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Cocoa flavanols, chocolate, cocoa beans and a balance representing legal assessment

Cocoa flavanols, including flavan-3-ols, occur naturally in cocoa beans. Commercial communication cannot simply say that cocoa is “rich in antioxidants” or “supports the heart”. For the specific vascular effect, the product, evidence, authorisation conditions and presentation must all line up.

1. What exactly has been authorised?

The authorised wording concerns helping to maintain the elasticity of blood vessels, which contributes to normal blood flow. The first entry was adopted in Commission Regulation (EU) No 851/2013, adopted on 3 September 2013 and applicable from 24 September 2013. Commission Regulation (EU) 2015/539 of 31 March 2015 later amended the conditions of use and covered a defined category of cocoa extract.

This distinction matters: an EFSA scientific opinion is not, by itself, permission to use a claim. The legal basis is the Commission act and the Union claims system. The data protection associated with the original application has expired; the claim should not now be treated as an exclusive right of one company.

Label starting point: use the authorised wording or a cautious adaptation with the same meaning for the average consumer. “Healthy heart”, “protects blood vessels” and “antioxidant shield” are not automatically equivalent.

2. Two closed product routes

The conditions of use do not create a general permission for every cocoa product. The final entry covers two practical categories:

  • Cocoa beverages prepared with cocoa powder or dark chocolate – the recommended daily portion must provide at least 200 mg of cocoa flavanols with a degree of polymerisation from 1 to 10.
  • Capsules or tablets containing high-flavanol cocoa extract – these must also provide at least 200 mg per day within the DP 1–10 range.

For an extract, the claim cannot automatically be moved to a powder sachet, shot, gummy, bar, liquid or lozenge. An EFSA opinion may describe a broader scientific context, but the final Commission act and its conditions control the market communication.

flowchart TD
    A[Cocoa-flavanol communication] --> B{Uses the authorised claim?}
    B -->|No| C[Assess Article 10 of Regulation 1924/2006 and unauthorised-claim risk]
    B -->|Yes| D{Product and conditions of use}
    D -->|Cocoa beverage from powder or dark chocolate| E[At least 200 mg/day, DP 1–10]
    D -->|Capsule or tablet with cocoa extract| F[At least 200 mg/day, DP 1–10]
    D -->|Other extract format| G[Outside the final authorised category]
    E --> H{Dose supported throughout shelf life?}
    F --> H
    H -->|Yes| I[Further wording and labelling review]
    H -->|No| J[No reliable compliance basis]
    style C fill:#7f1d1d,stroke:#f87171,color:#fecaca
    style G fill:#7f1d1d,stroke:#f87171,color:#fecaca
    style J fill:#78350f,stroke:#f59e0b,color:#fef3c7
    style I fill:#064e3b,stroke:#10b981,color:#d1fae5
Diagram 1. Initial compliance screening.

3. 200 mg does not mean “any amount of cocoa”

The condition concerns the dose of cocoa flavanols, not the mass of powder or the percentage of cocoa solids on the pack. In its scientific opinion, EFSA discussed high-flavanol products for which 200 mg could correspond approximately to 2.5 g of high-flavanol cocoa powder or 10 g of high-flavanol dark chocolate. This is not a universal conversion for an ordinary retail bar.

Variety and origin, fermentation, roasting and alkalisation can affect the result. A “70–85% cocoa” declaration is therefore not proof of compliance. The manufacturer needs evidence for the actual recipe, batch or justified specification, together with an assessment of process variability.

4. Analytics: DP 1–10 is the relevant parameter

The Regulation does not ask for “total polyphenols”. The condition concerns cocoa flavanols with a degree of polymerisation from 1 to 10. A Folin–Ciocalteu result, or even a total-flavanol figure, may not answer that question. The method should separate the fractions covered by the condition, and the laboratory documentation should describe scope, validation and measurement uncertainty.

A practical compliance file should connect the raw-material specification, analytical method, finished-product results, serving calculation and stability data. The 200 mg dose must be credible under the product’s marketed shelf-life conditions, not only on the manufacturing date.

flowchart LR
    A[Cocoa product] --> B[Raw-material specification]
    B --> C[Analytical method: DP 1–10 flavanols]
    C --> D[200 mg in recommended daily portion]
    D --> E[Stability through end of shelf life]
    E --> F[Authorised wording + daily-dose information]
    F --> G[Review of label, advertising and digital channels]
    style A fill:#3b2418,stroke:#d39a6a,color:#fde68a
    style C fill:#1e3a5f,stroke:#38bdf8,color:#dbeafe
    style F fill:#064e3b,stroke:#10b981,color:#d1fae5
    style G fill:#312e81,stroke:#a78bfa,color:#ede9fe
Diagram 2. The evidence chain from raw material to communication.

5. What must not be added?

Regulation (EC) No 1924/2006 requires claims to be clear, evidence-based and used under their conditions. Broad phrases such as “healthy cocoa”, “supports circulation” or “protects against oxidative stress” may be assessed as separate health claims. The fact that flavanols show antioxidant activity in research does not create an authorised label claim.

Entries that are suspended or “on hold” must also be distinguished from authorisations. The appearance of a cocoa-related ingredient in such an entry cannot be presented as Commission approval of a specific cocoa-product slogan.

6. Chocolate and supplements are different compliance projects

For chocolate, the central question is whether the actual portion delivers the dose and retains it until the end of shelf life. For a capsule or tablet containing cocoa extract, the supplement framework also matters: composition, labelling, warnings, safety documentation and, in Poland, notification to the Chief Sanitary Inspectorate on first placing the product on the market. Notification is not a safety approval and does not prevent inspection or withdrawal action.

Labelling must be read together with Regulation (EU) No 1169/2011, supplement rules and the claims framework. Review should cover not only the label but also websites, advertising, social media, retailer materials and B2B communication.

Practical rule: do not approve a claim from one raw-material certificate. Assemble the product, serving, DP 1–10 result, stability evidence, exact wording and every communication channel.

7. Pre-use checklist

  1. Does the product fit one of the two final categories?
  2. Does the analytical method confirm DP 1–10 flavanols rather than total polyphenols?
  3. Does the recommended daily portion provide at least 200 mg?
  4. Is the dose supported through the end of shelf life?
  5. Is the consumer told that the beneficial effect is obtained with 200 mg per day?
  6. Do wording and visuals avoid adding an unauthorised health promise?
  7. For a supplement, have labelling and Polish GIS notification requirements been assessed?

Sources and documents