Czech Food Supplement Notification

Basic legal concept: A food supplement is a food, not a medicine

Many entrepreneurs make a mistake right at the outset: a food supplement is not a medicinal product. This is precisely the key to understanding the entire regulatory regime. In the Czech Republic, a food supplement is classified under Act No. 110/1997 Coll., on Foodstuffs and Tobacco Products, as amended, as a food product intended to “supplement the normal diet with concentrated sources of nutrients or other substances with a nutritional or physiological effect”.

This distinction has fundamental consequences. While medicinal products undergo lengthy and costly clinical authorisation and must demonstrate safety and efficacy, food supplements do not need this process.

Instead, a notification regime applies – you must inform the public authority in advance about the product you intend to place on the market. This is not an approval process, but a notification. In practice, healthcare law is also relevant when assessing whether your product remains within the food (food supplement) regime and how to correctly set up the notification and labelling. The authority registers your notification and informs you that it has been received. Only then are you entitled to sell the product.

The Czech Republic also applies the so-called principle of responsibility of the food business operator. This means that the food business operator (manufacturer, importer, distributor) bears full legal responsibility for ensuring that the product is safe. Among other things, they must ensure that it does not contain prohibited substances, that all labelling is correct and that claims are supported by scientific evidence, in accordance with Regulation (EC) No 178/2002 and Act No. 110/1997 Coll..

If a food supplement appears on the Czech market containing a toxic substance or without the required notification, the logic is not that damage is first proven and only then addressed. Here, your product is seized, banned, and you may face high fines or criminal prosecution.

The attorneys at ARROWS, a Prague-based law firm, know exactly how this liability is applied in practice and what you risk if you downplay it. Therefore, we recommend that a Slovak company with food supplements entering the Czech market work with lawyers who know not only the law but also the practice of the Czech Agriculture and Food Inspection Authority (CAFIA) and the Ministry of Agriculture. If an inspection, seizure of goods or a dispute arises as to whether the authority’s procedure is proportionate, commercial and litigation disputes are typically also involved.

Correct product classification: Food supplement or medicinal product?

One of the most common issues that Czech and Slovak companies encounter is uncertainty as to whether their product is a food supplement or a medicinal product. This question determines the entire legal regime to which the product will be subject.

Under Czech legislation and EU law, a food supplement is “a foodstuff the purpose of which is to supplement the normal diet and which is a concentrated source of one or more of the following substances: a vitamin, mineral, amino acid, fatty acid, plant or part of a plant, microorganism or fungi or part thereof, or a combination thereof, including substances of a similar category” under Directive 2002/46/EC.

By contrast, a medicinal product is a natural or synthetic substance that has a significant physiological effect and is intended for the treatment, prevention or diagnosis of diseases, as defined, for example, by the State Institute for Drug Control (SÚKL) and Act No. 378/2007 Coll., on Pharmaceuticals.

In practice, the difference is often thin. The article when does a food supplement become a medicine? The thin line that authorities monitor also addresses the boundary between a food supplement and a medicinal product in more detail. When a company finds that it has added melatonin to a food supplement, it may seem harmless.

But as of 2026, melatonin may be contained in a food supplement at a maximum of 0.5 mg per daily dose (limit effective from July 2024), according to the recommendation of the Ministry of Agriculture. If you exceed this threshold, your product is no longer a food supplement, but a medicinal product.

A product classified in this way will be subject to entirely different rules, including the need for authorisation by the State Institute for Drug Control (SÚKL) and approval by the European Medicines Agency (EMA) for sale in the EU. Similarly, DHEA (dehydroepiandrosterone) was generally prohibited in food supplements in the Czech Republic until July 2025. As of 2026, it is still considered a “novel food”, which must be authorised by the European Union before being placed on the market under Regulation (EU) 2015/2283 on novel foods.

