Water Treatment – Why a Regulatory Challenge?
Regulation (EC) No 1107/2009 lays down the rules for the authorisation of crop protection products in Europe with the aim of protecting humans and the environment. It is known that during primary disinfection processes for central water treatment (e.g. ozonation, chlorination) certain active substances included in crop protection products and their metabolites have the potential to form unwanted by-products with e.g. toxic, carcinogenic and genotoxic characteristics.
Notwithstanding that the EFSA (European Food Safety Authority), the scientific advisory body of the European Commission, has recently identified data gaps during the approval process of active substances, water treatment processes have not (yet) been implemented in the European data requirements (Reg. 283/2013 or 284/2013) relevant for the authorisation of crop protection products. Further, no guidance document for experimental testing is available. With this information pending, addressing water treatment processes successfully becomes a challenge for applicants of crop protection products.
Event: SETAC Europe 2019, Helsinki, Finland