Project Establishment Support for NANoREG-II

Scope: (1) To develop and demonstrate Safe-by-Design regulatory approaches for nanomaterial development. (2) To validate the tools and methodology, as well as their background data-sets, that will lead to the manufacture of novel, inherently safe nanom aterials. (3) To address barriers for the application of Safe-by-Design as standard industry practice. The project should seek to establish principles for grouping strategies for nanomaterials according to their assumed modes of toxicological action fo r regulatory purposes. Out of each group, a few representative materials should be selected and a toxicological profile shall be assessed. The scope may include novel materials, coated materials and self-assembled materials, nanomaterials with different s urface functionalisation, and third generation particles. The project should take into account future dossier requirements under REACH, or other related EU legislation, to limit the required additional information, especially animal testing, to the essent ial minimum. Active participation of industrial partners is strongly encouraged to establish strong industry-authorities collaboration and the partners should conclude a results communication policy before the start of the project. This collaboration shou ld be complemented by solid mechanisms networking state and private laboratories in nanotechnology toxicity testing and exposure control.