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,  
Having regard to the Treaty on the Functioning of the European 
Union,  
Having regard to Directive 98/8/EC of the European Parliament 
and of the Council of 16 February 1998 concerning the placing 
of biocidal products on the market (  1 ), and in particular the 
second subparagraph of Article 16(2) thereof,  
Whereas:  
(1) Commission Regulation (EC) No 1451/2007 of 
4 December 2007 on the second phase of the 10-year 
work programme referred to in Article 16(2) of Directive 
98/8/EC of the European Parliament and of the Council 
concerning the placing of biocidal products on the 
market (  2 ) establishes a list of active substances to be 
assessed, with a view to their possible inclusion in 
Annex I, IA or IB to Directive 98/8/EC. That list 
includes creosote.  
(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 
preservatives, as defined in Annex V to that Directive.  
(3) Sweden was designated as rapporteur Member State and 
submitted the competent authority report, together with 
a recommendation, to the Commission on 31 October 
2007 in accordance with Article 14(4) and (6) of Regu ­
lation (EC) No 1451/2007. It follows from the report 
that the evaluation only covers Grade B and Grade C 
creosote as specified in European Standard 
EN 13991:2003.  (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 
implementation of Directive 98/8/EC concerning the 
placing of biocidal products on the market.  
(5) The competent authority report was reviewed by the 
Member States and the Commission. In accordance 
with Article 15(4) of Regulation (EC) No 1451/2007, 
the findings of the review were incorporated, within 
the Standing Committee on Biocidal Products on 
17 December 2010 in an assessment report.  
(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, 
when applied on wood in some of the scenarios 
evaluated. Furthermore, there were strong indications in 
the abovementioned stakeholder consultation that there 
are considerable socioeconomic benefits of using 
creosote in certain applications. Life cycle analyses 
submitted and published in the context of the consul ­
tation have suggested that, in certain cases, no appro ­
priate alternatives to creosote exist, which are less 
damaging to the environment. It is therefore appropriate 
to include creosote in Annex I.  
(7) However, for certain wood use scenarios presented in the 
assessment report, unacceptable risks for the 
environment were identified in the risk assessment.  
(8) Furthermore, creosote is considered to be a non- 
threshold carcinogen and is classified as carcinogen 
category 1B in accordance with Regulation (EC) 
No 1272/2008 of the European Parliament and of the 
Council of 16 December 2008 on classification, labelling 
and packaging of substances and mixtures, amending and 
repealing Directives 67/548/EEC and 1999/45/EC, and 
amending Regulation (EC) No 1907/2006 (  3 ).EN L 195/46 Official Journal of the European Union 27.7.2011  
( 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.(9) Creosote, which is a mixture of hundreds of compounds, 
contains mainly polycyclic aromatic hydrocarbons 
(‘PAHs’). Some of these have been considered by the 
Committee for Risk Assessment of the European 
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 
Annex XIII 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 (  3 ). 
(10) PAHs are listed as substances subject to release reduction 
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 
European Parliament and of the Council of 29 April 
2004 on persistent organic pollutants and amending 
Directive 79/117/EEC (  4 ). 
(11) A guidance document adopted by Decision 2009/4 of 
the Executive Body to the 1979 Convention on Long- 
Range Transboundary Air Pollution lists best available 
techniques to control emissions of POPs from major 
stationary sources. Part E of Section V of that guidance 
document specifically addresses emissions of PAHs 
associated with the preservation of wood using coal tar 
derived products containing PAHs, such as creosote. The 
techniques relate to impregnation, storage, handling and 
use of the wood, and include using alternatives that 
minimise reliance on PAH-based products. It also 
recommends best available techniques to be applied if 
treated wood is burned.  
(12) According to the second subparagraph of Article 6(2) of 
Regulation (EC) No 850/2004 read in conjunction with 
Annex III to that Regulation, Member States are required 
to adopt action plans including measures to promote the 
development and, where they deem appropriate, require 
the use of substitute or modified materials, products and 
processes to prevent the formation and release of PAHs. 
Pursuant to Article 3(3) of Regulation (EC) No 850/2004, 
Member States and the Commission shall, within the 
assessment and authorisation schemes for existing chemicals and pesticides under the relevant Union legis ­
lation, take appropriate measures to control existing 
chemicals and pesticides which exhibit characteristics of 
POPs.  
(13) Directive 2000/60/EC of the European Parliament and of 
the Council of 23 October 2000 establishing a 
framework for Community action in the field of water 
policy (  5 ) identifies PAHs as priority hazardous 
substances, from which pollution of surface waters 
through discharge, emission or loss must cease or be 
phased out.  
(14) It is therefore appropriate to limit the inclusion to 5 
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 
inclusion in Annex I is renewed.  
(15) Furthermore, biocidal products containing creosote 
should be authorised only for applications where, all 
local and other circumstances taken into account, no 
appropriate alternatives are available. When an appli ­
cation is made for product authorisation or mutual 
recognition, the Member State receiving the application 
should therefore ask the applicant for an analysis 
regarding the technical and economic feasibility of substi ­
tution. Based on this analysis and any other information 
available to it, an authorising Member State should justify 
their conclusion that there are no appropriate alternatives 
and report the justification to the Commission at a stage 
when product authorisations can be expected to have 
been granted. In this context, to increase transparency, 
it is appropriate to require Member States to include in 
the report their information on how the development of 
alternatives is promoted in accordance with Article 6(2) 
of Regulation (EC) No 850/2004, either directly or by 
reference to a published action plan. To further 
increase transparency, it is appropriate to ensure that 
this information is made public.  
