1999/835/EC: Commission Decision of 26 October 1999 on the national provisions notified by the Kingdom of Denmark concerning the limitation to the placing on the market and use of creosote (notified under document number C(1999) 3427) (Text with EEA relevance) (Only the Danish text is authentic)
Date: 1999-10-26
Institutions: European Commission
Subjects: Denmark, marketing restriction, national law, pesticide, public health, wood product

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COMMISSION DECISION

of 26 October 1999

on the national provisions notified by the Kingdom of Denmark concerning the limitation to the
placing on the market and use of creosote

(notified under document number C(1999) 3427)

(Only the Danish text is authentic)

(Text with EEA relevance)

(1999/835/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. Community legislation: Directive 96/60/EC

of

laws,

regulations

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

and preparations (1),

the use of

substances

substances

as

specific

component,

(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
tar distillates, as well as
creosote and similar coal
preparations containing them, by limiting the content of
one
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
not respecting those limits may not be placed on the
market.

benzo[a]pyrene,

in

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

consumption,

animal

2. The Danish national provisions

(4) Under the Danish legislation, creosote are considered as
biocides
for which Denmark has had in place an
approval regime since 1980, following the adoption of
Law 212 of 23 May 1979 on chemical substances and
products (4). The approval
introduced,
because Denmark regarded the substances in question as
a
to health and the
environment. Details of the approval scheme are laid
the Law, which is entitled.
down in Chapter 7 of
Approval of chemical
for
specific purposes.

substances and products

significant potential

scheme was

threat

(5) All chemical substances or products used for a range of
purposes, which are specified in the Annex to the Law,
the
the Minister
for
approved by
have
to be
the
import or use of
to sale,
Environment prior
the
substance or product. Among other categories,

(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) Act on chemical substances and products, notified in the form of
the Consolidated Act from the Ministry of the Environment No
583 of 9 July, 1993.

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Annex lists the item (cid:145)pesticides(cid:146) which includes chemical
substances and products intended for control of:

(cid:151) plant diseases,

(cid:151) fungus attacking wood,

(cid:151) undesired plants,

(cid:151) algae,

(cid:151) mucus secreting organisms in pulp,

(cid:151) and others.

All wood preservatives, including creosote, are covered
by the second indent.

(6) Approvals are granted for periods of eight years. For
chemical substances and products classified as ,very
toxic, or ,toxic, approvals are valid for a period of four
years. The Minister may in special cases fix shorter
approval periods.

(7) Approvals granted before September 1, 1987, expired
on September 1, 1995. For chemical substances and
products classified as (cid:145)very toxic(cid:146) and (cid:145)toxic(cid:146), however,
approvals expired on September 1, 1991. The Law
stipulated that the Minister had to lay down rules for
renewal of approvals and on termination of the right to
sell or import substances, which cannot be approved.

(8) Applications for approval shall contain information on
the purposes for which the substance or product
is
intended, its composition and possible effects on health
or the environment, which its necessary to lay down the
approval terms. For approved substances or products,
addition to the
significant modification or
any
information submitted has to be notified.

advertising, and labelling prescribing its use and storage
etc. Moreover, approval may in special cases be granted
on the condition that within a specified time limit
further
investigation shall be made to clarify such
properties of the substance or product, which may be
relevant to health or the environment.

(11) Holders of approvals have to pay an annual charge and
an additional fee depending on turnover of the sale of
the product.

(12) An approval may be repealed if the approval terms are
violated or if deemed necessary on the basis of new
information. An approval shall be repealed immediately
upon demonstration that
the chemical substance or
product involved presents serious hazards to health or
the environment.

and

products,

the Minister

(13) To reduce the overall consumption of approvable
the
substances
Environment can lay down rules restricting or banning
the use of such substances and products in specific areas
of land. He can also lay down rules that professional
application of pesticides is allowed only by persons
training in environmentally
holding a certificate or
conscious and sound uses of such products.

for

Application of Chapter 7 of the Law on chemical substances
and products to creosote

(14) After a short period of time following the introduction
of the Law, a dispensation was granted to allow the
continued use of creosote without approval, as it was
considered reasonable to give the market more time to
meet the greatly increased documentation requirements.

(9) Approval cannot be granted:

(cid:151) for substances or products which in connection
with use or related handling and storage present, on
the basis of available investigations or experience
are suspected to present particular hazards to health
or damage to the environment,

(15)

In 1987 and 1989, approval was given for the use of
creosote for pressure impregnation of wood in closed
systems for railway sleepers and masts only, and the
general dispensation was withdrawn. Prior to this, the
substance had been used for a great number of
products. The approvals expired on 1st January 1991.
Since that
time there have been no applications for
approval of creosote for wood treatment in Denmark.

(cid:151) for

if other

substances or products,

substances,
products or methods exist
in the same field of
application, which present, or on the basis of
available investigations or experience are suspected
to present, significantly less hazards to health or
damage to the environment.

(10) The approval may be granted on the basis of detailed
conditions relating to the contents of the substance or
packaging,
product,

quantity,

import,

sale,

its

(16) The national

legislation applicable in Denmark was
notified, together with the request for derogation under
the former Article 100a(4) of the EC Treaty, by letter of
20 December 1995. In that letter, the Danish authorities
expressed their determination to completely ban the use
of creosote for wood treatment on the basis of existing
legislation,
i.e. by not approving creosote containing
products. In addition Denmark wants to ban completely
the current use of treated wood for private application
even if the B[a]P content is below 50 ppm and for

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letter,

in their

application even if

industrial
the B[a]P is below
the Danish
500 ppm. However,
authorities underlined the fact that the existing approval
regime allows for the placing on the market and the use
of creosote containing products in Denmark, if it can be
documented that their placing on the market or use will
not have undesirable consequences for human health or
the environment.

(17) However, no specific legislation on creosote was in
place. The described system applied to all pesticides,
including
application as wood
the
preservative.

creosote,

for

the

are,

condition:

in principle,

exemptions have

coherent with the
exemptions
there is an
provisions of Directive 94/60/EC, but
additional
to be
approved in accordance with Chapter 7 of the Law on
chemical substances and products. The order entered
into force on 20 July 1996. According to the Danish
authorities, this order should be seen as a temporary
measure, which does not affect the communication of
20 December 1995.

