cadmium i.e. risk char-
acterisation ratios (10) are larger
If
higher cadmium content
in fertilisers would be
allowed, a further increase in the exposure of and
the concern for effects in the aquatic environment
is expected to occur’,

than one (11).

— concerning the soil,

the Swedish risk assessment
report states that ‘by using the Swedish fertiliser for
100 years on common Swedish soils (PNEC 0,25
mg/kg), no
is
predicted when potatoes or wheat are grown. A
concern is predicted when carrots are grown, but

concern for

ecological

effects

this concern is also present at time zero. With the
EC fertiliser, a concern is predicted in all cases. In
acid, sandy soils that are poor in clay and organic
matter (PNEC 0,06 mg/kg), a risk is predicted even if
the cadmium content in fertilisers is zero’.

(32)

It is clear that these conclusions refer to the specific
situation of
the Swedish soil as well as the climatic
conditions prevailing in Sweden.

(33)

In conclusion, the risk assessment carried out by Sweden
shows that if fertilisers with a higher cadmium content
than currently permitted would be allowed, this would
lead to:

— a substantial increase in the cadmium concentrations
of soils, which in turn would lead to toxic effects on
soil organisms. Unacceptable concentrations could
also appear in watercourses in agricultural regions,

— a

increase

in the dietary intake of
substantial
safety margin between current
cadmium. The
exposure and the World Health Organisation provi-
sional tolerable weekly intake level is extremely small.
For some high-risk groups, such as women with low
body iron stores, there are no safety margins at all. A
high dietary intake of cadmium could therefore lead
to a larger number of people becoming subject to
reduced kidney function and increased osteoporosis.

(34)

(35)

The risk assessment submitted by the Swedish authorities
has been carried out according to the procedures and the
methodology established at Community level, which are
considered to ensure a high degree of reliability of the
information obtained.

The Commission already examined the information
in the context of
contained in the risk assessment
Decision 2002/399/EC which allowed
Sweden to
maintain their national provisions until 31 December
2005.

(8) Swedish National Chemical

Inspectorate, Assessment of risks to
health and the environment in Sweden from cadmium in fertilisers,
4 October 2000.

(9) PNEC: predicted no effect concentration.
(10) These ratios are PEC/PNEC where PEC is the predicted environ-

mental concentration.

(11) A PEC/PNEC ratio greater than 1 indicates that there will be adverse

effects.

(36) No other scientific and technical data was provided by
Sweden in 2005. The accumulation process is a slow one
which is not significantly modified on a three- year
period. Therefore,
the
situation is similar as in 2002.

it could be considered that

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(37)

The validity of the data provided by Sweden is confirmed
by the following scientific basis used to support
the
preparation of the Commission proposal on cadmium
in fertilisers:

mination. According to the ruling of the Court of Justice,
the absence of discrimination means
that national
restrictions on trade cannot be used in such a way as
to create discrimination in respect of goods originating in
other Member States.

— the opinion delivered on 24 September 2002 by the
SCTEE (12)
(now renamed SCHER (13)) concerning
cadmium accumulation in agricultural soils due to
fertiliser application. This opinion was based on risk
assessment reports of nine Member States which
address only the accumulation and not the possible
risks to health and environment; the conclusion of
the SCTEE was that the content of cadmium in ferti-
lisers does need to be limited to prevent accumu-
lation of cadmium in the soil,

(40)

The envisaged national provisions are general and apply
and imported phosphorous based EC-
to national
designated fertilisers alike. As a result,
there is no
evidence that they can be used as a means of arbitrary
in the
discrimination between economic operators
Community.

— the final draft of

risk assessment of
the general
cadmium and cadmium oxide, dated September
2004 produced in accordance with Council Regu-
lation (EEC) No 793/93 (14) and which considers all
sources of cadmium. The draft endorses the opinion
of the SCTEE concerning the accumulation in soil.
Although it
contribution from
cadmium in fertilisers may not, by itself, be sufficient
to cause a severe and immediate risk to human health
or to the environment, caution is needed, as the risk
to human health cannot be excluded for all local and
regional situations because of the large variability in
food cadmium concentrations, dietary habits and
nutritional status.

states

that

the

Pending finalisation of the general risk assessment on
cadmium and cadmium oxide as well as the potential
follow-up work on risk
the
Commission proposal on cadmium in fertilisers has
been subject to some delays.

reduction measures,

(38)

the

after having

re-examined
the Swedish request,

scientific
Therefore,
evidence in the light of
the
Commission considers that the Swedish authorities have
shown that cadmium-containing fertilisers pose environ-
mental and human health risks, and that the national
provisions notified by the Swedish authorities aiming
to limit to the minimum the exposure of the Swedish
are
environment
justified.

