Who can produce dietary supplements – a comprehensive guide to requirements and regulations

In 2022, the NIK report was published – the statistics were shocking. In the years 2017-2020, more and more dietary supplement manufacturers and wholesalers appeared on the Polish market every year. Consumer interest also grew regularly. More and more of us (according to the report, as much as 72%) declared using various types of preparations.

However, despite the popularity of supplements, the process of their production is subject to legal regulations. How restrictive and controlled are they? Can anyone become their producer?
In this guide, we explain the requirements and legal regulations for companies interested in producing dietary supplements in Poland.

Key conclusions

The dietary supplement market is developing very dynamically. It is estimated that its value in Poland in 2024 may amount to as much as PLN 7 billion.
Is it any wonder? This increase is not only due to the growing interest in a healthy lifestyle and increased awareness of health prevention, but also to the rather “unregulated” legal system regarding the production, certification and sale of dietary supplements – especially in comparison to pharmaceuticals.

The production of dietary supplements is regulated by regulations that are intended to ensure consumer safety. In order to operate legally, the manufacturer must meet certain formal, legal and technological requirements.

Key conclusions:

1. The manufacturer must have the appropriate technological facilities and comply with sanitary and hygienic requirements – in this matter, contract manufacturing of dietary supplements can be a great help.
2. Each dietary supplement introduced to the market must undergo the notification process at the Chief Sanitary Inspectorate.
3. The use of approved quality systems that define production standards is mandatory.

Basic information and formal and legal conditions for the production of dietary supplements

The production of dietary supplements in Poland is not available to every entrepreneur. It requires meeting specific requirements and adhering to quality and safety standards. Companies must ensure appropriate sanitary and hygienic conditions, implement approved production procedures and conduct a formal notification process.

Definition of a dietary supplement

A dietary supplement is a special food product. It serves to enrich a normal, daily diet and cannot replace a healthy, balanced diet. It is to be a source of concentrated nutrients (e.g. vitamins, minerals, amino acids or plant extracts), which reaches consumers in a form that allows its dosing. In this case, it is very important to control the content of active ingredients (it cannot be too high) and the production process itself.

The Food and Nutrition Safety Act of 25 August 2006 defines supplements as products that cannot be treated as medicinal products – which is associated with regulations regarding the concentration of active ingredients, labeling or advertising.

The following are distinguished:

• vitamin and mineral supplements,
• plant and herbal preparations,
• amino acid supplements,
• fatty acids,
• probiotics.

Requirements for manufacturers of dietary supplements

In order to be able to produce dietary supplements, a company must meet a number of requirements specified in Polish law. Each plant producing supplements must have facilities that will allow it to maintain the highest standards of quality and safety.

The manufacturer is obliged to implement systems that will provide full control over the production process – from raw materials to the finished product. It is required that all procedures comply with Good Manufacturing Practice (GMP), which specifies sanitary, hygienic and technological standards.

We mentioned earlier about contract production of dietary supplements – such a solution is becoming an increasingly popular choice for companies that want to introduce their own product lines. Why? Because it does not require investing in production plants and research and development facilities. This model allows the production process to be outsourced to an external entity that has the appropriate experience, infrastructure and certificates of compliance with applicable standards.

It is worth specifying that contract manufacturing of dietary supplements requires close cooperation between the client and the production contractor – it is the client who is responsible for the supplement’s compliance with the quality declaration.

Dietary supplement registration and certification process

Registration and certification of dietary supplements are two different processes.

• Registration means formally submitting a product to the appropriate office – in Poland, this is the Chief Sanitary Inspectorate. The entire procedure is carried out remotely and only requires completing the appropriate documentation. GIS may require additional information or corrections if the notification does not meet all formal requirements.
• Certification means granting the product a certificate confirming compliance with the required quality standards. In Poland, this is not mandatory. Obtaining additional documents (e.g. compliance with ISO standards) is voluntary and often used to increase the product’s competitiveness.

Other quality systems

The basic and mandatory system in the production of dietary supplements is the HACCP system (Hazard Analysis and Critical Control Point System).

