The NanoDefiner framework and tools

The overall goal of the NanoDefine project was to support the implementation of the EC Recommendation for a Definition of Nanomaterial (2011/696/EU) (EC NM Definition). The project has developed an integrated approach, which allows identifying any material as falling within or outside the EC NM Definition. Data, knowledge and tools developed, generated and/or evaluated in the project form the bases of the NanoDefiner Framework, e-tool and the NanoDefine Methods Manual. All these instruments are a result of a collaborative work of project partners, and development of NanoDefine Methods Manual and the NanoDefiner Framework were led by the JRC. The NanoDefiner Framework, e-tool and Methods Manual were developed in the context of the EC Recommendation for a definition of nanomaterial, which provides a common basis for regulatory purposes across all areas of European Union policy. The definition or core parts of it have been enacted in EU legislation, (e.g. REACH, Biocidal Products Regulation, Medical Devices Regulation). Therefore development of appropriate methods and approaches to understand if a material meets the criteria laid down in the EC NM Definition is of key importance both for industry, stakeholders and regulators. The objective of the NanoDefiner Framework is to provide the industry, stakeholders and regulators with information and procedures to decide, for particulate materials, whether they fulfil the EC's Recommendation on a Definition of Nanomaterial (2011/696/EU).