(20) Concerning the marketing and use of wood treated with
in the Danish

creosote,
legislation prior to the abovementioned order.

are no provisions

there

(18)

(19)

sale

In Annex to the letter of 20 December 1995, a draft
order was notified amending the existing order limiting
the
(PCP) by
and use of pentachlorophenol
introducing certain specific provisions on creosote.
However, the Danish authorities renounced to this draft
order, which never came into force.

3. Comparison between the Danish provisions and

Directive 94/60/EC

Instead, by letter of 18 July 1996, Denmark notified an
order limiting the sale and use of creosote. Article 2 of
this order lays down a total ban on import, sale, or use
certain exemptions. These
of

creosote

except

for

(21) Table 1 shows in detail

the differences between the
restrictions on marketing and use of creosote and wood
laid down in Directive
treated with creosote
94/60/EC and the Danish legislation in force at the date
of adoption of the Directive.

as

Table 1

Comparison between Directive 94/60/EC and the Danish legislation

Council Directive 94/60/EC

Danish legislation

B[a]P < 50 ppm

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

Sale and use of creosote are prohibited unless
approval according to the Law on chemical
substances and products has been obtained

No product is approved

There are no provisions concerning treated
wood

B[a]P
50(cid:151)500 ppm

Restrictions on sale of creosote:

As above

(cid:151) no sale to private consumers

(cid:151) use

only
installations

permitted

in

industrial

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

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Council Directive 94/60/EC

Danish legislation

B[a]P
50(cid:151)500 ppm
(cont’d)

B[a]P > 500 ppm
or water soluble
phenols > 3 %

Old treated
wood

Explicit restrictions on treated wood. It may
not be used:

(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

Sale and use of creosote and treated products
totally banned

As above

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

There are no provisions concerning old treated
wood

(22)

In summary, the Danish provisions which are the object
of this Decision are more restrictive in one aspect:

subparagraph) and the national provisions had to be
applied from 20 June 1996 (Article 2(1),
second
subparagraph).

(cid:151) products containing creosote intended for wood
preservation must be individually approved before
they can be used.

(23) However, in contrast to Directive 94/60/EC the Danish
the
legislation existing before entry into force of
Directive, contains no explicit rules with regards to
B[a]P content or other physical parameters of creosote
which can be used for the treatment of wood and are
therefore potentially less restrictive. Furthermore, no
restrictions exist regarding the use of treated wood. The
therefore, approve products
Danish authorities could,
that do not
the limits established by the
respect
Community Directive.

II. THE PROCEDURE

(24) Directive 94/60/EC was adopted on 20 December 1994.
In the Council meeting, Denmark stated that (cid:145)a total ban
on creosote is the only acceptable solution if health and
environmental protection are to be taken into account.
Denmark therefore reserves the right to apply stricter
national provisions(cid:146).

(25) The Directive had to be implemented into national law
of the Member States no later than one year after its
first
adoption,

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

(26) On 20 December 1995, the Danish authorities informed
the European Commission that Denmark, on grounds of
intended to continue applying its
health protection,
existing national provisions on creosote,
therefore
derogating from Directive 94/60/EC concerning creosote
by applying the former Article 100a(4) of the EC Treaty.

(27) The Commission invited other Member States to present
their observations regarding the Danish request by letter
of 27 March 1996. As a result of this consultation the
Commission received comments from Austria, Germany,
and Greece.

(28) Austria agrees with Denmark that creosote can be
regarded as carcinogenic independent of the content of
B[a]P. Austria supports the Danish position with regards
to the necessary protection of groundwater, given that
this is the main source of drinking water in Denmark
and that the degradation of creosote is slow due to the
prevailing geographic and climatic conditions, Austria
underlines, however,
link
between the contamination in the close vicinity of a
production site and the hazardousness of a substance
when it is used. The Austrian authorities consider it
justified allowing
creosote
containing up to 500 ppm B[a]P for the impregnation
of railway sleepers and poles in industrial installations
is
using pressure-vacuum technology.

there is not direct

continued use of

In contrast,

that

the

it

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indispensable to ban the sale and use for consumers,
who would use the product by brush application which
would lead to high inhalatory and dermal exposure and
contamination of
through spills,
dripping, and disposal of
left-overs. Overall, Austria
supports the Danish request.

environment

the

entry into force of the new provisions (1 May 1999).
the Treaty apply
Instead,
immediately from that date to the examination of this
notification.

the new provisions of

(29) Germany supports the Danish request and refers to its
own notification requesting derogation under the former
Article 100a(4) of the EC Treaty concerning Directive
94/60/EC.

2. Consideration of admissibility

(30) Greece informs the Commission that it agrees with the
Danish request to apply national provisions regarding
creosote in accordance with the former Article 100a(4)
of the EC Treaty.

(31) 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
Secretariat of
the Commission informed the Danish
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

(32) 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.

(33) 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 Danish notification which is
the subject of this Decision.

(34)

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

(35) The notification submitted by the Danish 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.

(36) 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
its
necessary to maintain national provisions on grounds of
major needs referred to in Article 30, or relating to the
protection of
the working
environment
it shall notify the Commission of these
environment,
provisions as well as the grounds for maintaining them.(cid:146)

the

or

(37) Directive 94/60/EC was adopted on 20 December 1994.
It had to be transposed by the Member States by 20
December 1995 and enforced by 20 June 1996.
Denmark notified its national
legislation relating to
creosote, which had been in place since 1980, on 20
December 1995 and thus before the date foreseen for
the application of the national provisions transposing
the Directive.

regulating

a new order

(38) As mentioned before, on 18 July 1996 the Danish
authorities notified
the
marketing and use of creosote and of wood treated with
creosote which entered into force on 20 July 1996. This
temporary
legislation has
implementation
is
underlined
their
by
notification, where they stress that the earlier request for
derogation based on the former Article 100a(4) of the
EC Treaty concerning the existing legislation is not
affected.

a
94/60/EC, which
authorities

to be
of
directive
the Danish

regarded

as

in

(39)

It is therefore well justified to consider that in this case
the conditions of Article 95(4) of the Treaty are met,
according o 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.

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(40)

the request of

In the light of what precedes, the Commission considers
the Kingdom of Denmark for
that
derogation from Directive 94/60/EC as notified on 20
December 1995 is admissible under Article 95(4) of the
EC Treaty.

