HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 195/46
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Official Journal of the European Union
27.7.2011
DIRECTIVES
COMMISSION DIRECTIVE 2011/71/EU
of 26 July 2011
amending Directive 98/8/EC of the European Parliament and of the Council to include creosote as
an active substance in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) A
stakeholder
consultation
was
launched
on
30
April
2008. The outcome of the consultation was made
public and discussed in the 30th meeting of represen
tatives of Members States Competent Authorities for the
Having regard to the Treaty on the Functioning of the European
implementation of Directive 98/8/EC concerning the
Union,
placing of biocidal products on the market.
Having regard to Directive 98/8/EC of the European Parliament
(5) The
competent
authority
report
was
reviewed
by
the
and of the Council of 16 February 1998 concerning the placing
Member States and the Commission. In accordance
of biocidal products on the market (
with Article 15(4) of Regulation (EC) No 1451/2007,

1 ), and in particular the
second subparagraph of Article 16(2) thereof,
the findings of the review were incorporated, within
the Standing Committee on Biocidal Products on
17 December 2010 in an assessment report.
Whereas:
(6) It
appears
from
the
assessment
report
that
wood
preserv
atives containing creosote may be expected to satisfy the
requirements laid down in Article 5 of Directive 98/8/EC,
(1) Commission Regulation (EC) No
1451/2007 of
when applied on wood in some of the scenarios
4 December 2007 on the second phase of the 10-year
evaluated. Furthermore, there were strong indications in
work programme referred to in Article 16(2) of Directive
the abovementioned stakeholder consultation that there
98/8/EC of the European Parliament and of the Council
are considerable socioeconomic benefits of using
concerning the placing of biocidal products on the
creosote in certain applications. Life cycle analyses
market ( 2 ) establishes a list of active substances to be
submitted and published in the context of the consul
assessed, with a view to their possible inclusion in
tation have suggested that, in certain cases, no appro
Annex I, IA or IB to Directive 98/8/EC. That list
priate alternatives to creosote exist, which are less
includes creosote.
damaging to the environment. It is therefore appropriate
to include creosote in Annex I.
(2) Pursuant
to
Regulation
(EC)
No
1451/2007,
creosote
has
been evaluated in accordance with Article 11(2) of
Directive 98/8/EC for use in product-type 8, wood
(7) However,
for
certain
wood
use
scenarios
presented
in
the
preservatives, as defined in Annex V to that Directive.
assessment report, unacceptable risks for the
environment were identified in the risk assessment.
(3) Sweden
was
designated
as
rapporteur
Member
State
and
submitted the competent authority report, together with
(8) Furthermore,
creosote
is
considered
to
be
a
non-
a recommendation, to the Commission on 31 October
threshold carcinogen and is classified as carcinogen
2007 in accordance with Article 14(4) and (6) of Regu
category 1B in accordance with Regulation (EC)
lation (EC) No 1451/2007. It follows from the report
No 1272/2008 of the European Parliament and of the
that the evaluation only covers Grade B and Grade C
Council of 16 December 2008 on classification, labelling
creosote as specified in European Standard
and packaging of substances and mixtures, amending and
EN 13991:2003.
repealing Directives 67/548/EEC and 1999/45/EC, and
amending Regulation (EC) No 1907/2006 ( 3 ).
( 1 ) OJ L 123, 24.4.1998, p. 1.
( 2 ) OJ L 325, 11.12.2007, p. 3.
( 3 ) OJ L 353, 31.12.2008, p. 1.

