Frame formulations under the BPD
It is possible under the Biocidal Products Directive to apply for a frame formulation. A frame formulation is a group of similar products with only minor variations in composition. The requirements for products within a frame are reduced, as is the fee for the individual products under the frame.
Definition of a frame formulation
The Biocidal Products Directive (BPD) enables the establishment of a frame formulation in relation to an application for a concrete product (reference product).
Frame formulations are defined as follows in article 2, section 1, litra j. of the BPD:
“ 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 composi-tions 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 . “
Establishment of a frame can only be accepted in relation to an application for a concrete product (reference product) under the BPD. The Biocides Directive does not allow for application for a frame on its own. The frame itself will not get an authorisation. It will only be assessed in relation to risk and efficacy. Each of the products under a frame will be authorised.
How to apply for a frame formulation
In R4BP you first create the individual products and you create the frame formulation. Then you create the application by clicking on “Create application with frame formulation”. Select in your portfolio of frame formulations, the one for which you want to create the application form. Secondly you need to link the reference product and the related products in your portfolio to that frame formulation.
In the R4BP user guide version 2.0 is a stepwise guide on how to create and apply for a frame formulation.
The dossier on the reference product shall also include information on every co-formulant of the proposed frame, in order to permit a risk and efficacy evaluation of the frame. The authorities may need to ask for additional information on the effects, efficacy and/or risk related to products within the frame.
Each individual product under a frame must be identified
Based on a harmonised decision between EU Member States, the individual products which are applied for within the frame must be identified with completespecification in the R4BP in view of their subsequent authorisation.
The fee for frame formulations
The fee is DKK 253,000 for the establishment of a frame in connection with the authorisation of a biocidal product with Denmark as the reference Member State.
For the other individual products under the frame the fee is DKK 5,530 per product.
Authorisation of individual products under a frame in Denmark
After the authorisation of the reference product and the evaluation of the frame, the individual products will get a separate authorisation letter. The authorisation of the individual products will consist of an authorisation letter, appendix 1 (complete list with the names and authorisation number of the products) and the confidential appendix 2 (complete composition of the products).
The authorisation of the frame products is given with the same conditions and validity as the reference product.
Each of the products under the frame will receive its own authorisation number which is linked to the authorisation number of the reference product; the authorisation number of the frame product will be three additional consecutive numbers after the authorisation number of the reference product.
The label of the reference product will also be valid for frame products, but the containers of the frame products must also be marked with its own the authorisation number and name.