1999/834/EC: Commission Decision of 26 October 1999 on the national provisions notified by the Kingdom of Sweden concerning the limitation to the placing on the market and use of creosote (notified under document number C(1999) 3426) (Text with EEA relevance) (Only the Swedish text is authentic
Date: 1999-10-26
Institutions: European Commission
Subjects: Sweden, marketing restriction, national law, pesticide, public health, wood product

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Official Journal of the European Communities

L 329/63

COMMISSION DECISION

of 26 October 1999

on The National Provisions Notified By The Kingdom Of Sweden Concerning The Limitation To
The Placing On The Market And Use Of Creosote

(notified under document number C(1999) 3426)

(Only the Swedish text is authentic)

(Text with EEA relevance)

(1999/834/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

respecting those limits may not be placed on the
market.

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

Whereas:

I. THE FACTS

1. Community legislation: Directive 94/60/EC

laws,

regulations

approximation of

(1) Council Directive 76/769/EEC of 27 July 1976 on
and
the
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
health and 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]pyrene (hereinafter
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

(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 %) by mass and water
extractable phenols up to 30 g/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
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
in playgrounds and in other
or animal consumption,
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

of

a

2. The Swedish national provisions

(4) Under the Swedish legislation, creosote and preparations

containing creosote are considered as pesticides.

(5) The Swedish provisions concerning the marketing and
use of creosote and wood treated with creosote are
included in two different legal instruments:

1. Order

(1985:836) on pesticides,

issued on 7
November 1985 and last
amended by order
(1995:208) establishing general provisions on the
marketing and use of pesticides

(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.

2. National Chemicals

Inspectorate regulation KIFS
1990:10 on wood treated with preservatives,
especially sections 7(cid:151)11, concerning wood treated
with preservatives containing creosote.

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(6) Section 3 of Order

that

stipulates

an assessment with regards

the
(1985:836)
Chemicals Inspectorate must approve pesticides before
they can be sold, transferred or used. The same applies
to the import of pesticides from countries that are not
members of the European Union. Section 5 states the
basic requirements for approval: The substance must
pass
to health and
environment protection and it must be shown that it is
required for
in the intended area of
application. An approval is limited in time (five years)
and may be subject to conditions. On approval of a
pesticide,
the
to labelling and other
requirements with regards
product
special
conditions to prevent harm.

Inspectorate establishes

information, handling,

the Chemicals

the purposes

and other

(7) On the basis of assessment concerning health and
environment, the pesticide is attributed to one of three
classes:

Class 1: Products for professional use by persons with

a special licence only

Class 2: Products for professional use only

Class 3: Products for general use

(8) The rules on labelling and other product information,
handling of the pesticide and other special conditions to
prevent harm are notified together with the approval
(section 7).

(9) The order also establishes that a fee must be paid in
to obtain an approval, and that any new
order
information on health and environmental effects must
be notified.

(10) Application of

these

rules has

resulted in wood
preservatives containing creosote being approved in
Sweden only for use in industrial
for
pressure impregnation. Such installations are subject to
special competence requirements. A series of earlier
approvals for general use were revoked with effect from
1 January 1986 based on the classification of creosote
as potential human carcinogen by the International
Agency for Research on Cancer (IARC).

installations

10 ppm. The phenol content
than 3 %.

in all products is less

(12) For treated wood, section 7 (in conjunction with section 6)
of the Chemical Inspectorate’s regulations KIFS 1990:10
establishes the following restrictions on its use, which
entered into force on 1 January 1992.

(13)

lines)

If fewer than 30 years have elapsed since impregnation
with creosote, the timber is permitted for professional
use only as railway sleepers or for round timber for
or marine
(e.g. power
transmission lines
installations. Thereafter, the timber may also be used for
non-professional
specified
applications: when the wood is buried in or otherwise
in permanent contact with damp soil or water, when
the wood in used for the construction of jetties or other
marine applications. These rules apply irrespective of
the B[a]P content in the wood preservative used for
treatment.

purposes

certain

for

(14) Section 8 prohibits the professional marketing, sale and
transfer of timber for the purposes that are prohibited
under the regulations. Section 9 lays down rules for the
marketing of treated wood: anyone who, in the course
of business activities,
transfers wood treated with
preservatives has to provide written information on the
following:

1.

2.

relevant restrictions on use according to sections 5
to 7;

the installation,
treatment was carried out;

in which the wood preservation

3. active ingredients of the wood preservative;

4. woodworking procedures for which the wood is

suitable and/or is not suitable;

5. health

risks
handling of the wood;

during woodworking

and

other

6.

suitable safety precautions;

7. measures for the disposal of waste wood.

(11) Four individual products are approved for exclusive
industrial use in Sweden. The decisions on approval did
not specify a particular limit
for B[a]P content, but
according to the information submitted by the Swedish
authorities,
all have B[a]P
approved products
contents of less than 50 ppm, in some cases less than

the

(15) According to section 10,

these indications must be
attached to each bundle of wood placed on the market.
Where wood treated with preservatives is offered for
sale in bulk to customers, who fetch it on the spot, the
information must be displayed at he storage site of the
wood. Additionally, a sheet with information is to be
made available free of charge for anyone collecting the

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wood. The regulation applies also to imported wood,
exported wood is exempted from most of the provisions
contained in sections 4 to 11.

wood treated with creosote depending on the B[a]P
content as laid down in Directive 94/60/EC and the
Swedish legal system.

