1999/832/EC: Commission Decision of 26 October 1999 concerning the national provisions notified by the Kingdom of the Netherlands concerning the limitations of the marketing and use of creosote (notified under document number C(1999) 3424) (Text with EEA relevance) (Only the Dutch text is authentic)
Date: 1999-10-26
Institutions: European Commission
Subjects: Netherlands, marketing restriction, national law, pesticide, public health, wood product

22.12.1999

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Official Journal of the European Communities

L 329/25

COMMISSION DECISION

of 26 October 1999

concerning the national provisions notified by the Kingdom of the Netherlands concerning the
limitations of the marketing and use of creosote

(notified under document number C(1999) 3424)

(Only the Dutch text is authentic)

(Text with EEA relevance)

(1999/832/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

preparations containing creosote not respecting those
limits may not be placed on the market.

Having regard of
Community, and in particular Article 95(6) thereof,

the Treaty establishing the European

Whereas:

I. FACTS

1. Communtity Legislation: Directive 94/60/EC

of

laws,

regulations

(1) Council Directive 76/769/EEC of 27 July 1976 on the
and
approximation
the
administrative 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 and the environment.

and preparations (1),

substances

as

(2) European Parliament and Council Directive 94/60/EC (3)
which amends Directive 76/769/EEC for the 14th time,
harmonises amongst others the use and marketing of
creosote and similar coal
tar distillates, as well as
preparations containing them, by limiting the content of
one specific component, benzo[a]pyren, in the following
B[a]P and water extractable phenols when used for
wood-treatment
(point 32 in the Annex to Directive
94/60/EC). The limit for B[a]P is fixed at a maximum of
50 ppm (= 0,005 %) by mass and the limit for water
extractable phenols is fixed at a maximum of 3 %
(= 30 g/kg) by mass. Wood treated with creosote or

(cid:145)For use

(3) However, by derogation, the Directive allows for the use
of creosote and preparations containing creosote with
up to 500 ppm (= 0,05 %) B[a]P by mass and water
extractable phenols up to 30 g/kg for wood treatment
in industrial
installations. Such products may not be
sold to the general public and containers have to be
labelled with the phrase
in industrial
installations only(cid:146). Wood treated this way and placed on
time can only be used in
the market
in
industrial
certain cases where its use is excluded, e.g.
inside
buildings, in contact with products intended for human
or animal consumption,
in playgrounds and in other
outdoor places for public pleasure or where there is a
treated wood
risk
commercialised for
can be used
irrespective of the creosote-type applied except in the
cases mentioned before.

for the first
and professional

skin. Old
second time

contact with

applications,

except

for

a

2. National provisions: The Control Substances Act

and the SIVEB Decision

(4) The Netherlands legal system concerning creosote is
established by The Control Substances Act of 1962 (4)
and the executing Decision concerning the composition,
classification, packaging
control
substances, adopted on 22 February 1980 (hereinafter
called the SIVEB Decision) (5) with its
subsequent
amendments. The legislation provides
for a general
prohibition combined with an approval system on an
individual basis.

labelling

and

of

(5) The Control Substances Act

crop control
substances (Article 1(1)(f)), which may not be supplied,
in stock, marketed, or used in the
possessed, kept
to the Act
Netherlands unless approved pursuant
(Article 2 (1)). Article 3(1) defines the general conditions

covers

(1) OJ L 262, 27.9.1976, p. 201.
(2) OJ L 207, 6.8.1999, p. 18.
(3) OJ L 365, 31.12.1994, p. 1.

(4) As amended by the Act of 15 December 1994, Law Gazette of The

Netherlands 1995, No 4.

(5) Official Journal of The Netherlands of 29 February 1980, No 43.

L 329/26

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Official Journal of the European Communities

22.12.1999

that a control substance has to meet for permission
(inter alia, to have no harmful effect on human health,
ground water and no unacceptable effects on the
environment).

glasshouses, the use of creosote is totally banned in the
approvals. Creosote can be applied only in special
industrial
installations by using a specified technique
(vacuum/pressure).

(6) Based

on

under

falling

substances

a ministerial

Substances Act,

the Controlled
(forming

the
SIVEB-Decision
regulation),
provides for the admissible contents of active agents in
control substances. This forms the basis for subsequent
approvals (licenses) of the competent Minister to use the
control
the Controlled
Substances Act. It is the amendment of 12 March 1992
to the SIVEB Decision (6), wich took effect on 18 March
1992, that provides for a maximum content of 50 ppm
B[a]P by mass of carbolineum and creosote consisting of
one or more coal tar distillates within the meaning of
the Directive and the content of water-soluble phenols
In
below 30 g/kg for all uses and applications.
particular, no exemption is given for wood treatment in
industrial installations.

(7) The Dutch government notified some examples of
individual approvals in the cases of creosote oil and
carbolineum, which contain certain exclusions for their
use or which determine the only permitted use. These
the Dutch
approvals
government, a legal effect equal to that of a general
statutory order, since the same conditions are imposed
in all similar cases. For certain uses, like on toys, inside
in green- or
buildings,

in contact with foodstuffs,

according

have,

shall

to

3. Comparison between the national provisions and

Directive 94/60/EC

(8) Table 1 shows in detail

the differences between the
restrictions on the use of creosote with regard to the
B[a]P content imposed by Directive 94/60/EC and the
Dutch legal system.

(9)

In summary, the Dutch provisions are more restrictive
in several aspects:

(cid:151) the B[a]P content of creosote is not permitted in the
range of 50 to 500 ppm for the use in industrial
installations

(cid:151) wood preservation has to be performed according to
in special

a specific technique (pressure/vacuum)
installations

(cid:151) in certain cases the use of creosote is excluded for
wood preservation, even if its B[a]P content is below
50 ppm.

Table 1

Comparison between Directive 94/60/EC and the Dutch regulations

Council Directive 94/60/EC

SIVEB Decision

B[a]P < 50 ppm

No restrictions on sale or use of creosote or
newly treated wood

only

Carbolineum: No restrictions on sale. Private
use
Explicit
restrictions on use of treated wood. It may not
be used:

treating wood.

for

(cid:151) on toys

(cid:151) inside buildings

(used by humans or

animals)

(cid:151) in spaces for storage of foodstuff

(cid:151) in green- or glasshouses

(6) Official Journal of The Netherlands of 17 March 1992, No 54.

22.12.1999

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L 329/27

Council Directive 94/60/EC

SIVEB Decision

B[a]P < 50 ppm
(cont’d)

Creosot: Permitted only for industrial use in
special installations for treating wood by the
vacuum and pressure method for:

(cid:151) railway sleepers

(cid:151) telephone and electricity poles

(cid:151) excavation, road and water works

(cid:151) fencing

B[a]P in range 50
to 500 ppm

Restrictions on sale of creosote:

Sale and use of creosote and treated products
totally banned.

(cid:151) no sale to private consumers

(cid:151) use

only

permitted

in

industrial

installations

(cid:151) Minimum drum size 200 l; Special

labelling required.

Creosoted wood may only be used for
professional and industrial applications:

(cid:151) railways

(cid:151) electricity poles

(cid:151) fencing

(cid:151) waterways

Explicit
may not be used:

restrictions on treated wood.

