Experiences with Union Authorisation and Biocidal Product Families

Experiences with Union Authorisation and Biocidal Product Families

At the recent Dublin Biocide Symposium organised by Kerona Scientific, Nathalie Hanon, Executive Vice President at CEHTRA in Spain, gave a presentation on her experiences with Union Authorisation (UA) and Biocidal Product Families (BPF).

Nathalie started the presentation with an overview of Article 3(1)(s) of the Biocidal Products Regulation (EU) No. 528/2012 (the BPR), which defines a BPF as a group of biocidal products having similar uses, composition and efficacy. The BPF was initially introduced in 2014 in the guidance document “Implementing the new concept of biocidal product families” and was revised 3 years later by the BPF Working Party, whereby the issues in the first implementation were amended. In 2019, the BPF Working Party presented the new BPF concept in the revised guidance document.

The BPF guidance is complex to understand and implement, consequently, some companies choose single-product dossiers. Companies that decide to implement a BPF should have a strategy defined well in advance because the notification process might be burdensome. Additionally, the approach on the BPF formation can yield different results, a risky approach could lead to splitting the BPF, so the recommended strategy is to plan simple BPFs with good communication between the Regulatory, R&D and Marketing departments.

Nathalie concluded the presentation by describing the UA application that was introduced in the BPR to implement similar conditions of use across the European Union. So far, there has been 57 BPC opinions for UA since 2017, with 42 BPFs and only 15 BPs.

If you would like to avail of the slides of the presentations from the Dublin Biocides Symposium, please follow this link:  https://kerona.ie/product/dublin-biocides-symposium-2021-speakers-presentations/

Please contact Kerona Scientific’s expert Biocide Team at info@kerona.ie or info@kerona.co.uk if you need support with any of your Biocides regulatory projects in the EU or in GB.