ALISE: Aligned Study for Environmental Health

Note regarding participation in the study: Participants are selected at random using a scientific procedure so that they represent the children and young people in their age group from a previously and randomly selected residential area. It is therefore unfortunately not possible to volunteer for the study.

In May 2022, PARC, the European Partnership for the Assessment of Risks from Chemicals, was launched, involving 200 institutions from 28 countries and three EU authorities. As part of this project, comparable human biomonitoring studies are being carried out in 12-20 partner countries (depending on the age group). This is a follow-up to the Aligned Studies carried out as part of the European HBM4EU initiative. Human biomonitoring (HBM) means that body fluids or tissue, such as urine or blood, are analysed for their content of pollutants. This allows conclusions to be drawn concerning the overall exposure to such substances in the human body.

The studies in several European countries are designed to be comparable and contribute to finding out whether the existing measures and regulations for pollutants of concern are effective or should possibly be improved in order to better protect human health. To achieve this, the Aligned Studies pursue the following aims:

• Generate HBM data that is comparable between EU countries and regions (Eastern, Southern, Western, Northern Europe),
• Calculate exposure levels at European level using a collective EU dataset,
• Identify sources and pathways of exposure using a European dataset,
• Analyse relationships between exposure and health effects.

These studies will therefore collect HBM data in order to create a picture of the current exposure of the European population and, as a result, a set of prioritised substances. In total, data from over 10,000 people from various EU countries will be collected.

The German contribution to the Aligned Studies is ALISE (Aligned Study for Environmental Health), which collects data from around 600 children and young adolescents aged 6-17 in Germany. This is intended to provide reliable and up-to-date data on the pollution levels of the German population. On this basis sources of pollution can be identified and measures for reducing and preventing these pollution levels can be derived. The study will be conducted over the duration of three years. The phase in which the surveys and sampling are carried out, the so-called ‘field phase’, will start in April 2025 and last about a year. No new data will be obtained from adults in ALISE, as the exposure data for adults obtained in the German Environmental Survey, GerES VI (2023-2024) will be incorporated into PARC.

As part of the ALISE field phase, questionnaires are used to conduct interviews and samples of drinking water, urine, and blood are collected. Children aged 6-11 will also be asked to provide hair samples. These are then analysed chemically for harmful environmental pollutants such as heavy metals, plasticisers, pesticides and perfluorinated and polyfluorinated chemicals (PFASs). The results from these analyses are then evaluated together with data from the questionnaires developed in the EU project and general environmental data on the living environment of the respective children and adolescents.

The home visit for all participants includes:

• A personal interview with the parents and the participating child (if they are at least 14 years old) which is intended to provide information about exposure to pollutants,
• A drinking water sample from the participant's household,
• A morning urine sample from the participating child,
• A blood sample from the child and
• A hair sample from the child (for children aged 6-11),
• The geographical coordinates of the respective household address so that general environmental data such as traffic data or data on land use, e.g. distance to agricultural land, can be linked to the home environment,
• The height and weight of the participating child and a blood pressure measurement.

If requested, each participant will receive a report of their personal results together with an evaluation from an environmental medicine perspective and recommendations for minimising any unusual exposure. Participation thus provides participants with valuable information about environmental pollutants and exposures that may affect their health.

This not only has an individual benefit for all participants themselves, but also a collective benefit for other people living in the same household (drinking water sample). The analyses in ALISE are only carried out in special laboratories. They are not part of the normal programme of a general practitioner's consultation and are sometimes very cost-intensive.

In addition, the participants make an invaluable personal contribution to environmental research and health reporting with their data. Both the participants and their families and the entire population in Germany and Europe will benefit from the measures to improve environmental protection that result from the study findings.

As the German contribution to the PARC Aligned Studies, the ALISE study provides exposure and health questionnaire data for Western Europe and thus represents an important component in achieving the objectives of the EU project PARC. The Aligned Studies are carried out according to predetermined criteria so that the studies are conducted as similarly as possible in the individual countries. This ensures comparability across Europe and a scientifically sound database. On this basis, conclusions can be drawn that allow the national and European authorities to improve chemicals policy in Germany and throughout Europe in order to better protect people's health.