3. Assessment of merits

(45)

(41)

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

creosote and creosote-treated wood by consumers has
been underestimated, whether the Danish population or
the environment are exposed to unusually high doses of
creosote through sale and use of the product itself or
the use of creosote-treated wood.
the
studies (6), which were
findings of
mandated by the Commission in the framework of
similar requests from other countries, have been used in
the assessment of the request from Denmark.

In addition,

further

three

It has to be noted that, in the light of the time frame
established by Article 95(6), which did not exist in the
former Article 100a(4) under he regime of which the
Danish request was notified, these substantial efforts of
the Commission to find the elements necessary for the
justification of the maintenance of the Danish national
provisions cannot constitute a precedent or 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
of the elements which are submitted by the requesting
Member State, without having to seek itself possible
reasons of justification.

State. Given

the Treaty,

of

(42) The Danish authorities have based their request on the
need
the
of
environment. Creosote, as other wood preservatives, is
deemed to pose a significant potential threat to health
and the environment.

protection

human

health

and

(43)

(44)

and

concerns

environmental

In support of the request, Denmark submitted a brief
memorandum, dated 5 December 1995, on the human
health
creosote
including an account of measurements of the pollution
of soil and groundwater arising from land previously
used by creosote treatment companies. However,
the
information contained in this memorandum was rather
limited. It was, therefore, not possible to examine the
merits of
request based exclusively on this
information.

the

of

to verify whether

concerning marketing

the Danish national
In order
of
provisions
creosote-treated wood,
and
are
proportionate to that end, the Commission mandated a
study to an external consultant (5). The study tries to
assess whether the risk of cancer arising from the use of

use
indeed necessary

and

(5) Dr P. M. Sorgo, Study on the Justification in Scientific Terms of
Allowing Denmark to Retain is National Laws on Creosote, Final
Report, November 1996.

a

as

designed

specifically

(46) None of the studies referred to above was completely
conclusive with regards to the effects of creosote on
human health, in particular concerning its carcinogenic
potential,
long-term
carcinogenicity study was still ongoing. This study (7)
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
to the Scientific Committee on toxicity,
available
exotoxicity, 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.

the
for Derogation from Provisions of Council Directive

(6) G. Grimmer, Study on the Justification in Scientific Terms of Allowing
the Netherlands to Retain its National Laws on Creosote in Place of
Council Directive 94/60/EC. Final Report, Biochemisches Institut f(cid:252)r
Umweltcarcinogene, Gro(cid:223)hansdorf (Germany), December 1995.
Environmental Resources Management, Scientific Evaluation of
German Request
94/60/CE Concerning Creosote, Final Report, 24 April 1996.
WS Atkins International Ltd, 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, Final Report, August 1997.
(7) Fraunhofer Institute of Toxicology and Aerosol Research, Dermal
Carcinogenicity Study of Two Coal Tar Products
(CTP) by Chronic
Epicutaneous Application in Male CD-1 Mice (78 Weeks), Final Report,
Hanover, October 1997.

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3.1. Justification on grounds of major needs

different coal tar distillates, all of them specified by their
names, Einecs and CAS numbers.

3.1.1. Creosote general information

(47) 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

agent.

Large-scale

(51) Creosote is principally and almost exclusively used as a
and
wood-preserving
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
for wood-preserving
used by individual consumers
purposes.

industrial

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

(52) The most important properties of creosote are:

(cid:151) acenaphthene

(cid:151) naphthalene

(cid:151) phenanthrene

(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

(49) Benzo[a]pyrene (B[a]P) is one of the most thoroughly
investigated PAHs 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 of specified distillation fractions and, most
important in this context, different contents of B[a]P.
Limiting values for classification standards are 500 ppm
and 50 ppm.

(50) Modifications

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

It

(cid:151) high fungicidal efficacy,

(cid:151) high insecticidal efficacy,

(cid:151) long-term persistence,

(cid:151) resistance to leaching and weathering.

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

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

Human health effects

(54) Despite the fact that creosote has been used as a wood
preservative for over a century,
there are only few
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.

(55) 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.

(56) 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 (8). The
study examined workers exposed to creosote between
1950 and 1975. The investigators found a somewhat
incidence than expected and an
lower

total cancer

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

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

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increased risk of cancer of
the skin an lip and on
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 (9)
found an increased 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 (10),

(57) 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 carcinogenic in
humans. There is no significant new evidence from
more recent
this
conclusion.

investigations, which would affect

in this class

substances

that

for

(58) For

as

to

last

amended

tar distillates,

several years, experts

from the Member States
examined the issue of classification of creosote, other
coal
so-called complex
and further
in the framework of Council Directive
substances
67/548/EEC of 27 June 1967 relating
the
classification, packaging and labelling of dangerous
substances (11),
by Directive
1999/33/EC (12). Drawing largely on the same data as
IARC, agreement was reached during the elaboration of
Commission Directive 94/69/EC (13), EC,
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 an carcinogen need not apply if it can
be shown that the substance contains less than 0,005 %
(= 50 ppm) per weight B[a]P (14). This is different from
the IARC classification, which applies without any
specification of the B[a]P content.

(59) The choice of a limit of 50 ppm to the concentration of
in Community

classification

purposes

B[a]P

for

(9)

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.

(10) J.M. Holland, E.L. Frome, Advances

in Modern Environmental
Toxicology, Vol. VI, Applied Toxicology of Petroleum Hydrocarbons, ed.
MacFarland et al., Princeton Scientific Publishers 1984.

(11) OJ 196, 16.8.1967, p. 1.
(12) OJ L 199, 30.7.1999, p. 57.
(13) OJ L 381, 31.12.1994, p. 1.
(14) Note M of

the foreword to Annex I of Council Directive

67/548/EEC is applicable to creosote.

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 abovementioned scientific study by the
Fraunhofer
Institute were known, which had been
initiated by industry in collaboration with the IARC and
was in progress at that time. It has 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.

through the

skin by measuring

(60) 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) (15): absorption appears to vary
between individuals and between different sites within
the same individual. In a separate study (16), the dermal
absorption of different PAH compounds was measured.
PAHs of higher molecular weight as pyrene, e.g. B[a]P
were absorbed less rapidly. Any estimation of B[a]P
uptake based upon the pyrene marker will
therefore
result
in an overestimation and can be considered
conservative.

