EN    EN EN  
EN    EN  EUROPEAN COMMISSION 
Brussels, xxx 
C(2010) yyy final D008217/01 
CA-May10-Doc.3.4  
  
Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
creosote as an active substance in Annex I thereto  
EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EU 
of  
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 Counc il concerning the pl acing 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 Directiv e 98/8/EC. That list 
includes creosote. 
(2) Pursuant to Regulation (EC) No 1451/2007, creo sote has been evaluated in accordance 
with Article 11(2) of Direc tive 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) a nd (6) of Regulati on (EC) No 1451/2007. 
(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 representatives of 
Members States Competent Authorities for the implementation of Directive 98/8/EC 
concerning the placing of biocidal produc ts on the market. Most stakeholders 
considered that the use of creosote is vital in the areas of railway sleepers and poles in 
electricity transmission and telecommunicati ons networks, and that a phasing out of 
creosote would have major practical  and economical disadvantages. Many 
                                                 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3.  
EN 3   EN stakeholders also warned that alternative technologies for thes e applications do not 
necessarily have a more favourable environmental impact. 
(5) The competent authority report was re viewed 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 27 May 2010, in an assessment report. 
(6) It appears from the examinations made  that biocidal products used as wood 
preservatives and containing creosote may be expected to satisfy the requirements laid 
down in Article 5 of Directive 98/8/EC. It is  therefore appropriate to include creosote 
in Annex I to that Directive. 
(7) Creosote is considered to be a non-threshol d carcinogen and is classified as carcinogen 
category 1B in accordance with Regulat ion (EC) No 1272/2008 of the European 
Parliament and of the Council of 16 D ecember 2008 on classification, labelling and 
packaging of substances and mixtures, am ending and repealing Directives 67/548/EEC 
and 1999/45/EC, and amending Re gulation (EC) No 1907/20063. The substance, 
which is a mixture of hundreds of compounds, also contains cons tituents that are 
persistent, bioaccumulative and toxic (PBT).  Creosote should therefore be included in 
Annex I for five years only and should be made subject  to a comparative risk 
assessment in accordance with the second  subparagraph of Article 10(5)(i) of 
Directive 98/8/EC before its incl usion in Annex I is renewed. 
(8) Not all potential uses of wood treated with creosote have been evaluated at the EU 
level. It is therefore appropr iate that Member States a ssess those uses or exposure 
scenarios and those risks to compartmen ts and populations that have not been 
representatively addressed in the EU leve l risk assessment and, when granting product 
authorisations, ensure that appropriate measures are ta ken or specific conditions 
imposed in order to reduce the iden tified risks to acceptable levels. 
(9) Entry number 31 in Annex XVII to Regula tion (EC) No 1907/2006 of the European 
Parliament and of the Council of 18 D ecember 2006 concerning the Registration, 
Evaluation, Authorisation and Restricti on of Chemicals (REACH), establishing a 
European Chemicals Agency, amending Di rective 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 Comm ission Directives 91/155/EEC, 93/67/EEC, 
93/105/EC and 2000/21/EC4 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 to require that product authoris ations for biocidal products containing 
creosote are subject to compliance with  those restrictions. Through Commission 
Decisions 1999/832/EC5, 2002/59/EC6, and 2002/884/EC7, the Commission has 
authorised the Netherlands to maintain ex isting and more stringe nt national provisions 
notified under the EC Treaty. By virtue of Article 67(3) of Regulation (EC) 
No 1907/2006, and as stated in the Communi cation from the Commission pursuant to 
                                                 
