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. Biznes.gov states: apply for establishment registration/approval at least 30 days before the planned start of activity. 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 vs explanatory proceedings
After filing you may place the product on your own responsibility. GIS may open Article 30 proceedings and request opinions (scientific unit, URPL, Dietary Supplements Team). Article 32 allows PPIS temporary suspension pending Article 30. The April 2024 NSA judgments (II GSK 589/23, 627/23, 806/23) ended automatism: the local authority cannot act as GIS’s “postman”; it must itself prove non-compliance, read with Article 138 of Regulation (EU) 2017/625. Detail: NSA 2024 and Article 32.
When to update or re-notify
Changes to trade name, qualitative/quantitative characterising composition, material claims on the label, or the responsible first-placing operator usually trigger an update or a new notification. Cosmetic layout tweaks rarely do; vitamin dose or botanical swaps usually do. 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.
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 (biznes.gov: ≥30 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 playbook: Placing food supplements on the market in Poland — importer.
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
- 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