This boundary between a “supplement” and a “medicine” is constantly shifting. Some substances that were previously prohibited are now permitted, but only as novel foods with EU authorisation. Others can be used without restriction. It happens that an entrepreneur believes they have classified their product correctly, but the Czech State Institute for Drug Control (SÚKL) says during an audit: “This is a medicine, and therefore we must fine you for unlawful sales.” Fines here reach millions of Czech crowns under Act No. 378/2007 Coll.

Recommendation: If you have even the slightest doubt about the correct classification of your product, contact the lawyers at ARROWS advokátní kancelář. Our attorneys in Prague can consult with SÚKL or prepare a legal opinion that correctly classifies your product and saves you years of issues and unexpected fines.

Composition and safety: List of permitted and prohibited substances

Once you know your product is a food supplement, you must verify that all of its ingredients are legal. This is a huge topic, and underestimating it leads to the most common fines.

Vitamins and minerals: Exact forms and limits

If your food supplement contains vitamins or minerals, they may only be in the forms expressly listed in Annexes I and II of Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements. This means that, for example, vitamin C may be ascorbic acid, sodium ascorbate, etc., but not any “industrial form” or exotic derivative you come up with.

The chemical form matters because different forms have different bioavailability, and the authorities will want to know why you chose yours.

In addition, if you add vitamin D to the product, you must not exceed a certain maximum daily dose. The European Food Safety Authority (EFSA) has issued a so-called “Tolerable Upper Intake Level” (TUL) for each vitamin and mineral.

TUL is the maximum amount that is safe to consume daily over a long period without health risk; see EFSA reports. Exceeding the TUL is not merely a “choice” or a “marketing move”—it is a breach of safety requirements and may result in seizure of the product and a fine under Act No. 110/1997 Coll..

Prohibited substances: A new threat from July 2025

This is where a critical change comes in: Czech legislation (specifically Decree No. 58/2018 Coll., on food supplements and the composition of foods, as amended) previously prohibited adding certain substances to food supplements.

As of 1 July 2025, the rule changed and as of 2026 the presence of these substances is prohibited, regardless of whether they were added intentionally, as the Ministry of Agriculture points out.

What does this mean in practice? If your raw material for a food supplement comes from a plant that may contain traces of a certain prohibited substance (e.g., certain alkaloids), and you do not know about it or do not detect it, you are still in breach of the law. The state inspection authority may seize the entire shipment and fine you. This is a new development that many Slovak and Czech manufacturers seriously underestimate.

Prohibited substances include (among others):

• narcotic and psychotropic substances,
• substances with anabolic effects,
• certain herbal preparations (e.g., Ephedra, Yohimbe),
• substances for which toxic, mutagenic, teratogenic, or hallucinogenic effects have been demonstrated.

Novel foods

If your food supplement contains an ingredient that was not traditionally consumed as food in the EU before 15 May 1997, it is a novel food. Such an ingredient cannot be legally sold without prior authorisation by the European Commission based on an EFSA assessment, in accordance with Regulation (EU) 2015/2283 on novel foods.

Example: If you want to use a particular new botanical raw material obtained from a rare plant or from a plant originating from another continent, you must first submit it for approval to the European Commission. The process typically takes 3–5 years and costs hundreds of thousands of euros. Many manufacturers do not do this at all and sell the product illegally. SZPI then bans sales, and fines can be up to CZK 50 million under Act No. 110/1997 Coll..

Notification to the Ministry of Agriculture: A mandatory step with no alternative

This brings us to an absolutely essential step you must not skip. If you want to sell a food supplement at all, you must notify it to the Ministry of Agriculture of the Czech Republic BEFORE you place it on the market for the first time, under Act No. 110/1997 Coll..

What is notification?

Notification is not an approval or registration in the sense that you would wait to be approved. It is simply a notice by which you tell the state: “I am going to sell this product on the Czech market; here is its composition and labelling.”

The Ministry of Agriculture then registers you in its food supplement register (RoBaP) and issues you a confirmation of notification. From that moment, your notification is considered accepted and you may legally sell.

