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

Official Journal EN of the European Union 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.

(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).

ELI: http://data.europa.eu/eli/reg_impl/2025/1490/oj 1/6EN OJ L, 25.7.2025 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 2/6 ELI: http://data.europa.eu/eli/reg_impl/2025/1490/ojEN OJ L, 25.7.2025 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) Specific condition or task description Fee (EUR) No 528/2012 Approval of an active substance; Fee for the first product-type for which that active 143 400 Article 7(2) substance is approved Additional fee per additional product-type 47 800 Additional fee per product-type (for both the first product- 23 900 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 Fee for the amendment of an approval, other than the 23 900 addition of a product-type Renewal of an approval; Fee for the first product-type for which renewal of that 17 925 Article 13(3) active substance is sought Additional fee per additional product-type 1 793 Additional fee for the first product-type for which renewal 29 875 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 Additional fee per additional product-type in case a full 2 988 evaluation is found necessary in accordance with Article 14(1) of Regulation (EU) No 528/2012 Additional fee per product-type (for both the first product- 23 900 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 Inclusion in Annex I of an active Fee for the first inclusion in Annex I of an active substance 11 950 substance; Article 28 Fee for the amendment of an inclusion of an active 2 390 substance in Annex I

Notification in accordance with Fee per substance/product-type combination. 11 950 Article 17(4) of Commission The fee for the notification shall be deducted from the Delegated Regulation (EU) subsequent application for approval No 1062/2014(1)

(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).’

ELI: http://data.europa.eu/eli/reg_impl/2025/1490/oj 3/6EN OJ L, 25.7.2025

(2) in Annex II, Table 1 is replaced with the following: ‘Table 1 Standard fees General description of task; relevant provision in Regulation (EU) Specific condition or task description Fee (EUR) No 528/2012 Granting of Union authorisation, Fee per product not identical with (one of) the representative 95 600 single product; Article 43(2) product(s) assessed for the purpose of the substance approval Fee per product identical with (one of) the representative 47 800 product(s) assessed for the purpose of the substance approval Additional fee per product when comparative assessment in 47 800 accordance with Article 23 of Regulation (EU) No 528/2012 is required Additional fee per product when the requested authorisation 11 950 is provisional in accordance with Article 55(2) of Regulation

(EU) No 528/2012 Granting of Union authorisation, Fee per family 179 250 biocidal product family;

Article 43(2) Additional fee per family when comparative assessment in 71 700 accordance with Article 23 of Regulation (EU) No 528/2012 is required Additional fee per family when the requested authorisation is 17 925 provisional in accordance with Article 55(2) of Regulation

(EU) No 528/2012

Notification to the Agency of an Fee per additional product 2 390 additional product within a biocidal product family;

Article 17(6) Union authorisation of a same Fee per product constituting a ‘same product’ within the 2 390 biocidal product; Article 17(7) meaning of Commission Implementing Regulation (EU) No 414/2013(1) Major change of an authorised Fee per application 47 800 product or product family;

Article 50(2) Minor change of an authorised Fee per application 17 925 product or product family;

Article 50(2) Administrative change of an Fee per notification 2 390 authorised product or product family; Article 50(2) Recommendation on the Fee per request in accordance with Commission 2 390 classification of a change of an Implementing Regulation (EU) No 354/2013(2) authorised product or product If the recommendation is to classify the change as an family; Article 50(2) 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 4/6 ELI: http://data.europa.eu/eli/reg_impl/2025/1490/ojEN OJ L, 25.7.2025 General description of task; relevant provision in Regulation (EU) Specific condition or task description Fee (EUR) No 528/2012 Renewal of Union authorisation, Fee per product 5 975 single product; Article 45(3) Additional fee per product in case a full evaluation is found 17 925 necessary in accordance with Article 14(1) of Regulation (EU) No 528/2012 Additional fee per product when comparative assessment in 47 800 accordance with Article 23 of Regulation (EU) No 528/2012 is required Renewal of Union authorisation, Fee per product family 8 963 biocidal product family;

Article 45(3) Additional fee per product family in case a full evaluation is 26 888 found necessary in accordance with Article 14(1) of Regulation (EU) No 528/2012 Additional fee per product family when comparative 71 700 assessment in accordance with Article 23 of Regulation (EU) No 528/2012 is required

(1) 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).

(2) 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).’

ELI: http://data.europa.eu/eli/reg_impl/2025/1490/oj 5/6EN OJ L, 25.7.2025 ANNEX II ‘ANNEX III Other fees General description of task; relevant Specific condition or task description Fee (EUR) provision in Regulation (EU) No 528/2012 Technical equivalence; Article 54(3) Fee, when difference between the active substance sources is 5 975 limited to a change in manufacturing location, and application is based solely on analytical data Fee, when difference between the active substance sources 23 900 goes beyond a change in the manufacturing location, and application is based solely on analytical data Fee when previous conditions are not met. 47 800 Annual fee for biocidal products Fee per Union authorisation of a biocidal product 11 950 authorised by the Union;

Fee per Union authorisation of a biocidal product family 23 900 Article 80(1)(a) Mutual Recognition Submission fee; Fee per product or product family concerned by an 837 Article 80(1)(a) application for mutual recognition, per Member State where mutual recognition is sought Appeal; Article 77(1) Fee per appeal 2 988 Submission for inclusion in the list of Fee per submission of a letter of access to a dossier already 2 390 relevant persons; Article 95 found complete by the Agency or an evaluating Competent Authority Fee per submission of a letter of access to part of a dossier 23 900 already found complete by the Agency or an evaluating Competent Authority, together with complementary data Fee per submission of a new dossier 47 800 Requests under Article 66(4) Fee per item for which confidentiality is requested 1 195’ submitted to the Agency 6/6 ELI: http://data.europa.eu/eli/reg_impl/2025/1490/oj