The Chief Sanitary Inspector (GIS) before placing it on the market. The process is conducted exclusively electronically via the e-Sanepid platform . After submitting a form containing the ingredients and label template (in Polish), the product can be sold without waiting for a decision, but at your own risk.
1. The biggest myth: Supplements are NOT "registered"
From a legal perspective (Food and Nutrition Safety Act), a dietary supplement is not a drug, but rather food . Therefore, in Poland and the European Union as a whole, there is no "registration" or "marketing authorization" procedure (which would involve clinical trials and waiting for regulatory approval).
You can legally put your product up for sale the second you successfully submit your online notification. There's no need to wait for a certificate or a positive decision from the authorities.
2. Iron requirements before submitting the application
Before you report a product, you must ensure that you meet 4 strict conditions:
- Entry to the Sanitary Inspectorate: Your company (even if it is just an online store and you outsource production and logistics to external companies) must submit an application to the local Sanitary and Epidemiological Station for entry into the register of establishments subject to official control (as entity introducing food to the market). The application must be submitted at least 14 days before the start of sales.
- Dose limits (GIS Resolutions): Ingredients may not exceed the maximum doses established in the so-called Resolutions of the Team for Dietary SupplementsExamples of restrictions: Vitamin B6 up to 6 mg/day, Ashwagandha up to a maximum of 3 mg withanolides, Vitamin D up to 2000 IU (for healthy individuals up to 75 years of age). Exceeding these limits will result in the Sanitary Inspectorate or the Chief Pharmaceutical Inspector (GIF) classifying the product as an illegal drug.
- No Novel Food Status: The raw material must have a documented history of mass consumption in the EU before May 15, 1997. If you use, for example, an extract from an innovative medicinal mushroom (or CBD oil) without long-term EU authorization novel food, the Sanitary Inspectorate will impose a hefty fine and order the disposal of the goods.
- Legal label (EU Regulation 1169/2011): It must include:
- Words "Dietary supplement" directly next to the trade name.
- Three warnings: "Do not exceed the recommended daily dose", “A dietary supplement cannot be used as a substitute for a varied diet”, “Keep out of reach of small children”.
- Table with the amount of active ingredients in the daily dose and percentage Rws (Reference Intakes) for vitamins and minerals.
3. Step by step procedure (ESP GIS System)
The application process is 100% free (no stamp duty).
- You are logging in to Electronic Notification System (ESP GIS) via the National Node (Trusted Profile / e-ID).
- You provide the name, form (e.g. capsules, drops) and full qualitative and quantitative composition by entering the data directly into the form.
- You attach a ready-made label design in Polish in a PDF or JPG file.
- Click "Send." The system immediately generates the file. UPP (Official Certification of Submission)From this moment on, you operate fully legally.
VIP zone
Insider Knowledge for Product Launches
Here's some information that offices don't talk about openly, and it will save you thousands of zlotys in fines.
Pro-Tip: Always archive your report (UPP file). In the event of a Sanitary Inspectorate inspection, this is your only proof that the product is legally on the market!
4. Consumer Information Legal Framework (Regulation 1169/2011)
The Regulation provides a legal basis guaranteeing consumers the right to reliable information enabling them to make informed dietary choices.
General Principles and Responsibilities
- Responsibility: The entity responsible for food information is the entity under whose name the product is placed on the market (or the importer from outside the EU).
- Reliability: Information must not be misleading regarding properties, composition, country of origin, or production methods. Attribution of medicinal properties to food is prohibited (except for mineral waters and foods for special purposes).
- Readability: Mandatory information must be printed in a font with an "x" height of at least 1,2 mm (or 0,9 mm for small packages with a surface area < 80 cm²).
Mandatory Detailed Data
According to Article 9, each package must contain, among others:
- Name of food.
- List of ingredients (including clear indication of allergens, e.g. by font or background).
- Net quantity.
- The date of minimum durability or use-by date.
- Storage conditions.
