Dietary Supplements in 2026: Notification, Labelling and Compliance in Czechia

Mgr. Dita Zbožínková, LL.M.
Mgr. Dita Zbožínková, LL.M.
2.4.2026 | ARROWS law firm

If you are planning to manufacture or import dietary supplements, you must be prepared for mandatory administrative requirements involving the Ministry of Agriculture and the State Agricultural and Food Inspection Authority. Errors in documentation or labelling may result in fines of up to CZK 50 million and the product being withdrawn from the market. In this article, we explain exactly what you must submit under the legislation in force in 2026.

The photograph shows a lawyer discussing the topic of dietary supplement regulatory compliance.

Key takeaways

  • Notification is mandatory: Before placing a food supplement on the Czech market for the first time, you must fulfil the notification obligation towards the Ministry of Agriculture.
  • You must guarantee safety: The food business operator bears full responsibility for product safety. As part of your compliance documentation, you should have raw material specifications available and ideally laboratory analyses confirming safety.
  • Labelling must comply with regulations: The label must include mandatory information under applicable legislation and Decree No. 58/2018 Coll. Incorrect labelling is the most common reason for penalties.
  • Health claims are strictly regulated: On the packaging and in marketing, you may use only authorised claims or those included on the “on hold” list.

Legislative framework and key authorities

The sale of food supplements in the Czech Republic is subject to strict regulation. The core legal framework is set out in Act No. 110/1997 Coll., on Food and Tobacco Products, and the implementing decree on food supplements. It is crucial to understand that a food supplement is, from a legal perspective, a food product, not a medicinal product.

Four main institutions are involved in the process:

  • State Agricultural and Food Inspection Authority (SZPI): The main supervisory authority, which checks safety and labelling and has the power to impose fines or ban sales.
  • Ministry of Agriculture (MZe): The authority to which you submit the notification and which administers the relevant register.
  • National Institute of Public Health (SZÚ): An expert body that prepares professional opinions on the safety of ingredients.
  • State Institute for Drug Control (SÚKL): Decides in disputed cases whether a product is a medicinal product or a food supplement.

Operator registration and administrative obligations

Before you start the notification process for a specific product, you must be registered as a food business operator. Under the Czech Food Act, this registration is mandatory and must be completed no later than on the day you commence operations with the locally competent SZPI inspectorate.

When registering and during subsequent operations, your role is key:

  • Manufacturer: Responsible for the entire manufacturing process, composition, and labelling.
  • Importer (from non-EU countries): Fully responsible for ensuring that the imported product complies with Czech and EU regulations.
  • Distributor: Assumes responsibility for labelling and regulatory compliance if it places the product on the market under its own brand.

In practice, this means that if you have supplements manufactured to order or you import them, you must obtain documentation from the supplier proving safety.

Notification with the Ministry of Agriculture and label preparation

The most important specific obligation for food supplements is notification, i.e., notifying the placing on the market. The operator must send the Ministry of Agriculture the Czech-language labelling text and other information before the food supplement is placed on the market for the first time.

Notification is not an approval process, but a registration step, typically carried out electronically via the Farmer’s Portal or via a data box.

The label must include mandatory information:

  • Product name and the designation “food supplement”.
  • The names of the categories of nutrients or substances that characterise the product.
  • Recommended daily dosage and a warning against exceeding it.
  • A statement that food supplements are not a substitute for a varied diet and must be kept out of the reach of children.
  • The amount of vitamins, minerals, and other substances in the daily dose.

The label of a food supplement must not contain any claim declaring medicinal properties, as such claims are reserved exclusively for medicinal products.

Laboratory analyses and HACCP

Although the law does not explicitly require laboratory test reports to be attached directly to the notification, as an operator you have a general obligation to place only safe food on the market. You must have procedures in place based on HACCP principles and, during an inspection, demonstrate that you have done everything possible to ensure safety.

In practice, this means having available:

  • Raw material specifications: Confirmation of food-grade quality.
  • Microbiological analyses: Confirmation of the absence of pathogens under Regulation (EC) No. 2073/2005.
  • Chemical analyses: Verification of the content of heavy metals and other contaminants.
  • Verification of active substance content: Checking that the product contains the declared amount of substances.

For imports from non-EU countries, you should not rely solely on the manufacturer’s certificate, but carry out random checks in the EU, as methodologies in the country of origin may differ.

Comprehensive overview of SZPI powers and the role of SÚKL

The State Agricultural and Food Inspection Authority (SZPI) carries out on-site inspections, takes samples, and analyses them in its own laboratories. It focuses on physical safety, correct labelling, and compliance with the notification obligation.

Fines for breaches of the Czech Food Act may reach up to CZK 50,000,000, although in common practice for minor infringements they typically range from tens to hundreds of thousands of Czech crowns.

The State Institute for Drug Control (SÚKL) becomes involved if the product, by its composition or presentation, meets the definition of a medicinal product. The fine for placing an unregistered medicinal product on the market may, under the Czech Act on Pharmaceuticals, reach up to CZK 20,000,000.

Health and nutrition claims

The use of claims such as “supports immunity” or “improves memory” is governed by Regulation (EC) No. 1924/2006. You may use only those claims that have been authorised by the European Commission and are listed in the EU Register.

