Introduction of a dietary supplement to the Polish market
In order to introduce a dietary supplement to the Polish market, notification is necessary Chief Sanitary Inspector (GIS) about the intention to introduce the product to the market. This requires submitting an electronic notification, which should include data on the product, such as name, form, composition (qualitative and quantitative), labeling model in Polish and data of the entity introducing it. This procedure does not require product registration, but is necessary to legally introduce the supplement to the market.
Steps to introducing a dietary supplement to the market
-
Report to GIS
- Introducing a dietary supplement to the Polish market requires notifying the Chief Sanitary Inspector (GIS).
- Notification is made electronically via the e-Powiatowa website.
- The notification form must include detailed information about the product and theiocie introducing.
-
Labeling
- The labeling of a dietary supplement must meet the requirements specified in the regulations, including the regulations of the Minister of Health and the EU.
- The label should include information about the product name, manufacturer, form, ingredients, recommended serving size and warnings.
-
Fulfillment of legal requirements
- Please ensure that the product meets all food safety and quality requirements.
- It is worth checking whether the product contains only permitted ingredients and whether its composition is consistent with the declaration on the label.
-
Market and competition analysis
- Before introducing a product, it is worth conducting a market analysis to identify consumer needs and assess the competitive position.
- It is important that the product stands out from the competition, e.g. through a unique composition, formula or packaging.
-
Marketing and promotion
- A marketing strategy should be developed that takes into account the product's health benefits and attractive image messages.
- It is worth building a positive brand image by emphasizing quality, natural ingredients and care for the environment.
Additional Information
- The introduction of a dietary supplement does not require registration with the GIS, but registration is necessary.
- After reporting the supplement to GIS, it can be introduced to the market, but GIS may conduct inspections and, if necessary, take action, e.g. withdraw the product from the market.
- The entrepreneur must have appropriate permits depending on the method of sale (e.g. stationary or online).
Production of dietary supplements – requirements
The production of dietary supplements in Poland is subject to a number of legal requirements and regulations aimed at ensuring the safety and quality of products. Key aspects include:
- registration of the production plant,
- compliance with the principles of Good Manufacturing Practice (GMP),
- appropriate product labeling,
- meeting requirements for raw materials and production processes.
The production of dietary supplements requires meeting standards at every stage, from raw materials to the finished product. Each ingredient and technological process must comply with national and EU regulations to ensure their quality and safety.
Detailed requirements regarding the composition and labelling of these products are specified in the Regulation of the Minister of Health of 9 October 2007.
The production of dietary supplements involves several key steps: formulation, sourcing ingredients, production, quality control, packing i labeling. These supplements can be produced from natural sources such as plants and animals, by microorganisms, or by laboratory synthesis. The final product can take a variety of forms, including tablets, capsules, powders, and liquids.
Detailed process of producing dietary supplements
Formulation and sourcing of ingredients
- Formulation: This step involves determining the desired composition of the supplement, including the type and amount of each ingredient.
- Acquisition: Raw materials are obtained from a variety of suppliers; these are often plants, animals and chemicals.
- Badani: Ingredients undergo quality control testing to ensure their purity, potency and compliance with safety standards.
Production of supplements
- Mixing and blending: Ingredients are thoroughly mixed to create a uniform mixture, ensuring consistent dosing.
- Formation: The mixture is then made into the desired dosage form such as tablets, capsules or powders.
- Quality control: Quality checks are carried out throughout the production process to ensure that the product meets the required standards.
Packaging and labeling of supplements
- Packing: The finished product is packaged to protect against environmental factors and ensure stability.
- Labeling: Clear and accurate labels are required, including information about the product's ingredients, dosage instructions, and any necessary warnings. Labels must comply with Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers and other specific regulations regarding dietary supplements.
Compliance with EU regulations on dietary supplements
- In the European Union, dietary supplements are regulated as food. Manufacturers must comply Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements and other relevant regulations (e.g. on nutrition and health claims – Regulation (EC) No 1924/2006).
- Manufacturers must also comply Good Manufacturing Practices (GMP), to ensure product quality and consistency. Many aspects of EU GMP are covered in Regulation (EC) No 852/2004 on the hygiene of foodstuffs.
- Unlike the US, in the EU it is Member States are responsible for supervising the introduction of dietary supplements to the market, and the products must be notified and/ or Registered with the relevant national authorities before being introduced to the market in a given country.
Distribution of dietary supplements
- The finished product is then shipped to distributors or retailers, making it available to consumers.
Comprehensive guide: Dietary supplement production – requirements and stages
The production of dietary supplements is a dynamically developing industry that requires meeting a number of legal and quality requirements. Many people are thinking about entering this business, especially since it is estimated that the value of the supplement market in Poland in 2024 may reach up to PLN 7 billion, and consumer interest is huge - as many as 72% of Poles declare using supplements. However, before you learn how to produce a dietary supplement, it is worth getting to know the entire production process, understanding the business aspects and legal requirements for manufacturers.
