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.
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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.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
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
’
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 (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32025R1490
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