Notifying the Chief Sanitary Inspector (GIS) 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, not a medicinal-product registration, and not a novel-food authorisation. The food business operator (FBO) that places or intends to place the product for the first time in Poland files through e-Sanepid (ESP). From the day of effective filing (qualified or handwritten signature per GIS rules) you may place the product on your own responsibility, subject to Article 30 explanatory proceedings and official controls. Close PSSE establishment and composition pre-screen before you file. Verify current GIS guidance.
Legal basis in one paragraph
Articles 29–32 of the Act of 25 August 2006 on food and nutrition safety (UBŻiŻ) govern notification of first placing for selected food categories — including food supplements — GIS explanatory proceedings and local sanitary measures. The notification form and product register are set by the Minister of Health regulation of 23 March 2011 (Dz.U. 2011 item 437, as amended). Operator steps are described on the GIS ESP pages and biznes.gov procedure 465. Directive 2002/46/EC defines food supplements at Union level — national notification does not replace composition, claims or novel-food rules.
Who must notify
The FBO that places or intends to place the product for the first time in Poland notifies. In practice:
| Scenario | Who files | Note |
|---|---|---|
| PL / EU manufacturer | FBO placing the product | PSSE premises + PL label |
| EU-seated importer | Importer / label FBO | Polish branch not required (biznes.gov) |
| Non-EU manufacturer | EU branch or local EU importer | GIS: at least one EU branch |
| Private label | FBO responsible for first placing | Contract who files and owns docs |
| Already notified in another MS | Still the PL FBO | Attach prior notification — annex, not substitute |
Order: PSSE establishment → GIS product
Before the SKU enters ESP, the FBO that produces or places food must have premises registered or approved by the competent district sanitary inspector. Art. 64 of the Polish Act on Food and Nutrition Safety: apply for establishment registration/approval at least 14 days before the planned start of activity. The 30-day period applies to notifying changes to data already on the register, not to the initial application. New importers often skip this step and stall at product filing because the ESP pack has no coherent premises backbone.
Product notification (Article 29) and establishment registration are separate duties. The first concerns the SKU first placed in Poland; the second concerns the place and activity under PIS control.
Document pack before ESP
- Qualitative and quantitative composition including characterising substances — consistent with the Polish label.
- CoA / manufacturing specs; for extracts — standardisation (marker, method), not a marketing “10:1” alone.
- Polish labelling specimen — mandatory notification element.
- Copy of another Member State notification/confirmation if already marketed in the EU — name that Member State’s competent authority; do not put your company or GIS in the authority field.
- Sworn Polish translations of foreign official documents.
- Claims scrub — Regulation 1924/2006; on-hold botanicals are not authorised claims. Notification does not clean the label.
ESP / e-Sanepid — operator view
Complete the electronic form via e.sanepid.gov.pl. GIS: the filing day is the day GIS receives the notification bearing a qualified electronic signature or handwritten signature per system rules. Mandatory fields include product and manufacturer name, form, Polish labelling specimen, the FBO’s food classification, qualitative and quantitative composition, and notifier identity with tax number if held. UPO confirms receipt — it is not an authorising decision. Common pitfalls: unit mismatch between composition and label; missing other-MS authority; wrong signature type; draft label without final warnings; private label without a clear FBO.
Selling after filing: UPO is not an authorisation
Biznes.gov and Article 29: after effective filing you may place the product on your own responsibility. UPO confirms receipt — it is not an authorising decision, does not close Article 30 risk and does not replace official controls. Marketplace and traditional distribution must use the same label specimen as in ESP.
Article 30 explanatory proceedings (step by step)
After receiving a notification, GIS may open explanatory proceedings (Article 30(1)): whether the product is a foodstuff under the FBO’s classification and meets supplement / fortified-food requirements, and whether it meets the requirements of another product type (in particular a medicinal product, cosmetic or medical device). GIS notifies the FBO of opening without delay (paragraph 2). The result is notified in writing (paragraph 4). Verify current GIS guidance.
