EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/1448/2023 
(POOL/E4/2023/1448/1448 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of propiconazole 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 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of propiconazole 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 t o Regulation (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 p ropiconazole was included in Annex I to Directive 98/8/EC of 
the European Parliament and of the Council2 as an active substance for use in biocidal 
products of product -type 8. Pursuant to Article 86 of Regulation (EU) No 528/2012, it 
was therefore consider ed approved under that Regulation subject to the requirements 
set out in Annex I to Directive 98/8/EC.  
(2) On 1 October 2018, an application was submitted in accordance with Article 13(1) of 
Regulation (EU) No 528/2012 for the renewal of the approval of propic onazole for use 
in biocidal products of product -type 8 (‘the application’). That application was 
evaluated by  the competent authority of Finland (‘the evaluating competent 
authority’) . 
(3) On 2 June  2021 , the evaluating competent authority submitted a recommendation on 
the renewal of the approval of propiconazole  to the European Chemicals Agency (‘the 
Agency’).  
(4) In accordance with Article 14(3) of Regulation (EU) No 528/2012, on 9 March  2022 
the Agency ad opted an opinion3 formulated by its Biocidal Products Committee, 
having regard to the conclusions of the evaluating competent authority.  
(5) Propiconazole  is classified as toxic for reproduction , category 1B in accordance with 
Regulation (EC) No 1272/2008 of t he European Parliament and of the Council4, and 
therefore meets the exclusion criterion set out in Article 5(1) , point (c) , of Regulation 
(EU) No 528/2012. Furthermore,  according to the opinion of the Agency , 
                                                 
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 approval of the active substance: 
propiconazole, Product type: 8, ECHA/BPC/324/2022, adopted on 9 March 2022.  
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 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 
1).  
EN 2  EN propiconazole is considered as having endocrine -disrupting properties that may cause 
adverse effects in humans, and therefore meets the exclusion criterion set out in of 
Article 5(1) , point (d) , of Regulation (EU) No 528/2012.  
(6) Pursuant to Article 12(1) of Regulation (EU) No 528/2012, the approval of a ctive 
substances meeting the exclusion criteria may only be renewed if the active substance 
still meets the conditions laid down in Article 4(1) or, where applicable, 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 pu blic consultation were 
discussed with Member States representatives in the Standing Committee on 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 Regulatio n (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 propiconazole is still needed in Member States for specific uses when compared 
with the risk to human health, animal health or the environment arising from the use of 
the substance.   
(10) Propiconazole is still needed for t emporary treatment against wood discolouring fungi 
(anti-sapstain use  through industrial treatment ). Tebuconazole could be a  possible 
alternative of propiconazole , commonly used together  with propiconazole  in biocidal 
products  for such use . However,  tebuconazole  has a  lower efficacy against 
discolouring fungi compared to propiconazole . Tebuconazole also meets the criterion 
in Article 10(1) , point (d), of Regulation (EU) No 528/2012 , being very persistent (vP) 
and toxic (T) in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the 
European Parliament and of the Council5. Boron compounds (boric aci d, disodium 
tetraborate pentahydrate) could act as possible alternatives to propiconazole  for such 
use due to  their anti-sapstain use . They meet the criterion in Article 5(1) , point (c), of 
Regulation (EU) No 528/2012 , as being classified  as toxic for reproduction, category 
1B in accordance with Regulation (EC) No 1272/2008 of the European Parliament and 
of the Council . The opinion of the Agency on the application for approval of 
propiconazole and the opinion6 of the Agency on the evaluati on of the availability and 
suitability of alternatives to boron compounds do not allow to assess whether boron 
compounds would be more appropriate for this use compared to propiconazole. Other 
alternative biocidal products for this use include products con taining the active 
substance IPBC, alone or in combination with propiconazole. However, IPBC might 
not be effective against all occurring discolouring fungi.  
