2000/509/EC: Commission Decision of 25 July 2000 concerning the draft national provisions notified by the Kingdom of Belgium concerning the limitations of the marketing and use of organostannic compounds (notified under document number C(2000) 2016) (Text with EEA relevance) (Only the French and Dutch texts are authentic)
Date: 2000-07-25
Institutions: European Commission
Subjects: Belgium, dangerous substance, derogation from EU law, environmental protection, marketing restriction, paints and varnishes

12.8.2000

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Official Journal of the European Communities

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II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 25 July 2000

concerning the draft national provisions notified by the Kingdom of Belgium concerning the
limitations of the marketing and use of organostannic compounds

(notified under document number C(2000) 2016)

(Only the French and Dutch texts are authentic)

(Text with EEA relevance)

(2000/509/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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

Whereas:

I. FACTS

(1)

(2)

1. Community Legislation: Directive 1999/51/EC

Council Directive 76/769/EEC (1) 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
dangerous substances and preparations, as last amended
by Commission Directive 1999/77/EC (2) of 26 July
1999, 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.

Council Directive 89/677/EEC (3) of 21 December 1989,
which amends for the eighth time Directive 76/769/EEC,
harmonises amongst others the placing on the market
and use of organostannic compounds. The provisions
concerning organostannic compounds were modified by
Commission Directive 1999/51/EC (4) 26 May 1999,

(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.

which adapts to technical progress for the fifth time
Annex I to Directive 76/769/EEC.

(3)

(4)

Directive 1999/51/EC prohibits the marketing and use
of organostannic compounds as substances and constit-
uents of preparations when acting as biocides in free
association antifouling paint.

The Directive also prohibits the use of organostannic
compounds as substances and constituents of prepara-
tions when acting as biocides to prevent the fouling by
mircroorganisms, plants or animals of

(a) the hulls of:

— boats of an overall

length, as defined by ISO

8666, of less than 25 metres,

— 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 litres,

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

professional users.

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(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 shall be legible and
indelibly marked as follows:

of

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

Restricted to professional users.’

The provisions under point 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 this date.

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

thus

The Directive
that organostannic
establishes
compounds may only be used in antifouling products
providing for controlled release of active ingredients for
ships of a length of more than 25 m that are not
predominately used on inland waterways and lakes.
Austria and Sweden are authorised to maintain their
existing stricter legislation in view of the specific needs
to protect the especially sensitive environments of the
Baltic Sea and inland waterways.

The Directive also establishes that the remaining allowed
uses are to be reviewed before 1 January 2003. In the
second whereas clause, specific reference is made to the
developments in the International Maritime Organisation
(IMO), which has recognised the risks posed by organo-
stannic compounds. The Marine Environment Protection
Committee of the IMP 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.

2. National provisions

Belgium intends to transpose the provisions of Directive
1999/51/EC concerning organostannic compounds by
modifying the Royal Decree of 25 February 1996
placing restrictions on the marketing and use of certain
dangerous substances and preparations. The existing
Article 1(2) will be replaced by a new text containing
exactly
adopted in the
the
Community Directive.

same provisions

as

(6)

(7)

(8)

(9)

(10)

(11)

Belgium also intends, after the implementation of the
Directive, to replace as from 1 January 2003 the said
Article 1(2) of the Royal Decree of 25 February 1996 by
the following provision:

‘Organostannic compounds may not be placed on the

market for use as substances and constituents of prepa-
rations when acting as biocides in antifouling paints.’

3. Comparison between the draft national provi-

sions and Directive 1999/51/EC

(12) When comparing the current Community legislation and
the draft national provisions which Belgium intends to
apply as of 1 January 2003, it emerges that the national
measures are more restrictive, as they amount to a total
ban on the marketing and use of organostannic
compounds in antifouling products.

