2001/570/EC: Commission Decision of 13 July 2001 on draft national provisions notified by the Federal Republic of Germany on limitations on the marketing and use of organostannic compounds (Text with EEA relevance) (notified under document number C(2001) 1912)
Date: 2001-07-13
Institutions: European Commission
Subjects: Germany, approximation of laws, dangerous substance, environmental policy, health policy, national implementing measure

27.7.2001

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Official Journal of the European Communities

L 202/37

COMMISSION DECISION

of 13 July 2001

on draft national provisions notified by the Federal Republic of Germany on limitations on the
marketing and use of organostannic compounds

(notified under document number C(2001) 1912)

(Only the German text is authentic)

(Text with EEA relevance)

(2001/570/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

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

Whereas:

I. FACTS

1. Community legislation

(1)

(2)

(3)

substances

Council Directive 76/769/EEC of 27 July 1976 on the
the laws, regulations and adminis-
approximation of
trative provisions of
the Member States relating to
restrictions on the marketing and use of certain
last
dangerous
amended by Commission Directive 1999/77/EC (2),
provides for the prohibition and restriction of the use of
certain dangerous substances and preparations. Directive
76/769/EEC is regularly amended to include in its
Annex additional substances which are dangerous to
man or the environment.

and preparations (1),

as

Council Directive 89/677/EEC (3) amended Directive 76/
769/EEC to harmonise amongst other things the placing
on the market and use of organostannic compounds in
certain areas. The provisions concerning organostannic
compounds were modified by Commission Directive
1999/51/EC of 26 May 1999 adapting to technical
progress for the fifth time Annex I to Council Directive
76/769/EEC on the approximation of the laws, regula-
tions and administrative provisions of the Member States
relating to restrictions on the marketing and use of
certain dangerous substances and preparations (tin, PCP
and Cadmium) (4).

Directive 1999/51/EC amends Directive 76/769/EEC to
prohibit
the marketing and use of organostannic
compounds as substances and constituents of prepara-
tions when acting as biocides in free association anti-
fouling paint.

(1) OJ L 262, 27.9.1976, p. 201.
(2) OJ L 207, 6.8.1999, p. 18.
(3) OJ L 398, 30.12.1989, p. 19.
(4) OJ L 142, 5.6.1999, p. 22.

Directive 1999/51/EC also serves to prohibit the use of
organostannic compounds as substances and constitu-
ents of preparations when acting as biocides to prevent
the fouling by mircro-organisms, plants or animals of:

(a) the hulls of:

— boats of an overall

length, as defined by ISO

8666, of less than 25 m,

— vessels of any length for use predominantly on

inland waterways and lakes;

(b) cages, floats, net and any other appliances or equip-

ment used for fish or shellfish farming;

(c) any totally or partly submerged appliance or equip-

ment.

Such substances and preparations:

— may be placed on the market only in packages of a

capacity equal to or greater than 20 l,

— may not be sold to the general public but only to

professional users.

(5) Without

to

prejudice

application

other
the
Community provisions on the classification, packaging
and labelling of dangerous substances and preparations,
the packaging of such preparations must be legible and
indelibly marked as follows:

of

‘Not to be used on boats of an overall length of less
than 25 m, or on vessels of any length for use
predominantly on inland waterways and lakes, or
any appliances or equipment used in fish or shellfish
farming.

Restricted to professional users.’

(6)

(7)

The provisions referred to under recital 4(a) and the
special labelling provisions are applicable to Sweden and
Austria from 1 January 2003 and will be reviewed by
the Commission in cooperation with Member States and
stakeholders before that date.

Furthermore organostannic compounds may not be used
as substances and constituents of preparations intended
for the use in the treatment of industrial waters.

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(8)

(9)

the
It also follows from Directive 1999/51/EC that
remaining allowed uses are to be reviewed before 1
January 2003. In recital 2, specific reference is made to
the developments in the International Maritime Organ-
isation (IMO), which has recognised the risks posed by
organostannic compounds to the marine environment.
The Marine Environment Protection Committee (MEPC)
of the IMO has called for a global prohibition of the
application of organostannic compounds which act as
biocides in antifouling systems on ships by 1 January
2003.