The key to success is registration of the establishment in the relevant supervisory authorities, report of each product to the appropriate office and strict compliance hygiene and quality standards (e.g. HACCP system). It is also mandatory correct product labeling (label with required information and warnings) and maintenance comprehensive documentation production and quality control for each batch. Meeting these requirements is essential to legally and safely introduce a dietary supplement to the market.
Below we present a comprehensive guide to help you navigate the next steps from idea to finished product on the shelf.
Legal requirements and regulations for the production of dietary supplements in Poland
The production of dietary supplements in Poland is subject to a number of legal requirements and regulations aimed at ensuring the safety and quality of products. Key aspects include: registration of the production plant, following the rules Good Manufacturing Practice (GMP), appropriate product labeling, as well as meeting the requirements for raw materials i production processes.
-
Registration of the establishment:
An entrepreneur involved in the production of dietary supplements must register a plant in State Sanitary Inspection (PIS). It is required to submit an application for entry in the register of establishments subject to official control at least 14 days before the planned commencement of activity.
-
Report to GIS:
You should report the product to Chief Sanitary Inspector (GIS) along with the product specification, at least 14 days before it is put on the market. This process dietary supplement notification it's simply informing the health inspection that you are introducing a product to the market.
-
Good Manufacturing Practice (GMP):
The production of dietary supplements must comply with the rules GMP, which include hygiene standards, quality control, documentation of production processes and monitoring of contamination.
-
Product labeling:
Labels must contain precise information about ingredients, nutritional value, recommended doses, overdose warnings and information that the supplement does not replace a varied diet.
-
Raw materials:
The ingredients used in production must come from reliable sources and meet certain requirements. quality standards.
-
Production process:
Production should be carried out in a way that ensures security i product quality, taking into account microbiological requirements and other standards.
How to produce a dietary supplement step by step? Legal requirements and process
The production of a dietary supplement requires careful planning and implementation of several key steps. Here are the most important ones:
-
Idea and market research
Start by identifying a niche or market need. Determine what health problem you want to solve or what benefits you want your product to provide. Analyze the market – see what supplements already exist, what ingredients they have, and how you can differentiate yourself. A good understanding of customer needs is the foundation for the success of a new supplement.
-
Recipe development
Once you have an idea, proceed to create a recipe. Select active ingredients with documented performance and safety. Establish appropriate doses of vitamins, minerals, plant extracts or other substances. At this stage, you often work with a food technologist or pharmacist to select ingredients that will be effective and also compliant with regulations. Remember, a dietary supplement cannot contain prohibited ingredients and must be classified as a food, not a medicine.
-
Laboratory tests and trials
Before full production starts, it is worth preparing a test batch and testing it. quality tests. It checks, among other things. formula stability, taste (if it is e.g. syrup or powder for dissolving), solubility, and in the case of tablets or capsules – their durability and disintegration. It is also good to check the product for microbiological purity i heavy metal contentto ensure it meets safety standards.
-
Choice of form and production process
Decide what form you want to introduce the supplement in. There are many possibilities – tabletki, capsules, powder in sachets, syrup in a dropper bottle etc. The supplement must be in a form that allows for dosing and must meet specific form requirements (according to regulations and government recommendations). The choice of form affects the technological process: e.g. tableting requires tablet presses, and encapsulation - capsule machines. Make sure that the selected technology is suitable for your formulation. Also plan single package – whether it will be a blister in a box with a leaflet or a bottle with a label (the form of packaging must protect the product, e.g. the bottle should protect against light and moisture).
-
Production and quality control
Once you have an approved formula and technology, it's time for the actual production. It is crucial to ensure high quality standards at every stage. The production plant must meet sanitary and hygienic requirements - it is necessary to implement a system HACCP (Hazard Analysis and Critical Control Points) and good practices in food production. In practice, this means controlling raw materials, process i final product in terms of cleanliness and safety. The HACCP system is mandatory in many countries for the production of supplements. It is necessary to conduct documentation from each stage (recipes, production reports, inspection results) to demonstrate compliance with quality procedures. Before the product goes on sale, samples for laboratory testing confirming that each batch meets the standards (e.g. contains the declared amount of ingredients and is free from contaminants).
-
Labeling and packaging
Label and packaging designs must be prepared in parallel with production. The dietary supplement must be properly marked before it hits the market. The packaging (label) must include, among other things: the name of the category ("dietary supplement"), recommended daily dose, appropriate warnings (e.g. not to exceed the indicated dose, that the product does not replace a varied diet) and information about storing in a place inaccessible to children. The lack of required information on the label is a violation of the regulations. Also, make sure that all declarations such as "BIO", "ECO", "VEGAN" are true to reality (e.g. if the product is marked as vegan, the capsules cannot be gelatin, but plant cellulose). The finished product should be aesthetic and functional package – protecting the content and providing all the necessary information to the consumer.
