ANNEX IISupplementary provisions
ANNEX II Fees for Union authorisation of biocidal products 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 80 000 Fee per product identical with (one of) the representative product(s) assessed for the purpose of the substance approval 40 000 Additional fee per product when comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012 is required 40 000 Additional fee per product when the requested authorisation is provisional in accordance with Article 55(2) of Regulation (EU) No 528/2012 10 000 Granting of Union authorisation, biocidal product family; Article 43(2) Fee per family 150 000 Additional fee per family when comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012 is required 60 000 Additional fee per family when the requested authorisation is provisional in accordance with Article 55(2) of Regulation (EU) No 528/2012 15 000 Notification to the Agency of an additional product within a biocidal product family; Article 17(6) Fee per additional product 2 000 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 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 ( 1 ) 2 000 Major change of an authorised product or product family; Article 50(2) Fee per application 40 000 Minor change of an authorised product or product family; Article 50(2) Fee per application 15 000 Administrative change of an authorised product or product family; Article 50(2) Fee per notification 2 000 Recommendation on the classification of a change of an authorised product or product family; Article 50(2) Fee per request in accordance with Regulation (EU) No 354/2013. 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 Regulation (EU) No 354/2013. 2 000 Renewal of Union authorisation, single product; Article 45(3) Fee per product 5 000 Additional fee per product in case a full evaluation is found necessary in accordance with Article 14(1) of Regulation (EU) No 528/2012 15 000 Additional fee per product when comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012 is required 40 000 Renewal of Union authorisation, biocidal product family; Article 45(3) Fee per product family 7 500 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 22 500 Additional fee per product family when comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012 is required 60 000 Table 2 Fee reductions for applications for the granting and renewal of Union authorisation of biocidal products or biocidal product families, if the prospective authorisation holder is an SME established in the Union, except where the product contains an active substance which is a candidate for substitution Type of enterprise Reduction (% of the standard fee) Micro enterprise 30 Small enterprise 20 Medium enterprise 10 ( 1 ) OJ L 125, 7.5.2013, p. 4 .