The MEPC met on 23 to 27 April 2001 and prepared a
legally binding instrument (International Convention on
the Control of Harmful Antifouling Systems)
to be
adopted at a diplomatic conference scheduled for 1 to 5
October 2001. The Council of the European Union had
adopted conclusions
in April,
which, among others, underline its intention to contri-
bute to the conclusion of a legally binding instrument to
prohibit the use of organostannic compounds as of 1
January 2003. They also urged the Commission to take
as soon as possible any additional steps deemed neces-
sary in relation to relevant Community legislation.

the negotiations

for

2. National provisions

(10) Germany intends to adopt new national provisions
going beyond the measures provided for under Directive
1999/51/EC by amending:

— the Annex to paragraph 1 of the Chemicals Prohi-
bition Order
re-
garding organostannic compounds in the version
published on 19 July 1996 and last amended by
Article 2 of the Order of 26 June 2000, and

(Chemikalienverbotsverordnung)

— Annex IV to the Dangerous Substances Order
(Gefahrstoffverordnung) in the version published on
15 November 1999 and last amended by Article 3 of
the Order of 26 June 2000.

(11)

The draft amendment of
the Chemicals Prohibition
Order modifies the existing section 11 (entitled ‘Orga-
nostannic compounds’) and seeks to ban the placing on
the market of organostannic compounds and prepara-
tions
the
following purposes:

containing organostannic

compound for

1. as antifouling paints,

2. for water treatment in the industrial, commercial, and

municipal sectors, regardless of use,

3. for wood preservation,

5. for the biocidal treatment of consumer articles within
the meaning of paragraph 5(1) No 6 of the Food-
stuffs and Consumer Products Law.

(12)

In addition, the following products may not be placed
on the market if they have a mass content of trior-
gano-tin compounds of more than 1 mg tin/kg:

(13)

(14)

(15)

1. heavy industrial textiles, and

2. products within the meaning of paragraph 5(1) No 6
of the Foodstuffs and Consumer Products Law.

the restriction referred to in
By way of derogation,
recital 11(1) will not apply until 31 December 2002 to
the placing on the market of
antifouling paints
containing chemically bound organostannic compounds
for ships with an overall length of more than 25 m that
are essentially intended for operation outside inland
waterways and lakes, if sold for professional purposes in
minimum quantities of 20 l. The prohibitions referred
to in recital 12 will not apply to products which were
placed on the market for the first time before the first
day of the calendar month following promulgation of
the draft national

legislation.

The draft amendment
to Annex IV (Restrictions on
production and use) to the Dangerous Substances Order,
seeks to modify points (entitled ‘Antifouling Paints’) and
8 (entitled ‘Organostannic Compounds’).

Point 5(1) already contains a general ban on the use of
organostannic compounds in antifouling paints, but, in
line with the provisions of Directive 1999/51/EC, the
current paragraph 2 provides for a derogation for ‘chem-
ically-bound organostannic antifouling paints for ships
length that are essentially
more than 25 m in total
intended to operate outside inland waterways and lakes
if sold for professional purposes in minimum quantities
of 20 l.’ The draft amendment seeks to limit the dura-
tion of the derogation by adding ‘until 31 December
2002’.

(16)

The draft amendment of point 8 (Organostannic
compounds) intends to replace the current text by:

‘Dangerous
compounds shall not be used:

substances

containing

organostannic

1. for the treatment if water in the industrial, commer-
cial and municipal sectors, regardless of its use;

2. for wood preservation;

3. for the biocidal

impregnation of heavy industrial

textiles and their constituent yarns, and

4. for the biocidal treatment of products within the
meaning of paragraph 5(1) No 6 of the Foodstuffs
and Consumer Products Law (5).’

4. for the biocidal

impregnation of heavy industrial

textiles and their constituent yarns, and

(5) According to paragraph 5(1) No 6 of that law these are: Objects,
that are intended to be in contact with the human body in a non-
transitory way, such as clothes, bedlinen, masks, wigs, hair pieces,
artificial eyelashes, bracelets, spectacle frames.

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II. PROCEDURE

(17) Directive 1999/51/EC was adopted on 26 May 1999.
Member States had to bring into force the national
provisions necessary to comply with it before 29
February 2000 and to apply them from 1 September
2000. Germany correctly transposed the Community
provisions through an amendment of the Dangerous
Substances Order (Order of 26 June 2000, Federal Law
Gazette I 2000, p. 932).

(18)

(19)

(20)

By letter of 22 January 2001, the German Permanent
Representation informed the Commission that Germany,
in accordance with Article 95(5) of the Treaty, intended
to apply stricter measures
regarding organostannic
compounds than those contained in Directive 1999/
51/EC. Germany considered it necessary to introduce
such national measures which are justified in accordance
with Article 30 of the Treaty to protect the environment
and human health against the harmful effects of orga-
nostannic compounds used as components in biocidal
preparations. The letter was received on 25 January
2001.

