Caffeine in a food supplement
How must it be labelled under Annex III point 4.2 of Regulation 1169/2011?

A food supplement to which caffeine is added with a physiological purpose must carry, in the same field of vision as the name “food supplement”, the statement “Contains caffeine. Not recommended for children or pregnant women”, followed immediately, in brackets, by the caffeine content per portion as recommended for daily consumption. That is Annex III point 4.2 of Regulation (EU) No 1169/2011 (FIC). The wording “High caffeine content”, the reference to breast-feeding women and the unit mg/100 ml belong to point 4.1, i.e. to beverages containing more than 150 mg of caffeine per litre. Carrying that beverage wording over to a capsule is the most common caffeine labelling error.

1. Wording of points 4.1 and 4.2 in the Polish, English and German versions

Annex III point 4 is headed “Beverages with high caffeine content or foods with added caffeine” and splits into two entries with different scope, different wording and a different unit. The wording in the consolidated text of 1 April 2025 is identical to the original 2011 text in each of the three language versions.

Three differences matter in practice. First, the point 4.2 statement does not mention breast-feeding women. Second, the same-field-of-vision requirement applies in both points, not only to beverages. Third, the words “from whatever source” appear only in point 4.1. Point 4.2 refers to caffeine that is “added”, which matters for botanical ingredients (section 3).

The rule for beverages above 150 mg/l comes from Commission Directive 2002/67/EC, repealed by the FIC. The Directive required only the message “High caffeine content” with the content in mg/100 ml. The advice on children and pregnant women and the whole of point 4.2 for foods other than beverages were introduced by Regulation 1169/2011, applicable from 13 December 2014.

2. Why a food supplement falls under point 4.2, not 4.1

Under Art. 2(a) of Directive 2002/46/EC a food supplement is a concentrated source of nutrients or other substances with a nutritional or physiological effect, marketed in dose form: capsules, tablets, sachets of powder, ampoules of liquids. Caffeine in such a product is as a rule a characterising ingredient, added for its effect. The legislator settled this expressly in the last sentence of point 4.2, which governs the unit of declaration precisely “in the case of food supplements”. The supplement rule sits in the entry for foods other than beverages, not in point 4.1.

Caffeine can also enter a food as a flavouring, e.g. for bitterness. Annex VII Part D point 3 FIC then requires it to be mentioned by name in the list of ingredients immediately after the term “flavouring(s)”. In a supplement where caffeine is meant to act, that route usually does not apply. Describing caffeine as a flavouring at 100 mg per capsule would mislead as to the nature of the ingredient (Art. 7(1)(a) FIC).

3. Caffeine from guarana, yerba mate, green coffee and green tea

The text of point 4.2 does not say whether caffeine contributed by a plant extract is “added” caffeine. The closest official source is the summary report of the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF), General Food Law section, of 16 October 2017. Belgium had notified draft national rules (2017/182/B) that extended the warning to supplements where caffeine is naturally present in an added ingredient, such as a botanical extract. The Commission recalled the position of the working group on Regulation 1169/2011: it was generally agreed that the point 4.2 requirement is not limited to caffeine added as such, but also applies to any other case where an ingredient containing caffeine is added with a physiological purpose. That is the case for a food with guarana extract, which contains a high level of caffeine. Chocolate, which contains low amounts of caffeine, would not be considered a source of caffeine with a physiological purpose when added as an ingredient.

Operational conclusions and the limits of that source:

• The summary report is not a legal act. It records an exchange of views and a working-group understanding. Binding interpretation comes only from the CJEU. It is nevertheless a Commission position that a control authority can rely on.
• The test is the purpose of adding the ingredient, not the mere presence of caffeine. Treat a guarana, yerba mate or green coffee extract standardised for caffeine, or an ingredient whose caffeine content you highlight in communication, as caffeine added with a physiological purpose.
• No quantitative threshold. The Commission named two poles: guarana and chocolate. A green tea extract added for catechins, with residual caffeine, lies in between. Document the caffeine content per daily portion and the reasoning for the classification in the product specification.

In Poland, GIS practice simplifies the question (section 8). The Food Supplements Team resolution expressly covers supplements “containing caffeine or plant preparations that are a source of caffeine”.

