Unit Risks of Subpopulations and Human Studies

The unit deals with the toxicological assessment of food ingredients with regard to health risks, with the focus on subpopulations. These comprise people who may have a higher risk compared to the majority of the population due to higher exposure, different dynamics (tissue sensitivity) and/or different kinetics (absorption, distribution, metabolism, excretion). Children are given special consideration here, as well as pregnant women, the elderly and people with certain illnesses.

The assessments are made within the scope of opinions providing scientific advice to the German government, as well as national and federal state authorities, and on issues related directly or indirectly with food safety in connection with the health of subpopulation which serve as a basis for management decisions.

An important area of the unit’s work is the evaluation of human data. This can be data from epidemiological surveys, pharmacological studies, controlled human studies or case reports. The unit works on the further development of assessment concepts for the above-mentioned population groups.

Of great importance is the identification of research requirements in the area of risks for people in general as well as for subpopulations. With the relevant issues, human studies are initiated and conducted too when necessary. This applies in particular to issues the resolution of which is expected to bring about a significant improvement of previous risk assessment.

The focus here is on the collection of data on bioavailability and internal exposure, as well as the biomarkers of the effect and sensitivity in human studies. Another important area of the unit’s work is to establish the necessary analytical and molecular methods. The unit participates in national and international research projects on the issues mentioned above.