- Opening. GIS opens Article 30 — UPO does not disappear; selling remains on the FBO’s responsibility, but control and request risk rises.
- Request for information. Typical scope: composition, Polish label, classification, claims, novel-food status, other-Member-State documentation, ESP pack consistency.
- FBO reply. Within the deadline in the request; content consistent with the ESP pack, not a new marketing brief.
- Opinions (optional). Biznes.gov: GIS may request opinions from a national scientific unit, URPL or the Dietary Supplements Team.
- Closure / result. A written outcome is not a “green light” for claims or novel food. The FBO remains accountable for compliance.
- Marketplace. Listing = the same label as the ESP specimen; do not reinstate claims removed from the Polish label.
Timelines: statute / GIS vs practice
| Stage | What the primary source says | Practice |
|---|---|---|
| PSSE premises registration / approval | Art. 64: apply ≥14 days before planned start of activity | Time to registration depends on the case; we do not invent a fixed range |
| Effective ESP filing | GIS: day of receipt with a valid signature | — |
| Selling after filing | biznes.gov: on your own responsibility | — |
| Opening Article 30 | UBŻiŻ Art. 30 — GIS may open where doubts arise; notifies without delay | How often and how soon after filing varies by case |
| Maximum Article 30 duration | Art. 30(3): no longer than 60 working days, excluding time needed to document compliance | FBO document time stops the clock; calendar time can be longer — do not build a launch only on “60 days” |
| Request for supplements | Administrative procedure + deadline stated in the authority’s request | Reply practice depends on the request content |
| Scientific / URPL / Team opinion | biznes.gov lists the possibility of requesting opinions | Whether and when it prolongs the case depends on the file |
| Article 32 suspension | UBŻiŻ Art. 32 + NSA 2024 line | See deep-dive; do not shorten to “automatic block” |
Common GIS objections before and after filing
Categories with legal hooks — no brand stories and no “largest category” claims without primary statistics. Scrub labels and listings before filing; notification does not clean claims. Verify current GIS guidance.
| Category | What is usually challenged | Primary anchors | What the FBO does before replying |
|---|---|---|---|
| Claims | unauthorised / outside conditions / medicinal | Reg. 1924/2006; health claims law; claims vs notification | Scrub label and listings |
| Novel food | no consumption history / extract vs plant / outside the list | Reg. 2015/2283; Union list 2017/2470; novel food | Stop/go before ESP — you cannot “fix” it by notifying |
| Medicine border | presentation, dose, indications | Pharmaceutical law / URPL path; Art. 30(1)(2) | Classify before filing |
| Dose / safety | substance level, vulnerable groups | UBŻiŻ; possibly Annex III Reg. 1925/2006 | Data + national limits where they exist |
| Labelling | missing FIC / MZ 2007 duties | Reg. 1169/2011; Polish MZ supplement rules | New PL specimen before reply |
| Pack completeness | composition ≠ label; missing other-MS authority; wrong signature | GIS ESP; biznes.gov proc/465; GIS 18.12.2024 | Correction or new notification — table below |
Selling, Article 32 and the NSA 2024 line
Article 32 UBŻiŻ lets the competent district or border sanitary inspector decide on temporary suspension of placing or withdrawal — until Article 30 ends — where there is suspicion that an Article 29 foodstuff that does not meet requirements is on the market; a decision is also taken where the notified product meets medicinal-product or medical-device requirements (Article 32(2)). The April 2024 NSA judgments (II GSK 589/23, 627/23, 806/23) ended automatism “Article 30 opened → PPIS blocks”: the local authority must itself prove non-compliance, read with Article 138 of Regulation (EU) 2017/625. Detail: NSA 2024 and Article 32. Opening Article 30 alone is not an automatic block.