cadmium-containing

fertilisers

to

2.2. Absence of arbitrary discrimination

(39) Article 95(6) obliges the Commission to verify that the
envisaged measures are not a means of arbitrary discri-

(12) Scientific Committee on Toxicity, Ecotoxicity and the Environment.
(13) Scientific Committee on Health and Environmental Risks.
(14) OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation (EC)
No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

2.3. Absence of a disguised restriction on trade

(41) More restrictive national measures governing the compo-
sition of EC-designated fertilisers that derogate from the
provisions of a Community Directive normally constitute
a barrier to trade. Products that can be legally placed on
the market in the rest of the Community cannot be
placed on the market in the Member State concerned.
is intended to
The concept enshrined in Article 95(6)
prevent the national provisions based on the criteria set
out
in paragraphs 4 and 5 being applied for inap-
propriate reasons, and in reality constituting economic
measures to be introduced to impede the import of
products from other Member States in order to indirectly
protect national production.

(42) As already established, there is concern with regard to
the protection of the environment and human health due
to the application on soil of cadmium-containing ferti-
lisers. Therefore, the protection of the environment and
human health appears to be the goal of maintaining the
national provisions and not
the creation of disguised
barriers to trade.

(43)

2.4. Absence of obstacles to the functioning of the internal market

This condition cannot be interpreted in such a way that
it prohibits the approval of any national measure likely
to affect the establishment of the internal market. In fact,
any national measure derogating from a harmonisation
measure aiming at the establishment and operation of
the internal market, constitutes in substance a measure
that is likely to affect the internal market. Consequently,
to preserve the useful character of the procedure for
derogation provided for by Article 95 of the EC Treaty,
the Commission considers that,
in the context of the
Article 95(6), the concept of obstacle to the functioning
of the internal market has to be understood as a dispro-
portionate effect in relation to the pursued objective.

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(44)

In view of the risks for both the environment and human
health resulting from the application of cadmium-
containing fertilisers to the Swedish soil and taking
into account that:

— as

national

indicated above,

the Act of Accession and
Directive 98/97/EC allowed Sweden to continue to
the
apply
its
cadmium content
the
completion of the review of Directive 76/116/EEC
as regards the issue of the cadmium content in ferti-
lisers, and

concerning
awaiting

provisions

fertilisers

in

— Decision 2002/399/EC allowed Sweden to maintain
their national provisions until 31 December 2005
based on the risk assessment provided by the
Swedish authorities, and

restrictive measure would provide

— ongoing work within the Commission for an approx-
imation of Community limit values for the cadmium
content in fertilisers does not lead to believe that a
less
sufficient
in Sweden.
protection of health and environment
The risk assessment shows that the specific soil and
Sweden require national
climatic
the environment
provision for
because
to
vulnerable
cadmium inputs due in particular to the acidic pH
of their soil. Under acidic conditions, the solubility of
cadmium increases and therefore could be more
easily taken up by the crops.

the protection of

condition of

are more

some

areas

The Commission considers that, at
the
review, there is no evidence indicating that the national
provisions do constitute a disproportionate obstacle to
in relation to
the functioning of
the pursued objectives.

the internal market

this stage of

2.5. Limitation in time

concerning

The period for which the derogation is granted should
allow sufficient time for the Commission to propose, and
for the Council and the European Parliament to adopt
legislation
at
Community level. In order to avoid the implications of
possible delays during the interinstitutional debate, the
provisions of the current Decision should therefore be
valid until the harmonised measure is applicable at EU
level.

cadmium in

fertilisers

(45)

IV. CONCLUSION

(46)

In the light of the foregoing, it can be concluded that the
request by the Kingdom of Sweden for maintaining
national provisions that are more restrictive than the
provisions of Directive 76/116/EEC with regard to the
cadmium content of fertilisers, as submitted on 29 June
2005, is admissible.

(47) Moreover,
provisions:

the Commission finds

that

the national

— meet needs on grounds of the protection of human

health and the environment,

— are proportionate to the objectives pursued,

— are not a means of arbitrary discrimination, and

— do not constitute a disguised restriction on trade

between Member States.

The Commission therefore considers that they can be
approved,

HAS ADOPTED THIS DECISION:

Article 1

In derogation from Regulation (EC) No 2003/2003, the Swedish
provisions which prohibit the placing on the Swedish market of
fertilisers containing in excess of 100 grams of cadmium per
tonne of phosphorous are approved.

The derogation shall apply until harmonised measures on
cadmium in fertilisers are applied at Community level.

Article 2

This Decision is addressed to the Kingdom of Sweden.

Done at Brussels, 3 January 2006.

For the Commission

Günter VERHEUGEN
Vice-President