Recommendations of the Biocidal Product Families Working Party – Upcoming changes and consequences on BPFs in general

Biocidal Product Families Working Party
26 April, 2019

Background to the BPF WP

Documentation discussed in the context of the BPF WP is available to the public on CIRCABC. The Commission, the Authority (ECHA), Member States Competent Authorities and accredited stakeholder organisations have formed this BPF WP in order to discuss and revise the presently valid criteria on the implementation of the concept of BPF as laid down in the CA document „CA-Nov14-Doc.5.8 – Final.rev3“. Just very recently, a revised CA document on the implementation of the BPF concept, CA-May19-Doc4.8, has been uploaded in CIRCABC and it is scheduled for discussion in the next CA meeting on 16-17 May 2019.

BPF WP discussions

The following criteria form the basis for the similarity check performed by the evaluating Competent Authorities (eCA):

  • Similar composition (with specified variations)
  • Similarity of uses
  • similar levels of risks
  • Similar level of efficacy

BPF WP outcome

The definition of the similarity criteria will be interpreted more strictly in the future, leading to less flexibility with regards to uses of the biocidal products accommodated in a BPF. Following limitations have been suggested with respect to similarity of uses:

  • a maximum of two pairs of “non-similar” uses in each family only
  • a maximum of three refinements per family (via so called subsets and/or extensions) are allowed

These numbers were arbitrarily defined and are not based on regulatory/scientific-technical aspects. The recommendations of the BPF WP presently available suggest that previously submitted BPF applications will have to be modified in order to comply with the revised similarity criteria.

  1. Splitting of the original BPF in different BPFs: this may be an option for national authorization applications; for Union authorization applications, a split in different BPF may not be economic due to the financial burden (e.g. annual fees to be paid to ECHA and eCA for each of these BPFs)
     
  2. Maintaining only one core BPF with a focus on core uses and core products an
    a) eliminating all other products and uses

    b) pursue single product authorizations (national or Union authorisations) for selected products/uses eliminated from the original BPF as feasible from the economical point of view; this may be an option for products having many uses at the same time as the BPF similarity criteria do not apply to single biocidal products
     

The final decision of the eCAs on implementing of the BPF WP recommendation will determine the consequences for currently running BPF applications. Regardless of whatever the eCA feedback is, the knoell biocides team with its long-standing regulatory and technical expertise in the biocides area can assist you with the regulatory and technical hurdles this development may bring.

 

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