1999/833/EC: Commission Decision of 26 October 1999 on the national provisions notified by the Federal Republic of Germany concerning the limitations of the marketing and use of creosote (notified under document number C(1999) 3425) (Text with EEA relevance) (Only the German text is authentic
Date: 1999-10-26
Institutions: European Commission
Subjects: Germany, marketing restriction, national law, pesticide, public health, wood product

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Official Journal of the European Communities

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COMMISSION DECISION

of 26 October 1999

on the national provisions notified by the Federal Republic of Germany concerning the
limitations of the marketing and use of creosote

(notified under document number C(1999) 3425)

(Only the German text is authentic)

(Text with EEA relevance)

(1999/833/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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

3 % (= 30 g/kg) by mass. Wood treated with creosote or
preparations containing creosote not respecting those
limits may not be placed on the market.

Whereas:

I. FACTS

1. Community legislation: Directive 94/60/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
prohibition and restriction of
certain
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

(2) European Parliament and Council Directive 94/60/EC (3),
which amends Directive 76/769/EEC for the 14th time,
harmonises among other things the use and marketing
of creosote and similar coal tar distillates, as well as
preparations containing them, by limiting the content of
in the
one
following B[a]P, and water extractable phenols when
used for woodtreatment
(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

component, Benzo-[a]-pyrene,

specific

(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

(cid:145)For use

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

second time

a

2. The German national provisions

(4) The German legislation uses

The

German

the term (cid:145)tar-oils(cid:146)

to
to the provisions in
designate the substances subject
question.
Ordinance
Tar-Oil
(Teer(cid:246)lverordnung), which contains the national provisions
concerning creosote, was notified to the Commission in
1990, promulgated on 5 June 1991, and entered into
force on 1 October 1991. As part of
the general
the legislation on manufacturing,
reorganisation of
the Tar-Oil
marketing, and use,
Ordinance where included on 1 November 1993 in two
ordinances,
Ordinance
(Chemikalien Verbotsverordnung, ChemVerbotsV) and the
Hazardous Substances Ordinance (Gefahrstoffverordnung,

the provisions of

Chemicals

Banned

the

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GefStoffV) without changing the substantive contents.
The provisions of the two ordinances concerning tar-oils
were amended by an ordinance of 19 Sepember 1994.

(c)

treated wood may not be used inside buildings
or as a consumer product within the definitions
of the Foodstuffs and consumer products Act
(e.g.
food packaging, hygiene products, and
toys).

(5) The

term (cid:145)tar-oils(cid:146)

are
produced as liquid by-products of the coking of coal or
wood, including those designated by the term (cid:145)creosote(cid:146).

substances

covers

that

all

(6) The legislation with regards to tar-oils in Germany is

now comprised of:

(cid:151) provisions relating to the placing on the market,
incorporated into the Banned Chemicals Ordinance
in section 17 of the Appendix to paragraph 1,

(cid:151) provisions relating to special labelling requirements,
incorporated
Substances
Ordinance in paragraph 12 in conjunction with
Appendix III, No 15,

the Hazardous

into

(cid:151) provisions

relating
into

and
use,
Substances
incorporated
Ordinance in paragraph 15 in conjunction with
Appendix IV, No 13.

to
production
the Hazardous

(7)

In principle, the German regulations place restrictions
on the production, marketing and use of substances and
preparations containing creosote and wood treated with
such substances, depending on various limit values of
the B[a]P content: 5 ppm, 50 ppm and 500 ppm.

(8) The German legislation applies to both, creosote and
preparations containing creosote, as well as products
made of wood, partially or completely, that have been
treated with creosote or products containing creosote.

(9) Restrictions on marketing and use of creosote and wood

treated with creosote are the following:

1. Sale

to

private

consumers

preparations
prohibited, irrespective of their B[a]P content.

containing

of
creosote

creosote
is

and
completely

2. Creosote with a B[a]P content lower than 5 ppm:

(a) use

is only

allowed

in closed

industrial

installations,

3. Creosote with a B[a]P content in the range of 5 to

50 ppm:

(a) placing on the market is only allowed for use in
installations by application of

closed industrial
certain impregnation techniques:

(cid:151) pressure impregnation with final vacuum

(cid:151) other impregnation processes for the partial
impregnation of wooden posts, which
ensure an in-depth protection, especially the
dipping in the hot-cold process with final
reduction of creosote content at the surface

(cid:151) other processes ensuring equal or better

protection of man and environment;

(b) sale of wood treated with such creosote is
prohibited if impregnation has not been done
abovementioned
according
techniques;

to one of

the

(c) sale of treated wood is completely prohibited for
use inside buildings, on children’s playgrounds
or other purposes with regular human skin
contact, or as a consumer product within the
definitions of
the Foodstuffs and consumer
products Act.

4. Creosote with a B[a]P content in the range of 50 to

500 ppm:

(a) use is permitted only for industrial treatment of
railway sleepers and electricity poles in a process
of pressure impregnation with final vacuum,

(b) sale of wood treated with such creosote is
prohibited except for use as railway sleepers or
electricity poles intended for export to countries
where
increased
conditions
climatic
wood protection.

require

(b) sale of wood treated with such creosote by
brushing, spreading, or dipping is prohibited,

5.

In addition, all types of creosote with B[a]P content
up to 500 ppm may be placed on the market for

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exclusive use in countries, where climatic conditions
require increased wood protection.

6. Previously treated railway sleepers, electricity poles
and posts may be marketed again as such (even
when the indicated limits are exceeded). Such
marketing is, however, prohibited if:

(cid:151) impregnation took place less than 15 years ago

(cid:151) fresh cut sites have not been permanently sealed

or covered

(cid:151) wood is intended for use inside buildings,

in
children’s playgrounds or other purposes with
regular human skin contact

(cid:151) wood

products

are

intended

for

private

consumers

(cid:151) the products are consumer products under the

Foodstuffs and consumer products Act.

(10) The German national

legislation regarding tar-oils was
amended for a second time by an ordinance of 12 June
1996. The latter transposed a part of the provisions of
Directive 94/60/EC into German law.
first
contain
version,
the German regulations did not
provisions concerning the content of water
soluble
requirements
phenolic
creosote
of
regarding

compounds
creosote,
in
the minimum drum size

In their

and a

specific

compounds

containing 50 to 500 ppm B[a]P or specific labelling
requirements of preparations containing such creosote,
whereas the Directive establishes a maximum content of
3 % phenolic
labelling
requirement for creosote containing more than 50 ppm
B[a]P. These provisions, being more restrictive than the
initial German regulations, have been incorporated in
the Banned Chemicals Ordinance and the Hazardous
Substances Ordinance by the amending Ordinance in
1996. However the labelling requirement
is slightly
different from the Community provisions. The German
national legislation requires the following wording: (cid:145)For
exclusive use in the pressure impregnation with final
vacuum for
railway sleepers and electricity poles(cid:146).
Furthermore the second amending decree restricted even
further the use of old treated wood: in addition to the
restrictions mentioned above, previously treated railway
sleepers, electricity poles and posts may only be
marketed (cid:145)as such(cid:146) again.