II. PROCEDURE

(13) Directive 1999/51/EC was adopted on 26 May 1999.
Member States had to bring into force the national
provisions necessary to comply with the Directive before
29 February 2000 and to apply them from 1 September
2000.

(14)

By letter of 21 February 2000, the Belgian Permanent
Representative informed the Commission that Belgium
would correctly transpose the provisions of Directive
1999/51/EC, but that in accordance with Article 95(5)
of the EC Treaty, it was intended to apply stricter meas-
ures as of 1 January 2003. Belgium considers it neces-
sary to introduce such national measures to protect the
environment against the harmful effects of antifouling
paints based on organostannic compounds, on the basis
of new scientific evidence. The letter was received on 23
February 2000.

(15)

By letter of 23 March 2000, the Commission informed
the Belgian authorities that it had received the noti-
fication under Article 95(5) and that the six months
period for its examination according to Article 95(6)
started on 24 February 2000, the day following the one
when the notification was received.

III. ASSESSMENT

1. Consideration of admissibility

(16)

The notification submitted by the Belgian authorities on
21 February 2000 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 EC Treaty.

(17) 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-
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.’

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(18) As required by Article 95(5) of the EC Treaty, Belgium
notified the Commission of the actual wording of the
provisions that are intended to be introduced as of 1
January 2003, accompanying the request by an explana-
tion of the reasons, which,
justify the
introduction of those provisions.

in its opinion,

(24)

classified according to
are
Tributyltin compounds
Council Directive 67/548/EEC of 27 June 1967 relating
to the
and labelling of
dangerous substances (6) as last amended by Directive
99/33/EC (7) as:

classification, packaging

(19)

The Commission, therefore, is of the opinion that the
notification submitted by Belgium on 21 February 2000
for the introduction of
in order to obtain approval
national provisions derogating from the provisions of
Directive 1999/51/EC is admissible under Article 95(5)
of the EC Treaty.

2. Assessment of merits

(20)

(21)

(22)

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

therefore assess whether the
The Commission must
conditions provided for by Article 95(5) of
the EC
Treaty are met. This requires (a) ‘new scientific evidence
with regard to the protection of the environment or the
working environment’, (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’.

In addition, pursuant to Article 95(6) of the EC Treaty,
where it feels that the introduction of such national
the Commission must check
provisions is justified,
whether or not those national provisions are a means of
arbitrary discrimination 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. Organostannic compounds - general information

(23) 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-
important and
fouling agents (5)
effective
and
Bis(tributyltin)oxide TBTO.

tributyltin, TBT,

compounds

for ships,

the most

being

— 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-lives in water of
two
weeks, biota two months, sediment 0,5 to 20 years. TBT
shows some bioaccumulation within the environment.

TBT is interfering with the metabolism of exposed
organisms (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).

Risks to the aquatic environment from TBT are well
recognised and already in 1989, the first Community
measures (Directive 89/677/EEC) were taken to reduce
the risks 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 metres.

(25)

(26)

(27)

(28)

(29) A thorough re-evaluation carried out by the Commis-
sion in cooperation with the Member States, led to the
adoption of Directive 1999/51/EC, which strengthens
these protective measures considerably. The 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.
the review
process, the Commission had mandated a study on the
matter to an external consultant (8) and, based on that
study, requested the opinion of the Scientific Committee
of Toxicity, Ecotoxicity, and the Environment (SCTEE),
which was adopted on 27 November 1998.

In the course of

(5) Fouling denotes the effect

that a wide range of organisms are
susceptible to colonise on ships' hulls and constructions in water.
The presence of fouling organisms on the surface of ship hulls can
have a very significant effect on the performance of a ship, leading
to reduced handling and increased fuel consumption.

