Biocidal product family
Under the Biocides Regulation, it is possible to admit multiple products under a single entry. This is important for producers, to facilitate market access and reduce administrative burdens. For authorisations based on the same active ingredient(s), the regulation describes the concept of the ‘biocidal product family’.
The definition of a biocidal product family (BPF) in Article 3(1)(s) of the BPR refers to a group of products having similar uses, the same active substances, similar composition within specified variations and similar levels of risk and efficacy. The BPF concept is further explained in the Note for guidance – Implementing the new concept of biocidal product families.
The uniform interpretation of "similar" is defined in harmonised guidance. This guidance on similarity is applicable for new applications as per October 1, 2019. As this guidance builds on the existing definitions of similar use, composition and levels of risk and efficacy, these principles can also be voluntary applied to pending applications of so-called complex families. This might imply that the initial application will be split into two or more, leading to higher fees. This way the competent authority can actually complete the assessment within a reasonable period of time.
In case of new applications it is recommended to contact the eCA to organize a presubmission meeting (PSM) in order to discuss whether the BPF to be submitted meets the definitions laid out in the guidances, and whether the interpretation of the family is the same for both eCA and the applicant.
Pre submission meetings on BPF
When applicants are in the planning phase for designing an application for a biocidal product family (BPF) a number of considerations might rise.
According to the BPR, Annex III (2): "The applicant has the obligation to initiate a pre-submission consultation. In addition to the obligation set out in Article 62(2), applicants may also consult with the competent authority that will evaluate the dossier with regard to the proposed information requirements and in particular the testing on vertebrates that the applicant proposes to carry out"(emphasis added).
In order to solve as many issues as possible and discuss the foreseen approach before the submission of the application, it is therefore essential that the applicant request a pre submission meeting with the competent authority (CA) that will be acting as reference member state (rMS). See also best practices for eCA agreement and pre-submission meetings related to applications for biocidal product families
Working party on biocidal product families
After the introduction of the BPF concept, Industry and MSCAs raised the need to address a number of identified issues in the Note for Guidance document. The document gives broad definitions of critical concepts such as "similar composition", "similar uses" and "similar level of risk and efficacy", which allow for certain flexibility but also different interpretations.
A working party (WP) consisting of representatives from industry and member states was established at the coordination group (CG)-22 meeting in 2017, to narrow down definitions given in the Note for Guidance. The last meeting is scheduled January 2019, after which recommendations will be sent to the CG/EC. Publicly available documents are expected late 2019.
Authorisation number + suffix
Biocidal product families, like individual biocidal products, are issued an authorisation number. Each member of the family is also given a suffix. Furthermore, applications for mutual recognition of a national authorisation can concern both an individual biocidal product or a biocidal product family.
Adding family members
If the composition of a new product falls within the established ranges, an authorisation holder only has to notify the authorities about the new product at least 30 days before placing it on the market. Notifications for placing a product on a national market must be sent to the relevant competent authority who has granted a national authorisation for a biocidal product family. In the case of an EU authorisation, the notification must be sent to ECHA and the Commission. All notifications must be sent through R4BP 3.
The notification must contain:
- the exact formulation,
- the trade name and
- the suffix to the authorisation number.
For Union authorisations, the authorisation holder notifies the Agency and the Commission.
If the variations of a new product compared to the authorised BPF only concern dyes, perfumes or pigments which are within the existing permitted ranges, the new product can be put on the market even without notification.
For additional information see also the ECHA, the guidance about biocidal product families (given in CA document Nov14-Doc.5.8-Final.rev3.) and the guidance on similarity CA document CAJuly19-Doc.4.2_BPF (see library CircaBC).