Cocoa flavanols, including flavan-3-ols, are naturally occurring compounds in the cocoa bean. In commercial communications, however, it is not sufficient to state that cocoa is "rich in antioxidants" or "supports the heart". For a specific vascular effect, you must navigate science, the conditions of authorisation and the requirements for product presentation simultaneously.
1. What exactly has been authorised?
The authorised wording relates to the maintenance of the elasticity of blood vessels, which contributes to normal blood flow. The initial entry was adopted by Commission Regulation (EU) No 851/2013 of 3 September 2013, applicable from 24 September 2013. The subsequent Commission Regulation (EU) 2015/539 of 31 March 2015 amended the conditions of use and also covered a specific category of cocoa extract.
This is an important distinction: an EFSA scientific opinion is not in itself a permission to use a health claim. The legal basis for communication is the Commission act and the entry in the EU health claims register. The data protection granted in connection with the original application has expired; the health claim should not today be treated as the exclusive right of a single operator.
2. Two closed product tracks
The conditions of use do not create a general permission for every product containing cocoa. The final entry covers two practical categories:
- Cocoa beverages prepared from cocoa powder or dark chocolate – the recommended daily serving must provide at least 200 mg of cocoa flavanols with a degree of polymerisation from 1 to 10.
- Capsules or tablets containing a high-flavanol cocoa extract – these must also provide at least 200 mg per day within the DP 1–10 range.
In the case of an extract, the health claim cannot automatically be transferred to a sachet of powder, a shot, a gummy, a bar, a liquid or a lozenge. An EFSA opinion may describe a broader scientific context or possible applications, but the binding significance lies in the final Commission act and its conditions.
flowchart TD
A[Cocoa flavanol communication] --> B{Does it use the authorised health claim?}
B -->|No| C[Assessment under Art. 10 of Regulation 1924/2006 and risk of an unauthorised claim]
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 form| G[Does not fall within the final authorised category]
E --> H{Dose confirmed throughout shelf life?}
F --> H
H -->|Yes| I[Claim subject to further linguistic and labelling review]
H -->|No| J[No safe 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:#d1fae53. 200 mg does not mean "any amount of cocoa"
The condition relates to the dose of cocoa flavanols, not to the mass of powder or the percentage of cocoa stated on the packaging. In its scientific opinion, EFSA described high-flavanol products for which 200 mg could correspond approximately to 2.5 g of cocoa powder or 10 g of dark chocolate. This is not a universal conversion factor for an ordinary bar from the retail market.
The result is influenced by, among other things, the variety and origin of the bean, fermentation, roasting and alkalisation. A declaration of "70–85% cocoa" is therefore not evidence that the condition has been met. The manufacturer should hold data for the specific recipe, batch or justified specification, together with an assessment of process variability.
4. Analytics: DP 1–10 is what counts
The Regulation does not refer to "total polyphenols". The requirement concerns cocoa flavanols with a degree of polymerisation from 1 to 10. A result from a Folin–Ciocalteu assay or a general flavanol count does not necessarily correspond to this parameter. The method must resolve the fractions covered by the condition, and the laboratory should describe the scope, validation and measurement uncertainty.
In practice, compliance documentation should combine the raw material specification, the analytical method, results for the finished product, a calculation based on the recommended serving and stability data. The 200 mg must be achievable under the conditions in which the product is sold, not only on the day of manufacture.
flowchart LR
A[Cocoa product] --> B[Raw material specification]
B --> C[Analytical method: flavanols DP 1–10]
C --> D[200 mg in the recommended daily serving]
D --> E[Stability through end of shelf life]
E --> F[Authorised wording + 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:#ede9fe5. What must not be added?
Regulation (EC) No 1924/2006 requires that health claims be clear, evidence-based and used in accordance with the conditions of authorisation. General slogans such as "healthy cocoa", "supports the cardiovascular system" or "protects against oxidative stress" may be assessed as separate health claims. The mere fact that flavanols exhibit antioxidant activity in studies does not create an authorised claim on a label.
It is also necessary to distinguish between entries that are suspended or "on hold" and actual authorisations. You cannot invoke the presence of an ingredient in such an entry as though the European Commission had approved a specific claim for a cocoa product.
6. Chocolate and a food supplement are two different compliance projects
In the case of chocolate, the fundamental question is whether a specific serving actually delivers the required dose and whether the product maintains that dose until the end of its shelf life. In the case of a capsule or tablet containing a cocoa extract, the requirements applicable to food supplements also apply: composition, labelling, warnings, safety documentation and — in Poland — the obligation to notify the Polish Chief Sanitary Inspectorate (GIS) prior to first placing on the market. Notification is not a safety approval decision, nor does it provide protection against inspection.
Labelling must be read in conjunction with Regulation (EU) No 1169/2011, the provisions on food supplements and the rules on health claims. Regulatory scrutiny does not end at the label: it also covers the website, advertisements, social media, materials for retailers and B2B communications.
7. Checklist before using the health claim
- Does the product fall within one of the two final authorised categories?
- Does the analytical method confirm flavanols at DP 1–10, rather than total polyphenols only?
- Does the recommended daily serving provide a minimum of 200 mg?
- Is the dose substantiated through to the end of the shelf life?
- Is the consumer informed of the beneficial effect at a daily intake of 200 mg?
- Do the text and graphics not add any unauthorised health promise?
- For a food supplement, has a labelling review and assessment of the GIS notification obligation been carried out?
Sources and documents
- Commission Regulation (EU) 2015/539 – final conditions of authorisation and product categories.
- Commission Regulation (EU) No 851/2013 – original authorisation.
- Regulation (EC) No 1924/2006 – rules on nutrition and health claims.
- EFSA Journal 2012;10(7):2809 – scientific basis for the health claim and characterisation of flavanols.
- EFSA Journal 2014;12(5):3654 – extension of the assessment to high-flavanol extract.
- Regulation (EU) No 1169/2011 – provision of food information to consumers.
- Polish Food Safety and Nutrition Act – Polish supervisory framework and food supplement notification.
- European Commission: health claims – information on the EU health claims system.