3. Comparison between the German provisions and

Directive 94/60/EC

(11) Table 1 shows in detail

the differences between the
restrictions on the marketing and use of creosote and
wood treated with creosote depending on the B[a]P
content as laid down in Directive 94/60/EC and the
German legal system in force at the date of adoption of
the Directive.

Table 1

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

Council Directive 94/60/EC

German regulations

B[a]P < 5 ppm

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

Sale of creosote to private consumers and for
use inside buildings prohibited

Industrial use only in closed plants

applied by brushing,

treated wood prohibited if creosote
Sale of
spreading, or
was
dipping, or for use in inside areas or as a
consumer product within the definitions of
Foodstuffs and consumer products Act

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Council Directive 94/60/EC

German regulations

B[a]P in range
5-50 ppm

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

of

Sale
prohibited

creosote

to

private

consumers

Industrial use only in closed plants with
certain impregnation techniques:

(cid:151) pressure impregnation with final vacuum

(cid:151) other processes with equal protection of

man and environment

(cid:151) other impregnation processes for partial
impregnation of wooden posts which
ensure an in-depth protection, especially
dipping in hot-cold process with final
reduction of creosote content on the
surface

of

prohibited

treated wood

Sale
if
impregnation has not been done with the
abovementioned techniques. Sale of
treated
wood completely prohibited for use inside
buildings, on children’s playgrounds or other
purpose with regular skin contact, or as a
consumer product within the definitions of
Foodstuffs and consumer products Act.

of

private

creosote

Sale
consumers
to
prohibited. However, all types of creosote with
B[a]P content up to 500 ppm may be placed
on the market for exclusive use in countries,
where climatic conditions
require increase
wood protection

Use permitted only for industrial treatment of
railway sleepers and electricity poles
in a
process of pressure impregnation with final
vacuum

Sale of treated wood prohibited except for use
as railway sleepers or electricity poles intended
for
climatic
conditions require increased wood protection.

countries where

export

to

B[a]P 50-500 ppm

Restrictions on sale of creosote:

(cid:151) no sale to private consumers

(cid:151) use

only

permitted

in

industrial

installations.

Minimum drum size 200 l. Special labelling
required

Treated 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 foodstuffs

(cid:151) for containers for growing purposes

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

skin contact

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Council Directive 94/60/EC

German regulations

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

Sale
and use of
products totally banned

creosote

and treated

Sale and use of creosote and treated products
totally banned when B[a]P content > 500 ppm
(no provisions on water soluble phenols!)

Old treated wood

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

Previously treated railway sleepers, electricity
poles and posts may be marketed again (even
when the limits indicated are exceeded).

Such marketing is, however, prohibited if:

(cid:151) impregnation was

less

than 15 years

before

(cid:151) fresh cut sites have not been sealed

(cid:151) wood is intended for use inside buildings,
other

in
or
purpose with regular skin contact

playgrounds

children’s

(cid:151) wood products are intended for private

consumers

(cid:151) the products

the

under
products Act

are
Foodstuffs

consumer products
consumer

and

(12)

In summary the German provisions are more restrictive
in several aspects:

applications (railway sleepers, electricity poles for
export),

(cid:151) creosote and preparations containing creosote may
not be sold to the private consumer irrespective of
their B[a]P content,

(cid:151) placing on the market and use of previously treated
wood are further restricted in comparison to the EC
Directive.

(cid:151) placing on the market of creosote and preparations
containing creosote with a B[a]P content up to
500 ppm is only possible for export to countries
with climatic conditions requiring enhanced wood
preservation and, domestically,
for industrial use.
the use of
Furthermore,
creosote and preparations containing creosote with
regards to process technology have been established
depending on the B[a]P content (5, 5 to 50, and 50
to 500 ppm),

specific obligations

for

(cid:151) newly treated wood may not be placed on the
market unless certain obligations with regards to the
treatment process have been met. Additional
restrictions apply for the use of wood treated with
creosote containing less than 50 ppm. Wood treated
with creosote containing B[a]P in the range 50 to
two specific
500 ppm may only be used for

II. THE PROCEDURE

(13) Directive 94/60/EC was adopted on 20 December 1994.
The Directive had to be transposed into the national law
of the Member States no later than one year after its
adoption, i.e. by 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).

(14) By letter of 4 July 1995, Germany transmitted a report
(dated 19 June 1995) by which they informed the
European Commission that on grounds of health
protection Germany deemed it necessary to continue to
apply the already existing legislation relating to (cid:145)tar-oils(cid:146),
and requested a derogation on the basis of the former
Article 100a(4) of
the EC Treaty from Directive
94/60/EC with regards to creosote. It was also stated
that some amendments would be made in order to

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incorporate a part of the provisions of the Community
These
the
Directive
amendments were notified on 8 July 1996.

legislation.

national

into

(15) By letter of 6 December 1995, the Commission invited
the other Member States to present their observations
the former Article
on the German request under
100a(4). The Commission received comments
from
Denmark, Sweden, The Netherlands, Austria, and the
United Kingdom.

(20)

(16) Denmark recalls

that

in its opinion, creosote is a
dangerous substance to both human beings and the
environment, and its use should be restricted as far as
possible, or banned completely. Denmark therefore fully
supports the idea that Germany should be given the
rules with
option to apply more stringent national
regards to creosote.

to have the greatest effects on German companies.
the more stringent
Austria therefore considers
measures constitute neither an arbitrary discrimination
nor a disguised restriction on trade.

that

the

standards

In contrast, the United Kingdom objects to the request
from Germany. The UK authorities consider that the
German request
is based on a disagreement with
scientific consensus, which was reached at Community
level during the
adoption of Directive 94/60/EC.
Following the UK opinion, all Member States should
accept
single market
measures, unless there are special circumstances which
would lead to an increase of risk in one Member State if
similar provisions applied. The UK is not aware of any
special circumstances in Germany, which would justify
the application of more stringent measures. The UK also
points out that the threshold of 50 ppm B[a]P used in
the Directive is entirely consistent with the classification
criteria used in Directive 67/548/EEC.

