Dietary Supplement Registration 2026: How to Register a Dietary Supplement?

GIS Dietary Supplement Register (Notification System)

An official public register maintained by the Chief Sanitary Inspector (GIS) pursuant to Article 29 of the Food and Nutrition Safety Act, used to monitor food introduced to the market in Poland for the first time.

Legal and practical essence of the notification

  • Notification instead of certification: A dietary supplement is a food. The procedure does not involve issuing an "approval" or "certificate" (as with medicines at the Office for Registration of Medicinal Products), but rather submitting an electronic notification (powiadomienia.gis.gov.pl).
  • Legality of trading from the date of notification: The marketing authorisation holder (EU manufacturers/importers) can start distribution once the application has been successfully submitted and a notification number has been generated, without waiting for the verification to be completed.
  • Formal requirements of the application: The notification requires attaching a label template in Polish, the exact composition with an indication of the chemical forms and the qualification of the product category.

How to interpret statuses in the public register?

  • During the procedure (Verification): The application has been submitted to the system. The product may be on the market, but the Chief Sanitary Inspectorate (GIS) is reviewing the composition, dosages, and claims (often seeking the opinion of the Dietary Supplements Team).
  • Investigation proceedings completed: GIS did not raise any concerns about the qualification and safety of the product or the entity provided sufficient evidence to support the declaration on the label.
  • Suspension of trading / Prohibition of introduction: Status assigned when a product poses a health risk, contains prohibited substances, is an unverified "novel food" (novel food) or has a healing effect.

Key Regulatory Risks and Pitfalls (Borderline Products)

Infographic about the rules of advertising dietary supplements and the obligations of manufacturers.

Legal and sanitary basics: Registration of dietary supplements in the Chief Sanitary Inspectorate

Under Polish food law, the common practice of registering a dietary supplement involves mandatory notification to the Chief Sanitary Inspector (GIS) of the intention to first introduce the product to the market. This process is conducted via the e-Sanepid digital platform.

  • Form requirement: Applications are submitted electronically only.
  • Key principle: All paper applications are automatically rejected. Registration of dietary supplements has undergone full digitalization.

This process requires the entrepreneur to submit a precise online form along with a complete set of attachments (qualitative and quantitative composition, a valid label template in Polish, and full details of the entity introducing the product). Successful notification means that your product will finally be included in the public, publicly available register of dietary supplements.

How to register a dietary supplement without waiting? (Presumption of Conformity)

Wondering how to register a dietary supplement and start selling it right away? Polish law is based on the principle of presumption of conformity. This means you can start selling immediately after clicking "Send" in the ePUAP system (you receive an Official Confirmation of Submission). You don't have to wait for a physical official's decision. However, you do so at your own risk, before the office's algorithms fully verify the entry in the database, which is the dietary supplement register.

Remember about the State Sanitary Inspectorate: Before the actual registration of dietary supplements begins , your entity (regardless of whether you are a manufacturer, distributor or e-commerce) must formally register your facility with the local State Sanitary Inspectorate and implement hygiene rules (HACCP/GHP).

Important rules and consumer safety: Food law is ruthless. A food, unlike a drug, cannot suggest any preventive or curative propertiesLegal amendments treat this aspect even more strictly, and regulatory bodies verify marketing messages extremely restrictively.

The guarantor of the highest quality in the company International Organic Company (IOC Sp. z o. o.) is an integrated contract manufacturing management system. We execute orders exclusively based on global certification standards: ISO 9001:2015, ISO 22000:2018, ISO 22716:2009, GMP, GHP, HACCP and ISO/IEC 27001. Thanks to our technology dietary supplement registration becomes a safe formality.

How to register a dietary supplement step by step

The marketing path itself is a process that requires rigorous analysis. The timeline below explains precisely how to register a dietary supplement efficiently and accurately.

1

Recipe Concept and Legal Composition Audit

Implementation time: 2-8 weeks

Selection of raw materials, audit of permissible limits (vitamins/minerals) in accordance with the latest resolutions of the Dietary Supplements Committee. Novel Food risk exclusion.

2

Trial Production and Laboratory Testing

Study time: 4-10 weeks

Creating a technological sample and performing rigorous testing for microbiological purity and the presence of heavy metals is your guarantee of safety before inspection.

3

Health Labels and Claims Project

Working time: 1-3 weeks

100% legal labeling. Using only authorized health claims from the European Food Safety Authority (EFSA) database.

4

GIS notification (Proper registration of dietary supplements)

Duration: 1 operational day

Log in to the e-Sanepid (ePUAP) platform, complete the form, and generate a UPP number. From that moment on, you can legally sell the product.

!