By letter of 22 February 2001,
the Commission
informed the German authorities that it had received the
notification under Article 95(5) and that the six month
period for its examination according to Article 95(6)
started on 26 January 2001, the day following the one
when the notification was received.

By letter of 17 April 2001, the Commission informed
the other Member States about the request received from
Germany and invited them to submit comments,
if
deemed necessary, within one month. The Commission
also published a notice regarding the request in the
Official Journal of the European Communities (6) in order to
inform other interested parties of
the draft national
measures that Germany intends to adopt.

III. ASSESSMENT

1. Consideration of admissibility

(21)

The notification submitted by the German authorities on
25 January 2001 intends to obtain approval to intro-
duce national provisions incompatible with Directive
1999/51/EC, which constitutes a harmonisation measure
adopted on the basis of Article 95 of the Treaty.

(22) Article 95(5) of the Treaty reads as follows: ‘If, after the
adoption by the Council or by the Commission of a
harmonisation measure, a Member State deems it neces-
sary to introduce national provisions based on new
scientific evidence relating to the protection of the envir-

(6) OJ C 120, 24.4.2001, p. 9.

onment or the working environment on grounds of a
problem specific to that Member State arising after the
adoption of the harmonisation measure, it shall notify
the Commission of the envisaged provisions as well as
the grounds for introducing them.’

(23) Annex I

to Directive 76/769/EEC as amended by
Directive 1999/51/EC deals with three different situa-
tions in which organostannic compounds are marketed
or used. These three situations are all concerned with the
aquatic environment, or more precisely they involve
applications in water or on objects partially or totally
submerged in water:

— point 21.1 currently prohibits the marketing of orga-
nostannic compounds for use as substances and
constituents of preparations when acting as biocides
in free association antifouling paints (7). Other types
of preparations are allowed to be placed on the
market,

— point 21.2 restricts

the use of organostannic
compounds as substances and constituents of prepa-
rations when acting as biocides to prevent
the
fouling by micro-organisms, plants or animals of the
hulls of boats of an overall length of less than 25 m,
of vessels of any length for use predominantly on
inland waterways and lakes, any equipment used for
fish or shellfish farming, and any totally or partly
submerged appliance or equipment,

— in addition, point 21.4 prohibits the use of organos-
industrial

tannic compounds in the treatment of
waters irrespective of their use.

(24) When comparing the current Community legislation and
the draft national provisions which Germany intends to
apply, it emerges that the national measures go beyond
the Community legislation, as they amount to:

(25)

(26)

— a ban on the marketing and use of organostannic
compounds in all kinds of antifouling products as of
1 January 2003,

— a ban on the use of organostannic compounds for a
range of other uses: wood preservation, impregna-
tion of heavy industrial textiles and their constituent
yarns, and treatment of consumer articles.

In addition, the draft national measures intend to limit
the maximum content of triorganic-tin compounds for a
number of products such as heavy industrial textiles and
consumer products.

The draft national provisions notified by Germany
concern the use of organostannic compounds in anti-
fouling paints, which is within the harmonised area
created by Directive 1999/51/EC. The draft national
provisions also seek to ban the use of organostannic
compounds for the treatment of wood, textiles, and
consumer articles. Here, two cases have to be distin-
guished:
if the treated products are intended for uses
where they are partly or totally submerged in water (i.e.

(7) Directive 98/8/EC of the European Parliament and of the Council of
16 February 1998 describes
in Annex V, antifouling products
(product-type 21) as ‘products used to control the growth and sett-
lement of fouling organisms (microbes and higher forms of plant or
animal species) on vessels, aquaculture equipment or other struc-
tures used in water’.

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use in the aquatic environment) or intended for equip-
ment or appliances for fish or shellfish farming, they are
within the harmonised area and Directive 1999/51/EC
already bans the use of organostannic compounds for
this purpose. Treatment of wood, heavy industrial
textiles and consumer products, which are intended for
other purposes is not regulated by the Directive.

(27) As required by Article 95(5) of the Treaty, Germany
notified the Commission of the actual wording of the
provisions that are intended to be introduced, accompa-
nying the request by an explanation of the reasons,
which, in its opinion, justify the introduction of those
provisions. However, only a part of the draft national
measures is within the area of harmonisation created by
Directive 1999/51/EC.

(28)

(29)

(30)

(31)

The notification submitted by Germany on 25 January
2001 in order to obtain approval for the introduction of
national provisions regarding the use of organostannic
compounds in antifouling products which derogate from
the provisions of Directive 1999/51/EC may therefore
be held admissible under Article 95(5) of the Treaty. The
notification of the draft national measures concerning
other uses of organostannic compounds, which are
outside the area of harmonisation created by Directive
1999/51/EC,

is inadmissible.