When deciding to implement the HACCP system, a food manufacturer must remember that the following will be subject to detailed analysis:

• conditions in which the food production process takes place,
• documentation, which is also important in the process of conducting HACCP certification.

The HACCP certificate is issued for 3 years, and after that time a recertification audit is carried out.

In addition, surveillance audits are carried out every year, which are aimed at optimizing quality management processes.

The production process of dietary supplements

The production of dietary supplements requires meeting standards at every stage – from the selection of raw materials to the control of the finished product. Each ingredient and technological process must comply with the regulations specified by national and EU regulations, which aim to ensure the quality and safety of supplements.

Both contract manufacturers of dietary supplements and companies operating independently must comply with detailed control and documentation rules.

Requirements for raw materials

Raw materials used in the production of dietary supplements must be thoroughly controlled in terms of quality and safety. According to EU regulations, all ingredients must come from sources that have been previously verified and approved as safe.

This applies to the certainty of the origin of vitamins, minerals, plant extracts and other active or filler ingredients.

Production process control

The production process of dietary supplements is controlled both by internal units in the production plant and by external institutions – primarily the State Sanitary Inspection (PIS)

Plants producing supplements must implement the HACCP system mentioned above. The control takes into account both microbiological and physicochemical parameters. Its aim is to exclude the presence of heavy metals, pesticides, microbiological contamination and other potentially harmful substances. This increases the safety of products entering the market.

inspections are random in nature, but may also be the result of consumer reports of possible irregularities.
Dietary supplements must meet the requirements of Regulation (EC) No. 1924/2006 of the European Parliament and of the Council on nutritional and health claims.

In practice, however, the process of inspecting dietary supplements in Poland leaves much to be desired — mainly due to limited resources and institutional capabilities. Although PIS has the authority to conduct inspections at production plants, only a small percentage of dietary supplements available on the market are subject to actual verification.

PIS activities mainly include checking sanitary conditions and compliance of products with the declared composition and health claims on the label. It is worth noting, however, that the lack of extensive, systematic inspections means that some supplements may not meet the declared standards.

From the perspective of an entity focusing on quality, investing in the services of the best contract manufacturers of dietary supplements can significantly increase the credibility of the brand and contribute to building consumer loyalty. Although PIS carries out a limited number of inspections, it is not worth taking advantage of “legal loopholes”. It is worth cooperating only with a company that emphasizes its commitment to quality. What is important? Voluntary certificates, transparency and cooperation with certified laboratories.

Documentation and records

Each manufacturer (including a contract manufacturer of dietary supplements) is required to maintain documentation that is the basis for the control and verification of manufacturing processes.

Documentation required by law

In Poland, regulations require detailed documentation regarding the production of dietary supplements, which includes:

• HACCP documentation,
• specifications of raw materials that confirm their compliance with quality requirements,
• documentation of the production process, including details of each stage of production,
• certificates of suppliers and results of quality tests for each batch of raw materials.

Notifications and notifications

Before a dietary supplement is released on the market, the manufacturer must submit a notification to the Chief Sanitary Inspectorate. The notification must provide the composition, name and form of the product, indicate the manufacturer and attach a labeling template.

The notification process takes place online and after submitting the notification, the product can be placed on the market.

FAQ

We answer the most frequently asked questions. What is worth knowing about the production of dietary supplements?

Can anyone produce dietary supplements?

No, the production of dietary supplements requires meeting rigorous technological, sanitary and formal requirements. To produce supplements, you need to have the appropriate technological background and implement the required quality systems.

How much does it cost to start producing dietary supplements?

Launching even a small production line can require investments in the range of several hundred thousand zlotys. However, there are solutions that allow you to enter the market with a lower investment outlay. Contract manufacturing of dietary supplements? The price list is much more affordable.

What is the difference between the production of medicines and dietary supplements?

Medicines and dietary supplements differ primarily in their intended use and legal requirements. The production of medicines is subject to much stricter quality standards and requires obtaining a permit for trade from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Medicines must undergo multi-stage clinical trials that confirm their effectiveness and safety. Dietary supplements do not require such tests because they are treated as foodstuffs, not therapeutics.