Aug 2026· Archives of Toxicology· 0 citations· 61 references
Medicine
TL;DR
Five key recommendations for future health risk assessments are concluded, prioritizing PFAS; improving analytical methods; promoting generation of robust data and data gap filling; promoting open science, including the development of shared data infrastructure and cross-institutional knowledge exchange; and strengthening risk communication.
Abstract
To review recent advances in research on per- and polyfluoroalkyl substances (PFAS) and outline priority steps for risk assessment in consumer health protection, the German Federal Institute for Risk Assessment (BfR) organized the 'International PFAS Conference' in Berlin in October 2025. Building on the European Food Safety Authority's (EFSA) opinion in 2020, global research activities on PFAS have intensified. The conference was attended by 200 participants from 18 countries and covered topics such as analytical methods, human exposure, toxicokinetics, toxicity, and future perspectives. Given that there are more than 21,000 different PFAS in use, discussions highlighted the need for further data collection and a basis for prioritizing substances. Robust exposure assessment requires improved analytical methods combined with newly developed predictive tools to quantify, identify, and make better use of non-target data. Hazard characterization may benefit from the combined use of classic experimental data sets, epidemiological data, and new approach methodologies (NAMs) data. The participants emphasized the continuous need for refined data and proposed a systematic consolidation of global data on shared data platforms, accompanied by corresponding guidelines for data usage. In the final panel discussion, effective risk communication was identified as a critical challenge, necessitating clear and consistent messaging for the public and policymakers. The conference concluded with five key recommendations for future health risk assessments: prioritizing PFAS; improving analytical methods; promoting generation of robust data and data gap filling; promoting open science, including the development of shared data infrastructure and cross-institutional knowledge exchange; and strengthening risk communication. These recommendations aim to support transparent, evidence-based and effective PFAS consumer health risk management in the decades ahead.
Abstract Regulatory concern over human exposure to chemical mixtures has intensified, as individuals are continuously exposed to multiple chemical substances from various sources. Historically, the European Food Safety Authority (EFSA) assesses risks based on individual chemicals or expected co‐occurring groups of chemical substances. Recognizing the need for comprehensive methodology, EFSA and the European Commission (EC) initiated in 2021 the gradual implementation of cumulative risk assessment (CRA) for dietary exposure to mixtures of pesticide residues. To facilitate CRA implementation, the Monte Carlo Risk Assessment (MCRA) platform, developed by Wageningen University & Research (WUR, Biometris) for the Dutch National Institute for Public Health and the Environment (RIVM), was selected as CRA tooling based on its potential to be transparent, accessible and fit‐for‐purpose. In the third Framework Partnership Agreement (FPA3; 2021–2026) between EFSA and RIVM, MCRA has been continuously improved in functionality and interoperability. Additionally, standard regulatory actions (SRAs) were developed to provide user‐friendly access to agreed‐upon methodologies and to simplify CRA execution for regulatory governmental users. This report details enhancements to four SRAs for retrospective and prospective CRA, achieved during the final year of FPA3 (Specific Agreement 4). In short, SRAs for prospective CRA were updated to reflect methodology developed by EFSA, which now include several sensitivity analyses. Furthermore, all SRAs include batch assessment options assessing multiple (selected) populations in one run, updated data needed to perform the calculations, and refinements of the user interface.
Marloes A. A. Schepens, J. Kruisselbrink, G. van Donkersgoed et al.· EFSA Supporting Publications· 0 citations
This review showed that in Côte d’Ivoire, peanut paste had 100% AFB1 contamination, with levels of 4535 µg/kg (AFB1) and 8094 µg/kg (total aflatoxins), and 99% of samples exceeded European Union limits.
Modified mycotoxins represent a significant yet underappreciated challenge in food safety assessment. Unlike their parent compounds, modified mycotoxins arise from plant, fungal, animal, microbial, or processing-induced transformations. Their toxicological relevance depends on factors such as bioavailability, reconversion to parent toxins, and intrinsic biological activity. To critically assess the current evidence and establish priorities for risk assessment, we systematically reviewed original research articles published from 2015 to 2025 using the four core steps of risk assessment: hazard identification, hazard characterization, exposure assessment, and risk characterization. In total, 151 studies were analyzed through evidence mapping, keyword network analysis, and topic modeling. The literature is dominated by research on deoxynivalenol and zearalenone derivatives, while other toxin classes-especially those related to diacetoxyscirpenol and nivalenol-remain underexplored. Occurrence and analytical detection are generally better characterized than internal exposure, compound-specific potency, or quantitative risk characterization. The evidence suggests that excluding modified forms may underestimate mycotoxin risks in certain foods, but significant uncertainties remain regarding bioavailability, reconversion, relative potency, and the application of parent-equivalent approaches. Although research has advanced toward more mechanistic and exposure-driven methodologies, evidence integration remains insufficient for routine risk assessment. This review identifies critical data gaps and proposes a practical framework to prioritize modified mycotoxins in future food safety management and regulatory decision-making.