(6) OJ 196, 16.8.1967, p. 1.
(7) OJ L 199, 30.7.1999, p. 57.
(8) WS, Atkins International Ltd, Assessment of the risks to health and to
the
in certain
biocidal products and of the effects of further restrictions on their marke-
ting and use, Final Report, April 1998.

compounds and of arsenic

environment of

tin organic

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2.2. The position of Belgium

(30)

The Belgian authorities take the view that the proposed
measure is designed to protect the health of humans and
animals as well as the environment, a fact supported by
a number of facts, which add to the underlying reasons
for Directive 1999/51/EC.

(31) According to them, it was already shown at the time of
preparation of Directive 1999/51/EC that the concentra-
tion of TBT from antifouling paint used to treat the hulls
of boats, on busy shipping lanes and in port areas,
reaches a level that is harmful to oysters and dogwhelk,
and causes shell thickening and imposex in those organ-
isms. These effects and others illustrate the endocrine-
destructive capacity of TBT for some animal species at
very low concentrations.

(32)

(33)

(34)

The Belgian authorities acknowledge that because of
economic considerations, i.e. the possible consequences
of a unilateral European TBT ban for European ship-
yards with relocation of activities and circumvention of
a ban imposed by the European Community, at Euro-
pean level the option for a restricted ban on TBT paint
was taken and that, as far as a total ban on TBT was
concerned, reference was made to an IMO Decision and
the prospect of 1 January 2003.

In their request,
the Belgian authorities state that a
recent study shows that exposure to TBT in flatfish
reduces resistance to infection. These fish live on the
seabed and are exposed to relatively high concentrations
of TBT.

the

daily

admissible

TBT can also damage the immune system of mammals,
such as sea otters, which feed on shellfish which live in
an environment contaminated with TBT. The effect on
immunity on humans is also a possible consequence of
exposure to TBT, which is one of the reasons for the low
value of
(ADI) of
0,25µg/kg/day regarded as possible by the SCTEE. Data
on the presence of organostannic compounds in fish,
shellfish and crustaceans are limited. The data that are
available, however, show that exceeding the ADI of TBT
may be the case in people whose eating habits contain a
sizeable proportion of fish and shellfish contaminated
with TBT, such as mussels. In support of these argu-
ments,
the Belgian authorities make reference to a
study (9) of June 1999.

intake

(35)

It is stated further that an analysis of dredging spoil
from Belgian ports showed that the concentration of
TBT is over 7 µg/kg, the limit for the marine environ-
ment. Samples taken in June 1999 provided readings of
more than double this limit.

(9) A.C. Belfoid, M. Puperhart and F. Ariese, Organotin levels in seafood
in relation to the tolerable daily intake (TDI) for humans, Institute for
Environmental Studies, Vrije Universiteit Amsterdam, June 1999.

µg

(36) According to the Belgian authorities, the scientific infor-
mation available indicates that within two weeks of
applying a fresh coating of paint TBT release averages
110
to
1 128 µg TBT/cm2/day. The treatment with antifouling
paints carried out in Belgian ports is likely to increase
the contamination in the port area and the nearby ship-
ping lanes, which helps to explain the high TBT levels in
the dredging spoil.

TBT/cm2/day, with

peaks

up

of

(37)

(38)

(39)

The Belgian authorities also point out that imposex is
not limited to dogwhelk but has been noted world-wide
in 72 species of marine snails.

It is underlined that at its 43rd meeting from 28 June to
2 July 1999 the Marine Environment Protection
Committee of the IMO took further steps to enable the
IMO Diplomatic Conference in 2001 to take the
decision to ban the use of organostannic compounds in
antifouling paint on sea-going vessels from 1 January
2003.

The Belgian authorities also claim that antifouling paints
without organostannic compounds and of equal dura-
tion and effectiveness are already available. Their cost
price, which at present is still considerably higher than
the price of paints containing TBT, is expected to drop
when production is on a larger scale, as was the case
years ago for paint containing TBT.

(40) As

the abovementioned damaging effects of TBT
contamination of the marine environment were estab-
lished at a time when TBT had already been banned for
some time on boats of less than 25 metres, the Belgian
authorities assume that further measures, namely, a total
ban on antifouling paints based on organostannic
compounds, will be needed in order to counter any
further detrimental effects for the environment.

