Fees

Biocides

(Biocidal Products Regulation (EU) No 528/2012)

The basic fees are charged fully or partly in advance.

Service Basic fee, € Surcharge, €/h Maximum fee for a service
6.1 Application for approval of an active substance      
6.1.1 Evaluation of an active substance and representative biocidal product in the first product-type 184 800 113  403 000
6.1.2 Evaluation of an active substance in the case of a micro-organism 81 550 113 196 000
6.1.3 Evaluation of an active substance and representative biocidal product in subsequent product-type 16 300 113 131 000
6.1.4 Renewal in the first product-type      

full evaluation 

120 000 113 403 000

concise additional evaluation 

46 740 113 185 000
6.1.5 Renewal in subsequent product-types 10 870 113 55 000
6.1.6 Evaluation of an active substance for inclusion in Annex I of the Biocidal Products Regulation (not applicable to the inclusion of an active substance in category 6) 38 050 113 81 500
6.1.7 Evaluation of an amendment of approval of an active substance other than the addition of a product-type 11 410 113 81 500 
6.1.8 Evaluation of the precursor of an active substance and/or evaluation of a combination of active substance, precursor and method 16 300 113 201 000
6.1.9 Expert work prior to the submission of the application 1 500 113  
6.2 Authorisation of a product      
6.2.1 Authorisation of a product as a reference Member State* or assessment of a product under Union authorisation*  35 870 113 141 000
6.2.2 Authorisation of a product as a reference Member State* or assessment of a product under Union authorisation*, when product and uses have been evaluated during the evaluation of active substances 17 390 113 71 000
6.2.3 Renewal of the authorisation of a product as a reference Member State* or reassessment of a product under a Union authorisation*      

full evaluation* 

26 630 113 141 000

concise reassessment* 

8 695 113 81 500
6.2.4 Provisional authorisation (Art. 55(2))*  35 870 113 141 000
6.2.5 Provisional authorisation of a product, when product and uses have been evaluated in the assessment of the active substance*  17 390 113 71 000
6.2.6 Mutual recognition of a product and product family 7 175 113 27 000
6.2.7 Renewal of the mutual recognition of a product and product family 3 590 113 13 500
6.2.8 Product authorisation, simplified authorisation procedure* 6 600 113 25 000
6.2.9 Renewal of product authorisation, simplified authorisation procedure*  3 300 113 6 600
6.2.10 Authorisation or renewal of an authorisation for the same product without reassessment*  2 650 113 6 000
6.2.11 Reassessment or major change of the same product*  8 695 113 82 000
6.2.12 Expert work prior to the submission of the application 1 500 113  
6.3 Additional measures
(surcharges related to Section 6.2 of the fee table)
     
6.3.1 Assessment of a substance of concern in a product  28 480 113 55 000
6.3.2 Comparative assessment of a product as a reference Member State or in a Union authorisation  7 175 113 55 000
6.3.3 Comparative assessment of a product in the context of mutual recognition or authorisation of the same product 1 845 113 11 000
6.3.4 Assessment of maximum residue limits of the product  5 705 113 20 000
6.4 Notifications      
6.4.1 Notification of the making available on the market of products authorised under the simplified
authorisation procedure*
1 140 113 5 100
6.4.2 Notification of the placing on the market of a product belonging to a biocidal product family  1 140 113 5 100
6.4.3 Notification of an experiment or test (Art. 56(2)) 830 113 3 425
6.5 Permit of a product for limited and controlled use (Art. 55(1)) 545 113 11 000
6.6 Parallel trade permit (Art. 53)  1 955    
6.7 Authorisation under Art. 55(3) of the Biocidal Products Regulation*  545 113  
6.8 Change to the authorisation (applies to Sections 6.2 and 6.4)      
6.8.1 Major change 50 % of the basic fee 113 basic fee
6.8.2 Minor change as reference Member State 3 585 113 14 000
6.8.3 Minor change: same product, simplified authorisation, mutual recognitions  1 000 113 4 500
6.8.4 Administrative change  650 113 3 400
6.9 Other fee-based regulatory tasks related to biocidal product authorisations and risk assessments    113  

Fees marked with an asterisk (*) in Section 6, other than those based on the hourly rate, will be charged as double in the case of the authorisation of a product family.

