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Frame formulations

Under transitional law it is possible to submit a combined application for a group of very similar products, which will each get their own authorisation. They must all have the same use and user type and the same active substance specifications. The compositions must have only variations that do not affect the level of risk and the efficacy. For example antifouling products in different colours.

Instructions for submission

  1. One application is submitted as a regular admission (TB) under transitional law (Forms B and C). If a comparison can be made with an already authorized product, the limited assessment (TBL) can be used.
  2. For the other products, an application for establishing a frame formulation (KB) is submitted separately for each product using form B. A complete file has to be submitted for each product.

Whether a limited assessment is possible, and whether the applications are seen as frame formulation, will become clear during the intake. After approval, the annual fee is due for each product.

Example costs for antifouling product in 2 colors:

Application fee 1 (TB/TBL): € 5,350

Application fee 2 (KB):         € 3,700

Assessment costs 1+2 : € 2,825 for limited assessment (TBL) ; € 11,900 for full assessment (TB)

Total:

  • for 2 authorisations via limited assessment: € 5,350 + € 3,700 + € 2,825 = € 11,875 + project management € 3.295,- = € 15.170,-
  • for 2 authorisations via full assessment: € 5,350 + € 3,700 + €11,900 = € 20,950 -+ project management € 4.950,- = € 25.900,-

Comparison of frame formulations (BPD) and BPF’s (BPR)

Under the Biocidal product Regulation (BPR), authorisation of frame formulations is not possible. The BPR offers the possibility of biocidal product families (BPF). Similar to frame formulations, BPF’s can contain a group of biocidal products with similar uses and the same active substances. Variations in the composition may not adversely affect the level of risk or significantly reduce the efficacy of the products. After authorisation of the BPF, it is possible to add new products by notification, as long as their composition fits within the specifications of the BPF.

See also the Guidance on how a frame formulation can be transferred to a biocidal product family.

Frame formulation:

  • Several products within a frame formulation can each get an individual authorisation by following one authorisation procedure. Only products that have been included in the frame formulation, with their exact composition, can be brought to the market. Each product gets its own authorisation number. After authorisation of the individual products, new products (with compositions within the specifications) cannot be added by notification, but need their own approval.
  • All products have the same use(s)
  • Co-formulants must always be included in the composition specification of the individual products within the frame formulation

Biocidal product family:

  • only products that have been included in the biocidal product family, with their exact composition, can be brought to the market. After authorisation of the BPF, new products (with compositions within the specifications) can be added by notification.
  • Products can have different uses
  • New products can be added to the family without notification when the variation in composition concerns only pigments, perfumes and dyes within the permitted variations