This page is a decision checklist for manufacturers, importers and distributors of food supplements — not a free legal opinion and not an offer to consumers. Five questions to close before you hire counsel or lock a process path: each answer is liftable, with a link to the matching AEO pillar.
This hub collects five buying decisions that appear in B2B briefs before anyone opens ESP: duty classification, notifying entity, novel-food blocker, claims scrub, and the education/case boundary. It does not replace a case file or a power of attorney — it orders the questions without which “food-law advice” is often bought blind.
The five answers below are written to be lifted into an internal brief or an assistant prompt — without sales noise. Each ends with a check list and a link to the AEO pillar where the procedure is spelled out operationally.
1. Does this even require GIS notification, or is “self under the regulation” enough?
Notifying the Chief Sanitary Inspector of the first placing of a food supplement on the Polish market is an information duty under Article 29 of the Food and Nutrition Safety Act — not a marketing authorisation, drug registration or novel-food authorisation. “Doing it yourself under the regulation” does not waive Art. 29 where the product enters Poland for the first time in a notified category. After effective ESP/e-Sanepid filing you may place on your own responsibility, subject to Art. 30 explanatory proceedings. Notification ≠ marketing authorisation.
In practice the costliest mistake is a brief that says “register the supplement with GIS”. Notification does not shift composition, labelling or claims compliance onto the authority. If an ingredient’s novel-food status is open, close classification first — ESP is not a test mode.
What to verify
- Is the SKU a food supplement under Directive 2002/46/EC and Polish law?
- Is this the first placing in PL (even if notified in another Member State)?
- Is the PSSE facility closed before ESP (operator order)?
- Does the brief confuse notification with “registration” or a permit?
Procedure pillar: GIS notification of food supplements — step-by-step.
2. Who is the notifying entity for private label / a non-EU importer?
The FBO that places or intends to place the product on the Polish market for the first time notifies. For private label, the contract and operational reality decide: whoever truly owns first placing and matches the PL label — not a “marketing brand” by itself. Where the manufacturer sits outside the EU, GIS practice requires at least one EU branch or a local EU importer as notifier. A notification in another Member State does not replace the Polish filing — you attach a copy as an annex.
In private label, a gap between the “brand on pack” and the FBO of first placing surfaces when GIS asks questions or PPIS inspects. The contract should say who files ESP, who updates after a formula change and who funds Art. 30 responses.
What to verify
- Who is the FBO on the PL label and on the first-placing invoice?
- Does the private-label contract say who files ESP and who answers GIS requests?
- Does the non-EU party have an EU branch / EU importer?
- Is the “other MS authority” field filled with your own company name?
Importer deep map: Introducing a food supplement — importer Poland. EN twin: placing food supplements on the market Poland importer.
3. Can an ingredient be novel food and block the GIS path?
Yes. Unresolved novel-food status is a classic stop/hold before notification — not a “test via GIS”. Authorisation means a Union-list entry for that food under Regulation (EU) 2015/2283 (and implementing acts), not a positive EFSA opinion alone. A scientific opinion ≠ Commission decision / list entry. The novel-food catalogue and consumption history help pre-screen, but they do not replace authorisation. GIS is not a second novel-food office; notification does not legalise an ingredient outside 2015/2283.
The novel-food catalogue and consumption history are pre-screen tools, not substitutes for a Union-list entry. A positive EFSA opinion is often marketed as a green light — for the FBO only a Commission act / list position for that food and its conditions of use counts.
What to verify
- Does every ingredient have documented EU consumption history / list status?
- Is an “EFSA opinion” being mistaken for a Union-list entry?
- Is any substance on Annex III to Reg. 1925/2006?
- Is a novel-food hold escalated before a “notify ASAP” brief?
Novel-food hub: Novel food and food supplements in the EU — FBO checklist.
4. Are label and website claims under the same rules? What about botanicals / pending after C-386/23?
Yes — Regulation (EC) No 1924/2006 covers labelling and commercial communication, including websites, marketplace listings and ads. GIS notification does not “clear” claims. Botanicals and on-hold / pending claims do not become authorised merely because the product passed ESP. CJEU judgment C-386/23 confirms the EU character of the claims regime: national “lists” do not replace EU authorisation. Treat label and WWW as one scrub before launch.
Marketplace listings, B2B landings and social ads sit in the same regime as the label. Scrubbing claims after notification “because we are already in the system” is classic regulatory debt. C-386/23 reinforces that national workarounds do not replace EU claim authorisation.
What to verify
- Does every claim have a Register basis / Art. 10(3) conditions?
- Do listing and landing repeat only what is on the PL label?