Fees for services relating to biocidal active substances and products under Sections 6 and 7 may be waived, in whole or in part, if the use of the chemical or biocidal product is minor or there is another reason why the fee may be considered to be unreasonable pursuant to section 54, subsection 2 of the Chemicals Act (599/2013).

Biocidal products according to chapter 5 of the Chemicals Act

(Chemicals Act 599/2013 and decrees adopted under it)
The basic fees are charged fully or partly in advance.

Service Basic fee, € Surcharge, €/h Maximum fee for a service
7.1 Authorisation of a product 7 500 113 26 000
7.2 Test permit for a product 830 113 3 400
7.3 Renewal of a product  3 750 113 13 000
7.4 Major change of a decision (e.g. extension of use, a significant change of composition or processing
method) 
3 750 113 7 500
7.5 Minor change of a decision (e.g. changes in classification and labelling)  1 000 113 4 500
7.6 Amendment of a decision for technical or similar reasons (e.g. changing the name of a product, change of applicant) 650    

Fees for services relating to biocidal active substances and products under Sections 6 and 7 may be waived, in whole or in part, if the use of the chemical or biocidal product is minor or there is another reason why the fee may be considered to be unreasonable pursuant to section 54, subsection 2 of the Chemicals Act (599/2013).

Plant protection products

(Act on Plant Protection Products (Laki kasvinsuojeluaineista 1563/2011), Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market)

Service Basic fee, € Surcharge, €/h Maximum fee for a service
8.1 Application for approval of an active substance (Art. 7, 8, 9, 11, 14, 15)      
8.1.1 Biological active substances, application for approval or reassessment; EUR 20,000 of the basic fee
will be charged in advance
 
115 000 104 180 000
8.1.2 Chemical active substances; EUR 20 000 of the basic fee will be charged in advance 229 000 104 390 000
8.1.3 Reassessment of a chemical active substance
(Art. 14, 15); EUR 20 000 of the basic fee will be charged in advance 
 
180 000 104 390 000
8.1.4 Additional assessment of an active substance   104  
8.1.5 Acting as co-rapporteur (Art. 7)   104  
8.1.6 Assessment of the equivalence of an active substance 3 050 104 15 000
8.1.7 Assessment of maximum residue levels (EU Pesticide Residue Regulation (EC)
396/2005)
 
  104  
8.2 Authorisation of a product      
8.2.1 Zone assessment, Finland as rapporteur Member State (Art. 28, 36(1)) 66 000 104 125 000
8.2.2 Additional zone assessment, Finland as rapporteur Member State (Art. 28, 36(1)) 10 000 104 30 000
8.2.3 Additional zone assessment, Finland as rapporteur Member State,
example product in assessment of the active substance (Art. 28, 36(1))
 