4. “Same field of vision as the name”: which name and which field

A “field of vision” means all the surfaces of a package that can be read from a single viewing point (Art. 2(2)(k) FIC). It need not be the principal field of vision (point (l)). It must, however, be the same field in which the name of the food appears. For a supplement, the legal name (Art. 17(1) FIC) is the name in Art. 6(1) of Directive 2002/46/EC: “food supplement” (in Poland “suplement diety”, in Germany “Nahrungsergänzungsmittel”). A brand name or fancy name does not replace it (Art. 17(4)). In practice:

• place the statement on the same panel as “food supplement”. If the name is on the front and the statement on the back, the requirement is not met, however large the font;
• the bracketed caffeine content “follows” the statement, so it also sits in that field of vision;
• on a cylindrical bottle, read the label from one point: the statement and the name must not require turning the pack.

Legibility. Point 4.2 refers to Art. 13(1): information marked in a conspicuous place, easily visible, clearly legible, not obscured by graphics. The minimum x-height in Art. 13(2)–(3) (1.2 mm, or 0.9 mm where the largest surface is below 80 cm²) literally covers the particulars in Art. 9(1), whereas the Annex III statements stem from Art. 10. The Regulation sets no separate font size for them. Applying at least the same values closes off any Art. 13(1) dispute.

Online sales. Art. 14(1)(a) requires mandatory food information to be available before the purchase is concluded. The point 4.2 statement and the caffeine content per daily portion must therefore appear on the web-shop product page, not only on an illegible pack photo.

5. Caffeine content per daily portion: worked example

For foods other than beverages, point 4.2 requires mg per 100 g/ml. For supplements, the last sentence of the provision changes the reference unit: the content “shall be expressed per portion as recommended for daily consumption on the labelling”. This is consistent with Art. 8(1)–(2) of Directive 2002/46/EC, which requires the amount of substances with a physiological effect to be declared numerically, per portion recommended for daily consumption. For capsules, a value per 100 g tells the consumer nothing: 200 mg of caffeine in 1.2 g of capsules is 16,667 mg/100 g.

Three remarks. Add up all sources to which you apply point 4.2: caffeine as such and caffeine from extracts added for their caffeine. With a dosage range (“1–2 capsules daily”) the provision does not say which value to give. Stating the value for the maximum recommended portion does not understate the information. The declared value is an average from the manufacturer’s analysis (Art. 9(1) of Directive 2002/46/EC). The EU has set no numerical tolerance for caffeine. The 2012 Commission guidance covers vitamins and minerals, and any deviation is assessed under the ban on misleading information in Art. 7 FIC. More: tolerances for declared values in supplements.

6. List of ingredients: caffeine, guarana and QUID

• Caffeine added as such is an ingredient within Art. 2(2)(f) FIC. It is listed under its specific name (Art. 18(2)), in descending order of weight (Art. 18(1)).
• Caffeine contained in an extract is not a separate ingredient, because it is not separately “used in the manufacture”. The ingredient is the extract, described by a name that identifies it. The caffeine from the extract is shown in the bracket after the point 4.2 statement, not as an extra “caffeine” entry in the list that the manufacturer never added.
• QUID. Where guarana appears in the name or is emphasised in words or graphics (“with guarana”), the quantitative ingredient declaration in Art. 22(1)(a)–(b) applies. It is a different obligation from the caffeine content and neither replaces the other.
• Flavouring. If caffeine is also used as a flavouring, Annex VII Part D point 3 requires it to be named right after the word “flavouring(s)”.

Point 4.2 is one of several Annex III statements that work the same way in supplements: a specific entry, verbatim wording, a defined placement. Compare the polyols laxative-effect statement (Annex III point 2.4).

7. Science: EFSA values and what the statement does not say

In its 2015 opinion on the safety of caffeine (EFSA Journal 2015;13(5):4102), the EFSA NDA Panel assessed caffeine intake from all dietary sources:

What this means for the label:

• The statement sets no dose. The EU has no maximum caffeine level for supplements. Point 4.2 informs; recipe safety is governed by Art. 14 of Reg. (EC) No 178/2002 and the operator’s assessment.
• Why “not recommended for children”. At 3 mg/kg bw a 30-kg child reaches 90 mg. One capsule with 100 mg of caffeine exceeds that level.
• Breast-feeding. EFSA set 200 mg for lactating women, but the point 4.2 statement, adopted in 2011, does not name them. Do not alter the mandatory wording. An additional sentence on breast-feeding may appear separately as voluntary information that is accurate and based on scientific data (Art. 36(2) FIC).
• Dietary context. EFSA values cover caffeine from all sources, including coffee and tea. A supplement with 200 mg per daily portion uses up half of the habitual level for adults and the whole level for pregnant women.

