EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10136/2022 
(POOL/E4/2022/10136/10136 -EN.doc)  
[…](2022) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of creosote as an active substance for use in biocidal products of 
product -type 8 in accordance with Regulation (EU) No  528/2012 of the European 
Parliament and of the Council  
(Text with EEA relevance)    
EN 2  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of creosote as an active substance for use in biocidal products of 
product -type 8 in accordance with Regulation (EU) No  528/2012 of the European 
Parliament and of the Council  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulat ion (EU) No  528/2012 of the European Parliament and of the 
Council of 22  May 2012 concerning the making available on the market and use of biocidal 
products1, and in particular Article  14(4) , point (a), thereof,  
Whereas:  
(1) The active substance creosote was included in  Annex I to Directive 98/8/EC of the 
European Parliament and of the Council2 for use in biocidal products of product -type 8 
and pursuant to Article 86 of  Regulation (EU) No  528/2012  is therefore considered 
approved under that Regulation subject to the conditions set out in Annex I to that 
Directive .  
(2) On 27 October 2016, an application was submitted  in accordance with Article 13( 1) of 
Regulation (EU) No 528/2012 for the renewal of the approval of creosote for use in 
biocidal product s of product -type 8. That application was evaluated by the competent 
authority of the United Kingdom as the evaluating competent authority.  
(3) On 16 September 2019, the evaluating competent authority submitted  a 
recommendation  on the renewal of the approval of creosote to the European 
Chemicals Agency ('the Agency'). Due to the withdrawal of the United Kingdom from 
the Union, t he competent authority of Poland has taken over the role of evaluating 
competent authority regarding  the application on 30 January 2020.   
(4) In accor dance with Article 14(3) of Regulation (EU) No 528/2012 , on 4 December 
2020 the Agency adopted an opinion3 formulated by its Biocidal Products Committee , 
having regard to the conclusions of the evaluating competent authority.  
(5) According to that opinion , creosote is classified as carcinogen category 1B in 
accordance with Regulation (EC) No 1272/2008  of the European Parliament and of the 
Council4 and meets the criteria for being a persistent, bioaccumulative and toxic (PBT) 
                                                 
1 OJ L  167, 27.6.2012, p.  1. 
2 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 (OJ L 123, 24.4.1998, p. 1).  
3 Biocidal Products Committee (BPC) opinion on the application for renewal of the approval of the active 
substance : creosote, Product type: 8, ECHA/BPC/274/2020 , adopted on 4 December 2020.  
4 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 
  
EN 3  EN substance and a very persistent and very bioaccumulative (vPvB) substance in 
accord ance with  Annex XIII to Regulation (EC) No 1907/2006  of the European 
Parliament and of the Council5. Creosote  therefore  meets the exclusion criteria set out 
in Article 5(1) , points (a) and (e) , of Regulation (EU) No  528/2012.  
(6) Pursuant to Article 12(1) of Regulation  (EU) No 528/2012 , the approval of active 
substances meeting the exclusion criteria may  only be renewed if the active substance 
still meets  at least one of the conditions set out in Article 5(2) of that Regulation.  
(7) The Commission , with the support of the Agency,  carried out  a public consultation in 
order to gather information as to whether the conditions set out in Article 5(2) of 
Regulation (EU) No 528/2012  were  satisfied .  
(8) The opinion of the Agency and the contributions to the  public consultation were  
discussed with Member States in the Standing Committee o n Biocidal Products . 
Member States were also requested to indicate whether they consider that at least one 
of the conditions set out in Article 5(2) of Regulation (EU) No 528/2012  would be met 
in their respective territory, and to provide justifications . 
(9) From the information collected and the views expressed by Member States, it appears 
that creosote and wood treated with creosote are still needed  in many Member States 
for railway sleepers and for utility  poles for electricity and telecommunications.   
(10) Wood treated with products containing creosote  is used to make wooden railway 
sleepers for various technical reasons (light weight compared to concre te sleepers  and 
corresponding ease of maintenance, good resilience, high service life expectancy 
sought for railway  infrastructures which are built to last several decades , sustainable 
material ). Wooden  railway  sleepers have  great flexibility in terms of where they can 
be used ( such as inaccessible areas, switching points, tunnels, bridges, small radius 
curves). Moreover, t he railway sleeper use class is a safety -critical application which 
may be subject to rail infrastructure type approval  or certificatio n requirements  for 
reasons related to  the safety of people (passengers, train operators, etc.) and railway 
equipment , namely  trains and infrastructures. Good  operation of train infrastructures is 
essential  for the proper  functioning of societ y and economic  activities.  Alternative 
biocidal products to treat wooden railway sleepers are under development and one 
product  (Tanasote S406) has recently been authorised in several Member States. 
However, time is needed to test  and have a sufficient return o n experience o f those 
alternative products , and to ensure that they can meet the long service life expected of 
railway sleepers .  
(11) Alternative  materials  to wood for railway sleepers exist,  including concrete, steel or 
composite materials such as  fibre -reinf orced foamed urethane , each  presenting 
advantages ( for example,  similar mechanical properties and durability to creosote -
                                                                                                                                                         