3. Comparison between the Swedish provision and

Directive 94/60/EC

(16) Table 1 shows in detail

the differences between the
restrictions on the marketing and use of creosote and

(17)

to the Directive,

the Swedish legislation
In contrast
contains no explicit rules with regards to the B[a]P
content or other physical parameters of the creosote,
which can be used for the treatment of the wood. In
their notification, the Swedish authorities claim that all
approved products contain less than 50 ppm B[a]P and
less than 3 % water-soluble phenols.

Table 1

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

Council Directive 94/60/EC

Swedish regulations

B[a]P < 50 ppm

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

containing

Preparations
purpose
of wood
approved individually.

creosote
for
preservation must

the
be

to

Sale
prohibited.

and

use

by

private

consumers

Industrial use only for pressure impregnation.

Newly treated wood may only be used for
professional purposes as railway sleepers, round
timber for transmission line construction and
marine installations.

Special labelling rules apply to the marketing of
treated wood:

Written information has to be provided on

1.

relevant use restrictions;

2.

installation,

the
preservation treatment was carried out;

in which the wood

3.

active ingredients of the wood preservative;

4. woodworking procedures

for which the

wood is suitable and/or is not suitable;

5. health risks during woodworking and other

handling of wood;

6.

suitable safety precautions;

7. measures for the disposal of waste wood.

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Council Directive 94/60/EC

Swedish regulations

B[a]P < 50 ppm
(cont’d)

B[a]P in range
50 to 500 ppm

is offered for

These indications must be attached to each
bundle of wood. Where wood treated with
preservatives
sale in bulk to
the
customers who fetch it on the
information must be displayed at the storage
site of
the wood. Additionally, a sheet with
information is to be made available free of
charge for anyone collecting the wood.

spot

Restrictions on sale of creosote:

In principle, as above.

In reality, no product containing B[a]P in the
range 50 to 500 ppm approved.

(cid:151) no sale to private consumers

(cid:151) use

only

permitted

in

industrial

installations.

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 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

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

Sale and use of creosote and treated products
totally banned

In principle as above.

In reality, no product containing more as
500 ppm B[a]P approved.

Old treated
wood

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

fewer

If
than 30 years have elapsed since
impregnation, only permitted for professional
use as railway sleepers or for round timber for
transmission lines or marine installations.

If treatment took place more than 30 years ago
wood may also be used for non-professional
purposes for certain specified applications:

(cid:151) when the wood is buried in or otherwise in
contact with damp soil or

permanent
water,

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Council Directive 94/60/EC

Swedish regulations

Old treated wood
(cont’d)

(18) The Swedish provisions are more restrictive in the

following aspects:

(cid:151) products containing creosote intended for wood
preservation must be individually approved before
they can be used. Creosote has been approved for
professional use only, not for use by consumers.
Wood impregnation has to be performed according
to a specific technique;

(cid:151) the use of treated wood is more restricted: newly
treated wood, and wood where treatment took place
less than 30 years ago, may only be used for
professional applications as railway sleepers or for
transmission lines or marine
round timber
installations. Wood treated more than 30 years ago
may be used by private consumers only when the
wood is buried in or otherwise in permanent
contact with damp soil or water and when the
wood is used for the construction of jetties or other
marine applications;

for

(cid:151) sale (transfer) of wood is subject

to a series of
requirements in Sweden regarding the providing of
information to consumers.

(cid:151) when

the wood

construction of
applications.

is

the
jetties or other marine

used

for

The same rules apply regarding marketing than
for newly treated wood.

(21) On 14 December 1995,

the Swedish authorities
informed the European Commission that Sweden
intended to continue applying its present national
provisions on creosote and creosote-treated wood,
therefore
94/60/EC
concerning creosote, on the basis of health protection,
applying the former Article 100a(4), of the EC Treaty.

from Directive

derogating

(22) The Commission invited other Member States to present
their observations on the Swedish request by letter of 4
this consultation the
April 1997. As a result of
Italy,
Commission received comments from Denmark,
Austria, The Netherlands, Finland, Spain,
the United
Kingdom, and Greece.

(23) Denmark

is

creosote

agrees with Sweden that

a
dangerous substance to both human beings and the
environment, and its use should be restricted as far as
possible, or banned completely. Denmark is therefore
completely in favour of Sweden being allowed to apply
stricter national provisions on creosote. Denmark has
informed the Commission that it also wishes to apply
more stringent national rules concerning creosote.

(19) The Swedish provisions are potentially less restrictive in

the following aspects:

(24)

(cid:151) order (1985:836) does not mention a limit in the
content of B[a]P as a criterion for approval. On the
basis of this Order, the Chemicals Inspectorate could
approve the use of a product containing quantities
superior to those established in Directive 94/60/EC
as a maximum limit.

Italy informs the Commission that it has no substantial
objections to the Swedish request. The Italian authorities
consider justified the necessity for Sweden to maintain
more restrictive rules concerning the use of creosote,
taking into account their specific climatic (less sunshine)
and geographical conditions (number of lakes). Italy also
recalls that
the legislation, which Sweden wants to
maintain, has been in force for more than 10 years and
has
the
commercialisation of creosote.

the market

concerning

disturbed

not

II. THE PROCEDURE

(20) The Order 94/60/EC was adopted on 20 December
1994. The Directive had to be implemented into
national
law of the Member States no later than one
year after its adoption, i.e. 20 December 1995 (Article
2(1), first subparagraph) and the national provisions had
to be applied from 20 June 1996 (Article 2(1), second
subparagraph).

