By Joanna Sackey
The concept of biocidal product families (BPF) was first introduced when the BPR came into force in September 2013 and allows the grouping of products based on:
(i) Similar uses
(ii) Same active substances
(iii) Similar composition
(iv) Similar levels of risk and efficacy
In November 2014 the ‘Note for Guidance implementing the new concept of product families’ was endorsed in order to provide a common understanding of the BPF concept.
However, the Note for Guidance does not clearly define exactly what can be regarded as ‘similar’. This in turn has led to submissions of product families containing numerous product types and complex families consisting of a diverse range of products.
Following discussions at Coordination Group (CG) meetings, Member States have agreed that the Note for Guidance needs to be revised to ensure a more robust approach with regards to the BPF concept in order to avoid such complex submissions and thus limit, as far as possible, the time and resources taken to evaluate such applications.
Taking into account the elements that have been discussed, further clarity to the concept of BPF is soon to be implemented…….
So what exactly can be considered as ‘similar’?
Similarity of uses
The Note for Guidance states: “Similar uses for products belonging to a BPF have to be understood as different uses within the PT(s) to which the BPF belongs”
This is of course left widely open to interpretation. For example: Can it be concluded that PT5 can be grouped into the same family as PT2, 3 and 4 as they are all considered disinfectants; or, that a PT1 use can be grouped with a PT19 use if both products are applied to human skin?
In order to further define the concept of similar uses, an automated tool, in the form of an excel matrix, has been developed to help decide which uses can be considered as ‘similar’.
The matrix will enable users to manually select from a list of ‘use patterns’ for each PT those that are relevant for the proposed family. The selection of use patterns will automatically generate a colour coded matrix based on a traffic light system as follows:
• Red: Uses cannot be considered as similar
• Yellow: Uses may be considered as similar on a case by case basis
• Green: Uses can be considered as similar
This will enable the applicant to visually ascertain whether or not their uses can be regarded as ‘similar’ enough to be grouped into a family. Where the matrix flags the uses as ‘red’ a reconsideration of the family may be required.
Similarity of composition
By definition, products belonging to a BPF must have a “similar composition within specified variations”.
So how do you decide on what is regarded as ‘similar composition’?
To help this decision a so called ‘backbone’ composition should be established.
It is considered that each individual product should contain the same basic set of ingredients which are essential to formulate all products.
The backbone should comprise the same active(s) and one or more co-formulants which is (are) essential to formulate all products. These could include for example binders, pH regulators or a specific solvent but easily exchangeable co-formulants such as perfumes, pigments and dyes should not be included as these are not considered essential.
The range of co-formulants that are essential to formulate should be included in a range starting from > 0% minimum content whereas previously it may have been ‘accepted’ to state 0% as a minimum for a specific co-formulant.
In addition the minimum concentration should be set in such a way that the presence of each coformulant remains essential for each product. This is in order to avoid any ‘abuse’ of the concept by including essential co-formulants at very low concentrations (e.g. < 0.1%) in all products to ensure all products fall within the ‘backbone composition’
A robust justification regarding the backbone composition should be provided.
Applicants may also, where appropriate, group co-formulants providing that they have the SAME function, the SAME impact on classification and the SAME impact on the level of risk and efficacy.
Similar levels of risk and efficacy
By definition: “Similar levels of risks for products belonging to a BPF have to be understood as different levels of acceptable risk resulting from the assessment of the maximum risks (to HH, animal health and the environment”
“Similar levels of efficacy for products belonging to a BPF have to be understood as different levels of proven efficacy”
So how different is different?
The BPF should generally be defined by one CORE assessment based on one worst case composition which may be different for human health, environment and efficacy assessment. Therefore a cross-reference of products may need to be selected.
Worst case composition for risk assessment:
The worst case composition can generally be defined as:
• Highest (in use) concentration of active
• Highest (in use) concentration of co-formulants negatively affecting the risk
Worst case for efficacy:
• Lowest (in use) concentration of active
• Lowest (in use) concentration positively affecting efficacy
• Lowest (in use) concentration negatively affecting efficacy
• Phys-chem property which is most unfavourable (e.g. pH/viscosity)
Justification should be given why the chosen test product(s) cover the whole core. It may be necessary to include an expert judgement and/or bridging studies where relevant.
Although the revised concept on BPF is yet to be endorsed, applicants should prepare themselves for a more robust, but also a more defined concept of what will be considered as an acceptable product family with the aid of a matrix tool.
It may arise that splitting of families for ongoing applications will be required because the biocidal products within the family are no longer considered to fulfil the conditions of similarity of uses, composition or levels of efficacy or risk.
Talk to the evaluating authority! Prior to submission of a BPF, a pre-submission meeting with the evaluating authority should be organised in order to discuss the approach (physical or virtual). These should start no later than 18 months before the expected date of submission. The applicant should be prepared to present an overview of the BPF to the eCA with relevant argumentation to support the proposal.
If you have any questions on this article, please don’t hesitate to contact Joanna Sackey
, EAS Group Biocides Regulatory Manager