27 200 104 62 800
8.2.4 Zone assessment, Finland not as rapporteur Member State (Art. 28, 36(2)), multiple uses or a product requiring an extensive risk assessment  6 600 104 15 700
8.2.5 Zone assessment, Finland not as rapporteur Member State (Art. 28, 36(2)), one use or a simple product 1 200 104 3 000
8.2.6 Mutual recognition (Art. 40) 6 600 104 15 250
8.2.7 Review of a comparative assessment (Art. 50) 1 150 104 6 300
8.2.8 Assessment of the adequacy of a generic applicant’s research material (Art. 33)   104  
8.2.9 Generic product, recognition pursuant to Article 34  6 600 104 15 000
8.2.10 Low-risk product (Art. 47), Finland as rapporteur Member State  5 000 104 30 000
8.2.11 Low-risk product (Art. 47), Finland not as rapporteur Member State 1 250 104 10 500
8.2.12 Derogations in case of emergency situations in plant protection (120 days) (Art. 53)  1 250 104 5 000
8.2.13 Product diluted for use 2 700 104 15 700
8.2.14 Identical product 1 250    
8.2.15 Parallel trade permit (Art. 52) 1 800    
8.2.16 Assessment of additional studies   104  
8.3 Renewal of product approval      
8.3.1 Zone assessment, Finland as rapporteur Member State (Art. 28, 36(1), 43)  49 200 104 100 000
8.3.2 Zone assessment, Finland as rapporteur Member State, example product in assessment of the active substance (Art. 28, 36(1), 43)  27 200 104 63 000
8.3.3 Additional zone assessment, Finland as rapporteur Member State (Art. 28, 36(1))  10 000 104 30 000
8.3.4 Zone assessment, Finland not as rapporteur Member State (Art. 28, 36(2), 43), multiple uses or a product requiring an extensive risk assessment  6 600 104 15 700
8.3.5 Zone assessment, Finland not as rapporteur Member State (Art. 28, 36(2), 43), one use or a simple product 1 200 104 3 000
8.3.6 Assessment of the adequacy of a generic applicant’s research material (Art. 33)   104  
8.3.7 Generic product, recognition pursuant to Article 34 6 600 104 15 000
8.3.8 Mutual recognition (Art. 40)  6 600 104 15 700
8.3.9 Review of a comparative assessment (Art. 50)  1 150 104 6 300
8.3.10 Low-risk product (Art. 47), Finland as rapporteur Member State 5 000 104 30 000
8.3.11 Low-risk product (Art. 47), Finland not as rapporteur Member State  1 250 104 10 500
8.3.12 Product diluted for use 2 700 104 15 700
8.3.13 Identical product  1 250    
8.3.14 Parallel trade permit (Art. 52) 1 800    
8.3.15 Document-based  2 500    
8.3.16 Assessment of additional studies    104  
8.4 Amendment of an authorisation (Art. 33, 44, 45, 51)      
8.4.1 Extension of use; several uses (Art. 33) 3 350 104 42 000
8.4.2 Extension of use; one use (Art. 33)  3 350 104 21 000
8.4.3 Extension of use; minor use (Art. 51) 3 350 104 5 200
8.4.4 Minor change, e.g. minor change in the composition of a product, change to the name of a product, the place of manufacture, the authorisation holder or the authorisation holder’s name, verification of a new notification on the place of manufacture of an active substance (Art. 45)  450 104 2 500
8.4.5 Major change, e.g. an assessment of a major change in the composition of a product (Art. 44, 45)  2 500 104 10 000
8.5 Verification of classification and labelling
(Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures)
     
8.5.1 Decision on the verification of classification and labelling/product 1 000 104 3 000
8.6 Trial permit conducted for the purpose of research and development      
8.6.1 Trial permit conducted for the purpose of research and development (Art. 54) 370 104 15 000
8.7 Facility testing the biological efficacy and usability of plant protection products      
8.7.1 Approval 3 900    
8.7.2 Reapproval 1 470    
8.7.3 Inspection fee/inspection 660    
8.8 Education, qualification and application equipment      
8.8.1 Recognition of a provider of training in the use and handling of plant protection products 440    
8.8.2 Recognition of a provider of plant protection certification 440    
8.8.3 Recognition of a tester of plant protection product application equipment  170    

Fees for services regarding the authorisation of plant protection products take into account
the provisions in section 46, subsection 2 of the Act on Amending the Plant Protection Act (Laki kasvinsuojeluaineista annetun lain muuttamisesta 372/2018).

25% of the fee for the recognition of certification in the use and handling of plant protection products specified in Section 8.8 will be charged if the applicant has already obtained the recognition of a provider of training in the use and handling of plant protection products, and the training programme has been approved. Similarly, if the applicant already has the recognition as a provider of the certification, 25% of the fee for the recognition of a provider of training in the use and handling of plant protection products and the approval of the training programme will be charged. If an applicant simultaneously applies for the recognition as the provider of the training,
the approval for the training programme and the recognition as a provider of plant protection certification, the full fee will be charged for the first recognition and 25% for the second one.