Tariffs for applications for biocidal products and active substances

The costs payable to ECHA

The costs payable to ECHA are the subject of the implementing regulation: (EU) 564/2013. And it is possible for small and medium-sized enterprises established in the European Union to benefit from reduced fees under Biocidal Products Regulation, depending on their size and provided that certain conditions are met. In order to benefit, companies need to submit documentary evidence to ECHA proving their entitlement to such reduction in advance of the actual application. The conditions and the instructions on how to submit the documentation for the SME check are described in more detail on the ECHA website.

Tariff decree

Ctgb The tariff decision for biocides applications has four categories for applications under the European regulation and three categories for applications under Dutch transitional law. A fixed fee and - if applicable - fixed fee add-ons are charged. For categories a and b of applications under the European regulation, rates apply based on subsequent calculation with an advance payment. See also the most important changes. Tariffs based on an advance payment and subsequent calculation. Applicants pay an advance fee for the assessment based on the standard costs. Then the risk assessment follows on various aspects, such as human toxicology, ecotoxicology, behavior and fate in the environment, physicochemical properties and efficacy. The costs depend on the required work and that differs considerably per type of application.

Tariffs based on an advance payment and subsequent calculation.

Applicants pay an advance fee for the assessment based on the standard costs. Then the risk assessment follows on various aspects, such as human toxicology, ecotoxicology, behavior and fate in the environment, physicochemical properties and efficacy. The costs depend on the required work and that differs considerably per type of application.

Ctgb fees

1. Application under regulation (EU) No 528/2012 (BPR)

a. Application for active substance - subsequent costing

See Tariffs Decree, page 10: Addendum lll 1a. Application for active substance - subsequent costing.

b. Application with the Netherlands as evaluating Competent Authority (eCA) - subsequent costing

See Tariffs Decree, page 10: Addendum lll 1b. Application with the Netherlands as evaluating Competent Authority (eCA) - subsequent costing.

c. Application with the Netherlands as Concerned Member State - fixed fee

See Tariffs Decree, page 11: Addendum lll 1c. Application with the Netherlands as Concerned Member State - fixed fee.

d. Other application or administrative application – fixed fee

See Tariffs Decree, page 12: Addendum lll 1d. Other application or administrative application – fixed fee.

2. Application under transitional law

See Tariffs Decree, page 12: Addendum lll 2. Fees and charges for product applications and other services and activities where one or more existing active substances for the requested PTs are not yet included in the Union list of approved substances or Annex I of Regulation (EU) 528/2012.

a. Application for full or limited assessment – fixed fee

See Tariffs Decree, page 12: Addendum lll 2a. Application for full or limited assessment – fixed fee.

b. Application for an extension of an authorisation – fixed fee

See Tariffs Decree, page 13: Addendum lll 2b. Application for an extension of an authorisation – fixed fee.

c. Other application or administrative application – fixed fee

See Tariffs Decree, page 13: Addendum lll 2c. Other application or administrative application – fixed fee.

3. Annual fee for a biocidal product authorised by the Ctgb

See Tariffs Decree, page 13: Addendum lll 3. Annual fee for a biocidal product authorised by the Ctgb.

For categories 1 and 2 of applications under the European regulation, rates apply based on subsequent calculation with an advance payment. A fixed rate applies to the other categories, with - if applicable - fixed add-ons.

Subsequent costing with advance fee

For applications for which fees based on subsequent costing with an advance fee apply, categories a and b of applications under the European regulation, it is difficult to predict in advance what the assessment costs will be. This is because there is considerable diversity in the required assessment time between the different applications of one type.

The total costs for an application are strongly determined by:

• the dossier quality
• the type of application
• the status of an active substance in the EU
• the number of PTs and the number of active substances
• the number of studies to be evaluated
• the number of uses applied for
• the fact whether an application applies to a single product or whether it concerns an application for a biocide family
• the complexity of the family structure within an application, in particular the number of meta pcs
• the number of co-formulants
• the comparative assessment
• the availability of guidance

As an indication, the recent average costs and highest costs per application type are shown below.

Please note: depending on the contents of an application dossier, the costs for your application may be lower or higher than the average costs mentioned in the table or the target fees in the tariffs decree. After the validation phase, the project manager can explain what the expected costs for your dossier are based on.

Average and highest cost by application types

Applicationtype		Average cost	Highest cost
Union authorisation application , single product,  (B-UTN, B-UTH)		€ 94,000	€ 157,000
Union authorisation application, biocidal product family (B-UTFN)		€ 170,000	€ 351,000
National application, single product,  (B-TN, B-TH)		€ 68,000	€ 131,000
National application, biocidal product family (B-TFN)		€ 102,000	€ 150,000
Simplified authorisation application, single product  (B-ET)		€ 14,000	€ 35,000
Prolongation of an authorisation, single product  (B-TR)		€ 40,000	€ 55,000
Major change of an authorisation, single product  (B-GW)		€ 38,000	€ 64,000

A number of request types for which subsequent calculation applies are missing from this table. Insufficient applications for these types have been processed recently and therefore the average and highest costs will not provide a reliable indication of the expected costs for your file.

