Dietary Supplements in 2026

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.