                                                 
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 Directiv e 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 Biocid al Products Committee (BPC) opinion on a request according to Article 75(1)(g) of Regulation 
(EU) No 528/2012 on the evaluation of the availability and suitability of alternatives to boric acid and 
disodium tetraborate pentahydrate , ECHA/BPC/ 271/2020, adop ted on 2 December  2020.  
EN 3  EN (11) Propiconazole is still needed for i ndustrial treatment of structural wood in certain use 
class es7  as described in EN 335:2013 and defined in terms of service conditions, with 
reference to the generalised moisture content and the prevailing biological agents of 
deterioration , and in particular for use class 3. 2 (situation in which wood and wood -
based products will remain wet for long periods; water may accumulate) and use class 
4 (situation in which the wood or wood -based product is in direct contact with ground 
or fresh water)  against discolouring and rotting fungi.  Several a lternative biocidal 
products  for such uses contain copper compounds, which need to be used in 
combination with another wood preservative active substance to formulate a water -
based biocidal product of sufficient efficacy. Propiconazole and/or  tebuconazole are  
commonly  used in  combination with copper compounds for such uses . Tebuconazole 
cannot replace propiconazole due to  the same reasons as explained above for the anti -
sapstain use. Moreover, tebuconazole has a compl ementary efficacy to propiconazole  
against rotting fungi , having a different spectrum of rotting fungicidal activity in 
wood. Other alternative water -based biocidal products contain quaternary ammonium 
salts (‘quats’), which on their own do not have sufficient efficacy against discolouring 
and rotting fungi. There are biocidal products containing mixtures of copper/quats 
formulations, but these present technical limitations  (e.g. lower long -term efficacy, 
may give rise to the corrosion of metal joints which are in contact with the treated 
wood ). Boron compounds are usually not technically suitable for such use , since  they 
are highly water soluble, making them prone to leaching. Finally, alternative oil -based 
biocidal products based on penflufen as an active substance have been recently 
developed, but more time is nee ded to test and have a sufficient return on experience 
of these biocidal products.  
(12) Propiconazole is still needed for p rofessional and industrial treatment of joinery in use 
class 2 (situation in which the wood or wood -based product is under cover and not 
exposed to the weather, particularly rain and driven rain, but where occasional, but not 
persistent, wetting can occur) and use class 3.1 (situation in which the wood and wood 
based products will not remain wet for long periods ; water will not accumulate)  
against discolouring and rotting fungi . Biocidal products for such uses usually contain 
IPBC , propiconazole  and/or tebuconazole . Tebuconazole cannot replace propiconazole 
for the same reasons as explained above  for the industrial use in use classes 3.2 an d 4. 
Biocidal products containing only IPBC for such uses exist but are not always suitable 
due to their insufficient efficacy against wood rotting fungi. Higher concentrations of 
IPBC could increase its efficacy but may give rise to yellowing of the treat ed wood. 
The isothiazolin ones 2-octyl -2H-isothiazol -3-one (‘OIT’) and 4,5-Dichloro -2-octyl -
2H-isothiazol -3-one (‘DCOIT ’) bear technical limitations compared to propiconazole 
for wood preservation  (OIT is known to exhibit a high leaching from treated wood ; 
DCOIT is highly corrosive and exhibits a low stability in many wood preservative 
formulation types ). There are currently no biocidal products in the market  authorized 
containing OIT or DCOIT for wood preservation. As a result, th ose biocidal products 
canno t act as alternatives to propiconazole in the short  term.  Alternative biocidal 
products based on penflufen as active substance have been recently developed, but 
more time is needed to test and have a sufficient return on experience of these biocidal 
products.   
(13) Propiconazole is still needed for b rush, spraying or injection applications by 
professional users  for use classes 2 and 3  (situation in which the wood or wood -based 
                                                 
7  ECHA Guidance on the Biocidal Products Regulation, Volume II: Efficacy, Parts B+C: Assessment 
and Evaluation, Version 5.0, November 2022.   
