The PARC consortium has released the first data gaps report under its work package on hazard assessment, marking a key milestone in efforts to strengthen the scientific foundation for chemical risk assessment in Europe. The report compiles initial results from a wide range of studies on selected chemical groups using both OECD regulatory methods and new approach methodologies (NAMs), covering human health and environmental endpoints. Beyond reporting results, it maps missing data and identifies evidence gaps critical for improving hazard identification and characterisation of prioritized natural toxins and BPA alternatives.

Understanding natural toxins

A major focus is on natural toxins, including mycotoxins such as enniatins, beauvericin, and Alternaria toxins, which are increasingly relevant due to their presence in food and feed chains and potential impact from climate change.

Selected enniatins and Alternaria toxins were studied for genotoxicity, immunotoxicity, and endocrine-related effects relevant to humans — data in high demand by EFSA for new scientific advice. The report also includes cyanotoxins such as microcystins, yessotoxin, and saxitoxin, testing their effects on fish, crustaceans, and algae to advance understanding of climate-driven algal bloom impacts.

BPA alternatives: assessing safety beyond substitution

The report explores BPA alternatives, chemicals increasingly used in consumer products and packaging. Using in vitro systems and aquatic models, researchers examined human metabolic pathways, potential endocrine, immune, genotoxic, and neurotoxic effects, as well as impacts on ecosystems. Early results show that some alternatives can be more biologically active than BPA for certain endpoints, reinforcing the need for careful evaluation to avoid regrettable substitutions.

Supporting European regulators

The data are shared with EFSA, ECHA, EEA, and other regulatory bodies to support evidence-based decision-making. The report provides a structured overview of available data, identifies priority gaps, and offers recommendations for further research and harmonized monitoring, aligning with the EU Chemicals Strategy for Sustainability ↗.

Why this matters

Understanding natural toxins, emerging contaminants, and chemical substitutes is essential for protecting food safety, water quality, ecosystems, and public health. The report demonstrates how coordinated EU research can provide regulators with the evidence needed for robust hazard assessment, even for chemicals like mycotoxins where no industrial data is available. 

Our data, co-created with regulators, demonstrate how experimental evidence generated by academic groups and institutions can directly support chemical regulation. This includes experts contributing to the EFSA working group on Alternaria toxins and presenting results on endocrine disruption by BPA alternatives at the ECHA Science Seminar, as highlighted by the coordinators of work package on hazard assessment.

Bringing scientists together across the EU around a common objective — in this case, the hazard characterisation of chemicals of concern — through a coordinated research effort that complements different fields of expertise is a major asset of PARC. Future chemical risk assessments must be evidence-based, including for substances such as mycotoxins, where no industrial partner is obliged to generate this type of data, the leaders of the task on toxicity testing addressing data gaps of concern highlighted.

Next steps

Many experimental studies are still ongoing. Updated findings will be incorporated into future editions of the data gaps report, progressively strengthening Europe’s scientific capacity for chemical risk assessment.

You can access the full report here.