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.1 2.2008, p. 
1). 
5 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 (OJ L 396, 30.12.2006, p. 1).  
6 Tanasote S40 , containing a mixture of copper  hydroxide , DDA Carbonate and penflufen : 
https://echa.europa.eu/information -on-chemicals/biocidal -products/ -/disbp/factsheet/SE -0026477 -
0000/authorisationid   
EN 4  EN treated wood railway sleepers) and disadvantages ( for example,  issues of main tenance 
of certain tracks in inaccessible areas, switching  points, tunnels , secondary lines ; cost; 
higher negative environmental footprint than wood; difficulty in track maintenance to 
mix wooden sleepers  with sleepers made from other materials  due to the different 
ballast requirements ). A non-renewal of approval  of creosote  as an active substance for 
use in biocidal products  for the treatment of wood to make railway sleepers would 
create serious technical and economic impacts on railway infrastructure operators  in 
some Member States  where substitution would be technically or economically difficult  
for the moment .   
(12) Wood treated with products containing creosote is used  to make utility poles for 
electricity  and telecommunication s for various technical reasons ( for example , light 
weight  compared to concrete  poles  and corresponding ease of maintenance , good 
resilience , high service life expectancy  sought for electricity and telecommunication 
infrastructures which are built to last several decades , sustainable material ). 
Alternative biocidal products to treat wooden poles are under development and the 
product Tanasote S40  has recently been authorised in several Member States. Some 
other biocidal products , based on  copper compounds  or quaternary ammonium 
compounds as active substances , have reached the final stage of a uthorisation  
procedure . However,  time is needed to test  and have a sufficient return o n experience 
of those alternative products .  
(13) Alternatives to wood as a material for utility  poles exist , including  steel, concrete , 
fibreglass  or composite  materials , each presenting advantages ( for example , rigidity ; 
invariant physical characteristics ; fire retardancy) and disadvantages ( for example, the 
need for further testing ; possible  shorter service life or other technical concerns ;  more 
expensive when compared to wooden poles ). Another alternative is  the laying of 
transmission cables underground,  in particular in urban and city environments, 
although this option may become  more technically challenging depending on the 
natural ter rain across which the network must traverse ( for example, remote areas  or 
mountains) , and an  installation and maintenance may appear  more complex , costly  and 
not feasible in all circumstances. A non-renewal of approval of creosote for use in 
wooden poles m ight create an economic impact on electricity and telecommunication 
infrastructure operator s, and problems  for the  maintenance of certain transmission 
cables  (for example,  areas not easily accessible, rapid response in case of serious 
storms) in some Membe r States where substitution with other materials or 
underground transmission cables  would be technically or economically difficult  for the 
moment .  
(14) The Agency identified r isks for human health  arising  from the use of biocidal products 
containing creosote  for the treatment of railway sleepers and utility poles for the 
workers responsible for the treatment of wood, for the pole installers and the 
electricity  pole installers , and for the exposure of the general public . Risk mitigation 
measures should  be imple mented to limit the exposure to creosote  as far as possible , 
for example the recourse to mechanical or automated processes to avoid ma nual 
handling of treated wood , and the wearing of personal protective equipment  by 
workers , and ensuring that treated wood  is not accessible to the general public during 
storage. Risks for the environment have also been identified as creosote  is PBT/vPvB, 
and risk  mitigation measures should be implemented to limit the exposure  of the 
environment  to creosote as far as possible , for example providing that industrial 
application is to  be conducted within a contained area or on imperme able hard 
standing with bunding;  that freshly treated timber is to be stored after treatment under  
EN 5  EN shelter or on impermeable hard standing, or both, to prevent direct losses to soil, sewer 
or water; and that any losses from the application of the product are to  be collected for 
reuse or disposal . 
(15) On the basis of the infor mation collected, it is conclude d that the non -approval  of 
creosote as an active substance for use in biocidal products  would have a 
disproportionate  negative impact on society in comparison to the risks arising from the 
use of the substance  for the treatm ent of wood used to make railway sleepers and 
utility  poles for electricity and telecommunications . The condition set out in Article 
5(2), point (c), of Regulation (EU) No 528/2012  is thus satisfied  for th ose uses .  
(16) It is therefore appropriate to renew the  approval  of creosote  for use in  biocidal 
products of product -type 8, subject to compliance with certain conditions . 
(17) Creosote  is a candidate for substitution in accordance with Article 10(1) , point s (a), (d) 
and (e),  of Regulation (EU) No 528/2012 and therefore the period  of renewal should 
not exceed 7 years, pursuant to  Article 10(4) of that Regulation . 
(18) To keep exposure to humans and the environment to a minimum, biocidal products 
should  only be authorised for the tr eatment by vacuum pressure impregnation of wood 