Consequently, this Decision will only refer to the draft
antifouling products
regarding
national provisions
intended for use in the aquatic environment, for which
derogation is sought. The draft national measures for the
other uses are not concerned by this Decision and will
have to be notified and evaluated according to the
the
procedures established by Directive 98/34/EC of
European Parliament and of the Council of 22 June
1998 laying down a procedure for the provision of
information in the field of technical standards and regu-
lations (8), as amended by Directive 1998/48/EC (9).

2. Assessment of merits

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

the Treaty,

The Commission must
therefore assess whether the
conditions provided for by Article 95(5) are met. This
requires (a) ‘new scientific evidence with regard to the
protection of the environment or the working environ-
ment’, (b) which causes the applicant Member State to
consider the introduction of national provisions to be
necessary ‘on grounds of a problem specific to that

Member State’, (c) where the problem concerned arose
‘after the adoption of the harmonisation measure’.

(32)

In addition, pursuant to Article 95(6), where it considers
that the introduction of such national provisions is justi-
fied, the Commission must check whether or not those
national provisions are a means of arbitrary discrim-
ination or a disguised restriction on trade between
Member States and whether or not they constitute an
obstacle to the functioning of the internal market.

2.1. The nature of organostannic compounds

(33) Organostannic compounds are a group of substances,
which are composed of tin and a variable number of
organic groups, which are directly bound to the tin
atom. Organostannic compounds are very effective anti-
fouling agents for ships, the most important and effec-
tive
and
being
compounds
Bis(tributyltin)oxide TBTO.

tributyltin,

TBT,

(34)

(35)

(36)

(37)

classified according

Tribuyltin compounds
to
are
Council Directive 67/548/EEC of 27 June 1967 relating
to the
and labelling of
dangerous substances (10), as last amended by Directive
99/33/EC (11), as:

classification, packaging

— harmful

in contact with skin,

— toxic if swallowed,

— irritating to eyes and skin,

— toxic: danger of

serious damage to health by
prolonged exposure through inhalation and if swal-
lowed,

— very toxic to aquatic organisms, may cause long-
term adverse effects in the aquatic environment.

For an antifoulant to be effective, the active substance
must be bioavailable, and hence constantly released to
the surrounding environment. As a result of this release
to the aquatic environment and the high acute and
chronic toxicity of organostannic compounds, damage
can result to exposed ecosystems.

TBTO is strongly absorbed to sediment. The principal
degradation pathway of TBT is biodegradation to dibu-
tyltin and monobutyltin and eventually tin oxide. The
speed of the degradation is strongly influenced by the
surrounding matrix, with half
two
weeks, biota two months, sediment 0,5 to 20 years. TBT
shows some bioaccumulation within the environment.

lives in water of

TBT interferes with the metabolism of exposed organ-
isms (inhibition of enzymes and denaturing of proteins),
and the endocrine system of certain snails (imposing the
development of male sexual characteristics in females; a
phenomenon called imposex).

(8) OJ L 204, 21.7.1998, p. 37.
(9) OJ L 217, 5.8.1998, p. 18.

(10) OJ L 196, 16.8.1967, p. 1.
(11) OJ L 199, 30.7.1999, p. 57.

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(38)

Risks to the aquatic environment from TBT are well
recognised and even in 1989,
the first Community
measures (Directive 89/677/EEC) had been taken to
reduce
from the use of organostannic
compounds in antifouling paints by restricting their use
to professional users for ships of a length of more than
25 m.

risks

the

(39) A thorough reevaluation carried out by the Commission
in cooperation with the Member States, led to the adop-
tion of Directive 1999/51/EC, which strengthens these
protective measures considerably. That Directive bans
completely the use of those types of antifouling paints,
which are liable to higher and uncontrolled release of
organostannic compounds, and the use on boats of any
size predominantly employed on inland waterways and
lakes. In the course of the review process, the Commis-
sion had commissioned a study on the matter by an
external
study,
requested the opinion of the Scientific Committee of
Toxicity, Ecotoxicity, and the Environment
(SCTEE),
which was adopted on 27 November 1998.

and, based on that

consultant (12)

these measures can ensure adequate protection of the
abovementioned legal rights.

(44) Germany recalls that

in the context of a ‘concerted
action’ at the 45th MEPC meeting, the parties to the
OSPAR Convention (including Germany and the Euro-
pean Commission emphasised that the proposed date
for the entry into force of the ban on organostannic
compounds as antifouling agents in ships' paint
(1
January 2003) must be regarded as definitive and that it
was extremely important
the proposed globally
binding instrument to take effect on time (MEPC docu-
ment 45/4/8 of 9 August 2000).

for

(45) Accordingly, the draft national measures intend to elimi-
nate the existing exemption on the marketing of chemi-
cally-bound organostannic antifouling paints for ships of
more than 25 m in total
length that are essentially
intended to operate outside inland waterways and lakes
as of 1 January 2003.