Wider scientific context on caffeine and the cardiovascular system: caffeine, coffee and the heart: AHA 2026 statement.

8. Polish practice: Resolution No 16/2019 of the Food Supplements Team

For products sold in Poland, the Food Supplements Team (Zespół do spraw Suplementów Diety), operating at the Sanitary-Epidemiological Council, adopted on 25 October 2019 Resolution No 16/2019 “expressing an opinion on the maximum amount of caffeine in the recommended daily portion of food supplements” (legal basis: Art. 9(2b)(1) of the Polish Act on the State Sanitary Inspection). Its § 1 states:

• caffeine may be used up to 400 mg per day, in divided portions, provided the product contains no other ingredients with a synergistic effect; a portion consumed at one time may not exceed 200 mg;
• the labelling of supplements “containing caffeine or plant preparations that are a source of caffeine” must give the total caffeine content per recommended daily portion and the warning: „Zawiera kofeinę; nie zaleca się stosowania u dzieci i kobiet w ciąży; nie spożywać z innymi produktami będącymi źródłem kofeiny lub innych składników o podobnym działaniu” (“Contains caffeine; not recommended for children and pregnant women; do not consume with other products that are a source of caffeine or of other ingredients with a similar effect”);
• the maximum amount applies to supplements for healthy adults, excluding pregnant and lactating women.

The resolution is an opinion of an advisory body, not a generally binding rule. GIS publishes the Team’s resolutions as guidance for composing supplements, and the resolution’s reasoning bases the 400 and 200 mg values on the 2015 EFSA opinion. The first two parts of the recommended warning are verbatim the Polish point 4.2 wording. The third sentence is an addition. On the label, place it after the mandatory statement and the bracketed content, so that the point 4.2 wording stays intact (Fig. 2). The notification to GIS on first placing a supplement on the Polish market (Art. 29 of the Act on Food and Nutrition Safety) is not approval of the label. The food business operator is responsible for the wording and placement of the statement.

9. Health claims on caffeine: status at 16 October 2026

The EU Register of nutrition and health claims contains no authorised claim for caffeine. Caffeine entries have the status “non-authorised”:

• increased fat oxidation leading to a reduction in body fat mass (ID 735, 1484), increased energy expenditure (ID 1487), physical performance during short-term high-intensity exercise (ID 737, 1486, 1489) — EFSA opinions 2011;9(4):2053 and 2054;
• the Art. 13(5) application “caffeine helps to increase alertness” for 40–75 mg per serving — refused by Commission Regulation (EU) 2016/1411. In recital 6 the Commission recalls that EFSA had earlier assessed alertness in adults favourably for products containing at least 75 mg of caffeine per serving.

The favourable EFSA opinions of 2011 (alertness, attention, endurance) did not lead to authorisation. The Commission prepared a draft (SANTE/12128/2015, discussed in the working group on 9.11.2015) authorising four claims on endurance, alertness and concentration. In its resolution of 7 July 2016 (2016/2708(RPS)) the European Parliament objected to its adoption and called on the Commission to withdraw the draft. The regulation was not adopted. “Increases alertness”, “improves concentration” or “increases endurance” attributed to caffeine are therefore not claims on the permitted lists (Art. 10(1) of Reg. 1924/2006). A general reference such as “energy” must be accompanied by an authorised specific claim of another ingredient (Art. 10(3)). See CJEU C-524/18 Schwabe: accompanying a general health claim and health claims on food supplements. The point 4.2 statement is not a claim and does not “legalise” any message about the effect of caffeine.

10. What the rules leave open

• A drinkable liquid supplement (e.g. a “shot” in an ampoule). The FIC does not define “beverage”. The last sentence of point 4.2 and the unit “100 g/ml” indicate that the legislator placed supplements, liquid ones included, in point 4.2. Read literally, however, a liquid above 150 mg/l also fits point 4.1. The text does not resolve this. Document the product’s classification.
• Threshold for botanical ingredients. The Commission’s 2017 position names guarana and chocolate, with no numerical value.
• Dosage ranges. The act does not say whether to give the content for the minimum or the maximum portion.
• Additional mg/100 g on a supplement. On a literal reading of point 4.2, the unit for a supplement is the daily portion. Adding a per-100 g value is not prohibited, but it must not obscure the per-portion value.
• Transitional status of non-authorised claims with a favourable EFSA opinion. Recital 11 of Reg. 432/2012 allows continued use of claims whose consideration by the Commission has not been completed (Art. 28(5)–(6) of Reg. 1924/2006). No act settles whether that covers the caffeine claims after the Parliament’s objection. Such claims are not authorised, and using them places the full legal risk on the operator.

