Assistance in hazard, exposure and risk assessment of nanomaterials
Although there are no explicit provisions for nanomaterials in REACH and CLP, manufacturers, importers and downstream users need to demonstrate the technical, occupational/consumer and environmental safety of their materials and products. We will help you to meet all the information requirements set out in these regulations and needed for the preparation of the registration dossier and chemical safety report on human and environmental health effects. This will include hazard characterization and classification, exposure analysis and risk assessment of the substance or product that may contain nanomaterials. In case you need to register your substance or product to a national product register, we will assist you also in drafting the necessary safety dossier with all the necessary technical information.
Support in material classification according to the EU Nano-Definition
According to the new EU definition (2011/696/EU), nanomaterials are all natural, incidental or manufactured materials that contain particles in an unbound state or as an aggregate or agglomerate, and where 50 % or more of the particles in the number size distribution are for one or more external dimension in the size range 1-100 nm. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness, the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %. If a material is classified as nanomaterial, any risks need to be evaluated and ingredients labeled accordingly. We will help you to select and apply the appropriate particle measurement technique or strategy to find out, if your material (a substance or product) is or contains nanomaterial, or not, according to the EU definition.
Developing Safety by Design (SbD) concepts for nanomaterials
To produce safe materials and products containing nanomaterials, less or non-hazardous nanoforms need to be designed based on their specific inherent physicochemical and functional properties. We will support you in using well-tested design principles to reduce any potential health risk associated with a new material or product. By using an iterative approach of testing and optimizing, we will implement the “Safe by Design” concept, starting with non-testing tools, such as grouping, read-across or modeling (e.g., QSARs), but also considering real test systems, where needed, such as “High Throughput Screening”, in vitro models or short-term in vivo assays.
Critical literature review and synthesis of current knowledge
Before any decision can be made, it is often essential to get a critical overview of the “state-of-the-art” and of the current knowledge in the particular field or market you want to invest and develop. In close agreement with our client, we offer well-targeted literature and database surveys, market analysis and feasibility studies in your chosen area that are tailored to your specific need and business. We critically review and synthesize the relevant knowledge, identify gaps and limitations as well as new development opportunities, or define areas for future research and innovation.
Project proposal coordination, management and exploitation
Based on the vast experience obtained in developing, coordinating and managing large EU research and international technical assistance projects, we can help you in bringing your research, innovation or business idea into practice, from proposal or tender writing, consortium formation up to its practical realization and successful implementation, and the final scientific, technical or commercial exploitation of achieved results.