imposed by

(17) Sweden shares the German views regarding the risks
posed by creosote and wood treated with creosote and
has no objections to the notified more stringent German
provisions. Sweden underlines that creosote has adverse
impacts as it is highly toxic to certain
environmental
are
aquatic
bioaccumulating.
and
creosote-treated wood should therefore be limited in
order to minimise the risk of damage. Sweden recalls
that it had also notified its intention to maintain its
national provisions on creosote in view of
special
circumstances applying in its territory.

components
creosote

certain
use

organisms

The

and

of

(18) The Netherlands recall that, they had made a statement in
the Council underlining that the level of protection for
public health, the workplace, and the environment set
insufficient. The Netherland
by the Directive was
themselves already had notified a request for derogation
under
the former Article 100a(4). The Netherlands
consider that the German measures meet a real need,
and cannot be seen as a hidden barrier to trade, and
the
therefore
Commission.

confirmation

support

their

by

(19) According to Austria,
is

the
the primary objective of
the protection of consumer
German provisions
health, which is the objective of
the former Article
100a(3). Austria agrees to the position that the cancer
risk to consumers from direct dermal exposure to B[a]P
containing tar-oils or wood treated with such tar-oils is
considerable as the risks are highest during direct brush
application of tar-oils (dermal and inhalatory exposure)
and the (unnecessary) use of
treated wood inside
buildings. Austria therefore considers the continuous
application of the national provisions as justified. The
German regulations are proportional as they reduce the
risk of exposure by addressing specific situations, while
the free circulation of goods is only hindered to a very
limited extent. Futhermore, the national measures seem

(21) 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, signed at Amsterdam, 2 October 1997,
entered into force. By letter of 24 August 1999 the
General
the Commission informed
Germany 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.

Secretariat of

III. ASSESSMENT

1. Applicable Rules

the former Article 100a of

(22) 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
numbering of all Articles,
the amended Article has
the Treaty establishing the
become Article 95 of
European Community.

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

(24)

In the absence of specific provisions extending their
application, the old provisions of Article 100a(4) of the
EC Treaty are regarded as repealed from the day of the

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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

2. Consideration of admissibility

(25) The notification submitted by Germany 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.

for maintaining them after

notified, for which a Member State wishes to obtain
the date of
approval
implementation of a Community harmonisation measure,
that
must have been adopted before the adoption of
harmonisation measure.
therefore
exclusively deals with the legislation existing before
adoption of Directive 94/60/EC as notified in the request
of 4 July 1995. The provisions
introduced by the
amending Decree of 12 June 1996 (notified on 8 August
1996), for which an approval has not been requested,
implement certain provisions of Directive 94/60/EC and
are not subject to this Decision.

This Decision

3. Assessment of merits

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

the

or

(27) Directive 94/60/EC had to be transposed by the
Member States by 20 December 1995 and enforced by
20 June 1996. Germany notified its national legislation
relating to (cid:145)tar-oils(cid:146) which it intended to maintain on 4
July 1995 and thus before the date foreseen for
application of the national provisions transposing the
Directive.

(28) The national provisions

for which derogation was
sought had entered into force on 1 October 1991 and
thus before Directive 94/60/EC was
adopted (20
December 1994).

(29)

(30)

law that were more

In the notification Germany announced its intention to
legislation in order to transpose
amend the national
those parts of the provisions of Directive 94/60/EC into
national
restrictive. By the
amending ordinance of 12 June 1996, which was
notified to the Commission on 8 August 1996, a
maximum permissible content of water soluble phenols,
a list of specific substances being covered by the term
(cid:145)tar-oil(cid:146), and a minimum drum size and specific labelling
requirement
for tar-oils containing 50 to 500 ppm
B[a]P were included. The existing restrictions for old
treated wood were also slightly modified.

In the light of what precedes, the Commission considers
that the request of the Federal Republic of Germany for
derogation from Directive 94/60/EC as notified on 4
July 1995 under
is
admissible under Article 95(4) of
the EC Treaty.
the national provisions
According to Article 95(4),

former Article 100a(4)

the

(31)

to assure that all

the Commission has

In accordance with the provisions of Article 95 of the
Treaty,
the
conditions enabling a Member State to avail itself of the
possibilities of derogation provided for in this Article
are met. The Commission has,
in particular, to verify
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)).

(32) Germany has based its

request on the need for
protection of human health. In order to substantiate its
request
for derogation, Germany submitted a brief
justification for the more restrictive national measures
which was substantiated by three documents: A report
from the Senate Commission on the testing of materials
injurious to health of the German Research Association
(MAK Commission) on the suitability of B[a]P as a
marker substance for mixtures of polycyclic aromatic
hydrocarbons originating
in combustion processes
(completed in 1984), a study on the carcinogenic
properties of B[a]P (4), and a collection of data on the
identity, availability, and application of alternative wood
protection agents
toxicological and
including their
ecotoxicological effects. However, it was not possible to
examine the merits of the request based exclusively on
this information.

(33)

to verify whether

In order
provisions
creosote-treated wood,

concerning marketing

the German national
of
and

use
indeed necessary

and

are

(4) 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.

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Official Journal of the European Communities

22.12.1999

contamination

proportionate to that end, the Commission mandated a
study to an external consultant to assess the situation of
environmental
in
Germany (5). In addition, the findings of three further
studies (6), 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
Germany.

creosote

by

(34)

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
German request was notified, these substantial efforts of
the Commission to find the elements necessary for the
justification of the maintenance of the German 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 provisions of
the responsibility of
proving that these measures are justified, lays with the
requesting Member
procedural
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,

the

a

as

designed

specifically

(35) 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
long-term
potential,
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
below. 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.

(5) Environmental resources management, Scientific evaluation of the
German request
for derogation from provisions of Council
Directive 94/60/EC concerning creosote, Final report, 24 April
1996.

f(cid:252)r

(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
(Germany),
Umweltcarcinogene, Gro(cid:223)hansdorf
December 1995.
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.
W. S. 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, Hannover, October 1997.

3.1. Justification on grounds of major needs

3.1.1. Creosote general information

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

is a mid-heavy distillate of coal

It

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

(cid:151) acenaphthene

(cid:151) naphthalene

(cid:151) phenanthrene

(cid:151) anthracene

(cid:151) fluorene

(cid:151) fluoranthene

(cid:151) chrysene

(cid:151) tripenylene

(cid:151) benzo[a]anthracene

(cid:151) benzo[b]fluoranthene

(cid:151) benzo[k]fluoranthene

(cid:151) benzo[a]pyrene

(38) 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 phenols 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.

