,The European Food Safety Authority (EFSA) has opened a public consultation on a draft scientific opinion concerning the safety of plant preparations containing berberine, following endorsement of the draft by EFSAs NDA Panel on 29 January 2026. According to the preliminary assessment, EFSA concluded it was not possible to establish a safe intake level for berberine, raising potential implications for its continued use in food supplements in the European Union.
Key Points of the Draft Opinion
1.Safe Dose Not Established-EFSAs draft opinion indicates available data do not allow establishment of a safe daily intake for berberine-containing plant preparations.
2.The assessment was conducted under Article 8(2) of Regulation (EC) No 1925/2006, which addresses substances added to foods or used in food supplements that may present potential health concerns.
The opinion covers preparations from multiple berberine-containing plants and plant parts, including:
1.Berberis aristata (root, bark)
2.Berberis vulgaris (root, bark)
3.Berberis aquifolium (root)
4.Chelidonium majus (herb)
5.Coptis japonica, C. teeta and C. trifolia (rhizomes)
6.Coscinium fenestratum (root, stem)
7.Hydrastis canadensis (rhizome)
8.Jateorhiza palmata (root)
9.Phellodendron amurense (bark)
10.Thalictrum flavum (root)
11.Tinospora sinensis (root, stem, leaf)
Potential Regulatory Implications
While the opinion is still in consultation and does not itself impose restrictions, a final unfavorable safety conclusion could support future risk management action at EU level, including possible restrictions or prohibition under the botanicals framework.
National measures already vary: Sweden and Greece have reportedly prohibited berberine in supplements and Belgium has established a 10 mg/day level.
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