Legal Requirements for Launching Dietary Supplements in the Czech Republic

Are you planning to launch a dietary supplement on the Czech market and looking for information regarding licensing? The answer might surprise you – no specific license is required. In this article, our Prague-based legal team provides an overview of all legal requirements you must meet under Czech legislation before placing a dietary supplement on the market, helping you avoid financial penalties and unnecessary delays.

License or notification? Basic legal framework for dietary supplements in the Czech Republic

Many entrepreneurs mistakenly assume that launching a dietary supplement on the market requires a license similar to that for pharmaceuticals. The reality is different. Dietary supplements are not medicinal products, but foodstuffs – specifically foodstuffs intended to supplement a normal diet. Specific legal obligations under Czech law arise from this classification.

A food business operator wishing to place a dietary supplement on the market for the first time in the Czech Republic has a notification obligation toward the Ministry of Agriculture. This is a notification, not an approval process. The Ministry of Agriculture does not assess the correctness of the composition or the effectiveness of the product – it merely receives the notification. In practice, this means that before the first launch of a dietary supplement on the market, you must send the Czech text of the labeling, including all mandatory food information that will be listed on the packaging, to the Ministry of Agriculture.

This notification obligation may seem simple, but in practice, it contains many pitfalls. You must not only correctly label the product but also avoid using prohibited substances, comply with limits for permitted substances, and ensure that your marketing text does not slip into medicinal claims, which are prohibited for dietary supplements. For an immediate solution to your situation, write to our Prague-based attorneys at office@arws.cz.

FAQ – Legal tips for launching a dietary supplement on the Czech market

1. Do I need a trade license to sell dietary supplements?
Yes, if you intend to manufacture, distribute, or sell dietary supplements, you need a trade license. The specific type of license depends on whether you will be manufacturing or just selling finished products. If you manufacture plant-based dietary supplements, a notification to the Czech Agriculture and Food Inspection Authority (CAFIA) is sufficient. For animal products, registration with the State Veterinary Administration is required. 

2. How long does the notification at the Ministry of Agriculture take?
Notification is not an approval process with a set deadline. The Ministry of Agriculture only receives the notification and stores the information. After submitting the notification, you can place the dietary supplement on the market. In practice, we recommend waiting for confirmation of receipt of the notification. 

What the notification must contain and how to submit it correctly

You submit the notification by sending the Czech text of the product labeling, including all mandatory food information that will be listed on the packaging of the dietary supplement. The preferred form is electronic submission, but a paper version can also be used.

The label of a dietary supplement must contain the following mandatory information under Czech legislation:

• The designation "doplněk stravy" (dietary supplement) as part of the product name
• A list of ingredients indicating all substances, including vitamins, minerals, and other substances with a nutritional or physiological effect
• The recommended daily dose of the product
• A warning not to exceed the recommended daily dose
• A statement that the dietary supplement is not a substitute for a varied and balanced diet
• A statement that the product must be stored out of reach of children
• The content of nutrients or substances with a nutritional or physiological effect in the recommended daily dose

When preparing the notification, you will encounter a number of detailed requirements that are not obvious at first glance. For example, selecting the correct health claims requires knowledge of Commission Regulation (EU) No 432/2012, which contains a list of permitted health claims. Using an unapproved claim can lead to a fine of up to CZK 50 million. 

Our law firm in Prague regularly prepares notification documentation for dietary supplements and helps clients avoid sanctions. Contact our Czech legal team at office@arws.cz.

Risks and Sanctions	How ARROWS helps (office@arws.cz)
Incorrect or incomplete notification: Fine up to CZK 500,000 for failure to fulfill the notification obligation.	Preparation of complete notification documentation with verification of all mandatory data, ensuring correct submission to the Ministry of Agriculture.
Missing mandatory data on the label: Fine up to CZK 50,000,000 for misleading labeling, withdrawal of the product from the market.	Review and preparation of labels with legal assessment of all data, checking compliance with Regulation 1169/2011.
Use of prohibited substances: Fine up to CZK 50,000,000, immediate withdrawal of the product, blocking of the e-shop.	Legal analysis of product composition, assessment of compliance with Decree No. 58/2018 Coll. and Regulation 1925/2006, consultation with specialized laboratories.

