On the uses of predictive toxicology to approve the use of engineered nanomaterials as biocidal active substances under the Biocidal Products Regulation

摘要

To date only two engineered nanomaterials(ENMs)have been approved to be used as biocidal active substances in the formulation of biocidal products under product type 18(insecticides,acaricides and products to control other arthropods).Such materials are silicon dioxide(as a nanomaterial formed by aggregates and agglomerates)and synthetic amorphous silicon dioxide(nano).The use of non-animal alternative test methods has been foreseen in the Biocides Product Regulation,Regulation(EU)258/2012(BPR).Further,the BPR is one of the existing regulations that includes a specific definition of nanomaterials.On the present article,a review is made on the potential uses of Quantitative Structure-Activity Relationship approach(Nano-QSARs)to be used as a non-testing method for the generation of ecotoxicological data required for the approval of new active substances in the nanometric scale.Relevant challenges are to be faced in the application of computational chemistry but it could meet the needs imposed by the BPR in relation to the use of non-testing methods.However nanospecific adaptations need to be implemented further on ecotoxicological testing so that obtained results are considered a suitable input for models’building.The BPR,thus,sets the framework for innovative approaches in the regulatory approval of new chemicals that integrate special considerations derived from the chemical nature of ENMs and the application of non-testing methods but,to date,the implementation of such actions is not feasible in practical terms.