2006/348/EC: Commission Decision of  3 January 2006  on the national provisions notified by the Republic of Finland under Article 95(4) of the EC Treaty concerning the maximum admissible content of cadmium in fertilisers  (notified under document number C(2005) 5542)   (Text with EEA relevance)
Date: 2006-01-03
Institutions: European Commission
Subjects: Finland, cadmium, derogation from EU law, fertiliser, marketing, plant health legislation

17.5.2006

EN

Official Journal of the European Union

L 129/25

COMMISSION DECISION

of 3 January 2006

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

(notified under document number C(2005) 5542)

(Only the Finnish and Swedish texts are authentic)

(Text with EEA relevance)

(2006/348/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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

establishing the European

Whereas:

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.

(5)

(6)

(7)

Directive 76/116/EEC, as amended, has been replaced
by Regulation (EC) No 2003/2003 of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.

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.

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

on cadmium in fertilisers.

According to Article 7 of Directive 76/116/EEC Member
States were not permitted on grounds of composition,
identification, labelling or packaging, to prohibit, restrict
or hinder the marketing of fertilisers marked ‘EC fertiliser’
which comply with the provisions of this Directive.

(9)

Commission Decision 2002/398/EC of 24 May 2002 on
the national provisions notified by the Republic of
Finland 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 Finnish provisions which prohibit the
placing on the Finnish market of phosphorous mineral
fertilisers with a cadmium content exceeding 50 mg for
each kilogram of phosphorus. This derogation wass
applicable until 31 December 2005.

2. The accession of Finland

the use

concerning

Finland acceded to the European Union on 1 January
1995. The Act of Accession (4)
lays down transitional
and marketing of
provisions
cadmium in that State. Article 84(1) provides
that
during a period of
from the date of
four years
accession, the provisions referred to in Annex X of the
Act shall, in accordance with that Annex and subject to
the conditions set out
therein, not apply to Finland.
Article 84 of and point 2 of Annex X to the Act of
of Directive
that Article
Accession
76/116/EEC,
in so far as it concerns the cadmium
content of fertilisers, shall not apply to Finland before
the provisions of Directive
1 January 1999 and that
76/116/EEC will be
reviewed in accordance with
Community procedures by 31 December 1998.

provide

7

(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. 15.

(3) OJ L 304, 21.11.2003, p. 1. Regulation as last amended by
L 359,

(EC) No 2076/2004 (OJ

Commission Regulation
4.12.2004, p. 25).

(4) OJ C 241, 29.8.1994, p. 37 and p. 308.

(1)

(2)

(3)

(4)

L 129/26

EN

Official Journal of the European Union

17.5.2006

(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

(15)

(16)

regards

subsequently

(11) Directive 98/97/EC of the European Parliament and of
Council (5),
the
amended Directive
the marketing in Austria,
76/116/EEC as
Finland and Sweden of fertilisers containing cadmium.
inter alia, Finland may prohibit
Article 1 provides that,
fertilisers containing
the marketing on its territory of
cadmium at concentrations in excess of
that which
were fixed nationally at the date of accession and that
this derogation applies for the period from 1 January
1999 until 31 December 2001.

national

(12) On 7 December 2001, the Republic of Finland 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
2002/398/EC granted a prolongation of the derogation
from Directive 76/116/EEC until 31 December 2005.

consideration,

deviating

careful

After

3. National provisions

(13)

inter alia,

lays down a limit value for

The Decision of Finland's Ministry of Agriculture and
Forestry on fertilisers (6) No 45/1994 of 21 January
1994,
the
cadmium content in fertilisers,
including EC-designated
it is prohibited to
fertilisers. According to Section 3,
place on the Finnish market phosphorus mineral ferti-
lisers with a cadmium content exceeding 50 mg for
each kilogram of phosphorus.

By letter of 30 June 2005, the Commission informed the
Finnish authorities that it had received the notification
under Article 95(4) and that the six months period for its
examination according to Article 95(6) started on 8 June
2005, the day following the one when the notification
was received.

