To place health supplements on the Czech market, the manufacturer or the regulatory team must ensure compliance with two sets of regulations: EU legislation on food supplements and the notification requirements of the Czech Republic.
This guide explains the Health Supplements Registration Process in the Czech Republic to successfully enter the market.
Regulatory Authority for Health Supplements in the Czech Republic
Authorities that regulate health supplements are:
- Ministry of Agriculture (MZe): Gets the mandatory pre-market notifications for food supplements.
- Czech Agriculture and Food Inspection Authority (SZPI): Responsible for monitoring product safety, product labelling, inspections, and enforcement once products are on the market.
What Are Health Supplements Under Czech Republic Regulations?
Health supplements are considered a food product in the Czech Republic in accordance with Decree No. 58/2018 Coll., which implements Directive 2002/46/EC. They are intended to be used in addition to the regular diet and come in measured dose forms like liquids, powders, tablets, and capsules.
Products that qualify as health supplements can include:
- Vitamins and minerals
- Botanicals and plant extracts.
- Amino acids
- Other materials that have nutritional and/or physiological importance.
Also Read: Cosmetics Regulations & Registration Process in the European Union
Compliance Checklist for Health Supplement Approval in the Czech Republic
When introducing a health 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 novel food authorised.
- Compiled a Czech-compliant label with required statements.
- Ensured all nutrition and health claims are in accordance with EU regulations.
- Filed pre-market notification with the Ministry of Agriculture via the SOP system.
Health Supplements Registration Process in the Czech Republic
Follow the step-by-step process given below for a compliant entry to the Czech Republic for your health supplements:
Step 1: Confirm Product Classification
Ensure that the product can be called a food supplement and not be considered a medicinal product or novel food.
Step 2: Verify Ingredient Compliance
Check the formulation to make sure that all ingredients are allowed under Czech and EU legislation and restricted ingredients are covered.
Step 3: Prepare a Czech-Compliant Label
Print the product label in the Czech language with all the information and warnings necessary according to Decree No. 58/2018 Coll.
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.
Step 5: Place the Product on the Market
After the notification, the product is allowed to be marketed until further inspection and market surveillance by SZPI.
Need help with health supplement registration in the Czech Republic? Artixio supports product classification, documentation, and notification for compliant market entry.
Documents Required for Health Supplements Registration 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 intake
- The amount of active ingredients in the dose that is taken once a day.
- Mandatory warning statements
- Details of the food business operator, whether it is the manufacturer, importer, or distributor.
Also Read: Cosmetic Ingredient Compliance: US vs EU Banned Substances Comparison
Czech Republic Labelling Requirements for Health Supplements
The label should contain:
- The name of the product is labelled as “food supplement”.
- List of ingredients
- Recommended daily dose
- The amount of active ingredients in each dose.
- Name and address of the food business operator (FBO)
- For storage, as outlined if applicable.
- Minimum durability date
Every health supplement label should contain:
- Don’t use more than the daily recommended dose.
- Food supplements should not be relied upon as the sole source of food.
- Avoid use by children.
Only health claims authorised under Regulation (EC) No. 1924/2006 may be used. Claims made on labels and marketing materials should not be made to imply the product is used to prevent, treat, or cure disease.
Looking for a compliance audit? Artixio supports the validation of formulations, health claims, and Czech labelling before it hits the market.
Licensing Requirements for Health Supplements in the Czech Republic
In the Czech Republic, health supplements do not have to be licensed or need marketing authorisation. Rather, the food business operator should make a notification to the Ministry of Agriculture in advance of placing on the market.
Is a product licence required?
No. Health supplements are not regulated via a pre-market notification, but rather a licensing or approval process.
Business requirements
Manufacturers, importers, and distributors must be registered as a food business operator and must adhere to the Czech food law.
GMP Requirements for Health Supplements in the Czech Republic
Health 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 is not mandatory for notification of a food supplement; however, Czech food supplement manufacturers could get a GMP certificate from the Czech Agriculture and Food Inspection Authority (SZPI) after having successfully passed an inspection.
Health Claims and Advertising Regulations 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.
Import Regulations for Health 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.
Health Supplement Registration 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.
Health Supplement Registration 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.
Conclusion
Health 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 Health Supplement Registration 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 health supplements?
No. Health 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 Health Supplement Registration Process in the Czech Republic take?
The product can be sold once the notification has been submitted and it meets the requirements.