Prohibited substances and permitted composition: what is allowed and what is not

The area of dietary supplement composition is strictly regulated and undergoes frequent changes. The basic regulation in the Czech Republic is Decree No. 58/2018 Coll., on dietary supplements and food composition. From July 2025, a fundamental change applies: the prohibition now applies not only to the addition of prohibited substances but also to their mere presence in the dietary supplement. 

This change has significant impacts on manufacturers and importers, who must monitor whether their products contain prohibited substances, even if no one added them intentionally.

Annex No. 2 of Decree 58/2018 Coll. contains a list of plants prohibited in food production and a list of certain other substances prohibited in food production. Prohibited substances include, for example, narcotic or psychotropic substances, drug precursors, substances with anabolic and other hormonal effects, and other substances for which toxic, genotoxic, teratogenic, hallucinogenic, narcotic, or other adverse effects on the human body have been proven.

In July 2025, specific amendments were made to the list of permitted and prohibited substances under Czech law. Melatonin is now permitted up to 0.5 mg per daily dose – exceeding this threshold classifies the product as a medicinal product. Substances such as DHEA (dehydroepiandrosterone) and 5-hydroxytryptophan (5-HTP) were removed from the list of prohibited substances as they are considered potential "novel foods," the regulation of which is subject to European Union mandates.​

In addition to these specific substances, when formulating a dietary supplement in the Czech Republic, you must ensure that vitamins and minerals are in the forms listed in Annexes I and II of Directive 2002/46/EC. Their quantity in the daily dose must be proportionate and must not exceed the safe upper limits established by European legislation.

A highly complex area is that of "novel foods." These are foods or food ingredients that were not used for human consumption to a significant degree within the European Union before May 15, 1997. If your dietary supplement contains a novel food, you must have it approved by the European Commission based on a safety assessment conducted by the European Food Safety Authority (EFSA). 

This procedure is demanding in terms of both time and finances, often taking several years. Our Prague-based attorneys at ARROWS will assess whether your product contains a novel food and assist you with preparing the application for approval or finding alternative solutions. Contact us at office@arws.cz.

Health and nutrition claims: what you are permitted to promise

One of the most sensitive areas when placing dietary supplements on the Czech market is the use of health and nutrition claims. This issue is governed by Regulation (EC) No 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on foods.

The fundamental rule is: you must not attribute properties to dietary supplements regarding the prevention, treatment, or cure of human diseases. This means you cannot claim that your supplement "treats osteoarthritis," "eliminates pain," or "addresses the cause of your health problems." 

Such formulations are considered therapeutic claims, and their use may lead the State Institute for Drug Control (SÚKL) to reclassify your product as an unregistered medicinal product. In such a case, you face a fine of up to CZK 2,000,000 for promoting an unregistered drug, and your marketing department would move from the relatively lenient regulation of the Czech Agriculture and Food Inspection Authority (SZPI) into the strict jurisdiction of SÚKL.

Health claims that you may use must be approved by the European Food Safety Authority (EFSA) and published in the relevant European Commission regulations. The list of permitted health claims is contained in Commission Regulation (EU) No 432/2012. Typical permitted claims include, for example, "vitamin C contributes to the normal function of the immune system" or "calcium is needed for the maintenance of normal bones."

In practice, however, it is not enough to simply use an approved claim. You must also meet a number of accompanying requirements:

• Include a statement on the importance of a varied and balanced diet and a healthy lifestyle
• Specify the quantity of the food and the pattern of consumption required to obtain the claimed effect
• Provide a warning for persons who should avoid consuming the food
• Include an appropriate warning if excessive consumption of the product may represent a health risk

Furthermore, you must demonstrate that the substance to which the claim relates is contained in the product in a sufficient quantity to produce the beneficial nutritional or physiological effect. 

The ARROWS law firm in Prague provides expert legal opinions on the use of health claims, prepares label texts and marketing materials in accordance with Czech and EU regulations, and represents clients in disputes with the SZPI or SÚKL. For a consultation, please contact us at office@arws.cz.

In addition to the rules mentioned above, advertising for dietary supplements is subject to the Czech Act on the Regulation of Advertising. Every advertisement for a dietary supplement must contain the clear text "doplněk stravy" (dietary supplement), which must be easily legible in printed advertisements. Failure to comply with this obligation can result in a fine of up to CZK 500,000. 

