EU Commission allows flexibility on biocidal product families

A European Commission guidance note relating to the biocidal product family (BPF) concept will benefit companies by allowing a flexible approach to assessment and evaluation, says consultancy CEHTRA. The note, which specifically tackles applications for biocidal products that are considered the same as a member of a BPF, clarifies the logic of grouping products into a family. In a video interview with Chemical Watch, CEHTRA senior consultant Sara Kirkham says this will allow companies to sub-group product families and tailor their assessments according to the properties of the sub-group. In addition, a negative evaluation may only impact a sub-group of a family, rather than all of its members, she says. The concept of BPFs was introduced by the biocidal products Regulation and allows companies to make one application to cover many products – preparing one dossier and paying one fee. Companies have been working on how to construct product families, or how they might add products to existing authorisations to create a family. The Commission’s guidance note analyses the relevant legal provisions, referring to the Regulation on same biocidal products (SBP), and other guidance, notably that on implementation of the BPF concept. In accordance with the legal description of a product family it is possible to sub-group a family by giving a meta summary of product characteristics (meta-SPC). This requires a family to be defined in accordance with three specific levels of information that:

  • describe the generic composition and permitted variation of the authorised BPF;
  • provide the meta-SPC, to describe how products are sub-grouped within the family, for example by composition, uses and/or levels of risk and efficacy; and
  • provide the detailed composition of the different products covered by each meta-SPC and make up the family.

Any application for a product family should include a solid justification for the grouping, says Ms Kirkham. These arguments need to be scientific, logical and easy to follow, she says, noting the importance of getting the meta-SPCs right for any sub-grouping within a BPF. “People tend to concentrate on composition and that these are similar across products in a family, but you also need to think about the hazards, uses, and risk mitigation. There are all sort of different factors that need to be considered,” she says. She also notes the potential benefits of making a union authorisation for a BPF to gain access across the EU. But she points out that, at present, no-one is clear if there is a “magic number” for the optimum quantity of biocidal products that should be included in a family. Ms Kirkham will be speaking on biocidal product families at the upcoming CW+BiocidesHub Biocides Symposium in Ljubljana on 11-13 May.

Chemical Watch, 30 April 2015 ; ;