To place food supplements on the Czech market, the food business operator must ensure compliance with two sets of regulations: EU legislation on food supplements and the notification requirements of the Czech Republic.
Since food supplements are classified as food, all applicable food law requirements must be fulfilled. This guide explains the food supplements notification process in the Czech Republic to successfully enter the market. It covers product formulation, classification, labelling, claims, and ongoing compliance details.
Regulatory Authority for Food Supplements in the Czech Republic
The following authorities regulate and control food supplements in the Czech Republic:
- Ministry of Agriculture (MZe): Receives the mandatory pre-market notifications for food supplements. The notification is for information only. It’s not for product approval.
- Czech Agriculture and Food Inspection Authority (SZPI/ CAFIA): Responsible for monitoring product safety, product labelling, inspections, and quality.
After the market starts, the food business operator is the responsible body for ensuring compliance with food law requirements.
What Are Food Supplements Under Czech Republic Regulations?
Food supplements are classified as foodstuffs in the Czech Republic. Under Section 2(1)(g) of Act No. 110/1997 Coll., these food products have the intention to supplement a person’s normal diet. They contain concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone, or in combination.
Companies market them in measured dosage forms such as capsules, pastilles, tablets, pills, powder sachets, liquid ampoules, drop-dispensing bottles, and other similar forms.
Food Supplements Notification Process in the Czech Republic
Food supplements in the Czech Republic are not subject to a conventional product registration or marketing-authorisation process. Instead, a food business operator that manufactures or places a food supplement on the Czech market must notify the Ministry of Agriculture before the product is first placed on the market. So, follow the process mentioned below for a compliant entry:
Step 1: Confirm Product Classification
The Ministry of Agriculture confirms that food supplements are classified as foodstuffs. CAFIA, on the other hand, says that they must not be presented as medicines or marketed with disease-treatment, prevention, or cure claims. So, companies need to review their product’s formulation, form of dosage, usage, daily consumption recommendation, ingredients, claims, or novel food status.
Step 2: Verify Ingredient Compliance
The ingredients used and their quantity should be according to EU and Czech Republic’s legislation. These are given in Decree No. 58/2018 Coll. on Food Supplements and Food Composition, as amended by Decree No. 368/2024 Coll., effective from 1 July 2025, laying down specific Czech requirements for food supplements.
These cover specific plants, minerals, vitamins, and other substances. The annexes in these decrees specify which substances can be used under specific conditions and when they are not allowed in manufacturing.
These annexes are not exhaustive, so other Czech and EU legislation may also apply. Companies should also determine whether an ingredient they used qualifies as a novel food under EU legislation before marketing the product.
Step 3: Prepare a Czech-Compliant Label
Print the product label in the Czech language. It should have all the information and warnings necessary according to Decree No. 58/2018 Coll. Check the labelling requirements below.
Step 4: Submit the Notification
Submit the Czech label and product information of the required product to the Ministry of Agriculture via SOP (Food Notification System) prior to the first marketing.
SOP allows operators to submit food-supplement notifications. Alongside, it lets them maintain a record of submitted notifications, download confirmation in Czech and English, and delete draft submissions. They can also enter a foreign company registration number.
Step 5: Place the Product on the Market
The Ministry states that it does not assess the product’s safety, laboratory results, composition, or labelling as part of the notification. The food business operator is fully responsible for compliance. So, after the notification, the product is allowed to be marketed until further inspection and market surveillance by SZPI.
Need help with food supplement notification in the Czech Republic? Artixio supports product classification, documentation, and notification for compliant market entry.
Documents Required for Food Supplements Compliance in the Czech Republic
The notification to the Ministry of Agriculture shall contain the Czech-language wording, including all mandatory product information. Other documentation may be necessary to prove compliance, based on the product.
Documents required:
- The name and designation of the product as a food supplement.
- The mandatory information required on labels is in the Czech language.
- Complete ingredient list and composition
- Recommended daily consumption
- The amount of active ingredients in daily dose/ per serving.
- Mandatory warning statements
- Details of the food business operator, whether it is the manufacturer, importer, or distributor.
Food Supplement Notification Timelines in the Czech Republic
The Czech Republic has a notification system for food supplements and does not have an approval system.
In general, the product can be put on the market once the required notification is made and the product meets the requirements of the relevant regulations. Products with novel ingredients or ingredients at the border of being novel will need further review.
Food Supplement Notification Costs in the Czech Republic
There is no fee charged by the Ministry of Agriculture for filing a food supplement notification. But businesses need to factor in the translation, formulation review, lab testing (if applicable), and regulatory consulting fees associated with the labels.
Compliance Checklist for Food Supplements in the Czech Republic
When introducing a food supplement to the Czech market, make sure that you have:
- Confirmed that a product meets the criteria for a food supplement.