(25) Austria points out,

it

that

completely shares

the
evaluation that sale of creosote to private consumers
should be prohibited an that the level of protection of
the measures, the cancer risk to consumers from the
brush application of B[a]P containing tar-oils for the
impregnation of wood is especially high (dermal and
inhalatory exposure) and,
this procedure
creates environmental and waste problems. Application
of creosote should therefore be restricted to cases where
no alternative is available. The Swedish provisions
concerning prescribed impregnation technologies and

in addition,

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the use of treated wood are justified. In addition, the
Swedish regulations do not in any case constitute an
arbitrary discrimination or a disguised restriction on
trade. The specific climatic and geographic situation in
Sweden also supports the recourse to the former Article
100a(4).

(26) The Netherlands share the Swedish concern that Directive
94/60/EC does not adequately safeguard the desired
level of protection for the environment and human
health. The Dutch authorities refer to their own request
for derogation and the substantial documentation that
justification. The Swedish
they have submitted for
measures are supported and the Netherlands expresses
its
carefully
confidence
examine whether
are necessary on
the measures
grounds of the major needs referred to in the former
Article 100a(4) and also meet
for
recourse to this provision in other respects.

the Commission will

the conditions

that

(27) Finland considers that the requirements established in
the former Article 100a(4) of the EC Treaty are fulfilled,
and the Commission should confirm the Swedish
the maximum
it also considers that
legislation, but
concentration limits for B[a]P contents in creosote and
for water
in accordance with
Directive 94/60/EC should be incorporated into Swedish
national legislation.

extractable phenols

(28) Greece informs the Commission that it agrees with the
Swedish request. If Sweden maintains its national policy,
their will not be particular consequences for Greece.

(29)

there were

In contrast, Spain understands that the acceptance of
Swedish national regulations would provoke barriers to
trade, as Directive 94/60/EC would not succeed in its
goal. When Directive 94/60/EC was
harmonising
adopted
the
lengthy
Commission and Council about the limitations, which
would be imposed, and the restrictions in point 32 of
the Annex were laid down on the basis of the risk of
the
creosote. The Spanish authorities consider
Swedish request to impose more stringent restrictions
than those already applicable should not be admitted.

discussions

that

in

health, safety or environmental protection. This is not
considered to be the case in this instance.

(31) On the 1 May 1999,

the Treaty of Amsterdam
amending the Treaty on European Union, the Treaties
establishing the European Communities and certain
related acts, signet at Amsterdam, 2 October 1997,
entered into force. By letter of 24 August 1999 the
the Commission informed the
General Secretariat of
Swedish authorities of the fact that their notification
regarding the placing on the market and use of creosote
would be
the new
provisions of the Treaty.

treated in the

framework of

III. ASSESSMENT

1. Applicable Rules

the former Article 100a of

(32) The Treaty of Amsterdam has amended substantially the
the Treaty
provisions of
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 Swedish 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
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

(30) The same opinion is expressed by the United Kingdom.
The UK notes that the Swedish authorities do not offer
any scientific evidence or data, new or otherwise, to
justify their assertion of a health risk. The UK seeks to
uphold the principle that all Member States accept the
standards imposed by single market measures, unless a
Member States has special circumstances which require
more stringent provisions to achieve the same level of

2. Consideration of admissibility

(35) The notification submitted by the Swedish authorities
intends to obtain the authorisation to maintain national
provisions incompatible with Directive 94/60/EC, which
constitutes a harmonisation measure adopted on the

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basis of former Article 100a (now Article 95) of the EC
Treaty.

(36) Article 95(4) of the Treaty reads as the 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 need referred to in Article 30, or relating to the
the working
environment
protection of
environment,
it shall notify the Commission of these
provisions as well as the grounds for maintaining them.(cid:146)

the

or

the

In support of

(41) The Swedish authorities have based their request on
reasons of protection of human health and the
environment.
request, Sweden
submitted a brief Memorandum, dated 14 December
1995, explaining the reasons why Sweden deemed it
necessary to maintain its stricter national provisions.
However,
this
Memorandum was very limited and remained general. It
was not possible to examine the merits of the request
based on this information alone.

information

contained

the

in

(42)

(43)

(37) Directive 94/60/EC had to be transposed to the Member
States by 20 December 1995 and enforced by 20 June
1996. Sweden notified its national legislation relating to
creosote and wood treated with creosote, which had
been in place since 1985 and 1992, respectively, on 14
December 1995 and thus before the date foreseen for
the application of the national provisions transposing
the Directive.

(38)

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
the harmonisation
adopted before the adoption of
measure.

(39)

the request of

In the light of what precedes, the Commission considers
that
the Kingdom of Sweden for
derogation from Directive 94/60/EC as notified on 14
December 1995 under the former Article 100a(4)
is
admissible under Article 95(4) of the EC Treaty.

3. Assessment of merits

to verify whether

the Swedish national
In order
provisions concerning marketing and use of creosote
treated wood, are indeed necessary and proportionate to
that end,
the Commission mandated a study to an
external consultant (4). The study tries to assess the risk
of cancer arising from the use of creosote and creosote
treated wood
the
consumers,
implementation of Directive 94/60/EC in Sweden would
result
in unacceptable high creosote exposure of the
public, and in unacceptably high creosote exposure of
In addition, the findings of
the aquatic environment.
three further studies (5), 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 Sweden.

and whether

by

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 the regime of which the
Swedish request was notified, these substantial efforts of
the Commission to find the elements necessary for the
justification of the maintenance of the Swedish 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
of the elements which are submitted by the requesting
Member State, without having to seek itself possible
reasons of justification.

