The biocidal product family – what options are there?

The European Biocidal Products Regulation (BPR) makes it possible to combine several biocidal products into one biocidal product family (BPF) for authorization. This reduces the time and effort required for testsand studies. Dossier creation is simplified overall. However, a major advantage is that the fees to be paid to the authorities for the BPF are considerably lower than if separate applications for authorization had been submitted for each individual biocidal product.

In 2014, the legislator revised the definition of the requirements for the formation of a biocidal product family in the BPR. This has made it a little clearer what requirements need to be met for a family. At the same time, guidelines were drawn up in the same year to provide assistance in fulfilling and interpreting the requirements. For example, what is meant by similar uses and similar risks and efficacy.

These guidelines opened up a generous interpretation for the biocidal product family. Some applicants then created extraordinarily extensive families – with the aim of significantly reducing the costs per biocidal product by combining a wide variety of products and applications.

However, the complexity of some very extensive biocidal product families meant that the evaluating authorities no longer felt able to assess such BPFs. In consultation with the member states, ECHA therefore published new guidelines in July 2019 that impose significantly stricter requirements on applicants.

The new guidelines have been in force since October 1, 2019.

For dossiers submitted before October 1, 2019, the applicant’s consent is required for their applicability. Irrespective of this, the evaluating authorities will refer to the unamended BPR and its Articles 3(1)(s) and 19(6). These define the biocidal product family and describe the requirements for authorizing a biocidal product family.

The July 2019 guidelines are not easy to understand. They require a rethink of the approval strategy. Prosacon has therefore already held several workshops on this topic. In these workshops, we worked with the participants to develop options on how to successfully prepare an application for admission.

We would like to share the experiences of these discussions with you. ⇒ Contact