2.2. The position of Germany

(46)

(40) A description is given of all the arguments behind the
notified provisions,
including those relating to areas
which have been considered as falling outside of the
scope of Directive 1999/51/EC.

(41) Germany takes the view that the knowledge both of the
ecotoxicological effects and possible health damage justi-
fies a more comprehensive ban on the use of organos-
tannic compounds as biocidal agents than is provided
for in Directive 1999/51/EC.

(42)

In the interests of health and environment protection,
Germany considers
it necessary to transpose into
national
law IMO Resolution A.895(21), which was
adopted on 25 November 1999, and to lay down
further requirements prohibiting the use of organos-
tannic compound as biocidal agents in certain consumer
products.

(43) Germany believes that the national provisions set out in
the draft measures are necessary and justified for reasons
of protection of human and animal health and life
pursuant to Article 30 of the Treaty. In its view, only

(12) WS Atkins International Ltd, ‘Assessment of the risks to health and
to the environment of tin organic compounds and of arsenic in
certain biocidal products and of the effects of further restrictions
on their marketing and use’, final report, April 1998.Opinion of
the SCTEE on the report by WS Atkins International Ltd. Expressed
at the sixth SCTEE plenary meeting, Brussels, 27 November 1998.

In addition, Germany thinks that as yet, Directive 76/
769/EEC does not cover
the use of organostannic
compounds as biocidal agents in heavy textiles and
consumer products. In view of the need for action to
protect the environment and human health, the existing
prohibitions on the marketing and use of organostannic
compounds
these
preparations
substances will be extended. Their use will be prohibited
for the biocidal impregnation of heavy industrial textiles
and their constituent yarns, the biocidal treatment of
certain consumer products and as wood preservatives.

containing

and

(47) Wood preservatives containing biocidal organostannic
compounds have not been used in Germany for several
years. More ecologically acceptable alternatives for the
biocidal treatment of heavy textiles are also available.
The particular objective of the ban is to prevent the
diffusion of triorgano-tin compounds in the environ-
ment. Since high concentrations of organostannic
compounds are necessary to achieve biocidal effects, the
biocidal treatment of consumer products, which have
prolonged contact with the human body must also be
prohibited because of
these
substances.

the toxic properties of

(48) Germany claims that there is new scientific evidence,
which was discussed on 14 March 2000, when the
Federal Environmental Office and the Federal Institute
for Consumer Protection and Veterinary Medicine on
behalf of the Federal Ministry of the Environment, orga-
nised a panel hearing in Berlin on the ‘Production and
use of organotin compounds in Germany’. The report

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(which was annexed to the request), outlines recent find-
ings on use, environmental concentrations and toxi-
cology. According to Germany, a number of the results
were obtained only after the preparation of Directive
1999/51/EC, and reflect
the environmental damage
caused by organostannic compounds in Germany and
thus justify the tighter restrictions contained in the draft
measures.

In the case of sediment, a distinction should be drawn
between ‘normal’ concentrations and concentrations in
the vicinity of ‘hot spots’ (ports, production. facilities of
organostannic compounds). As expected, concentrations
of organostannic compounds in suspended matter and
sediments also generally correlate with the percentage of
municipal waste waters in the examined water.

In the course of various measurement programmes,
maximum concentrations of 10-77 µg Tributyltin
(TBT)/kg were recorded in the suspended matter of water
taken from the rivers Rhine, Main, Fulda, Lahn and
Nidda, with typical values lying between 5 and 20 µg
TBT/kg dry matter (DM). Comparable values were also
recorded for mono- and di-butyltin.

(49)

(50)

(51) Maximum values in sediments are very much higher.
Thus, the ‘Elbe Association’ reported levels ranging from
1 000 to 5 000 µg organostannic compounds/kg DM in
the rivers Elbe and Mulde. Greenpeace identified simi-
larly high values in the vicinity of shipyards in 1999 and
organostannic
reported
compounds/kg close to the Neptune shipyard floating
dock. The area around the largest German ship repair
yard (Norderwerft)
the most contaminated, with
103 795 µg TBT/kg being recorded.

measuring

4 978 µg

is

(52)

The particularly high contamination with organostannic
compounds of the German Bay is essentially due to the
fact that it encompasses the estuaries and lower reaches
not only of the Elbe but also of the Weser and Ems,
which have some of the busiest shipping lanes in the
Community. This problem is aggravated by the prox-
imity of these routes to the Wadden Sea, a particularly
vulnerable area enjoying special protection as a national
park. Since TBT degrades much more slowly in sediment
than in water, high sedimentary concentrations create a
special problem for countries having mudflats that
warrant protection.

