Short answer
A GIS notification for a food supplement in Poland is filed electronically with the Chief Sanitary Inspector (GIS) by the food business operator placing the product on the Polish market, before the product is first placed on the market. You submit product data and the Polish label design. GIS may then open explanatory proceedings if it doubts the composition, doses or classification.
What the GIS notification for food supplements is - and what it is not
The GIS notification for food supplements is the Polish implementation of the notification mechanism allowed by Article 10 of Directive 2002/46/EC. In Poland it is set out in the Act of 25 August 2006 on food and nutrition safety: the operator who first places a food supplement on the Polish market informs the Chief Sanitary Inspector (Główny Inspektor Sanitarny, GIS) about it and attaches the label design.
Two misunderstandings cost foreign brands the most time:
- A notification is not an approval. GIS does not issue a marketing authorisation for supplements. Filing the notification lets you sell, but it does not confirm that your product is compliant. Responsibility for compliance stays with the operator.
- A notification in another EU country does not carry over. If your product is already notified in Germany, Ireland or the Netherlands, Poland still needs its own notification, with a Polish label.
The register built from these notifications is large. Our AI agent, Wellmade Intelligence, works on a cleaned copy of it: roughly 200,000 notifications from 2015 to mid-2026. About 23% of them come from bulk registrations by a couple of companies selling personalised formulas, so the real number of distinct commercial products is noticeably lower than the headline figure. That is the competitive landscape your product enters on the day it is notified.
Who files the notification
The notification is filed by the food business operator that places the product on the Polish market for the first time. In practice that is one of three parties:
- The manufacturer, if the product is made in Poland.
- The importer, if the product comes from outside the EU - for example from the UK or the US.
- The operator introducing the product from another EU member state, which can be the foreign brand itself or its Polish distributor.
Who files matters beyond the form itself. The notifying operator is the party the sanitary inspection will contact with questions, the party that answers in explanatory proceedings, and usually the party whose name and address appear on the label as the responsible operator. If your distributor files in its own name and the relationship ends, you want a clear contractual answer to what happens to the notification and the product data. We cover the entry structures in our guide for foreign companies launching a supplement brand in Poland.
When to file: before the first placing on the market
The rule is simple: the notification must be filed before the product is first placed on the market in Poland. “Placing on the market” is understood broadly. It is not only the first sale to a consumer, but also holding the product for sale and supplying it to a distributor, a pharmacy wholesaler or a marketplace seller.
What this means for your timeline:
- Do not ship finished goods to a Polish customer before the notification is filed.
- Do not start pre-sales that take payment for a product that has not been notified.
- Build the notification into your launch plan after the label is final, not after the first production batch is in the warehouse.
The practical order is: final formula, final Polish label, notification, then printing and stock. If the label changes after the notification, you are back to the start.
What is submitted with the notification
The notification is a structured electronic form plus attachments. The exact fields change as the system evolves, so treat the list below as orientation and check the current form before filing.
| Element | What it covers | Where foreign brands slip |
|---|---|---|
| Operator data | Name, address and identifiers of the notifying operator | Notifying from a non-EU entity with no EU operator in place |
| Product name | The trade name as it appears on the Polish label | A name that differs from the label, or suggests a medicinal effect |
| Product form | Capsules, tablets, powder, liquid, gummies and so on | Formats close to the medicine or ordinary food border without explanation |
| Composition | Ingredients and amounts per recommended daily portion | Chemical forms and plant parts not stated precisely |
| Polish label design | The full label as the consumer will see it | Machine translation, missing mandatory warnings, missing %NRV |
| Claims | Health and nutrition claims used on the label | Claims not in the EU register or reworded beyond their meaning |
| Origin data | Manufacturer and country of origin information, where requested | Inconsistency between label, form and supply documents |
One data point from the register is worth knowing: the ingredient composition field has only been filled in systematically from 2020 onwards. Older notifications often show little more than a name, which is one reason why benchmarking competitors on composition requires label research, not just a register search.
The electronic procedure, step by step
Notifications are filed through the electronic system run by GIS. The steps below describe the flow in general terms.
- Confirm the product is a food supplement. Check composition, doses and presentation against the medicine border and against novel food rules. See our guide to novel food and maximum doses.
- Finalise the Polish label. Every mandatory element, three warnings, %NRV for vitamins and minerals, and only authorised claims. Use our label checklist.
- Set up the notifying operator's access. The filer needs an account and a way to sign electronically in the Polish system. Foreign entities often do this through a Polish representative or law firm.
- Fill in the product data. Enter composition per daily portion with the exact forms of vitamins, minerals and plant extracts.
- Attach the label design. A clean, legible file of the final Polish label, not a working draft.
- Submit and archive the confirmation. Keep the confirmation with your product file. Distributors, pharmacies and marketplaces will ask for it.
- Monitor correspondence. Questions from GIS arrive to the notifying operator. Someone must read them and answer within the deadline set in the letter.
What happens after filing
Once the notification is filed, the product can be placed on the market. GIS reviews notifications and, where it has doubts, can start explanatory proceedings. Typical triggers:
- Doses of vitamins, minerals or other substances above the levels the Polish expert team at GIS considers appropriate.
- Ingredients of uncertain status - a possible novel food, a plant with a pharmacological profile, or a substance on the border with medicines.
- Presentation - a name, claim or graphic that suggests treatment or prevention of disease.
In explanatory proceedings GIS may ask the operator for evidence, for example studies supporting safety or documents on the regulatory status of an ingredient, and may request opinions from scientific institutions. The outcome can range from closing the case, through a request to change the label or composition, to a decision restricting or withdrawing the product from the market.
The products that are notified appear in the public register of products covered by notification. The register shows that a notification exists and, for older entries, little else. Being in the register is not a quality badge, and you should not present it to consumers as one.
Common reasons notifications run into trouble
- Doses copied from the home market. A dose that is routine in the US or the UK can be well above Polish practice.
- Health claims that do not exist in the EU register, or authorised claims rewritten in stronger language. See our guide to health claims.
- Unclear plant data - no plant part, no extract ratio, no standardisation.
- Labels in poor Polish, which read as a sign of low care and invite a closer look.
- Changes after notification. A new dose, a new ingredient or a changed label means the notified product is not the one on the shelf. In our practice, material changes are handled as a new notification; confirm the approach with a food law firm.
Pre-filing checklist
| Check | Question to answer | Status |
|---|---|---|
| Operator | Which EU entity places the product on the Polish market? | Decided / open |
| Classification | Is it clearly a food supplement, not a medicine or ordinary food? | Confirmed / to review |
| Ingredient status | Any novel food or restricted substances? | Cleared / to review |
| Doses | Are doses in line with Polish expert team practice? | Cleared / to review |
| Label | All mandatory elements in correct Polish? | Final / draft |
| Claims | Every claim from the EU register, with conditions met? | Verified / to review |
| Product file | Specifications, certificates of analysis, supplier documents ready? | Complete / gaps |
If you want this checked against your actual product before filing, our market entry report covers composition, doses, claims and the competitive picture from the register in one document.