(61)

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
an
non-occupational environmental context.

investigations

exposure

creosote

to

to

in

(62) 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.

(15) Van Rooij

J.G.M.,

al., Absorption of Polycyclic Aromatic
Hydrocarbons Through Human Skin: Differences between Anatomical
Sites and Individuals, J. Tox. Environ. Health, 38,1993, p. 355.

et

(16) Van Rooij,

J.G.M., Dermal

Exposure
Hydrocarbons Among Workers, Thesis
Nijmwegen 1993.

to
Polycylic Aromatic
ISBN 90-9007080-X,

L 329/90

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Official Journal of the European Communities

22.12.1999

Environment effects

difficult to ascribe their levels to any particular source
such as creosote treated wood.

facilities often being the source of

(63) 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 contamination left
Environmental
from disused
contamination has been traced by an analysis of selected
PAH compounds, notably B[a]P.

creosote

plants.

(64) 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.

(65) The main characteristics of PAHs in the environment

are:

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

(67) A study in Sweden (17) 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.

of

creosote-treated wood. Migration

(68) The presence of elevated levels of PAH in aquatic
environments has often been attributed to the presence
creosote
of
components from treated wood 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 (18). The pollution of sediments by
creosote leaching from waterbank protection has been
documented in the Netherlands (19) and also in studies
on pollution from former impregnation facilities.

(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

(cid:151) the main breakdown processes 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,

(cid:151) PAHs reaching watercourses are rapidly transferred

to sediment,

are

removed

primarily

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

occurs

under

and

(66) 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 are originating from a variety of sources
(e.g. all combustion processes, traffic etc.) and it is often

(69) As for human exposure, actually measured data on
in

pollution by

originating

PAHs

environmental
creosote are scarce.

3.1.2. The Danish position

(70) Denmark regards creosote containing any concentration
of B[a]P as carcinogenic, not only if the concentration
of B[a]P is higher than 50 ppm, as classified in Directive
94/69/EEC, the 21st adaptation to technical progress of
Directive 67/548/EEC. Unlike the classification in the
EC, the IARC classification of creosote applies without
the B[a]P content. No data are available
limit of
regarding
creosote
containing less than 50 ppm B[a]P.

carcinogenic properties of

the

(71) Creosote is evaluated as mildly to moderately toxic by
ingestion and by dermal contact, and as irritant to the

(17) S. Holmroos, Analys av kreosotstolpar i Siml(cid:229)ngsdalen efter 40 (cid:229)rs
exponering i f(cid:228)lt. Rapport nr. M205-252.092. ˜lvkarleby: Vattenfall
Utveckling. 1994.

(18) L.L. Ingram et al., Migration of Creosote and its Components from
Treated Piling Sections in a Marine Environment, Proc. Ann. Meet.
Am. Wood Preserv. Assoc. 78, 1982, p. 120. See also footnotes 8
and 18.

(19) Bkh consulting engineers, Foundation of the appeal against the EC

Directive on creosote, Final Report, Delft, 1 July 1995.

22.12.1999

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Official Journal of the European Communities

L 329/91

skin and eyes. It induces phototoxicity of the skin and
has been demonstrated to be a skin carcinogen in
animals. Presence of co-carcinogens can be important in
the development of
also induces
phototoxic eczema after dermal exposure in connection
with sunlight.

skin cancer.

It

(72) Denmark considers that occupational exposure to coal
tar creosote increases
skin cancer
among workers. This claim is substandiated by reference
to the
in
Scandinavian creosote impregnation plants (20).

abovementioned study among workers

the incidence of

concrete data are given for any of this in the Danish
memorandum).

against

(77) The Danish authorities also mention that creosote also
has ecotoxic effects in both soil and water. Creosote and
sediment polluted with creosote show a high acute
toxicity
the
substances in creosote can bioaccumulate in nature. The
high acute toxicity against aquatic organisms and the
lipophilic properties of creosote and many of
its
components, which enable them to bioaccumulate,
makes it an undesirable substance in the environment.

aquatic organisms. Many of

(73)

in

the

In addition to dermal contact with creosote or treated
products, occupational exposure to PAHs occurs via
inhalation of contaminated workplace air. Impregnation
of wood by creosote contributes to atmospheric PAH
pollution. Denmark has a limit value of 200 (cid:181)/m3 for
benzene-soluble
the workplace measured
particulate fraction. The Danish memorandum contains
one example of measurements in one American plant
(made before 1985) where results in the range 0,05 to
650 (cid:181)g/m3 had been found. In some investigations the
concentration of B[a]P has been measured separately.
Especially when the treated wood is heated as in manual
metal-arch welding the
concentration of B[a]P is
significant (0,39 to 0,89 (cid:181)g/m3). Metabolites of creosote
compounds could be found in the urine of creosote
workers after inhalation and dermal exposure.

(74) Non-occupational

(of

exposure

consumers) occurs
through treated wood, e.g. old railroad sleepers are used
in Denmark in gardens and playgrounds. Dermal
exposure can occur during outdoor activities, especially
in summer when high temperatures lead to increased
creosote concentrations at the wood surface and people
expose more unprotected skin for contact. Wood
samples from the surface of old railroad sleepers used in
playgrounds showed a high concentration of B[a]P (no
concrete figures are provided).

(75) Non-occupational

if
impregnated wood is used for construction work and in
connection with surface treatment with creosote paints.

exposure

occur

also

can

(76) Open burning of

in high concentrations of PAHs.

creosote-treated railway sleepers
results
lifetime
accumulated doses are used as the best indicator risk,
one time acute exposure at sufficient separation distance
probably results
risk, whereas
multiple exposures may present unacceptable risks (no

in an insignificant

If

and

aerobic

in time. Some of

(78) PAHs evaporate from creosote-treated wood and the
the PAH
composition changes
compounds at the soil surface can be degraded by solar
irradiation. Microbial degradation can also contribute to
the removal of PAHs. Microbial degradation can occur
under
PAHs
compounds with four rings and more may be poorly
degradable. The degradation is not complete and studies
have been conducted at water temperatures above 20 (cid:176)C
whereas
is
below 10 (cid:176)C. As the temperature and solar irradiation
are lower in Denmark compared to other countries in
the Community,
and microbial
the photochemical
degradation of creosote are reduced.

the temperature in Danish groundwater

conditions.

anaerobic

(79) Resuming the use of creosote in Denmark would add to
the pollution by PAHs, which already exists, and is very
slowly degradable due
to Denmark’s geographical
conditions. Combustion of
climatic
position and
creosote treated wood can release high concentrations
of PAH compounds. If the treated wood is burned in
fireplaces
the concentrations will
increase the risks of effects on human health.

in private homes

(80) Creosote also contains

substances other

than B[a]P
which are harmful to health and which would threaten
the quality of drinking water in Denmark if they were
to seep into the groundwater. Phenols, naphthalene and
benzopyrenes are some of the substances in creosote
that can reach the groundwater. The concentration
exceeds
the Danish quality criteria. Denmark uses
unpurified groundwater as drinking water.