By letter of 10 August 2005, the Commission informed
the other Member States about the request received from
Finland. 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 Finland intends to
maintain.

in the Official

Journal of

III. ASSESSMENT

1. Consideration of admissibility

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

if, after the
adoption by the Council or by the Commission of a
harmonisation measure,
it
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

(18)

The notification submitted by the Finnish authorities on
7 June 2005 intends to obtain authorisation to extend
beyond 31 December 2005 the current derogation
provided in Decision 2002/398/EC. This Decision
allows Finland to maintain the application of national
provisions
concerning the
composition of EC-denominated fertilisers contained in
Regulation (EC) No 2003/2003.

incompatible with those

(19) 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,
the
EC-denominated
requirements of that Regulation can be placed on the
market regardless of their cadmium content.

complying

fertilisers

with

II. PROCEDURE

(14)

By letter of 7 June 2005 the Republic of Finland notified
the Commission that, in accordance with article 95(4) of
the EC Treaty,
intends to continue to apply from
1 January 2006 national provisions concerning the
cadmium content in fertilisers. The Finnish authorities
request an extension of the current derogation provided
by Decision 2002/398/EC.

it

(20)

In the light of the abovementioned, it is clear that the
national provisions notified by Finland, in so far as they
prohibit the placing on the market of EC-denominated
phosphorus mineral fertilisers with a cadmium content
exceeding 50 mg for each kilogram of phosphorus, are
more restrictive than those contained in Regulation (EC)
No 2003/2003.

(5) OJ L 18, 23.1.1999, p. 60.
(6) Statutes of Finland No 45/1994 of 26 January 1994, p. 117.

(7) OJ C 197, 12.8.2005, p. 4.

17.5.2006

EN

Official Journal of the European Union

L 129/27

(21)

indicated above,

The national provisions notified by the Finnish autho-
rities were adopted before Finland acceded to the
European Union. As
the Act of
Accession lays down transitional provisions allowing
Finland 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 Finland was
authorised to continue to apply the above national
2001. Decision
31 December
provisions
2002/398/EC extended the derogation until December
2005.

cadmium content of

fertilisers

until

the

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

in its opinion,

it

(23)

and that

The reasons provided by the Finnish authorities are those
lead the
already submitted in the past
Commission, in Decision 2002/398/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.

(24)

to obtain approval

The notification submitted by Finland on 7 June 2005 in
order
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.

2. Assessment of merits

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,

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.

In addition, pursuant
where it considers

to Article 95(6) of

the Treaty,
the national provisions are

that

(25)

(26)

(27)

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.

(28)

Finland 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, Finland makes
reference to the conclusions of a Finnish study published
in April 2000 (8) which contains an assessment of the
risks posed by cadmium-containing fertilisers.

2.1. Justification on grounds of major needs

(29) As regards the general

information on cadmium, from
the scientific data available up to now,
it can be
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

(30) As regards cadmium in fertilisers,

the most relevant
the risk assessment carried out by

information of
Finland can be summarised as follows:

aquatic

— concerning water, the Finnish risk assessment report
states that ‘risk characterisation reveals that there is
risk for
calculated
environment
scenarios, both at present time and in the future. In
practice this means that no margin of safety can be
established, and any increase to the natural back-
ground concentrations is likely to present a risk for
the aquatic environment’,

for

all

a

the

the

risk for

available data,

‘based on the

— concerning the soil, the Finnish risk assessment states
that
current
cadmium concentrations in Finnish agricultural soils
environment. This
present
conclusion can be reached both by using mean
cadmium concentrations (9)
and 90
extractable
percentile values
in the five Finnish cultivation
zones
the year 1987. Only in the most
for
the PEC/PNEC ratio (10) using the
northern zone,
mean concentration is below 1. Risk ratios for the
different cultivation zones vary from 1,2 to 2,8’,

soil

(8) Finnish Ministry of Agriculture and Forestry, Cadmium in fertilisers,

risks to human health and the environment, April 2000.

(9) The concentration of cadmium that

is available for uptake by

plants.

