Speciality Chemicals Magazine SEP / OCT 2021 | Page 51

BIOCIDES being authorised , while others could be rejected . After continued discussion and building on growing experience within the sector , an updated CA guidance note was published five years later in July 2019 , containing no fewer than 46 pages . This narrowed the concept of similarity and , in doing so , further narrowed the concept of a BPF . For example , it clarified that ‘ similar composition ’ in practice required ‘ the same basic set of ingredients essential to formulate all products ’. The note stated that it was applicable to applications made from 1 October 2019 onwards , but could be applied to applications submitted beforehand if applicants agreed .
Inherent problems with BPF rollout
Despite the laudable intention and efforts explained above , the BPF rollout was beset by inherent problems from the beginning . Firstly , in hindsight , the lack of clarity surrounding the legal concept of a BPF went on for too long . The necessary clarifications only arrived in July 2019 , seven years after the BPF concept was introduced . In that vacuum , it is no surprise that different actors adopted different interpretations and built expectations accordingly . Industry , trying to make best use of the flexible BPF concept , often submitted large and complicated dossiers . This caused headaches for CAs because of a lack of necessary resources , experience and time to deal with these applications . Secondly , the BPR does not sufficiently accommodate for the practicalities of a BPF review . For example , it grants the same amount of time to a CA to complete a single biocidal product evaluation as a ( complex ) BPF evaluation and the CA fee structure is not usually properly adapted for ( complex ) BPFs . Thirdly , the ECHA IT systems were not ready for such complexity . For example , the oft-maligned SPC online editor was not , and is still not , fit for inputting BPFs and their respective meta SPCs .
Experience
In my experience , and as can be divined from the above history , the biggest challenge faced by BPF applicants is what to include in the BPF . In 2012 , industry naturally anticipated a relatively flexible concept . By and large , it tried to include many and varied products ( within reason ) in the BPF application . This flexibility has been steadily eroded , first by the amendment to the definition of ‘ BPF ’ in 2014 , then by the November 2014 guidance and finally by the July 2019 guidance . This often leads to a complete reorganisation of the meta SPCs , delays , increased CA and consultant fees , increased internal ‣
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