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27.7.2011 Official
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Union L
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(9)
Creosote, which is a mixture of hundreds of compounds,
chemicals and pesticides under the relevant Union legis
contains mainly polycyclic aromatic hydrocarbons
lation, take appropriate measures to control existing
(‘PAHs’). Some of these have been considered by the
chemicals and pesticides which exhibit characteristics of
Committee for Risk Assessment of the European
POPs.
Chemicals Agency as persistent, bioaccumulative and
toxic (‘PBT’; anthracene ( 1 )) or very persistent and very
bioaccumulative (‘vPvB’; fluoranthene, phenanthrene and
pyrene ( 2 )) in accordance with the criteria set out in
(13) Directive
2000/60/EC
of
the
European
Parliament
and
of
Annex XIII to Regulation (EC) No 1907/2006 of the
the Council of 23 October 2000 establishing a
European Parliament and of the Council of
framework for Community action in the field of water
18 December 2006 concerning the Registration,
policy ( 5 ) identifies PAHs as priority hazardous
Evaluation, Authorisation and Restriction of Chemicals
substances, from which pollution of surface waters
(REACH), establishing a European Chemicals Agency,
through discharge, emission or loss must cease or be
amending Directive 1999/45/EC and repealing Council
phased out.
Regulation (EEC) No 793/93 and Commission Regulation
(EC) No
1488/94 as well as Council Directive
76/769/EEC and Commission Directives 91/155/EEC,
93/67/EEC, 93/105/EC and 2000/21/EC (
(14) It is therefore appropriate to limit the inclusion to 5

3 ).
years only and to make it subject to a comparative risk
assessment in accordance with the second subparagraph
of Article 10(5)(i) of Directive 98/8/EC before its
(10) PAHs
are
listed
as
substances
subject
to
release
reduction
inclusion in Annex I is renewed.
provisions in Annex III to the Protocol to the 1979
Convention on Long-Range Transboundary Air
Pollution on Persistent Organic Pollutants (‘POPs’) and
in Annex III to Regulation (EC) No 850/2004 of the
(15) Furthermore, biocidal products containing creosote
European Parliament and of the Council of 29 April
should be authorised only for applications where, all
2004 on persistent organic pollutants and amending
local and other circumstances taken into account, no
Directive 79/117/EEC (
appropriate alternatives are available. When an appli

4 ).
cation is made for product authorisation or mutual
recognition, the Member State receiving the application
should therefore ask the applicant for an analysis
(11) A
guidance
document
adopted
by
Decision
2009/4
of
regarding the technical and economic feasibility of substi
the Executive Body to the 1979 Convention on Long-
tution. Based on this analysis and any other information
Range Transboundary Air Pollution lists best available
available to it, an authorising Member State should justify
techniques to control emissions of POPs from major
their conclusion that there are no appropriate alternatives
stationary sources. Part E of Section V of that guidance
and report the justification to the Commission at a stage
document specifically addresses emissions of PAHs
when product authorisations can be expected to have
associated with the preservation of wood using coal tar
been granted. In this context, to increase transparency,
derived products containing PAHs, such as creosote. The
it is appropriate to require Member States to include in
techniques relate to impregnation, storage, handling and
the report their information on how the development of
use of the wood, and include using alternatives that
alternatives is promoted in accordance with Article 6(2)
minimise reliance on PAH-based products. It also
of Regulation (EC) No 850/2004, either directly or by
recommends best available techniques to be applied if
reference to a published action plan. To further
treated wood is burned.
increase transparency, it is appropriate to ensure that
this information is made public.
(12) According
to
the
second
subparagraph
of
Article
6(2)
of
Regulation (EC) No 850/2004 read in conjunction with
(16) Not all potential uses of wood treated with creosote have
Annex III to that Regulation, Member States are required
been evaluated at the Union level. It is therefore appro
to adopt action plans including measures to promote the
priate that Member States assess those uses or exposure
development and, where they deem appropriate, require
scenarios and those risks to compartments and popu
the use of substitute or modified materials, products and
lations that have not been representatively addressed in
processes to prevent the formation and release of PAHs.
the Union level risk assessment and, when granting
Pursuant to Article 3(3) of Regulation (EC) No 850/2004,
product authorisations, ensure that appropriate
Member States and the Commission shall, within the
measures are taken or specific conditions imposed in
assessment and authorisation schemes for existing
order to reduce the identified risks to acceptable levels.
( 1 ) Member State Committee support document for identification of
anthracene as a substance of very high concern, adopted on
8 October 2008.
(17) Entry
number
31
in
Annex
XVII
to
Regulation
(EC)
( 2 ) Member State Committee support document for identification of
No 1907/2006 regulates the conditions for the use of
anthracene oil, anthracene low as a substance of very high
creosote in wood treatment and for the placing on the
concern because of its CMR, PBT and vPvB properties, adopted on
market of wood treated with creosote. It is appropriate to
4 December 2009.
( 3 ) OJ L 396, 30.12.2006, p. 1.
( 4 ) OJ L 158, 30.4.2004, p. 7.
( 5 ) OJ L 327, 22.12.2000, p. 1.

