The editorial notes that proposed EU legislation, including a Biotech Act and a food and feed safety omnibus package, could expand EFSA’s remit. Provisions include scientific pre-submission advice, regulatory sandboxes for testing innovative products, and an extension of EFSA’s mandate on nutrition.
Designing nutraceutical clinical trials for EFSA success: Where science meets conviction
This article by Dr. Sachin Dighe, associate director, claim substantiation, Vedic Lifesciences examines best practices for clinical trial design to meet EFSA standards for scientific evidence. It outlines the importance of methodological honesty through clear hypotheses, proper controls, unbiased procedures, transparent reporting, and no manipulation of design or data to force an outcome. Read the full article.
The paper also addresses ultra-processed foods. It states that no EU regulatory framework or EFSA mandate currently exists for them, but that the agency is monitoring policy discussions in case it receives future requests for advice.
How Does EFSA Plan to Use AI?
EFSA describes a move from document-based assessments to a human-led, AI-enabled model. AI tools could retrieve, structure, compare, draft, and flag information, the authors write, but would not replace scientific judgment or authority, the authors state.
The editorial envisions dossiers arriving as structured data packages that can be checked automatically for completeness and consistency. It also suggests AI could support pre-submission advice for applicants.
The paper also included a statement from Nikolaus Kriz, executive director of EFSA, upon his appointment to the role in September 2025: “My top priorities are to deliver high-quality scientific advice more quickly; to harness digital technologies and artificial intelligence for more streamlined risk assessments and enhanced data processing capabilities; and to strengthen the important partnerships we have with EU institutions, Member States, sister agencies, academia and civil society.”
What Did EFSA’s 2025 Paper Cover?
An earlier EFSA editorial, approved April 8, 2025, outlined research needs in omics, the gut microbiome, new approach methodologies (NAMs), allergenicity risk assessment, aggregate exposure, and environmental risk assessment.2
On omics, the 2025 paper said adoption beyond genomics remains limited by a lack of standardization, difficulty integrating large data sets, and few case studies. On the gut microbiome, it identified gaps in understanding how chemicals interact with gut microbes, in biomarkers of adverse effects, and in real-world evidence linking exposure to health outcomes. It also said regulatory data requirements that still mandate in vivo testing hinder wider use of NAMs.
The 2026 paper carries several of these themes forward. It says animal studies, at least for subchronic toxicity, will remain necessary until NAM testing batteries mature, and that progress has been slow for complex functions such as neurodevelopment, immune function, and metabolic disorders. It also lists microbiome methods, including metagenomics for characterizing complex microbial mixtures as regulated products, and allergenicity among its cross-cutting priorities.
References
- European Food Safety Authority. EFSA needs for scientific excellence and regulatory readiness. EFSA J. 2026;24(9):e240901. doi:10.2903/j.efsa.2026.e240901
- European Food Safety Authority. Advancing EFSA’s regulatory science: updated research and innovation needs. EFSA J. 2025;23:e220401. doi:10.2903/j.efsa.2025.e220401