It

(cid:151) inside buildings

(cid:151) in contact with foodstuff

(cid:151) for containers for growing purposes

(cid:151) at playgrounds or other sites at risk of

skin contact

B[a]P > 500 ppm

Sale
and use of
products totally banned

creosote

and treated

Sale and use of creosote and treated products
totally banned

Old treated wood

Use controlled as for wood treated with
creosote containing B[a]P between 50 und
500 ppm

No other regulations than for newly treated
wood

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II. PROCEDURE

(10) Directive 94/60/EC was adopted on 20 December 1994.
The Netherlands submitted the following declaration to
the minutes of the Council:
(cid:145)The Netherlands is voting
the proposed Directive concerning the 14th
against
amendment of Directive 76/769/EEC, as
to
comply with regard to (cid:147)Creosote(cid:148) with the basic
principle enshrined in the EC Treaty that a high level of
protection be achieved for the environment and public
health. The Netherlands therefore reserves the right, by
recourse to Article 100a(4) of the EC Treaty, to adopt
national provisions in the filed of creosote that are
justified on the important grounds referred to in Article
36 or connected with the protection of working
conditions on the environment(cid:146).

fails

it

(11) The Directive had to be implemented into the national
law of the Member States no later than one year after its
first
adoption,
subparagraph) and the national provisions had to be
applied from 20 June 1996 (Article 2(1),
second
subparagraph).

i.e. 20 December 1995 (Article 2(1),

(12) By letter of 9 March 1995,

informed the Commission that

the Dutch Permanent
the
Representative
Netherlands considered it necessary to maintain,
in
accordance with the former Article 100a(4) of the EC
Treaty, the national
legal provisions contained in the
Control Substances Act of 1962 (7) and the (cid:145)SIVEB
Decision(cid:146) with its
amendments, which
subsequent
provide for more restrictive measures on the use of
creosote offering further protection of public health, the
working environment than would be the case on a strict
implementation of the Directive.

of Dutch waters and their beds with polycyclic aromatic
hydrocarbons (PAHs) can only be remedied by reducing
the maximum permissible B[a]P content in creosote to
an ecologically acceptable level. Austria takes the view
that
in any way be
regarded as an arbitrary discrimination or disguised
barrier to trade, and that the reference to the former
Article 100a(4) is justified.

the stricter provisions cannot

(15) Sweden emphasises the fact that creosote is a mixture of
several hundreds of
including polycyclic
substances
aromatic compounds. Many were shown in animal
testing to be mutagenic or carcinogenic. Creosote is
highly toxic to aquatic organisms and most of
the
contained are bioaccumulating. Creosote
substances
strongly irritates the skin and causes,
in combination
with sunshine, photoallergic reactions as blisters and
severe eczema. There is, according to Sweden, at the
time being, no scientific evidence to prove that the use
of creosote with levels of B[a]P lower than 50 ppm or
wood treated with such substances,
for
consumers or for the environment.

safe

is

(16) Denmark agrees with the Netherlands that creosote is a
and the
highly dangerous
substance
environment. Use of the substance should, therefore, be
restricted as far as possible, and preferably banned.

for humans

(17)

In supporting the Dutch views, Germany refers to its
own request under the former Article 100a(4).

(18) Finland expresses the opinion that

in this case the
conditions contained in the former Article 100(4)a are
fulfilled and that the Commission should confirm the
Dutch national provisions.

(13) The Commission consulted the other Member States by
letter of 21 June 1995 with regard to the Dutch request
to maintain stricter provisions on creosote. Seven
replied. Austria, Denmark, Finland,
Member States
Germany and Sweden support the Dutch request, while
Ireland and the United Kingdom are opposed.

(19)

is necessary
in

(14) Austria’s assessment of the Dutch position is that the
higher
level of protection offered by the national
provisions
in order
the
as
the
environment
creosote-impregnated timber is used in large amounts in
shoreline defences and other installations and in ships
and ships’ hulls. The rate of leaching is particularly high
owing to the constant contact with salt water, and
accumulation in the sediment poses a considerable
hazard to aquatic communities. The massive pollution

Netherlands,

to protect

(7) As amended by the Act of 15 December 1994, Law Gazette of the

Netherlands 1995, No 4.

the request

Ireland considers that

In contrast,
is not
based on new scientific evidence. Ireland therefore sees
no reason to move away from the agreed dual standard
of 50 ppm and 500 ppm of Directive 94/60/EC nor to
introduce controls on the use of wood treated with
coal-tar distillates containing less than 50 ppm B[a]P.

(20) The United Kingdom argues that the Dutch request does
not reflect the sort of risk assessment which is now
widely accepted in the evaluation of chemicals
in
general, and of pesticides in particular. It criticises the
Dutch request for only looking at the hazards and that
it did not include a summary of toxicological and other
data, followed by a risk assessment of permitted uses.
The United Kingdom states that the arguments raised by
the Netherlands had already been raised and rejected at
the
the Council Working Group

during

stage

22.12.1999

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Official Journal of the European Communities

L 329/29

negotiation of the Directive. The United Kingdom also
the scientific
remarks that a fuller demonstration of
grounds justifying the request would be needed, before
the derogation could be accepted. As for the genotoxic
mechanism supposedly caused by creosote, the United
Kingdom maintains that the Netherlands fail to provide
any compelling evidence.

(21) On 1 May 1999, the Treaty of Amsterdam amending
the Treaty on European Union, the Treaties establishing
the European Communities and certain related acts,
signed at Amsterdam on 2 October 1997, entered into
force. By letter of 24 August 1999 the General
the Commission informed the Dutch
Secretariat of
authorities of the fact that their notification regarding
the placing on the market and use of creosote would be
treated in the framework of the new provisions of the
Treaty

III. ASSESSMENT

1. Applicable rules

the former Article 100a of

(22) The Treaty of Amsterdam has amended substantially the
provisions of
the Treaty
establishing the European Community, by replacing
paragraphs 3, 4, and 5 of this article with eight new
paragraphs numbered 3 to 10. Due to the new
the amended article has
numbering of all articles,
become Article 95 of
the Treaty establishing the
European Community.

(23) The Treaty of Amsterdam does not comprise specific
transitional provisions on the rules applicable to the
notifications made previously to the time of entry into
force of this treaty, like the Dutch notification, which is
the subject of this Decision.

(24)

In the absence of specific provisions extending their
application, the old provisions of Article 100a(4) of the
EC Treaty are regarded as repealed from the day of the
entry into force of the new provisions (1 May 1999).
Instead,
the Treaty apply
immediately from that date to the examination of this
notification.

the new provisions of

2. Consideration of admissibility

(25) The notification submitted by the Dutch authorities
intends to obtain the authorisation to maintain national
provisions incompatible with Directive 94/60/EC, which

constitutes a harmonisation measure adopted on the
basis of the former Article 100a (now Article 95) of the
EC Treaty.

(26) Article 95(4) of the Treaty reads as follows: (cid:145)If, after the
adoption by the Council or by the Commission of a
harmonisation measure, a Member State deems
it
necessary to maintain national provisions on grounds of
major needs referred to in Article 30, or relating to the
protection of
the working
environment
environment,
it shall notify the Commission of these
provisions as well as the grounds for maintaining them.(cid:146)

the

or

(27) Directive 94/60/EC was adopted on 20 December 1994.
The Directive had to be transposed by the Member
States by 20 December 1995 and enforced by 20 June
its
1996. The Netherlands notified the provisions of
national regulations that it intended to maintain on 9
March 1995 and thus before the date foreseen for the
application of the national provisions transposing the
Directive.

(28) The Dutch provisions in question, namely the relevant
amendment of the SIVEB Decision, was adopted on 12
March 1992 and thus before Directive 94/60/EC was
adopted (20 December 1994).

(29)

It is therefore well justified to consider that in this case
the conditions of Article 95(4) of the Treaty are met,
according to which the national provisions notified, for
which a Member State wishes to obtain approval for
maintaining them after the date of implementation of a
Community harmonisation measure, must have been
adopted before the adoption of
that harmonisation
measure.

(30)

In the light of what precedes, the Commission considers
that the request of the Kingdom of the Netherlands for
derogation from Directive 94/60/EC as notified on 9
is
March 1995 under
admissible under Article 95(4) of the EC Treaty.

the former Article 100a(4)

3. Assessment of merits

(31)

the Commission has

In accordance with the provisions of Article 95 of the
the
Treaty,
to assure that all
conditions enabling a Member State to avail of
the
possibilities of derogation provided for in this article are
to verify
met. The Commission has,
whether the provisions notified by the Member State are
justified by the major needs of protection referred to in
Article 30, or relating to the environment or working
environment. In addition, the Commission has to verify,
these measures are justified,
when it considers that

in particular,

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Official Journal of the European Communities

22.12.1999

whether or not
they are
arbitrary
a means of
a disguised restriction on trade
discrimination or
between the Member States, and whether or not they
constitute an obstacle to the functioning of the internal
market (Article 95(6)).

of the elements which are submitted by the requesting
Member State, without having to seek itself possible
reasons of justification.

of

and

health

protection

human
In order to substantiate its request

(32) The Dutch authorities have based their request on the
need
the
of
for
environment.
derogation of Directive 94/60/EC the Dutch government
submitted a study made on behalf of the Ministry of
Housing, Spatial Planning and Environment (8). The
study mainly gives an overview on the use of creosote
in The Netherlands and its environmental and health
effects.
It examines the origin, the pathways and the
deposition of polycyclic aromatic hydrocarbons (PAHs),
among which B[a]P is the most thoroughly investigated.

a

as

designed

specifically

(35) None of the studies referred to above was completely
conclusive with regards to the effects of creosote an
human health, in particular concerning its carcinogenic
potential,
long-term
carcinogenicity study was still ongoing. This study (11)
was made available to the Commission at the beginning
of 1998. The findings of all these studies are set out in
the following. In addition, all studies have been made
available to the Scientific Committee on Toxicity,
Ecotoxicity, and the Environment, which expressed a
first opinion on the cancer risk to consumers from
creosote and/or wood treated with such creosote on 27
November 1998. This opinion was revised on 4 March
1999.