3.1.3. Evaluation of the Danish position

(20) See footnote 8.

(81) The positions of

the Danish authorities have to be
evaluated in comparison to the information on the

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22.12.1999

toxicity end ecotoxicity of creosote. In addition, it has
the information on health and
to be noted that all
environmental concerns with regards to creosote, which
is put forward by the Danish authorities, was old and
had already been known at the time of preparation of
data
Especially
Directive 94/60/EC.
regarding carcinogenicity had been discussed in great
depth
the Directive
of
preparation
the
concerning the classification of creosote.

available

during

the

(82) All findings of the various studies have been mentioned
in the general
information part above. Only very
recently, experimental data have become available that
show that the carcinogenic risk of creosote containing
less than 50 ppm B[a]P might be non-negligible.

(83) With regards to the exposure of workers via inhalation,
it is doubtful whether the data measured a considerable
time ago in one American plant are of relevance in the
Danish context, where relevant standards exist, ensuring
a high protection of workers. Furthermore the Dutch
authorities in their request for application of the former
Article 100a(4) of the EC Treaty concerning the same
Directive have also examined the risks to workers from
inhalatatory exposure and have concluded that the risks
involved are acceptable.

have been observed with high level chronic exposures in
animal experiments or under occupational exposure. No
reports have been found in the literature of examples of
cancer of the skin (or any other sites) which could be
attributed
any
exposure
to
non-occupational contexts.

creosote

to

in

(86)

In Denmark wood preservation with creosote had taken
place for more than 100 years. Three impregnation
facilities were operating in 1987, when the approval
system was applied. The individual
licenses approved
the use of creosote only for treating wood in closed
treated wood was
industrial
restricted to railway sleepers and poles. The
last
approval expired in January 1991. No approvals have
been granted since. Table 2 shows the use of creosote
treated wood in Europe in 1990,
i.e. before the last
approval for the use of creosote in Denmark expired.

installations. Use of

(87) Already in 1990, Denmark hat the second lowest use of
creosote-treated wood-per capita and one of the lowest
per surface. A decline in the use of creosote-treated
wood started already in the early 70s to the benefit of
other
copper
substances
chromium arsenic complexes (CCA).

impregnation

such

as

(84) The study, on which the Danish authorities base their
claim that creosote exposure leads to higher incidence
of skin cancer, has already been mentioned above (21).
In fact, the conclusions of the authors themselves are far
less clear than those of the Danish authorities ((cid:145)no valid
conclusions(cid:146)); so are those of other epidemiological
studies.

(88)

(85) With regards to non-occupational exposure, it has to be
underlined, that all adverse health effects of creosote

In Denmark, there is no epidemiological evidence, no
reports of adverse incidents, and no data or estimates
for creosote intake from various exposures available. It
is therefore not possible to make direct estimates of the
amount of creosote taken in by or affecting the
members of the Danish population. But given the low
use per capita and surface, exposure is probably lower.
If Directive 94/60/EC was applied, there would probably
be
to make
even a significant
quantitative
increase would not lead to exposure values higher than
in other European countries.

it
estimates. However,

an increase but

is not possible

Table 2

Consumption of creosoted wood in Europe (1999) (22)

Country

Annual use 1990
(m3/y)

Annual use/capita
(10ﬂ3 m3/cap.y)

Annual use/km2
(m3/km2/y)

Germany

Netherlands

Spain

Italy

150 000

100 000

93 000

74 000

2,3

6,7

2,4

1,3

0,4

2,9

0,2

0,3

(21) See footnote 8.
(22) Source: see footnote 19, p. 6.

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Official Journal of the European Communities

L 329/93

Country

Annual use 1990
(m3/y)

Annual use/capita
(10ﬂ3 m3/cap.y)

Annual use/km2
(m3/km2/y)

United Kingdom

Sweden

France

Belgium

Norway

Ireland

Finland

Denmark

65 000

57 000

45 000

26 000

20 000

20 000

13 000

5 000

Europe

1 000 000

1,1

7,1

0,8

2,6

5,0

5,0

2,6

1,0

2,0

0,3

0,1

0,08

0,8

0,06

0,3

0,04

0,1

0,2

if

(89) Denmark mentions the emission of PAHs from treated
wood,
this is burnt by consumers. No data are
presented on the quantities of wood that are so
disposed of; furthermore,
it has to be noted that the
burning of wood (treated or not) always produces a
certain amount of PAHs. The concern of the Danish
authorities with regards to the disposal of old and
disused railway sleepers
from the
situation in other countries with a second hand market
of creosote-treated wood and cannot be a proof of a
specific situation.

is not different

and the dissemination of

(90) Contamination of the environment by creosote-related
sources can include emissions to air and water from
Creosote impregnation plants, seepage and run-off from
disused plants
creosote
constituents from treated wood into soil and water. As a
is possible that constituents such as
consequence it
PAHs will contaminate terrestrial and aquatic organisms.
However, PAHs found in environmental compartments
are originating from a variety of sources.
It is often
difficult to ascribe their levels to any particular source
such as creosote.

(91)

has

closed

groundwater

facilities. Denmark

In Denmark, creosote compounds were only found in
down wood
soil
near
and
impregnation
established
guideline limit values for some organic substances in
soil and groundwater. Total PAH compounds should be
to avoid ecotoxicological
below 1 mg/kg dry weight
effects. For B[a]P alone, the limit value is 0,1 mg/kg.
The water quality criterion in groundwater is 0,2 (cid:181)g/1
for the sum of six PAH compounds (including B[a]P. At
some
impregnation
(closed
facilities), concentrations of B[a]P up to 320 mg/kg were

polluted

down

sites

found in soil and up to 3 (cid:181)g/1 in some water samples.
However, no data were provided for the normal or
general situation.