Types of claims:

  • Permitted health claims: Approved claims, provided the product meets the conditions.
  • “On hold” claims: For botanical substances, certain claims that have not yet been finally approved may also be used.
  • General non-specific claims: Must always be accompanied by a specific approved health claim.

You must always follow the exact wording or its meaning and must not attribute to a foodstuff properties of preventing, treating, or curing human diseases.

Most common questions on preparing documentation

1. Do I need to have the analyses carried out by an accredited laboratory in the Czech Republic?
The law does not directly require the laboratory to be Czech, but it must be credible. Results from an accredited laboratory (under ISO 17025) are decisive for the inspection authority.

2. How long does notification at the ministry take?
Notification is an administrative act that is fulfilled immediately upon delivery of the data. There is no waiting for approval, and the ministry only records the product in the RoBaP database.

3. What is Novel Food and why should you watch out for it?
If you want to use an exotic herb or a new synthetic substance that was not consumed in the EU before 1997, it may be a novel food. You must not place such an ingredient on the market without prior authorisation by the European Commission.

Risk and solution table

Possible issues

How ARROWS helps (office@arws.cz)

Incorrect label: Risk of a fine of up to CZK 50 million, obligation to relabel or withdraw.

ARROWS attorneys review labels under Act No. 110/1997 Coll. and EU regulations.

Missing notification: Breach of Section 3d of the Food Act, penalties for failure to comply with the obligation.

ARROWS will ensure proper submission of the notification to the Ministry of Agriculture and handle administrative communication.

Novel Food content: Immediate sales ban, high penalties.

ARROWS conducts legal research of the composition in EU databases and consults on the status of ingredients.

Borderline products: Risk of classification as an unregistered medicinal product.

ARROWS will prepare an analysis and opinion on the product classification and, if necessary, represent you in proceedings before SÚKL (the Czech State Institute for Drug Control).

Import and customs clearance: Detention of goods by customs due to insufficient documentation.

ARROWS provides support in customs proceedings and checks documentation compliance.

Notification vs. registration

It is necessary to distinguish between the terms notification and registration. Notification concerns food supplements, is directed to the Ministry of Agriculture, and is a unilateral act of notification. Registration is a complex authorisation process with SÚKL, which applies to medicinal products.

If you are not sure whether your product falls under the definition of a food supplement or a medicinal product, it is essential to carry out a legal and expert assessment. This will help you avoid the risk of selling an unregistered medicinal product.

Who is responsible for the documentation

Under European law, responsibility lies with the food business operator under whose name the food is placed on the market. If you are an importer, you bear full responsibility for compliance with EU law and cannot rely on an error by the manufacturer in a third country.

If you are a distributor selling a third-party brand, you must act with due professional care and not sell products that you know do not comply with regulations. Due diligence, i.e., supplier verification, is therefore essential.

Attorneys from ARROWS advokátní kancelář ensure, for their clients, the review of supplier contracts so that they include warranties and liability for quality defects and legal defects of the goods.

How an SZPI inspection proceeds

SZPI inspectors have the right to enter premises and warehouses, review documentation, and take samples. The inspection may be announced or unannounced, and if deficiencies are found, the inspection authority will initiate administrative proceedings.

In the case of serious errors, such as endangering safety or misleading consumers, the inspection authority imposes a ban on placing the product on the market and a fine.

Legal representation during the inspection and subsequent administrative proceedings can significantly affect the outcome. An experienced attorney will help with formulating objections to the inspection report or with minimising the imposed sanction.

Final summary

Placing food supplements on the market in 2026 requires more than just a good product and marketing. The key steps are operator registration, composition review, label preparation, securing evidence of safety, and notification to the Ministry of Agriculture.

If you want to save yourself trouble and unnecessary costs, it is advisable to consult the process with experts, for example with attorneys from ARROWS advokátní kancelář.

If you need legal assistance, contact ARROWS advokátní kancelář at office@arws.cz.

Most common questions

1. What are the most common mistakes on labels?
Errors in allergen declarations, failure to include the words “food supplement” in the name, missing warnings for specific groups, or the use of unauthorised medicinal claims.

2. How long does preparation take?
Notification is quick, but preparing a correct label, reviewing the composition, and any laboratory tests usually take 1–3 months.

3. Do I need to have a registered office in the Czech Republic?
For notification and sale, you need an entity established in the EU or an authorised representative. For imports from third countries, an entity in the Czech Republic or the EU acts as the importer with full responsibility.

4. What is the level of fines?
The statutory cap is CZK 50 million. In practice, fines for labelling errors are in lower ranges, but in cases of serious deception or endangering health they rise into the millions.

5. How often do inspections take place?
SZPI carries out inspections based on risk analysis and reports. New entities and e-shops are often subject to inspection actions focused on specific segments such as CBD or sports nutrition.

Notice: The information contained in this article is of a general informational nature only and serves for basic orientation in the matter under the legal status as of 2026. Although we take maximum care to ensure the accuracy of the content, legal regulations and their interpretation evolve over time. We are ARROWS advokátní kancelář, an entity registered with the Czech Bar Association (our supervisory authority), and for maximum client protection we are insured for professional liability with a limit of CZK 400,000,000. To verify the current wording of regulations and their application to your specific situation, it is necessary to contact ARROWS advokátní kancelář directly (office@arws.cz). We accept no liability for any damages arising from the independent use of information from this article without prior individual legal consultation.

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