(33) The Commission mandated a study to an external
consultant to critically review the study submitted by
the Dutch authorities and to further assess the situation
of environmental contamination and the possible risks
to human health by creosote in the Netherlands (9). In
addition, the findings of three further studies (10), which
were mandated by the Commission in the framework of
similar requests from other countries, have been used in
the assessment of the request from the Netherlands.

(34)

It has to be noted that, in the light of the time-frame
established by Article 95(6), wich did not exist in the
former Article 100a(4) under the regime of which the
Dutch request was notified, these substantial efforts of
the Commission to find additional elements for the
justification of the maintenance of the Dutch national
provisions cannot constitute a precedent for the future.
When examining whether the national measures notified
under Article 95(4) are justified by a major need, the
Commission has to take as a basis (cid:145)the reasons(cid:146) put
forward by the Member State to justify the maintenance
of its national provisions. This means that, according to
the responsibility of
the provisions of
lays on the
proving that these measures are justified,
requesting Member
procedural
the
framework established by Article 95, the Commission
normally has to limit itself to examining the relevance

State. Given

the Treaty,

(8) bkh consulting engineers,

(cid:145)Foundation of the appeal against the

EC-directive on creosote(cid:146), Final report, Delft, 1 July 1995.

(9) G. Grimmer,

(cid:145)Study on the Justification in Scientific Terms of
Allowing The Netherlands to retain its National Laws on Creosote
report,
Place
in
Biochemisches
f(cid:252)r Umweltcarcinogene, Gro(cid:223)hansdorf
(Germany), December 1995.

of Council Directive

94/60/EC.(cid:146)

Institut

Final

(10) Environmental Resources Management,

(cid:145)Scientific Evaluation of
the German Request for Derogation from Provisons of Council
Directive 94/60/EC Concerning Creosote(cid:146), Final Report, 24 April
1996. Dr. P.M. Sorgo,
(cid:145)Study on the Justification in Scientific
Terms of Allowing Denmark to Retain its National Laws on
Creosote(cid:146), Final Report, November 1996. WS Atkins International
Ltd.,
(cid:145)Study on the Justification in Scientific Terms of Allowing
Sweden to Retain its National Laws on Creosote in Place of
Council Directive 94/60/EC(cid:146), Final Report August 1997.

3.1. Justification on grounds of major needs

3.1.1. Creosote (cid:151) general information

(36) Creosote is a complex mixture of over 200 chemical
compounds, predominantly aromatic hydrocarbons, as
well as phenolic and aromatic nitrogen and sulphur
compounds.
tar
(boiling point approximately 200 to 400 (cid:176)C).

is a mid-heavy distillate of coal

It

(37) Creosote can contain over 30 different polycyclic
aromatic hydrocarbons (PAHs) with a possible total
PAH content of 85 %. The most important ones are:

(cid:151) acenaphthene

(cid:151) naphthalene

(cid:151) phenathrene

(cid:151) anthracene

(cid:151) fluorene

(cid:151) fluoranthene

(cid:151) chrysene

(cid:151) triphenylene

(cid:151) benzo[a]anthracene

(cid:151) benzo[b]fluoranthene

(cid:151) benzo[k]fluoranthene

(cid:151) benzo[a]pyrene

(11) Fraunhofer Institute of Toxicology and Aerosol Research, (cid:145)Dermal
Carcinogenicity Study of two Coal Tar Products (CTP) by Chronic
Epicutaneous Application in Male CD-1 Mice (78 Weeks)(cid:146), Final
Report, Hanover, October 1997.

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(38) Benzo[a]pyrene (B[a]P) is one of the most thoroughly
investigated PHAs and the B[a]P content is used as an
indicator or marker substance for classification purposes
and does not, in itself, reflect the total PAH content of
creosote. Depending on the type of creosote concerned,
the B[a]P content may vary between 0,003 and 0,3 % by
weight (30 to 3 000 ppm). A refined distillation of coal
tar and selection of the fractions can lead to lower B[a]P
or phenol contents. Different industry standards have
been developed by the Western European Institute for
Wood Preservation, characterised mainly by different
contents
and, most
important in this context, different contents of B[a]P.
Limiting values for classification standards are 500 ppm
and 50 ppm.

specified distillation fractions

(39) Modifications

It

and chemical
to both the physical
properties of creosote are possible if they are required
is possible to
for use or environmental purposes.
create a lower viscosity product, better suited to brush
application, by incorporating components with a lower
boiling point, which is sometimes called carbolineum.
Directive 94/60/EC does not make a distinction:
it
covers and treats in an identical way a whole range of
different coal tar distillates, all of them specified by their
names, Einecs, and CAS numbers.

(40) Creosote is principally and almost exclusively used as a
wood preserving agent. Large-scale
and
professional applications are by far the most important
ones: railway sleepers, poles for electricity transport,
hydraulic engineering (bank protection), agriculture and
fruit production. Creosote and similar products are also
used by individual consumers
for wood preserving
purposes.

industrial

(41) The most important properties of creosote are:

(cid:151) high fungicidal efficacy,

(cid:151) high insecticidal efficacy,

(cid:151) long-term persistence,

(cid:151) resistance to leaching and weathering.

(42) A very small quantity of creosote is used in medicinal
products for the treatment of certain skin diseases, e.g.
psoriasis.

published data on the effects to humans of sustained
exposure to creosote. Many of the studies are rather old
and do not always conform to modern standards with
regards to documentation.

(44) Exposure can occur via inhalation,

ingestion, or skin
contact. Creosote is evaluated as mildly to moderately
toxic by ingestion. Most effects resulting from animal
experiments and all epidemiological studies in humans
are linked to dermal exposure.

(45) Skin photosensitivity from coal tars has been described
by a number of authors.
Irritation symptoms, pitch
warts, skin discoloration and dermal tearing have been
reported to occur amongst workers exposed to creosote.
The most recent study on workers exposed to creosote
in Sweden and Norway was published in 1992 (12). The
study examined workers exposed to creosote between
1950 and 1975. The investigators found a somewhat
incidence than expected and an
lower
total cancer
the skin and lip and of
increased risk of cancer of
non-Hodgkin lymphomas. However, the composition of
the creosote was not documented and the authors
conclude that the small number of cases did not permit
valid conclusions. The increase could be attributed to
exposure both to creosote and to sunlight. One other
study (13)
found an increases risk of mortality from
scrotal cancer
for brickmakers exposed to creosote
during the period 1911 to 1938. Again, neither the
B[a]P content of the creosote nor a clear dose response
relationship are known.

the

lifetime (14),

(46) Mostly based on an animal experiment, where the skin
of mice was regularly exposed to B[a]P solutions in
International
acetone during their
Agency for Research on Cancer (IARC) has classified
IARC
creosote as a group 2A human carcinogen.
estimates
there is
sufficient evidence that creosote is carcinogenic in
animals and certain evidence from epidemiological
studies to conclude that creosote can be cacinogenic in
humans. There is no significant new evidence from
more recent
this
conclusion.

investigations, which would affect

in this class

substances

that

for

T o x i c i t y o f c r e o s o t e :

Human health effects:

(43) Despite the fact that creosote has been used as a wood
there are only few

preservative for over a century,

(12) S. Karlehagen et. al., Cancer Incidence Among Creosote-Exposed

Workers, Scand. J. Work Environ. Health, 1992: 18, p. 26.

(13) IARC, Monograph on the Evaluation of Carcinogenic Risk to
Humans, Vol. 35, Polynuclear Aromatic Compounds, Part 4,
Bitumen, Coal Tars and Derived products, Shale Soils and Soots,
Lyon, 1985.

