Biocidal product families with quats - limits of the BPF concept
Quaternary Ammonium Compounds (quats) are present in a vast variety of products mainly intended for household and professional disinfection. Product suppliers would like to group as many products as possible per family. Grouping in one product family is certainly possible, when the focus is on human health, if the products have vastly similar compositions and uses; otherwise, the grouping possibilities are quite limited.
Let us take disinfectants for private use as an example. As mentioned above, suppliers understandably prefer to group as many disinfection products as possible in a single product family. However, due to their characteristics and areas of use (product types), these disinfectants would have to be divided into five meta SPCs:
|Meta SPC n°||Meta SPC 1||Meta SPC 2||Meta SPC 3||Meta SPC 4||Meta SPC 5|
|Product||Hand soaps (RTU) (PT1)||Surface disinfectant (concentrated) (PT2)||Laundry disinfection (PT2) (RTU)||Surface disinfectant (PT4) (RTU)||Airborne disinfection (PT4)|
|Route of primary human exposure||Dermal||Dermal Inhalation (potentially)||Dermal Inhalation (potentially)||Dermal Inhalation (potentially)||Dermal (potentially) Inhalation (potentially)|
PT1: Human hygiene; PT2: Disinfectants and algaecides not intended for direct application to humans or animals; PT4: Food and feed area
For these five meta SPCs, a core composition may be defined, which allows the meta SPCs to be grouped in one family. But the Human Health Risk Assessment (HHRA) cannot be just one. For meta SPC 1 the relevant route of exposure is dermal as indicated in the table above. Also for surface disinfection the dermal route of exposure is most relevant considering pouring and wiping (e.g. meta SPC 2 and 4). However, using the same product in meta SPC 2 and 4 as trigger spray the inhalation route of exposure needs to be considered additionally. Adding further uses, e.g. laundry disinfection, may already result in the formation of subgroups or the splitting of the family based on non-similar use patterns (maximum of two non-similar pairs of uses) or different risks, decided on a case-by case basis.
This example already shows that, even for product families that are only meant for non-professional uses, it is not simple and straightforward to define the core risk assessment without introducing of subsets. The competent authorities will tend to simplify the product family and potentially split it in to two individual families. When planning your family it is important to keep it simple and to stick to the BPF guidance, but ensure that the flexibility they still offer is used.
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