(53)

That extreme contamination of the marine environment
leads to high accumulation of organostannic compounds
in marine animals. The Institute for Environmental
Chemistry and Ecotoxicology of the Fraunhofer-Gesell-
schaft, Schmallenberg, completed a research project on

phenols,

the ‘Monitoring of environmental pollution caused by
organostannic
alkyl
bisphenol A and
compounds in representative samples’
in 1999. The
study identified up to 459 µg TBT/kg in bream muscula-
ture and 940 µg TBT/kg in dreissenidae mussels.

(54)

fish, and particularly mussels, can
Consumption of
account
for a significant proportion of consumer
exposure. The consumption of 200 g of highly polluted
fish containing 100 µg organostannic compounds/kg
would result in the ingestion of 20 µg, corresponding to
0,33 µg/kg bodyweight (60 kg). This would be slightly
in excess of the TBTO admissible daily intake (ADI).
Values exceeding that level by an even greater margin
can be expected in fish taken from problem waters, for
example in the vicinity of ports, dense shipping lanes
and shipyards.

(55) Organostannic

compounds were

also detected in
consumer products. Thus, the current textiles resources
catalogue (2000) offers anti-microbial agents, which,
according to their chemical composition, contain orga-
nostannic compounds. These are TBT compounds.
Maximum values of 130 mg TBT/kg were detected in
textile clothing samples examined in 1999 and 2000
(cycling-shorts padding). Assuming a resorption rate of
1 % whenever such garments are worn and a 20 %
resorption quota, the uptake will come close to the
WHO ADI value.

(56)

(57)

TBT is not only used as an antifouling paint but is also
employed, as indicated above, for the biocidal impregna-
tion of heavy textiles (i.e. heavy industrial textiles such
as awnings and tarpaulins of Lorries) and articles of
clothing. When washed out of textiles, TBT is released to
the environment. Sludge concentrations, particularly
from municipal areas, are an appropriate indicator of
current wastewater
contamination by hydrophobic
substances having a generally diffuse emission spectrum.

The concentrations of organostannic compounds meas-
ured in municipal sludge vary considerably. Starting at
approximately 10 µg/kg DM,
they increase to the
several mg/kg DM range. TBT is almost totally (97,5 %)
sludge-bound. An average concentration of 0,3 mg/kg
TBT in dry sludge mass (median value of 53 samples
from German treatment plant) and the generation of
2,95 million t of sludge per annum, gives a national
annual value of 885 kg. The fact that 40 % of this
sludge is used in agriculture means that approximately
350 kg of TBT is spread on farmland each year.

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(58)

(59)

The harmful effect of TBT on the metabolism of exposed
organisms (enzyme inhibition and protein denaturation)
and the hormone system of certain snails (appearance of
male sexual characteristics in females; imposex) together
with the associated threat to the aquatic environment are
sufficiently well known and generally recognised.

Recent scientific studies of human cell cultures,
the
results of which were published after the entry into force
of Directive 1999/51/EC, confirm that TBT also inhibits
the enzyme system responsible for female sex hormone
development. It therefore seems possible that TBT, even
in small concentrations, could damage human health.

(60) Germany does not believe that the proposed new regula-
tions will hamper the operation of the internal market.

(61) As regards implementation of the IMO Resolution, the
industry concerned is already preparing for the complete
worldwide ban on the use of antifouling ships' paint
containing organostannic compounds, which is due to
come into force on 1 January 2003. The draft Order has
also adopted this reference date for its proposed ban on
use.

(62) One company based in Germany is the market leader in
TBT production, accounting for approximately 80 % of
worldwide output. This proves that the proposed restric-
tions are neither a means of arbitrary discrimination
against foreign producers nor a hidden barrier to intra-
Community trade. Since they primarily affect TBT
they do not
producers and shipyards in Germany,
obstruct the operation of the internal market.

(63)

(64)

The most recent scientific findings with regard to the
toxicological properties of organostannic compounds
and current German exposure data justify a complete
ban, in line with the IMO Resolution, on the aquatic
discharge of TBT ships' paint and the imposition of
further restrictions on organostannic compounds. This is
the only way of ensuring adequate human and environ-
ment protection against the harmful effects of these
substances.