(14) J.M. Holland, E.L.Frome, Advances
in Modern Environmental
Toxicology, Vol. VI, Applied
Petroleum
of
Toxicology
Hydrocarbons, ed. MacFarland et. al, Princeton Scientific Publishes
1984.

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(47) For

as

to

last

and

further

so-called

amended

distillates,

several years, experts

from the Member States
examined the issue of classification of creosote, other
coal-tar
complex
in the framework of Council Directive
substances
67/548/EEC of 27 June 1967 relating
the
classification, packaging and labelling of dangerous
substances (15),
by Directive
1999/33/EC (16). Drawing largely on the same data as
IARC, agreement was reached during the elaboration of
Commission Directive 94/69/EC (17) the 21st adaptation
to technical progress, according to which creosote and
some other coal tar distillates are classified as category 2
carcinogens and must be labelled with the risk phrase R
45 (cid:145)May cause cancer(cid:146). However, the classification as a
carcinogen need not apply if it can be shown that the
substance contains less than 0,005 % (= 50 ppm) per
weight B[a]P (18). This
from the IARC
classification, which applies without any specification of
the B[a]P content.

is different

for

purposes

classification

(48) The choice of a limit of 50 ppm to the concentration of
B[a]P
in Community
legislation in order to distinguish carcinogenic from
non-carcinogenic coal tar distillates has been accepted
by the Member States
in the working group for
adaptation of Directive 67/548/EEC to technical
progress only on the basis of a joint declaration by the
Commission and the Member States. The declaration
states that the situation would be reviewed when the
results of the above mentioned scientific study by the
Fraunhofer
institute, which had been initiated by
industry in collaboration with the IARC and was in
progress at
to be
recognised that in 1994, there were no experimental
data available to prove whether creosote containing less
than 50 ppm B[a]P was carcinogenic or not. This
situation has changed and the results of the Fraunhofer
study will be presented further down.

time were known.

It has

that

through the

(49) Little is known about the toxicokinetics of creosote in
humans or experimental animals. Only very recent
studies have investigated quantitative absorption of
PAHs
excreted
metabolites of pyrene (19): absorption appears to vary
between individuals and between different sites within
the same individual. In a separate study (20), the dermal
absorption of different PAH compounds was measured.
PAHs of higher molecular weight than pyrene, e.g. B[a]P

skin by measuring

(15) OJ 196, 16.8.1967, p. 1..
(16) OJ L 199, 30.7.1999, p. 57.
(17) OJ L 381, 31.12.1994, p. 1.
(18) Nota M of

the foreword to Annex I

to Council Directive
67/548/EEC is applicable to creosote. Van Rooij
J.G.M., et al.,
Absorption of Polycyclic Aromatic Hydrocarbons Through Human
Skin: differences between Anatomical Sites and Individuals, J. Tox.
Environ. Health, 38, 1993, p. 355.

(19) Van Rooij

J. G. M., et. al., Absorption of Polycyclic Aromatic
between
Skin: Differences
J. Tox. Environ. Health, 38,

Hydrocarbons Through Human
Anatomical Sites and Individuals,
1993, p. 355.

(20) Van Rooij

J. G. M., Dermal Exposure to Polycyclic Aromatic
ISBN 90-9007080-X,

Hydrocarbons Among Workers, Thesis
Nijmwegen 1993.

were absorbed less rapidly. Any estimation of B[a]P
therefore
uptake based upon the pyrene marker will
result
in an overestimation and can be considered
conservative.

(50)

It has to be noted that all effects observed in animal
experiments or
in
in epidemiological
humans are based on high level chronic exposures. No
reports have been found in the literature of examples of
cancer of the skin (or any other sites) which could be
attributed to exposure to creosote in a non-occupational
environmental context.

investigations

(51) Exposure of consumers can occur during the use of
preparations containing creosote (or carbolineum)
for
wood preservation by brush application (dermal and
inhalatory) or through the use of treated wood (e.g.
adults during the construction of
fences or other
wooden structures for private use, children playing on
structures made of treated wood). No measured data are
available concerning the exposure of consumers
to
creosote, either directly through use of the product, or
indirectly through contact with wood treated with
creosote. Various models and calculations of exposure
have been developed in the studies and will be discussed
later.

Environment effects:

facilities often being the source of

(52) Environmental contamination by creosote has been
reported in a number of countries, with old wood
treatment
the
contamination. In fact, most information on the fate of
creosote in the environment has been obtained from
industrial creosote spills and from cantamination left
from disused
Environmental
contamination has been traced by an analysis of selected
PAH compounds, notably B[a]P.

creosote

plants.

(53) Creosote is toxic to certain organisms in the soil and
highly toxic against aquatic organisms (with 96h LC-50
values often below 1 mg/l). Many of its components are
bioaccumulating.

(54) The main characteristics of PAHs in the environment

are:

(cid:151) PAHs bind strongly to soil organic matter.

(cid:151) The rate of degradation of PAHs in soil and other
environmental
slow.
compartments
Creosote residues can persist for many years in the
environment (> 20 to 30 years).

usually

is

22.12.1999

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Official Journal of the European Communities

L 329/33

(cid:151) The

main

processes

breakdown

are
photodegradation (i.e. under irradiation from the
sun) and microbial degradation (i.e. by certain
bacteria). Microbial degradation can occur under
aerobic and anaerobic conditions. PAHs compounds
with four rings and more may be poorly degradable.

creosote leaching from waterbank protection has been
documented in the Netherlands (23) and also in studies
on pollution from former impregnation facilities.

(cid:151) PAHs reaching watercourses are rapidly transferred

to sediment.

(58) As for human exposure, actually measured data an
in

pollution by

originating

PAHs

environmental
creosote are scarce.

are

removed

primarily

(cid:151) In watercourses, most of the lower molecular weight
by microbial
PAHs
degradation and the higher molecular weight
compounds by photooxidation and sedimentation.
the more water-soluble
Microbial degradation of
PAHs
anaerobic
conditions. The PAH constituents have been shown
to bioaccumulate in aquatic species.

aerobic

occurs

under

and

(55) Emissions of PAHs to air, water and soil can occur
during the impregnation process and storage at
the
impregnation site, as well as during use of treated wood.
However PAHs found in the various environmental
compartments originate from a variety of sources (e.g.
all combustion processes,
is often
difficult to ascribe their levels to any particular source
such as creosote-treated wood.

traffic etc.) and it

(56) A study (21) in Sweden has shown that after 40 years in
soil, creosote impregnated poles had lost a part of the
compounds contained in creosote, especially those with
the lowest boiling point (< 270 (cid:176)C). The part of the poles
above the ground lost
the larger amount. However,
mobility of the leached compounds was very low as
they could only be detected in the soil in close contact
with the poles. This is coherent with the observation
that the mobility of PAHs in soil is extremely low due
to their strong absorption to organic matter.

creosote-treated wood. Migration

(57) The presence of elevated levels of PAH in aquatic
environments has often been attributed to the presence
creosote
of
components from treated wool into water is higher into
fresh water than into seawater and has been proven in
many studies. Migration seems to be more limited in
seawater; in one study, after 10 years in the sea, marine
pilings retained 93 % of
the original composition of
creosote compounds (22). The pollution of sediments by

of

(21) S. Holmroos,

(cid:145)Analys av kreosotstolpar i Slml(cid:229)ngsdalen efter 40
f(cid:228)lt(cid:146). Rapport nr. M205-252.092. ˜lvkarleby:

(cid:229)rs exponering i
Vattenfall Utveckling. 1994.

(22) L. L. Ingram et. al.,

(cid:145)Migration of Creosote and Its Components
from Treated Piling Sections in a Marine Environment(cid:146), Proc. Ann.
Meet. Am. Wood Preserv. Assoc. 78, 1982, p. 120. See also
footnotes 8 and 13.

3.1.2. The positions of The Netherlands

(59)

In the Netherlands, a vigorous policy is
in place
regarding PAH. In 1993, the Dutch Parliament adopted
limit values and target values for individual PAH, related
to a maximum permissible concentration (MPC). PAH
concentrations have repeatedly exceeded the MPC in
certain environmental compartments. As a consequence,
considerable emission reductions are required by the
National Environment Policy Plan 2. All sources for
PAH containing coatings, coal tar varnish, cable burning
plants,
industry,
chemical industry, wood-burning stoves and traffic.

sewerages, basic metal

refineries,

be

for

the

Policy

following

(60) A number of measures in the form of agreements
between the government and various sectors have or
will
Statement
taken
Environmental Objectives
the Building Industry
1995 (BMB 1995). The SIVEB decision forms part of a
this strict general policy of the Netherlands aiming at a
strong reduction of emissions of PAH from all sources.
Reduction of emissions from creosoted wood during its
production, use, and destruction after use plays an
important part in these measures. The major goal is the
reduction of the application of creosoted wood where
alternatives are available.