11. Checklist for the regulatory team

1. Classify: product form (dose form, not a beverage) and the purpose of adding caffeine or a caffeine-containing ingredient. Record the reasoning in the specification.
2. Calculate caffeine: total from caffeine as such and extracts added for caffeine, per recommended daily portion; separately, the single intake.
3. Insert the verbatim point 4.2 wording in the language of the country of sale, with the bracket giving mg per daily portion. Do not use the point 4.1 wording.
4. Field of vision: statement and bracket on the same surface as “food supplement”, legible (Art. 13(1)).
5. List of ingredients: caffeine added as such by name; extract described identifiably; QUID if you emphasise guarana; caffeine as flavouring after the word “flavouring”.
6. Polish market: the sentence from resolution 16/2019 after the statement; daily portion ≤ 400 mg, single intake ≤ 200 mg, no synergistic ingredients.
7. Communication: no alertness, concentration, endurance or fat-burning claims attributed to caffeine. Statement and content also on the web-shop product page (Art. 14).

Glossary

Field of vision

All the surfaces of a package that can be read from a single viewing point (Art. 2(2)(k) FIC).

Name of the food

The legal name, for a supplement “food supplement”; not replaced by a brand name or fancy name (Art. 17(1) and (4)).

Caffeine added with a physiological purpose

Caffeine as such or a caffeine-containing ingredient added for its effect (Commission position, SCoPAFF 16.10.2017), as distinct from caffeine used as a flavouring.

Recommended daily portion

The portion of the product recommended for daily consumption, mandatory on a supplement (Art. 6(3)(b) of Directive 2002/46/EC). The caffeine content refers to it.

Conclusion

For caffeine in a food supplement, Annex III point 4.2 FIC applies: the statement “Contains caffeine. Not recommended for children or pregnant women”, in the same field of vision as the name “food supplement”, with a bracket giving the caffeine content per recommended daily portion. Point 4.1, with “high caffeine content”, breast-feeding women and mg/100 ml, covers beverages above 150 mg/l. Caffeine from guarana and similar extracts added for their caffeine falls under point 4.2 on the Commission’s 2017 position, and in Poland expressly under resolution 16/2019. The statement is neither a dose limit nor a claim: assess the dose against EFSA 2015 and GIS practice, and note that no claim on the effect of caffeine has been authorised in the EU.

Primary sources

1. Regulation (EU) No 1169/2011 on the provision of food information to consumers: Art. 2(2)(f), (k), (l); Arts 7, 9, 10, 13, 14, 17, 18, 22, 36; Annex III point 4; Annex VII Part D point 3; consolidated text 02011R1169-20250401 (original text: CELEX 32011R1169).
2. Directive 2002/46/EC on food supplements: Art. 2(a), Arts 6, 8, 9; consolidated text 02002L0046-20251126.
3. Commission Directive 2002/67/EC on the labelling of foodstuffs containing quinine and of foodstuffs containing caffeine: Art. 2 (repealed by Reg. 1169/2011).
4. Regulation (EC) No 1924/2006: Arts 10, 13, 28(5)–(6); Commission Regulation (EU) No 432/2012: recitals 10–11.
5. Commission Regulation (EU) 2016/1411 refusing to authorise certain health claims: recital 6 (caffeine and alertness, EFSA-Q-2013-00399).
6. EFSA NDA Panel, Scientific Opinion on the safety of caffeine, EFSA Journal 2015;13(5):4102.
7. EFSA NDA Panel, opinions on caffeine health claims: EFSA Journal 2011;9(4):2053 and 2011;9(4):2054.
8. European Commission, SCoPAFF summary report, General Food Law section, 16.10.2017, item A.03 (Belgian notification 2017/182/B, interpretation of point 4.2).
9. European Parliament, resolution of 7.7.2016, 2016/2708(RPS), on the draft regulation amending Reg. 432/2012 (caffeine claims).
10. UK Department of Health, update from the Commission working group on health claims, 9.11.2015 (draft SANTE/12128/2015).
11. European Commission, EU Register of nutrition and health claims (status at 16.10.2026).
12. Polish Food Supplements Team, Resolution No 16/2019 of 25.10.2019 on the maximum amount of caffeine in the recommended daily portion of food supplements (in Polish); Team page on the GIS website.