- Confirmed that all ingredients are in line with EU and Czech standards.
- Evaluated if any component needs to be authorised as a novel food.
- Compiled a Czech-compliant label with required statements.
- Ensured all nutrition and health claims are in accordance with EU regulations.
- Filed a pre-market notification with the Ministry of Agriculture via the SOP system.
Czech Republic Labelling Requirements for Food Supplements
Dietary supplement labels should follow Czech and applicable EU food-information requirements. The label should display the following information:
- The name of the product is labelled as “food supplement”.
- Ingredients used
- Recommended daily consumption
- The active ingredients amount in each dose.
- Name and address of the food business operator
- For storage, as outlined, if applicable.
- Minimum durability date
Apart from these details, the following mandatory statements should also be on the label:
- Don’t use more than the daily recommended dose.
- Food supplements should not be considered a substitute for a varied diet.
- Keep it away from children’s reach.
Health Claims and Advertising Regulations for Food Supplements in the Czech Republic
Food supplements must only use health claims which are approved under Regulation (EC) No. 1924/2006. Claims have to meet the conditions of use listed in the EU Register.
No claims are allowed for disease prevention, treatment, or cure. Advertising should not include claims of health properties on supplements, claim that a balanced diet isn’t strong enough, or be misleading.
The Czech authorities monitor marketing on all labels, websites, social media, and other marketing materials. If not complied with, product withdrawal or administrative penalties may be applied.
GMP Requirements for Food Supplements in the Czech Republic
Food supplement manufacturers are held to the same standard as other food manufacturers with respect to product manufacturing to comply with the applicable food hygiene requirements and good manufacturing practice. A GMP certificate isn’t compulsorily needed for notification of a food supplement. Instead, companies should maintain appropriate food-safety and quality controls. They should support ingredient compliance, manufacturing hygiene, product safety, traceability, correct labelling, complaint handling, and corrective measures.
If additional technical documentation is needed for compliance for a particular ingredient or product, the operator remains responsible for maintaining it.
Voluntary Certifications for Food Supplements in the Czech Republic
The Czech Ministry of Agriculture identifies two relevant but completely voluntary certificates for food supplements as follows:
Certificate of Conformity of a Product or Food Business Operator
It confirms that a product or the activities of a food business operator comply with applicable legal requirements. It is a certification option, not a substitute for the mandatory food-supplement notification.
Health Safety Certificate — National Institute of Public Health (NIPH)
It provides a health-safety assessment/certificate through the National Institute of Public Health. It is a separate certification route, rather than a mandatory document for the basic notification.
Notification Obligations for Food Supplements in the Czech Republic
The Czech Ministry of Agriculture identifies three separate notification obligations relevant to food supplements. These cover notifications related to the commencement of business activities, placing the product on the market, and the recipient at the place of destination. Here’s an explanation table for these:
| Notification | Who is responsible? | When? | Where? |
| Food-business activity | Food business operator established in the Czech Republic | On commencement, change or termination of activities | CAFIA/SZPI |
| Placing supplement on market | Operator manufacturing/placing supplement on the Czech market | Before first placing on the market |
Ministry of Agriculture (MZe)
|
| Shipment at destination | Recipient of imported supplement consignment | At least 24 hours before arrival |
CAFIA/SZPI information system
|
Import Regulations for Food Supplements in the Czech Republic
Food supplements brought into the Czech Republic must meet the requirements of EU food laws and Czech national requirements.
Foods that are imported from outside the EU countries have to comply with food safety, labelling, composition, and notification conditions prior to being sold. Compliance with the product must be ensured by an EU-established food business operator.
Conclusion
Food supplements in the Czech Republic are not approved but are regulated on a pre-market notification basis. It is essential that companies ensure that their products meet the requirements for the composition, labelling, health claims, and notification prior to placing the product on the market in both Czech and EU legislation.
Artixio offers manufacturers, brand owners and importers end-to-end regulatory services throughout the EU and the Czech Republic. Get in touch with us for more information at info@artixio.com.
FAQs
Is Food Supplement Notification mandatory in the Czech Republic?
Yes. The food supplements should be notified to the Ministry of Agriculture prior to the first placing on the Czech market.
Is a product licence required for food supplements?
No. Food supplements are not subject to a product licensing procedure or product marketing authorisation; instead, they are subject to a notification procedure.
How much time does the Food Supplement Notification Process in the Czech Republic take?
The Czech notification system does not operate as a product-approval procedure with a stated approval waiting period. The food business operator must fulfil the notification obligation before the food supplement is first placed on the Czech market and remains responsible for ensuring that the product complies with applicable food legislation.