Risks and Sanctions	How ARROWS Assists (office@arws.cz)
Use of unapproved health claims: Fine up to CZK 50,000,000, ban on using packaging, withdrawal from the market.	Preparation of health claims in accordance with Regulation 432/2012, review of all marketing materials and labels.
Therapeutic claims in advertising: Reclassification as an unregistered drug, fine up to CZK 2,000,000 from SÚKL.	Revision of all advertising copy, training for the marketing team, preparation of legally compliant alternatives.
Missing "dietary supplement" text in advertising: Fine up to CZK 500,000 from the Regional Trade Licensing Office.	Compliance check of advertising with the Czech Act on the Regulation of Advertising, preparation of internal marketing guidelines.

Production hygiene and the HACCP system: manufacturer obligations

The production of dietary supplements is subject to strict hygiene requirements set by Regulation (EC) No 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs. This regulation establishes general hygiene requirements applicable to all stages of production, processing, and distribution of food. 

Every food business operator must implement, perform, and maintain a permanent procedure based on HACCP (Hazard Analysis and Critical Control Points) principles. The HACCP system requires you to identify critical points in the production process where the risk of compromising product safety is highest and to monitor them regularly. Specifically, this involves:

• Analyzing all potential hazards during production, processing, and distribution
• Identifying Critical Control Points (CCPs) where control is essential to prevent or eliminate a hazard
• Establishing critical limits for these points
• Implementing a system to monitor the CCPs
• Establishing corrective actions for cases where monitoring indicates a CCP is not under control
• Establishing a system to verify that the HACCP system is working effectively
• Maintaining documentation and records

For smaller businesses, implementing an HACCP system can be challenging. In practice, however, a well-set system significantly reduces the risk of defects and protects the entrepreneur from sanctions by Czech inspection authorities. Furthermore, many distributors – especially in large-scale retail – require certification according to standards such as IFS or BRC, which are built upon HACCP principles.

In addition to the HACCP system, production facilities must comply with further hygiene requirements set out in Annex II of Regulation 852/2004. These requirements concern, for example, the construction and layout of premises, hand-washing facilities, lighting, ventilation, water supply, personal hygiene of employees, and other aspects. 

ARROWS law firm in Prague provides legal advice on implementing the HACCP system, prepares documentation for certification bodies, and represents clients during inspections by the Czech Agriculture and Food Inspection Authority (CAFIA). For a consultation, please contact us at office@arws.cz.

CAFIA inspections and potential sanctions: what to expect in case of non-compliance

The Czech Agriculture and Food Inspection Authority (CAFIA) is the primary supervisory body for dietary supplements in the Czech Republic. It monitors safety, quality, proper labeling, and promotion of dietary supplements. In 2024, CAFIA imposed final fines totaling CZK 189,056,750, representing a 47% increase compared to 2023. The highest individual fine amounted to CZK 5.25 million.

The most common inspection findings regarding dietary supplements include:

• Incorrect or misleading product labeling
• Use of medicinal claims
• Unauthorized or unapproved health claims
• Failure to meet notification obligations to the Czech Ministry of Agriculture
• Presence of prohibited substances in the product
• Lower content of active substances than declared on the packaging
• Presence of undeclared allergens

Fines for violations of food law in the Czech Republic range from several thousand to 50 million CZK. The amount of the fine depends on the severity, scope, and duration of the violation. For repeated misconduct, CAFIA imposes higher sanctions. In addition to fines, CAFIA may:

• Prohibit the use of packaging or labels for dietary supplements
• Seize dietary supplements before they are placed on the market
• Order the withdrawal of dietary supplements from the market
• Block websites offering non-compliant products

A very sensitive sanction is the publication of the non-compliant product in the media, which can lead to an immediate loss of trust among consumers and business partners.

During an inspection, CAFIA inspectors have the right to enter premises, take samples, inspect documentation, and conduct investigations. If they find deficiencies, they issue an inspection report, against which you can file objections. Objections must be filed within a short deadline and formulated professionally; otherwise, the report becomes the basis for initiating administrative proceedings to impose a fine. 