State. Given

the Treaty,

(40)

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
the
an obstacle
international market (Article 95(6)).

to the operation of

(4) 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.

Final

report, Biochemisches

(5) G. Grimmer, Study on the justification in scientific terms of allowing the
laws on creosote in place of Council
f(cid:252)r

Netherlands to retain its national
Directive 94/60/EC.
Institut
Umweltcarcinogene, Gro(cid:223)hansdorf (Germany), December 1995.
Environmental Resources Management, Scientific evaluation of
German request
94/60/EC concerning creosote, Final Report, 24 April 1996.
Dr. P. M. Sorgo, Study on the justification in scientific terms of allowing
Denmark to retain its national
laws on creosote, Final Report,
November 1996.

the
for derogation from provisions of Council Directive

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22.12.1999

a

as

designed

specifically

(44) 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 (6)
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.

3.1. Justification on grounds of major needs

3.1.1. Creosote (cid:151) general information

(45) 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

(46) 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) 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

(47) Benzo[a]pyrene (B[a]P) is one of the most thoroughly
investigated PAHs and the B[a]P content is used as an

(6) Fraunhofer Institute of Toxicology and Aerosol Research, Dermal
carcinogenicity
chronic
epicutaneous application in male CD-1 mice (78 weeks), Final report,
Hannover, October 1997.

tar products

(CTP) by

two coal

study of

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.

(48) Modifications

It

and chemical
to both the physical
properties of creosote are possible if they are required
for use or environmental purposes.
is possible to
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.

(49) 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

(50) 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.

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

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

Human health effects

(52) 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.

22.12.1999

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Official Journal of the European Communities

L 329/71

(53) 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.

(54) 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 (7). The
study examined workers exposed to creosote between
1950 and 1975. The investigators found a somewhat
lower
incidence than expected and an
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
a valid conclusions. The increase could be attributed to
exposure both to creosote and to sunlight. One other
study (8)
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.

their

lifetime (9),

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

in this class

substances

studies

that

the

for

(56) For

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

to

(7) S. Karlehagen et. al., Cancer incidence among creosote-exposed workers,

(8)

(9)

Scand. J. Work. Environ. Health, 1992:18, p. 26.
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.
J. M. Holland, E. L. Frome, Advances
in modern environmental
toxicology, Vol. VI, applied toxicology of petroleum hydrocarbons, ed.
MacFarland and others Princeton Scientific Publishers 1984.

(10) OJ L 196, 16.8.1967, p. 1.

as

last

amended

substances (10),
by Directive
1999/33/EC (11). Drawing largely on the same data as
IARC, agreement was reached during the elaboration of
Commission Directive 94/69/EC (12), 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 (13). This
from the IARC
classification, which applies without any specification of
the B[a]P content.

is different

for

purposes

classification

(57) 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 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.

through the

skin by measuring

(58) 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 (14): absorption appears to vary
between individuals and between different sites within
the same individual. In a separate study (15), 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.

(11) OJ L 199, 30.7.1999, p. 57.
(12) OJ L 381, 31.12.1994, p. 1.
(13) Nota M of

the foreword to Annex I of Council Directive

67/548/EEC is applicable to creosote.

(14) 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.

(15) Van Rooij,

J.G.M., Dermal

Exposure
Hydrocarbons Among Workers, Thesis
Nijmwegen 1993.

to
Polycyclic Aromatic
ISBN 90-9007080-X,

L 329/72

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Official Journal of the European Communities

22.12.1999

(59)

It has to be noted, that all effects observed in animal
in
in epidemiological
experiments or
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

(60) Exposure of consumers can occur during the use of
for
preparations containing creosote (or carbolineum)
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

(61) 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
from disused
Environmental
contamination has been traced by an analysis of selected
PAH compounds, notably B[a]P.

creosote

plants.

(62) 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.

(63) 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
slow.
compartments
environmental
Creosote residues can persist for many years in the
environment (> 20-30 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
by microbial
PAHs
degradation and the higher molecular weight
compounds by photooxidation and sedimentation.
the more water soluble
Microbial degradation of
anaerobic
aerobic
PAHs
conditions. The PAH constituents have been shown
to bioaccumulate in aquatic species.

occurs

under

and

(64) 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
difficult to ascribe their levels to any particular source
such as creosote treated wood.

(65) A study (16) 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 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

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

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

pollution by

originating

PAHs

environmental
creosote are scarce.

(16) 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.

(17) L. L. Ingram and others, 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.

(18) bhk 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 329/73

3.1.2. The Swedish position

a

is

insufficient. Creosote

(68) The Swedish authorities hold the opinion that the level
of protection of human health guaranteed by Directive
94/60/EC is
substance
resulting from a specific distillation range of coal tar
containing some 30 substances/substance groups that
are documented as carcinogenic and mutagenic. As
proved by the classification through IARC, creosote has
properties extremely hazardous to health. Apart from its
carcinogenic property it is a strong skin irritant and in
combination with sunlight can cause photoallergic
reactions such as blistering and serious eczema.

extremely important construction material for terraces,
bridges and other outdoor constructions in Sweden. Due
to the large number of wooden buildings, and the high
proportion of
its territory covered by surface water
(lakes/rivers) where the use of creosote-treated wood
consequences.
might have
Increased use of creosote-treated wood by consumers is
likely to have negative effects on human health and the
environment.
the
substitution principle to ensure that creosote is only
used where it is the best alternative.

environmental

regulation

localised

current

utilise

The

(69) The Swedish authorities underline that there are no data
to support the conclusion that creosote with a B[a]P
content less than 50 ppm presents an acceptable risk.
On the contrary, they assert that, as B[a]P is genotoxic,
there is not
threshold dose below which exposure
presents no health risks. The Swedish authorities recall
the Declaration made at the meeting of the Technical
Adaptation Committee in 1994 (mentioned above)
which according to them shows that
there was no
satisfactory basis for assessing the carcinogenicity of
complex coal-tar based substances containing less than
50 ppm B[a]P.