Invoicing, payment and subsequent costing/refund

Applications under the BPR for which rates apply based on subsequent costing with an advance fee

For applications for which fees based on subsequent costing with an advance fee apply, there are at least three moments when an invoice is sent:

Invoice 1

Once the application has been received, the Ctgb will charge application costs as an advance fee. The invoice is sent as soon as possible following receipt of the application in R4BP. The Biocidal Products Regulation provides that the costs of an application procedure must be paid within 30 days after the invoice date. Additional time for payment cannot be provided. If payment is late, the application is rejected.

The advance amount as indicated in the tariff decree is sufficient to complete the validation of the application and start the evaluation. If the advance fee for the application costs is higher than required, the remaining budget will automatically be transferred to the evaluation phase.

Invoice 2

After validation, the Ctgb sends an invoice for the advance fee for the remainder of the procedure. The amount of this advance fee is based on an estimate of the assessment costs for the dossier in question and average costs for the phases that follow this assessment. This is the amount charged to the applicant and it is the most realistic estimate of the costs at that time. An adjustment is made for the remaining budget from the application fee (invoice 1).

Final invoice

After completion of the entire application from validation to final decision, the total costs will ultimately be invoiced based on the actual costs.

If the actual costs incurred are less than the advance payment, the difference is refunded to the applicant within 30 days after date of the final invoice. If the actual costs are higher than the advance paid, an additional invoice follows with a payment term of 30 days.

The Ctgb aims to limit the number of invoice moments to the above three. However, it may be necessary to send an additional advance fee invoice in the meantime if the dossier requires more time investment than was estimated in advance. When estimating the total costs of the application, averages are taken into account for the phases following the assessment phase, such as assessing additional information or processing comments from other Member States. During the validation, it is not yet clear whether additional questions will be asked and how much time it will take to assess the additional information. This also depends on the applicant's response: withdrawn applications take less time to process than assessing many additional studies.

For applications submitted before 2018, one flat application fee was charged for national and Union applications. For these applications, if an assessment of additional data is necessary, the actual costs incurred will be charged. This is almost always the case.

If multiple applications are submitted simultaneously, for which a cluster assessment involving one or more expertises can be made for multiple applications, at the request of the applicant(s) the Ctgb can charge a reduced rate for these expertises (in accordance with Article 80.3.d). If there are multiple applicants, each applicant is jointly and severally liable for paying the entire amount to the Ctgb. The Ctgb does not become involved with the mutual payment arrangements between applicants.

Invoicing of fixed fees for applications for biocidal products under the Regulation (BPR) in the Netherlands

The fixed fees for applications under the regulation are in most cases invoiced in two parts.

1. First invoice
   We start with a fixed application fee that is invoiced immediately after submission.
2. Second invoice
   Prior to the evaluation, a second invoice will be sent, based on a fixed (basic) fee with - if applicable - fixed add-ons.
   
   For applications in which the Netherlands acts as the Member State concerned (CMS), it may happen that between submitting the application and being able to start the evaluation several years pass. This is the time the evaluating Member State needs to complete the (initial) assessment. The fee that the Netherlands, as the Member State involved, charges for these applications will be based on the costs as indicated in the Tariff Decree in the year in which the evaluation can be started. This applies to the entire amount, i.e. application costs and evaluation costs. Previously paid application costs will be deducted.

Invoicing of fixed fees for applications for biocidal products under transitional legislation in the Netherlands

Fixed fees are charged for applications under transitional law.

The fixed fees for applications under transitional law are in most cases invoiced in two parts.

1. First invoice 
   We start with a fixed application fee that is invoiced immediately after submission. The Ctgb will send an invoice for the application fee  which is due within 30 days. Late payment may lead to declaring the application non-admissible.
2. Second invoice
   rior to the evaluation, a second invoice will be sent, based on a fixed fee. The fee payable to the Ctgb is calculated based on the specified items and tariffs.  The Ctgb will send an invoice for the assessment costs which is due within 30 days. Late payment may lead to declaring the application non-admissible.
   
   Under transitional law it is possible to obtain, extend or request a change to an authorization through a limited assessment. Adjusted rates apply for this application type as indicated in the rates decision.
   
   If questions are asked after the first assessment and a second assessment is required after the provision of additional data, costs will be charged again based on the dossier components to be reassessed.

For other fees or charges, the applicant shall pay the invoice within 30 days of the invoice date, indicating the invoice number.

Annual fee

An annual fee (tariff) is charged to the authorization holder for all authorized substances included in the Board's register (Wgb article 10, paragraph 1). The reference date for this is February 1 of each year. The Ctgb does not charge an annual fee for Union authorizations issued by the European Commission. Authorization holders of Union authorizations do however owe an annual fee to ECHA, see Regulation (EU) 564/2013. For simplified authorizations, the Ctgb charges an annual fee if the Ctgb acted as evaluating competent authority and the authorization has been issued by the Ctgb. For biocides of a product family, a fee is charged for both the family and the individual members.

Service desk

For questions that can be answered directly by the front office a fee will not be charged. For questions that require the assistance of a specialist from the back office, costs will always be charged. See Tariffs Decree, page 5: Addendum I - Fees and charges, Service Desk.