Berberine and the EFSA Draft Opinion 2026
Art. 8 of Regulation 1925/2006, Annex III, and the Consequences for Food Supplement Manufacturers

Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods governs, among other things, the safety assessment procedure for substances other than vitamins and minerals. In the case of berberine — an isoquinoline alkaloid present in food supplements on the EU market — the European Commission has initiated the Art. 8 procedure, which may result in this substance being listed in Annex III of the Regulation.

The Facts: EFSA Draft Opinion of 29 January 2026

The EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) adopted on 29 January 2026 a draft scientific opinion on the safety of berberine as a food ingredient. It must be emphasised: this is a draft opinion, not a final opinion. The document was submitted for public consultation, with the original deadline in April 2026 extended to 10 July 2026.

The public consultation is intended to gather comments from interested parties — manufacturers, scientific communities, and Member State authorities. Only after the consultation closes will the NDA Panel consider the comments received and adopt a final opinion, which will be published in the EFSA Journal. On the basis of that opinion, the European Commission will take a decision through the comitology procedure (Standing Committee on the Food Chain) on whether to list berberine in Annex III of Regulation 1925/2006.

Expert Tip: Food supplement manufacturers using berberine should consider submitting comments through the EFSA public consultation (deadline: 10 July 2026). This is the only formal channel for influencing the content of the final opinion. Comments must be supported by scientific data — general commercial arguments will not be considered by the NDA Panel.

Legal Basis: Art. 8 of Regulation (EC) No 1925/2006

The assessment procedure for berberine is based on Art. 8 of Regulation (EC) No 1925/2006. This article concerns substances other than vitamins and minerals whose use in food may pose a risk to consumer health. On this basis, the European Commission may — following a scientific opinion from EFSA — list a substance in Annex III of the Regulation, resulting in a prohibition, restriction, or placement under Community scrutiny.

An important distinction: the legal basis for this procedure is not Directive 2002/46/EC on food supplements. Directive 2002/46/EC regulates the composition of supplements with regard to vitamins and minerals (Annexes I and II of the Directive), but does not regulate botanical substances or alkaloids such as berberine. It is Regulation 1925/2006 — specifically Art. 8 in conjunction with Annex III — that gives the European Commission the tool to intervene in the case of potentially hazardous substances, regardless of whether they appear in food supplements, fortified foods, or other food categories.

• Art. 8(1) of Regulation 1925/2006: the Commission may, on its own initiative or on the basis of information from Member States, initiate a substance assessment procedure
• Art. 8(2): EFSA issues a scientific opinion on the safety of the substance
• Art. 8(3)–(5): on the basis of the EFSA opinion, the Commission may list the substance in Annex III (Part A, B or C)
• Comitology procedure: the Commission's decision requires the opinion of the Standing Committee on the Food Chain

The Annex III Mechanism: Parts A, B and C

Annex III of Regulation 1925/2006 consists of three parts, each with different legal consequences for manufacturers:

Part A — prohibited substances: A substance listed in Part A may not be added to food or used in the production of food. The prohibition is absolute. For a manufacturer, this means the immediate withdrawal of products from the market and reformulation of the composition.

Part B — substances subject to restrictions: The substance may be used, but only under the conditions set out in the Annex — for example, with a quantitative limit (maximum daily dose), a mandatory warning on the label, or a prohibition on use in certain food categories.

Part C — substances under Community scrutiny: This is the most significant option from the perspective of berberine manufacturers. Listing in Part C means that the substance may continue to be used in food, but manufacturers (or other interested parties) have 4 years to provide safety data justifying continued use. If no operator provides sufficient data within 4 years, the Commission may transfer the substance to Part A (prohibition) or Part B (restriction).

Expert Tip: The Part C scenario is the most likely outcome for berberine manufacturers and at the same time gives them time to act. However, it is crucial that manufacturers organise themselves and jointly fund the safety studies required to keep berberine on the market. An individual manufacturer is unlikely to be able to bear the costs of the required toxicological dossier (estimated at EUR 500,000–1,500,000 for a full package of genotoxicity and chronic toxicity studies).

Toxicological Profile of Berberine According to the EFSA Draft Opinion

The 2026 draft opinion of the EFSA NDA Panel identifies a number of serious toxicological concerns relating to berberine. Key findings:

• Inability to establish a safe level of intake: EFSA concluded that the available data do not allow the establishment of an ADI (acceptable daily intake) or any other toxicological reference point for berberine
• In vitro genotoxicity signals: in vitro studies demonstrated genotoxic potential of berberine, although in vivo data are inconclusive and insufficient to rule out this hazard
• Carcinogenic activity in rodent studies: long-term rodent studies showed carcinogenic activity, although there are uncertainties regarding the relevance of these findings to humans
• Idiosyncratic liver injury: cases of liver injury were identified in humans taking berberine preparations, of an idiosyncratic nature (unpredictable, dose-independent)
• Significant data gaps: absence of adequate reproductive and developmental toxicity studies, insufficient pharmacokinetic data in humans

For context: Belgium has restricted the dose of isoquinoline alkaloids (as berberine) to 10 mg/day in food supplements, and Poland applies the same limit by mutual recognition. This limit is drastically lower than the doses used in many products available on the EU market, which typically contain 500–1,500 mg of berberine per daily dose. In its 2026 draft opinion, EFSA went further — it was unable to establish any safe level of intake, suggesting that even the Belgian/Polish limit (10 mg/day) may not be sufficiently conservative.

