8 Facts About Berberine and the EFSA Opinion
The Absence of a Safe Intake Level Could Remove Supplements from the EU Market

Berberine is an alkaloid found in plants such as barberry and Chinese goldthread, sold for years as a food supplement supporting glucose and lipid metabolism. The EFSA draft opinion of 29 January 2026 (draft Opinion on the safety of plant preparations containing berberine, issued under Article 8(2) of Regulation (EC) No 1925/2006, in public consultation until 10 July 2026) does not explicitly prohibit berberine — but the absence of an established safe intake level opens the door to regulatory action in Member States, including Poland.

1. The EFSA Scientific Opinion Is Not a Ban, but Its Legal Consequences Are More Serious Than They Appear

EFSA issues scientific opinions — not legally binding administrative decisions. The EFSA draft opinion of 29 January 2026 (draft Opinion on the safety of plant preparations containing berberine, issued under Article 8(2) of Regulation (EC) No 1925/2006, in public consultation until 10 July 2026) concerns the safety of berberine as an ingredient in food supplements and functional foods. The NDA Panel (Nutrition, Dietetic Products and Allergies) concluded that there were insufficient data to establish a Tolerable Upper Intake Level (UL) or even an Acceptable Daily Intake (ADI). The absence of a UL does not constitute an automatic ban, but it triggers the mechanism under Article 8 of Regulation (EC) No 1925/2006, Annex III: the European Commission may place the substance in Annex III (Parts A, B or C), resulting in a prohibition, restriction, or placement under Community scrutiny.

• Regulation (EC) No 1925/2006 (on the addition of vitamins and minerals and of certain other substances to foods), in conjunction with Article 17 of Regulation (EC) No 178/2002, places the obligation to demonstrate product safety on the manufacturer — the burden of proof lies with the operator, not the supervisory authority.
• The Polish Chief Sanitary Inspectorate (GIS) may issue a decision ordering the withdrawal of a product from the market under Article 29 of the Act of 25 August 2006 on food and nutrition safety, if the product poses a risk to health.
• The EFSA scientific opinion constitutes evidence within the meaning of Article 75 of the Code of Administrative Procedure (KPA) for the purposes of GIS proceedings and administrative courts — the authority is not required to apply it automatically, but it is difficult to disregard in the course of proceedings.

GIS enforcement practice demonstrates that EFSA scientific opinions identifying safety concerns have already served as the basis for initiating proceedings against food supplement manufacturers in relation to other ingredients (including yohimbine and synephrine). Berberine is now entering the same regulatory pathway.

2. Poland Has No National Limit for Berberine — and That Is a Trap, Not a Safe Harbour

The absence of a Polish regulation establishing maximum doses of berberine in food supplements is treated by some manufacturers as a green light. This is a mistake. The Regulation of the Minister of Health of 9 October 2007 on the composition and labelling of food supplements does not include a list of permitted doses for berberine (as it is neither a vitamin nor a mineral), and the Regulation of 22 November 2010 on permitted food additives does not cover it either.

The absence of national regulation does not create a presumption of legality for any given dose. Article 17 of Regulation (EC) No 178/2002 (general food law) places responsibility for product safety on the operator at every stage of the supply chain. The Polish Chief Sanitary Inspectorate (GIS), relying on the 2026 EFSA draft opinion, may challenge any dose of berberine in a food supplement if the manufacturer does not hold its own toxicological documentation demonstrating the safety of the specific dose for the specific target population.

3. Doses Currently on the Market (500–1,500 mg/day) Fall Precisely Within the Range EFSA Identified as Potentially Unsafe

The 2026 EFSA draft opinion indicates that genotoxicity signals and effects on the gut microbiota and drug metabolism (inhibition of CYP3A4 and P-glycoprotein) occur at doses comparable to those used in commercial food supplements. The NDA Panel analysed data for doses ranging from 200 mg to 2,000 mg/day and was unable to identify a threshold below which the risk is acceptable.

• Drug interactions: berberine inhibits CYP3A4 — potentially causing dangerous increases in plasma concentrations of statins, ciclosporin, certain antibiotics, and immunosuppressive drugs.
• Genotoxicity signals: EFSA noted positive results in in vitro tests that were not conclusively refuted by in vivo data — hence the inability to establish an ADI.
• Vulnerable populations: pregnant women, children, and individuals taking prescription medications — for these groups the risk profile is particularly unclear, which complicates the development of targeted food supplements.

What does this mean for a manufacturer? If a product contains 500 mg of berberine per daily serving and is intended for the general adult population, the manufacturer currently has no scientific opinion — from EFSA or any other recognised agency — confirming the safety of that dose in light of the 2026 draft opinion data.

4. Notification of a Food Supplement with GIS Does Not Protect Against Withdrawal Following a Change in Scientific Assessment

Manufacturers frequently confuse the notification of a product with the Polish Chief Sanitary Inspectorate (GIS) — an obligation under Article 29 of the Act on food and nutrition safety — with obtaining marketing authorisation. GIS acknowledges receipt of the notification; it does not issue an approving decision. A notification submitted prior to the publication of the 2026 EFSA draft opinion affords no legal protection in circumstances where the safety assessment of an ingredient changes.

A precedent exists: GIS issued decisions ordering the withdrawal of yohimbine-containing food supplements after the EFSA scientific opinion (2013) called their safety into question — even though those products had previously been notified. The legal mechanism is identical for berberine. A manufacturer who notified a berberine-containing product in 2022 currently holds no documentation protecting it against action by the supervisory authorities.