- Instructions for use (if necessary).
- Nutritional information (energy, fat, saturated fat, carbohydrates, sugars, protein, salt).
Distance Selling
For online commerce, all mandatory information (except the best before date) must be available to the consumer before making a purchase . All information must be provided at the time of delivery.
5. Analysis of the Dietary Supplements Market (NIK Report)
The Supreme Audit Office (NIK) audit revealed systemic problems related to the supervision of dietary supplements, which are legally treated as foodstuffs, not medicinal products.
Systemic Problems and Market Scale
- Dynamic growth: In 2015, Poles spent PLN 3,5 billion on supplements. The number of new applications increased from 3-4 per year (2013-2015) to over 7 in 2016.
- Supervision failure: At the Chief Sanitary Inspectorate (GIS), just seven people were responsible for reviewing 30 notifications per day. The average review time was 455 days, and record-breaking procedures lasted over eight years.
- Notification system: The product can be sold immediately after notification, which allows the circulation of hazardous substances before they are blocked by the inspection.
Laboratory tests commissioned by the Supreme Audit Office revealed drastic irregularities:
- Pollution: In one of the probiotic samples, fecal bacteria were detected (Enterococcus faecium).
- Lack of stability: 89% of the tested probiotic samples showed a dynamic decrease in the number of live bacteria during storage (up to a billion-fold).
- Prohibited substances: Fat burner supplements adulterated with amphetamine-like stimulants and a plant have been detected. Acacia rigidula containing the psychoactive substance DMT.
- Interactions: Unjustified use of supplements may result in overdose (e.g. vitamin A) or dangerous interactions (e.g. Ginkgo biloba weakening antiepileptic drugs).
6. CBD's Status as a Novel Food
The use of cannabidiol (CBD) in food is subject to restrictive regulations on novel foods, which generates significant consequences for entrepreneurs.
Position of the European Commission
- Definition: Products containing cannabinoids (including CBD) derived from Cannabis sativa L. are considered novel foods because their significant consumption in the EU has not been demonstrated before 15 May 1997.
- Permit requirement: No new food can be placed on the market unless it is on the EU list. To date, CBD has not been approved for use in food.
- Procedures in progress: The Commission received over 190 applications; 20 of these are currently being assessed by EFSA. Several dozen applications (including those for CBD isolates, oils, and tinctures) were rejected.
Consequences for Companies
| Aspect | Status / Effect |
|---|---|
| Legal status | CBD in supplements and food is currently illegal without authorization. |
| Sanctions | Fines, restriction or deprivation of liberty (Article 99 of the Food Safety Act). |
| RASFF system | Numerous reports of unauthorized CBD in oils and capsules (e.g. from the Netherlands, Austria, Switzerland). |
7. Updates to the Composition and Labeling of Supplements (2025)
Polish regulations are gradually being adapted to changes in EU law, which enables the use of new forms of vitamins and minerals.
New substances approved in 2025:
- Calcidiol monohydrate (a new form of vitamin D).
- Iron hydroxide adipate tartrate (nano).
- Iron caseinate from milk.
Condition of use: These substances may only be used after obtaining authorization as novel food, which is recorded in the annexes to the national regulation.
8. Recommendations and Conclusions of the Supreme Audit Office (de lege ferenda)
NIK calls for radical changes in the law to protect consumers:
- Introduction of notification fees: This is intended to reduce the reporting of "fictitious" products.
- Warning system: Openly informing consumers about untested supplements on the market.
- Advertising Regulation: A ban on using the images of people from the medical community and putting an end to the practice of "umbrella branding" (making supplements look like drugs of the same name).
- Increased penalties: Increasing sanctions for entities introducing illegal or dangerous products to a level that will be an effective deterrent.
Supplement Labeling: Law and Risks, Dietary Supplements and Drugs
🔥 Secret Knowledge "Behind the Scenes" 🔥
High Information Gain – Expert legal and business strategies
The information below is a collection of market "keywords", loopholes and strict official interpretations that you usually won't find in free articles, and which in practice determine the financial "to be or not to be" in this industry.