At this stage, it is crucial to have legal representation that can assess the severity of the findings and prepare a qualified defense. Our Prague-based law firm provides legal assistance during CAFIA inspections, prepares objections to reports, and represents clients in administrative proceedings regarding fines. Do not hesitate to contact our office – office@arws.cz.

FAQ – Legal tips on sanctions and inspections

1. How long do administrative proceedings for imposing a fine take?
Administrative proceedings can last from several months to over a year depending on the complexity of the case and the number of hearings. After a decision is issued, you have the right to appeal, which is handled by a superior authority. The entire process, including potential appeals and subsequent judicial review in Czech courts, can take several years. 

2. Can I continue selling while administrative proceedings are ongoing?
If CAFIA has not ordered the withdrawal of the product from the market or prohibited its sale, you may continue selling even during administrative proceedings. However, we recommend immediately rectifying the identified deficiencies, as this can lead to a reduction of the fine or termination of the proceedings. 

International element: how to proceed with import and export

If you import dietary supplements from abroad or export them, you must account for additional legal obligations. For the import of dietary supplements into the Czech Republic, the product must meet all requirements of Czech and European legislation. This means it must comply with Decree No. 58/2018 Coll., Regulation 1925/2006, Regulation 1169/2011 on food information to consumers, and other relevant regulations.

When importing from countries outside the European Union, you must also verify whether the product contains substances that are prohibited in the EU but permitted in the country of origin. A typical problem involves dietary supplements containing plant extracts that have not yet been approved as novel foods in the EU. Another risk is insufficient quality control – CAFIA regularly detects the presence of heavy metals, pesticides, or undeclared substances in imported dietary supplements.

The importer bears full responsibility for placing safe and properly labeled products on the market. For this reason, it is essential to have a properly drafted contract with the supplier governing responsibility for product quality and safety. The contract should include:

• The supplier's commitment that products meet all legal requirements of the Czech Republic and the EU
• The supplier's obligation to provide documentation proving the safety and composition of the products
• The supplier's liability for damages caused by a defective product
• The importer's right to withdraw from the contract in case of non-compliance with legal regulations

For export, you must verify the requirements of the target country. These requirements may differ significantly from European legislation. Some countries require registration of each individual product, others set their own limits for vitamins and minerals or have a different list of prohibited substances. 

ARROWS law firm provides comprehensive legal services for the import and export of dietary supplements, including the preparation and review of supplier contracts, negotiation of terms, and representation in disputes. If you are seeking financing or a business partner for purchase or sale, please contact us – office@arws.cz.

Thanks to the ARROWS International network built over a decade, we routinely handle cases with an international element and provide legal services outside the Czech Republic. Our experience in providing long-term services to more than 150 joint-stock companies, 250 LLCs, and 50 municipalities and regions allows us to quickly and efficiently resolve even complex international transactions.

Specific situations: what to do when your product is on the borderline between a dietary supplement and a medicinal product

One of the most complex legal issues is determining whether your product is a dietary supplement or a medicinal product. This question is not always straightforward and, in case of doubt, is assessed by the State Institute for Drug Control (SÚKL). 

SÚKL does not decide on other specific categories – it only determines whether it is a medicinal product. If it is, you must withdraw the product from the market and apply for registration as a medicinal product, which is a very time-consuming and costly process under Czech legislation.

The main differences between a dietary supplement and a medicinal product lie in the purpose of use and the mode of action:

• A food supplement is intended to supplement a normal diet and has no proven medicinal effect under Czech law.
• A medicinal product has curative or preventive properties and has undergone clinical trials proving its efficacy.

In practice, the way the product is presented is decisive. If you use therapeutic claims for a food supplement (e.g., "treats osteoarthritis," "eliminates pain," "protects against disease"), the State Institute for Drug Control (SÚKL) may reclassify the product as an unregistered medicinal product, regardless of its actual composition. This reclassification results in an immediate sales ban and the threat of high fines in the Czech Republic.

If you have doubts about whether your product is correctly classified, you can request an assessment from SÚKL. This procedure takes several months and is subject to a fee. In practice, however, it is an investment that can save you much higher costs associated with fines and product recalls from the Czech market. 