Investigation (Threat)

Possible delay: Up to 3-12 months

If errors are found in the label or ingredients, the Chief Sanitary Inspectorate (GIS) suspends the entry. A rejected dietary supplement registration will result in a sales ban until scientific clarification is provided.

Dietary Supplement and Medicine – Market Foundation

Incorrect product classification is the most serious error in the industry. Legal, simplified registration of dietary supplements is only possible for products that complement normal nutrition.

Classification Criterion Diet supplement Medicinal Product (Drug) Product Medical
Legal basis Food law (Foodstuff) Pharmaceutical law Products Act medical
Market target Supplementing your daily diet with nutrients Disease treatment and pharmacotherapy Physical action, diagnosis, relief
Controlling office GIS (official register of dietary supplements) URPL and GIF President of the Office, URPL
Admission to trading Registration of a dietary supplement (Notification by notification) Extremely difficult and expensive to obtain a permit Conformity assessment, rigorous certificate CE

Registration Procedure in GIS – Hard Data 2026

By understanding how to register a dietary supplement , you need to master the strict guidelines that determine the success of your application.

Legal Guidelines for the 2026 Notification

Market Compendium for the Food Industry

§ 1. Claims (EFSA) and Qualification

Mandatory

It's prohibited to use phrases that attribute disease-preventing properties to the product (e.g., "lowers blood pressure," "treats insomnia"). Your only recourse is the authorized claims in the EFSA Register. Aggressive marketing that circumvents this law will result in dietary supplement registration being challenged by the office.

§ 2. Threats: New Foods and Limits

Action Required
I. Novel Food Botanicals without a documented and extensive history of safe consumption in the EU before May 15, 1997, are illegal. They require dedicated, very expensive authorization from the European Commission. dietary supplement registration won't help here.
II. Limit Dosing (RWS) Each country sets its own maximum limits for substances. Poland has restrictive regulations (e.g., the limit for vitamin D is 4000 IU). Exceeding these strict doses immediately changes the classification from food to drug.

§ 3. Standardization of Packaging (Labels)

Inspector's Checklist

The label design is the most important file attached to the e-Sanepid system. Before applying, make sure it includes:

  • A clear and striking definition of “dietary supplement”;
  • The recommended daily portion of the product is indicated;
  • Wording clearly warning against exceeding the recommended dose;
  • A provision to store it out of the reach of small children;
  • A message that the supplement cannot be used as a substitute for a varied diet.

§ 4. Risk, Liability and Inspections

Every violation of food law is monitored by inspectorates. Administrative fines imposed by supervisory authorities (GIS/UOKiK) can amount to up to PLN 50,000 for misleading consumers. Furthermore, full legal liability for the product (even if production is outsourced) rests with the entity marketing it under its own brand.

Interactive Pre-Registration Label Audit

Use this tool. Poorly designed labels are the most common reason dietary supplement registration is delayed.

GIS 2026 Compliance Simulator

Dietary Supplements Register – Market Analysis and Research Results

Each successful e-procedure adds a new product to the universal, official register of dietary supplements . In-depth analysis of these databases provides free knowledge about what the Polish e-commerce industry is investing in.

Statistics from the e-Sanepid platform (Chief Inspectorate)

Increase in the number of supplement notifications in Poland

Main reasons for GIS investigations

In-Depth Analysis: What exactly is hidden in the dietary supplement registry?

We've reviewed the last 500 notifications. Find out how to register your dietary supplement to secure the safest margins on the market.

🏆Top 5 Notified Ingredients

  • 1.Vitamin D3 + K2 Complexes 21 %
  • 2.Magnesium chelates and citrates 16 %
  • 3.Hydrolyzed Collagen Fish 11 %
  • 4.B multivitamins 9%
  • 5.Adaptogens (e.g. Ashwagandha) 7%

📦Preferred Market Forms

71 %
Capsules (V-Caps)
14 %
Powders / Measures
9%
Liquid Forms

Strategic conclusion: The market registration of dietary supplements today is primarily vegan capsules with a clean composition (so-called Clean Label trend), free from harmful anti-caking substances and artificial colors.

Registration of dietary supplements outside the EU (World 2026)

Global scaling requires abandoning the territorial e-Sanepid system in favor of the often much stricter requirements of foreign markets.

Market Architecture Differences (Deep Dive):

  • USA (FDA System): Instead of a notification portal, the principle of "self-certification" (DSHEA law) applies here. Each new botanical ingredient triggers a massive documentation process – NDI NotificationThe barrier to entry into the local market is the enormous requirements for product liability insurance (often in the millions of dollars).
  • European Union (No full harmonization): Central EU register of dietary supplements It doesn't exist. The principle of mutual recognition applies, but in practice, you have to send separate notifications to each destination country (e.g., Italy, which requires an additional stamp duty). A major challenge is the inconsistent list of permitted plants (the so-called BelFrit list).
  • China (CBEC Pickaxe): Cross-border sales via special e-platforms (Cross-Border E-commerce) from duty-free zones allow for a legal way to bypass the extremely strict and expensive standard SAMR registration procedure ("Blue Hat").
  • Canada (Site Licensing): National dietary supplement registration results in the assignment of an NPN. Importantly, the foreign importer in Canada must present a certified warehouse license demonstrating compliance with Good Manufacturing Practices (GMP).

