Dietary Supplement Registration Guide (Updated 2025)
The dynamic development of the dietary supplement market in Poland and the EU requires manufacturers to meet rigorous standards. At the stage of product implementation, it is necessary to develop a formula that complies with the highest quality and safety standards, which is associated with mandatory registration - reporting to the Chief Sanitary Inspectorate or the appropriate body in the EU.
In situations where a preparation stands out with a unique composition or properties, it is worth using an individual dietary supplement registration procedure. Such a strategy allows for a precise assessment of the product and adjustment of formalities to its specificity, which increases the credibility of the manufacturer and increases consumer safety.
Table of Contents
Registration of supplements takes place exclusively online through the ESP system – Electronic Notification System, using a dedicated form. Paper applications are not considered.
The procedure is available to domestic and foreign companies with headquarters or branches in the EU. Before introducing a product to the market, the plant must be entered into the register of the State Sanitary Inspectorate (along with data, type of activity according to PKD and type of food) and the necessary certificate must be obtained.
ESP provides automatic submission verification, qualitative and quantitative composition analysis, generation of an ingredient list, and protection of confidential composition, manufacturer, and label data.
Market planning and analysis
Before you formulate a supplement, research the market to address real consumer needs. Determine which products are hits, which niches remain untapped, and how you stack up against the competition.
- Trends: Check if your formula harmonizes with current health expectations.
- Recipients: Decide whether you are targeting athletes, seniors or beauty conscious people.
- Competition: Identify what makes your proposition stand out in the market.
Market monitoring and control
Procedure registration of dietary supplements implemented by GIS enables continuous market surveillance, which allows for the immediate detection of any non-compliance with applicable standards.
If deficiencies are detected, GIS responds immediately by taking action, including product recall, which ensures ongoing safety monitoring and protects public health.
Submitting a product to GIS – a step before entering the market
Are you planning to launch a dietary supplement, a special purpose food or a vitamin-enriched product? Before introducing it to the market, you must report the product to the Chief Sanitary Inspector. In practice, this means carrying out the procedure dietary supplement registration arising from the Food Safety Act.
The GIS system allows for ongoing market monitoring, which contributes to increased consumer safety and strengthens the credibility of producers.
Dietary supplement production stages
- Step 1: Preparation and calibration of production equipment
- Step 2: Recipe development and optimization
- Step 3: Selection of the highest quality ingredients
- Step 4: Detailed analysis of production costs
- Step 5: Submitting an application to start the production process
- Step 6: Order approved raw materials
- Step 7: Rigorous testing of raw material quality
- Step 8: Carrying out the proper production process
- Step 9: Thorough quality control of the finished product
- Step 10: Efficient packaging and professional labeling
- Step 11: Organizing storage and logistics
- Step 12: Distribution and sales begin
Find out more - read a detailed post about the production process of supplements in IOC.
Notification of the introduction of the supplement to the market
- Housing: The manufacturer must register the supplement via the Electronic Notification System – nowy.gis.gov.pl/esp.
- Product register: GIS provides a public register of reported supplements.
This process enables effective monitoring of new products by supervisory authorities, ensuring that the supplements offered meet safety requirements.
Composition and safety of dietary supplements
The Act specifies, among other things, that dietary supplements may contain only those vitamins and minerals that naturally occur in food. Each product must be safe for recommended use – according to the information on the label.
The maximum levels of individual ingredients are regulated so that even when consumed regularly, they do not pose a health risk. Additionally, it is worth remembering about appropriate tests and quality controls that will confirm the consistency of the composition with the declarations.
Labeling and product information
The key to building consumer trust lies in a clear and reliable label. It should provide precise information that allows for an informed choice of dietary supplement.
- Daily portion: clear statement of recommended dosage.
- Warnings: information about the consequences of exceeding the standard.
- Complementarity: note that the supplement does not replace a varied diet.
- Product designation: a clear statement that it is a “dietary supplement.”
Additionally, all advertising messages must comply with the law – they cannot suggest medicinal properties unless confirmed by appropriate procedures.
The procedure for reporting dietary supplements in practice
The online form available on the GIS website simplifies the process of entering the product into the register. To perform registration of dietary supplements, you should prepare:
- Trade name of the product,
- Manufacturer and distributor details,
- Precise quantitative and qualitative composition,
- Label template in Polish,
- Information about the product form (e.g. tablets, capsules, powder).
After sending a complete set of documents and paying the appropriate fees, the supplement is registered, which allows it to be introduced to the market. It is worth monitoring the updates of the regulations, because GIS can re-evaluate the product if irregularities are detected.
What is the GIS Register?
This is a public database that collects information about products, substances and entities supervised by GIS.
Types of GIS registers:
- Dietary supplements and products for special nutritional purposes: Register of reported products.
- Establishments producing or introducing food: Data from companies in the production and distribution sector.
