Registration of dietary supplement in GIS:

Application form: Electronic only.
Important: Applications submitted on paper are automatically rejected.

Registration of a dietary supplement requires mandatory notification to the Chief Sanitary Inspector (GIS) via the e-Sanepid platform. The process requires submitting an online form along with key documents (ingredients, label template, manufacturer details). Once notified, the product can be legally sold immediately.

To register a dietary supplement, you must electronically notify the Chief Sanitary Inspector (GIS) using the form available on the GIS website, before introducing the product to the market. Registration is free but requires the preparation of appropriate documents, such as ingredients, labeling template, and data regarding the entity introducing the supplement to the market. Registration (notification) itself does not require waiting for an official decision, but the product must meet all legal requirements.

Bringing a dietary supplement to market is a process where the devil is in the details. The colloquial term "registration" is misleading—in reality, we're talking about notification of the Chief Sanitary Inspector (GIS) in accordance with Article 29, Section 1 of the Food and Nutrition Safety Act. This guide is an in-depth analysis of the entire process, designed to give you an advantage and protect you from costly mistakes.

Registration of the Supplement in a Pill

To register a dietary supplement, you must electronically notify the Chief Sanitary Inspector (GIS) using the form available on the ePUAP platform, before introducing the product to the market. This process is free of charge but requires the preparation of key documents, such as the product's composition, its labeling template, and details of the entity introducing it to the market. The notification itself does not require waiting for an official decision – the product can be sold immediately after notification, but it must meet all legal requirements.

Registration Step by Step

Register your facility with the Sanitary and Epidemiological Station: Before you can register a product, your company must be approved by the State Sanitary Inspectorate (PIS) as an entity operating in the food market.
Prepare complete documentation: Develop the qualitative and quantitative composition, label template in Polish and product specifications.
Complete the electronic form: Applications are submitted exclusively online via ePUAP, using a trusted profile or a qualified signature.
Provide the required data: In the form, you must precisely specify the product details (name, form, composition), manufacturer and notifying entity.
Introduce the product to the market: After submitting the notification and receiving the UPP (Official Certificate of Submission), you can legally start selling.
Ensure ongoing compliance: Please note that GIS reserves the right to initiate investigations at any time. You are solely responsible for the safety and compliance of this product.

Supplement, Drug, Medical Device – Understand the Differences Before You Begin

Misclassifying a product is one of the most serious mistakes. Understanding the fundamental differences is crucial to the entire process.

Criterion	Diet supplement	Medicinal Product (Drug)	Medical Device
Legal basis	Food law	Pharmaceutical law	Medical Devices Act
The main objective	Diet supplement	Disease treatment and prevention	Diagnosing, alleviating, preventing disease (physical action)
Supervision	GIS (Sanepid)	URPL, GIF	URPL, President of the Office
Introducing to the market	Notification in GIS	Marketing Authorization (long and expensive process)	Conformity assessment, CE certificate, notification to the Office of Registration, Evaluation, and Registration of Medicinal Products

Expert Module: Component Analysis – What Does GIS Verify?

GIS doesn't assess efficacy, only safety. Your formulation will be analyzed for regulatory compliance. Here are the key areas:

1. Vitamins and Minerals

Their chemical forms must be listed with Regulations of the Minister of Health of 9 October 2007 The maximum permitted levels in a daily dose are specified in Resolution No. 4/2019 of the Team for Dietary SupplementsExceeding these doses is a red light for the GIS.

2. Botanicals

This is the most complex area. GIS here relies on Resolutions of the Team for Dietary Supplements, which specify maximum doses and required warnings for specific plants (e.g., Ashwagandha). Many health claims for herbs are on the so-called "pending list."

Warning: Always check the current resolutions of the Dietary Supplement Committee before using a plant-based ingredient. They're a treasure trove of information on how the GIS approaches risk assessment.

3. Novel Food

If your ingredient was not widely used in the EU before 15 May 1997, it is likely to be a "novel food" (under EU Regulation 2015/2283). It is illegal to introduce it without authorisation from the European Commission.

Expert Module: Health and Nutrition Claims

Supplement marketing relies on claims. Their improper use is the most common cause of fines from the Sanitary Inspectorate.

How to legally use health claims?

go to the website EU Register of nutrition and health claims (easy to find on Google).
Search for your ingredient (e.g. "Vitamin C").
Check the list of Authorised Claims and their conditions of use.
Copy the statement exactly as it appears in the register. It cannot be modified.

Summary: The Path to Success

Properly notifying a dietary supplement involves much more than filling out a form. It involves a thorough analysis of the ingredients, labeling regulations, and marketing. Investing in understanding these regulations from the outset is the best insurance policy for your business.

Feeling overwhelmed? It's natural.

We specialize in guiding clients through this complex process. producentsuplementow.pl We offer comprehensive legislative advice, assistance in creating compliant recipes and labels, and full contract manufacturing services.Contact usto turn your idea into a safe, legal and ready-to-sell product.

Infographic: Registration of Dietary Supplements in Poland

Number of dietary supplement notifications in Poland (est. 2024)

17 500+

The dietary supplements market in Poland is dynamic and constantly growing, which places high demands on both entrepreneurs and supervisory authorities.

Market Square Landscape

Before we dive into the process, let's understand the scale of the phenomenon and define the key players and terms. This market is strictly regulated.

📜 What is a Dietary Supplement?

It's a food, not a medicine. Its purpose is to supplement a normal diet, providing a concentrated source of vitamins, minerals, and other substances. It doesn't cure, but rather supports.

🏛️ The role of GIS

The Chief Sanitary Inspectorate (GIS) is the authority responsible for receiving and analyzing notifications of the first introduction of dietary supplements to the market. It maintains a register and conducts explanatory proceedings.

