Urgently needed: New strategies for the risk assessment of genotoxic substances

Risk assessment of substances that are harmful to the genetic material (genotoxic) is a challenge. Actually, such substances should not be present in food or consumer products at all, as they can impair health and in some cases cause cancer. However, their presence cannot always be excluded, for example because a substance is widespread in the environment or is naturally present in food - even if only in small quantities. Risk assessment is faced with the question of how to derive from the available data and facts what amount of a substance is still acceptable in a food or product according to the current state of science.

International experts will discuss different approaches for risk assessment of genotoxic substances at a symposium organised by the German Federal Institute for Risk Assessment (BfR) from 26 to 28 February 2024 in Berlin. "With this meeting, we want to contribute to the further development of the established assessment concepts and also to the harmonisation of the risk assessment methods of various national and international institutions," explains BfR President Professor Andreas Hensel. "This is also an essential prerequisite for clear and targeted risk communication."

Substances that have a proven genotoxic effect are not authorised in the EU, for example as active ingredients in pesticides or as additives for food. Nevertheless, genotoxic substances do find their way into the human body: some of them are widespread in the environment, for example, and can enter food crops. One example is inorganic arsenic, which can migrate from soil and groundwater into rice. Other genotoxic substances can be formed during the production and preparation of food or by microorganisms in or on food. These include, for example, aflatoxins produced by moulds (especially Aspergillus flavus and Aspergillus parasiticus). Aflatoxins are among the strongest naturally occurring carcinogenic substances. Aflatoxins can also damage the genome.

Genotoxic substances that react directly with DNA and thus damage the genetic information of the cell are a challenge for risk assessment because, according to current scientific knowledge, even low concentrations can be potentially harmful to health. For this reason, it is not yet possible to establish health-based guideline values for these substances, that exclude health risks with sufficient probability. Contamination with DNA-reactive genotoxic substances, such as aflatoxins, cannot always be prevented. Therefore, the ALARA principle (as low as reasonably achievable) is applied in this situation as part of risk management. According to this principle, the concentration of a genotoxic substance should be kept as low as reasonably achievable by means of technical or other measures.

However, in order to be able to prioritise risk management and to enable a better assessment of the actual health risks, quantitative information is desirable - for example, an indication of the intake level up to which there is only a low risk of impairment, according to current knowledge.

At the symposium, after introductory presentations, different aspects of the assessment of genotoxic substances will be discussed in detail in four workshops, and perspectives for future concepts will be discussed during a panel discussion at the end of the event. Around 150 experts from research, industry and authorities are expected to attend - including national and international organisations such as the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA) and the Federal Institute for Drugs and Medical Devices (BfArM). Numerous online participants are also expected

All presentations and the concluding panel discussion can be followed via live stream. You can find the access data here:

Link to the symposium programme:

About the BfR

The German Federal Institute for Risk Assessment (BfR) is a scientifically independent institution within the portfolio of the Federal Ministry of Food and Agriculture (BMEL) in Germany. The BfR advises the Federal Government and the States (‘Laender’) on questions of food, chemicals and product safety. The BfR conducts independent research on topics that are closely linked to its assessment tasks.

This text version is a translation of the original German text which is the only legally binding version.

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