(39) Modification to both the physical

and chemical
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

It

22.12.1999

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Official Journal of the European Communities

L 329/51

application, by incorporating components with a lower
boiling point, which is sometimes called carbolineum.
Directive 94/60/EC does not make a distinction:
it
covers and treats in an identical way a whole range of
different coal tar distillates, all of them specified by their
names, Einecs and CAS numbers.

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

industrial

(41) The most important properties of creosote are:

(cid:151) high fungicidal efficacy

(cid:151) high insecticidal efficacy

(cid:151) long-term persistence

(cid:151) resistance to leaching and weathering.

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

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

Human health effects

(43) Despite the fact that creosote has been used as a wood
preservative for over a century,
there is very little
published data on the effects on humans of sustained
exposure to creosote. Many of the studies are rather old
and do not always conform to modern standards with
regards to documentation.

(44) Exposure can occur via inhalation,

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

(45) Skin photosensitivity from coal tars has been described
by a number of authors.
Irritation symptoms, pitch
warts, skin discoloration and dermal tearing have been
reported to occur among workers exposed to creosote.
The most recent study on workers exposed to creosote
in Sweden and Norway was published in 1992 (8). The

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

study examined workers exposed to creosote between
1950 and 1975. The investigators found a somewhat
incidence than expected and an
lower
total cancer
increased risk of cancer of
the skin and lip and of
non-Hodgkin lymphomas. However, the composition of
the creosote was not documented and the authors
conclude that the small number of cases did not permit
valid conclusions. The increase could be attributed to
exposure both to creosote and to sunlight. One other
study (9)
found an increased risk of mortality from
for brickmakers exposed to creosote
scrotal cancer
during the period 1911 to 1938. Again, neither the
B[a]P content of the creosote nor a clear dose response
relationship is known.

life-time (10),

(46) Mostly based on an animal experiment, where the skin
of mice war regularly exposed to B[a]P solutions in
the International
acetone during their
Agency for Research on Cancer (IARC) has classified
creosote as a group 2A human carcinogen. The IARC
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

(47) For

several years, experts

from the Member States
examined the issue of classification of creosote, other
coal tar distillates, and further (cid:145)complex substances(cid:146) in
the framework of Council Directive 67/548/EEC of 27
June 1967, relating to the classification, packaging and
labelling of dangerous substances (11), as last amended
by Directive 99/33/EC (12). Drawing largely on the same
data as the IARC, agreement was reached during the
elaboration of Commission Directive 94/69/EC (13), 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
the substance contains less than
can be shown that
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.

(48) The choice of a limit of 50 ppm in 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) See footnote 4.
(11) OJ L 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

to Council Directive

workers, Scand. J. Work environment health, 1992:18, p. 26.

67/548/EEC is applicable to creosote.

L 329/52

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Official Journal of the European Communities

22.12.1999

legislation in order to distinguish carcinogenic from
non-carcinogenic coal-tar distillates has been accepted
by the Member States in the working group for the
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 below.

through the

skin by measuring

(49) Little is known about the toxicokinetics of creosote in
humans or experimental animals. Only very recent
studies have investigated quantitative absorption of
PAHs
excreted
metabolites of pyrene (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
for
rapidly. Any
example B[a]P were
estimation of B[a]P uptake based on the pyrene marker
will therefore result in an overestimation and can be
considered conservative.

than pyrene,

absorbed

less

(50)

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

investigations

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

(15) Van Rooij,

J. G. M., et al.,

(cid:145)Absorption of polycyclic aromatic
hydrocarbons through human skin: differences between anatomical sites
and individuals(cid:146), J. Tox. environ. health, 38, 1993, p. 355.

(16) Van Rooij,

J. G. M.,

(cid:145)Dermal exposure to polycyclic aromatic
ISBN 90-9007080-X,

among workers(cid:146), Thesis

hydrocarbons
Nijmwegen 1993.

Environmental effects

facilities often being the source of

(52) Environmental contamination by creosote has been
reported in a number of countries, with old wood
the
treatment
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.

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

(54) The main characteristics of PAHs in the environment

are:

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

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

usually

is

(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 photooxidation and sedimentation.
the more water soluble
Microbial degradation of
PAHs
and Anaerobic
conditions. The PAH constituents have been shown
to bioaccumulate in aquatic species.

aerobic

occurs

under

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

22.12.1999

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Official Journal of the European Communities

L 329/53

(56) A study (17) in Sweden has shown that after 40 years in
soil, creosote impregnated poles had lost a part of the
compounds contained in creosote, notably 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 in organic matter.

of

creosote-treated wood. Migration

(57) The presence of elevated levels of PAH in aquatic
environments has often been attributed to the presence
creosote
of
components from treated 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.

(60) Germany holds the opinion that the stricter national
measures are necessary due to the high carcinogenic
potential of
tar-oils. A reduction to the level of
protection as established by Directive 94/60/EC would
lead to an unacceptable additional risk to the population
of contracting cancer.

(61) Depending on their origin and on the production
tar-oils varies.
the carcinogenic potency of
process,
level of
Individual
every tar-oil component is impracticable. Nevertheless,
in order to be able to take a position on the effect level,
the MAK-Kommission has carried out an extensive
evaluation of the available data and has concluded that:

the carcinogenic effect

testing of

(cid:151) B[a]P can be used as a reference substance for

estimating the carcinogenic effect of tar-oils

(cid:151) the carcinogenic effect of tar-oils is greater by a
factor of 7 to 20 than the effect due to the
B[a]P-content alone.

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

pollution by

originating

PAHs

environmental
creosote are scarce.

3.1.2. The position of Germany

is

by

in general

(59) Germany justifies its request for maintaining the more
in place of Directive
restrictive national provisions
the level of
94/60/EC exclusively on the claim that
the Community
health protection guaranteed
provisions
insufficient, especially with
regards to health hazards to consumers. Germany does
not share the assessment that hazards related to the use
of creosote containing less than 50 ppm B[a]P and
wood treated with such creosote are very low, as it has
been agreed during
elaboration of Directive
94/69/EC, the 21st adaptation to technical progress of
Directive 67/548/EEC, according to which coal-tar
distillates containing B[a]P in concentrations lower than
the limit value of 50 ppm B[a]P need not be classified
as carcinogens. Germany bases
judgment on a
study (20) published in 1984 presenting the results of
carcinogenicity tests with B[a]P.

the

its

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

(cid:145)Migration of creosote and its components
from treated piling sections in a marine environment(cid:146), Proc. ann.
meet. AM. wood preserv. assoc. 78, 1982, p. 120. See also
footnotes 8 and 13.

