LegalizeCommission Implementing Regulation (EU) 2025/1490 of 24 July 2025 amending Implementing Regulation (EU) No 564/2013 as regards the adaptation of fees to inflation
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| Image omitted; see official source | Official Journal of the European Union | EN L series |
| --- | --- | --- |
| 2025/1490 | 25.7.2025 |
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
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 |
| Approval of an active substance; Article 7(2) | Additional fee per additional product-type | 47 800 |
| Approval of an active substance; Article 7(2) | 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 |
| Approval of an active substance; Article 7(2) | 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 |
| Renewal of an approval; Article 13(3) | Additional fee per additional product-type | 1 793 |
| Renewal of an approval; Article 13(3) | 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 |
| Renewal of an approval; Article 13(3) | 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 |
| Renewal of an approval; Article 13(3) | 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 1062/20143 | 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 4 | 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 354/20135 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 |
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).’
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).
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 |
| Technical equivalence; Article 54(3) | 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 |
| Technical equivalence; Article 54(3) | 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 |
| Annual fee for biocidal products authorised by the Union; Article 80(1)(a) | 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 |
| Submission for inclusion in the list of relevant persons; Article 95 | 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 |
| Submission for inclusion in the list of relevant persons; Article 95 | 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)
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