Health claims on food supplements are EU-harmonised. Regulation (EC) No 1924/2006 prohibits a health claim that fails Chapter II and IV and is not on the Article 13/14 lists — with a narrow Article 28(5)–(6) transitional window. The EU Register and Regulation (EU) No 432/2012 supply wording and conditions of use. Product notification is a different layer (Directive 2002/46/EC Article 10; in Poland Article 29 UBŻiŻ). GIS filing does not authorise a claim. This page is the FBO operating system: Register wording → Article 10(3) pairing → dose → channels (pack, web, ads, marketplace) → botanicals after CJEU C-386/23 and the GIS notice of 18 June 2025. Verify the current Register and GIS stance.
Framework: 1924/2006, 432/2012 and the EU Register
Regulation (EC) No 1924/2006 applies to nutrition and health claims in the labelling, presentation and advertising of foods for the final consumer, including food supplements. Article 2(2)(5) defines a health claim as any claim that states, suggests or implies a relationship between a food category, a food or one of its constituents and health. Article 10(1) prohibits health claims that do not meet the general and specific requirements and are not included in the Article 13 and 14 lists. Commission Regulation (EU) No 432/2012 establishes the list of permitted function claims other than disease-risk reduction and children’s development. The Commission maintains the EU Register — authorisations, rejections and conditions.
A nutrition claim (“source of vitamin C”, “high protein”) is a separate Annex list with its own thresholds. It does not unlock an immunity health claim without an Article 10(3) pair. Novel-food status or a permitted vitamin form under Directive 2002/46/EC does not grant a claim — those are composition gates.
Acts: 1924/2006 (consolidated), 432/2012, Commission claims page. Re-check the Register per SKU.
Workflow: label → website → advertising (including marketplaces)
Article 1 of Regulation 1924/2006 covers commercial communication. A product-detail page, an Amazon/Allegro listing, a banner, an influencer script and an “why it works” block on your own site are not claim-free zones. Keep one matrix: pack, the Polish labelling specimen filed with GIS, PDP, marketplace, ads, social. An EN claim on the listing and a different PL pack is a classic inspection angle because the same provision applies to every channel.
Marketplace-as-labelling means: text the FBO controls or should control (title, bullets, A+ / rich content, seller Q&A) is assessed like a label. Translating an EN claim “by eye” does not create a lawful PL claim. Conditions of use must be readable in the channel where the claim appears — or the claim falls.
Specific versus general claims (Article 10(3))
Article 10(3): a reference to general, non-specific benefits of a nutrient or food for overall good health or health-related well-being may be made only if accompanied by a specific health claim from the Article 13 or 14 lists. C-386/23 confirmed the same structure for botanicals: a general slogan without a specific pair is prohibited unless the pair is a transitional Article 28(6) claim.
Educational example (not a SKU): vitamin C has a Register claim that it contributes to the normal function of the immune system — if the condition of use (amount) is met. “Supports immunity” on the front of the pack is a general reference: without a visible specific pair and a qualifying dose there is no lawful Article 10(3) construction. The same on the listing.
| Element | What the FBO checks | Typical failure |
|---|---|---|
| Specific wording | Register / 432/2012; same health relationship | Marketing paraphrase instead of the claim |
| General slogan | Whether a list claim actually accompanies it | “Immunity”, “energy”, “detox” alone |
| Dose / condition | Amount per serving = authorisation condition | Claim at a cosmetic dose |
| Article 10(2) | Mandatory information with the claim | Claim without varied-diet context |
| Channel | Pack = PDP = ads = marketplace | EN listing with a different claim than the PL pack |
Flexible wording (recital 21 / recital 9) is for consumer understanding — synonym, explanation, same health relationship — not for strengthening the message or implying treatment. GIS on pending: a modified wording must not mislead or suggest treatment; stay as close as possible to the authorised wording. The operator bears the Article 6 burden.
Botanicals / on-hold list after C-386/23 (update 18 June 2025)
On 30 April 2025 the Court (Fifth Chamber) delivered C-386/23 Novel Nutriology (ECLI:EU:C:2025:304). The BGH asked whether Article 10(1) and (3) apply to botanical advertising claims (in the case: saffron extract and melon juice — psychological functions) while the Commission has not finished the botanical assessment. The Court: Article 10(1) and (3) apply; off-list use in presentation and advertising is prohibited unless Article 28(6) applies.
On 18 June 2025 GIS published its notice on the judgment. What GIS actually wrote — without inventing extra “inspection conditions”:
- Article 10(1) and (3) apply to botanical claims (including psychological / behavioural functions);
- if they are not on the Article 13/14 lists they may not be used, except Article 28(6);
- the permitted list does not include pending claims; pending may be used under Article 28(5) and (6) until a Commission decision (recitals 10–11 of 432/2012);
- GIS: the prior interpretation is consistent with the judgment;
- presence on the pending list is necessary, not sufficient — 1924/2006 compliance is required (including Articles 3, 5, 6, 10);
- GIS conclusion: operators may still use pending claims (including botanicals) until the Article 13(2) list or another Commission decision, if (1) the claim is on the pending list (meaning an application before 19 January 2008) and (2) it complies with 1924/2006, including scientific evidence on the operator.