(19) See footnote 8.
(20) See footnote 4.

however,

(62) Therefore, Germany agrees that, for pragmatic reasons,
the effect level of tar-oils can be assessed on the basis of
their content of certain constituents, for example B[a]P.
cannot
quantified
This,
assessments,
different
the
carcinogenic substances
tar-oils are not
the substances have been
identical and not all of
identified and classified. For many of
them, precise
effect levels are not known.

lead
contents of
in various

since

fully

the

to

consumer.

the private

(63) According to Germany, the primary aim of the national
regulations restricting tar-oils is the protection of the
the
In addition,
health of
provisions have
effects of protecting
workers and the environment. As the determining factor
for the broader restrictions was the hazard to the health
of the private consumer, Germany does not proceed
the
with any further analysis of
professional user or the environment.

the exposure of

the positive

(64)

In estimating the hazards to the private consumer, the
following types of potential
exposure have been
identified by Germany:

(cid:151) skin contact during the use of
through brush application),

tar-oils (generally

(cid:151) skin contact in the course of installing/carrying out

carpentry work on the treated wood,

(cid:151) skin contact with the installed treated wood,

(cid:151) inhalation exposure in the course of using the

tar-oils,

(cid:151) inhalation exposure to tar-oil components which

escape from the treated wood as gases.

L 329/54

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Official Journal of the European Communities

22.12.1999

(65)

is recognised that

the level of actual exposure to
It
shows a marked dependency on individual
tar-oils
behaviour, as is usual
in the consumer sector. When
considering the exposure provisions, therefore, account
must be taken of those situations where the level of
exposure is considerably above the average (worst-case
scenarios).

and use of wood treated with creosote containing B[a]P
in the range 50 to 500 ppm are necessary, as despite
the reduction in tar-oil content at the surface of wood
treated that way, there is still a considerable hazard to
relatively frequent and even
health in the case of
either measured, or
occasional
estimated are presented to support these assertions.

contact. No data,

(66) Germany considers that according to the data of the
only study establishing a dose-response relation for
exposure to B[a]P (21), a solution containing 50 ppm of
B[a]P causes skin tumours in 95 % of the animals. A less
concentrated solution, containing 25 ppm of B[a]P, still
produces tumours in 44 % of the animals, which proves
that also at this concentration B[a]P is a strong dermal
carcinogen in mice.

(70)

In what concerns the restrictions on the sale of used
wood which was treated previously, they are considered
necessary since there is an unacceptable cancer risk
from skin contact as in the past tar-oils had higher
the wood
B[a]P contents,
can be
surface,
considerable even after a number of years, and tar-oils
migrate from freshly cut sites of the wood. No data,
either measured, or estimated, are presented to support
this assertion.

the content of
solar

especially under

tar-oil at

exposure,

(67) Germany justifies their claim that the level of protection
established by Directive 94/60/EC is insufficient, by
analysing more thoroughly one of
the five exposure
scenarios mentioned above: through the calculation of a
risk assessment for children playing on wood treated
with creosote containing 25 ppm B[a]P. Frequency of
contact is assumed to be once a week over five years,
tar-oil each time. Assuming a
transferring 10 (cid:181)l of
lifetime of 70 years,
the cumulative lifetime risk
calculated by Germany is 0,02 (2 %).

(71) Finally, according to Germany,

less hazardous and
equally effective substitutes for creosote are available for
legislation bans or
all applications where the national
restricts more severely the use of tar-oils than the EU
Directive.
the German
request contains a report on various wood preservation
agents, giving the names as well as the health and
environmental hazards presented by the substitutes.
However, tar-oils are not covered by the report.

In support of

this opinion,

(68) Germany thus arrives at

the

conclusion that

the
In
cumulative lifetime risk is in the percent range.
internationally acceptable cancer
for
contrast,
risks
substances are situated in the range of
individual
1 (cid:215) 10-5 (i.e. 0,001 %). The potential cancer
risk of
tar-oils containing 25 ppm of B[a]P and of wood treated
with such oils, therefore, is not acceptable. Furthermore,
the exposure dose is estimated for children playing on
treated wood, only taking into account dermal exposure
and
probably
underestimating the actual risk (which could be higher
owing to inhalation and oral ingestion).

according

Germany,

thus,

to

required

(69) Germany justifies the other part of their more restrictive
national measures,
impregnation
the
technologies and the restrictions on the marketing and
use of treated wood, also by referring to this evaluation
according to which the health risks to consumers would
otherwise
prescribed
unacceptable. Only
be
impregnation processes
a high depth of
penetration of the tar-oils and therefore permanent and
effective protection of the wood. The reduction of the
tar-oil content at the wood surface, which is required
following the treatment,
to
minimise the health hazards. Simple brush application
by consumers leads to ineffective impregnation as well
as high exposure during application and from elevated
surface concentrations. Restrictions on the marketing

is necessary in order

ensure

the

(21) See footnote 4.

3.1.3. Evaluation of the German position

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

(72) The study made by ERM undertook to examine all
available
information regarding the possible direct
exposure of the German population to unusually high
doses of creosote through products sold to consumers
and by contact with creosote-treated wood, as well as
regarding the possible direct exposure of the German
aquatic environment
to high doses of PAH from
creosote-treated wood in order to establish whether
there was a specific situation, albeit not
invoked by
that could justify maintaining the more
Germany,
restrictive national measures
in place of Directive
94/60/EC.

(73) As mentioned in the

for wood treatment

chapter
containing general
the application of coal-tar
information on creosote,
distillates
is only one possible
source of emissions of B[a]P and other PAHs into the
environment. Emissions occur in association with a
broad range of human activities, the main sources today
being traffic, industrial activities, and energy generation.
Table 2, originating from the ERM study gives an
overview on estimated emissions of B[a]P in several
European countries.

22.12.1999

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Official Journal of the European Communities

L 329/55

Table 2

Estimated emissions of B[a]P in selected European countries (22)

Country

Total emissions
(t/year)

Source
(%)

Fuel
combustion

Transport

Industry

Others

Denmark

Sweden

Norway

Germany

United Kingdom

France

Netherlands

Europe

1

6

8

215

49

54

7

1 409

57,5

42,0

14,9

79,9

61,2

26,2

20,0

69,3

0,0

2,0

72,6

1,3

0,7

34,5

4,8

6,0

21,2

48,2

9,6

17,1

32,8

34,3

67,5

23,3

21,3

7,8

2,9

1,7

5,3

5,0

7,7

1,8

(74)

It is clear from Table 2 that the use of creosote (which would be comprised in category (cid:145)others(cid:146) or
(cid:145)industry(cid:146)) constitutes only a small contribution to overall B[a]P levels in the German environment.