When to update or re-notify (GIS 18.12.2024)
On 18 December 2024 GIS published when a change requires a new notification and when a correction suffices. We cite the GIS rule — it is not a house rule. Verify current GIS guidance.
| Change | New notification? | Correction request to GIS? | Source |
|---|---|---|---|
| Complete change of active substances / name / classification / parameters that may change physiological, nutritional properties or intended use | Yes | Not instead of a new filing | GIS 18.12.2024 |
| Technical layout / colour / information arrangement; change of nutrition claims; additives/flavours with no effect on nutrition, effect or classification; legal adaptation without reclassification | No (per GIS) | Form correction if an error remains in an already filed notification | GIS 18.12.2024 |
| Typo / wrong label in a filed notification | Not as a “new SKU” | Correction request: name + notification number + error description + correct data/label — to [email protected] (digital signature) or by post | GIS 18.12.2024 |
| Vitamin dose change / botanical swap affecting the characterising composition | Treat as new until GIS confirms otherwise for the specific case | — | Cautious reading of GIS “complete change of active substances…” + FBO change control |
Changing health claims on the label is a separate Regulation 1924/2006 path — do not confuse it with the “nutrition claims” GIS lists as a technical change. Keep change control tied to the notification reference.
Pre-filing red flags
- Ingredient without EU consumption history → novel-food path, not a GIS test.
- Annex III substances under Regulation 1925/2006.
- Vitamin/mineral form outside Directive 2002/46/EC lists.
- Medicinal claim or URPL-typical dose → supplement/medicine border.
- EN-only label for the Polish market.
FAQ
Is GIS notification a registration or authorisation?
No. It is an Article 29 first-placing notification — not a marketing authorisation, drug registration or novel-food authorisation.
Who files for private label and non-EU import?
The FBO responsible for first placing in Poland. Non-EU seat: at least one EU branch or a local EU importer as notifier.
May I sell from the filing / UPO day?
Yes, on your own responsibility after effective filing. GIS may open Article 30; PPIS may act under Article 32 where non-compliance is established.
What happens in Article 30 step by step?
GIS may open proceedings, request supplements, the FBO replies, GIS may seek opinions (scientific unit / URPL / Dietary Supplements Team), then notifies the result in writing. UPO is not an authorisation. Article 30(3): max 60 working days excluding time to document compliance.
When is a new notification required vs a correction?
Per GIS 18.12.2024: a new notification for a complete change of active substances, name, classification or parameters that may change physiological, nutritional properties or intended use. A correction request ([email protected]) for typos and wrong labels in an already filed notification.
Does a German notification waive Poland?
No. Attach the prior notification and still file in Poland.
What did NSA 2024 change for Article 32?
It ended automatism “Article 30 opened → PPIS blocks”. PPIS must itself prove non-compliance (II GSK 589/23, 627/23, 806/23).
What order with PSSE?
Premises first (Art. 64 of the Polish food safety act: ≥14 days before start), then the product in ESP.
Case consult (CTA)
If you are assembling an ESP pack, answering a GIS letter, or assessing Article 30/32 risk — 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.
Foreign FBO: overview — placing on the market (importer) and deep — introducing food supplements (importer). Novel food before filing: novel food pillar. Claims: claims vs notification.
Operator checklist before send
- PSSE premises filed with lead time; status known.
- Polish label FBO = notifier (or power of attorney + stamp duty).
- Numbers match the label; no marketing conversion factors.
- Claims: authorised paths only; no medicinal claims.
- Novel food / Annex III / vitamin forms: go/no-go documented.
- Other MS: authority + prior notification copy.
- Signature per e-Sanepid; archive UPO and PDF pack.
After filing, keep a channel for GIS requests. Changing composition after filing without an update is a classic regulatory debt at Sanepid or marketplace checks. UPO closes intake, not responsibility — the FBO remains accountable for composition, labelling, claims and batch safety.
Primary sources
- GIS — Electronic Notification System
- GIS — changes to a filed notification (18.12.2024)
- biznes.gov.pl — proc/465
- UBŻiŻ — Articles 29–32
- Minister of Health regulation 23 March 2011 (Dz.U. 2011 item 437)
- Directive 2002/46/EC
- e.sanepid.gov.pl
- NSA 2024 and Article 32
- Regulation (EU) 2017/625 — Article 138