S p e c i a l s i t u a t i o n i n t h e N e t h e r l a n d s

(61)

In Europe a total of 1 million m3 of creosoted wood
was used in 1990. Table 2 gives an overview of the
consumption of creosoted wood in Europe.

(23) See footnote 8.

L 329/34

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Official Journal of the European Communities

22.12.1999

Table 2

Consumption of creosoted wood in Europe (1990) (24)

Country

Annual use 1990
(m3/y)

Annual use/capita
(10ﬂ3 m3/cap.y)

Annual use/km2
(m3/km2y)

Germany

Netherlands

Spain

Italy

United Kingdom

Sweden

France

Belgium

Norway

Ireland

Finland

Denmark

Europe

150 000

100 000

93 000

74 000

65 000

57 000

45 000

26 000

20 000

20 000

13 000

5 000

1 000 000

2,3

6,7

2,4

1,3

1,1

7,1

0,8

2,6

5,0

5,0

2,6

1,0

2,0

0,4

2,9

0,2

0,3

0,3

0,1

0,08

0,8

0,06

0,3

0,04

0,1

0,2

(62)

is

the

after

Sweden,

second highest

In absolute figures, the Netherlands is the second largest
user of creosoted wood after Germany. The use per
capita
the
consumption per km2 is by far the highest
in the
Netherlands and amounts to 15 times the European
average. The Netherlands is a water-abundant country,
almost 15 % of the surface consists of lakes, rivers canals
is due to the specific
and other waterways. This
geographic situation of the Netherlands being located in
the delta of three large rivers: the Rhine, the Meuse, and
the Scheldt.

are

areas, most banks
constructions.

(65) To prevent caving in of the banks of the waterways in
supplied with
the polder
Approximately
bank-protective
are protected with
10 000 kilometres of banks
creosoted timber. Due to this necessity,
leaching from
creosoted wood is one of the major sources of pollution
of the aquatic envrionment with PAH, such as B[a]P.
Allowing for higher B[a]P contents in creosote (up to
500 ppm instead of 50 ppm) would strongly increase
emissions.

(63) From the Middle Ages onward, areas subject to flooding
by the sea and the rivers have been protected by the
In order to adapt the land for
construction of dikes.
habitation and agriculture, the polder system has been
developed: the dike protected areas of land are drained
by a finely distributed network of artificial water
courses. The water so collected is pumped into the
rivers and the sea. At present, almost half the surface of
the Netherlands consist of polders, the larger part of
which is below sea level.

(66) The solubility of PAH including B[a]P in water in very
limited; however, water serves as a transport medium
In slowly
prior to absorption to suspended particles.
flowing waterways these particles tend to settle down, a
process reinforced by high salt concentrations. Both
effects are present in the Dutch polder regions leading
thus
PAH contaminated
sediments. The degradation of accumulated PAH in the
sediments
is poor due to the prevailing anaerobic
conditions.

to an accumulation of

(64) The Netherlands is the most densely populated country
the population
in Europe. Moreover, almost 75 % of
lives or works
areas. The high
in the polder
concentration of population, as well as the extensive
industrialisation and agriculture have made the polder
areas very sensitive to environmental pollution.

(24) Source: See footnote 8.

(67) Sediments polluted with PAH influence the functioning
of the aquatic ecosystem. The presence of B[a]P in the
sediment of Dutch coastal areas shows a correlation
with the occurrence of
liver of
flounders. Earlier species in the food chain also have
shown to suffer from sediment contamination. Polluted
sediments may cause risks to man in case of fishing,
recreation and drinking water supply. A specific danger

tumours

in the

22.12.1999

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L 329/35

occurs in the case of large scale flooding, where parts of
the sediment can be distributed over vast areas of land
used for agricultural purposes.

(68) As part of the general policy for the protection of the
environment, a tolerable limiting value of 0,05 mg
B[a]P/kg dry mass of sediment has been established by
the Dutch Parliament.

(69) A survey made in 1990 classified sediment samples in
four classes, delimited by their B[a]P content. Only
sediments in class 1 comply with the limiting value.
Results of the survey are show in Table 3.

(73)

quantities). These imports form other countries as well
as the pollution by shipping (and/or traffic) are limited
to the main waterways (= governmental waters in the
Dutch terminology). No upward flow of sediment into
regional waters occurs. Thus
the main source of
sediment contamination in the biggest part of the Dutch
waterways (regional waters) appears to be leaching from
bank protection with creosoted wood.

(1993),

investigations

It has been confirmed by several
in
different parts of the Netherlands (Fleverwaard (1992),
Noordoostpolder
Haarlemmermeerpolder
islands and Wadden Sea (1991), Walcheren
(1989),
(1993), Groenendalse Wetering (1995)) that about 80 %
of the PAH present in sediments originates form bank
protection with creosoted wood (for both newly
installed protection and treated wood that had been in
place for several years).

Table 3

Quality of waterbed sediment (1990) (25)

Class

Regional waters

Governmental
waters

1: < 0,05 mg B[a]P/kg dry

mass

2: 0,05 to 0,8 mg/kg

3: 0,8 to 3 mg/kg

4: > 3 mg/kg

14 %

50 %

26 %

10 %

22 %

24 %

35 %

10 %

class 1:

permitted to be distributed as such over land
and water

class 2:

permitted to be distributed if no threat to the
ecosystem exists

class 3:

deposition of
undesired

sludge on adjoining land

class 4:

investigation into decontamination necessary

(70) A survey in 1993, consisting of more than 10 000
samples of newly formed sediment, showed that in 95 %
(90 % in regional waters) of the samples the limiting
value had been exceeded.

correlation between sediment
(74) A clear quantitative
contamination by
PAH and bank protection by
creosoted wood has been established by the Fleverwaard
water board which has examined the sediment layers of
two waterways. One year after placing the new bank
protection the sediment was classified in class 2; two
years after placing it was already in class 3. The main
classification criterion is the content of 3 PAHs: pyrene,
fluoroanthene and phenanthrene. Also however B[a]P
concentrations alone, amounting to a maximum of 0,5
to 2,3 mg/kg (in dry sediment),
largely exceeded the
limit value of 0,5 mg/kg (in dry sediment).

(75) The investigation reveals

and

bank

protection

the PAH leach out
are

from
creosoted
subsequently
deposited into the sediment, resulting in an increase of
the total PAH concentration by more than a factor of
six. A further study in the Groenendalse Wetering has
noted an increase of
the B[a]P concentration in the
sediment after the installation of a bank protection of
by creosoted wood from 0,10 to 0,25 mg/kg within a
period of half a year.

(71) Apparently the situation has not improved in recent
years, and it seems that the overwhelming majority of
sediments in Dutch waterways is contaminates by B[a]P
to an extent beyond the acceptable standards.

(76)

In view of these results, the Dutch State Council has
introduced an additional
restriction on the use of
creosoted wood for bank protection: a licence under the
Surface Water Act is now necessary before creosoted
wood can be used.

(72) Several investigations estimate the total B[a]P emissions
in the Netherlands
approximately
100 kg/year. Additionally, the rivers flowing into the
Netherlands carry more than 1 800 of B[a]P (which
the nationally emitted
would be about 18 times

into water

as

(25) Source: See footnote 8.

(77) The

study provided by bkh consulting engineers
acknowledges that nowhere in the Netherlands the limit
(1 ng/m3
value determined by the Dutch Parliament
annually averaged concentration) has been exceeded at
the monitoring stations of the national air monitoring
net.

L 329/36

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Official Journal of the European Communities

22.12.1999

(78) About 36 % (825 tonnes out of 2 300) of

the air
pollution by PAH is due to the use of creosote for the
conservation of wood. Total emissions to air of B[a]P
from creosoted wood during its phase of use are
calculated as 212 kg per year (see Table 4).