(75) A recent study (23) using the German Environmental Specimen Bank (supported by the German
Ministry of Environment) which provides a historical databank of a range of different species from
selected locations within Germany, has concluded that PAH concentrations have decreased
significantly in the atmospheric and marine environment in the period 1985 to 1994.

(76) Table 3 gives an overview of the consumption of creosoted wood in Europe.

Table 3

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

Country

Annual use in 1990
(m3/y)

Annual use/capita
(10ﬂ3m3 /cap.y)

Annual use/km2
(m3/km2.y)

Germany

Netherlands

Spain

Italy

United Kingdom

Sweden

France

Belgium

Norway

Ireland

Finland

Denmark

Europe

150 000

100 000

93 000

74 000

65 000

57 000

45 000

26 000

20 000

20 000

13 000

5 000

1 000 000

2,3

6,7

2,4

1,3

1,1

7,1

0,8

2,6

5,0

5,0

2,6

1,0

2,0

0,4

2,9

0,2

0,3

0,3

0,1

0,08

0,8

0,06

0,3

0,04

0,1

0,2

(22) Source: van den Hout KD, 1994. (cid:145)The impact of atmospheric deposition of non-acidifying pollutants on the quality

of European forest soils and the North Sea(cid:146), main report of the Esquad project, p. 145.

(23) J. Jakob, G. Grimmer, A. Hildebrandt, (cid:145)Trends in environmental pollution by PAH in Germany during the period

1985 to 1995(cid:146), published in Polycyclic aromatic compounds (1996).

(24) bkh consulting engineers, Foundation of the appeal against the EC of Directive on creosote, Final report, Delft,

1 July 1995, p. 6.

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Official Journal of the European Communities

22.12.1999

(77)

In Europe a total of 1 million m3 of creosoted wood
was used in 1990. In absolute figures, Germany is the
largest user of creosoted wood. However, the use per
capita is not exceptionally high (rank 8 out of 12), the
consumption per km2 is above average, but far lower
than in The Netherlands. It is important to note that the
data are from 1990, i.e. before the German regulations
on tar-oils entered into force.

(78)

It is clear that there are no data supporting the existence
of a specific situation in Germany with regards to
pollution of the environment by PAH and B[a]P owing
to the use of creosote and creosote-treated wood or the
overall use of creosote-treated wood, which would
necessitate a more restrictive national policy.

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

(79) Before commenting on the actual evaluations regarding
the risks to human health, it has to be noted that none
of the problems raised in this chapter are specific to
Germany, and that all of them would apply in a similar
manner to other Member States.

(80) With regards to the risks to human health, it has to be
noted that Germany neither presents new data (i.e. data
unknown during the deliberations preparing Directive
94/60/EC) nor data demonstrating a higher exposure to
creosote of
the general population in Germany in
comparison with the other Member States. The claim
that the fact that the cancer risk of creosote containing
less than 50 ppm B[a]P has been underestimated is
sustained by referring to the same study that was used
by the IARC for classification and was also discussed as
a basis for assessing the carcinogenic potency of B[a]P
and
the
the
tar-oils
(cid:145)Workshop
carcinogenicity of
complex and petroleum derived
substances(cid:146) organised by the EC in Ispra in 1992, which
let to the classification rules of Directive 67/548/EEC.
This means that the study received due consideration
before the adoption of Directive 94/60/EC.

during

on

(81) The estimations made by Germany during the risk
for children playing on creosote-treated
assessment
wood rely on a series of assumptions, which need to be
compared with similar evaluations made by other
assessors, notably those of the Dutch authorities and the
study mandated by the Commission in the framework
of the Swedish request for derogation under the former

Article 100a(4) concerning the same Directive, as well
as the Scientific Committee of Toxicity, Ecotoxicity, and
the Environment.

(82) The German assessment is fundamentally different from
the others in so far as the dose of exposure to B[a]P is
simply assumed to be identical to the total quantity of
B[a]P transferred on the skin and is not calculated based
on measured absorption data. The daily exposure dose
to B[a]P according to Germany
is 39,3 ng/day
(assuming a transfer once a week of 10 (cid:181)l creosote of a
density of 1,1 g/ml containing 25 ppm B[a]P).

(83)

In contrast to the other studies, Germany does not take
into account the body weight and skin specificities of
the exposed individual humans by directly using a
dose-response relationship from a study performed on
mice. When normalising the calculated exposure to a
body weight (bw) of 15 kg (as the other assessors have
done), the daily dose amounts to 2,62 ng/kg bw/day.
This is somewhat higher but not very different from the
results of the Dutch authorities (2 ng/kg bw/day) and
the
study mandated by the Commission in the
framework of the Swedish request (0,85 or 1,7 ng/kg
bw/day).

is

(84) Despite the fact that the daily dose of exposure to B[a]P
calculated by Germany (when normalised to the body
from the dose
weight)
thus not very different
(and the study
estimated by the Dutch authorities
mandated by the Commission for the Swedish request),
the results for the calculated risk are,
in fact, very
different. According to the Dutch authorities, the risk is
only slightly above an acceptable level (in the range of
1 (cid:215) 10ﬂ5)
for wood treated with creosote containing
50 ppm B[a]P and daily exposure over 10 years.
In
contrast, Germany calculates a risk which is orders of
for wood treated with
magnitude higher
creosote containing only 25 ppm B[a]P with exposure
once a week over five years, i.e. a much lower exposure
results in a much higher risk. The assumptions made by
Germany could thus lead to a clear overestimation of
the risks involved.

(2 (cid:215) 10ﬂ2)

(85) This interpretation is supported by the ERM study (25),
which criticises the risk assessment made for children
playing on creosote-treated wood presented in the
German request
and not
quantitative. ERM points out that if the assumptions and
calculations made by Germany were applied to exposure
data measured for workers in occupational studies, all
workers should have contracted skin cancer (risk higher
than 300 %) which obviously was not the case.

comprehensive

as not

(25) See footnote 5.

