EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10136/2022 ANNEX 
(POOL/E4/2022/10136/10136 -EN 
ANNEX.docx)  
[…](2022) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
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    
EN 1  EN ANNEX  
Common Name  IUPAC Name  
Identification Numbers  Minimum degree of 
purity of the active 
substance1 Expiry 
date of 
approval  Product 
type Specific conditions  
Creosote  IUPAC Name:  
Creosote  
 
EC No: 232 -287-5 
CAS No: 8001 -58-9 100%  (w/w)  
 
Creosote shall 
contain less than:  
- 0,005 % 
(w/w) of 
benzo [a]pyr
ene 
- 3 % (w/w) 
of  w ater 
extractable 
phenols  
 
 31 
October  
2029  8 Creosote is  considered  a candidate for substitution in 
accordance with Article 10(1) , points (a), (d) and (e) , of 
Regulation (EU) No 528/2012.  
 
The authorisations of biocidal products are subject to the 
following conditions:  
(1) Products may only be authorised for the treatment 
by vacuum pressure impregnation of wood in 
industrial installations to make railway sleepers, or 
utility poles for electricity or telecommunications.  
(2) Pursuant to point 10 of Annex VI to Regulation 
(EU) No 528/2012, the product assessment shall 
include an eval uation as to whether the condition set 
out in Article 5(2) , point (c),  of Regulation (EU) No 
528/2012 is satisfied.  
(3) 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 528/2 012 is 
satisfied . 
(4) Products may be placed on the market only in 
packaging of a capacity equal to or greater than 200 
litres, and shall not be made available on the market 
to the general public.  
                                                 
1 The purity indicated in this column was the minimum degree of purity of the active substance evaluated . The active substance in the product placed on the market can be of 
equal or different purity if it has been proven to be technically equivalent to the evaluated active substance .  
EN 2  EN (5)  The assessment of applications for product 
authorisation shall  pay particular attention  to:  
(a) professional users;  
(b) secondary exposure of the general public;  
(c) the soil and aquatic compartments ; 
(d) the risks and the efficacy linked to any uses 
covered by an application for authorisation, but 
not addressed in  the Union level risk assessment 
of the active substance . 
(6) Labels and, where provided, safety data sheets of 
products authorised , shall indicate that industrial 
application shall be conducted within a contained 
area or on impermeable hard standing with bund ing; 
that freshly treated timber shall be stored after 
treatment under 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 shall be collected for 
reuse or disposal.  
 
The placing on the market of treated articles is subject to 
the  following conditions:  
(1) By 31 January 2023, the Agency shall make publicly 
available on its website, based on the requests made 
by Member States:  
(a) a list of Member States where  railway sleepers 
treated with creosote may be placed on the 
market;  
(b) a list of Member States where utility poles for 
electricity and telecommunication s treated with  
EN 3  EN creosote may be placed on the market.  
(2) As from 30 April 2023, only  railway sleepers, or 
utility poles for electricity or telecommunications 
treated with creosote may be placed on the market  in 
Member States included in the respective  list 
referred to in this paragraph, point (1) . A Member 
State may ask the Agency to  be remove d from the 
respective list at any time. When the Agency 
removes a Member State from either of the list s, the 
date of removal shall be indicated, and treated 
articles for the concerned use shall no longer be 
placed on the market of that Member State 18 0 days 
after the date of removal.  
(3) The person responsible for the placing on the market 
of a treated article  shall ensure that the label of that 
treated article provides the information listed in 
Article 58(3) , second subparagraph,  of Regulation 
(EU) No 528/2012.  
(4) The person responsible for the placing on the market 
of  a treated article  shall ensure that the label of that 
treated article includes the statement: “During 
storage, treated wood shall not be accessible to the 
general public. Measures shall  be taken to prevent 
unauthorised access. Treated wood must be stored 
on impermeable hard standing or on absorptive 
material to prevent runof f to the environment, and 
under shelter or covered with a tarpaulin. Any spill 
or contaminated material must be collected on such 
sites and disposed as hazardous waste.”.  
(5) As from 30 April 2023, the  person responsible for 
the placing on the market of a treated article  shall  
EN 4  EN ensure that the label of that treated article  includes 
the statement : “Only allowed for use as a railway 
sleeper” or “Only allowed for use as utility pole for 
electricity lines or for telecommunication lines”, as 
appropriate.  
(6) As from 30 April 2023, the  person responsible for 
the placing on the market of a treated  article  shall 
ensure that the label of that treated article  includes 
the statement: “The placing on the market is 
restricted to certain Member States of the European 
Union: verif y on the website of the European 
Chemicals Agency where the placing on the market 
is allowed.”.