The Prague-based law firm ARROWS prepares documentation for SÚKL product assessment requests, represents clients in communication with SÚKL, and provides legal assistance during product reclassification if necessary. For a consultation, please contact our Czech legal team at office@arws.cz.

Risks and Sanctions	How ARROWS Assists (office@arws.cz)
Reclassification of a food supplement as an unregistered medicine: Fines up to CZK 2,000,000, immediate sales ban, criminal liability.	Preventive product and marketing assessment, preparation of SÚKL assessment requests, negotiations with SÚKL authorities.
Uncertainty regarding product classification: Risk of inspections, uncertainty in business relationships.	Expert legal opinion on product classification, analysis of composition and presentation, recommendations for further action.
Import of products from the EU with a different regime: A product approved in another Member State may not comply with Czech legislation.	Analysis of compliance with Czech legislation, preparation of documentation for Czech authorities, ensuring mutual recognition.

Practical steps: how to launch a food supplement on the Czech market without risk

After reviewing the information above, you may feel that bringing a food supplement to market is an extremely complex process. And you are right – the legal framework is extensive and constantly evolving. That is why it is advisable to entrust the entire agenda to experts. Our attorneys in Prague handle these matters daily, significantly reducing time and minimizing the risk of errors for our clients.

The basic steps for launching a food supplement on the Czech market can be summarized as follows:

Step 1: Legal analysis of product composition
Before any investment in production or importing goods, it is essential to verify that the product contains only permitted substances and does not fall under the novel food regime. This analysis requires knowledge not only of the Czech Decree No. 58/2018 Coll., but also relevant European regulations and the novel food list. If problematic substances are identified, we can suggest recipe adjustments or alternative procedures.

Step 2: Preparation of labeling and packaging
The label must contain all mandatory information and must not be misleading. Crucial is the correct selection of health claims from Regulation (EU) No 432/2012 and avoiding any medicinal claims. During label preparation, we also check nutritional values, allergens, and other specific requirements under Czech law.

Step 3: Notification to the Ministry of Agriculture
Before the first placement on the market, we submit the Czech labeling text, including all mandatory information, to the Czech Ministry of Agriculture. We prefer electronic submission, which is faster and allows for better monitoring of the proceedings.

Step 4: Ensuring hygiene requirements
For manufacturers, we ensure the implementation of the HACCP system and compliance with all hygiene requirements set by Regulation (EC) No 852/2004. For distributors and importers, we handle registration with the Czech Agriculture and Food Inspection Authority (SZPI) and prepare supplier documentation.

Step 5: Preparation of marketing materials
We review all advertising texts, websites, e-shops, and other promotional materials for compliance with the Czech Act on the Regulation of Advertising and health claim requirements. We also train marketing teams on what they can and cannot claim.

Step 6: Ongoing compliance monitoring
Legislation is constantly changing, and the SZPI is tightening inspections in the Czech Republic. Therefore, we recommend regular reviews of documentation and labels at least once a year or whenever legislation changes.

In practice, this entire process is much more complex than it appears. Real-world steps involve hidden exceptions, procedural details, links to other regulations, and risks that a layperson often overlooks. For example, choosing a specific health claim requires not only knowledge of Regulation 432/2012 but also an understanding of European case law and current EFSA opinions. 

Incorrect selection of claims can lead to a fine of up to CZK 50 million and a recall of the entire batch from the market. ARROWS law firm is insured for damages up to CZK 500,000,000. It is therefore safer for the client to have the matter professionally secured. We also commonly act as partners to in-house counsel for specialized matters.

Why entrust the launch of a food supplement to ARROWS law firm

As noted above, launching a food supplement on the market is a legally complex process requiring detailed knowledge of both Czech and European legislation. Any error can lead to high fines, product recalls, or even criminal liability. ARROWS law firm specializes in food law and has been providing comprehensive legal services in the field of food supplements for over fifteen years.