- Cosmetics register: Information about cosmetics, supplemented with data from the CPNP system.
- Active substances in plant protection products: Information about pesticides and their ingredients.
Purpose of GIS registers:
GIS registers provide public health safety by controlling the quality of products and their compliance with sanitary and food regulations in Poland and the EU.
Hassle-free registration in the e-Sanepid system with IOC
Take advantage of our free service, which allows you to quickly and stress-free report your supplement via the e-Sanepid system. We will take care of the formalities, so you can focus on developing your business.
- Create an account in e-Sanepid: Visit e-Sanepid and follow the instructions Registration instructions.
- Add us as administrator: After logging in, go to the "users" tab and select "add user". Enter the activation date and the period of full rights that will allow us to continue registration.
- Our intervention: Once added, we take over the supplement application, attach the necessary documents and take care of every formal detail.
- Expert support: We are available at every stage – you will always find help from us if you have any questions or concerns.
- Self-registration option: If you prefer to act on your own, please read the detailed instructions on the website Self-reporting.
By choosing our service you gain the assurance of professionalism and security - the registration process is quick, efficient and completely free of charge.
Production costs and development of dietary supplement
Production costs depend on the composition, number of tests, order size (MOQ) and type of packaging. More and more companies are opting for contract manufacturing, which allows them to focus on marketing and sales, leaving technological issues to specialists.
Tip: When preparing your project, include a budget that includes registration costs, laboratory testing, and activities related to introducing the product to the market, such as marketing campaigns and distribution.
Check the current costs of contract manufacturing of the supplement.
Investment cost: The average cost of producing a supplement under your own brand in 2025 is PLN 40.000 (EUR 9.500), which provides a finished product in the amount of 2.500-5.000 pieces. In the case of larger orders, the price per piece may drop to PLN 4-5 (approx. EUR 1).
To find out the exact cost of producing your supplement – fill in the form and/ or write an e-mail – and you'll receive a quote within 48 hours.
Frequently Asked Questions (FAQ)
Does every dietary supplement have to be reported to GIS?
How much does it cost to register the supplement in GIS?
Can a dietary supplement cure disease?
How long does the supplement approval process take?
What conditions must be met to become a producer of dietary supplements?
Registration and approval of supplement manufacturing plants – Poland and EU (2025)
Does a company commissioning production have to register its plant?
The regulations require that every entity involved in the production or sale of food registers its establishment. This includes both the manufacturer and the company commissioning production if it introduces a product under its own brand. The establishment must be reported to the sanitary inspection at least 14 days before starting its business.
Registration of companies dealing exclusively with distribution
Companies distributing supplements, even if they do not produce them themselves, must register their business as entities involved in food trade. In the case of stationary or wholesale sales, registration of the establishment is required, while in online trade, a simplified entry in the register is sufficient. Business can only begin after approval or registration by the relevant authorities.
Do companies importing supplements from outside the EU also have to register?
Yes. Importers from outside the EU must report their facilities (e.g. warehouses or distribution centers) to the State Sanitary Inspectorate. In addition, the first introduction of a supplement to the Polish market requires notification of the product to the GIS to confirm compliance with EU standards.
What sanitary requirements must contract manufacturers meet?
Contract manufacturers must implement the HACCP system, as well as apply GMP and GHP principles to ensure proper hygiene and quality control. The plants are regularly inspected by sanitary inspections, and the implementation of additional certificates (e.g. GMP, ISO) increases the level of product safety and quality.
Do Polish regulations differ from EU regulations?
Regulations in Poland are in line with EU requirements, mainly resulting from Regulation (EC) No. 852/2004. Each establishment must be reported or approved at least 14 days before starting operations, and differences between EU countries mainly concern administrative formalities.
Penalty for selling supplements without notification
The production or distribution of supplements without registration is a violation of the law. According to Article 103 of the Food Safety Act, such action may result in a fine of PLN 1 to PLN 000. The sanitary inspection may also order the suspension of activity or the withdrawal of products from circulation, which affects consumer safety.
Sources: Act on Food and Nutrition Safety (25 August 2006), Regulations (EC) No. 852/2004, (EC) No. 178/2002 and announcements of the Chief Sanitary Inspectorate.
Registration of dietary supplements in 2025 – changes and updates to regulations
1. Reporting to GIS via the Electronic Notification System (ESP)
A new dietary supplement must be reported online to GIS using the ESP system. The form requires the product name, manufacturer's data, label template in Polish and a detailed description of the composition. After an electronic signature, the report is sent to the public register, which allows legal sales to begin.
2. New product qualification criteria
Current regulations define supplements as products that complement the diet. GIS, in cooperation with experts, sets limits on the content of vitamins and minerals. If the composition of the product resembles the properties of drugs, it may be reclassified, requiring an additional opinion from the President of the Office for Registration of Medicinal Products.