(16) Not all potential uses of wood treated with creosote have 
been evaluated at the Union level. It is therefore appro ­
priate that Member States assess those uses or exposure 
scenarios and those risks to compartments and popu ­
lations that have not been representatively addressed in 
the Union level risk assessment and, when granting 
product authorisations, ensure that appropriate 
measures are taken or specific conditions imposed in 
order to reduce the identified risks to acceptable levels.  
(17) Entry number 31 in Annex XVII to Regulation (EC) 
No 1907/2006 regulates the conditions for the use of 
creosote in wood treatment and for the placing on the 
market of wood treated with creosote. It is appropriate toEN 27.7.2011 Official Journal of the European Union L 195/47  
( 1 ) Member State Committee support document for identification of 
anthracene as a substance of very high concern, adopted on 
8 October 2008.  
( 2 ) Member State Committee support document for identification of 
anthracene oil, anthracene low as a substance of very high 
concern because of its CMR, PBT and vPvB properties, adopted on 
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.require that product authorisations for biocidal products 
containing creosote are subject to compliance with those 
restrictions. Through Commission Decisions 
1999/832/EC of 26 October 1999 concerning the 
national provisions notified by the Kingdom of the 
Netherlands concerning the limitations of the marketing 
and use of creosote (  1 ), 2002/59/EC of 23 January 2002 
concerning draft national provisions notified by the 
Kingdom of the Netherlands under Article 95(5) of the 
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- 
treated wood notified by the Netherlands under 
Article 95(4) and (5) of the EC Treaty (  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 
Regulation (EC) No 1907/2006, and as stated in the 
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 
creosote-treated wood for applications involving contact 
with surface water or groundwater.  
(18) In the light of the findings of the assessment report, it is 
appropriate to require that risk mitigation measures are 
applied at product authorisation level to products 
containing creosote and used as wood preservatives. 
Due to the carcinogenic properties of creosote, it is 
appropriate to require that product authorisations for 
biocidal products containing the substance are subject 
to the requirement that all possible measures in 
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 
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, 
including down-stream users, from exposure during 
treatment and handling of treated wood. In the view of 
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 
after treatment under shelter or on impermeable hard 
standing, or both, and that any losses must be 
collected for reuse or disposal.  
(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 
market containing the active substance creosote and 
also to facilitate the proper operation of the biocidal 
products market in general.  (20) A reasonable period should be allowed to elapse before 
an active substance is included in Annex I in order to 
permit Member States and the interested parties to 
prepare themselves to meet the new requirements 
entailed and to ensure that applicants who have 
prepared dossiers can benefit fully from the 10-year 
period of data protection, which, in accordance with 
Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the 
date of inclusion.  
(21) After inclusion, Member States should be allowed a 
reasonable period to implement Article 16(3) of 
Directive 98/8/EC.  
(22) Directive 98/8/EC should therefore be amended 
accordingly.  
(23) The Committee established by Article 28(1) of Directive 
98/8/EC has not delivered an opinion on the measures 
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 
2-month period provided for by Article 5a of Council 
Decision 1999/468/EC of 28 June 1999 laying down the 
procedures for the exercise of implementing powers 
conferred on the Commission (  6 ), and the Commission 
therefore submitted the proposal to the European 
Parliament without delay. The European Parliament did 
not oppose the measure within 4 months from the 
abovementioned forwarding,  
HAS ADOPTED THIS DIRECTIVE:  
Article 1  
Annex I to Directive 98/8/EC is amended in accordance with 
the Annex to this Directive.  
Article 2  
Transposition  
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.  
They shall apply those provisions from 1 May 2013.  
When Member States adopt those provisions, they shall contain 
a reference to this Directive or be accompanied by such a 
reference on the occasion of their official publication. Member 
States shall determine how such reference is to be made.EN L 195/48 Official Journal of the European Union 27.7.2011  
( 1 ) OJ L 329, 22.12.1999, p. 25.  
( 2 ) OJ L 23, 25.1.2002, p. 37.  
( 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. 23.2. 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 BARROSOEN 27.7.2011 Official Journal of the European Union L 195/49ANNEX  
In Annex I to Directive 98/8/EC, the following entry is added: 
‘45 Creosote  Creosote 
EC No: 232-287-5 
CAS No: 8001-58-9  Grade B or Grade C 
creosote as specified 
in European Standard 
EN 13991:2003  1 May 2013  30 April 2015  30 April 2018  8  Biocidal products containing creosote may only be auth ­
orised for uses where the authorising Member State, based 
on an analysis regarding the technical and economic feasi ­
bility of substitution which it shall request from the 
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. 
The active substance is to be subject to a comparative risk 
assessment in accordance with the second subparagraph of 
Article 10(5)(i) before its inclusion in this Annex is 
renewed. 
When assessing the application for authorisation of a 
product in accordance with Article 5 and Annex VI, 
Member States shall assess, where relevant for the 
particular product, those uses or exposure scenarios and 
those risks to environmental compartments and popu ­
lations that have not been representatively addressed at 
the Union level risk assessment. 
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 ). 
(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.EN L 195/50 Official Journal of the European Union 27.7.2011(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 
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.  
(1 ) OJ L 396, 30.12.2006, p. 1. 
(2 ) OJ L 158, 30.4.2004, p. 50.’EN 27.7.2011 Official Journal of the European Union L 195/51