(10) PEC = predicted environmental concentration, PNEC = predicted no
effect concentration. A PEC/PNEC ratio greater than one indicates
that there will be adverse effects.

L 129/28

EN

Official Journal of the European Union

17.5.2006

— concerning human health, the Finnish risk assessment
report states that ‘in Finland, there is no margin of
safety for the risk group (worst cases) between the
estimated urinary levels and the critical
levels that
have been associated with adverse health effects
caused by cadmium’. The Finnish risk assessment
report also states
fertilisers
containing average Community level of cadmium
were to be used in Finland the dietary intake of
cadmium would increase by more than 40 % over
one hundred years, based on model calculations’.

‘if phosphorus

that

— the opinion issued on 24 September 2002 by the
SCTEE (11)
(now renamed SCHER (12)) 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,

(31)

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

(32)

(33)

(34)

In conclusion, the risk assessment carried out by Finland
shows that present cadmium concentrations in Finnish
agricultural soil pose a risk for soil organisms and that
the leaching of cadmium from the agricultural soil
is
causing a risk for
the aquatic environment. Finland
maintains that the risk assessment concludes also that
there is a risk of adverse health effects as a result of
the present total cadmium exposure in the Finnish popu-
lation. While the average cadmium intake from food
alone does not pose a risk in Finland, some sectors of
the population are at risk because of high dietary intake,
increased absorption and/or smoking.

The risk assessment submitted by the Finnish 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.

(37)

The Commission already examined the information
in the context of
contained in the risk assessment
Decision 2002/398/EC which allowed
to
maintain their national provisions until 31 December
2005.

Finland

— the final draft of

the general risk assessment of
cadmium and cadmium oxide, dated September
2004 produced in accordance with Council Regu-
lation (EEC) No 793/93 (13) 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,

the

in the

light of

re-examined

after having

the Finnish request,

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

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

2.2. Absence of arbitrary discrimination

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

(36)

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

(11) Scientific Committee on Toxicity, Ecotoxicity and the Environment.
(12) Scientific Committee on Health and Environmental Risks.
(13) 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).

17.5.2006

EN

Official Journal of the European Union

L 129/29

(39)

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.

2.3. Absence of a disguised restriction on trade

(40) 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.
The concept enshrined in Article 95(6)
is intended to
prevent the national provisions based on the criteria set
in paragraphs 4 and 5 being applied for inap-
out
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.

(41) 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.

(44)

(42)

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,
in the context of the
the Commission considers that,
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.

(43)

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

— as

national

indicated above,

the Act of Accession and
Directive 98/97/EC allowed Finland 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 2002/398/EC allowed Finland to maintain
their national provisions until 31 December 2005
based on the risk assessment provided by the
Finnish authorities, and

— 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
restrictive measure would provide sufficient
less
protection of health and environment
in Finland.
The risk assessment shows that the specific soil and
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.

Finland
the protection of

condition of

are more

some

areas

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

the internal market

this stage of

2.5. Limitation in due 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 inter-institutional debate, the
provisions of the current Decision should therefore be
valid until the harmonised measure is applicable at EU
level.

cadmium in

fertilisers

IV. CONCLUSION

(45)

In the light of the foregoing, it can be concluded that the
request by the Republic of Finland 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 7 June
2005, is admissible.

(46) 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,

L 129/30

EN

Official Journal of the European Union

17.5.2006

— are not a means of arbitrary discrimination, and

— do not constitute a disguised restriction on trade

between Member States.

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

The Commission therefore considers that they can be
approved,

This Decision is addressed to the Republic of Finland.

Article 2

HAS ADOPTED THIS REGULATION:

Article 1

Done at Brussels, 3 January 2006.

In derogation from Regulation (EC) No 2003/2003, the Finnish
provisions which prohibit the placing on the Finnish market of
phosphorous mineral
cadmium content
exceeding 50 mg for each kilogram of phosphorous are
approved.

fertilisers with a

For the Commission

Günter VERHEUGEN
Vice-President