1. Shield for Sanitary Inspection: Technological Overages (Overage)
What happens if you declare 100 mg of vitamin C on the label, and a year later, the Sanitary Inspectorate takes your product off the shelf, tests it in a laboratory, and detects only 80 mg? Vitamins naturally degrade over time, but the Inspectorate can fine you for adulterating food and misleading customers.
EU law ( EC Guidelines SANCO/10728/2012 ) allows for enormous analytical deviations for vitamins in supplements: the permissible tolerance ranges from -20% to as much as +50% . Experienced manufacturers force factories to deliberately implement overage —for example, 25-30% more of a sensitive vitamin is added during production. This costs pennies, but at the end of the expiration date, the product still perfectly adheres to the 100 mg label, protecting you from batch recalls.
2. The status of "Investigation" (IED) is NOT a sales ban
Due to severe staffing shortages, GIS assigns a large number of supplements a "Pending Investigation" status several weeks after they are reported and sends a letter requesting clarification (e.g., scientific literature). Panicked beginners then suspend sales.
Under Article 30 of the Food Safety Act, the mere initiation of an investigation does not prohibit trade! The exchange of official letters (often handled by hired lawyers) can take from two to four years. Until the Chief Sanitary Inspectorate issues a separate, formal administrative decision ordering the product to be withdrawn from the market, your product remains 100% legally on shelves, advertised, and generating profits.
3. Legal Herb Marketing, or the "Pending" List
The rule is that only EFSA-approved health claims may be used on labels and in advertising. The problem is that EFSA hasn't issued a verdict for plant extracts ( botanicals ) for years. How is it possible that pharmacies are bursting with herbs labeled "Lemon balm helps you sleep" or "Ginseng gives you energy"?
Companies use the so-called Pending List . According to EC guidelines, as long as plant claims are "frozen" and awaiting evaluation, you have the right to legally use over 2000 claims from this list in your marketing (Article 13, paragraph 1). You simply need to download the European Commission's public Excel spreadsheet ( "Botanical substances on hold" ), find the claim ID number assigned to your plant, and rely on it (with a scientific study in your "drawer" to support your claim).
4. The Geometric Label Trap (The "Little x" Principle)
Many manufacturers are forced to dispose of entire batches of printed packaging (boxes and labels) at their own expense due to a simple graphic error. EU regulations require mandatory information to be printed in a font size of at least 1,2 mm.
This 1,2 mm does NOT refer to the total font height (font size) in the graphics program. This dimension refers solely to the physical height of the lowercase "x" (so-called x-height) in a given typeface! If your graphic designer simply sets the font size to 1,2 mm in the program, the printed lowercase "x" will be only ~0,6 mm – the label is automatically illegal. For a lowercase "x" to be 1,2 mm when printed, the font in Adobe Illustrator typically needs to be between 6 and 8 points (pt).
5. Lifeline: The Principle of Mutual Recognition
If you come up with an innovative supplement (or one with a high dose of an ingredient, e.g. melatonin) that the Polish Chief Sanitary Inspectorate wants to block based on restrictive internal resolutions, you have powerful assistance from Brussels.
Regulatory optimization leverages Regulation (EU) 2019/515 of the European Parliament and of the Council on Mutual Recognition . You first register and market the product in a country with a much more liberal system (e.g., the Czech Republic, Italy). Then, you register it in the Polish GIS (Chief Sanitary Inspectorate), marking it in the system as already legally marketed in another EU country . The Polish authority's hands are then completely tied – to block such a product in Poland, it would have to clearly and scientifically prove to the European Commission that it poses a drastic threat to consumer life.
6. The ESP GIS system and the "DER and Extractor" trap
A classic mistake a GIS newbie makes is to simply enter "Maca Root Extract – 500 mg" in the ingredients list . Recently, such automated notifications have been attracting inspectors' attention and leading to cumbersome investigations.
