No abstract

The Biocidal Products Regulation (BPR) contains several provisions for nanomaterials (NMs) and is the first regulation in the European Union to require specific testing and risk assessment for the NM form of a biocidal substance as a part of the information requirements. Ecotoxicological data are one of the pillars of the information requirements in the BPR, but there are currently no standard test guidelines for the ecotoxicity testing of NMs. The overall objective of this work was to investigate the implications of the introduction of nano-specific testing requirements in the BPR and to explore how these might be fulfilled in the case of copper oxide nanoparticles. While there is information and data available in the open literature that could be used to fulfill the BPR information requirements, most of the studies do not take the Organisation for Economic Co-operation and Development’s nanospecific test guidelines into consideration. This makes it difficult for companies as well as regulators to fulfill the BPR information requirements for nanomaterials. In order to enable a nanospecific risk assessment, best practices need to be developed regarding stock suspension preparation and characterization, exposure suspensions preparation, and for conducting ecotoxicological test.

Nanomaterials (NMs) are currently being used for a wide variety of products, and a number of them are utilized as biocides due to their antimicrobial or antifungal properties. Little is known to what extent these biocides are available on the market as consumer products. In the EU, Biocidal Product Regulation (BPR) is laying out a list of requirements that manufacturers of biocidal products have to comply with before they can place their products on the market. It is not entirely clear which commercially available articles in the EU that have been treated with or incorporate NMs to provide biocidal properties to the product. To obtain an insight into what biocidal products are on the EU market, we used The Nanodatabase (nanodb.dk) for analyzing which NMs are being used and what product categories they represent. In this paper, we are addressing the issue of current uses of NMs in biocidal products and discussing how they are currently regulated under the BPR. Even though BPR already entails nanospecific provisions, correct labelling of biocidal products containing NMs is virtually non-existent. By using The Nanodatabase it was possible to identify 88 biocidal products containing NMs available on the EU market, none of which had the specific labelling required by BPR. The analysis of biocidal products pinpoints the challenges and limitations for obtaining a reasonable overview of the current uses of NMs in biocidal products as defined in the BPR.