Unit Exposure Assessment and Exposure Standardisation

The work of the Exposure Assessment and Exposure Standardisation Unit is associated in the relevant scientific community with the First German Total Diet Study, the KiESEL Study (German food survey for infants, toddlers and children), and other data collections to facilitate refined exposure assessments.

In the context of health risk assessment, exposure describes the contact between people and substances or microorganisms via the mouth (oral route), the skin (dermal route) and the lungs (by inhalation) - and is therefore one of the preconditions for the assessment of health risks resulting from the consumption of food or the use of mixtures or products in households. Various types of information are needed to carry out an exposure assessment, such as details on the behaviour of exposed persons (e.g. contact duration or consumption habits) and personal details (e.g. size, weight, age).This information is summarised in an exposure scenario. The results of the exposure assessment are the basis for a quantitative characterisation of the health risk, taking account of the toxicological or microbiological characterisation of the substance or microorganisms, respectively.

The Unit is the central point of contact at the BfRshort forGerman Federal Institute for Risk Assessment for all questions relating to the ongoing development and standardisation of exposure assessment including the characterisation of uncertainties. The main task of the Unit is to prepare exposure assessments on risks of chemical substances due to exposure via food and mixtures or products used in households; it handles all questions relating to consumer exposure in the context of the REACH Regulation. In performing its second main task, namely the assessment of exposure through food, the Unit requires data on the occurrence and concentrations of the substances to be assessed as well as consumption data. The general requirements include the availability of representative, up-to-date and reliable data. The concentration data are based on the food monitoring programme of the national food surveillance system, and additional data will in future be provided by a Total Diet Study. The consumption data are taken from the second German National Nutrition Survey (NVS II) conducted by the Max Rubner Institute (MRIshort forMax Rubner Institute), the EsKiMo Study of the Robert Koch Institute (RKI) and the University of Paderborn, as well as the Consumption Survey of Food Intake among Infants and Young Children (VELS).

The Unit is responsible for all exposure assessments in the context of the various legal procedures of European chemical law (REACH Regulation), including substance assessments or the specification of substances of very high concern (SVHCs). There is often a lack of real data (e.g. measured data or consumption data for consumers) on which to base assessments of consumer exposure to chemicals, which means that the Unit not only develops standard scenarios and computer-supported exposure models (e.g. ConsExpo) but also initiates and carries out surveys to improve data availability for exposure assessments.

The Unit is supported in its work by the BfRshort forGerman Federal Institute for Risk Assessment Committee for Exposure Assessment and Exposure Standardisation and is responsible for the management of this committee. Together with the committee, the Unit has drawn up a guidance document on exposure assessment and uncertainty analysis. In its various activities, the Unit cooperates closely with national (e.g. Robert Koch Institute, Max Rubner Institute, Federal Institute for Occupational Safety and Health (BAuA), Environmental Protection Agency (UBAshort forGerman Environment Agency), Federal Office of Consumer Protection and Food Safety (BVLshort forGerman Federal Office of Consumer Protection and Food Safety), German Institute of Human Nutrition (DIFE)) and international institutes (e.g. French Agency for Food, Environmental and Occupational Health & Safety (ANSES), Dutch National Institute for Public Health and the Environment (RIVM)) as well as university institutes (e.g. of the University of Paderborn and Giessen University). For example this cooperation is institutionalised in the scientific advisory committees for the first Total Diet Study for Germany and the KiESEL Study.

• Exposure assessments on the risk assessment of chemicals from the consumer perspective within the framework of the REACH Regulation
• Exposure assessments on the risk assessment of foods (e.g. with regard to environmental and process contaminants, additives, nutrient fortification, mycotoxins)
• Further scientific development of exposure assessment
• Probabilistic exposure assessment and modelling as well as model testing
• Implementation of exposure modelling in regulatory context
• Improving the data situation for exposure assessments by performing own studies or public invitations to tender

The unit coordinates the First German Total Diet Study (TDS) and also the Germany-wide representative nutritional study of children to document their food consumption (KiESEL Study) and a consumption survey on high consumers of caffeinated energy drinks and ad-hoc surveys on rarely consumed foods.

The substance groups currently being assessed include heavy metals (e.g. lead, cadmium), dioxins and PCBs, mycotoxins (e.g. aflatoxins), additives (e.g. additives containing aluminium), natural plant substances (e.g. pyrrolizidine alkaloids, capsaicin, thujone), veterinary drugs (e.g. within the framework of the National Residue Monitoring Plan), perfluorinated compounds (e.g. per- and polyfluoroalkyl substances (PFASs)) and process contaminants (e.g. acrylamide).