The dietary supplement market in Poland and other EU countries is growing at a dizzying pace. However, before you start selling your own product, you have to deal with a number of formalities and legal requirements. The following article will help you go through the process of introducing a dietary supplement to the market step by step - from planning the recipe, through registration with the Chief Sanitary Inspectorate (GIS), to appropriate labeling and distribution.
Table of Contents
Market monitoring and control
Market planning and analysis
Before you start developing a supplement formula, it is worth conducting a detailed market analysis. Check which products are popular, what the competition looks like, and which niches are not yet developed. This will help you prepare a supplement that actually meets the needs of your future customers.
- Trend Research: Make sure the product fits into current health trends.
- Target group: Think about who your supplement is for: athletes, seniors, or maybe people who care about their beauty?
- Competition analysis: Find out how you can stand out from the brands already on the market.
Obligation to notify before introducing a supplement to the market
If you are introducing or intending to introduce to the market in Poland for the first time dietary supplements, foodstuffs for special purposes or enriched with vitamins and minerals – you must notify the Chief Sanitary Inspector (GIS) about this.
According to Polish law, every entrepreneur planning to introduce a dietary supplement to the market for the first time in the Republic of Poland must report this fact to the Chief Sanitary Inspector. This requirement results from the Food and Nutrition Safety Act, which requires the registration of each product in a specially maintained online register.
How to produce a dietary supplement?
- Step 1: Preparation of production equipment
- Step 2: Formula development
- Step 3: Selection of raw materials
- Step 4: Cost consideration
- Step 5: Placing order
- Step 6: Ordering raw materials
- Step 7: Testing of raw materials
- Step 8: Production process dietary supplement
- Step 9: Quality control
- Step 10: Packaging and labeling
- Step 11: Warehousing and distribution
- Step 12: Sale of dietary supplements.
Notification of placing on the market
- Obligation to notify: Those introducing dietary supplements to the market must report the product via the Electronic Notification System: nowy.gis.gov.pl/esp.
- Product register: The Chief Sanitary Inspector maintains a register of reported products, publicly available online.
This process is crucial because it allows regulators to monitor new products introduced to the market. This allows consumers to be sure that supplements offered for sale 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 label of a dietary supplement must be clear, accurate and not misleading to the consumer. It should include:
- Information about the recommended daily portion of the product.
- Warnings about the possible effects of exceeding the recommended dose.
- Note that the supplement cannot replace a varied diet.
- The definition that it is a “dietary supplement.”
Additionally, all advertising slogans must be legal and cannot suggest that the supplement cures or prevents diseases (unless this has been proven in the required procedures).
The procedure for reporting dietary supplements in practice
The electronic application form is available on the website of the Chief Sanitary Inspectorate. To complete it, you will need, among other things:
- Trade name of the product.
- Manufacturer and distributor data.
- Accurate quantitative and qualitative composition.
- Label template in Polish.
- Information about the form of the supplement (tablets, capsules, Powder).
After sending the necessary documents and paying any fees, you can start selling the dietary supplement. However, it is worth remembering to systematically check the regulations, because the regulations may change, and GIS has the right to re-evaluate a given product.
Production costs and development of dietary supplement
The production costs of dietary supplements depend on, among others, the raw material composition, the number of quality tests, the size of the print run (MOQ – Minimum Order Quantity) and type of packaging. Many companies choose contract manufacturing, which allows them to focus on marketing and sales, leaving the technological issues to professional production plants.
Tip: Before starting a project, it is worth estimating the budget, taking into account registration costs, laboratory tests and the costs of introducing the product to the market (marketing campaigns, distribution, etc.).
Frequently asked questions (FAQ)
Does every dietary supplement have to be reported to GIS?
Yes, according to Polish law, each dietary supplement introduced to the market in the Republic of Poland for the first time must be notified to the Chief Sanitary Inspector.
How much does it cost to register the supplement in GIS?
Registering a dietary supplement with GIS is free of charge.
Can a dietary supplement cure disease?
No. Dietary supplements cannot be treated as medicines and cannot be attributed with curative or preventive properties in relation to diseases. Their main task is to supplement the daily diet.
How long does the supplement approval process take?
The registration of a dietary supplement in GIS is mainly a form of notification, not an acceptance process. After submitting the documents and paying the appropriate fee, sales can usually begin. The time needed for formal entry in the register depends on the workload of the body.
Summation
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.
