Fees
Under the Biocidal Products Directive/Regulation the cost of work for a clearly identified customer will be recovered by means of fees. For example an assessment of an application for inclusion of an active substance on Annex I, an application for authorisation of a biocidal product or an application for a Process-Orientated Research and Development (PORD) or Experimental Authorisation (EA).
The fees charged by the UK Competent Authority (CA) will reflect the full cost of resources used to assess and evaluate the active substance or product dossier submitted.
The figures quoted below are only estimates of the likely fees involved. These figures will be updated when further information becomes available.Estimated Fees for the Evaluation of an Active Substance Dossier
If a company wishes to submit a dossier (either as a review or a new active substance) to the UK CA they should contact us via e-mail as soon as possible to arrange an initial meeting where any general issues can be discussed and a dossier submission date agreed. This initial meeting will not attract a fee.
If a company then wishes to have further contact to discuss specific issues relating to the active substance dossier submission a non-refundable fee of £10,000 will be charged. This will cover any further meetings, and actions arising from those meetings as well as our work on the Completeness Check once the dossier arrives. This fee must be paid before any further meetings take place.
If after the initial meeting a company does not require further contact to discuss specific issues relating to the active substance dossier submission, the non-refundable £10,000 completeness check fee should be paid when the active substance dossier is submitted to the UK CA for Completeness Check.
Once the Completeness Check has been carried out and the dossier is deemed complete, the final fee will be estimated and this will include any over spend or under spend from the Completeness Check fee.
We will continue to monitor the costs incurred during the evaluation and defence in the EU, and if necessary we will either ask for a "top-up" fee or give a refund dependant on the initial fee received and the total cost of the evaluation.
The current UK CA estimated fees for Evaluating an Active Substance Dossier under the Biocidal Products Directive are detailed below.
| Application type | Fees |
|---|---|
| Initial Meeting to discuss general issues relating to a dossier submission | Free |
| Completeness Check (includes further meetings to discuss specific issues relating to the active substance dossier submission) | £10,000 - Non-refundable |
| Evaluation of an Active Substance Dossier for Inclusion on Annex I, IA or IB, together with one supporting product | £150,000 - Estimated |
Estimated Fees for the Authorisation of a Biocidal Product Dossier
Product authorisation fees relate to the amount of work required in evaluating the data (hazard, efficacy, physical chemistry etc.) and carrying out a new risk assessment. The more work involve the greater the fee will be.
The estimated cost of first authorising a biocidal product in the UK, following the Annex I inclusion of an active substance could be £2,000, if the product is similar to the representative product. However if product is not similar to the representative product the fee will be assigned on a case by case bases.
However once the initial product has been authorised it is envisaged that it will set a 'precedent' and other products may be able to be authorised that contain the same active ingredient, are the same formulation etc. as the original product (providing the company seeking authorisation holds the relevant letters of access). As there will less work involved in such an authorisation, so the cost of the authorisation is expected to be much lower.
Frame formulation
Frame formulations are a specific tool used by the Competent Authority to establish efficient system of work for authorising and registering biocidal products. Frame formulations are defined in Article 2 of the Biocidal Products Directive (BPD) as follows:
"Specifications for a group of biocidal products having the same use and user type.
This group of products must contain the same active substances of the same specifications, and their compositions must present only variations from a previously authorised biocidal product which do not affect the level of risk associated with them and their efficacy.
In this context, a variation is the allowance of a reduction in the percentage of the active substance and/or an alteration in percentage composition of one or more non-active substances and/or the replacement of one or more pigments, dyes, perfumes by others presenting the same or a lower risk, and which do not decrease its efficacy."
Product Authorisations using the Frame formulations tool could be in the region of £500 - £2000, however as product authorisations have not started under BPD/R this figure is only an estimate and is likely to change as experience is gained carrying out product authorisations.
The UK CA estimated fees for the Authorisation of a Biocidal Product Dossier under the Biocidal Products Regulations are detailed below.
| Application type | Estimated fees |
|---|---|
| Application for authorisation of a biocidal product similar to the Representative Product. | Estimated £2,000 but will be dependant on the amount of evaluation work that has already been completed at the Annex I inclusion stage. |
| Application for authorisation of a biocidal product NOT similar to the Representative Product. | Case by Case Bases, will be dependant on the amount of evaluation work |
| Application for authorisation of a biocidal product within an existing frame formulation | There will be lower fees for such applications, which could be in the region of £500 - £2000 but this will be dependant on the amount of evaluation work |
Please note product authorisation under BPD/R is still in the early stages and these figures may change as experience is gained.
Charges for the evaluation of Process-Orientated Research and Development (PORD) or Experimental Authorisation (EA)
The competent authority is required to charge a fee for the work done to assess the information provided by the applicant before deciding whether or not to grant an authorisation under this regulation. .
| Application type | Fees |
|---|---|
| Process Orientated Research & Development (PORD) | £500 |
| Experimental Authorisation (EA) | £500 (Sift) £6000 (Full Fee) |