Mandatory documents for notification

For notification, you must prepare, in accordance with the Ministry of Agriculture’s instructions:

• Product labelling in Czech – the complete text that will appear on the packaging, exactly as you will sell it. It must include the requirements under Act No. 110/1997 Coll. and Decree No. 58/2018 Coll.
• Analyses and certificates
• Raw data – a list of all ingredients, their quantities, especially vitamins and minerals in the specified forms.
• Safety declaration – as the responsible person, you confirm that the product complies with Czech and EU legislation and does not contain prohibited substances, in accordance with Regulation (EC) No. 178/2002.

The notification procedure in practice

Notification is submitted to the Ministry of Agriculture of the Czech Republic via the Farmer’s Portal or a data box. The form is relatively standard, but every detail must be accurate. Errors in labelling or in the list of ingredients may lead the Ministry to return your notification as incomplete, and you will have to submit it again.

How long does it take? If your notification is correct and complete, it is recorded in the register immediately upon submission. There is no statutory waiting period for assessment. You are therefore authorised to sell immediately after the notification is accepted by the Ministry of Agriculture.

What is the cost? Notification is an administrative task, but the mandatory analyses and laboratory tests are not covered. You must order these yourself from accredited laboratories, which typically costs CZK 10,000 to CZK 50,000 depending on the scope of testing.

Labelling, packaging and health claims: The most common cause of fines

Errors in labelling and health claims make up the vast majority of findings during inspections by SZPI. The lawyers at ARROWS advokátní kancelář see in practice that companies may notify the product correctly, but then allow themselves certain “small details” on the packaging or in marketing that cost them tens to hundreds of thousands of Czech crowns.

Mandatory information on the packaging

On the packaging of a food supplement in the Czech Republic, the following must be stated in Czech, under Act No. 110/1997 Coll. and Decree No. 58/2018 Coll., and according to the Ministry of Agriculture’s guidance:

• Product name and the words “food supplement”
• List of all ingredients
• Content of vitamins, minerals and other active substances in the recommended daily dose
• Recommended daily dose
• Warning: “Do not exceed the recommended daily dose”
• Warning: “Food supplements are not a substitute for a varied and balanced diet”
• Warning: “Keep out of reach of children”
• Name and address of the manufacturer, importer or distributor
• Expiry date and storage conditions
• Batch identification number
• Declaration of individual food allergens (e.g., milk, eggs, legumes, etc.) in accordance with Regulation (EU) No 1169/2011 on the provision of food information to consumers.

If any of this information is missing, the Czech Agriculture and Food Inspection Authority (SZPI) will seize the product, ban its sale and fine you. Missing Czech-language text is a particularly serious breach and may result in a fine of up to CZK 50 million under Act No. 110/1997 Coll.

Health claims: The most commonly exceeded line

Many companies want to claim that their food supplement “boosts immunity”, “improves memory” or “reduces fatigue”. If you put this on the packaging or in advertising without the claim being on the EFSA list of authorised claims under Regulation (EC) No 1924/2006 on nutrition and health claims made on foods, you are breaking the law.

The European Commission has a list of approximately 260 authorised health claims that may be used legally in the EU and therefore also in the Czech Republic. Claims such as “supports the normal function of the immune system” are authorised on the list, but claims such as “cures flu” or “prevents cancer” are strictly prohibited — on both food supplements and foods.

The reality is that although EFSA has assessed more than 2,300 health-claim applications, over 70% of them were rejected due to a lack of scientific evidence. If your claim is not authorised, you cannot use it, and the ban applies across all media — packaging, websites, social media, advertising — under Regulation (EC) No 1924/2006.

Most common mistakes:

• Claims relating to the treatment or prevention of diseases (especially: “boosts immunity against COVID-19”, “treats arthritis”, “prevents dementia”)
• Unsubstantiated claims such as “clinically proven” when no study exists
• Claims in a foreign language without a Czech translation

If SZPI identifies an unauthorised health claim, it will seize your product, ban its further sale, and fines may reach CZK 50 million under Act No. 110/1997 Coll. And that is without even mentioning reputational damage and a potential lawsuit from a competitor, who may also pursue you for unfair commercial practices.

