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The risks from exposure to chemical contaminants in food must be scientifically assessed, in order to safeguard the health of consumers. Risk assessment of chemical contaminants that are both genotoxic and carcinogenic presents particular difficulties, since the effects of such substances are normally regarded as being without a threshold. No safe level can therefore be defined, and this has implications for both risk management and risk communication. Risk management of these substances in food has traditionally involved application of the ALARA (As Low as Reasonably Achievable) principle, however ALARA does not enable risk managers to assess the urgency and extent of the risk reduction measures needed. A more refined approach is needed, and several such approaches have been developed. Low-dose linear extrapolation from animal carcinogenicity studies or epidemiological studies to estimate risks for humans at low exposure levels has been applied by a number of regulatory bodies, while more recently the Margin of Exposure (MOE) approach has been applied by both the European Food Safety Authority and the Joint FAO/WHO Expert Committee on Food Additives. A further approach is the Threshold of Toxicological Concern (TTC), which establishes exposure thresholds for chemicals present in food, dependent on structure. Recent experimental evidence that genotoxic responses may be thresholded has significant implications for the risk assessment of chemicals that are both genotoxic and carcinogenic. In relation to existing approaches such as linear extrapolation, MOE and TTC, the existence of a threshold reduces the uncertainties inherent in such methodology and improves confidence in the risk assessment. However, for the foreseeable future, regulatory decisions based on the concept of thresholds for genotoxic carcinogens are likely to be taken case-by-case, based on convincing data on the Mode of Action indicating that the rate limiting variable for the development of cancer lies on a critical pathway that is thresholded.

The identification and characterization of benefits as a consequence of consumption of food, food constituents or nutrients used to be neglected in comparison to the assessment of risks because the safety of food had priority. Interest in benefit assessment is the consequence of the realisation that both adverse and positive effects on health can follow the consumption of the same food or food constituent and that a balance between the two should be the aim. Moreover, proven benefits in connection with food are the basis of health related claims on food labels. Benefit assessment should follow a procedure which is parallel to structured risk assessment and apply the same stringent criteria with respect to substantiation. Benefits will consist of either the reduction of the probability of adverse health effects or the increase of the probability of positive health effects.

This publication is linked to the following EFSA Supporting Publications articles: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2023.EN-8441/full, http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2023.EN-8440/full, http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2023.EN-8437/full [ABSTRACT FROM AUTHOR]

From 18–21 September 2018, EFSA hosted its third Scientific Conference on Science, Food and Society in Parma, Italy. This paper summarises the overall recommendations on future actions and research priorities of the conference and complements the earlier multi‐authored papers in this issue. The conference started and closed with the plenary sessions 'where science meets society: putting risk assessment in context' and 'staying relevant in a changing world', respectively. In between, there were seven breakout sessions five of which aimed at advancing risk assessment science in the areas of human health, the environment, biological hazards, nutrition and managing evidence, and two of which were dedicated to the societal aspects of risk assessment: engaging with society and envisioning the expertise of the future. During the 4 days of the event, participants addressed the complex interplay between science, risk assessment, policy and society, and explored how to advance food safety risk assessment to address the challenges of a changing world and ensure preparedness. Acknowledging that good science alone is no longer sufficient to ensure fit‐for‐purpose food safety risk assessments, EFSA must further build on its current five Strategic Objectives. To ensure that its risk assessments remain scientifically robust and sound, EFSA should strive for robust and fit‐for‐purpose risk assessments; consider food in the context of safety, nutrition and sustainability; and explore further how EFSA can work with other organisations to achieve the One Health/One Environment goals. In addition, EFSA should base scientific risk assessments on reliable science while capitalising on scientific advances; address scientific uncertainties; and fully publish the evidence and data used. In line with societal expectations, EFSA, in coordination with risk managers, should frame risk assessments through clear policy goals and problem formulation; be explicit about value judgements; communicate clearly and consistently and in coordination with risk assessors and risk managers; involve society; avoid conflicts of interest; and follow trustworthy processes. [ABSTRACT FROM AUTHOR]

The Scientific Committee confirms that the Threshold of Toxicological Concern (TTC) is a pragmatic screening and prioritisation tool for use in food safety assessment. This Guidance provides clear step‐by‐step instructions for use of the TTC approach. The inclusion and exclusion criteria are defined and the use of the TTC decision tree is explained. The approach can be used when the chemical structure of the substance is known, there are limited chemical‐specific toxicity data and the exposure can be estimated. The TTC approach should not be used for substances for which EU food/feed legislation requires the submission of toxicity data or when sufficient data are available for a risk assessment or if the substance under consideration falls into one of the exclusion categories. For substances that have the potential to be DNA‐reactive mutagens and/or carcinogens based on the weight of evidence, the relevant TTC value is 0.0025 μg/kg body weight (bw) per day. For organophosphates or carbamates, the relevant TTC value is 0.3 μg/kg bw per day. All other substances are grouped according to the Cramer classification. The TTC values for Cramer Classes I, II and III are 30 μg/kg bw per day, 9 μg/kg bw per day and 1.5 μg/kg bw per day, respectively. For substances with exposures below the TTC values, the probability that they would cause adverse health effects is low. If the estimated exposure to a substance is higher than the relevant TTC value, a non‐TTC approach is required to reach a conclusion on potential adverse health effects. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2019.EN-1661/full [ABSTRACT FROM AUTHOR]