In conclusion, Germany points out that it would have
preferred to see the adoption of the proposed measures
for the whole of the Community. To that extent,
it
regrets that the Commission was unable to comply with
the request made in its memorandum of 20 September
2000 concerning the presentation of a corresponding
draft directive.

2.3. Evaluation of the position of Germany

2.3.1. The burden of proof

(65)

It has to be noted that, in the light of the time frame
established by Article 95(6) of the Treaty, the Commis-
sion, when examining whether the draft national meas-
ures notified under Article 95(5) are justified, has to take
as a basis ‘the grounds’ put forward by the Member

State. This means that, under the Treaty, the responsi-
bility of proving that these measures are justified, lies
with the requesting Member State. Given the procedural
framework established by Article 95, including in partic-
ular a strict six-month deadline for a Decision to be
adopted, the Commission normally has to limit itself to
examining the relevance of
the elements which are
submitted by the requesting Member State, without
having to seek itself possible justifications.

(66)

If the elements submitted by the requesting Member
State are not sufficient to enable the Commission to
the conditions of Article 95(5) are
assess whether
fulfilled and the Commission therefore rejects the draft
national measures, the Member State is not precluded
from notifying its request again and substantiating it
with all additional and/or new elements, which are
necessary to establish whether or not the conditions of
Article 95(5) are fulfilled.

2.3.2. New scientific evidence concerning the protection
of the environment or the working environment
regarding a problem specific to the Member State
arising after the adoption of the harmonisation
measure

(67) Germany has submitted a number of documents in
support of its request for application of Article 95(5).
However, only a part of the information contained in
both, the request and these documents, relates to the use
of organostannic compounds in antifouling paints. In
the following the statements and positions of Germany
regarding this area of application will be evaluated in the
light of the criteria established in that Article.

(68)

The arguments put forward by Germany to justify the
draft national provisions regarding the use of organos-
tannic compounds in antifouling paints relate to the
protection of
in part also to
human health.

the environment, but

(69) Germany makes extensive reference to the work of the
IMO, and in particular its Resolution A.895(21), which
was adopted on 25 November 1999. However,
the
subject of this resolution and in particular the prepara-
tory work of the MEPC were already well known at the
time when Directive 1999/51/EC was adopted and are
specifically mentioned in it. The second recital states that
the development of the work and the decisions taken in
the IMO will be fully taken into account during the
revision of provisions on TBT, which will be carried out
before 1 January 2003.

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(70) Germany mentions a number of data regarding TBT
concentrations in river sediments (Rhine, Main, Fulda,
Lahn and Nidda). However, these data are of no rele-
vance for the justification of measures going beyond the
restrictions of Directive 1999/51/EC, as the Directive
already prohibits completely the use of organostannic
compounds for antifouling paints for boats that are
predominantly used in inland waterways.

(71) Germany mentions particularly high concentrations of
TBT in sediments in the vicinity of hotspots (ports,
organotin production facilities, dockyards) and give as
example measurements from the river Elbe and Mulde
(1 000 to 5 000 µg/kg dry mass), 4 978 µg/kg around
the Neptune shipyard dock, and up to 103 795 µg/kg
around the Norderwerft ship repair yard. These data are
from a Greenpeace
study published in July and
September 1999 and thus after the adoption of Directive
1999/51/EC. However, Germany does not indicate when
the data were measured nor is the full text of the study
available.

(72) Germany also refers to a particular high contamination
of the German Bight by the rivers Elbe, Weser and Ems,
which all are very busy shipping lanes leading to major
ports. According to Germany, this problem is aggravated
by the proximity of these routes to the Wadden Sea
(mudflats), a particulary vulnerable area enjoying special
protection as a national park. No data are provided to
support these claims and Germany itself states that the
latter problem is
specific for all countries having
mudflats that warrant protection.

(73) Although it is likely that the data referred to in recital 71
were indeed measured at a time, when Directive 1999/
51/EC was already adopted, they do not per se constitute
new information. The effect that there are specifically
high releases of biocides (including TBT)
from fresh
antifouling paint was
already well known when
Directive 1999/51/EC was prepared and is specifically
documented in the study mandated by the Commis-
sion (13) in the course of the preparatory work. Further-
more the argument is applicable to any port in the
world where drydock work involving
antifouling
painting is carried out.