Risks of notification and labelling

Import and traceability: The obligation to track where each raw material comes from

If a Slovak company is the manufacturer and you (or its representative) are the importer into the Czech Republic, as the importer or distributor you have an obligation to ensure that the product complies with all Czech and EU safety regulations already at the moment you first take it over in the Czech territory under Regulation (EC) No 178/2002.

Notification of the arrival of goods

If your food supplement comes from another EU Member State (i.e., Slovakia) and enters the Czech Republic, you must file a notification of the arrival of goods with SZPI.

This notification is submitted via SZPI’s online form through the CAFIA system and forms part of compliance obligations under Act No. 172/2015 Coll., on the performance of controls of the import and export of food and feed and on amendments to certain related acts, and related implementing regulations. It must include:

• Name and identification details of the natural person or legal entity that is the first consignee of the goods in the Czech Republic
• Quantity and description of the product
• Origin (country of manufacture or the country from which it is exported)
• Expected arrival date

The notification must be submitted no later than 24 hours before the goods arrive. If you fail to do so, you will be in breach of Act No. 172/2015 Coll., and you may face a fine, as stated by SZPI.

Traceability system: Who knows what, and who knows it from whom

The basic principle of EU food legislation is the so-called “one step back and one step forward”. As an importer or distributor, you must be able to say from whom you received the goods and to whom you sold them (in accordance with Regulation (EC) No. 178/2002 laying down the general principles and requirements of food law).

This means you must have a contract with the Slovak manufacturer who will provide you with Certificates of Analysis (CoA), documents on the origin of raw materials, safety analyses and microbiological test results, and a declaration of compliance with EU legislation.

If it is later found that your product contains a prohibited substance, the Czech state inspection authority will be able to trace the route back to the manufacturer, and you will be able to demonstrate that you have fulfilled your duty to verify safety. Without such documentation, the Czech state inspection authority will turn to you, and you will be liable.

Laboratory testing: You must not rely only on a German set of tests

Many Slovak and Czech manufacturers believe that if they have analyses from a French or German laboratory, that is sufficient. In the Czech Republic, however, it is required under Act No. 110/1997 Coll. that the analyses come from a laboratory accredited under ISO/IEC 17025 and that they are available in Czech or at least in English.

Moreover, if SZPI has doubts during an inspection about the accuracy of the analyses, it may itself order independent testing from a state laboratory. If the results differ from your certificate, you become suspected of falsification and you may face both a fine and criminal liability.

Special situation: Online sales and social media

Recently, more and more food supplements have been sold via e-shops and social media. Here, the risk of breaching legal regulations is particularly high, because it is easy to write unauthorised health claims. Inspectors most often look for breaches there, as evidenced by SZPI inspections of online sales.

E-shop obligations

If you sell food supplements online, you have the same obligations as a brick-and-mortar store, plus additional ones:

• You must register as a food business operator with the State Agricultural and Food Inspection Authority (SZPI) and state that you operate an e-shop.
• If you have physical warehouses in the Czech Republic, you must submit a notification of these warehouses.
• All product information (composition, labelling, health claims) must be available directly on the website in the Czech language under Regulation (EU) No. 1169/2011 and Regulation (EC) No. 178/2002.
• If you have an e-shop, you must have an accurate description of whom the e-shop is intended for (the Czech Republic, the EU, etc.), because this determines which language versions and labelling you must have.
• Any advertising or health claim on the e-shop is regulated in the same way as on the packaging and must comply with Regulation (EC) No. 1924/2006.

Social media: A hidden advertising bomb

On TikTok, Instagram and Facebook, it is becoming common for “influencers” to promote food supplements with phrases such as “it changed my life”, “it really works”, etc. If you, as a food supplement company, pay these influencers, you are responsible for their statements.

If an influencer makes false statements or uses unapproved health claims, you may be fined by Czech state inspection authorities (e.g., the Czech Trade Inspection Authority (ČOI)) and also by consumers themselves under Regulation (EC) No. 1924/2006 and Act No. 40/1995 Coll., on the regulation of advertising.