Table 4

Annual emission of B[a]P from creosoted wood in use in
the Netherlands (26)

Source

Soil
(kg/year)

Air
(kg/year)

Water
(kg/year)

Railways

Waterway engineering

Fruit growing industry

Agriculture

Other fencing

55

166

13

15

24

110

33

26

30

47

(cid:151)

133

(cid:151)

(cid:151)

(cid:151)

Total

256

212

133

(79) Emissions of B[a]P from carbolineum are estimated at
50 kg/year. Additionally, national emissions of B[a]P
into air from creosoted wood during the creosoting
process and strorage amounts to 100(cid:151)150 kg/year.

(80) The

claims
plants

that neighbouring residents
have

to
study
odour
complained
creosoting
nuisance
and irritated mucous membranes. Here,
emissions can occur during the treatment process and
especially during the storage period of
the newly
impregnated wood. However, only very limited data is
available on PAH or B[a]P measured in air in the
vicinity of creosoting plants.

about

3.1.3. Evaluation of the position of the Netherlands

(81) From the foregoing the conclusion can be drawn that
in the Netherlands,
there are specific requirements
resulting form a high use of creosote-treated wood and
the resulting contamination of
in Dutch
waterways,
that justify the ban on the use of wood
treated with creosote containing B[a]P in the range of
specific
50 to 500 ppm and the requirement of
preservation techniques that
reduce leaching out of
creosote from treated wood.

sediments

(26) Source: See footnote 8.

3.1.4. Human Health Risks

(82) Before commenting on the actual evaluations it has to
be noted that none of these problems are specific to the
Netherlands, and that all of
them would apply in a
similar manner to other Member States.

( a ) T h e p o s i t i o n o f t h e N e t h e r l a n d s

In fact,

(83) A major part of the Dutch study is concerned with the
problem of risk assessments for the exposure of human
individuals to B[a]P.
it is this risk evaluation
which is presented as the justification for those Dutch
provisions that prohibit the use of creosoted wood for
the B[a]P content remains
certain purposes even if
below 50 ppm. Furthermore, the evaluation is supposed
to give further support to the Dutch position that a
B[a]P content of creosote > 50 ppm is not acceptable in
any case.

(84) Risk evaluation has been performed on three groups of

the population:

(cid:151) employees in creosote plants

(cid:151) neighbouring inhabitants of creosoting plants

(cid:151) children playing on equipment made of creosoted

wood.

For

inhalation,

concentrations, originating
these have

(85) The risk evaluation on employees of creosoting plants
has been calculated on the basis of their exposure to
form
measured pyrene
simply been
creosote.
transformed for B[a]P on the assumption that
the
concentration of B[a]P and pyrene in air are in the same
proportion as in liquid creosote. Results indicated that
dermal exposure was below effect limit (= maximum
concentration deemed acceptable in the Netherlands) for
creosote containing B[a]P < 50 ppm and above effect
limit for B[a]P content of 500 ppm. Inhalatory exposure
was always found to be below effect limit, for B[a]P
concentrations based on estimated and measured data.
The study made for the Commission supports the Dutch
results for dermal exposure. For the inhalatory exposure
it states that the Dutch assumptions are reflecting a
should also be noted that
worst-case scenario.

It

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L 329/37

regulation of occupational exposure is not an objective
of Directive 94/60/EC and is dealt with in other
Community and national legislation (27).

(89) On the basis of these assessments, the Dutch authorities
the protection of human
in general
is

tried to demonstrate that
health guaranteed by the Directive
insufficient.

(86) The

exposure of neighbouring residents has been
calculated completely on the basis of estimated emission
data from creosoting plants. No real data were available.
It resulted in the highly theoretical approach that both,
dermal and inhalatory exposure,
lead to unacceptable
risks for creosote containing up to 500 ppm B[a]P and
acceptable risks for creosote with B[a]P < 50 ppm.

( b ) E v a l u a t i o n o f t h e S c i e n t i f i c C o m m i t t e e
f o r T o x i c i t y , E c o t o x i c i t y , a n d t h e
E n v i r o n m e n t

(87) The risk evaluation on children playing on creosoted
wood showed that oral exposure was below effect limit.
As no data were available for dermal exposure, it was
calculated based on exposure of hands and forearms of
employees
in assembly plants working with wood
treated by creosote 50 ppm of B[a]P. The calculated
the study
exposure was above effect
made for the Commission points out an error in the
Dutch calculations;
for calculated
the correct
exposure would be one order of magnitude lower and,
therefore, would be rather close to the effect limit.

limit. However,

result

(88) Table 5 gives a summary of
assessments undertaken:

the results of

the risk

Table 5

Results of risk evaluation performed (28)

Group

Type of
exposure-

B[a]P content of
creosote (ppm)

Risk unac-
ceptable

Employees

Skin

Inhalation

Neighbours

Inhalation

Ingestion

Children

Ingestion

Skin

500
50

500
50

500
50

500
50

50

50

Yes
No

No
No

Yes
No

Yes
No

No

Yes (?)

(27) Council Directive 89/391/EEC on the introduction of measures to
encourage improvements in the safety and health of workers at
work (OJ L 183, 29.6.1989, p. 1). Council Directive 90/394/EEC
on the protection of workers from risks related to exposure to
carcinogens at work (OJ L 196, 21.6.1990, p. 1).

to

progress

technical

(90) During the elaboration of Directive 94/60/EC, the 21st
adaptation
of Directive
67/548/EEC, a B[a]P content of 50 ppm had been
accepted as safe by the Member States. However, as was
already mentioned, the Commission and the Member
States agreed in a joint declaration to review the
the study
situation in the light of
concerning the carcinogenic properties of coal
tar
distillates currently undertaken on initiative of industry
and in collaboration with the IARC.

the results of

the

sponsoring

(91) This study (29) had been scheduled to be completed in
December 1996.
It was finally made available to the
Commission in January 1998. The study tested the
carcinogenic effects of two creosote products provided
by
(R(cid:252)ttgers-VfT AG,
company
Germany) containing 10 and 275 ppm B[a]P. Due to
the high viscosity of the products, they could not be
applied directly to the skin of the mice but had to be
diluted in Toluene. Solutions with various concentration
of the product and thus various B[a]P concentrations, as
well as pure B[a]P solutions and a control of pure
Toluene were applied to groups of 62 mice for a time
of 78 weeks (two times per week, 25 (cid:181)l). Development
of tumours was observed during this time and the test
animals were carefully examined after termination of the
study.

and

scientific

containing

(92) The Commission submitted this study and all other
documents
exposure
information on creosote to the Scientific Committee for
Toxicity, Ecotoxity and the Environment. The SCTEE
there was sufficient
was asked to evaluate whether
scientific evidence to support the opinion that there is a
cancer risk to consumers from creosote containing less
than 50 ppm B[a]P and/or from wood treated with such
creosote, and if such a risk exists, whether its magnitude
can be estimated or quantified. The SCTEE adopted its
opinion on 27 November 1998.

(93) The SCTEE observes

study is
well-designed and reaffirms the carcinogenic potential of
coal tar preparations. Due to the genotoxic potential of

the Fraunhofer

that

(28) Source: See footnote 8.

(29) See footnote 11.

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22.12.1999

is

of

no

the

there

B[a]P,

including

PAHs
threshold
concentration determining carcinogenicity. The study
indicates clearly a linear dose-response relationship
between the B[a]P
administered
content
preparations and the number of animals developing
tumours. Both preparations have a five-fold higher
than pure B[a]P,
potency to induce skin tumours
presumably
other
the
carcinogenic substances in creosote. It can be inferred
from the study that creosote containing 50 ppm B[a]P
would induce a significant incidence of skin cancer in
mice.

the presence

due

to

of

for

study

insufficient.

skin-painting
are

human
Extrapolating

(94) Data to fully evaluate the relevance of effects seen in a
exposure
mouse
situations
skin
carcinogenicity data from mice to the human situation
also entails a number of uncertainties
leading to
difficulties in directly using cancer potency data from
mice to assess cancer risk in humans. Species-dependent
sensitivity of dermal exposure to the carcinogenic
actions of creosote will be affected by morphology and
physiology of
the skin, by metabolic activation and
inactivation in the skin and by repair processes. On the
the available information; a scientifically
basis of all
justified assessment of carcinogenic risk, e.g.
for the
dermal exposure of children playing an wood treated
with creosote is therefore difficult.

