Do's and don'ts when building a Biocidal Product Family (BPF)
In 2020, two widely used active substances Didecyldimethylammonium chloride (DDAC) and Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC) have been approved for use as PT3 and PT4. At the end of 2021, the Biocidal Products Committee (BPC) had also issued a favourable opinion on their approval as PT1 and PT2.
DDAC and ADBAC are also known as “quats” (quaternary ammonium compounds) and are potent disinfectant chemicals commonly found in wipes, sprays and other household and professional disinfectant products. The approval for use as PT1-PT4 would mean that a huge number of products with different uses would have to be authorised. The cheapest and smartest way to do this is to create a BPF. Our article collects some suggestions based on our experience with these molecules. Several actions need to be taken to initiate the authorisation procedure:
- Product portfolio: It is highly unlikely that your entire portfolio will fit into a single product family. It is therefore recommended to start with the products that represent your core business and then add the others by giving them a rating based on their market importance. This will help you to identify which products you need to keep and which you can abandon.
- Product compositions: Products that belong to the same family should be similar to each other. If possible, do not mix clear solutions, gels and emulsions; otherwise it might become difficult to identify a common backbone composition. It is essential to check the CAS of the molecule since there are 3 for ADBAC and 2 for DDAC and only 1 for each molecule has been approved so far. Furthermore, think to check the Substances of Concern and the EDs, amongst the co-formulants, and if possible change the formulations in order to eliminate them. These substances could affect your registration.
- Claims: Create a table of uses, target organisms, interfering conditions and group products that are similar in terms of claims. You can group PT1 and PT2 in the same family, even if they are quite different (as it is a tolerated exception). The uses of PT2 and PT4 are usually similar enough that the products can remain in the same family, with the exception of laundry products. This use is not compatible with a number of other PT2 uses, so it is recommended to group laundry products in a different family or to register them as separate products. Products for veterinary hygiene (e.g. teat disinfection) might be difficult to be grouped with PT2 and PT4. The different uses also affect the efficacy of the product and the assessment of risks to human health and the environment. It is important to manage the complexity of families and to avoid that they are considered too complex by the authorities, because in this case the families could be split.