There is no single EU food-supplement registration. Health claims are Union-harmonised under Regulation (EC) No 1924/2006 and sit in the EU Register (with Regulation (EU) No 432/2012 for most function claims). Product notification is a national information duty that Member States may require under Article 10 of Directive 2002/46/EC. In Poland that duty is Article 29 of the Food and Nutrition Safety Act, filed with GIS through e-Sanepid. A GIS receipt does not authorise a claim. A German or French notification does not waive Poland. This page keeps the two layers apart, uses Poland as the worked national example, and points to the claims operating system (pillar #2) and the GIS / importer playbooks (#1, #6). Verify current GIS and Commission pages.
Two layers (what is harmonised, what is national)
Consultants often sell one product called “EU registration”. The acts do not. Layer 1 is the nutrition-and-health-claims regime: a health claim is prohibited unless it meets Chapters II and IV of Regulation 1924/2006 and is on the Article 13 or 14 lists, subject to the narrow Article 28(5)–(6) transitional window. The Commission publishes the EU Register. That layer is the same in every Member State.
Layer 2 is first-placing information. Article 10 of Directive 2002/46/EC allows a Member State to require notification of the placing on the market of a food supplement. The Commission’s food-supplements page lists national competent authorities. Forms, portals and whether a prior-MS copy is an annex differ. Mutual recognition of goods does not delete a national information duty that the Member State has maintained.
Poland implements layer 2 as Article 29 UBŻiŻ: the FBO that first places the SKU in Poland notifies GIS via ESP/e-Sanepid. UPO confirms receipt. It is not a URPL marketing authorisation and not a novel-food authorisation. Full procedure: GIS notification of food supplements in Poland.
Health-claims workflow (the EU layer, in English)
Before you write launch copy, lock the claim matrix — not the GIS password. For each slogan on pack, PDP, ads and marketplace:
- Is it a nutrition claim (1924/2006 Annex) or a health claim (Article 2(2)(5))?
- If health: is the specific wording on the Register (Articles 13/14, including 432/2012) with a met condition of use?
- If you want a general slogan (“supports immunity”, “for energy”), Article 10(3) requires a specific list claim to accompany it. C-386/23 confirmed the same pairing logic for botanicals.
- Article 10(2) mandatory information belongs in the channel where the claim appears.
- Flexible wording (recital 21 of 1924/2006, recital 9 of 432/2012) is for understanding the same health relationship — not for strengthening or implying treatment. The FBO bears the Article 6 evidence burden.
Marketplace-as-labelling is not a metaphor. Title, bullets, A+ / rich content and seller Q&A that the FBO controls are presentation and advertising. An EN immunity claim on Amazon that is absent from the Polish pack is still a claim in the Union. Translating “by eye” does not create a lawful local claim. The Polish-led operating system with dose tables, grey-zone language and GIS inspection angles is pillar #2; this page only states the layer so exporters do not file GIS and stop.
Botanicals / on-hold after C-386/23
On 30 April 2025 the Court of Justice (Fifth Chamber) delivered C-386/23 Novel Nutriology (ECLI:EU:C:2025:304). Article 10(1) and (3) apply to health claims relating to botanical substances (including psychological or behavioural functions). Off-list use in presentation and advertising is prohibited unless Article 28(6) applies.
Poland’s GIS published a notice on 18 June 2025. What that notice actually says — without inventing extra “GIS conditions”:
- the prior GIS interpretation is consistent with the judgment;
- pending claims, including botanicals, may still be used until a Commission Article 13(2) list or another Commission decision;
- two conditions: (1) presence on the pending list (which GIS treats as meaning an application before 19 January 2008) and (2) compliance with 1924/2006, including scientific evidence on the operator;
- presence on the list is necessary, not sufficient;
- dates next to IDs in the EFSA database are Commission-to-EFSA transmission dates, not application dates, and are not decisive for Article 28(6)(b).
The older pending-conditions page adds evidence, quantity, Articles 7 and 10 information, and a ban on medicinal properties. GIS did not declare pending botanicals “free”. If you have no pending ID and no Article 6 dossier, treat the claim as prohibited under Article 10(1). Check the competent authority in each launch Member State — GIS is the Polish node, not a Union botanical licence. Detail and diagrams: health-claims OS.