3 OJ L 353, 31.12.2008, p. 1. 
4 OJ L 396, 30.12.2006, p. 1. 
5 OJ L 329, 22.12.1999, p. 25. 
6 OJ L 23, 25.1.2002, p. 37. 
7 OJ L 308, 9.11.2002, p. 30.  
EN 4   EN Article 67(3) of Regulation (EC) No 1907/20068, these restrictions may be maintained 
until 1 June 2013. They include a prohibition of the use of creosote-treated wood for applications involving contact wi th surface water or groundwater.  
(10) Unacceptable risks were identified during the in-service use of treated wood 
permanently exposed to salt water (use class 5 as defined by OECD
9), including the 
scenario wharf. Unacceptable risks were also identified during in-service use of treated 
wood in contact with the ground or fresh water and thus permanently exposed to 
wetting (use class 4 as defined by OECD10), including the scenarios transmission pole, 
fence post, jetty in lake a nd sheet pilings in waterway. Risk assessments were also 
carried out for various scenarios representi ng in-service use of treated wood not under 
cover and not in contact with the ground, eith er continually exposed  to the weather or 
protected from the weather but subject to wetting (use class 3 as defined by OECD11). 
Within this use, unacceptable risks were iden tified for the specific scenario bridge over 
pond (on a foundation), but not for the scenarios house (on a foundation), fence (except posts in contact with the ground), ra ilway sleepers (on a bed of ballast), or 
noise barriers (on a foundation). Due to the co mbination of these ri sks and the specific 
characteristics of creosote, in particular the non-threshold carcinogenicity and the PBT 
nature of some of its compounds, products containing creosote and used as wood 
preservatives should not be authorised for those uses where unacceptable risks were 
identified, unless data demonstrating th at the products can be used without 
unacceptable risks for the environment is subm itted in order to amend Annex I to this 
directive. 
(11) In the light of the findings of the assessment report, it is appropriate to require that risk 
mitigation measures are applied at product au thorisation 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 s ubject to the requirement that all possible measures in 
accordance with Regulation (EC) No 1907/ 2006 and Directive 2004/37/EC be applied 
to protect workers, including down-stream users, from exposure during treatment and 
handling of treated wood. In th e 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 in dicate that treated timber must be stored 
after treatment under sh elter and/or on impermeable hard  standing and that any losses 
must be collected for reuse or disposal.  
(12) It is important that the provisions of this Directive be applied simultaneously in all the 
Member States in order to ensure equal tr eatment 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. 
(13) A reasonable period should be allowed to elap se before an active substance is included 
in Annex I in order to permit Member Stat es and the interested parties to prepare 
themselves to meet the new requirements enta iled and to ensure that applicants who 
                                                
 
8 OJ C 130, 9.6.2009 EN, p. 3. 
9 OECD series on emission scenario documents, Nu mber 2, Emission Scenario Document for Wood 
Preservatives, part 2, p. 64. 
10 Ibid. 
11 Ibid.  
EN 5   EN have prepared dossiers can benefit fully fr om the 10-year period of data protection, 
which, in accordance with Artic le 12(1)(c)(ii) of Directive 98/8/EC, starts from the 
date of inclusion. 
(14) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC. 
(15) Directive 98/8/EC should therefore be amended accordingly. 
(16) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Annex I to Directive 98/8/EC is amended in a ccordance with the Annex to this Directive. 
Article 2 
 
Transposition 
1. Member States shall adopt and publish, by 31 October 2011 at the latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive.  
They shall apply those provi sions from 1 November 2012. 
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 determin e how such reference is to be made. 
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 tw entieth day following that of its publication in 
the Official Journal of  the European Union . 
Article 4 
This Directive is addressed to the Member States. 
Done at Brussels,  
 For the Commission 
 The President  
EN 6   EN  José Manuel BARROSO  
EN 7   EN ANNEX  
The following entry for the substance creosote is  inserted in Annex I to Directive 98/8/EC:  
No Comm
on 
Name  IUPAC Name 
Identification 
Numbers Minimum purity 
of the active 
substance in the 
biocidal product as placed on the 
market Date of 
inclusion Deadline for compliance with Article 16(3) 
(except for products containing more than 
one active substance, for which the deadline 
to comply with Article 16(3) shall be the 
one set out in the last of the inclusion 
decisions relating to its active substances) Expiry 
date of 
inclusion Produc
t type Specific provisions (*) 
 
"(**) 
[OPOCE: please 
insert 
substance 
number] Creosot
e 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 November 2012 31 Oc tober 2014 31 October 
2017 8 The active substance is to be 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 
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, the populations that may be exposed to the product and the use or exposure scenarios that have not 
been representatively addressed at the EU level risk 
assessment. 
Member States shall ensure th at 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. 
(2) Products containing creosote and used as wood 
preservatives shall not be authorised for the 
treatment of wood 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.  
(3) Without prejudice to paragraph 2, products 
containing creosote and used as wood preservatives shall not be authorised for the treatment of   
EN 8   EN No Comm
on 
Name  IUPAC Name 
Identification 
Numbers Minimum purity 
of the active 
substance in the 
biocidal product as placed on the 
market Date of 
inclusion Deadline for compliance with Article 16(3) 
(except for products containing more than 
one active substance, for which the deadline 
to comply with Article 16(3) shall be the 
one set out in the last of the inclusion 
decisions relating to its active substances) Expiry 
date of 
inclusion Produc
t type Specific provisions (*) 
 
• wood permanently exposed to salt water  
• wood in contact with the ground or fresh water 
and thus permanently exposed to wetting, or  
• wood used for the specific scenario bridge 
over pond. 
(4) Appropriate risk mitigation measures must 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. 
(5) Appropriate risk mitigation measures must be taken 
to protect the soil and aquatic compartments. In particular, labels and/or safety data sheets of 
products authorised shall indicate that freshly treated 
timber must be stored af ter treatment under shelter 
and/or on impermeable ha rd standing to prevent 
direct losses to soil or water and that any losses must 
be collected for re-use or disposal. 
•  
  
EN 9   EN (*) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are availabl e on the Commission website: 
http://ec.europa.eu/comm/environment/biocides/index.htm