Quat BPFs : Opportunities & challenges
Daniela Romano of Knoell explores the limits of the biocidal product families approach to authorisation
Quaternary ammonium cations , or quats , are positively charged polyatomic ions of the structure
NR + 4
, where R is an alkyl or aryl group . Their salts , which are referred to as quaternary ammonium salts or quaternary ammonium compounds , are cationic , surfactant-type biocidal active substances . Biocidal products based on quats in different product types ( PTs ), as defined in the EU Biocidal Product Regulation ( BPR , 528 / 2012 ) are intended for use to disinfect skin , surfaces , inanimate objects and materials , and equipment in several sectors . Their in-use concentrations vary , depending on the area and circumstances , e . g . frequency of use , level of soiling etc . The target organisms can be bacteria , yeasts or enveloped viruses ; their efficacy against fungi is rather limited .
Some regulatory deadlines
Two disinfecting quat molecules widely used in the consumer and health care scenarios are benzalkonium chloride
( BKC , Cas 68424-85-1 )) and didecyldimethylammonium chloride ( DDAC , Cas 7173-51-5 ). Both have been approved for the uses in PTs 3 ( veterinary hygiene ), 4 ( food & feed areas ) and 8 ( wood preservatives ); and have received a favourable opinion for approval in PTs 1 ( human hygiene ) and 2 ( disinfectants and algaecides not intended for direct application to humans or animals ). The authorities are still discussing the approval date for these two latter uses . The European Commission has sent a draft notification for DDAC to the World Trade Organisation , with an approval date on 1 February 2024 . It is likely , but not certain , that the approval date will be the same for BKC . The delay in the notification is due to the minority opinions of Germany , Sweden and Finland on the risk for the environment posed by the use of the active substance in PT2 applications .
Opportunities of BPF
The BPR provides a great opportunity for industry by allowing the authorisation of biocidal product families ( BPFs ), as well as single products . Article 3 ( s ) defines a BPF as a group of biocidal products ( having similar uses , the active substances of which have the same specifications , and presenting specified variations in their composition which do not adversely affect the level of risk or significantly reduce the efficacy of the products ) that can be covered by the same authorisation . This approach makes it possible to save money in many steps of the procedure : management , tests ( analytical , efficacy , ( eco- ) toxicological ), risk assessment , number of hours dedicated to the project and registration fees . This is especially true for PT2 biocidal products containing quats , as these products are often similar to one another . Companies often have a wide portfolio of these products with similar compositions , efficacy , classification and uses . Small and medium-sized enterprises could think of joining with one another and registering one family
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