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Official Journal of the European Communities

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(86) Nevertheless, based on the assessments carried out by
the Dutch authorities, and those contained in the two
studies mandated by the Commission in the framework
of
the German and Swedish requests for derogation
under the former Article 100a(4), the result that the
likely exposure to B[a]P for children playing on creosote
treated wood, which are mentioned above, is such that
the risk is unacceptable,
the claim of Germany that
Furthermore,
cannot
both
consultants recommend that
the Commission, before
taking a decision, awaits the results of the long-term
carcinogenicity study that was ongoing at that time (26)
(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 below.

dismissed.

totally

be

3.1.4. Evaluation of the Scientific Committee for Toxicity,

Ecotoxicity, and the Environment

to

progress

technical

(87) 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, the Commission and the Member
States agreed in a Joint Declaration to review the
the study
situation in the light of
concerning the
coal-tar
distillates currently undertaken on initiative of industry
and in collaboration with the IARC.

carcinogenic properties of

the results of

(88) This study (27) 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. Owing 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 products 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 over a period 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.

(89) 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

containing

scientific

and

(26) See footnote 7.
(27) See footnote 7.

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.

(90) The SCTEE observes

that

there

the Fraunhofer

including B[a]P,

study is
well-designed and reaffirms the carcinogenic potential of
coal-tar preparations. Owing to the genotoxic potential
of PAHs
is no threshold
concentration determining carcinogenicity. The study
indicates clearly a linear dose-response relationship
between the B[a]P
administered
preparations and the number of animals developing
tumours. Both preparations have a fivefold higher
than pure B[a]P,
potency to induce skin tumours
presumably
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.

to the presence off

content of

due

the

are

exposure

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

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

tested had a

that

children playing on creosote

(93) Should the value of exposure estimates for the scenario
treated wood as
of
calculated by Germany (2,62 ng B[a]P per kg bw/day)
approximate the true exposure, this would result in a
life-time cancer risk of 2,52 (cid:215) 10ﬂ4 for a life long daily
exposure which gives clear concern, a risk of 3,6 (cid:215) 10ﬂ5
for a daily exposure over ten years out of 70 (the Dutch

L 329/58

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Official Journal of the European Communities

22.12.1999

assumption) and 1,8 (cid:215) 10ﬂ5 for a daily exposure over
five years out of 70 (the German assumption). Using the
doses as calculated by the Dutch authorities (2 ng/kg
bw/day) or in the study mandated by the Commission
for the Swedish case (0,85 or 1,7 ng/kg bw/day), would
reduce these risks proportionally.

(94) Based on the most recent study with regards to the
dose-response relation for dermal carcinogenicity of
creosotes as derived by the SCTEE and the exposure
model chosen by Germany, the calculated risk is several
orders of magnitude lower than estimated by Germany.
Depending on the exposure model selected, the risk is,
however, slightly or more clearly above a value of
1 (cid:215) 10ﬂ5, which is proposed as an acceptable risk level
for genotoxic carcinogens in drinking water by the
World Health Organisation.

(95) 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 63 ng/kg bw for a person weighing 70 kg (i.e.
much higher than the dermal exposure).

(96) Overall the SCTEE concludes:

1. (cid:151) Given the

the

and the
genotoxicity of B[a]P
skin-application
Fraunhofer
outcome of
study, there is 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.

(cid:151) 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 B[a]P dose. However, the cancer
potency of
the creosote preparation was five
times higher than judged from its B[a]P content.

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
concern. However,
estimated
the
exposure is some 6 to 30 times lower than the

highest

the

oral exposure of the adult population to B[a]P in
food.

(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

(97) Germany has neither

claimed, nor

could it be
demonstrated through further research, that a specific
situation exists in Germany with regards to the general
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 of Germany applied the provisions of
Directive 94/60/EC.

(98) However,

the Commission has

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

study carried out after

(99) 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

(100) The legislation notified to the Commission by Germany
takes account of the general principle of proportionality,
i.e. the measures do not seem to exceed what is suitable
and necessary for the pursuit of the legitimate objective,
as this legislation provides for the possibility to use
creosote
creosote when
compatible with the needs for the protection of health
and the environment.

and products

containing

(101)

In accordance with Article 95(7) of
the
Commission is already examining the appropriateness of

the Treaty,

22.12.1999

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Official Journal of the European Communities

L 329/59

adapting to technical progress
the provisions of
Directive 94/60/EC regarding creosote. In addition, the
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 (28) 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 (29).

3.2. The absence of arbitrary discrimination

(102) 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.

(103) The limitations on marketing and use of products
containing creosote in the German ordinances is based
on their content of B[a]P: 5, 50 or 500 ppm. The
restrictions apply without distinction to all products,
whether
in Germany or
imported. The same applies for wood treated with
preparations
containing creosote. The Commission
considers, therefore, that there is no evidence that the
German regulations can be used as a means of arbitrary
discrimination between economic operators
in the
Community.

are manufactured

they

3.3. The absence of a disguised restriction on trade

(104) 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
Article 95(6)
the restrictions
is intended to prevent
based on the criteria of paragraph 4 being applied for
inappropriate
constituting
economic measures introduced to impede the import of
products from other Member States in order to protect
indirectly national production.

and in reality

in the rest of

reasons,

(28) OJ L 123, 24.4.1998, p. 1.
(29) Research

contract

framework
FAIR5-CT98-3933
programme for RTD), Integrating the processes involved in the
production of creosoted utility poles.

(fourth

to

all

examine

available

(105) The Commission mandated a study (30) to analyse the
effects on trade and competition of the retention by
Germany of its stricter national provisions. The study
undertook
information
regarding the volume and value of
trade with other
the interest which Germany
Member States affected,
might have in using its national rules to promote a
national
interest in substitutes, and the interest which
Germany might have in using its national rules to
promote alternatives to creosote-treated wood. To this
end, interviews took place with regulators in Germany,
with industry representatives, and with the relevant
industry associations.

(106) According to the study, Germany imports all

the total production of

the
creosote for domestic consumption (about 6 000 t). On
the other hand,
the only
producer of creosote in Germany is exported (30 000 t,
it is to be taken into
mostly to the USA). However,
account
that export of creosote containing up to
500 ppm B[a]P is only permitted to countries with
specific climatic conditions requiring enhanced wood
protection. This means
in practice the same
that
restrictions apply to exports as to the national market.
Therefore the national legislation on creosote does not
try to protect the national market by creating barriers to
imports while allowing unrestricted exports. Germany
also seems to import creosote treated timber; exact
figures were, however, unavailable.

(107) More recent and higher-value timber treatment biocides
(like metal or boron salts) can substitute for creosote.
These products are produced and imported in Germany
in a similar manner to creosote.

(108)

It was established before that there is a real concern
with regards to human health related to the use of
creosote and treated timber. Therefore, the protection of
health seems to be the real goal of maintaining the
legislation, and not the creation of disguised
national
barriers to trade.