(92) With regards to the specific situation of Denmark,
which was evoked in the request, the following analysis
applies: Denmark claims to have a specific problem,
because in general, drinking water is being generated
directly from unpurified groundwater, which therefore
needs special protection. The use of treated wood could
lead to the contamination of groundwater through the
leaching of creosote compounds from the treated wood
in contact with soil. At present there are three sites of
closed down creosote impregnation plants in Denmark,
where elevated levels of PAHs in groundwater were
found and where the adjacent groundwater is excluded
as a source of drinking water. This contamination is,
the
however, due
impregnation sites
and cannot be generalised for
creosote-treated wood used as sleepers or poles. As has
been
from
creosote-treated wood into soil and or ground water is
unlikely to be significant since they remain mostly
within a very short distance of the poles and posts from
which they originate, even after years of contact. PAHs
are strongly adsorbed on the soil’s organic matter and
the possibility of reaching groundwater is minimal. The
argument of a general protection of groundwater from
creosote originating in treated wood is
thus not
applicable.

to the operating practices of

leakage

shown

above,

PAHs

of

(93) No data

could be

found with regards

to the
concentration of creosote constituents in Danish waters
and sediments. From the available information, it would
from localised contamination from
seem that apart
the Danish
three disused wood impregnation sites,

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Official Journal of the European Communities

22.12.1999

aquatic environment is not unduly contaminated with
creosote or its PAH constituents.

3.1.4. Evaluation of the Scientific Committee for toxicity,

ecotoxicity, and the environment

(94)

If Denmark were to apply the provisions of Directive
94/60/EC, exposure of
the public would potentially
increase due to the then allowed use of creosote by
increased use of treated wood, and higher
consumers,
B[a]P content of creosote used industrially for railway
sleepers and poles. It is rather impossible to estimate
how big this increase will be, as the product has not
been on the market for many years.

to

progress

technical

(98) During the elaboration of Directive 94/69/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 in recital 59, the Commission and
the Member States agreed in a Joint Declaration to
review the situation in the light of the results of the
study concerning the carcinogenic properties of coal tar
distillates currently undertaken on initiative of industry
and in collaboration with the IARC.

available

(95) A particular concern expressed by the Dutch and
German authorities in their requests for derogation from
Directive 94/60/EC under the former Article 100a(4) of
the EC Treaty lies with creosote-treated wooden
playground equipment. As in these other cases, no data
are
and
estimates would probably result in figures comparable
to those
in the
framework of the Dutch, German, and Swedish requests,
as the scenario of children playing on creosote-treated
playground equipment is not country specific. Therefore
the exposure assessments made in relation to these
requests are also applicable. Results were as follows:

for Denmark, but

contained in the

studies made

calculations

(99) This study (24) was made available to the Commission in
January 1998. The study tested the carcinogenic effects
of two creosote products provided by the sponsoring
company (R(cid:252)ttgers-VfT AG, 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 concentrations 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.

(96) The exposure through dermal contact

for children
playing on dry wood treated with creosote calculated in
study mandated by the Commission in the
the
framework of
the Swedish request was 0,85 ng/kg
bw/day for the scenario of 2 hours a day, 50 % coverage
of open skin, body weight (bw) of 15 kg and 1,7 ng/kg
bw/day for an exposure time of four hours a day. The
Dutch authorities,
though
using a slightly different methodology, have arrived at
daily exposure dose of 2 ng/kg bw/day, which is very
increases confidence.
result and thus
close to this
Exposure in Denmark would normally be similar.

in their model calculation,

and

scientific

containing

(100) The Commission submitted this study and all other
documents
exposure
information on creosote to the Scientific Committee for
toxicity, ecotoxicity and environment. The SCTEE was
asked to evaluate whether there was sufficient 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. This opinion was
revised on 4 March 1999.

(97) The magnitude of

the

various

Furthermore,

the risks due to such a level of
exposure are deemed to be unacceptable by the Dutch
studies
authorities.
the Commission, before taking a
recommended that
decision,
long-term
the
carcinogenicity study that was ongoing at that time (23)
(received at the beginning of 1998). The findings of this
study have been examined by the Scientific Committee
for toxicity, ecotoxicity, and the environment and the
analysis will be presented in the following.

results

awaits

the

of

(101) The SCTEE observes

that

there

B[a]P,

including

the Fraunhofer

study is
well-designed and reaffirms the carcinogenic potential of
coal tar preparations. Due to the genotoxic potential of
threshold
PAHs
concentration determining carcinogenicity. The study
indicates clearly a linear dose-response relationship
between the B[a]P
administered
preparations and the number of animal developing
tumours. Both preparations have a five-fold higher
than pure B[a]P,
potency to induce skin tumours
other
the
presumably

to the presence

content of

due

the

no

of

is

(23) See footnote 7.

(24) See footnote 7.

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L 329/95

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.

Extrapolating

study
insufficient.

skin painting
are

(102) Data to fully evaluate the relevance of effects seen in a
for human exposure
mouse
situations
skin
carcinogenicity data from mice o 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 o carcinogenic risk, e.g.
for the
dermal exposure of children playing on wood treated
with creosote is therefore difficult.

(103) 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 per kg bodyweight, which induces in 25 % of
the test animals tumours at a specific tissue site within
the species. The creosote
the standard life span of
formulations
five-fold higher overall
carcinogenic potency (2,7 (cid:181)g/kg bw/day).

tested had a

(104) Should the value of exposure calculated in the study
mandated by the Commission for the Swedish request
apply (0,85 ng B[a]P per kg bw/day (for two hours play
time) and 1,7 ng (for four hours play time) approximate
the true exposure, this would result in a lifetime cancer
risk of 8,2 (cid:215) 10ﬂ5 (respectively 1,63 (cid:215) 10ﬂ4) for a life long
daily exposure, which would give clear concern, a risk
of 1,16 (cid:215) 10ﬂ5
(respectively 2,33 (cid:215) 10ﬂ5)
for a daily
exposure during ten years out of 70 (the Dutch
assumption) and 0,58 (cid:215) 10ﬂ5 (respectively 1,16 (cid:215) 10ﬂ5)
for a daily exposure during five years out of 70 (the
German
doses
calculated by the Dutch authorities (2,62 ng/kg bw/day)
or the German authorities (2,62 ng/kg bw/day) would
increase these risks proportionately.

assumption). Using

exposure

the

acceptable
drinking water by the World Health Organisation.

for genotoxic

risk level

carcinogens

in

(106) The SCTEE also mentions that the figure of 2 ng B[a]P
per kg bw/day as a worst-case exposure to B[a]P from
playing on creosote-treated wood has to be compared to
estimates for intake of B[a]P via food. Annual intakes of
B[a]P from food has been estimated to be in the order
of 0,3 to 1,6 mg, which would result in daily exposures
of 12 to 62 ng/kg bw for a person weighing 70 kg (i.e.
much higher than the dermal exposure).