GIS warns: dates next to IDs in the EFSA database are dates of transmission to EFSA by the Commission, not application dates — they are not decisive for Article 28(6)(b). The separate pending-conditions notice adds: evidence-based use; quantity sufficient for the declared effect; Article 7 and 10 mandatory information; no medicinal properties; pending wordings were not vetted for Regulation compliance; botanicals should not use “essential / required” or “restore” language for impaired function; a pending health-relationship slogan must match the listed relationship; the FBO shows it is pending and produces evidence and quantity. That is the notice — not a fine schedule or a brand story.
Grey-zone language
“Supports immunity” / “for energy” / “detox”. The first two are usually general references — they need a Register pair and a dose. “Detox”, “cleanses the body”, “kills viruses” engage Article 3 (misleading / medicinal implication) or pharmaceutical law.
“Natural”, “superfood”, “clean”. Usually not health claims under Article 2, but they remain subject to the misleading-information ban (Article 3 of 1924/2006 and Article 7 of Regulation 1169/2011).
Negative safety claims (“does not cause addiction”, “no side effects”). Often imply a medicinal product or an unauthorised absence-of-risk claim.
Disease-risk reduction (Article 14) is a narrow separate list. Do not confuse it with a medicinal claim (“prevents flu”, “treats”). The food/medicine border is a qualification (presentation, composition, claims) — not a marketing-tone issue.
GIS / Sanepid inspection angles (no case stories)
Repeatable angles follow from the act: off-Register and off-pending wording; a general slogan without a specific pair; pending without an ID or an Article 6 dossier; pack ↔ listing mismatch; medicinal implication or an individual doctor endorsement (Article 12(c)); missing Article 10(2) information; a claim kept while the dose is below the condition of use. Articles 30/32 UBŻiŻ and the 2024 NSA line concern product notification and suspension, not a substitute claims assessment. If a letter mixes layers, split them: composition/notification versus 1924/2006. NSA Article 32: 2024 judgments — only when the dispute is a hold, not wording alone.
C.L.A.I.M.S. (a map, not a clearance)
C.L.A.I.M.S. (app.foodlaw.ai) maps Register and pending claims. The output is a starting point for RA/marketing — not a GIS decision, not an authorisation, not a legal opinion on a SKU.
Article 12(c) — doctor endorsements
Article 12(c) of Regulation 1924/2006 prohibits health claims that make reference to recommendations of individual doctors or health professionals and associations. Already covered: health claims and doctor recommendations. Keep endorsement as a separate scrub check beside the Register and pending.
FAQ
Which claims are allowed on food supplements in the EU?
Those on the EU Register (Articles 13/14, including 432/2012) meeting conditions of use — or, narrowly, pending claims under Article 28(5)/(6) if they are on the pending list and comply with 1924/2006. Others are prohibited (Article 10(1)).
Must wording match the Register exactly?
Stay as close as possible. A minor modification (recital 21 / recital 9) is for understanding, same health relationship — not for strengthening or implying treatment. The FBO justifies flexibility (Article 6).
How does Article 10(3) pairing work?
A general slogan may appear only with a specific Article 13/14 claim (or, within C-386/23, a pending claim meeting Article 28(6)). “Supports immunity” alone is not a pair.
Are website and marketplace texts “labelling”?
1924/2006 covers labelling, presentation and advertising. Listings and PDPs the FBO controls are assessed like a label. Same wording, same dose, same pair.
What changed for botanicals after C-386/23 and the GIS notice?
Article 10(1) and (3) apply to botanicals. Pending remains under Article 28(5)/(6) with a list ID and 1924/2006 compliance (evidence on the FBO). GIS 18 June 2025: prior interpretation consistent with the judgment. Verify the notice.
Does GIS notification approve claims?
No. It is a first-placing information duty. Claims are a separate layer — pillar #5 and GIS procedure.
Case consult (CTA)
If you are scrubbing pack and listings, answering a claims letter, or assessing a pending botanical after C-386/23 — book an introductory call. For producers, importers and distributors of food supplements. Not for consumers. The 15 minutes are an introductory call, not a free legal opinion.
Notification layer: GIS notification · claims ≠ notification · importer: placing on the market — Poland.
Primary sources
- Regulation (EC) No 1924/2006 — consolidated text
- Regulation (EU) No 432/2012
- EU Register of nutrition and health claims
- CJEU C-386/23 Novel Nutriology (30 April 2025, ECLI:EU:C:2025:304)
- GIS notice on C-386/23 (18 June 2025)
- GIS — pending-list conditions
- Directive 2002/46/EC — Article 10
- Article 12(c) — doctor recommendations
- European Commission — nutrition and health claims
Scrub checklist before launch
- Every slogan on pack, PDP, ads and marketplace: Register or pending with ID, or removed.
- A general slogan has a visible Article 13/14 pair (or pending under Article 28(6)) and a qualifying dose.
- Article 10(2) information is in the channel where the claim appears.
- Botanicals: pending ID + Article 6 dossier, or no claim. Do not confuse EFSA dates with the application date.
- No medicinal implication and no individual doctor endorsement (Article 12(c)).
- GIS notification filed or scheduled — as a separate layer, not “claim clearance”.
- Re-check the Register and both GIS pages on sign-off day, not on last quarter’s brief.