National notification matrix (high level) — Poland worked
Article 10 of Directive 2002/46/EC is an option for Member States, implemented differently. Use the Commission competent-authorities list; do not invent a “EU portal”. High-level pattern:
| Question | EU layer | Poland (worked example) |
|---|---|---|
| Who owns wording? | 1924/2006 + Register | Same — GIS does not rewrite the claim |
| Who must be told the SKU exists? | No Union product register | GIS via ESP (Art. 29 UBŻiŻ) |
| May I sell after filing? | n/a | Yes, on own responsibility; Art. 30 may open |
| Does another MS filing help? | Claims remain EU-wide | Attach the copy; still file in Poland |
| Label language | FIC + claims language rules | Polish specimen is mandatory in the pack |
Germany has its own BVL / food-supplement practice — already on this site: Germany supplements 2025 guide. That guide does not waive GIS. The importer-shaped journey (PSSE premises, pre-screen, PL label, border) is pillar #6 and the deeper pillar #3. This page stops at the layer split.
Myths
“We did the EU notification / EU registration”
There is no Union-wide food-supplement product registration. Claims are entered in the EU Register. The product, if the Member State so requires, is notified nationally. A slide that says “EU registered” usually means someone mixed the two layers.
“Mutual recognition means no Polish GIS filing”
No. Biznes.gov procedure 465 and Article 29 still require a Polish notification. A prior DE/FR/IT notification is an attachment (name the other competent authority; sworn translation of foreign official documents). It does not transfer claims, fix novel food, or replace the Polish label. Deep treatment: pillar #6.
“GIS accepted the file, so the claims are fine”
UPO is a receipt. 1924/2006 remains a separate duty on every channel. GIS may later open Article 30 on composition or classification; Sanepid may still look at wording. Do not treat filing as a claims opinion.
“Marketplace EN text is outside labelling law”
Article 1 of 1924/2006 covers labelling, presentation and advertising. Distance-selling copy the FBO controls is in scope. EN-only immunity copy aimed at Polish buyers is still a claim.
“Pending botanicals are free after C-386/23”
The judgment applies Article 10 to botanicals. GIS says pending remains available under Article 28(5)/(6) on two conditions the FBO must prove. That is a cautious, conditional window — not a green light. Verify the live GIS notice.
C.L.A.I.M.S. (optional map)
C.L.A.I.M.S. (app.foodlaw.ai) maps Register and pending entries. It is a starting point for RA/marketing, not a GIS decision and not a legal opinion on a SKU.
FAQ
Is there an EU-wide food supplement registration?
No. Claims are EU-harmonised. Product notification is Member-State level under Article 10 of Directive 2002/46/EC where that State requires it.
Which layer governs health claims versus product notification?
Claims: Regulation 1924/2006, 432/2012, EU Register. Notification: national law implementing Article 10 — in Poland, Article 29 UBŻiŻ / GIS ESP.
Do I need exact Register wording?
Stay as close as possible. A minor modification must keep the same health relationship and not strengthen or medicalise the message. The FBO justifies flexibility (Article 6). Pair general slogans under Article 10(3).
On-hold botanicals after C-386/23?
Article 10 applies. Pending use remains under Article 28(5)/(6) if the claim is on the pending list and complies with 1924/2006 (evidence on the operator). GIS 18 June 2025: prior interpretation consistent with the judgment. Verify GIS. Check the competent authority in each MS.
Does mutual recognition remove the Poland GIS filing?
No. Attach the other-MS copy and still file Article 29. Details: GIS procedure and importer guide.
Are Amazon / marketplace texts labelling?
They are labelling, presentation or advertising under 1924/2006 when the FBO controls them. Same wording, same dose, same pair as the pack.
Case consult (CTA)
If you are building a multi-Member-State launch matrix, rewriting claims for Poland, or deciding whether a GIS file and a claims scrub are both closed — 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.
Polish-led claims OS: oświadczenia zdrowotne — prawo UE · EN twin: health-claims OS. GIS: procedure. Importer: #6.
Primary sources
- Regulation (EC) No 1924/2006
- Regulation (EU) No 432/2012
- EU Register of nutrition and health claims
- Directive 2002/46/EC — Article 10
- Commission — food supplements (competent authorities)
- CJEU C-386/23 Novel Nutriology
- GIS notice on C-386/23 (18 June 2025)
- GIS — pending-list conditions
- biznes.gov proc/465