(107) Overall the SCTEE concludes:

Fraunhofer

1. Given the genotoxicity of B[a]P and the outcome of
the
is
skin painting
sufficient scientific evidence to support the opinion
from
that
creosote containing less than 50 ppm B[a]P and/or
from wood treated with such creosote.

risk to consumers

there is a cancer

study,

there

B[a]P is a good indicator for the carcinogenic hazard
of the creosote preparation tested, since there was a
linear relationship between cancer incidence and
the
B[a]P dose. However,
than
creosote preparation was
judged from its B[a]P content.

the cancer potency of

five-fold higher

2. On the basis of

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

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.

(105) 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 selected
exposure model, the risk is thus slightly or more clearly
above a value of 1 (cid:215) 10ﬂ5, which is proposed as an

(108) The Danish authorities have not shown, nor could it be
demonstrated through further research, that a specific
situation exists in Denmark with regards to the general

3.1.5. Overall evaluation

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Official Journal of the European Communities

22.12.1999

pollution of the environment by PAHs, or the exposure
of man and the environment to PAHs originating in the
use of creosote and creosote treated wood or that this
would be the case if Denmark applied the provisions of
Directive 94/60/EC.

(109) However,

the Commission has

received additional
information in the framework of similar requests from
the Netherlands, Germany, and Sweden for derogation
from Directive 94/60/EC under
the former Article
100a(4) of the EC Treaty, and new scientific evidence
the
through an extensive
adoption of the Community Directive.

study carried out after

application of the national Danish legislation cannot be
approved under Article 95(4).

(113) Although the Danish authorities, in their notification of
20 December 1995 under the former Article 100a(4) of
the EC Treaty have expressed their intention to ban the
existing uses of wood treated with creosote, the national
legislation notified by the Danish authorities in that
request does not contain provisions concerning treated
wood. Such measures, as they have not been formally
notified to the Commission, cannot be approved in this
Decision.

(114)

(110) Based on these most

recent experimental data,

the
SCTEE has estimated that here is a cancer risk to
humans from creosote containing less than 50 ppm
the
B[a]P and wood treated with such creosote,
magnitude of which cannot be estimated with certainty.
Taking into consideration the uncertainties concerning
exposure, he Commission considers
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.

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 provisions 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 (25) 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 for research and technological development
is reviewing the production chain and in-service life of
poles treated with creosote (26).

(111) However,

such measures can only be regarded as
justified under the condition of being in conformity
with the general principle of proportionality,
i.e. the
measures do not have to exceed what is suitable and
necessary for he pursuit of he legitimate objective.
Consequently, the legislation notified to the Commission
by the Danish authorities can be approved only in so
far
legislation sets up an authorisation
arrangement for the use of creosote which allows for
the possibility to actually obtain such an authorisation,
when it is compatible with the needs for the protection
of health and the environment.

this

as

(112)

It has to be noted that the Danish provisions existing
before adoption of Directive 94/60/EC comprise an
approval system without specifying a particular limit for
B[a]P content or other physical-chemical parameters of
creosote. Article 95(4) only permits the approval of
national legislation on grounds of major needs referred
to in Article 30, or
the
environment or working environment. This means that
it is not possible to approve national measures that are
less protective than those laid down in the Directive.
Therefore, the Danish national
legislation can only be
approved as its application in practice has shown that
no product was authorised that was not respecting the
limits established by Directive 94/60/EC. A different

relating to protection of

3.2. The absence of arbitrary discrimination

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

(116) The limitation on marketing and use of products
containing creosote in the Danish legislation is general,
relating to all products
that contain creosote. The
Danish legislation does not establish special rules for
different sorts of products.
It does not affect some
products in a different manner to others, either national
or imported, but applies to all products containing
creosote. So there is no evidence that it can be used as a
means of arbitrary discrimination between economic
operators in the Community.

(25) OJ L 123, 24.4.1998, p. 1.
(26) Research

Contract

FAIR5-CT98-3933

programme for RTD),
production of creosoted utility poles.

Integrating the processes

(fourth

framework
involved in the

22.12.1999

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L 329/97

3.3. The absence of a disguised restriction on trade

(117) More restrictive national measures

in the area of
limitations of marketing and use of products derogating
from 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
paragraph 6 of Article 95 is intended to prevent the
restrictions based on the criteria of paragraph 4 being
applied for
and in reality
constituting economic measures introduced to impede
the import of products from other Member States in
order to protect indirectly national production.

in the rest of

inappropriate

reasons,

(118) The Commission mandated a study (27) to examine the
implications of maintaining the national provisions in
Denmark on the functioning of the internal market. The
study undertook to collect all available information
regarding the volume and value of
trade with other
Member States affected,
the interest which Denmark
might have in using its national rules to promote a
interest in substitutes, and the interest which
national
Denmark might have in using its national rules to
promote alternatives to creosote-treated wood. To this
end, interviews took place with regulators in Denmark,
with industry representatives, and with the relevant
industry associations.

(119)

framework of

In the general
its legislation on wood
preservatives, the Danish Ministry of the Environment
has restricted, or is in the process of trying to restrict
the use of a number of products. Inorganic metal salts
(CCA) were used as the primary alternative to creosote
in Denmark until the use of such treated wood was
banned by order No 1042 of 17 December 1997.