(75)

that

(70) Creosote has properties detrimental to health and the
environment, which means
its use should be
limited to applications where long-lasting protection is
required. Contact with skin should be avoided as far as
possible. Creosote should therefore not be used by
consumers who do not have the necessary protective
equipment.
pressure
impregnation, the workers are informed and protected
as far as possible.

industrial

case

the

of

In

(74) Furthermore, Sweden claims

that

Photochemical
process

it has a special
national need due to its geographical location with low
annual average temperatures and low annual average
leading to reduced degradation of
insolation levels,
creosote.
the main
aromatic
decomposition
hydrocarbons (PAH), of which creosote is composed.
Several
types of bacteria can break down creosote.
Sweden’s geographical situation means that the number
of warm, sunny days are fewer there than in most other
countries of
lower
photochemical and bacterial decomposition of creosote.

the Community. The result

conversion
for

polycyclic

is

is

In summary,
the Swedish authorities underline that
there are strong health and environmental objections to
amending the Swedish provisions on creosote. The
Swedish Government is not intending to ban the use of
creosote completely, it wishes to see the continued uses
of creosote in applications for which it is considered the
best alternative.
the approval
procedure for each individual product to ensure that
this goals are met. The rules of creosote are part of the
general Swedish policy of
restriction the use of
dangerous chemicals.

is the objective of

It

(71) Creosote oils have been developed and are already
available on the market where certain fractions of the
most dangerous substances have been removed. It has
not emerged that the B[a]P content in the product has
any effect on the impregnation method, the creosote
uptake in the wood or the durability of the protection.
These products have B[a]P contents of less than 10 ppm.
This development may be halted if products with up to
50 ppm are accepted.

(72) With regard to the environmental impact, the Swedish
authorities underline that creosote is highly toxic to
certain aquatic organisms and that certain components
are bioaccumulating. Creosote components leak from
treated piles in both fresh and salt water.

(73) Sweden has a special national need because, unlike the
the EU, wood is an

situation in other countries of

3.1.3. Evaluation of the Swedish position

(76) The issue of health effects of creosote has been
examined very carefully in the studies mandated by the
Commission. All known findings have already been
mentioned in the general information part above.

less

than 50 ppm B[a]P might

(77) Experimental data that have become available only
the carcinogenic risk of creosote
recently show that
be
containing
non-negligible. However, it has to be underlined, that all
available information was considered in great detail
during the deliberations
leading to the Community
provisions regarding the classification of creosote and
the provisions of Directive 94/60/EC. Also, all adverse

L 329/74

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Official Journal of the European Communities

22.12.1999

health effects of creosote 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 to exposure to
creosote in any non-occupational contexts.

far

exposure

as possible

(78) The analysis carried out by the Swedish authorities
during product approval is based upon the principle of
seeking to minimise risk wherever possible, both by
reducing as
to harmful
substances and by substitution of alternative products
perceived to be more acceptable. In the case of creosote
the alternatives are copper-chronium-arsenic derivatives
(CCA). The Swedish position towards the acceptability
of a risk linked to the use of a chemical substance is
therefore
than the Community
position applied towards
the adoption of Directive
94/60/EC.

somewhat different

could

Swedish

(79) According the study mandated by the Commission,
provide
authorities
the
assessments
documentation regarding
carried out during approval of
the four creosote
products which are currently allowed for industrial use,
nor were documents made available which proved the
claim that all four products contain less than 50 ppm
B[a]P and 3 % water soluble phenols.

concrete

neither

the

(80) There are, however, strong indications to believe that
this is the case. According to the study mandated by the

Commission, the four products have been authorised
under a voluntary agreement between the authorities
and the relevant
trade association. The letter had
undertaken its own research to reduce and eliminate
creosote bleeding from treated wood, which leads to
increased exposure of the environment and of workers
handling or working with treated poles. There has been
pressure on the wood impregnation industry to reduce
leaching from the principal clients, the electricity and
telecommunication companies. The new specifications
to be produced from a much
require the product
narrower distillation range than standard creosotes
which eliminates many of the volatile and high boiling
components (esp. PAH,
including B[a]P). The sample
technical approval document obtained by the consultant
from a major industrial user and an internal document
from the Chemicals Inspectorate also specify that the
B[a]P content should be lower than 50 ppm. As a
result, all approved products
in Sweden are thick,
viscous oils consisting of up to 100 % of creosote within
the specific distillation range for respective oils. The oils
are suitable only for use in a specialised,
industrial
pressure/vacuum impregnation process designed for
optimum impregnation of round timber in particular.
The technique results in timber containing an average of
135 kg creosote/m3 and gives a very durable wood
(approximately 40 to 50 years).

claim that

(81) Regarding the issue of a specific situation in Sweden,
an exceptionally
the
in Sweden is partially
important construction material
corroborated by data on the consumption of creosote
treated wood in Europe in 1990:

treated wood is

Table 2

Consumption of creosoted wood in Europe (1990) (19)

Country

Annual use 1990
(m3/y)

Annual use/capita
(10ﬂ3 m3/cap.y)

Annual use/km2
(m3 / km2.y)

Germany

Netherlands

Spain

Italy

United Kingdom

Sweden

France

(19) Source: See footnote 18.

