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 | 170 000 | 104 | 370 000 |
6.1.2 Evaluation of an active substance in the case of a micro-organism | 75 000 | 104 | 180 000 |
6.1.3 Evaluation of an active substance and representative biocidal product in subsequent product-type | 15 000 | 104 | 120 000 |
6.1.4 Renewal in the first product-type | |||
full evaluation |
170 000 | 104 | 370 000 |
concise additional evaluation |
43 000 | 104 | 170 000 |
6.1.5 Renewal in subsequent product-types | 10 000 | 104 | 50 000 |
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) | 35 000 | 104 | 75 000 |
6.1.7 Evaluation of an amendment of approval of an active substance other than the addition of a product-type | 10 500 | 104 | 75 000 |
6.1.8 Evaluation of the precursor of an active substance and/or evaluation of a combination of active substance, precursor and method | 15 000 | 104 | 185 000 |
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* | 33 000 | 104 | 130 000 |
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 | 16 000 | 104 | 65 000 |
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* |
24 500 | 104 | 130 000 |
concise reassessment* |
8 000 | 104 | 75 000 |
6.2.4 Provisional authorisation (Art. 55(2))* | 33 000 | 104 | 130 000 |
6.2.5 Provisional authorisation of a product, when product and uses have been evaluated in the assessment of the active substance* | 16 000 | 104 | 65 000 |
6.2.6 Mutual recognition of a product and product family | 6 600 | 104 | 25 000 |
6.2.7 Renewal of the mutual recognition of a product and product family | 3 350 | 104 | 12 600 |
6.2.8 Product authorisation, simplified authorisation procedure* | 5 300 | 104 | 12 000 |
6.2.9 Renewal of product authorisation, simplified authorisation procedure* | 2 650 | 104 | 6 000 |
6.2.10 Authorisation or renewal of an authorisation for the same product without reassessment* | 1 675 | 104 | 3 150 |
6.2.11 Reassessment or major change of the same product* | 8 000 | 104 | 75 000 |
6.3 Additional measures (surcharges related to Section 6.2 of the fee table) |
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6.3.1 Assessment of a substance of concern in a product | 26 200 | 104 | 50300 |
6.3.2 Comparative assessment of a product as a reference Member State or in a Union authorisation | 6 600 | 104 | 50 300 |
6.3.3 Comparative assessment of a product in the context of mutual recognition or authorisation of the same product | 1 700 | 104 | 10 000 |
6.3.4 Assessment of maximum residue limits of the product | 5 250 | 104 | 10 000 |
6.4 Notifications | |||
6.4.1 Notification of the making available on the market of products authorised under the simplified authorisation procedure* |
1 050 | 104 | 4 700 |
6.4.2 Notification of the placing on the market of a product belonging to a biocidal product family | 1 675 | 104 | 3 150 |
6.4.3 Notification of an experiment or test (Art. 56(2)) | 765 | 104 | 3 150 |
6.5 Permit of a product for limited and controlled use (Art. 55(1)) | 500 | 104 | 10 000 |
6.6 Parallel trade permit (Art. 53) | 1 800 | ||
6.7 Authorisation under Art. 55(3) of the Biocidal Products Regulation* | 500 | 104 | |
6.8 Change to the authorisation (applies to Sections 6.2 and 6.4) | |||
6.8.1 Major change | 45% of the basic fee | 104 | basic fee |
6.8.2 Minor change as reference Member State | 3 300 | 104 | 13 000 |
6.8.3 Minor change: same product, simplified authorisation, mutual recognitions | 500 | 104 | 3 150 |
6.8.4 Administrative change | 370 | 104 | 3 150 |
6.8.5 Other regulatory activities subject to a charge related to biocide authorisations | 104 |
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 | 6 300 | 104 | 24 000 |
7.2 Authorisation of an identical product | |||
Additional product name | 270 | ||
Parallel product or equivalent | 810 | 104 | 3 050 |
7.3 Test permit for a product | 765 | 104 | 3 150 |
7.4 Renewal of a product | 3 000 | 104 | 12 000 |
7.5 Major change of a decision (e.g. extension of use, a significant change of composition or processing method) |
3 000 | 104 | 6 000 |
7.6 Minor change of a decision (e.g. changes in classification and labelling) | 600 | 104 | 3 000 |
7.7 Amendment of a decision for technical or similar reasons (e.g. changing the name of a product, change of applicant) | 300 |
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.