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.

Moment of sale: You can sell the product immediately after sending the notification (you do not wait for "consent" or decision), but you do so at your own risk.

Registration of the establishment: Each entity (producer, distributor, online store) must register with the local Sanitary Inspectorate and comply with hygiene rules (HACCP/GHP).

Registration of a dietary supplement

To register diet supplement, belongs electronically notify the Chief Sanitary Inspector (GIS) using the form available on the office's website. This should be done before introducing the product to the market market.

Registration is free and does not require waiting for an official decision, but the product must meet all legal requirements, including the appropriate composition, labeling model and full details of the responsible entity.

Important rules and safety:

Polish right strictly regulates food safetyProducts inspected by the Sanitary Inspectorate they cannot suggest medicinal propertiesRemember that the new regulations tighten advertising rules and introduce severe fines for violations.

Introducing dietary supplements to the Polish market

In Poland you do not "register" a supplement, but you notify about its introduction.

Key Facts (Hard Data):

Principle of "Presumption of Conformity":
You can start selling within seconds of submitting the form in the GIS ESP system, without waiting for the green light. However, you risk having your batch recalled if GIS questions the composition after the fact.
Bottleneck – Label:
It must include: the definition of "dietary supplement," the recommended serving size, a warning not to exceed the recommended dose, and a statement that it does not replace a varied and balanced diet. Failure to include these elements will result in automatic blocking.
Claims:
You may only use those listed in the EFSA Database. Any marketing creativity (e.g., "burns fat" instead of "supports metabolism") will result in an administrative penalty.
Novel Food:
If the ingredient was not in the EU diet before 1997 (check the Novel Food Catalogue), the product is illegal without certification for thousands of euros.
National Limits:
Poland has specific dosage limits (e.g. vitamin D, K2, B6), which can be found in the Supplement Committee Resolutions. Exceeding even by a microgram turns the product into lek, the sale of which without permission is a crime.

How to register dietary supplements outside the EU – Notification of supplements around the world 2026

Global scaling is a transition from notification regime (EU) on pre-market registration regime and/ or insurance systems (USA).

Market Architecture (Technical Deep Dive):

USA – DSHEA and NDI Umbrella: A market based on "self-certification." The key is Section 8 of DSHEAIf the ingredient is "new" (introduced after 1994), you must submit NDI NotificationFailure to pass NDI during FDA inspection means the product is considered "adulterated" by law, opening the door to class action lawsuits.
China – Cross-Border E-commerce (CBEC): A "keylock" to the Chinese market. By selling through platforms like Tmall Global, you bypass the registration requirement. Blue Hat (SAMR) and animal testing, provided that the goods are shipped from Bonded Warehouse (customs warehouse) or from abroad.
Australia – Listing vs Registration: Products are divided into Listed (AUST L – low risk, automatic entry) and Registered (AUST R – high risk, like medication). Gain: Even for AUST L you must have Evidence Package – scientific support for every label claim, ready for immediate TGA review.
ASEAN – Harmonization (TMHS): Southeast Asian countries are implementing common standards for supplements. Key: The limits for heavy metals (Arsenic, Cadmium, Lead) are much stricter here than in the Codex Alimentarius standards, which often disqualifies European plant extracts.
Canada – Site Licensing: In Canada, not only does a product need to have a number NPN, but the importer/distributor must have Site LicenseThis requires proof that storage and distribution processes meet GMP (Good Manufacturing Practices) standards for natural products.

Fast Decision Matrix:

Distance	Barrier Principle	Information Gain (Pro-Tip)
USA	Liability	Product Liability insurance of at least USD 2-5 million is required.
Persian Gulf	Halal Compliance	Certification production line, not just ingredients (no ethanol in extracts).
Brazil (ANVISA)	Pharmaceutical Control	Supplements treated almost like medicines; rigorous stability testing in tropical climates.

Introduction of supplements in the EU: Key barriers

The EU market is not a monolith, but a system national notifications based on Regulation (EU) 2019/515 on mutual recognition.

Operational Pillar (Information Gain):

Notification: There is no central EU register. You register your product separately in each country (e.g., DGCCRF in France, BELVAl in Belgium). Some countries (Germany) only require registration, others (Italy) charge an administrative fee (approximately €160).
Botanical ingredients (BelFrit): Lack of full harmonization of herbs. If an ingredient is on the BelFrit list (Belgium, France, Italy), you have a strong legal argument, but Scandinavian countries may consider it a medicinal product (so-called borderline products).
VAT and OSS: B2C sales in the EU require registration in the VAT OSS system once the threshold of EUR 10,000 of intra-EU trade is exceeded, which simplifies the settlement of domestic rates.
Safe Dose Principle: In the absence of EU maximums, the guidelines apply EFSA Tolerable Upper Intake Levels (UL)Exceeding the UL without hard scientific evidence is a surefire roadblock in 27 countries.
Audit Trail: You must have full documentation of the origin of the raw material (HACCP/ISO 22000). In the EU, Product Liability rests with the supplier.iocand the fines for pollution (e.g. ethylene oxide) amount to millions of euros.

2026 Registration Procedure

Legal and Operational Compendium (Information Sort)

§ 1. Qualification and Classification

Definicja

The product must be classified as foodstuffThe primary function is to supplement the diet. The use of nomenclature suggesting therapeutic (medicinal) properties is strictly prohibited.

§ 2. Procedural Requirements

Action Required

I. GIS notification Electronic filing before the date of introduction to trading. No stamp duty for filing itself.

II. Registration with the Sanitary Inspectorate Obligation to report the facility to the local sanitary and epidemiological station (at least 14 days before the start).

§ 3. Standardization of Labeling

Checklist

The label must be in Polish and contain the following mandatory elements:

The explicit term "dietary supplement";
Recommended daily intake;
Warning not to exceed the indicated portion;
The statement that supplement does not replace a varied diet.

§ 4. Liability and Sanctions

Critical

Introducing a defective product or false advertising results in criminal and administrative liability. Regulatory authorities (GIS/UOKiK) are authorized to impose fines up to 50 000 PLN for a single violation and immediate withdrawal of the batch from the market.

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, paragraph 1 of the Act on Food and Nutrition Safety. This przewodnik 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+

Supplement market Diet 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 quality capsule product is still the most popular strategy. Standing out requires either an innovative format 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 2026: how to register a dietary supplement?