📈 Increase in the number of notifications to GIS

The chart below illustrates the dynamic increase in the number of new applications in recent years, which indicates growing interest in the market.

Market Division

What do entrepreneurs most often report? The vast majority of notifications concern vitamin and mineral products.

📊 Main Supplement Categories

The doughnut chart shows the percentage share of each supplement category in the total number of applications in 2024.

Vitamins and minerals: 45%.
Herbal ingredients: 25%.
Probiotics: 15%.
Fatty acids: 10%.
Other: 5%

Step by Step Notification Process

Introducing a supplement to the market requires following a strictly defined procedure within the GIS. Here are six key steps.

Product Classification

Is this really a supplement? Misclassification (e.g., as a drug) is a fundamental error that disqualifies a submission.

Completion of Documentation

Preparation of a label template in Polish, composition specifications and (recommended) scientific research and justifications.

Electronic Notification

Notification is submitted exclusively via a dedicated GIS system, using a qualified signature or trusted profile.

Formal Verification

GIS checks the submission for completeness and places the product in a public register. This does not constitute acceptance yet!

Investigative Proceedings

If GIS has doubts (e.g. regarding the composition or label), it initiates proceedings, requesting the company to provide explanations.

Introduction to Trading

The product can be introduced to the market on the day of notification, but the entrepreneur does so at his own risk.

Pitfalls and Challenges

The investigation process is the most common problem. See what raises the most concerns for GIS.

📊 Most Common Reasons for Investigations

The chart shows that problems with labelling and health claims account for more than half of all proceedings.

⚠️ Incorrect Labeling

Using unauthorized "health claims", suggesting treatments or errors in reporting RDAs (Reference Intakes).

⚠️ 'Novel Food' Ingredients

The use of a "novel food" (an ingredient with no history of consumption in the EU before 1997) requires special authorisation from the EC, and not just notification to the Chief Sanitary Inspectorate.

⚠️ Misclassification

A product that is a medicine due to its composition (e.g. high doses) or intended use cannot be registered as a supplement.

📋 Obligations after Notification

Notification is not the end. The entrepreneur remains fully responsible for the product throughout its market presence.

Full responsibility for safety, composition and labeling.
Monitoring changes in law and product adaptation.
Updating the application in GIS in case of significant changes (e.g. composition).
Advertising supervision and marketing materials.
Willingness to provide full documentation upon request by supervisory authorities.

Contact us

Deep Market Analysis: What Do the Last 500 Notifications in GIS Say?*

We did an unprecedented job analyzing 500 of the latest supplement submissions to give you the clearest, most up-to-date picture of the market. Here's what we discovered.

Methodology: The analysis included the 500 most recent dietary supplement notifications from the public GIS registry (period: September–November 2025). The data was cleaned and categorized to identify key trends, dominant ingredients, and hidden niches.

🥇Market Leaders: Top 5 Ingredients

Five components that absolutely dominate the latest submissions, forming the core of the market.

1.Vitamin D (mainly D3 + K2) 21%.
2.Magnesium (various forms) 16%.
3.Collagen (fish and beef) 11%.
4.Vitamin Complexes (Multi and B)9%
5.Ashwagandha7%

Proposal: The basics (vitamins, minerals) are the foundation, but adaptogens (Ashwagandha) have become a mainstream staple.

🚀Rising Stars and Niches

Ingredients that appear less frequently but show the greatest growth dynamics and indicate new consumer needs.

▶Gut Health (Pro/Prebiotics, Butyrate)6%
▶Liver Support (Milk Thistle, Choline)4%
▶Nootropics (Bacopa, Gotu Kola)3%
▶Sleep Support (Melatonin, Lemon Balm)3%
▶Berberine2%

Proposal: The market specializes in specific issues: stress, sleep, digestion, and cognitive function. This is where the greatest potential for innovation lies.

📊Market in Numbers: Key Observations

71%.

Capsule Domination

This is the absolute standard. Powders (14%) and liquids (9%) are a distinct minority.

>40%

The Clean Labels Trend

Mono-ingredient or simple composition products are extremely popular.

💪 The Power of Duos

The most popular and most frequently repeated calls in reports are invariably Vitamin D3 + K2 and Magnesium + Vitamin B6.

Strategic conclusion: Entering the market with a simple, high-quality capsule product remains the most popular strategy. Standing out requires either an innovative approach or entering a rapidly growing niche.

*Analysis conducted by the team producentsuplementow.pl Based on the 500 most recent notifications from the public GIS register (period: September-November 2025). The data is for illustrative purposes only and illustrates market trends.

Entrepreneur's Essentials - Key Links Database

I. Company and Product Registration

Entry of the plant into the register of plants subject to Sanitary and Epidemiological Station inspection

The official government website where you can submit an application for approval of your business with the Sanitary and Epidemiological Station. This is the first, mandatory step.

GIS Notification System (ePUAP)

A direct gateway to the electronic notification system for dietary supplements. Here you can submit the appropriate notification for product introduction to the market.

II. Databases and Registers (Verification)

Public GIS Product Register

The official, public register of all products (including supplements) reported to the Chief Sanitary Inspector. Here you can check whether your product or a competitor's has been notified.

EU Health and Nutrition Claims Register

A key tool for verifying which health claims you can legally use on labels and in marketing. The database is in English.

III. Guidelines and Resolutions (Expert Knowledge)

Resolutions of the Dietary Supplements Team

An extremely important website containing the opinions and resolutions of GIS experts on specific ingredients (e.g. vitamins, herbs), their maximum doses and required warnings.

Regulation (EC) No 1924/2006 on health claims

The full text of the EU regulation that governs the use of nutrition and health claims. Advanced reading.

Dietary Supplement Notification in 2025: how to register a dietary supplement?