ANNEX ISupplementary provisions
ANNEX I Fees relating to active substances 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 120 000 Additional fee per additional product-type 40 000 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 20 000 Fee for the amendment of an approval, other than the addition of a product-type. 20 000 Renewal of an approval; Article 13(3) Fee for the first product-type for which renewal of that active substance is sought 15 000 Additional fee per additional product-type 1 500 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 25 000 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 2 500 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 20 000 Inclusion in Annex I of an active substance; Article 28 Fee for the first inclusion in Annex I of an active substance 10 000 Fee for the amendment of an inclusion of an active substance in Annex I 2 000 Notification in accordance with Article 3a of Regulation (EC) No 1451/2007 Fee per substance/product-type combination. The fee for the notification shall be deducted from the subsequent application in accordance with Article 7 of Regulation (EU) No 528/2012. 10 000 Table 2 Fee reductions for applications for the approval, renewal of approval, inclusion in Annex I of active substances if the active substance manufacturer is an SME established in the Union, except where the active substance is a candidate for substitution Type of enterprise Reduction (% of the standard fee) Micro enterprise 60 Small enterprise 40 Medium enterprise 20