Building a Biocidal Product Family: opportunities and challenges

The Biocidal Product Family concept - a fine balance between creating a sustainable product portfolio while ensuring the complexity of your biocidal product dossier remains manageable. 

Together with BPR the entering into force, a new biocidal concept was introduced, the Biocidal Product Family. From that moment on, companies could combine different biocidal products within one biocidal product authorisation dossier as long as it was demonstrated that the different biocidal products would have ‘similar’ uses, same active ingredient(s), ‘similar’ compositions within specified variations and ‘similar’ levels of risk and efficacy.

 

To be completely honest, this concept was not completely new but an improved version of the frame formulation concept which existed under the former Biocidal Products Directive already. The Biocidal Product Family concept, in short the BPF, was however still to be seen as an opportunity for the applicants. A new concept which would result in lowering the required amount of data needed to complete a dossier and significantly decreasing the cost of dossier submission as only one fee was to be paid for the full family of products.

The additional advantage of the concept is that new products can easily be added to the BPF through a notification once the BPF authorisation has been put in place. One simply needs to notify the relevant authorities that have granted the authorisation 30 days prior to placing a new product on the market. In case of a Union authorisation, the notification is to be directed to ECHA and the Commission instead of the concerned Member State. Obviously in all cases it needs to be verified whether the new product is eligible for notification or whether first a change to the family would need to be filed.

Based on the above, one might conclude that applying this BPF concept to your product portfolio seems to have only benefits… increased flexibility, less resources and decreased costs especially when applied in a Union Authorisation context! And you are right! To a certain extent…

The appealing benefits resulted in an almost unforeseen success. Companies on their own started to form BPFs, but also consortia were formed to enlarge the advantages of this concept even further. These consortia were presented as the best (read cheapest) solution to get products on the market. As more companies joined these consortia, the authorisation costs further decreased. However, as more products were added to the consortium biocidal product families, the families got more complex. Large families started to be huge families, with many metaSPC, to allow the grouping of products with similar hazard properties, similar compositions and similar uses. Sadly this also resulted in complex exposure and risk assessment, difficult to compose but apparently even more difficult to evaluate by authorities. As result, the note for guidance on BPFs was fully re-written.

New guidance... New rules

Note for guidance on BPF:  CA-July19-Doc.4.2-Final – Guidance note on BPF concept-1

Relevant Apeiron Services

Apeiron-Team can guide you through the options of compiling a Biocidal product family avoiding the pitfalls but making us of this new process.

Biocidal product strategy
Biocidal product authorisation

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Posted by
Tine Vandenbrouck
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