(41)

(42)

Being close to the ports and one of the busiest shipping
lanes, the marine environment off the Belgian coast is
particularly exposed to the consequences of TBT produc-
tion from sea-going vessels. The abundant sediment in
that area forms a reservoir from which, protected against
rapid degradation, TBT will pose a threat to the aquatic
environment many years after the use of TBT has been
stopped.

To prevent dredging spoil contaminated with TBT from
damaging the environment, it will have to be specially
the
treated, which will mean very high costs
community. These costs will increase the longer the use
of paints based on organostannic compounds continues.
In view of these costs economic justification for delaying
the total ban of TBT is no longer tenable for Belgium.

for

(43)

The Belgian Government therefore takes the view that
the use of antifouling paints should be stopped from 1
January 2003 onwards, the date proposed by the Marine
Environment Protection Committee of the IMO.

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2.3. Evaluation of the position of Belgium

occur or become known only after the adoption of
Directive 1999/51/EC.

(44)

The material and data submitted by the Belgian authori-
ties in support of their request for application of Article
95(5) is rather limited. In the following their statements
and positions will be evaluated in the light of the criteria
established in that article.

(45)

(46)

(47)

2.3.1. The burden of proof

It has to be noted that, in the light of the time frame
the Commission, when
established by Article 95(6),
examining whether the draft national measures notified
under Article 95(5) are justified, has to take as a basis
‘the grounds’ put forward by the Member State. This
means that, according to the provisions of the Treaty,
the responsibility of proving that these measures are
justified, lays on the requesting Member State. Given the
procedural
established by Article 95,
including in particular a strict six months 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 reasons of justifica-
tion.

framework

If the elements submitted by the requesting Member
State are not sufficient to enable the Commission to
assess whether
the conditions of Article 95(5) are
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

The arguments put forward by the Belgian authorities do
relate to the protection of the environment. However,
the Belgian authorities acknowledge themselves that a
very large amount of information on the environmental
effects of TBT and other organostannic compounds was
already known and taken into account in the prepara-
tion of Directive 1999/51/EC. This applies particularly
to the work of the IMO, which is specifically mentioned
in the second recital of Directive 1999/51/EC. In fact, it
is clearly stipulated there that the development of the
work and the decisions taken in the IMO will be fully
taken into account during the revision of the Directive
which will be made before 1 January 2003.

(48)

The Belgian authorities claim that a recent study has
shown that exposure to TBT in flatfish reduces resistance
to infection. No further information is provided, neither
the text of the study, nor a reference. It is therefore not
possible to verify whether this information did indeed

(49)

(50)

(51)

(52)

Effects on human health, specifically due to exposure in
the working environment, have been assessed both in
the study mandated by the Commission and the opinion
of the SCTEE during the preparation of Directive 1999/
51/EC. It is therefore unclear whether the information
provided by the Belgian authorities based on a study
from June 1999 (10) to which reference is made (but the
text is not provided) constitutes new evidence in the
sense of Article 95(5).
In particular, the information
relates to daily intake of TBT through food, and there-
fore is not linked to the protection of humans in the
working environment.

The Belgian authorities claim that samples of dredging
spoil taken from Belgian ports in June 1999 showed that
the concentration of TBT was more than twice the level
of 7µg/kg. No further details are provided. Although
these data were measured at a time, when Directive
1999/51/EC was already adopted, they do not per se
constitute new information. In fact, 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 Nether-
lands), dating from 1989 to 1995 showing TBT concen-
trations in harbour sediments from 10 to 2 100 µg/kg.
This clearly shows that neither the levels of TBT found
in sediments in Belgian ports are of a kind not already
known when the Directive was prepared, nor are they
unique for Belgium. The problem seems, however, to be
specific for Member States, where busy ports are located.