graph TD
    A[European Commission initiates Art. 8 procedure under Regulation 1925/2006] --> B[EFSA NDA Panel assesses safety of substance]
    B --> C[Draft opinion]
    C --> D[Public consultation - deadline 10.07.2026]
    D --> E[EFSA final opinion]
    E --> F{Commission decision - comitology}
    F -->|Substance hazardous| G[Annex III Part A: PROHIBITION]
    F -->|Substance poses risk| H[Annex III Part B: RESTRICTIONS]
    F -->|Insufficient data| I[Annex III Part C: SCRUTINY 4 years]
    I --> J{Did manufacturers provide data within 4 years?}
    J -->|Yes - data sufficient| K[Substance remains on market]
    J -->|No or data insufficient| L[Transfer to Part A or Part B]
    G --> M[Manufacturer: withdrawal of product from market]
    H --> N[Manufacturer: reformulation or label warnings]
    I --> O[Manufacturer: 4 years to submit safety dossier]

CJEU Case Law and the Reclassification of Berberine Supplements

A separate risk for food supplement manufacturers using berberine is the possibility of product reclassification by national authorities. Pharmaceutical inspection authorities in certain Member States (e.g. BfArM in Germany) may attempt to classify a berberine supplement as a medicinal product on the basis of the pharmacological action criterion (so-called medicinal product by function).

In this context, the case law of the Court of Justice of the EU (CJEU) is relevant. The judgment in Case C-140/07 (Hecht-Pharma) of 2009 established the principle that the mere fact that a substance has pharmacological properties is not sufficient to classify a product as medicinal. It must be demonstrated that the product, under the specific conditions of use (dose, form, manner of use), actually restores, corrects or modifies physiological functions in a significant way. Similarly, in Case C-211/03 (HLH/Orthica), the Court emphasised that classification must be based on the specific characteristics of the individual product, not on the general properties of the active substance.

Food supplement manufacturers using berberine may rely on this line of case law in the event of reclassification attempts. However, the limitation of this argument must be emphasised: CJEU case law protects against product reclassification (supplement vs. medicinal product), but does not protect against the Annex III procedure under Regulation 1925/2006. The Annex III procedure concerns the safety of substances in food and is independent of product classification — even if a product remains a food supplement, the substance may be prohibited or restricted under Regulation 1925/2006.

• C-140/07 (Hecht-Pharma, 2009): the mere presence of a pharmacologically active substance does not determine the classification of a product as medicinal
• C-211/03 (HLH/Orthica, 2005): classification must be based on the specific characteristics of the product, not on the general properties of the substance
• Limitation: CJEU case law does not apply to the Annex III procedure under Regulation 1925/2006, which is a separate regulatory pathway

Expert Tip: A food supplement manufacturer using berberine should simultaneously prepare for two scenarios: (1) the Annex III procedure under Regulation 1925/2006, in which safety data will be key, and (2) a potential reclassification attempt by the pharmaceutical inspectorate, in which arguments based on CJEU case law (C-140/07, C-211/03) will be key. These are two separate proceedings requiring different legal strategies.

Consequences for Polish Manufacturers: Art. 103 of the Act on Food and Nutrition Safety

If berberine is ultimately listed in Part A of Annex III of Regulation 1925/2006, placing on the market food supplements containing this substance will constitute a violation of EU food law. Under Polish law, enforcement of prohibitions arising from Regulation 1925/2006 takes place on the basis of the Act of 25 August 2006 on food and nutrition safety.

Art. 103 of the Act on food and nutrition safety provides for financial penalties reaching multiples of the average salary. In the event of placing on the market food that does not comply with the requirements of EU regulations, the sanitary inspection authorities (district or regional sanitary-epidemiological stations, operating under the supervision of the Polish Chief Sanitary Inspectorate (GIS)) may additionally:

• Order withdrawal of the product from the market
• Prohibit the placing of the product on the market
• Order destruction of the product
• Publish information about the infringement in the RASFF system (Rapid Alert System for Food and Feed)
• In the case of repeated violations — apply for revocation of the operating licence

It must be emphasised that these penalties apply to the situation following a potential listing of berberine in Annex III. At the current stage (EFSA draft opinion in public consultation), there is no legal basis for penalising manufacturers for using berberine in food supplements. However, manufacturers should monitor the progress of the procedure and prepare a contingency plan including product reformulation.

Strategy for Manufacturers: What to Do Now

The current legal situation regarding berberine requires manufacturers to take active steps rather than wait for the Commission's decision. Recommended actions:

• Participation in the EFSA public consultation (deadline: 10 July 2026): submission of substantive comments on the draft opinion, ideally prepared by a toxicologist with experience in EFSA procedures
• Industry organisation: formation of a berberine manufacturers' consortium to jointly fund safety studies (in the event of a Part C listing and the need to submit a dossier within 4 years)
• Preparation of a reformulation plan: identification of alternative active ingredients in the event of a prohibition (Part A) or quantitative restrictions (Part B)
• Portfolio audit: assessment of which products in the portfolio are exposed to the effects of the procedure and what the costs of reformulation would be
• Regulatory monitoring: tracking the work of the Standing Committee on the Food Chain and the publication of the EFSA final opinion

Disclaimer: This article is for informational and educational purposes only. It does not constitute legal or scientific advice and does not replace an individual analysis of the regulatory situation by a food law specialist or toxicologist. The legal status described in this article refers to the situation as of 10 July 2026 and may change following publication of the EFSA final opinion and the European Commission's decision.

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