-
Legal formalities and market introduction
After the first batch is produced, formalities must be completed in order to legally sell the supplement. Dietary supplements are treated as food in many countries, so introducing them to the market often does not require obtaining a permit or registration as in the case of medicines (however, it may require reporting to the appropriate office). In Poland, for example, each new dietary supplement must be reported to Chief Sanitary Inspector (GIS), including its composition, form, proposed label and information about the manufacturer. This process dietary supplement notification it is simply informing the sanitary inspection that you are introducing a product to the market. After sending the notification, you can usually start selling - you do not always have to wait for formal "approval" of the product. Remember, however, that the inspection authorities can inspect your plant and product at any time. That is why it is so important to meet all quality and legal requirements in advance.
-
Distribution and Marketing
The final step is to market and promote the product. Decide if you will sell the supplement online (e.g. through your own online store), in pharmacies, herbal shops or other channels. Prepare marketing materials that comply with the law – advertising a dietary supplement cannot attribute medicinal properties to it (this is an important difference in relation to medicines). Rather, emphasize the benefits for well-being or supplementing the diet, in accordance with permitted health claims. If everything has been buttoned up, you can celebrate – your dietary supplement reaches customers!
Dietary Supplement Production – Business Requirements and Market Aspects
From a business point of view production of dietary supplements can be very attractive, but requires a well-thought-out strategy. The production of dietary supplements as a business involves investments, market analysis and ensuring the right background. What is worth remembering when planning such a business?
-
A growing market, but also competition
As mentioned, the demand for supplements is high and constantly growing. This is good news for new manufacturers – there is no shortage of customers. However, a large market also attracts many competitors. Therefore, you have to reckon with competition and plan how you will distinguish your offer. Maybe a unique composition, your own expert brand, high quality confirmed by certificates? Finding competitive advantage is the key to success in the supplement industry.
-
Business plan and entry costs
Launching even a small production line involves significant the costs of producing dietary supplements. You need to buy or rent a suitably adapted premises (meeting sanitary standards), equip it with machines for the production of dietary supplements (mixers, tablet presses, capsule machines, packaging equipment), hire qualified personnel. In addition, there are expenses for quality testing, packaging, marketing... The sum can be considerable. If you do not have a lot of capital, there are other solutions, such as contract production.
-
Contract manufacturing or private label
Many start-up companies choose to work with a specialized manufacturer on a contract manufacturing basis. This allows you to enter the market with a lower capital investment, because you pay for the manufacturing service instead of investing in your own facility. Contract manufacturing prices are usually more affordable for small businesses. Another option is the so-called (private-label, where the manufacturer offers a ready-made supplement (from their catalog of recipes) with your own brand.
-
Quality and consumer trust
Remember that in the long run, the companies that win in the supplement industry are the ones that care about quality i customer trust. Although the legal requirements for supplements are less stringent than for drugs, this does not mean that you can afford to be mediocre. A supplement brand's reputation is built on the effectiveness and safety of its products. Therefore, from the beginning, focus on high quality ingredients, reliable research i transparency towards customers. You may also consider obtaining voluntary certifications (e.g. GMP – Good Manufacturing Practice, ISO 22000 for food safety) to increase credibility in the eyes of recipients.
-
Marketing and Education
Production alone is not everything – in the supplement business, the key is marketing. Prepare a solid promotion strategy your product. Use different channels: content marketing (e.g. educational articles on a company blog), social media, cooperation with dietitians or influencers from the fitness/health industry. Educate customers about the effects of your supplement ingredients to distinguish it from others. However, avoid unauthorized promises. Building a conscious brand and relationships with customers translates into long-term success.
Additional requirements and market aspects
-
Food safety:
Dietary supplements are treated as food products and are subject to regulations Food and Nutrition Safety Act.
-
Certifications:
Additional Certificates (NP. organicgluten-free, vegan) can increase the value of the product on the market.
-
Market monitoring:
It should be followed market trends and adapt the offer to changing consumer preferences.
Summary of requirements for the production of dietary supplements
When deciding on production of dietary supplements, remember that the global market is becoming increasingly diverse and regulated. Understanding the specifics of a given region, legal requirements and consumer preferences will allow you to effectively compete and develop your own brand. To fully use the potential of your product, take care of both the technological aspect (high-quality formula, certified ingredients, quality control) and the business aspect (precise market positioning, promotional strategy, logistics). Thanks to this, how to produce a dietary supplement and be successful will cease to be a secret and will become a real opportunity to create a profitable business that helps people around the world take care of their health.