To enter the system without any problems, you must strictly obtain from the raw material supplier and enter two production parameters in the form:
- DER (Drug Extract Ratio): e.g. 10:1 (means that 10 kg of root was used to make 1 kg of extract).
- Extractant: what solvent was used in the extraction process (e.g. water 100% and/ or 70% ethanol).
The correct entry is: "Maca root extract, DER 10:1, extractant: water ." The lack of information about the extractant is currently the number one excuse for blocking procedures.
7. Risk Management: Artificial Division into "Lot Numbers" (LOT)
When, during a routine inspection, the Sanitary Inspectorate detects micro-contaminants (e.g. trace amounts of ethylene oxide or heavy metals) in one random sample from a pharmacy, it issues a strict order to immediately withdraw a specific product batch number (LOT) from the market.
Order a factory to produce 20,000 units of a supplement and assign them a single batch number (e.g., LOT: 012026). If a sample fails the test, you lose 100% of the product and go bankrupt.
In your contract with the contract manufacturer, always enforce an artificial division of a given day's production into, for example, five different batch numbers (4000 units each), printed on the packaging. If a random sample is found on the market, the Sanitary Inspectorate (Sanepid) will order the recall and disposal of only 20% of the goods (one defective batch), while the remaining 80% of the inventory under different batch numbers remains legally available for sale.
8. The Essence of the Dietary Supplement Market (Knowledge Pill)
A dietary supplement is legally considered food (a dietary supplement, a source of vitamins/minerals), not a medicine. It does not prevent or cure disease. Balancing on the borderline is severely punished.
Procedure and Legalization (Notification, not registration)
- Sanitary Inspectorate: Registration of the establishment at least 14 days before the start of sales.
- ESP GIS: Mandatory, free product reporting to the Chief Sanitary Inspector (name, form, composition, label).
- Investigative Procedure: GIS does not issue "consent." It can initiate proceedings and request scientific opinions, but the sale is not formally suspended (it is conducted at the company's risk).
Labeling and Standardization of Raw Materials
- Etiquette (Reg. 1169/2011): It requires the word "dietary supplement", a daily portion, a table of RDA% and 3 statutory warnings (do not exceed the serving, keep out of reach of children, do not use as a dietary substitute).
- Quality of extracts: Feeding required THE (ratio of the plant used to the extract obtained, e.g. 10:1) and Standardization (guaranteed percentage of active substance).
Only health claims from the EFSA database are permitted . Using the words "treats," "prevents," or "cures" risks significant sanctions from the Chief Sanitary Inspectorate (GIS) or the Office of Competition and Consumer Protection (UOKiK) (proposed fines are up to 100 times the average salary).
9. Answers to key questions (Updates 2025/2026)
What are the consequences of the groundbreaking judgment of the Supreme Administrative Court of 6 May 2025 (II GSK 1813/24)?
The ruling removes the absurd dictionary restrictions from producers. Entrepreneurs can fully legally use the word "dosage" on packaging and in advertisements (unless the context suggests treatment). The NSA also found it legal to use the term "supplement composition" instead of the previously forced word "ingredients".
What new forms of vitamins and minerals are approved for marketing in September 2025?
In accordance with the EU Novel Food Catalogue, a new, highly bioavailable form of vitamin D has been added to the Polish list of chemical forms: calcidiol monohydrateInnovative forms of iron are also permitted: iron caseinate from milk and nanotechnology Iron Hydroxide Adipate Tartrate (Nano-Iron IHAT).
What are the penalties for attributing medicinal properties to supplements in advertising?
Both the Chief Sanitary Inspectorate (GIS) and the Office of Competition and Consumer Protection (UOKiK) can impose draconian financial penalties on businesses for misleading consumers. According to the proposed amendments for 2025/2026, this penalty could amount to up to up to 100 times the average salary in the national economy.