Our services include:

• Legal analysis of product composition with assessment of compliance with Decree No. 58/2018 Coll. and identification of potential novel foods
• Preparation of complete documentation for notification to the Czech Ministry of Agriculture
• Review and preparation of labels with verification of all mandatory data and health claims
• Review and preparation of contracts with suppliers, distributors, and customers
• Expert training for your marketing and sales teams
• Legal consultations on implementing HACCP systems and ensuring hygiene requirements
• Representation during inspections by SZPI, SÚKL, and other Czech authorities
• Representation in administrative proceedings regarding fines and preparation of appeals
• Obtaining SÚKL opinions in case of doubts regarding product classification

Thanks to our international network, ARROWS International, we can also provide legal services for the import and export of food supplements abroad. We handle cases with international elements practically every day and have experience with the legislation of numerous European and non-European countries.

It is important for our clients to know that our experience stems from providing long-term services to more than 150 joint-stock companies, 250 limited liability companies, and 50 municipalities and regions in the Czech Republic. We pride ourselves on speed and high quality. The ARROWS law firm in Prague is insured for damages up to CZK 500,000,000, providing our clients with additional security. We also regularly act as partners to in-house legal counsel for resolving specialized matters and complex cases under Czech law.

If you are looking for financing or a business partner for a purchase or sale in a given area, we can connect our clients with each other if they have interesting investment or business opportunities. And we are always happy to hear interesting entrepreneurial or business ideas.

If you want to launch a dietary supplement on the market safely and without unnecessary risks, contact the ARROWS law firm in Prague at office@arws.cz. Our Czech legal team will provide you with expert legal advice and ensure all documentation is in full compliance with Czech and EU regulations.

FAQ – Most frequent legal questions regarding launching dietary supplements on the Czech market

1. How much does it cost to launch a dietary supplement on the market?
Costs depend on the complexity of the product and the scope of services. Notification to the Czech Ministry of Agriculture is free of charge. Costs arise during the preparation of documentation, legal analysis of the composition, review of labels, and potential assessment by SÚKL (the State Institute for Drug Control) if the product is on the borderline between a dietary supplement and a medicinal product. Average costs for legal services range in the tens of thousands of Czech koruna, which is a fraction of the potential fine for incorrect product placement. If you are dealing with a similar issue, contact us at office@arws.cz.

2. Can I sell dietary supplements on an e-shop without notification?
No. The notification obligation to the Czech Ministry of Agriculture must be fulfilled before the first placement of the dietary supplement on the market in the Czech Republic. This applies to both brick-and-mortar stores and e-shops. The Czech Agriculture and Food Inspection Authority (SZPI) also conducts inspections online and in 2023 found non-compliant results in 48% of inspected dietary supplements sold online. 

3. Do I have to notify each individual product separately?
Yes, the notification obligation applies to every single dietary supplement. If you are launching multiple products on the Czech market, you must notify each of them separately. In the event of a change in composition or labeling, a new notification must be submitted. For bulk preparation of notifications, contact our Prague-based attorneys at office@arws.cz.

4. What happens if I sell without fulfilling the notification obligation?
You face a fine for failure to comply with the notification obligation, likely in the hundreds of thousands of Czech koruna. Furthermore, the SZPI can ban further sales of the product, order its withdrawal from the market, and block your e-shop. If the product also contains prohibited substances or has incorrect labeling, the total fine can reach up to 50 million CZK under Czech legislation. 

5. How do I know if my product contains a "novel food"?
Assessing whether a product contains a novel food requires expert analysis. The European Commission maintains a list of approved novel foods (Union list). If your product contains an ingredient that is not on this list and was not used for human consumption in the EU before May 15, 1997, it is likely a novel food. For a legal assessment of your product under Czech and EU law, contact us at office@arws.cz.

6. Can I use the label provided by a foreign supplier?
Not without a review. The label must meet Czech and European legal requirements, which may differ from the requirements of the country of origin. Especially when importing from countries outside the EU, it is necessary to completely check and often redesign the label. Typical problems include the use of unauthorized health claims, missing mandatory information, or the presence of substances prohibited in the EU. 

Disclaimer: The information contained in this article is for general informative purposes only and serves as a basic orientation on the issue. Although we ensure maximum accuracy of the content, legal regulations and their interpretation evolve over time. To verify the current wording of regulations and their application to your specific situation, it is essential to contact the ARROWS law firm in Prague directly (office@arws.cz). We bear no responsibility for any damages or complications arising from the independent use of information from this article without our prior individual legal consultation and expert assessment. Every case requires a tailored solution; therefore, do not hesitate to contact our Czech legal team.