Berberine

Berberine is found in such plants as Berberis vulgaris (barberry), Berberis aristata (tree turmeric), Mahonia aquifolium (Oregon grape), Hydrastis canadensis (goldenseal), Xanthorhiza simplicissima (yellowroot), Phellodendron amurense (Amur cork tree), Coptis chinensis (Chinese goldthread), Tinospora cordifolia, Argemone mexicana (prickly poppy), and Eschscholzia californica (Californian poppy).

As of 27/4/2023 there is a public consultation from EFSA looking at the safety of berberine containing plants, this will be updated when new information is released.

An email from the HFMA on 27/8/24 stated:

Berberis aristata and products containing Berberis in general may require final determinations by the MHRA regarding their classification as borderline products. It is our understanding that the MHRA generally regards this herb as medicinal and its classification as a medicine may also depend on the specific part of the plant used, which could have implications for safety concerns.

Overall, there is strong evidence that herb itself has medicinal uses, therefore one might presume that a substance isolate from this herb would also be considered medicinal.  For a definitive answer, I would recommend that you contact the MHRA Borderline Advice team on borderline_medicine@mhra.gov.uk

Regarding isolated berberine, as an isolated substance, it is likely to be considered novel when used in foods. Consequently, there is a potential risk in marketing a product containing berberine as a food supplement in the UK. Ultimately, the company would bear the responsibility of defending its use as a food supplement should its suitability be questioned.

As for the EU, there are varied national restrictions/authorised and unauthorised parts of Berberis aristata, for example:

• In France, the roots only are authorised in food supplements, under the following conditions:

Doctrine teledeclaration October 2019, updated October 2023: Anses in its 2019 opinion relating to the use of plants with berberine in food supplements recommends that “pregnant and breastfeeding women, diabetics and people with liver or heart disorders should refrain from consuming food supplements containing berberine, due to the adverse effects that may occur. In the absence of specific data, this recommendation also applies to children and adolescents. A pharmacological dose of 400 mg is retained, therefore maximum 380 mg (5% tolerance). The substance to be monitored is: Berberine (recommended: ≤ 380 mg).

• In Italy, root and bark of the branches are authorised in food supplements. For botanical claims, the Italian authorities already have national provisions: physiological effects listed in Annex 1 Decree of 10 august 2018 (as amended) usable.
• In Hungary, the whole plant is unauthorised in all foods, including food supplements.
• In Belgium, the roots only are authorised in food supplements, the recommended daily amount should not lead to an intake of isoquinoline alkaloids (expressed as berberine) exceeding 10 mg. The substance to be monitored is: Berberine (≤ 10 mg).
• In Estonia, similarly to the UK, there is a risk of classification as medicine, application to Agency of Medicines possible for a case by case analysis.

Barberry root powder is R2052 in Access, and may be a possible alternative, as there are no active claims, although it would be up to the customer to decide.

We do have Berberine in Access but it is only for use outside the UK/EU.