Quaternary ammonium compounds, also called quats or QACs, are a group of chemicals used for a variety of purposes including as preservatives, surfactants, antistatic agents and as active ingredients in disinfectants and sanitizers. Quats can be highly effective at killing bacteria, fungi and viruses, and are found in many common disinfectant products. Within the current global scenario, the threat caused by COVID-19 is clear, and a reasonable response is elevated use of QACs to mitigate spread of infection. These practices will continue to evolve as people return to work and resume other activities, leading to more routine and thorough disinfection, reason why these products represent a strategic and critical challenge for manufacturers.
Disinfectant products containing Quaternary Ammonium Compounds have been recently impacted from important regulatory updates under BPR. The draft approval regulations of ADBAC/BKC (C12-C16) and DDAC are now published for use in hygiene products such as product-type 3 and product-type 4. According to Biocides Regulation (UE) No. 528/2012, BPR product authorization dossiers should be submitted within October 31st, 2022 for products containing at least one of these active substances (in addition to other active substances already approved). These active substances have been also evaluated by Italian authorities for use in human hygiene (product-type 1) and for disinfection of surfaces (product-type 2).
A review by the Biocidal Products Committee (BPC) was made in November 2021 while approval date is expected by the end of 2023 or beginning of 2024. Under these terms BPR dossiers will be necessary as well.
For all manufacturers that need their QUATs-based products to remain on the EU market, or are planning to launch new ones, it is important to determine the critical product claims and uses. They should also identify the data needed to support such claims as data requirements in EU, that are different to those under FIFRA and FDA.
This webinar aims to give an overview on QUATS, product authorization pathways under EU regulatory framework and how to overcome challenges to market these products successfully.
You will also gain valuable insights on the most effective strategy to implement to manage your product portfolio and how to implement a BPF.