Su Been Park, Soyoung Gwon, H. Yuk et al.· Comprehensive Reviews in Foo...· 0 citations
The EU Partnership for the Assessment of Risk from Chemicals (PARC) develops novel methods for human health and environmental risk assessment (RA) for regulatory application. Large amounts of environmental monitoring, in vitro, in silico and other types of data are generated. To facilitate data reuse and information exchange within and between research and regulatory stakeholders, it is important to document and manage data. In 2016, the FAIR (Findable, Accessible, Interoperable and Reusable) data principles were introduced to foster reuse of data. To adopt FAIR within PARC, a PARC FAIR data policy (PFDP) was developed.
To determine PFDP topics, expert panel discussions were held, followed by review of 37 stakeholder documents issued by authorities in RA and environmental, health, (open) data sciences. This resulted in a taxonomy of 57 topics (“narrower term(s)” (NT(s), together with 15 “broader terms”), forming the basis of the PFDP. These included, aside FAIR, aspects specifically relevant for RA, such as GDPR, sensitive data, transparency and data valuation. Large Language Models (LLMs) were used to contrive novel terms for PFDP revisions. Seventy-eight novel terms were discovered by LLMs, compared to 57 NTs already identified by experts. Based on a frequency analysis within stakeholder documents, of all 135 terms (57 + 78) -further categorized under eight ChatGPT-derived “FAIR categories”- and subsequent cluster analyses (PCA, K-means), differences between stakeholders were identified. Organizations concerned with environmental and human chemical RA (e.g. European Chemicals Agency, European Food Safety Authority) could be distinguished from those focused on technical FAIR data issues and those involved in publicly funded research and open science.
To foster environmental and human health research data for research purposes and adoption of research data in regulatory applications, a taxonomy of terms and FAIR data policy was developed. A frequency analysis of the taxonomy (augmented with LLM-derived) terms in stakeholder documents revealed differences between stakeholders, which may help identify trends e.g. the adoption of FAIR principles within and across sciences and regulatory domains for (NG) RA. The PFDP is designed to support data driven RA improvement within PARC but can equally contribute to FAIR data in other environmental RA research and regulatory communities.
R. Stierum, Gino Kalkman, S. Bijlsma et al.· Environmental Sciences Europ...· 0 citations
Pharmaceutical risk minimization, as an essential element of pharmacovigilance, aims to reduce medicinal product risks in order to improve a product's benefit-risk profile. However, to date the practical application of risk minimization has proved challenging. In particular, risk minimization standards developed by and for high-income countries have been shown to have limited suitability in low and middle income countries (LMICs) and high-income countries have struggled to deliver these programs with consistently high quality and demonstrable long-term impact. The World Health Organization's new 2025 framework for pharmacovigilance-'The Global Smart Pharmacovigilance Strategy'-calls for developing comprehensive and sustainable safety monitoring and risk management practices as integral components of healthcare and regulatory systems in all member countries globally. The field of implementation science offers a robust set of approaches to address current gaps and challenges in risk minimization, one that can help meet the needs of twenty-first century pharmacovigilance. We call for the convening of an internationally representative expert forum to develop a pragmatic framework and set of recommendations regarding the application of implementation science good practices to advance risk minimization for medicinal products globally. The framework and recommendations should be practical, sustainable and equally applicable for use in LMIC and high-income countries. In addition, the framework and recommendations should be accompanied by a blueprint for implementation science capacity building as well as a dissemination plan for promoting uptake of the framework and recommendations by industry and regulatory authorities worldwide.
Meredith Y. Smith, P. Bahri, D. Darko et al.· Drug Safety· 0 citations
Per- and polyfluoroalkyl substances (PFAS) are manufactured chemicals used for their water-, grease-, and stain-resistant properties in a wide range of products. Efforts are being made to strengthen how PFAS are regulated to reduce their presence in both the environment and the food chain. These measures aim to mitigate potential long-term health and environmental consequences associated with exposure to PFAS.
The Food Standards Agency (FSA) identified a lack of official control laboratory capacity in GB to test for PFAS in food. To address this, Fera Science Ltd was commissioned to develop and validate analytical methods for detecting PFAS in fruit and vegetables. This project would build on the previous FSA-funded work where Fera developed and validated methods for the detection of PFAS in products of animal origin. Overall, these methods will enable the FSA to assess potential health risks to consumers from PFAS contamination in food and to respond effectively to food safety incidents.
The developed methods comply with European guidance. Ten different food types were selected to represent a broad range of fruit and vegetables. These samples were sourced from supermarkets and contained detectable levels of PFAS. When carrying out the method validation, as the concentration of PFAS added to the samples was increased, the number of samples in which the four EU-regulated PFAS analytes could be detected, also increased. Beetroot was the only food type that met the validation criteria for all four EU-regulated PFAS compounds at the lowest level.
To achieve full validation at the lowest level, further screening of fruit and vegetables will be necessary to identify samples that contain PFAS below the lowest level of detection. Additional validation was attempted for 23 emerging PFAS compounds. However, due to issues with sample preparation and contamination, data for several of these compounds were incomplete. This will be addressed in future work.
S. MacDonald, A. Oxley, Stuart Adams et al.· FSA Research and Evidence· 0 citations