3. Labeling requirements update
The label must clearly state that it is a “food supplement”, provide the recommended daily dose and warnings not to exceed the dose. In addition, the vitamin and mineral content must be presented both per serving and as a percentage of the reference intake, and provide instructions for safe storage, especially for the protection of children.
4. Advertising and sanctions
Advertising messages for supplements must clearly state that the product has no medicinal properties and does not replace a varied diet. It is prohibited to use the image of medical authorities or to direct advertising to children. Violations of these rules may result in high fines, and failure to report a supplement to GIS may result in financial sanctions of hundreds of thousands of złoty.
5. Obligations for producers and distributors
From 2025, companies are required to provide additional scientific opinions upon request from the GIS and to continuously monitor the safety of their supplements after they are placed on the market.
6. Registration of the establishment before starting the business
Before starting to produce or sell supplements, the entrepreneur must obtain an entry in the register of sanitary-hygienic establishments by submitting an application at least 14 days before the planned start of business. Only after receiving the registration number or an approving decision, the circulation of the product becomes legal.
Source: Official announcements of the GIS, the Ministry of Health and the publication of the Food Hygiene, Nutrition and Cosmetic Products Section on the gov.pl website
| Section | Content |
|---|---|
| Does the company commissioning the production have to register the plant, or only the manufacturer? | The obligation to register the establishment covers both the manufacturer and the company ordering the production of dietary supplements, if this company introduces the product to the market under its own brand. Every company operating in the food trade, including dietary supplements, must be listed in the register of establishments subject to sanitary control. |
| Registration obligations of companies engaged exclusively in distribution | Companies that exclusively distribute dietary supplements must also register their business. In the case of stationary sales, approval of the establishment by the Sanitary Inspectorate is necessary, while for mail order sales, entry in the register of establishments is sufficient. |
| Does the registration requirement apply to companies importing supplements from outside the EU? | Yes, importers of dietary supplements from outside the European Union must also register their establishment. Additionally, the importer is responsible for the compliance of the supplements with EU and national requirements and for notifying the products to the GIS. |
| Sanitary procedures for contract manufacturers | Contract manufacturers of supplements must adhere to the HACCP system and apply Good Manufacturing Practice (GMP) and Hygiene Practice (GHP). These plants are subject to regular inspections by the sanitary inspection authority. |
| Regulatory differences Poland vs EU | Polish regulations on the approval of establishments are in line with EU regulations, primarily Regulation (EC) No. 852/2004. Throughout the EU, there is an obligation to register an establishment before it starts operating. |
| Consequences of failure to register the establishment | Running a business without the required registration may result in a fine of up to PLN 5000 and an order to immediately suspend the business. Products may also be withdrawn from circulation and more serious legal consequences may arise if consumer health is endangered. |
| Information sources |
Registration of dietary supplements, notification
Introduction of a dietary supplement to the market
- Dietary Supplement Production Business – A Comprehensive Guide – In this guide, we provide detailed information on the costs and steps required to start a dietary supplement business. List of …
- How to produce a supplement and meet legal requirements? – Production of dietary supplements step by step – from developing a recipe, through business aspects, to meeting legal and quality requirements.
- Custom-made dietary supplements – Current business information – How long does it take to produce a custom dietary supplement? On average, 12–16 weeks, depending on the complexity of the recipe and the selected form of the supplement. How long …
- How to start producing dietary supplements? – Contract manufacturing encompasses everything from formula development, through raw material procurement, production, packaging, and distribution. It’s the perfect solution if …
- Production of dietary supplements - business, market, costs, regulations – You will learn why investing in the dietary supplement industry can bring high returns and how to properly plan each step to launch your own brand…
- Dietary Supplement Manufacturing: The Complete Guide – How Dietary Supplements Are Made: An overview of regulations, quality control, manufacturing processes, and trends in the dietary supplement industry.
- Dietary Supplements and Food Law: Poland, EU, USA and Other Countries – The Regulation of the Minister of Health on dietary supplements, available here, regulates aspects related to dietary supplements in Poland. Key points …
- How to Produce a Dietary Supplement – How to Get Started? Guide – In this simple guide you will learn how to produce your own dietary supplement in 6 steps – how to produce your own dietary supplement.
- Costs of production of dietary supplements in Poland | IOC – The cost of investment in the production of supplements on demand, the REAL average cost of producing a dietary supplement under your own brand in 2025 is PLN 40.000 (9500 EUR).
Summary
Introducing a dietary supplement to the Polish market requires careful preparation and meeting specific legal and quality requirements. Although the GIS notification procedure is not overly complicated, it is important to conduct it reliably, providing a complete set of necessary documents and ensuring the product complies with the regulations.
Remember that a dietary supplement – although very popular – must be safe for users. Systematic checks, research and label updates will allow you to keep the product on the market and at the same time gain the trust of consumers.