(120) There are four producers of (cid:145)organic(cid:146) wood preservatives
in Denmark producing
tin-based and azole-based
preservatives. Competitors from outside Denmark have
expressed their concern that one of the effects of the
Danish policy on wood preservatives would be the
exclusive possibility to use products manufactured in
Denmark for the treatment of wood to be sold in
existing producers of other
Denmark, while
preservatives in Denmark would continue to export to
other countries. However, as the use and import of
wood treated with creosote are not
the
national legislation does not have the alleged effect on
the sale of treated wood in Denmark.

regulated,

the

(121) Concerning he import of wood preservatives there are
no special rules for imported products that are not
applicable to domestically produces products. Although
the producers of certain
there is the possibility that
alternative wood preservatives
in Denmark would
benefit from the overall Danish policy regarding wood
preservatives, it is also to the detriment of the domestic
producers of preservatives currently used.

(122) The Danish authorities should take into consideration
that the possibility to export creosote, while its use and
thus import are prohibited in Denmark, could constitute
a disguised restriction on trade to the benefit of the
Danish producer of creosote.

(123) However, as was established before,

there is a real
concern with regards to human health, which justifies
the more restrictive national
legislation as it has been
found for other Member States. The primary objective
legislation is thus the protection of
of
human health and not
the preference of domestic
production.

the national

(124) Overall,

the Commission considers that

there is no
evidence of a disguised restriction on trade between
Member States provoked by the Danish provisions
concerning the use of creosote.

3.4. The absence of obstacles to the functioning of the

Internal Market

(125) This condition, which is established by Article 95(6),
first subparagraph, is new in comparison to the text of
the former Article 100a(4) of
the EC Treaty. This
condition cannot be interpreted in such a way that it
prohibits the approval of any national measure likely to
affect the establishment of the internal market. In fact,
any national measure derogating from a harmonisation
measure aiming a 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 operation
the internal market has to be understood as a
of
in relation to the pursued
disproportionate
objective.

effect

(126) The

European

creosote-production
characterised by the following features:

industry

is

(27) 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.

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

product,

L 329/98

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Official Journal of the European Communities

22.12.1999

(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.

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

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

(128) According to ERM (28), producers of creosote are located
the
in Germany, Austria, Belgium, Denmark, France,
Netherlands, Italy, Spain, and the UK. 90 % of creosote
impregnation of wood by
is used for the industrial
professional wood
The
remaining 10 % of creosote are used by individual
consumers, mostly in the United Kingdom and Ireland.

preservation

companies.

(129) 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
detailed specifications in relation to boiling curves and
the
in the
specific
creosote. Most, but not all, of
the producers can
produce creosote containing less than 50 ppm B[a]P.

concentration of

components

(130) The following Table 3 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 Denmark.

tar derived products

(131) Denmark is an exclusive exporter of creosote. There is
in Denmark, with a
one producer of
creosote
production of approximately 14 000 tonnes per year.
Production of creosote accounts for about 4,5 % of
overall output of coal
(pitch,
carbon black etc.). The complete production of creosote
is being exported, mostly to Sweden, Norway and
Germany. The quantities of creosote sold in Denmark
were 630 tonnes in 1987, 552 tonnes in 1988, 434
tonnes in 1989 and 0 tonnes in 1990. A very small
quantity of creosote is imported as part of medicinal
preparations and in creosote-derived carbolineum paint
preparations.

Table 3

Production, sales and trade in creosote in Europe (29)

Country

Number of producers

Possibility to produce
creosote with B[a]P
< 50 ppm

Sales of creosote
(tonnes/year) 1995

Trade with Denmark

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

(cid:151)

No

Yes

No

No

No

No

Yes

No

Yes

No

(28) See footnote 27.
(29) Source: See footnote 27, and: W:D: Betts, Study of the Effects on
the Retention by the Netherlands of
its
Trade and Competition of
National Rules in Place of
the Rules to be Established by Directive
94/60/EC, Tar Industries Services, Chesterfield (UK), December
1995.

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Official Journal of the European Communities

L 329/99

(132) Since January 1991 there have been no applications for
approval of creosote to be used in wood impregnation
facilities in Denmark. The last
impregnation facility
using creosote closed down already in 1989. There is
still a limited damand for creosote-treated railway
sleepers and poles, which are imported: 1 365 tonnes in
1992 and 770 tonnes in 1995 (about 7 500 m3). No
creosote-treated timber is exported from Denmark.

(133) The market for the treatment of wood with creosote
appears to have been declining already prior to the
expiration of the last approval for the use of creosote in
Denmark, although the legislation does appear to have
accelerated the trend. Trends to use alternatives for the
main applications of treated wood (railway sleepers and
because
poles)
already
replaced by
creosote-treated railway sleepers were
concrete sleepers,
telephone poles
the demand for
declined as more and more lines were put underground,
and creosote-treated timber pilings were replaced with
concrete/steel pilings.

existed

before,

had

(134) Overall,

to

preservation

the Danish wood

industry
produces about 220 000 m3 of treated wood per year.
According
1995,
69 500 tonnes of
types) were
treated timber
imported into Denmark (about twice the quantity of
1994), and 2 700 tonnes exported. Denmark is thus a
net importer of treated timber.

from Eurostat,
(all

data

in

(135) Taking into account

the preceding observations,

the
Commission considers hat there is no evidence that he
Danish 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) can be considered justified on grounds of major
need of protection of health when applied in
conformity with
of
proportionality,

principle

general

the

(cid:151) do

not

constitute

arbitrary
discrimination, a disguised restriction on trade
between Member States, or
a disproportionate
obstacle to the functioning of the internal market.

a means

of

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

HAS ADOPTED THIS DECISION:

Article 1

The provisions applicable to the marketing and use of
creosote, as contained in Chapter 7 of Law No 212 of 23 May
1979 are approved, in so far as they are applied in such a
manner:

(cid:151) that the limits for benzo[a]pyrene and water extractable
established by Directive 94/60/EC are not

phenols
exceeded, and

(cid:151) that the placing on the market and use of creosote are
allowed when compatible with the need to protect health
and the environment.

IV. CONCLUSION

Article 2

(136)

of

the

the

light

above

considerations,

In
the
Commission is of the opinion that the provisions with
to the use of creosote as notified by the
regards
Kingdom of Denmark pursuant to the former Article
100a(4) and examined under the new Article 95(4) and
(6) of the EC Treaty:

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

and are to be admitted,

This Decision is addressed to the Kingdom of Denmark.

Done at Brussels, 26 October 1999.

For the Commission

Erkki LIIKANEN

Member of the Commission