The Belgian authorities point out that after application
of TBT paint in dockyards (which is done in Belgian
ports), there are specifically high releases of TBT from
the fresh paint, which is one of the reasons why the
levels of TBT in harbour sediments are elevated. No
specific data for Belgium, nor the timing when the data
became available are provided. On the other hand, 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 Commission (11). Furthermore
is
applicable to any port in the world where drydock work
involving antifouling painting is carried out.

the argument

The remaining arguments from the Belgian authorities
(see above) give rise to the following comments. The
study mandated by the Commission does already
acknowledge that imposex is not limited to dogwhelk
and occurs
in a number of other marine snails.
However, the dogwhelk is the most sensitive species.
The objective of the actions taken by the Marine Envir-
onment Protection Committee of the IMO at its meeting
from 28 June to 2 July 1999, namely to enable the IMO
Diplomatic Conference to ban the use of organostannic
compounds in antifouling paints on sea-going vessels

(10) See footnote No 9.
(11) See footnote No 8, page 1-7.

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(53)

from 1 January 2003, was already known at the time
when Directive 1999/51/EC was adopted and is specifi-
cally mentioned in the recitals. The fact that alternative
paints without organostannic compounds are available
and will become less expensive is not relevant in the
justification of the Belgian request.

Lastly the Belgian authorities state that being close to the
ports and one of the biggest shipping lanes, the marine
environment off the Belgian coast is particularly exposed
to the consequences of TBT production from sea-going
vessels. To prevent damage to the environment,
the
sediments will have to be dredged and decontaminated,
which will entail high economic costs. No further data,
neither on the actual contamination along the Belgian
coastline, nor on the economic costs of decontamination
are provided. The study mandated by the Commission is
well aware of the fact that coast-lines close to major
ports and busy shipping lanes are environments at high
risk. The example of
line is
presented in detail. However, the data from the Nether-
lands indicate that the contamination of the coast line is
more due to the effluents and dumping of dredged spoil
from busy ports than from the fact that busy shipping
lanes are close by.

the Netherlands' coast

(54) Overall

it can be seen that the data and justification
submitted by the Belgian authorities in support of their
request for Article 95(5) do not allow to conclude that
the draft national measures are based on new scientific
evidence relating to the protection of the environment
or the working environment on grounds of a problem
specific to Belgium arising after the adoption of the
harmonisation measure. The conditions of Article 95(5),
therefore are not fulfilled.

(55) Given these results of the analysis of the submitted
material, there is no basis to consult the other Member
States, interested groups or request a new opinion of the
SCTEE.

2.4. Absence of arbitrary discrimination/disguised
restriction of trade/obstacle to the functioning of
the internal market

(56) Under Article 95(6), the Commission will either approve
or reject
the draft national provisions notified ‘after
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

(57)

(58)

shall constitute an obstacle to the functioning of the
internal market’.

Since the request made by Belgium does not fulfill the
basic conditions set out in Article 95(5) (see point 2.3),
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.

IV. CONCLUSION

In the light of the above considerations, the Commission
is of the opinion that the request by Belgium for intro-
legislation derogating from the provi-
ducing national
sions of Directive 1999/51/EC with regards to organo-
stannic compounds as submitted on 21 February 2000:

— is admissible,
— but does not fulfill the conditions established by

Article 95(5).

(59)

The Commission therefore concludes by rejecting that
request in accordance with Article 95(6) of the Treaty,

HAS ADOPTED THIS DECISION:

Article 1

The draft national provisions
concerning organostannic
compounds, which the Kingdom of Belgium notified to the
Commission by letter dated 21 February 2000, and which
intend to derogate from Directive 1999/51/EC as of 1 January
2003, are hereby rejected.

Article 2

This Decision is addressed to the Kingdom of Belgium.

Done at Brussels, 25 July 2000.

For the Commission

Erkki LIIKANEN

Member of the Commission