in industrial installations to make railway sleepers, or utility poles for electricity or 
telecommunications.  Pursuant to point 10 of Annex VI to Regulation (EU) No 
528/2012, the product assessment should  include an evaluation as to whether the 
conditions of Article 5(2) of that Regulation are satisfied. It should be provided that 
products  may only be authorised for use in Member States where the condition set out 
in Article 5(2) , point (c) , of Regulation (EU) No 528/2012 is satisfied . 
(19) To ensure that products are only supplied for use  in industrial installations,  it should 
be allowed  to place  products  on the market only in packaging of a capacity equal to or 
greater than 200 litres, and it should not be allowed to  make products  available on the 
market to the general public.  
(20) Furthermore, to ensure a high level of safety for human health, animal health and the 
environment, the placing on the market of wood treated with creosote should be 
subject to conditio ns. In particular, to ensure that wood treated  with creosote is placed 
on the market only in Member States where  the use of the biocidal products containing 
creosote could be authorised as the condition set out in Article 5(2) , point (c) , of 
Regulation (EU) No 528/2012 is satisfied , lists of Member States where the placing on 
the market of railway sleepers or utility poles for electricity and telecommunication  is 
allowed should be made publicly available . It should be possible for  a Member  State 
to ask to be removed from either of  those lists so that wood treated for the concerned 
use(s) can no longer be placed on the market of that Member State . In addition, the 
person responsible for the placing on the market of wood treated with creosote  should 
ensure that the label of that treated wood includes s pecific statements aiming to protect 
human health and the environment, avoid unauthorised use  of the treated wood, and 
ensure that treated wood is pl aced on the mark et only in  Member S tates inclu ded in 
such lists and in the Member States that have been removed from a list for a certain 
period of time . 
(21) In accordance with the Agreement on the withdrawal of the United Kingdom of Great 
Britain and Northern Ireland from the European Union and the Europ ean Atomic 
Energy Community ( ‘Withdrawal Agreement ’), and in particular Article 5(4) of the 
Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, 
Regulation (EU) No 528/2012 as well as the Commission acts based on it, applies t o  
EN 6  EN and in the United Kingdom in respect of Northern Ireland after the end of the 
transition period provided for in the Withdrawal Agreement . For that reason  the list s 
of states where treated wood may be placed on the market should also include the 
United Kingdom in respect of Northern Ireland , where necessary . 
(22) In respect  of uses of  creosote other than for the treatment of wood to make   railway 
sleepers and ut ility poles for electricity and telecommunications  referred to in th e 
application for renewal of approval , it has not been demonstr ated that any of th e 
conditions set out in Article 5(2) of Regulation (EU) No 528/2012 is met . In particular, 
as regards   the condition set out in  Article 5(2) , point (c), of Regulation (EU) No  
528/2012 , it has not been demonstrated  that the non -renewal of creosote  as an active 
substance for use in biocidal products  for such uses will have  a disproportionate 
negative impact on society compa red to the risks of us ing creosote and wood treated 
with creosote. Suitable and sufficient alternatives exist  and are already implemen ted in 
almost all Member States, and can be implemented in the entire Union. In order to 
allow sufficient  time for economic operators to adapt  to the requirements set down in 
this Implementing Regulation , a period of transition should be set after which  that 
wood treated with biocidal products containing creosote is no longe r placed on the 
market other than as railway  sleepers and utility poles for electricity and 
telecommunications . The same period should apply to the placing on the market o f 
railway sleepers and utility  poles for electricity and telecommunication s treated with 
creosote in Member States  not included i n the lists for the concerned uses.  
(23) By Commission Implementing Decision (EU) 2021/18397, the expiry date of approval 
of creosote  for use in biocida l products of product -type 8  was postponed to 31 October 
2022 . As the  examination of the application for the renewal of that approval  is now 
finalised, it is appropriate to repeal Implementing Decision (EU) 2021/1839 .  
(24) Creosote, its compounds, and wood treated with them, are subject to restrictions laid 
down in Annex XVII to Regulation (EC) No  1907/2006 . This Regulation  does not 
affect the obligation to comply with those restrictions .  
(25) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing  Committee on Biocidal Products , 
HAS ADOPTED THIS REGULATION:  
Article  1 
The approval of creosote  as an active substance for use in biocidal products of product -type 8 
is renewed , subject to the specifications and conditions set out in the Annex.  
 
Article  2 
Implementing Decision (EU) 2021/1839 is repealed.  
                                                 
7 Commission Implementing Decision (EU) 2021/1839 of 15 October 2021 postponing the expiry date of 
approval of creosote for use in biocidal products of product -type 8 (OJ L 372, 20.10.2021, p. 27 ).  
EN 7  EN Article  3 
This Regul ation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Com mission  
 The President  
 Ursula VON DER LEYEN