Effective Registration with an Expert

No time for paperwork and GIS reporting? We'll do it for you!

Unsure how to register a dietary supplement without fear of making a mistake? We'll take the burden off your shoulders. Our food law specialists will quickly complete the notification process. Legally accurate registration of dietary supplements is a routine service within our contract manufacturing services.

  1. You provide us with access to: You log in to the state platform and give our lawyer administrator rights on your e-Sanepid company account.
  2. We do all the work: We complete raw material documents, create a 100% legal Polish label, and authorize the online submission.
  3. Finished result: In a split second, your product powers a powerful government register of dietary supplements, and you receive a UPP number authorizing you to legally sell and ship e-commerce.
Leave Sanitary Epidemiological Station procedures to specialists – Contact IOC

Digital GIS Toolkit (Official Portal Database)

Main Portal of the Notification System (e-Sanepid)

A direct, encrypted and ePUAP/Trusted Profile authorized gateway through which every formal registration of a dietary supplement in the Republic of Poland is physically carried out.

State Public Register of Dietary Supplements

An open system managed by the Chief Inspectorate. It guarantees access to a database of all approved and notified products. It's an excellent tool for analyzing and monitoring competitors in Polish e-commerce.

Approval of the PIS Department (Biz.gov.pl)

A key, legally enforced "zero" step enabling the company to officially launch e-commerce in terms of hygiene and sanitary requirements for food trade, without which any official registration of dietary supplements simply does not legally exist.

EFSA Authorised Health Claims Database

The only legal marketer's dictionary. Checking the wording in this EU register will guarantee that your electronic dietary supplement registration won't result in immediate investigation by supervisory authorities.

Dietary Supplement Manufacturer - contract manufacturing, labels, certificates, compliance.
Procedure stage Entity responsible Required data and documents IT system Deadlines and timeframes Possible sanctions and risks Reviewing institutions
Notification of the first introduction of a supplement to the market (Notification) Manufacturer, importer or brand owner (responsible entity) Full name and form of the product, labelling template in Polish, qualitative and quantitative composition (active substances), product qualification, notifier's details (NIP) ESP (e.sanepid.gov.pl), RPWDL, SEPIS, e-GIS, ePUAP Before the first introduction to the market; the date of receipt of the signed form by GIS is considered Withdrawal of the product from the market, a fine of up to 30 times (current) or 100 times (project) the average salary, up to PLN 50,000, notification to the prosecutor's office Chief Sanitary Inspector (GIS)
Verification of labeling and composition (Labeling) Entrepreneur (producer / importer) The term "dietary supplement", recommended serving, warnings, storage information, nutritional values, compliance with the health claims register EU Health Claims Register (http://ec.europa.eu/nuhclaims/) Before placing on the market; from 11/09/2025 new requirements for vitamin D and iron A fine of up to 30 times (currently) or 100 times (project) the average salary for incorrect labelling Dietary Supplements Panel (recommendations), EFSA (novel foods)
Entry of the establishment into the register or approval of the establishment (Sanepid) Entity operating in the food market (producer, distributor, e-shop) Application for entry or approval, company details (NIP, REGON, PKD), plant/warehouse location, optional GHP/GMP, HACCP documentation and technological design e-Sanepid, Biznes.gov.pl, SEPIS, website wsse.gda.pl At least 14 days before the planned start of business A fine of up to PLN 5,000 for failure to register or approve; fines; no possibility of legal production/storage State Sanitary Inspection (PPIS / PSSE)
Investigation procedure (in case of doubts GIS) Chief Sanitary Inspector (GIS) Additional quality documentation, opinions from scientific units, laboratory tests, Certificates cleanliness/safety, DER specifications ESP, SEPIS, online notification system Typically 30-90 days; 60 working days for GIS steps; design assumes 14 days for request for opinion Suspension of product marketing, withdrawal from the market, necessity to change the recipe or name, negative entry in the public register Office for Registration of Medicinal Products (URPL), Dietary Supplements Team, EFSA, scientific units (e.g. PZH, IŻŻ)
Business registration (PKD 47.27.Z) Entrepreneur Selection of the appropriate PKD code, legal form (JDG or limited liability company) CEIDG, KRS Before the sale begins Penalty for conducting activities inconsistent with the profile No data in the source

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