Bologna: Plant extracts occupy an odd corner of European food law. A capsule of concentrated botanical sold as a supplement sits under food rules, not medicines rules, even when it contains a pharmacologically active compound at a meaningful dose. Regulators have long known the boundary is uncomfortable. They are now redrawing part of it.
The European Food Safety Authority’s Scientific Committee has proposed merging three separate guidance documents into a single cross-sectoral text covering the safety assessment of botanicals and botanical preparations across the entire food and feed chain. A public consultation on the draft mandate ran from 8 June to 3 August. Stakeholder responses are now with the committee.
Consolidation sounds procedural. In practice it changes who has to prove what. Existing guidance developed piecemeal, with different documents applied to novel foods, feed additives and supplements, each carrying its own evidentiary expectations. A single framework would apply consistent standards regardless of which regulatory route a substance travels, which raises the bar for the routes that were previously lighter.
The berberine case shows why the authority wants a cleaner method. Its NDA Panel endorsed a draft opinion in January concluding that no safe intake level could be established for plant preparations containing berberine. A consultation on that draft ran from March to May, and the assessment covers preparations from a long list of species including Berberis aristata, Berberis vulgaris, Coptis, Hydrastis canadensis and Phellodendron amurense.
Berberine sells widely across Europe in supplements marketed for cholesterol and blood sugar management. Manufacturers dispute the draft, arguing that the underlying toxicological dataset is thin and that the panel treated heterogeneous preparations as interchangeable. The authority convened a targeted stakeholder meeting with food business representatives to work through the objections.
Whatever the panel concludes, the opinion is advice rather than law. The Commission and member states decide what follows, and the usual instrument is a restriction under the food supplements framework. Those decisions take time, and products stay on shelves while they are made.
That lag is the consumer protection issue. A shopper choosing a supplement has no way to know that its principal ingredient is under active safety review, because nothing on the label says so. Industry argues that flagging draft opinions would cause unwarranted alarm and damage products later cleared. Consumer organisations argue the asymmetry favours sellers.
Botanicals also carry a structural evidence problem. Composition varies with growing conditions, harvest timing and extraction method, so two products naming the same plant may deliver very different doses. Any guidance that treats a botanical as a single entity risks assessing something that does not exist in the market.
The revised framework will have to handle that variability explicitly. The berberine consultation suggests how contested each attempt will be.
