BPF :
Taking stock two years on
Gerard McElwee , partner , and Elise Van Gerven , associate , in EU regulatory law at Fieldfisher , discuss the evolution of biocidal product families in the EU and current status
The concept of a biocidal product family ( BPF ) was first introduced by the EU Biocidal Products Regulation 528 / 2012 ( BPR ) in 2012 . The accompanying recital clarified the intent of that introduction , namely ‘[ t ] o facilitate access to the market it should be possible to authorise a group of biocidal products as a biocidal product family ’. The BPR listed three requirements for biocidal products belonging to one BPF dossier , namely that : the products should be based on the same active substance ; they should have similar uses ; and the variations in composition between the products could not adversely affect risk and efficacy . Then in 2014 , the definition of a BPF was amended , in effect changing the last condition into two new ones : similar composition with specified variations ; and similar levels of risk and efficacy . This expanded use of the word ‘ similar ’ narrowed the concept of the BPF and reduced flexibility . Remarkably , the amendment also did not contain a definition of what ‘ similar ’ meant .
Guidance
For the first 15 months that the BPR was applied , from 1 September 2013 , the BPF concept existed without much further harmonising guidance . Finally in November 2014 , the European Commission and Member State ( MS ) competent authorities ( CAs ) published an 18-page guidance note .
The 2019 Guidance Note further narrowed key definitions
In an attempt to structure BPF applications , the concept of ‘ meta SPC ’ was introduced and further explained by the note . This was a tool to sub-divide the BPF , helping both industry and CAs . It allowed for risk and efficacy assessment evaluations at meta SPC level and could result in certain meta SPCs of the BPF
“ Remarkably , the 2014 amendment also did not contain a definition of what ‘ similar ’ meant .”
50 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981