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L 195/48
EN
Official Journal of the European Union
27.7.2011
require that product authorisations for biocidal products
(20) A
reasonable
period
should
be
allowed
to
elapse
before
containing creosote are subject to compliance with those
an active substance is included in Annex I in order to
restrictions. Through Commission Decisions
permit Member States and the interested parties to
1999/832/EC of 26 October 1999 concerning the
prepare themselves to meet the new requirements
national provisions notified by the Kingdom of the
entailed and to ensure that applicants who have
Netherlands concerning the limitations of the marketing
prepared dossiers can benefit fully from the 10-year
and use of creosote ( 1 ), 2002/59/EC of 23 January 2002
period of data protection, which, in accordance with
concerning draft national provisions notified by the
Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the
Kingdom of the Netherlands under Article 95(5) of the
date of inclusion.
EC Treaty on limitations on the marketing and use of
creosote-treated wood
( 2 ), and 2002/884/EC of
31 October 2002 concerning national provisions on
restrictions on the marketing and use of creosote-
(21) After
inclusion,
Member States should
be allowed
a
treated wood notified by the Netherlands under
reasonable period to implement Article 16(3) of
Article 95(4) and (5) of the EC Treaty
(
Directive 98/8/EC.

3 ), the
Commission has authorised the Netherlands to
maintain existing and more stringent national provisions
notified under the EC Treaty. By virtue of Article 67(3) of
(22) Directive 98/8/EC should therefore be amended
Regulation (EC) No 1907/2006, and as stated in the
accordingly.
Communication from the Commission pursuant to
Article 67(3) of Regulation (EC) No 1907/2006 ( 4 ),
these restrictions may be maintained until 1 June
2013. They include a prohibition of the use of
(23) The
Committee
established
by
Article
28(1)
of
Directive
creosote-treated wood for applications involving contact
98/8/EC has not delivered an opinion on the measures
with surface water or groundwater.
provided for in this Directive and the Commission
therefore submitted to the Council a proposal relating
to the measures and forwarded it to the European
Parliament. The Council did not act within the
(18) In the light of the findings of the assessment report, it is
2-month period provided for by Article 5a of Council
appropriate to require that risk mitigation measures are
Decision 1999/468/EC of 28 June 1999 laying down the
applied at product authorisation level to products
procedures for the exercise of implementing powers
containing creosote and used as wood preservatives.
conferred on the Commission ( 6 ), and the Commission
Due to the carcinogenic properties of creosote, it is
therefore submitted the proposal to the European
appropriate to require that product authorisations for
Parliament without delay. The European Parliament did
biocidal products containing the substance are subject
not oppose the measure within 4 months from the
to the requirement that all possible measures in
abovementioned forwarding,
accordance with Regulation (EC) No 1907/2006 and
Directive 2004/37/EC of the European Parliament and
of the Council of 29 April 2004 on the protection of
HAS ADOPTED THIS DIRECTIVE:
workers from the risks related to exposure to carcinogens
or mutagens at work (Sixth individual Directive within
the meaning of Article 16(1) of Council Directive
89/391/EEC) ( 5 ) be applied to protect workers,
Article 1
including down-stream users, from exposure during
Annex I to Directive 98/8/EC is amended in accordance with
treatment and handling of treated wood. In the view of
the Annex to this Directive.
the risks identified for the soil and aquatic compartments,
appropriate measures should be taken to protect those
compartments. Instructions should therefore be provided
to indicate that freshly treated timber must be stored
Article 2
after treatment under shelter or on impermeable hard
standing, or both, and that any losses must be
Transposition
collected for reuse or disposal.
1. Member
States
shall
adopt
and
publish,
by
30
April
2012
at the latest, the laws, regulations and administrative provisions
necessary to comply with this Directive.
(19) It is important that the provisions of this Directive be
applied simultaneously in all the Member States in order
to ensure equal treatment of biocidal products on the
They shall apply those provisions from 1 May 2013.
market containing the active substance creosote and
also to facilitate the proper operation of the biocidal
products market in general.
When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
( 1 ) OJ L 329, 22.12.1999, p. 25.
reference on the occasion of their official publication. Member
( 2 ) OJ L 23, 25.1.2002, p. 37.
States shall determine how such reference is to be made.
( 3 ) OJ L 308, 9.11.2002, p. 30.
( 4 ) OJ C 130, 9.6.2009, p. 3.
( 5 ) OJ L 158, 30.4.2004, p. 50.
( 6 ) OJ L 184, 17.7.1999, p. 23.