(95) From the data contained in the Fraunhofer study, the
SCTEE calculated a T25 carcinogenic potency value for
pure B[a]P of 13 (cid:181)g/kg bw/day. The T25 is the chronic
daily dose kg bodyweight (bw), which give 25 % of the
test animals tumours at a specific tissue site within the
standard life
creosote
that
formulations
five-fold higher overall
carcinogenic potency (2,7 (cid:181)g/kg bw/day).

span of
tested had a

species. The

to the

and scenarios.

(96) The SCTEE did not have measured data at its disposal
the public to creosote.
regarding the exposure of
Various values have been calculated in the studies made
different models,
SCTEE, using
available
assumptions
critical
the most
For
children playing on wood treated with
exposure,
creosote containing 50 ppm B[a]P, the Dutch authorities
have arrived at an exposure of two ng B[a]P per kg
bw/day (playtime of three hours per day). One of the
studies mandated by the Commission, in using a slightly
different methodology arrives at exposure doses of
0,85 ng/kg bw/day (playtime of two hours per day) and
1,7 ng/kg bw/day (playtime of four hours per day).

(97) Should the value of exposure estimates for the scenario
of children playing on creosote treated wood (two ng
B[a]P per kg bw/day) approximate the true exposure,
this would result in a life-time cancer risk of 1,92 (cid:215) 10ﬂ4

for a life-long daily exposure, which would give clear
concern, 2,74 (cid:215) 10ﬂ5 for a daily exposure during 10
years out of 70 and 1,37 (cid:215) 10ﬂ5 for a daily exposure
during five years out of 70. Using the exposure doses
calculated in the other study would change the risk
proportionately.

(98) Based on the most recent study with regards to the
dose-response relation for dermal carcinogenicity of
creosote, as derived by the SCTEE, and depending on
the exposure model selected, the risk is therefore slightly
or more clearly above a value of 1 (cid:215) 10ﬂ5 , which is
for genotoxic
proposed as an acceptable risk level
carcinogens in drinking water by the World Health
Organisation.

(99) However,

to

there

SCTEE,

are many uncertainties
the

regarding
exposure. According
the Dutch
calculation is on the one hand an over-estimation (due
to an exaggerated exposure model), on the other hand
an under-estimation (due to the fact that the five fold
higher potency of creosote in comparison to B[a]P was
not taken into account). As the SCTEE has taken the
latter into account, the result could be an over-estimate
as the exaggerated risk model is used.

(100) Also, the SCTEE mentions that the figure of two ng
B[a]P per kg bw/day as a worst-case exposure to B[a]P
from playing on creosoted-treated wood has to be
compared to estimates for intake of B[a]P via food.
Annual intakes of B[a]P from food have been estimated
to be in the order of 0,3 to 1,6 mg, which would result
in daily exposures of 12 to 63 ng/kg bw for a person
weighing 70 kg and are thus clearly higher than the
doses received form playing an creosote-treated wood.

(101) Overall the SCTEE concludes:

1. (cid:151) Given the

and the
genotoxicity of B[a]P
outcome of the Fraunhofer skin-painting study,
there is sufficient scientific evidence to support
the opinion that
risk to
consumers from creosote containing less than
50 ppm B[a]P and/or from wood treated with
such creosote.

there is a cancer

(cid:151) B[a]P is a good indicator for the carcinogenic
hazard of the creosote preparation tested, since
there was a linear relationship betweeen cancer
incidence and B[a]P dose. However, the cancer
potency
creosote preparation was
five-fold higher
than judged from its B[a]P
content.

the

of

22.12.1999

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Official Journal of the European Communities

L 329/39

the

into

account

2. (cid:151) On the basis of the available information, even
considerable
taking
uncertainties in assessing the risks for children
coming into contact with creosote-treated wood,
the magnitude of the risk gives clear reason for
estimated
the
concern. However,
exposure is some 6 to 30 times lower than the
oral exposure of the adult population to B[a]P in
food.

highest

(cid:151) In order to get a better estimate of the exposure
situation, one would have to perform a real-life,
mass-balance study in exposed children.
In
addition to being very complicated and resource
intensive, to conduct such a study would raise
ethical questions.

3.1.5. Overall Evaluation

(102) The Dutch authorities have demonstrated that

the
specific geographic situation of the Netherlands, which
necessitates extensive bank protection of watercourses,
has lead to the highest consumption of creosote-treated
wood per surface in the European Union. Leaching of
components form creosote into the watercourses has
caused the pollution of the major part of sediments
limits.
with PAH compounds
the
Measures aiming at an enhanced reduction of
leaching
aquatic
environment are therefore justified in the Netherlands.

compounds

acceptable

beyond

these

into

the

of

has

the Commission

(103) With regards to the risks posed by creosote to human
health,
additional
information in the framework of similar requests from
Germany, Sweden and Denmark for derogation from
Directive 94/60/EC under the former Article 100a(4) of
the EC Treaty, and new scientific evidence through an
extensive study carried out after the adoption of the
Community Directive.

received

(104) Based on these most

recent experimental data,

the
SCTEE has estimated that
there is a cancer risk to
humans from creosote containing less than 50 ppm
B[a]P and wood treated which such creosote,
the
magnitude of which cannot be estimated with certainty.
Taking into consideration the uncertainties concerning
exposure,
that measures
aiming at reducing the probability of prolonged dermal
exposure to creosote, either through direct contact with
creosote or wood treated with creosote, are justified in
the light of the precautionary principle.

the Commission considers

(105) The legislation notified to the Commission by the Dutch
authorities takes account of
the general principle of
proportionality, i.e. the measures do not seem to exceed
the
what suitable and necessary for the pursuit of

legitimate objective, as this legislation provides for the
possibility to use creosote-containing products, when
compatible with the needs for the protection of health
and the environment.

(106)

In

addition,

regarding

the Treaty,

In accordance with Article 95(7) of
the
Commission is already examining the appropriateness to
adapt to technical progress the provision of Directive
94/60/EC
the
creosote.
Commission will evaluate the use of creosote under the
review programme
in Article 16 of
established
European Parliament and Council Directive 98/8/EC of
16 February 1998 on the placing of biocidal products
on the market (30) in a time-frame compatible with the
general timing of the review programme and taking into
account other possible priorities
identified when
effectively setting up the programme. Furthermore, an
ongoing research project under the Fourth Framework
Programme of research and technological development
is reviewing the production chain and in-service life of
poles treated with creosote (31).

3.2. Absence of arbitrary discrimination

(107) Article 95(6) obliges the Commission to verify that the
national provisions are not a means of arbitrary
discrimination. According to the ruling of Court of
the absence of discrimination means that no
Justice,
different treatment should be given to similar situations,
nor similar treatment to different situations.

of

use

creosote

imported

(108) The maximum content of 50 ppm of B[a]P by mass for
the
for
carbolineum and
wood-protection provided for by the Dutch regulations
(Controlled Substances Act and SIVEB Decision) applies
without distinction to all products, whether they are
manufactured in the Netherlands or imported (treated
the
according
wood may
be
from other
the Dutch authorities)
communication of
Member States. Regarding the approval
system for
individual
licences, setting even stricter conditions for
the use of carbolineum and creosote, this cannot by
nature amount
to arbitrary discrimination since the
conditions are imposed only on manufacturing uses in
the Netherlands. Therfore, there is no evidence that the
Dutch regulations have been used as a means of
arbitrary discrimination between economic operators in
the Community.

to

(30) OJ L 123, 24.4.1998, p. 1.
(31) Research

Contract

Programme for RTD)
production of creosoted utility poles(cid:146).

FAIR5-CT98-3933
Framework
(cid:145)Integrating the processes involved in the

(Fourth

L 329/40

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Official Journal of the European Communities

22.12.1999

3.3. The absence of a disguised restriction on trade

seems to be the real goal of maintaining the national
legislation, and not the creation of disguised barriers to
trade.

(109) More restrictive national measures

in the area of
limitations of marketing and use of products derogating
form the provisions of a Community Directive do
normally constitute a barrier to trade. Products that can
be legally placed on the market
the
Community, cannot be placed on the market in the
Member States concerned. The concept enshrined in
Article 95(6),
the restrictions
is intended to present
based on the criteria of paragraph 4 being applied for
inappropriate
constituting
economic measures introduced to impede the import of
products from other Member States in order to protect
indirectly national production.

and in reality

in the rest of

reasons,

(110) The Commission mandated a study (32) to analyse the
effects on trade and competition of the retention by the
Netherlands of its stricter national provisions. The study
by TIS undertook to collect information on the annual
quantities of creosote used wood preservation and
treated wood production in the Member States,
the
historical development and on how these will change if
the Netherlands were to retain its own legislation in
place of Directive 94/60/EC. To this end, questionnaires
were prepared and distributed to creosote producers,
creosote traders and wood impregnators within the EC.

