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ECHA harmonising handling of Biocidal Product Families

ECHA has been working on harmonising and standardising the way biocidal product families (BPFs) are handled.

What are BPF’s?

The definition of a BPF is a group of biocidal products having:

(i) similar uses;

(ii) the same active substances;

(iii) similar composition with specified variations; and

(iv) similar levels of risk and efficacy.

ECHA has developed a work programme that has been dedicated to producing documents that will clarify these points, and are currently deciding on when these clarifications will come into effect. This includes:

  • A decision tree and an automated tool that will determine whether uses are similar enough.

  • Guidance on proving similar composition, including 2 major concepts: backbone formulation, grouping of co-formulants.

  • Guidance on proving the similarity of risk and efficacy through use of a core assessment based on a worst case composition.

Each concept will have examples and exceptions provided.

Pre-submission consultations are required for BPFs, and a best-practice guide for setting these up has now been released.

The concept of splitting families for ongoing applications that will not meet the BPF requirements was introduced.

ECHA is still deciding when and how these documents will become applicable, as this will effect applications currently ongoing. They are looking for a fair and equal way to deal with this.