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

3.4. The absence of obstacles to the functioning of the

internal market

(110) This condition, which is established by Article 95(6),
first subparagraph, is new in comparison with the text
of the former Article 100a(4) of the EC Treaty. This

(30) 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.

L 329/60

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Official Journal of the European Communities

22.12.1999

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

effect

(111) Germany asserts that the effects of the more restrictive
German legislation on the functioning of the internal
market can be considered to be small, and this for the
following reasons:

(cid:151) tar-oils are unavoidable byproducts of the coking
industry, having a low economic value. Major
producers are located in Germany and the United
Kingdom,

(cid:151) the parties most affected by the more stringent
the German
are
national provisions
producers, which clearly demonstrates
the
that
national regulations have not been enacted as a
means of economic discrimination or disguised
restriction on trade.

therefore

(112) Germany further affirms

there are no other
measures possible which would have a smaller adverse
effect on the functioning of the internal market while
retaining a comparable level of protection.

that

(113) According to the study by ERM (31),

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

(cid:151) creosote is produced as a byproduct, not a primary

one,

(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.

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

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

(115) Producers of creosote are located in Germany, Austria,
Italy,
Belgium, Denmark, France, The Netherlands,
Spain, and the UK. 90 % of creosote is used for the
industrial impregnation of wood by professional wood
preservation companies. The remaining 10 % of creosote
is used by individual consumers, mostly in the UK and
Ireland.

(116) 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
in the
specific
the
creosote. Most, but not all, of
the producers can
produce creosote containing less than 50 ppm B[a]P.

concentration of

components

(117) Table 4 gives a survey of the situation with regard to
location,
producers of
whether they can produce creosote with B[a]P content
< 50 ppm and whether
they have had trade with
Germany.

geographic

creosote,

their

Table 4

Production, sales and trade in creosote in Europe (32)

Country

Number of producers

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

Sales of Creosote
(tonnes/year) 1995

Trade with Germany

Austria

Belgium

Denmark

1

1

1

No

Yes

Yes

(cid:151)

3 900

0

Yes

No

Yes

(31) See footnote 30.
(32) Source: see footnote 30, and: W. D. Betts, (cid:145)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(cid:146), Tar Industries Services, Chesterfield (UK), December
1995.

22.12.1999

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Official Journal of the European Communities

L 329/61

Country

Number of producers

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

Sales of Creosote
(tonnes/year) 1995

Trade with Germany

France

Germany

Netherlands

Spain

United Kingdom

Italy

Greece

Ireland

Sweden

Finland

1

1

1

2

2

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

Yes

Yes

Yes

Yes/No

Yes

(cid:151)

(cid:151)

(cid:151)

(cid:151)

(cid:151)

6 750

5 000

5 900

13 950

20 000

11 100

6 700

3 000

6 000

5 000

No

(cid:151)

Yes

No

No

No

No

No

Yes

Yes

(118) Marketing and use of creosote have been regulated in
Germany since 1991. The effect of the legislation has
been mainly the elimination of the market for brush
application (private consumers) and the introduction of
restrictions on the professional market
(treatment
process, use of creosote containing less than 50 ppm
B[a]P except for railway sleepers and electricity poles for
export).

could result from the fact that only wood treated with
creosote containing less than 50 ppm B[a]P can be
creosote
imported, whereas wood
containing up to 500 ppm B[a]P can be exported.
However,
the quantity of such
wood exported seems to be very small.

the study states that

treated with

(119) As a result the German creosote market is restricted to
producers who are able to produce creosote with B[a]P
level of < 50 ppm, which eliminated the Austrian
creosote producer from the German market. Most of the
producers in other Member States can comply with the
German regulations.
In fact, almost all domestically
consumed creosote is imported from other Member
States. A very small market for creosote containing up
to 500 ppm B[a]P still seems to exist (exemption in the
national
is
virtually unknown.

for export) but

this market

regulations

(120) Due to the restrictions, competition has increased and
the margins have been lowered in creosote products for
marketing and use within Germany. The decline in the
market has mainly and disproportionately affected the
German producer who had to reduce its creosote
output,
surplus
output into lower value products such as carbon black
feedstock and electrode pitch. This situation does not
seem to have changed after the approval of Directive
94/60/EC.

focus on export markets,

re-direct

(122) The market for railway sleepers has declined from a
peak of 200 000 sleepers per year during the 1950s to
approximately 30 000 sleepers per year in 1995. The
main reason is the replacement by concrete as the
increased mass of the sleepers is required for modern
lines used by high-speed trains. The market
for
creosote-treated poles is also declining as salt treatment
(power
is
transmission; telecommunication, agriculture). A review
on behalf of the Federal Environment Agency into the
German market for treated timber in 1992 concluded
that about 2 million m3 of wood is used per year in
Germany. 750 000 m3 is pressure treated with salt,
which accounts for 70 to 90 % of the overall market for
the treatment of wood.

applications

increasingly

used

all

in

to

have

declining

(123) The market for the treatment of wood with creosote
appears
the
been
implementation of the German legislation, although the
legislation appears to have accelerated the trend. Trends
to use alternatives for the main applications of treated
wood (railway sleepers and poles) had already existed
before the implementation of the German regulations
and were thus merely reinforced.

prior

to

(121)

In what concerns the creosote treated timber, there are
some five companies
treating wood with creosote
(pressure/vacuum impregnation) and it is primarily used
for
and power/telecommunications
poles. Market distortion in trade with treated wood

railway sleepers

(124)

In conclusion, the direct volume and value of trade in
creosote affected by German regulations is small since
the use of creosote has already been effectively reduced.
As the national legislation has been in place since 1991,

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Official Journal of the European Communities

22.12.1999

the maintenance of
legislation after the
the national
approval of Directive 94/60/EC does not change the
previously existing situation, which did not seem to
have provoked significant distortions of
the internal
market for treated timber or for creosote.

(125) Taking into account

the preceding observations,

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

IV. CONCLUSION

(126)

of

the

the

light

above

considerations,

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

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

and are to be admitted,

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

HAS ADOPTED THIS DECISION:

Article 1

tar-oils,
The provisions relating to marketing and use of
contained in the Banned Chemicals Ordinance, section 17
appended to paragraph 1, and the Hazardous Substances
Ordinance, paragraph 12 in conjunction with Appendix III, No
15, and paragraph 15 in conjunction with Appendix IV No
13, as notified on 4 July 1995 are approved.

Article 2

This Decision is addressed to The Federal Republic of
Germany.

(cid:151) can be considered justified on grounds of major

need of protection of human health,

Done at Brussels, 26 October 1999.

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

For the Commission

Erkki LIIKANEN

Member of the Commission