(111) According to the study,

there is one producer of
creosote in the Netherlands. About three quarters of the
is exported, whereas
total production (5 200 t/year)
about 3 400 t/year
from
(mostly
Germany). Most of
the producers in other Member
States can comply with the Dutch regulations and those
who
business with the
Netherlands in the past.

cannot, have not had

imported

are

(112) As far as possible substitutes to creosote are concerned,
there is no information indicating that the Netherlands
has national economic interests in their development,
production or export.

(113)

It was established before that there is a real concern
with regards to human health related to the use of
creosote and treated timber, and with regards to the
environment due
the
Netherlands. Furthermore the national provisions on
creosote are a part of a more general policy on PAHs.
Therefore, the protection of health and the environment

situation of

specific

to the

(114) Overall, the Commission considers therefore that there
is no evidence of a disguised restriction on trade
between Member States provoked by
the Dutch
legislation concerning creosote.

3.4. The absence of obstacles to the functioning of the

Internal Market

(115) This condition, which is established by Article 95(6),
first subparagraph, is new in comparison to the text of
the EC Treaty. This
the former Article 100a(4) of
condition cannot be interpreted in such a way that it
prohibits the approval of any national measure likely to
affect the establishment of the internal market. In fact,
any national measure derogating from a harmonisation
measure aiming at the establishment and operation of
the internal market, constitutes in substance a measure
that is likely to affect the internal market. Consequently,
to preserve the useful character of the procedure for
derogation provided for by Article 95 of the EC Treaty,
the Commission considers that,
in the context of the
Article 95(6), the concept of obstacle to the functioning
the internal market has to be understood as a
of
disproportionate
in relation to the pursued
objective.

effect

(116) According to a study by ERM (33),

the European
creosote-production industry is characterised by the
following features:

(cid:151) creosote is produced as a by-product, not primary

product

(cid:151) production exceeds consumption to a significant

degree

(cid:151) there are a small number of creosote producers

(cid:151) there is a decline in demand

(117) Because of this situation, suppliers are generally willing
the product specifications required by their

to meet
customers (if they can do so technically).

(118) Producers of creosote are located in Germany, Austria,
Belgium, Denmark, France, the Netherlands, Italy, Spain
and the United Kingdom. 90 % of creosote is used for
impregnation of wood by professional
the industrial

(32) W. D. Betts, Study of the Effects on Trade and Competition of the
Retention by The Netherlands of its National Rules in Place of the
Rules to be Established by Directive 94/60/EC. Tar Industries
Services, Chesterfield (UK), December 1995.

(33) Environmental Resources Management, Trade and Competition
Assessment of the German and Danish Request for Derogations
on the Marketing and Use of Creosote, Final Report, June 1996.

22.12.1999

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Official Journal of the European Communities

L 329/41

wood preservation companies. The remaining 10 % of
creosote are used by individual consumers, mostly in
the United Kingdom and Ireland.

concentration of

detailed specifications in relation to boiling curves end
in the
specific
the
creosote. Most, but not all, of
the producers can
produce creosote containing less than 50 ppm B[a]P.

components

(119) Professional impregnators primarily treat timber for use
as telecommunications and power poles and railway
sleepers. The composition of creosote varies according
to the coal tar feedstock used, the production method
employed and the requirements of the customer. In fact,
most of the large-scale users have developed their own

(120) The following Table 6 gives a survey of the situation
with regards to producers of creosote, their geographic
location, whether they can produce creosote with B[a]P
content < 50 ppm and whether they have had trade
with the Netherlands.

Table 6

Production, sales and trade in creosote in Europe (34)

Country

No of
producers

Possibility of
producing creosote
with B[a]P < 50 ppm

Sales of creosote
(tonnes/year) 1995

Trade with
the Netherlands

Austria

Belgium

Denmark

France

Germany

Netherlands

Spain

United Kingdom

Italy

Greece

Ireland

Sweden

Finland

1

1

1

1

1

1

2

2

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

No

Yes

Yes

Yes

Yes

Yes

Yes/No

Yes

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

3 900

0

6 750

5 000

5 000

13 950

20 000

11 100

6 700

3 000

6 000

5 000

No

No

No

No

Yes

(cid:151)

No

No

No

No

No

No

No

the national production of

(121) According to the study by TIS (35) about three-quarters
is
of
is imported.
exported and about
come mostly from
Imports
Germany and concern with a B[a]P content, which
already complies with the Dutch regulations. Creosote
producers in several other Member States could comply
with the Dutch requirements.

into the Netherlands

the same amount

the Netherlands

Netherlands has decreased steadily (36) from 120 000 m3
in 1985 to around 78 000 m3 in 1992 and was
expected to decrease to 60 000 m3 in 1995. This trend
the
seems thus to have started before adoption of
national legislation.

(122) Creosote-treated wood in the Netherlands is mainly used
in the railway industry (sleepers), hydraulic engineering
(protection of waterbanks), agriculture (fencing) and the
trees). The
fruit-growing industry (support of
the
consumption

creosote-treated wood

fruit

of

in

(123) There are three creosote treatment

facilities

in the
Netherlands. The national production of treated round
wood and sawn timber has decreased by 40 % between
1990 and 1995 (to about 23 000 m3), and the
production of treated railway sleepers by about 50 % to
10 000 m3. The amounts of
treated wood used are
about twice as high. As part of the treated wood is
exported, the Netherlands are also a net importer of
treated wood, also with decreasing tendency. Both these
trends had already started before the adoption of the

(34) Sources: See footnotes 32 and 33.
(35) See footnote 32.

(36) See footnote 8.

L 329/42

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Official Journal of the European Communities

22.12.1999

national
have
Directive 94/60/EC being in place.

legislative

and

continued without

Article 100a(4) and examined under Article 95(4) and
(6) of the EC Treaty:

(124) The amount of creosote produced and exported has
grown steadily over the years from 1990 to 1995,
whereas the amount of creosote imported and used has
decreased. However, the creosote, which is exported by
the Dutch producer, does in general meet the stricter
requirements of the Dutch legislation.

(125) Some producers have expressed their concern about the
possibility that creosote produced in the Netherlands
containing more than 50 and less than 500 ppm B[a]P
could be sold in other Member States at a price not
reflecting the true costs as the Dutch producer could
not market it legally in the Netherlands and would seek
to avoid disposal costs. However, there seems to have
been only one case which supports this assumption
from the
where a consignment of 1 000 tonnes
Netherlands
of
complying with
Directive 94/60/EC was sold at a lower price than that
of the traditional suppliers. This seems to have been a
singular event and does not provide sufficient evidence
for the presumption that the internal market would be
distorted if
the Dutch regulations were approved, as
normally the exported creosote also conforms to the
stricter national requirements.

requirement

the

(126) Taking into account

the preceding observations,

the
Commission considers that there is no evidence that the
Dutch provisions subject to this Decision do constitute
a disproportionate obstacle to the functioning of the
internal market in relation to the pursued objectives.

(cid:151) fulfil the formal requirements of the said provisions

and are to be admitted,

(cid:151) can be considered justified on grounds of major
need of protection of human health and, due to a
specific situation, on grounds of major need of
protection of the environment,

(cid:151) do not constitute either a means of arbitrary
disguised restriction on trade between Member
States, or
to the
functioning of the internal market.

a disproportionate obstacle

(128) The Commission therefore has reason to consider that
the national provisions notified can be approved,

HAS ADOPTED THIS DECISION:

Article 1

of

The provisions
in
the Controlled
conjunction with the Decision concerning the composition,
classification, packaging and labelling of control substances of
12 March 1992 concerning carbolineum and creosote are
approved.

Substances Act

Article 2

This Decision is addressed to the Kingdom of the Netherlands.

IV. CONCLUSION

Done at Brussels, 26 October 1999.

(127)

of

the

the

light

the
In
Commission is of the opinion that the provisions with
to the use of creosote as notified by the
regards
to the former
Kingdom of

the Netherlands pursuant

considerations,

above

For the Commission

Erkki LIIKANEN

Member of the Commission