150 000

100 000

93 000

74 000

65 000

57 000

45 000

2,3

6,7

2,4

1,3

1,1

7,1

0,8

0,4

2,9

0,2

0,3

0,3

0,1

0,08

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Official Journal of the European Communities

L 329/75

Country

Annual use 1990
(m3/y)

Annual use/capita
(10ﬂ3 m3/cap.y)

Annual use/km2
(m3 / km2.y)

Belgium

Norway

Ireland

Finland

Denmark

Europe

26 000

20 000

20 000

13 000

5 000

1 000 000

2,6

5,0

5,0

2,6

1,0

2,0

0,8

0,06

0,3

0,04

0,1

0,2

(82) The use of creosoted wood has remained relatively
constant since 1990. In 1995, 74 400 m3 of wood were
railway
treated with creosote (63 % poles,
sleepers), about one quarter was exported.

the rest

the use of

(83) Table 2 shows that the use of creosote treated wood per
capita in Sweden is the highest in Europe, whereas the
use per km2 is among the lowest. The latter figure
might be misleading as it can be reasonably assumed
treated wood is more
that
concentrated in the areas of higher population density
(e.g. southern Sweden). The high use per capita could
lead to a potentially higher exposure of the Swedish
population. On the other hand, the low figure of use
the likelihood of
per surface seems to indicate that
contact for an individual of the population is rather low.

creosote

E x p o s u r e o f t h e e n v i r o n m e n t

(84) For the exposure of the environment, the use of treated
wood per surface area is the decisive indicator. It can be
seen from Table 1 that this figure is particularly low in
Sweden; even a significant increase would not bring it
to or above the European average.

(85)

It is clear that the construction of jetties will not lead to
wooden constructions in water as dense and intense as
continuous water bank protection in the Netherlands.
Therefore, the surface of treated wood in contact with
water is much smaller, the water volume higher. No
data were presented by the Swedish authorities
to
local negative effects on
support
that
In
aquatic organisms occur in the vicinity of
and
contrast, based on measured leaching
assuming the presence of sediment, where creosote is
strongly
the
Commission concludes that concentrations of creosote
in water are least an order of magnitude lower than
toxic levels.

study mandated

jetties.
rates

the statement

absorbed,

the

by

(86) The study could identify data regarding the soil around
treated posts (some of them having received very high
impregnation quantities). Already at distances of 10 to
15 cm from the treated posts, the concentrations of
various
normal
background concentrations. A second study by Uppsala
University indicated that no creosote was found in soil
at a distance of 10 cm from creosote treated poles after
a 37-year period.

agreement with

PAHs were

in

by

the Commission

(87) No measured data were available to support the Swedish
claims regarding the specific situation for degradation of
creosote. Although, the irradiation levels in Sweden are
the study
lower than in most other Member States,
mandated
that
out
points
photochemical degradation is an important mechanism
only in places where light can penetrate, i.e. at the soil
surface and the top of the water column. For creosote
treated posts in soil, the majority of leached material
will not be at the surface as the mobility is very low, in
it will be absorbed to the
the aqueous environment
sediment. Hence,
be
important
the overall degradation of creosote.
Bio-degradation of creosote is slow in general. No data
were provided concerning the effects of temperature on
bio-degradation and whether this would have significant
effects on the degradation of creosote in Sweden in
comparison to other Member States.

photodegradation will

not

for

(88) Overall, Sweden did not prove, and the study mandated
by the Commission could not confirm, that there is a
specific situation in Sweden regarding the risks to the
environment from creosote in comparison to the other
Member States.

H u m a n e x p o s u r e

(89)

If Sweden 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 possibilities to re-use old treated
consumers,

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Official Journal of the European Communities

22.12.1999

wood, higher B[a]P content of creosote used industrially
is rather
for railway sleepers and poles. However,
impossible to estimate how big this increase will be, as
the product has not been on the market for over 20
years. The same holds for the question of how much
would exposure increase if the rules regarding use of
newly treated and old treated wood were changed.

it

the Dutch authorities in their request)
is 2,1 ng/kg
bw/day. The worst case exposure is thus clearly lower.
For a scenario of exposure of six weeks a year it would
be 0,7 ng/kg bw/day and thus still higher than the
calculated worst case exposure.

(90)

the overall

trying to assess

Instead of
increase in
exposure, and similar to the proceeding of the Dutch
and German authorities in their respective requests, the
study mandated by the Commission proceeds to two
exposure assessments under the conditions of Directive
94/60/EC: an adult member of the public construction a
private jetty using creosote treated wood and brush
application of creosote and children playing on creosote
the
treated wooden play equipment.
creosote was assumed to contain 50 ppm B[a]P.

In both cases

(91) Before commenting on the actual evaluations, it has to
be noted that this is not specific to Sweden and would
apply in a similar manner to other Member States.