EN 4  EN product is above ground and exposed to the weather, particularly rain) . Biocidal  
products for such use s usually contain IPBC , propiconazole  and/or tebuconazole . 
Tebuconazole cannot replace propiconazole for the same reasons as explained above. 
Biocidal products containing only IPBC for such uses are not suitable  because IPBC 
does not have sufficient efficacy against wood rotting fungi . Biocidal products with 
higher concentration of IBPC could  provoke skin sensitizing issues  and yellowing of 
the treated wood. Alternative biocidal products based on penflufen and IPBC as active 
substances  have been recently developed, but more time is needed to test and have a 
sufficient return on experience of these biocidal products.  
(14) Alternative methods to the use of biocidal product s to extend the durability of wood 
against fungi  exist. Heat treatment of wood and to a less er extent chemical 
modification , such as acetylation and furfurylation , are used to produce wood  products  
for use classes 2 and 3. Due to the technical characteristics of these types of wood , 
they are not suitable for all the forms of timber construction materials that 
propiconazole is currently used to treat.  Another alternative is the use of durable 
tropical hardwood , but this is characterised by a lesser availability, higher costs and 
sustainability aspects.  
(15) Alternative materials to  wood for the required use applications  exist , such as steel, 
plastic, aluminum, and concrete , but th ose materials may not always be technically or 
economically feasible and may raise their own sustainability issues.  
(16) On the basis of the information collec ted, it is concluded that the non -renewal of the 
approval of propiconazole as an active substance for use in biocidal products of 
product -type 8  would have a disproportionate negative impact on society in 
comparison to the risks arising from the use of the  substance  for temporary treatment 
against wood discolouring fungi (anti -sapstain use  through industrial treatment ), for 
industrial treatment of structural wood  in use classes 3.2 and 4, for professional and 
industrial treatment of joinery  in use classes 2  and 3.1, and for brush , spraying  or 
injection  applications by professional use rs in use classes 2 and 3 . The condition set 
out in Article 5(2), point (c), of Regulation (EU) No 528/2012 is thus satisfied for 
these uses.   
(17) The Agency concluded that there are no unacceptable risks to human health and the 
environment from the use of biocidal products containing propiconazole , when leaving 
aside  the endocrine disrupting properties of propiconazole , and when risk mitigation 
measures are applied  to limit the ex posure of propiconazole to humans, animals and 
the environment as far as possible, for example through the wearing of personal 
protective equipment by workers ; by requiring that industrial application is to be 
conducted within a contained area, situated on  impermeable hard standing, with 
bunding to prevent run -off and a recovery system in place (e.g. sump); that freshly 
treated timber is to be stored after treatment under shelter or on impermeable hard 
standing, or both, to prevent direct losses to soil, se wer or water, and that any losses 
from the application of the product are collected for reuse or disposal; and providing 
that the ground is covered with a plastic foil or tray during outdoor professional 
brush ing/rolling application s, and any losses from t he applications of products should  
be collected and disposed by safe means.  However, no conclusion on the level of risks  
of using propiconazole to human health and the environment considering its endocrine 
disrupting properties was drawn by the Agency.   
(18) Therefore, it has ultimately not been demonstrated based on the data available in the 
application submitted for the renewal of approval that the representative biocidal  
EN 5  EN product containing propiconazole  for product -type 8 may be expected not to have 
unacceptable effects itself, or as a result of its residues, on human health and on the 
environment , and that it may be  expected to satisfy the criteria set out in Article 19(1), 
point (b)(iii) and (iv), of Regulation (EU) No 528/2012.  
