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Commission Implementing Regulation (EU) No 564/2013Show full title

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 (Text with EEA relevance)

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ANNEX IU.K.

Fees relating to active substances

Table 1
Standard fees
General description of task; relevant provision in Regulation (EU) No 528/2012Specific condition or task descriptionFee (EUR)
Approval of an active substance; Article 7(2)Fee for the first product-type for which that active substance is approved120 000
Additional fee per additional product-type40 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 528/201220 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 sought15 000
Additional fee per additional product-type1 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 528/201225 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 528/20122 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 528/201220 000
Inclusion in Annex I of an active substance; Article 28Fee for the first inclusion in Annex I of an active substance10 000
Fee for the amendment of an inclusion of an active substance in Annex I2 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 enterpriseReduction (% of the standard fee)
Micro enterprise60
Small enterprise40
Medium enterprise20

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