Decoding the European Food Supplement Project Report: Between Field Nutrivigilance and Toxicological Evidence
This report constitutes a document of major strategic importance for the European nutraceutical sector. By identifying, at an early stage, emerging risks associated with the consumption of food supplements (excluding vitamins and minerals), this text acts as an important signal of EFSA’s future priorities. It foreshadows the substances that may, in the short or medium term, be subject to an assessment procedure under Article 8 of Regulation (EC) No 1925/2006, potentially leading to restrictions or bans on placing them on the market.
The project was coordinated by a consortium of experts bringing together 8 reference agencies and institutions (Anses (France, coordination), SPF (Belgium), DTU (Denmark), NVWA (Netherlands), ISS (Italy), FSAI (Ireland), as well as Portugal’s dual structure comprising ECTS-CBIOS and ASAE).
This document is an External Scientific Report. It is essential to emphasise that it is not a scientific opinion adopted by EFSA, but rather work carried out under a grant agreement (Article 36), with no immediate regulatory effect. Nevertheless, it constitutes the technical foundation on which the Authority could rely for future mandates.
Despite the absence of any direct legal constraint, the methodological rigour applied and the involvement of national agencies call for increased vigilance from economic operators.
The report deploys a complementary methodological approach combining nutrivigilance, exploration of available toxicological data, product occurrence on the market and theoretical predictive approaches, with the aim of ensuring comprehensive monitoring across the spectrum of health safety.
Nutrivigilance (Work Package 1)
This component is based on the analysis of 130 serious cases (severity levels 3 and 4) with a strong level of causality (probable or very probable), collected through European nutrivigilance systems. Assessed according to the PECO framework, the scientific literature made it possible to isolate 61 “ingredient / adverse effect” pairs classified as category B1 (poorly documented), defining the grey area of potential emerging risks where a clinical signal from the field encounters an absence of validated pathophysiological mechanisms in humans or relies solely on animal data.
Prioritised according to a concern score, this analysis highlighted 6 key ingredients (Bifidobacterium, Coleus, Guggul, Huperzia serrata, Raphanus sativus L., Panax ginseng), while also highlighting critical scientific gaps: recurrence is based on isolated cases, actual exposure and concentrations are not quantified, and data collection systems remain heterogeneous between Member States, explaining why these signals constitute uncertainties to be investigated rather than established risks.
Compounds (Work Package 2)
This chemical and analytical component is based on the identification of 52 substances of concern, selected from EFSA’s Compendium of Botanicals. This selection is based on experimental toxicological data for genotoxic molecules and on predictive QSAR (in silico) tools for molecules suspected of being carcinogenic or reprotoxic in the absence of experimental data. From the 229 plants containing the identified compounds, the agencies assessed their availability on the European market using a two-tier approach: Tier 1 (identification through national notification databases in 5 Member States) and Tier 2 (web searches simulating consumers’ access to unregistered products). This dual approach made it possible to identify substances whose presence on the European market appears disproportionate to the current safety assurances available.
Three molecules show particularly widespread occurrence on the market: furfural (detected in 11 014 food supplements), emodin and chrysophanol.
The scope of the results is tempered by conservative assumptions. The lack of specifications regarding the preparations (e.g. extracts vs. powders) and the absence of actual dosage data constitute major areas of uncertainty for a more precise risk assessment.
The CEHTRA Experts’ Analysis
For the ingredients and compounds identified by the report, anticipation is the key to avoiding sudden regulatory injunctions. The neutral nature of this report offers manufacturers an opportunity to strengthen their portfolio defence strategy before any potential activation of Article 8.
Three pragmatic anticipation levers are recommended:
Analytical characterisation: Moving from theoretical assumptions to tangible data through precise quantitative measurements of the compounds of interest present in raw materials and finished products. This characterisation makes it possible to address concerns regarding the potential presence of compounds of concern, either by demonstrating their absence or by demonstrating that toxicological reference values are not exceeded under the recommended conditions of use.
Scientific evidence: Strengthening the available toxicological datasets by incorporating additional analyses of bioavailability and safety (particularly in relation to CMR effects). These elements are essential to reassess QSAR predictions, which are conservative by construction, and to demonstrate the actual physiological effects.
Active vigilance: Integrating robust internal nutrivigilance systems in order to document, on well-characterised products, the absence of serious adverse effects under real-world conditions of use and to provide a scientific response to the signals reported by authorities for other products.
Finally, toxicological profiles are not static data; they are expected to evolve as new scientific publications emerge. This report highlights that toxicological monitoring of strategic ingredients in the nutraceutical sector is no longer optional, but must be fully integrated into product lifecycle management in order to anticipate regulatory developments.
In conclusion, transparency, toxicological monitoring and the proactive generation of high-quality scientific data remain the best safeguards for operators facing regulatory uncertainties at European level.
Author: Marie LIAMIN, Head of Food Market and Toxicologist
