This page details the different types of product applications under BPR. You need to know which type of application you are making as it affects what you need to do within the application process. A product is considered to be ‘authorised’ if the active substance is included on Annex I of the BPD and ‘registered’ if the active substance is on Annex IA of the BPD.
A full product authorisation/registration can be granted once all the active substances in the product are actually entered into Annex I/IA of the Biocidal Products Directive (BPD) (i.e. when the decisions in the relevant Inclusion directive take effect).
Full product authorisations/registrations have a finite duration. The authorisation/registration will normally last until the Annex I/IA entry of any of the active substance(s) in the product expires. Most active substances remain in Annex I/IA for a period of 10 years (although after re-assessment this may potentially be extended).
There are several administrative application routes for full product authorisations/registrations:
A lead authorisation/registration application will contain all the data, evaluations, information and risk assessments required to satisfy the data requirements of the relevant Annexes to the BPD.
If a lead authorisation/registration application is similar to the representative product usually the amount of work required in evaluating the data (hazard, efficacy, physical chemistry etc.) and carrying out a new risk assessment will be reduced.
If a lead authorisation/registration application is not similar to the representative product the amount of work required in evaluating the data (hazard, efficacy, physical chemistry etc.) and carrying out a new risk assessment will be on a case by case basis.
Once a lead product is authorised/registered it is envisaged that it will set a 'precedent' and other products may be able to be authorised/registered under a read across, back-to-back or marketing authorisation route (providing the company seeking authorisation holds the relevant letters of access).
The read across authorisation/registration is aimed primarily at a company who bases their product authorisation/registration on data that has already been used to authorise/register another product. The read across authorisation/registration is independent to the original on which it was based. The read across authorisation/registration will only need to be modified if the specific data to which it applies is changed.
The product authorisation/registration application will be based on data that has already been assessed and authorised/registered but the product is not identical to the lead product therefore the back-to-back or marketing application routes cannot be followed.
The back-to-back authorisation/registration is aimed primarily at a company who bases their product authorisation/registration on a lead product that has already been authorised/registered. The back-to-back authorisation/registration is independent to the original on which it was based. The back-to-back authorisation/registration will only need to be modified if the specific product to which it applies is changed. Any changes to the original product and its authorisation/registration do not require a change to the back-to-back authorisation/registration.
The product authorisation/registration application will be based on a product that has already been assessed and authorised/registered. As a result there will usually be little extra assessment required in order to grant the back-to-back authorisation/registration.
It is recognised that for marketing and business purposes the same product (in terms of composition and intended use) may be sold by different companies (i.e. marketing companies) under different trade names. Each individual product must still be authorised in order to be placed on the market. The concept of so-called "marketing authorisations/registrations" has been introduced to facilitate and expedite the processing of applications for such products.
In marketing authorisations/registrations each version of a product placed on the market, i.e. each individual trade name, is individually authorised/registered. The authorisation/registration holder for each product is the supplier (the manufacturer or formulator) of the product. The application for authorisation/registration should specify the details of the marketing company and the trade name of the product that the marketing company will place on the market. In this case the marketing company simply sells the product and cannot themselves make any changes to it. Any changes to the product must be notified to HSE by the authorisation/registration holder to allow the authorisation/registration to be revised. If the authorisation/registration expires or is revoked then the sale of that product by the marketing company has to cease.
Where a product has already been authorised/registered subsequent applications for marketing authorisations/registration will usually require little extra assessment in order to grant the authorisation/registration and so will generally be charged a lower fee.
A frame formulation is a generic specification of a biocidal product for a particular use and user type. It defines the composition of the product within specified limits.
A given frame formulation will define the active and non-active substances present and the range of concentration at which each may be present at. It will only cover products containing the same active substance(s) with some degree of flexibility on the presence of other non-active substance components.
Figure. A conceptual frame formulation.
The concentration ranges defined for each component in the product will usually be relatively small (perhaps a range of up to around 10%w/w between the lower and upper limit for the concentration of a particular component), depending on the nature of the substance and its properties and how its concentration may affect the product overall. For non-active substances, the concentration range could potentially include 0% to allow for products where the substance is not present. This approach might be useful for instance for products which may be marketed in a range of colours. The frame formulation could be defined to include several dyes which can be incorporated in different amounts to give the desired colours. Products of certain colours may not need one or more of the dyes but such products would still fall within the frame formulation. A similar situation could be envisaged for products containing different perfumes etc.
A frame formulation will be assessed according to the same criteria as for a single product in terms of risks to health and the environment and efficacy. As a general rule, changes in composition within the frame specification should not significantly change the risks or efficacy of the products within the frame.
In general terms the assessment of the frame formulation will be conducted to assess the maximum risks to health and environment and minimum level of efficacy of products that could fall within the frame formulation. To help with this assessment it should be clearly indicated what the function (e.g. surfactant, stabiliser) of each component in the product is.
The establishment of a frame formulation will usually be done as part of an application for authorisation/registration of a specific product that falls within that frame. Once a frame formulation is established subsequent applications for product authorisations/registrations may refer to that frame formulation. If the product is within the frame formulation then the assessment required should be minimal (presuming the same label claims etc).
The provision for provisional authorisation/registration only applies to products which contain new active substances; the product may also contain existing active substances. Any product containing no active substances other than existing substances is subject to the transitional provisions (schedule 13 of BPR) which do not allow for the provisional authorisation/registration of such products.
The earliest stage in the BPD active substance programme that a provisional authorisation/registration can be issued by HSE is after the initial review of the UK Competent Authority Report (CAR) on the active substance (and representative product containing that active substance) by Member State Competent Authorities (during the 90 day consultation period on CIRCA) has been completed and if no adverse comments have been raised. Please note that other Member States may choose to grant provisional authorisation/registration at a different stage in the process to the UK so you should contact the appropriate Competent Authority for further details if you intend to apply for provisional authorisation/registration elsewhere.
The information requirements and evaluation criteria for obtaining provisional product authorisation/registration are the same as for obtaining full product authorisation/registration. A provisional authorisation/registration can only be granted if the criteria for a full authorisation/registration (excluding the requirement for actual listing in Annex I entry) are met in relation to health and the environment and efficacy.
A provisional authorisation/registration can be granted for up to three years, with a possible extension of a further year if the decision on Annex I inclusion is delayed at Commission level, at the discretion of HSE. In most cases a provisional product authorisation/registration will become a full product authorisation/registration once the active substance goes into Annex I as most, if not all, of the required assessment will already have been carried out in order to grant the provisional authorisation/registration.
A company can seek product authorisation/registration in any Member State. It is expected that in most cases the application will be made to the Member State that either was the Rapporteur for the active substance in the product when it went through the BPD review process or to the Member State where the product will first be placed on the market. However, in principle, the application can be made to any Member State.
Once a product is successfully authorised/registered in one Member State (the reference Member State) the applicant may apply for that authorisation/registration to be recognised in other Member States. An application for such mutual recognition of the authorisation/registration will need to be made to the Competent Authority in each Member State where the product will be marketed. The application cannot be made until the product authorisation/registration has been granted in the reference Member State. It is not possible to seek mutual recognition of a provisional authorisation.
An emergency authorisation allows a biocidal product to be placed on the market for a limited and controlled use to deal with an unforeseen danger which cannot be contained by any other means. In the first instance the authorisation will last up to 120 days, with the possibility of extension or renewal if deemed appropriate.
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