(92) The study mandated by the Commission elaborates in
great detail on the issue of absorption through the skin
trying to use various models as proposed by the EC’s
technical guidance documents on risk assessment,
which, however, were not really applicable. The study
therefore carries out a reasonable worst case exposure
calculation. Experimental data on the uptake of PAH
components through the skin and into the system were
used to determine the amount of creosote absorbed
rather than relying upon the model calculations. The
creosote
derived
experimentally for absorption of PAHs through human
skin (20).

employed

uptake

was

rate

(93) The worst-case scenario for exposure through dermal
contact for the individual constructing a jetty results in
0,43 ng/kg bw/day B[a]P for a creosote containing
50 ppm B[a]P (eight hours exposure per day, 50 %
covering of open skin, average bodyweight (bw) and
skin surface). Assuming that a member of the public
spends eight hours a day for two weeks every year
using creosote products and creosote treated wood for
construction purposes (such as building and maintaining
jetties), the permissible daily dose for a probability of
cancer in 1 in 100 000 (based on the calculations by

(94) The worst-case scenario for exposure through dermal
contact for children playing on dry wood treated with
creosote (two hours a day, 50 % covering of open skin,
body weight of 15 kg) amounts to 0,85 ng/kg bw/day.
It is interesting to note that the Dutch authorities,
in
their model calculation, though using a slightly different
methodology, have arrived at a daily exposure dose of
2 ng/kg bw/day, which is very close to this result and
thus increases confidence. Assuming that a child plays
for two hours a day during six months of the year, the
permissible daily dose (based on the Dutch assumptions)
for a risk of one to 100 000 is 4,8 ng/kg bw/day, and
thus higher than the permissible dose is 2,4 ng/kg
bw/day and the uptake 1,7 ng/kg bw/day (and thus
approaching the limit).

(95) Although there are clearly many uncertain assumptions
in these calculations, overall, the results indicate that it
can not be
certain
individuals who could be exposed at levels approaching
the permissible daily doses, but
for the general
population this is unlikely to be the case.

there may be

excluded that

that

3.1.4. Evaluation of the Scientific Committee for Toxicity,

Ecotoxicity, and the Environment

(96) During elaboration of Directive 94/60/EC,

to

progress

technical

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

(20) Van Rooij J.G.M., de Roos J.H.C., Bodelier-Bade M.M., Jongeneelen
F.J., Absorption of PAHs through human skin: differences between
anatomical
and
and
Environmental Health, 83 (1993), p. 355.

Journal of Toxicology

individuals,

sites

(97) This study (21) was made available to the Commission in
January 1998. The study tested the carcinogenic effects

(21) See footnote 6.

22.12.1999

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Official Journal of the European Communities

L 329/77

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 (twice a
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

(98) The Commission submitted this study and all other
documents
exposure
information on creosote to the Scientific Committee for
Toxicity, Ecotoxicity and the 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.

(99) The SCTEE observes

is

no

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
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 due to presence of the other 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

of

are

cancer

Extrapolation

skin painting

study
insufficient.

(100) Data to fully evaluate the relevance of effects seen in a
for human exposure
mouse
situations
skin
carcinogenicity data from mice to human situation also
entails a number of uncertainties leading to difficulties
in directly using cancer potency data from mice to
assess
risk in humans. Species dependent
sensitivity of dermal exposure to the carcinogenic
actions of creosote will be affected by morphology and
the skin, by metabolic activation and
physiology of
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 on wood treated
with creosote is therefore difficult.

(101) From the data contained in the Fraunhofer study, the
SCTEE calculated a T 25 carcinogenic potency value for
pure B[a]P of 13 (cid:181)g/kg bw/day. The T 25 is the chronic
daily dose per kg bodyweight, which induces 25 % of
the test animals tumours at a specific tissue site within
that 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

(102) Should the value of exposure calculated in the study
mandated by the Commission 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 life-time 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 10
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 assumption). Using the
exposure doses calculated by the Dutch authorities
(2 ng/kg bw/day) or the German authorities (2,62 ng/kg
bw/day) would increase these risks proportionately.

(103) 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
the risk is thus slightly or
selected exposure model,
more clearly above a value of 1 (cid:215) 10ﬂ5, which proposed
as an acceptable risk level for genotoxic carcinogens in
drinking water by the World Health Organisation.

creosote-treated wood has

(104) 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 the
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(cid:151)1,6 mg, which would result
in daily exposures of 12 to 63 ng/kg bw for a person
weighing 70 kg (i.e. much higher than the dermal
exposure).

(105) Overall the SCTEE concludes:

1. (cid:151) Given the

and the
genotoxiticy 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

L 329/78

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Official Journal of the European Communities

22.12.1999

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

the

of

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 six 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

(106) The Swedish authorities have not shown, nor could it
be demonstrated through further
a
specific situation exists in Sweden with regards to the
the
general pollution of environment by PAHs, or
exposure of man and the
to PAHs
originating in the use of creosote and creosote treated
wood or that this would be the case if Sweden applied
the provisions of Directive 94/60/EC.

environment

research,

that

(107) However,

the Commission has

received additional
information in the framework of similar requests from
the Netherlands, Germany, 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
the
adoption of the Community Directive.

study carried out after

(108) 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 with 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

(109) However,

i.e.

such measures can only be regarded as
justified under the condition of being in conformity
with the general principle of proportionality,
the
measures do not have to exceed what is suitable and
necessary for the pursuit of
the legitimate objective.
Consequently, the legislation notified to the Commission
by the Swedish authorities can be approved only insofar
as this 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.

(110)

(111)

an approval

to be noted that

the Swedish provisions
It has
concerning creosote
system
comprise
without specifying a particular limit of 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
relating to protection of the environment or working
environment. This means that
is not possible to
approve national measures that are less protective than
those laid down in the Directive. Therefore, the Swedish
national
its
application in practise has shown that no product was
approved that was not respecting the limits established
by Directive 94/60/EC. A different application of the
national Swedish legislation cannot be approved under
Article 95(4).

legislation can only be

approved as

it

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 (22) 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, on
ongoing research project under the Fourth Framework
Technological
Programme
for
Development
is reviewing the production chain and
in-service life of poles treated with creosote (23).