(74)

The data regarding the TBT concentrations in the sedi-
ments of busy shipping lanes are not new either. The
study mandated by the Commission in the review of the
Community legislation gives examples of various ports
around the world (Hong Kong, France, New Zealand, the

(13) See footnote 12.

sediments

in harbour

Netherlands), dating from 1989 to 1995 showing TBT
concentrations
from 10 to
2 100 µg/kg. This clearly shows that the levels of TBT
found in sediments in the river Elbe (close to the port of
Hamburg) are of a kind that was already known when
Directive 1999/51/EC was drawn up, and that they are
not unique for Germany. The problem seems, however,
to be specific for Member States, where busy ports are
located (14).

(75) Given that no data are provided concerning the pollu-
tion of the Wadden Sea, it is not possible to comment
on their potential relevance for the justification of the
draft national measures.

(76) Germany also mentions high concentrations of organos-
tannic compounds found in seafood, fish, and mussels in
a study published in 1999. This could lead to an
exposure of humans consuming such polluted fish and
seafood slightly in excess of recommended admissible
daily intake (ADI), or even higher from seafood coming
from problematic areas (vicinity of ports, dense shipping
lanes, and shipyards). However, these observations are
not specific for Germany, and only human health argu-
ments related to the working environment are relevant
in the framework of the evaluation procedure under
Article 95(5) of the Treaty. It has to be noted that the
implications for consumer health from the accumulation
of organostannic compounds in food products are
undergoing assessment by the Scientific Committee on
Food. The outcome of this assessment and the need for
future legislation to protect consumers
from these
compounds in food will be considered.

(77) All other information and data provided by Germany
relate to the use of organostannic compounds in areas of
application that are not harmonised by Directive 1999/
51/EC and therefore need not be evaluated here.

(78) Overall

the

regarding

it can be seen that the data and justification
submitted by Germany in support of its request under
Article 95(5) do not establish that the draft national
measures
organostannic
compounds in antifouling paints are based on new
scientific evidence relating to the protection of the envir-
onment or the working environment on grounds of a
problem specific to Germany arising after the adoption
of the harmonisation measure. The conditions for the
application of Article 95(5), are, therefore, not fulfilled.

use

of

(14) Similar arguments were raised by the Belgian authorities and
examined by the Commission in the framework of a request by
Belgium according to Article 95(5)
to introduce draft national
measures
regarding organostannic compounds as of 1 January
2003. The Commission adopted a Decision rejecting the draft
national measures on 25 July 2000 (Decision 2000/509/EC; OJ L
205, 12.8.2000, p. 7).

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L 202/45

(79)

In view of that analysis of the material submitted, there
are no grounds for consulting the other Member States
or interested groups or for requesting a new opinion of
the SCTEE.

2.4. Absence of any arbitrary discrimination, any disguised
restriction of trade or any obstacle to the functioning of
the internal market

(80) Under Article 95(6) the Commission is either to approve
the draft national provisions notified ‘after
or reject
having verified whether or not they are a means of
arbitrary discrimination or a disguised restriction on
trade between Member States and whether or not they
shall constitute an obstacle to the functioning of the
internal market’.

(81)

Since the request made by Germany does not fulfil the
basic conditions set out in Article 95(5) (see section 2.3
of this Decision), the Commission is not obliged to
verify whether or not the draft national provisions are a
means of arbitrary discrimination or disguised restriction
on trade between Member States, and whether or not
they constitute an obstacle to the functioning of the
internal market.

(83)

That request should, therefore, be rejected in accordance
with Article 95(6) of the Treaty.

(84) However, developments in the IMO should be followed
very closely and taken into account when Directive 76/
769/EEC has to be reviewed, before 1 January 2003. In
addition, the necessary conclusions will be drawn from
the outcome of the ongoing assessment on the implica-
tions for consumer health from the accumulation of
organostannic compounds in food products, including
the need for future legislation to protect consumers
from these compounds,

HAS ADOPTED THIS DECISION:

Article 1

The draft national provisions
concerning organostannic
compounds, which the Federal Republic of Germany notified
to the Commission by letter dated 22 January 2001, and which
seek to derogate from Directive 1999/51/EC as of 1 January
2003 regarding the use of organostannic compounds in anti-
fouling products intended for use in the aquatic environments
are rejected.

IV. CONCLUSION

Article 2

(82)

In the light of the foregoing, it should be concluded that
the request by Germany for introducing national legisla-
tion going beyond Directive 1999/51/EC as submitted
on 25 January 2001:

— is admissible in so far as it refers to antifouling
products intended for use in water (i.e. in the aquatic
environment) but is inadmissible as regards the rest,
— to the extent it is admissible, does not fulfil the
conditions established by Article 95(5) of the Treaty.

This Decision is addressed to the Federal Republic of Germany.

Done at Brussels, 13 July 2001.

For the Commission

Erkki LIIKANEN

Member of the Commission