Commission Implementing Regulation (EU) 2025/1490 of 24 July 2025 amending Implementing Regulation (EU) No 564/2013 as regards the adaptation of fees to inflation
Date: 2025-07-24
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Chemicals Agency, chemical product, inflation, market approval, payment








L_202501490EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/1490


25.7.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/1490
of 24 July 2025
         
amending Implementing Regulation (EU) No 564/2013 as regards the adaptation of fees to inflation
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to 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 products (1), and in particular Article 80(1) thereof,

Whereas:







(1)


In accordance with Article 17 of Commission Implementing Regulation (EU) No 564/2013 (2), the fees provided for in that Regulation are to be reviewed annually by reference to the inflation rate as measured by means of the European Index of Consumer Prices as published by Eurostat.












(2)


In order to perform this annual review for the year 2024, the fees should be adjusted in accordance with the average annual inflation rates for 2021, 2022 and 2023, as published by Eurostat, so as to reflect the cumulative inflation rate of 19,5 %.












(3)


Implementing Regulation (EU) No 564/2013 should therefore be amended accordingly.












(4)


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
Regulation (EU) No 564/2013 is amended as follows:






(1)


Annexes I and II are amended in accordance with Annex I to this Regulation;










(2)


Annex III is replaced by the text set out in Annex II to this Regulation.






Article 2
This Regulation 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, 24 July 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2)  Commission Implementing Regulation (EU) No 564/2013 of 18 June 2013 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (OJ L 167, 19.6.2013, p. 17, ELI: http://data.europa.eu/eli/reg_impl/2013/564/oj).




ANNEX I
Annexes I and II of Regulation (EU) No 564/2013 are amended as follows:






(1)


in Annex I, Table 1 is replaced with the following:

‘Table 1


Standard fees








General description of task; relevant provision in Regulation (EU) No 528/2012


Specific condition or task description


Fee (EUR)




Approval of an active substance; Article 7(2)


Fee for the first product-type for which that active substance is approved


143 400 




Additional fee per additional product-type


47 800 




Additional fee per product-type (for both the first product-type and any additional product-type) if the active substance is a candidate for substitution in accordance with Article 10 of Regulation (EU) No 528/2012


23 900 




Fee for the amendment of an approval, other than the addition of a product-type


23 900 




Renewal of an approval; Article 13(3)


Fee for the first product-type for which renewal of that active substance is sought


17 925 




Additional fee per additional product-type


1 793 




Additional fee for the first product-type for which renewal of that active substance is sought in case a full evaluation is found necessary in accordance with Article 14(1) of Regulation (EU) No 528/2012


29 875 




Additional fee per additional product-type in case a full evaluation is found necessary in accordance with Article 14(1) of Regulation (EU) No 528/2012


2 988 




Additional fee per product-type (for both the first product-type and any additional product-type) if the active substance is a candidate for substitution in accordance with Article 10 of Regulation (EU) No 528/2012


23 900 




Inclusion in Annex I of an active substance; Article 28


Fee for the first inclusion in Annex I of an active substance


11 950 




 


Fee for the amendment of an inclusion of an active substance in Annex I


2 390 




Notification in accordance with Article 17(4) of Commission Delegated Regulation (EU) No 1062/2014 (1)



Fee per substance/product-type combination.
The fee for the notification shall be deducted from the subsequent application for approval


11 950 














(2)


in Annex II, Table 1 is replaced with the following:

‘Table 1


Standard fees








General description of task; relevant provision in Regulation (EU) No 528/2012


Specific condition or task description


Fee (EUR)




Granting of Union authorisation, single product; Article 43(2)


Fee per product not identical with (one of) the representative product(s) assessed for the purpose of the substance approval


95 600 




 


Fee per product identical with (one of) the representative product(s) assessed for the purpose of the substance approval


47 800 




 


Additional fee per product when comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012 is required


47 800 




 


Additional fee per product when the requested authorisation is provisional in accordance with Article 55(2) of Regulation (EU) No 528/2012


11 950 




Granting of Union authorisation, biocidal product family; Article 43(2)


Fee per family


179 250 




 


Additional fee per family when comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012 is required


71 700 




 


Additional fee per family when the requested authorisation is provisional in accordance with Article 55(2) of Regulation (EU) No 528/2012


17 925 




Notification to the Agency of an additional product within a biocidal product family; Article 17(6)


Fee per additional product


2 390 




Union authorisation of a same biocidal product; Article 17(7)


Fee per product constituting a ‘same product’ within the meaning of Commission Implementing Regulation (EU) No 414/2013
 (2)



2 390 




Major change of an authorised product or product family; Article 50(2)


Fee per application


47 800 




Minor change of an authorised product or product family; Article 50(2)


Fee per application


17 925 




Administrative change of an authorised product or product family; Article 50(2)


Fee per notification


2 390 




Recommendation on the classification of a change of an authorised product or product family; Article 50(2)


Fee per request in accordance with Commission Implementing Regulation (EU) No 354/2013 (3)

If the recommendation is to classify the change as an administrative or minor change, the fee for the request shall be deducted from the subsequent application or notification in accordance with Implementing Regulation (EU) No 354/2013


2 390 




Renewal of Union authorisation, single product; Article 45(3)


Fee per product


5 975 




 


Additional fee per product in case a full evaluation is found necessary in accordance with Article 14(1) of Regulation (EU) No 528/2012


17 925 




 


Additional fee per product when comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012 is required


47 800 




Renewal of Union authorisation, biocidal product family; Article 45(3)


Fee per product family


8 963 




 


Additional fee per product family in case a full evaluation is found necessary in accordance with Article 14(1) of Regulation (EU) No 528/2012


26 888 




 


Additional fee per product family when comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012 is required


71 700 










(1)  Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1, ELI: http://data.europa.eu/eli/reg_del/2014/1062/oj).’
         

(2)  Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4., ELI: http://data.europa.eu/eli/reg_impl/2013/414/oj).

(3)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj).’
         





ANNEX II



‘ANNEX III
Other fees







General description of task; relevant provision in Regulation (EU) No 528/2012


Specific condition or task description


Fee (EUR)




Technical equivalence; Article 54(3)


Fee, when difference between the active substance sources is limited to a change in manufacturing location, and application is based solely on analytical data


5 975 




Fee, when difference between the active substance sources goes beyond a change in the manufacturing location, and application is based solely on analytical data


23 900 




Fee when previous conditions are not met.


47 800 




Annual fee for biocidal products authorised by the Union; Article 80(1)(a)


Fee per Union authorisation of a biocidal product


11 950 




Fee per Union authorisation of a biocidal product family


23 900 




Mutual Recognition Submission fee; Article 80(1)(a)


Fee per product or product family concerned by an application for mutual recognition, per Member State where mutual recognition is sought


837 




Appeal; Article 77(1)


Fee per appeal


2 988 




Submission for inclusion in the list of relevant persons; Article 95


Fee per submission of a letter of access to a dossier already found complete by the Agency or an evaluating Competent Authority


2 390 




Fee per submission of a letter of access to part of a dossier already found complete by the Agency or an evaluating Competent Authority, together with complementary data


23 900 




Fee per submission of a new dossier


47 800 




Requests under Article 66(4) submitted to the Agency


Fee per item for which confidentiality is requested


1 195 






            ’
         



ELI: http://data.europa.eu/eli/reg_impl/2025/1490/oj
ISSN 1977-0677 (electronic edition)