Research

and

3.2. The absence of arbitrary discrimination

(112) Article 95(6) obliges the Commission to verify that the
national provisions are not a means of arbitrary

(22) OJ L 123, 24.4.1998, p. 1.
(23) 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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Official Journal of the European Communities

L 329/79

discrimination. According to the ruling of the Court of
the absence of discrimination means that no
Justice,
different treatment should be given to similar situations,
nor similar treatment to different situations.

not create an advantage for a national production of
creosote.

(113) The limitation on marketing and use of products
containing creosote in the Swedish legislation is general,
relating to all products that contain creosote, which are
designed to used in the way the Orders specify. The
Swedish 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.

3.3. The absence of a disguised restriction on trade

(114) 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
the
be legally placed on the market
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,

(115) The Commission mandated a study (24) on the effects of
the Swedish legislation on trade and competition. The
study undertook in particular to look at the volume and
value of
trade with other Member States which is
affected; the interest, if any, which Sweden may have in
using its national rules on creosote-treated wood to
to
promote
creosote-treated wood. Various representatives from the
creosote and timber trade were consulted, as well as the
relevant Swedish regulators.

substitutes

national

interest

in

a

(116) There is no producer of creosote in Sweden and the
four approved products are all imported from other EU
legislation does
countries. Consequently,

the national

(24) Environmental Resources Management, Effects

Competition of
Creosote, Final report, August 1997.

the Retention by Sweden of

on Trade
and
its National Rules on

(117) There are three producers of creosote-treated timber in
Sweden, operating in five plants. Treated wood is
imported from Finland, Norway and the Netherlands.
Exports occur to most of
the other Member States.
Wood for export can only be treated with the products
approved in Sweden. Therefore
is not any
advantage for Swedish exporters as they have the same
limitations in their production than the other European
Union producers that want to import into Sweden.

there

it has

to be noted that

(118) Concerning the alternative products (e.g. chromium-
copper-arsenic salts, boron compounds or other organic
all wood
compounds),
in
preservation products are classified as pesticides
In
Sweden and are subject
to the same regulations.
addition,
any wood
does
preservatives and has them all imported. Therefore the
limitations on creosote do not hide a protection of an
alternative product in the market and are not disguised
restrictions on Trade.

produce

Sweden

not

(119) As established before, there is a concern with regards to
human health, and it appears that the Swedish request
for a derogation is motivated by a desire to maintain
control on the use of a potentially harmful product
rather
in
alternatives to it in favour of Swedish producers.

trade in that product or

than to affect

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

3.4. The absence of obstacles to the function of the

Internal Market

(121) This condition, which is established by Article 95(6),
first subparagraph, is new in comparison to the text of
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
In fact, any
establishment of
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 procedure for derogation provided for
the Commission
the EC Treaty,
by Article 95 of

the internal market.

L 329/80

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Official Journal of the European Communities

22.12.1999

considers that, in the context of the Article 95(6), the
the internal
concept of obstacle to the operation of
market has to be understood as a disproportionate effect
in relation to the pursued objective.

(122) According to the study by ERM (25),

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.

(124) 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
the industrial
impregnation of wood by professional
wood preservation companies. The remaining 10 % of
creosote are used by individual consumers, mostly in
the United Kingdom and Ireland.

(125) 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

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

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

(126) 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 Sweden.

Table 3

Production, sales and trade in creosote in Europe (26)

Country

Number of producers

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

Sales of creosote
(t/year) 1995

Trade with Sweden

Austria

Belgium

Danmark

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

Yes

No

Yes

No

No

No

No

No

No

(cid:151)

No

(25) See footnote 24.
(26) Source: See footnote 24, and: 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.

22.12.1999

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Official Journal of the European Communities

L 329/81

(127) There are no producers of wood preservatives

in
containing creosote or

Sweden and all products
alternatives are imported.

(128) Even were Directive 94/60/EC implemented in Sweden,
it is, according to the study, unlikely that the operators
of the wood impregnation plants would revert to using
creosote formulations with a higher B[a]P content since
the approved products are of superior quality and most
clients would not purchase poles impregnated with old
formulations. The new products are slightly more
expensive than the old ones, but the difference in terms
of the overall cost of a treated pole is marginal.

(129) Referring to the effect of

the Swedish legislation on
creosote for the European internal market, the study
shows that Swedish exports of creosote-treated timber
are slightly greater than imports. But the introduction of
the restriction on marketing and use of creosote and
creosote-treated timber, in 1985 and 1990, did not have
any significant or lasting impact on the market trend at
the time, and did not introduce a barrier to trade with
the European Member States.

(130)

In addition, the fact that the more restrictive rules on
the use and marketing on creosote and creosote-treated
timber existed in Sweden before it became a member of
the European Union, shows that the goal of that more
restrictive legislation is not to create obstacles to the
function of the internal market.

(131) Taking into account

the preceding observations,

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

the internal market

subject

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

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

HAS ADOPTED THIS DECISION:

Article 1

The provisions relating to marketing and use of creosote and
creosote-treated wood, contained in Order (1985:836) and the
National Chemical Inpectorate’s regulations KIFS (1990:10) 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

(132)

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 Sweden pursuant
to the former Article
100a(4) and examined under the new Article 95(4) and
(6) of the EC Treaty:

This Decision is addressed to the Kingdom of Sweden.

Done at Brussels, 26 October 1999.

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

and are to be admitted,

For the Commission

Erkki LIIKANEN

Member of the Commission