The worst-case scenario is when you think you are giving an influencer a product for review and they then say something non-compliant. You can still be fined if it was clear that you “bought” their positive statement. It must always be clear that this is paid promotion (e.g., by using #reklama or #spolupráce) under the Advertising Regulation Act and Regulation (EU) 2017/2394.

Practical timelines and checklists

Before a Slovak company starts selling on the Czech market at all, it should create a realistic schedule. Most often, companies are mistaken in thinking that notification takes months. That is not true—the notification itself is immediate.

However, preparing all documents, verifying the product composition, and ensuring correct labelling can easily take 3 to 6 months, in line with guidance from the Czech Ministry of Agriculture.

Recommended schedule

Months 1–2: Preparation

• Collect all product analyses from European laboratories
• Verify that all ingredients are permitted and in permitted forms, and that they do not contain prohibited substances
• Prepare a draft Czech label
• Prepare a list of all raw material sources and their certificates

Month 3: Legal review

• Consultation with an attorney (e.g., from ARROWS advokátní kancelář) regarding the correct classification of the product
• Verification that the labelling meets all requirements under Act No. 110/1997 Coll., Decree No. 58/2018 Coll., and Regulation (EU) No. 1169/2011
• Verification that all health claims (if any) are on the list of authorised claims under Regulation (EC) No. 1924/2006 and are not misleading under Regulation (EC) No. 178/2002 
• Preparation of the notification form for the Ministry of Agriculture

Month 4: Filing the notification

• Filing the notification with the Ministry of Agriculture via the Information System for Food Notifications (ISPOP)
• Expected registration in the ISPOP system

Months 5–6: Initial rollout

• Ordering Czech packaging with legally compliant labelling
• Stocking the warehouse in the Czech Republic
• Setting up the e-shop (if you sell online) in compliance with Czech legislation

If you fall behind anywhere or need to carry out new analyses, the timeline can easily extend to a year or longer. The attorneys at ARROWS advokátní kancelář can help speed up the process by knowing which documents are most important and how to communicate with the authorities.

Sanctions and supervisory authorities: What are you facing if you do not do it properly?

When you say to yourself, “Please, what is the worst that can happen to me?”, your answer should always be: “The Czech Agriculture and Food Inspection Authority (SZPI) and the Ministry of Agriculture.”

SZPI and its powers

SZPI is a state administrative authority subordinate to the Ministry of Agriculture and has the right to enter your premises (warehouse, production facility, e-shop) without prior notice to verify that the product meets safety standards and is correctly labelled under Act No. 110/1997 Coll..

In 2024, SZPI imposed a total of CZK 189,056,750 in fines, which is 47% more than in 2023. The highest single fine reached CZK 5.25 million, as SZPI regularly reports in its press releases. The most common breaches concerned:

• Incorrect or missing labelling
• Illegal health claims
• Unapproved levels of active substances
• Presence of prohibited substances
• Lack of notification
• Presence of undeclared foreign allergens

Fines vary depending on severity. Minor breaches may be fined in the hundreds of thousands of CZK. Serious breaches (e.g., selling a product containing a toxic substance) may be fined up to CZK 50 million, regardless of the size of the company, under Act No. 110/1997 Coll., on Food and Tobacco Products.

In addition, SZPI may order under Act No. 110/1997 Coll.:

• Seizure of the product from the warehouse, shop, or e-shop
• A ban on the sale of a specific product
• Blocking of the e-shop (if you sell online without authorisation)
• An order to immediately withdraw the product from the market

Criminal liability

In the most serious cases (manufacturing and selling a product that contains a high level of a toxic substance and causes harm to consumers’ health), criminal liability may also apply under Act No. 40/2009 Coll., the Criminal Code. This means that not only are you facing a fine, but you may also end up in criminal proceedings before the local public prosecutor’s office.