(19) However, the factor set out in Article 19(5) of Regulation (EU) No 528/2012 should  
be taken into account when considering the conditions for approval set out in Article 
4(1) of that Regulation. In accordance with Article 19(5) of that Regulation, and 
notwithstanding paragraph s 1 and 4 of that Article, a biocidal product may be 
authorised when the conditions laid down in paragraph 1(b)(iii) and (iv) of that Article  
are not fully met where not authorising the biocidal product would result in 
disproportionate negative impacts fo r society when compared to the risks to human 
health, animal health or the environment arising from the use of the biocidal product 
under the conditions laid down in the authorisation , which is similar to the condition 
set out in Article 5(2), point (c), o f Regulation (EU) No 528/2012 . Since the condition 
set out in Article 5(2), point (c), of that Regulation is met for specific uses of 
propiconazole, the condition set out in Article 19(5) of that Regulation is also 
considered satisfied for the same uses. T herefore, the conditions set out in Article 4(1) 
of Regulation (EU) No 528/2012 in conjunction with the conditions set out in Article 
5(2)(c) of that Regulation are considered satisfied.  
(20) It is therefore appropriate to renew the approval of propiconazole  for use in biocidal 
products of product -type 8, subject to compliance with certain conditions.  
(21) In particular, p ropiconazole  is a candidate for substitution in accordance with Article 
10(1), points (a), (d) and (e), of Regulation (EU) No 528/2012 and there fore the period 
of renewal should not exceed 7 years, pursuant to Article 10(4) of that Regulation.  
(22) 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.  
(23) Exposure to the environment sh ould be minimised as far as possible, since no 
conclusion on the risk derived from the endocrine disrupting properties of 
propiconazole could be established. Based on the views expressed by Member States, 
spray -drift by manual spraying is impossible to be mitigated at a site outdoors. 
Therefore, to guarantee the protection for the environment, in -situ s praying 
applications of products by professional users should  only be authorised for indoor 
use.  
(24) Furthermore, to ensure a high level of safety for human hea lth, animal health and the 
environment  and to ensure equal treatment between EU -manufactured and imported 
treated  articles , the placing on the market of wood treated with propiconazole should 
be subject to conditions. In particular, in line with the condit ions set out in the renewal 
of approval for the authorisation of biocidal products of product -type 8 containing 
propiconazol e, treated articles treated with or incorporating propiconazole may be 
placed on the market only for use as wood treated for protection  against wood 
discolouring fungi (anti -sapstain  industrial treatment ), as structural wood for use class 
3.2 ( situation in which the wood and wood -based products will remain wet for long 
periods; water may accumulate) and use class 4 (situation in  which the wood or wood -
based product is in direct contact with ground or fresh water), and as joinery for use 
class 2 (situation in which the wood or wood -based product is under cover and not  
EN 6  EN exposed to the weather, particularly rain and driven rain, but where occasional, but not 
persistent, wetting can occur) and use class 3.1 ( situation in which the wood and wood 
based products will not remain wet for long periods ; water will not accumulate ). 
(25) In order to guarantee a safe use of treated articles treated w ith or incorporating 
biocidal products containing propiconazole  and to enable users of treated articles to 
make informed choices, the person responsible for the placing on the market of a 
treated article treated with or incorporating propiconazole  should e nsure that the label 
of that treated article provides the information listed in Article 58(3), second 
subparagraph, of Regulation (EU) No 528/2012.  Furthermore , Member States 
competent authorities should specify in the summary of the biocidal product 
chara cteristics of a biocidal product containing propiconazole  the relevant instructions 
for use and precautions to be included on the label of the treated articles under Article 
58(3), point (e), of Regulation (EU) No 528/2012.  Precautions sh ould also include 
appropriate measures to reduce leaching and minimi se exposure of humans, animals 
and the environment as far as possible.  
(26) Furthermore, to ensure a high level of safety for human health  and taking into account 
that no conclusion on the risk derived from endo crine disrupting properties could be 
established , wood treated with propiconazole shall  not be placed on the market to 
produce playground structures  and furniture . 
(27) 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 propiconazole  as an active substance for use in biocidal products of product -
type 8 is renewed, subject to the conditions set out in the Annex.  
Article 2 
This R egulation 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  Commission  
 The President  
 Ursula VON DER LEYEN