5. EU Member States Are Beginning to Act Independently — Market Fragmentation Is a Real and Present Risk

France (ANSES) and Belgium (FASFC) issued national warnings concerning berberine even before the 2026 EFSA draft opinion. Belgium limited the dose of isoquinoline alkaloids (as berberine) to 10 mg/day, and Poland applies the same limit through the mutual recognition procedure. Given standard commercial products (500 mg per serving), this amounts to a de facto prohibition on use as a food supplement at recommended doses. Belgium placed berberine on its list of ingredients requiring enhanced monitoring.

Harmonisation of food supplement law in the EU is incomplete — Directive 2002/46/EC harmonised only vitamins and minerals. Berberine, as an isoquinoline alkaloid, is subject to the procedure under Regulation (EC) No 1925/2006 (Annex III) and national regulations. This means that a product lawfully marketed in Poland may be unlawful in Belgium, restricting exports and creating the risk of notifications to the RASFF system (Rapid Alert System for Food and Feed). A RASFF notification is publicly accessible and can cause irreparable reputational damage to a brand, regardless of the ultimate outcome of the case.

graph TD
    A[Berberine-containing food supplement on the Polish market] --> B{Does the manufacturer hold safety documentation compliant with the 2026 EFSA draft opinion?}
    B -- NO --> C[Risk of GIS enforcement proceedings]
    B -- YES --> D[Audit of health claims on the label]
    C --> E[GIS decision: withdrawal from the market or financial penalty - multiple of average monthly salary]
    D --> F{Are unauthorised health claims being used?}
    F -- YES --> G[Removal of claims / label amendment]
    F -- NO --> H[Monitoring of European Commission and GIS actions]
    G --> H
    H --> I{Will the European Commission or GIS introduce a berberine dose limit?}
    I -- YES --> J[Dose adjustment or product withdrawal]
    I -- NO --> K[Continued sale with current documentation]
    E --> L[Possible proceedings for reclassification as a medicinal product - URPL]

6. Berberine Could Be Reclassified from a Food Supplement to a Medicinal Product — and This Is Not a Theoretical Risk

Directive 2001/83/EC (Article 2(2)) provides that where there is doubt as to whether a product is a food supplement or a medicinal product, pharmaceutical law shall apply. Berberine at high doses exhibits pharmacological activity (lowering blood glucose, antibacterial effects, effects on lipid profiles) — which may constitute grounds for classifying the product as a medicinal product by function (Article 2(1)(b) of Directive 2001/83/EC).

• The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) has the competence to classify a product as a medicinal product — which results in an immediate prohibition on its sale as a food supplement without a marketing authorisation as a medicinal product.
• The cost of obtaining a marketing authorisation for a medicinal product is a minimum of several hundred thousand Polish zloty and involves a procedure lasting several years — which is beyond the reach of most food supplement manufacturers.
• Precedent: the Court of Justice of the EU (CJEU) in its judgment in Case C-140/07 (Hecht-Pharma, 15 January 2009) confirmed that a product may be classified as a medicinal product by function if it exhibits significant pharmacological effects — i.e. it significantly affects physiological functions in a manner exceeding normal nutrition.

7. Health Claims for Berberine Are Already Blocked — Products Are Being Sold on the Margins of Legality

No health claim for berberine has been authorised by the European Commission under Regulation (EC) No 1924/2006 (the Regulation on nutrition and health claims). Berberine does not appear on the list of authorised health claims (the EU Register of authorised health claims, maintained by the European Commission). This means that any statement on a label or in marketing materials suggesting that berberine affects blood glucose levels, cholesterol, or body weight constitutes an unauthorised health claim.

Market practice is nevertheless widespread: manufacturers use formulations such as 'supports normal glucose metabolism' or 'helps maintain normal cholesterol levels' — without authorised health claims, in breach of Article 10(1) of Regulation (EC) No 1924/2006. The Polish Chief Sanitary Inspectorate (GIS) may impose a financial penalty under Article 103 of the Act on food and nutrition safety — the penalty is calculated as a multiple of the average monthly salary (up to 100 times the average monthly salary per infringement), and the Office of Competition and Consumer Protection (UOKiK) may initiate proceedings for unfair commercial practices against consumers. The 2026 EFSA draft opinion further strengthens the position of the supervisory authorities, as it undermines the scientific basis for such marketing communications.

8. What Manufacturers Should Do Now — A Concrete Action List, Not Generalities

The situation is serious, but not without remedy — provided that action is taken before a decision is issued by the authority, not after. A manufacturer or distributor of a berberine-containing food supplement should, as a first priority, commission an audit of the product's safety documentation, with particular focus on compliance with the 2026 EFSA draft opinion of 29 January 2026.

• Commission an independent toxicological opinion for the berberine dose used — the opinion should address data published after 2020 and take into account the genotoxicity signals identified by EFSA.
• Review all marketing materials for unauthorised health claims — remove any statements concerning effects on glucose, cholesterol, or body weight that are not supported by authorised claims listed in the EU Register.
• Consider reducing the berberine dose in the product or reformulating — some European manufacturers are moving below 200 mg/day, arguing that at such low doses the toxicological data are less alarming.
• Monitor GIS enforcement actions and national regulatory responses to the EFSA draft opinion — Poland may issue a regulation restricting the permitted doses of berberine (analogous to regulations on yohimbine or synephrine), and the market's response time to such a regulation can be measured in weeks.
• Consult a lawyer regarding the possibility of voluntary product withdrawal or label amendment before GIS initiates proceedings — voluntary corrective action is taken into account as a mitigating circumstance in administrative proceedings.

Manufacturers who have invested in safety documentation and regular legal audits of their products now hold a genuine advantage: they can either defend their product before the supervisory authority, or make an informed decision to modify or withdraw it — rather than waiting for a GIS decision ordering immediate withdrawal.