If it is proven that you knew the product contained a toxic substance and you still sold it, this constitutes fraud or endangering human life and health, which are serious criminal offences.

Sanctions and impacts

How ARROWS advokátní kancelář can help

If it is unpleasant to read how many things you can do wrong, that is exactly why a Slovak company should work with the attorneys at ARROWS advokátní kancelář already when preparing to enter the Czech market—attorneys who specialise in food law and the regulation of food supplements under Czech legislation.

ARROWS attorneys can provide a legal review of your product range: verifying that each product is correctly classified as a food supplement and not as a medicinal product, and that it does not contain prohibited substances or unauthorised novel foods.

They can also assist with preparing the complete notification: preparing all mandatory documents, consulting with the relevant authorities (the Ministry of Agriculture, SZPI), filing the notification, and ensuring registration in RoBaP.

They will also ensure legally compliant Czech-language labelling: checking that all information on the packaging complies with Act No. 110/1997 Coll., that no illegal health claims are present, and that the label is legible and properly structured.

They will verify health claims: checking that each claim in marketing, on the website, or on social media is on the EFSA list and is not misleading under Regulation (EC) No. 1924/2006.

ARROWS attorneys will prepare contracts with importers and distributors: ensuring that your business partners in the Czech Republic have clear obligations regarding safety, traceability, and liability.

They will represent you in inspections and disputes: if SZPI initiates an inspection and identifies breaches, ARROWS attorneys will represent you, liaise with inspectors, and seek to minimise sanctions. Defence against fines: if SZPI imposes a fine, ARROWS attorneys can defend you in court proceedings.

Given that ARROWS advokátní kancelář is insured for professional liability up to CZK 400 million, you have the assurance that if an attorney makes a mistake, the insurer will reimburse any damages.

Final summary

At first glance, a Slovak company’s entry into the Czech market with food supplements looks like a simple procedural invitation—notification, labelling, sales. In reality, it is delicate manoeuvring in an environment where the smallest mistake costs thousands, tens of thousands, or millions of Czech crowns. The public authorities in this sector are not lenient towards breaches; the market is monitored thoroughly and fines are high.

Key points to remember:

• Notification is mandatory and unconditional: Without notification to the Ministry of Agriculture, you are not entitled to sell a food supplement. A breach can cost you up to CZK 50 million under Act No. 110/1997 Coll.
• All product ingredients must be lawful: As of 2026, even the mere presence of prohibited substances is banned, regardless of whether it was added intentionally, as stated by the Ministry of Agriculture.
• Labelling must be in Czech and include all mandatory information: Missing information is the most common reason for fines and product withdrawal from the market under the Ministry of Agriculture’s guidance.
• Health claims may only be taken from the EFSA list: An improvised claim without scientific substantiation automatically breaches the law under Regulation (EC) No. 1924/2006.
• The importer or distributor is the responsible person: If you represent a Slovak company, you bear full responsibility for the safety and correctness of the product on the Czech market under Regulation (EC) No. 178/2002.

If you take these points seriously and comply with them, entry into the Czech market will be smooth and safe. If you take them lightly, you risk sanctions that may cost you tens of millions of Czech crowns and may ultimately lead to criminal proceedings.

We recommend that you contact ARROWS advokátní kancelář already in the early stages of your strategy for entering the Czech market. The ARROWS attorneys are familiar with every detail of the legislation, know the practice of SZPI, and know how to avoid the most common mistakes. Investing in high-quality legal support now will save you millions of Czech crowns later.

Contact ARROWS advokátní kancelář via consultation@arws.cz and have a detailed legal and regulatory analysis of your product line prepared, which will protect you and give you peace of mind.

Read also:

• Dietary Supplements in 2026: Notification, Labelling and Compliance in Czechia
• EU Food Supplement Compliance: Notification, Claims, Labelling and Risks
• EU Health Claims for Food Supplements: Czech Rules and Liability Risks
• Which Czech Authority Regulates Your Health and Personal Care Product in 2026?
• Legal Duties for Storing Dietary Supplements and Monitoring Shelf Life