Berberine and the EFSA Draft Opinion 2026
Art. 8 of Regulation 1925/2006, Annex III, and Consequences for 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 regulates, among other things, the procedure for assessing the safety of 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 procedure under Article 8, which may result in the listing of this substance 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 a draft scientific opinion on the safety of berberine as a food ingredient on 29 January 2026. It must be emphasised: this is a draft opinion, not a final opinion. The document was submitted for public consultation, the deadline for which – originally set for April 2026 – was extended to 10 July 2026.

The public consultation aims to collect comments from interested parties – manufacturers, the scientific community, and Member State authorities. Only after its conclusion 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 a possible listing of berberine in Annex III of Regulation 1925/2006.

Expert Tip: Manufacturers of food supplements containing berberine should consider submitting comments during the EFSA public consultation (deadline: 10 July 2026). This is the only formal route for influencing the content of the final opinion. Comments should be supported by scientific data – general commercial arguments will not be taken into account by the NDA Panel.

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

The assessment procedure for berberine is based on Article 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 its 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 food supplements with respect 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 its Article 8 in conjunction with Annex III – that gives the European Commission the instrument to intervene in the case of potentially hazardous substances, regardless of whether they are present in food supplements, fortified foods, or other food categories.

• Art. 8(1) of Regulation 1925/2006: the Commission may initiate the procedure on its own initiative or on the basis of information from Member States
• 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 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 distinct legal consequences for manufacturers:

Part A – prohibited substances: A substance listed in Part A may not be added to food or used in food production. The prohibition is absolute. For a manufacturer, this means the obligation to immediately withdraw products from the market and reformulate.

Part B – restricted substances: A substance may be used, but subject to conditions specified in the Annex – for example, a quantitative limit (maximum daily dose), a mandatory label warning, or a prohibition on use in specific 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 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 entity 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 probable for berberine manufacturers and simultaneously provides them with time to act. It is critical, however, that manufacturers organise collectively and co-fund the safety studies required to keep berberine on the market. An individual manufacturer is unlikely to bear the costs of the required toxicological dossier (estimated at EUR 500,000–1,500,000 for a full genotoxicity and chronic toxicity testing package).

Toxicological Profile of Berberine According to the EFSA Draft Opinion

The 2026 EFSA NDA Panel draft opinion identifies a number of serious toxicological concerns associated with berberine. Key findings:

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

For context: the French Agency for Food Safety (ANSES) previously recommended not exceeding 20 mg of berberine per day in food supplements. This recommendation is dramatically lower than the doses used in many products available on the EU market, which typically contain 500–1500 mg of berberine per daily dose. EFSA in its 2026 draft opinion went further – it was unable to establish any safe intake level, suggesting that even the ANSES recommendation of 20 mg/day may not be sufficiently conservative.

graph TD
    A[European Commission initiates Art. 8 procedure under Reg. 1925/2006] --> B[EFSA NDA Panel assesses substance safety]
    B --> C[Draft opinion adopted]
    C --> D[Public consultation - deadline 10.07.2026]
    D --> E[Final EFSA 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 B]
    G --> M[Manufacturer: withdraw product from market]
    H --> N[Manufacturer: reformulate or add label warnings]
    I --> O[Manufacturer: 4 years to submit safety dossier]

CJEU Case Law and Reclassification of Berberine Supplements

A separate threat for berberine supplement manufacturers is the potential reclassification of products by national authorities. Pharmaceutical inspectorates in some Member States (e.g. BfArM in Germany) may attempt to classify a berberine supplement as a medicinal product on the basis of pharmacological action (the so-called medicinal product by function criterion).

In this context, the case law of the Court of Justice of the EU is significant. The judgment in Case C-140/07 (Hecht-Pharma, 2009) established that the mere fact that a substance has pharmacological properties is not sufficient to classify a product as a medicinal product. It must be demonstrated that the product, in its specific conditions of use (dose, form, method of use), actually restores, corrects, or modifies physiological functions in a significant manner. Similarly, in Case C-211/03 (HLH/Orthica, 2005), the Court emphasised that classification must be based on the specific properties of the product in question, not on the general characteristics of the active substance.

Manufacturers of berberine supplements may invoke this line of case law in the event of reclassification attempts. However, it is important to emphasise the limitation of this argument: 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 food safety 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 classification of a product as a medicinal product
• C-211/03 (HLH/Orthica, 2005): classification must be based on the specific properties of the product, not on the general characteristics of the substance
• Limitation: CJEU case law is not applicable to the Annex III procedure under Regulation 1925/2006, which is a separate regulatory pathway

Expert Tip: A berberine supplement manufacturer should prepare in parallel for two scenarios: (1) the Annex III procedure under Regulation 1925/2006, where safety data will be key, and (2) a potential reclassification attempt by a pharmaceutical inspectorate, where 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 food supplements containing this substance on the market will constitute a violation of EU food law. Under Polish law, enforcement of prohibitions arising from Regulation 1925/2006 is carried out on the basis of the Act of 25 August 2006 on food and nutrition safety.

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

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

It should be emphasised that these penalties relate to the situation after 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 of berberine requires manufacturers to take active steps rather than wait for the Commission decision. Recommended actions:

• Participate in the EFSA public consultation (deadline: 10 July 2026): submit substantive comments on the draft opinion, preferably prepared by a toxicologist with experience in EFSA procedures
• Industry organisation: establish a consortium of berberine manufacturers to co-fund safety studies (in the event of a Part C listing and the requirement to submit a dossier within 4 years)
• Prepare a reformulation plan: identify alternative active ingredients in case of a prohibition (Part A) or quantitative restrictions (Part B)
• Portfolio audit: assess which products in the portfolio are exposed to the consequences of the procedure and what the costs of reformulation would be
• Regulatory monitoring: track 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 final EFSA opinion and the European Commission decision.

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