Industrial chemical substances are used in different fields of application, from one-site intermediates to consumer products with wide dispersive use. These chemicals need to be registered at ECHA according to the European REACH chemicals regulation EU 1907/2006. Depending on the manufactured or imported quantity, defined data have to be provided. For chemicals produced or imported in quantities of more than ten tonnes per year, potential risks have to be assessed in addition in a chemical safety report.
The process does not stop with registration but also requires companies to keep their dossiers up to date, respond to additional data requirements, e.g. from Member State evaluations, and integrate new data. Over the past 20 years, we have prepared substance documentations and assessments for new and existing substances at national (GDCh BUA activity) and international levels (OECD ICCA HPV program). Fraunhofer ITEM supports its customers in all scientific and regulatory issues. This includes the evaluation of all data available, identification and assessment of critical hazards, and dossier preparation and submission. For questions beyond standard toxicology, we create tailor-made solutions for our clients by applying read-across/ bridging principles or integrated testing strategies including in-vitro methods.
Our aim is to identify risks to health and the environment and to reduce these, while not losing sight of the desired reduction of animal testing to a realistic minimum.