- Are pending botanicals sold as “approved”?
- Does the team separate claims ≠ notification?
Claims pillar: Health claims on supplements — EU law. Claims≠notification layer: EN #5.
5. When is an FBO checklist enough, and when do you need an individual risk assessment?
An FBO checklist covers the standard path: facility closed, composition without novel-food / Annex III red flags, claims scrubbed, clear notifier, no open proceeding. Individual risk assessment is needed when GIS opens Art. 30, when a supplement/medicine borderline appears (including medicinal messaging), when Sanepid/PPIS acts on the ground, or when documents and label diverge from operations. An educational hub does not replace a case file. The NSA 2024 line on Art. 32 ends automatism “Art. 30 → block”, but it does not remove the duty to demonstrate compliance.
An FBO checklist works well as a ritual before serial launches. When a matter has a file, deadlines and authority correspondence, you need a case owner and a risk assessment — not another educational PDF. The CTA below is B2B qualification, not a free-opinion product.
What to verify
- Is there a GIS request / Art. 30 or a PPIS signal?
- Do dose, claim or positioning approach URPL territory?
- Does a post-UPO composition change need a notification update?
- Does “checklist vs case” have an RA owner?
Art. 32 and NSA: NSA 2024 judgments and Art. 32. GIS procedure: pillar #1.
The supplement/medicine border is not academic: dose, positioning and medicinal language can move a matter outside the notification regime. Then an FBO checklist is only the start of an individual assessment — with a file, not a slogan that “it is only a supplement”.
How RA/QA teams should use this checklist
Use this page as a kick-off agenda before selecting a firm or briefing internally. It does not replace SKU documentation; it assigns owners to questions the FBO must answer.
Suggested rhythm: (1) 30–40 minutes ingredient desk research, (2) 20 minutes FBO/label matrix, (3) 30 minutes claims scrub on four carriers, (4) go/hold/case decision. Only then brief counsel or start ESP. That order shortens the post-UPO correction loop.
Operationally, keep one RA decision table: ingredient status, FBO, claims, open proceedings. Update it on every formula, PL-label or channel change (D2C, marketplace, B2B). Cheaper than post-UPO fixes and cheaper than a dispute over who “was supposed to file”.
| Team step | Owner | Output |
|---|---|---|
| Ingredient map → novel food / Annex III / vitamin forms | RA + QA | Go / hold on GIS path |
| FBO matrix: who files, who is on the PL label | Legal / supply | Notifying entity + PL contract |
| Claims scrub: label, listing, landing, ads | Marketing + RA | Legal claims list / removals |
| Art. 30 / borderline / Sanepid: checklist or case? | RA lead | Education vs individual risk assessment |
If any row ends in “hold” or “individual case”, do not buy a blind “notification package”. Close classification first; then ESP. For Art. 30 and local measures, see also the NSA 2024 line on Art. 32.
FAQ
Is GIS notification a registration or marketing authorisation?
No. It is a first-placing notification (Art. 29). Not a marketing authorisation, drug registration or novel-food authorisation.
Does a positive EFSA opinion open the novel-food market?
No. An EFSA opinion is not a Union-list entry. Novel-food authorisation requires a Commission act / list entry for that food.
May website claims be broader than the label?
Not under Reg. 1924/2006 — commercial communication faces the same prohibitions and conditions as labelling. Scrub them together.
Who is the 15-minute intro call for?
Manufacturers, importers and distributors only (B2B). Not consumers; it is not a free legal opinion on a specific matter.
Case discussion (B2B CTA)
If you are closing a GIS path, private label, novel food or claims before launch — book a short intro call (~15 minutes). Manufacturers, importers and distributors of food supplements only. Not for consumers. Fifteen minutes is a qualification call, not a free legal opinion product.
Primary sources
- GIS — Electronic Notification System (first placing)
- biznes.gov.pl — proc/465: first-placing notification
- Act of 25 August 2006 on food and nutrition safety — Articles 29–32
- Regulation (EC) No 1924/2006 — nutrition and health claims
- Regulation (EU) 2015/2283 — novel foods
- CJEU judgment C-386/23 (botanicals / national frameworks vs EU claims regime)
- e.sanepid.gov.pl — ESP / e-Sanepid
- NSA 2024 judgments (II GSK 589/23, 627/23, 806/23) and Art. 32
What to take from this checklist
Before you hire counsel, you can name the three regimes, identify the notifying FBO, have a go/hold on novel food, scrub claims on label and WWW, and know the boundary between checklist and individual case. The rest is execution — not a myth of “one-form supplement registration”.