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2. Member States shall communicate to the Commission the text of the main provisions of national law
which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the
European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 26 July 2011.
For the Commission
The President
José Manuel BARROSO

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L 195/50
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
‘45 Creosote Creosote
Grade B or Grade C
1 May 2013 30
April
2015 30
April
2018
8 Biocidal
products
containing
creosote
may
only
be
auth
creosote as specified
orised for uses where the authorising Member State, based
EC No: 232-287-5
in European Standard
on an analysis regarding the technical and economic feasi
EN
EN 13991:2003
bility of substitution which it shall request from the

CAS No: 8001-58-9
applicant, as well as on any other information available
to it, concludes that no appropriate alternatives are
available. Those Member States authorising such
products in their territory shall no later than 31 July
2016 submit a report to the Commission justifying their
conclusion that there are no appropriate alternatives and
indicating how the development of alternatives is
promoted. The Commission will make these reports
publicly available.
Off
The active substance is to be subject to a comparative risk
icial
assessment in accordance with the second subparagraph of
Article 10(5)(i) before its inclusion in this Annex is
Jour
renewed.
nal
When assessing the application for authorisation of a
of
product in accordance with Article 5 and Annex VI,
the
Member States shall assess, where relevant for the
particular product, those uses or exposure scenarios and
European
those risks to environmental compartments and popu
lations that have not been representatively addressed at
the Union level risk assessment.
Union
Member States shall ensure that authorisations are subject
to the following conditions:
(1) Creosote may only be used under the conditions
mentioned in point 2 of the second column of entry
No 31 in Annex XVII to Regulation (EC)
No 1907/2006 of the European Parliament and of
the Council of 18 December 2006 concerning the
Registration, Evaluation, Authorisation and Restriction
of Chemicals (REACH), establishing a European
Chemicals Agency, amending Directive 1999/45/EC
and repealing Council Regulation (EEC) No 793/93
and Commission Regulation (EC) No 1488/94 as
well as Council Directive 76/769/EEC and
Commission Directives 91/155/EEC, 93/67/EEC,
93/105/EC and 2000/21/EC (1 ).
27.7.2011
(2) Creosote shall not be used for the treatment of wood
intended for those uses referred to in point 3 of the
second column of entry No 31 in Annex XVII to
Regulation (EC) No 1907/2006.

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27.7.2011 Off
(3) Appropriate risk mitigation measures shall be taken to
protect workers, including down-stream users, from
exposure during treatment and handling of treated
wood in compliance with Regulation (EC)
No 1907/2006 and Directive 2004/37/EC of the
European Parliament and of the Council of 29 April
2004 on the protection of workers from the risks
EN
related to exposure to carcinogens or mutagens at

work (Sixth individual Directive within the meaning
of Article 16(1) of Council Directive 89/391/EEC) (2 ).
(4) Appropriate risk mitigation measures shall be taken to
protect the soil and aquatic compartments. In
particular, labels and, where provided, safety data
sheets of products authorised shall indicate that
freshly treated timber must be stored after treatment
under shelter or on impermeable hard standing, or
both, to prevent direct losses to soil or water and
that any losses must be collected for reuse or disposal.
icial
(1 ) OJ L 396, 30.12.2006, p. 1.
(
Jour
2 ) OJ L 158, 30.4.2004, p. 50.’
nal
of
the
European
Union
L
195/51

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