Food supplements are regulated as food products across the European Union, but market-entry procedures remain partly national. All three Baltic States apply national notification or registration procedures: in Estonia and Lithuania, food supplements must be notified to the national authority, while in Latvia they must be registered in the Food and Veterinary Service Register of Food Supplements. The timing, documentation, language requirements and fees differ between the three countries.
This Q&A explains how food supplements are notified or registered in Estonia, Latvia and Lithuania, the key differences between the three procedures, and practical considerations for companies planning a Baltic launch.
What EU requirements apply before a food supplement can be marketed?
A food supplement must meet the EU definition of products intended to supplement the normal diet and supplied in dose form, such as capsules, tablets, sachets, ampoules or dropper bottles. Key EU requirements include general food safety obligations, food information and labelling rules, rules on vitamins and minerals used in food supplements, novel food requirements where relevant, and restrictions on nutrition and health claims.
In practice, a company planning a Baltic launch should verify at least the following before notification or registration:
- food or medicinal-product classification
- permitted ingredients and ingredient forms
- vitamin and mineral levels
- novel food status
- warnings and mandatory statements
- national-language labelling
- operator details and food business operator documentation where required
- claims substantiation
- consistency between the label, website, advertising and other consumer-facing materials.
What are the food supplement notification requirements in Estonia?
Food supplements placed on the Estonian market must be notified to the Agriculture and Food Board no later than the day they are first placed on the market. The notification is free of charge, although official controls after notification may be subject to supervision fees.
The notification package should include:
- product labelling as it appears on the sales pack, including text, images, symbols and other consumer-facing information
- information about the product and the person placing the product on the market
- the date on which the product is placed on the market.
The label example must be readable and should be provided in Estonian and in the original language, unless the original packaging is already in Estonian. A product cannot be considered notified without the required labelling artwork.
Notification may be submitted through the national customer portal by Estonian-registered companies, or by email or post where applicable.
If the product contains botanicals or medicinal herbs, classification by the Agency of Medicines should also be considered. Full Latin names of the plants used in the product should be provided. A new notification is generally required if the product name, brand name, manufacturer or country of origin changes. Different pack sizes of the same product do not normally require separate notification.
What are the food supplement registration requirements in Latvia?
Food supplements must be registered in the Food and Veterinary Service Register of Food Supplements before they are placed on the Latvian market. Registration is subject to a state fee, and applications are typically processed within 20 working days.
The registration dossier should include:
- an application or notification form for registration
- Latvian-language labelling information
- labelling artwork
- proof of payment of the state fee
- an extract from the Business Register
- evidence that the responsible food business operator is registered or recognised, where required by the procedure.
Some supporting documents may not be accepted in English. Where required by the authority or the specific procedure, documents should therefore be translated into Latvian before submission.
The applicable state fee depends on factors such as the origin of the product and the registration scenario. The authority may register the food supplement or refuse registration if the product does not meet applicable food-law requirements.
Latvian requirements also need to be considered when preparing labelling and advertising. Food supplements must be presented as food products and must not be marketed as treating or preventing disease unless the relevant claim is legally authorised under EU legislation.
What are the food supplement notification requirements in Lithuania?
Food supplements must be notified to the State Food and Veterinary Service (SFVS) before they are placed on the Lithuanian market. The initial assessment and entry into the SFVS List of Notified Food Supplements typically takes around five business days, provided that all required documentation has been submitted.
Food business operators must notify the authority of food supplements produced in Lithuania and supplements imported for the first time into Lithuania from other EU, EEA or third-country markets.
A product may be placed on the market once it appears in the SFVS List of Notified Food Supplements. The authority does not normally issue a separate confirmation of notification, so the SFVS list needs to be monitored. A more detailed assessment may subsequently take up to 20 business days and may result in comments, requests for additional documentation or requirements to amend the labelling.
The Lithuanian notification dossier normally includes:
- a completed notification form
- Lithuanian-language label text or a label example in editable format
- information identifying the responsible food business operator
- proof of payment
- supporting product documentation
- evidence of food business operator registration or approval, where required.
Unlike in Estonia and Latvia, final labelling artwork is generally not required for the Lithuanian notification, which can allow the procedure to be initiated before final artwork approval.
As in the other Baltic States, market entry depends on correct product classification, compliant ingredients, national-language labelling and lawful claims. This applies not only to the physical label but also to online shops, advertisements, social media and distributor materials.
What are the main differences between Estonia, Latvia and Lithuania?
The main differences relate to the competent authority, market-entry mechanism, timing, language and submission requirements, and costs:
| Estonia | Latvia | Lithuania | |
| Competent authority | Agriculture and Food Board | Food and Veterinary Service | State Food and Veterinary Service |
| Market entry mechanism | Notification of food supplements marketed in Estonia. | Registration in the PVD Register of Food Supplements. | Notification to the State Food and Veterinary Service. |
| Timing | No later than the day the product is placed on the Estonian market. | The notification/registration must be completed before the product is placed on the Latvian market. The registration procedure is typically processed within 20 working days. | The notification must be submitted before the product is placed on the Lithuanian market. The notification is typically processed within 5 business days if the documentation is complete. Depending on the product origin and procedure, a more detailed assessment may subsequently take up to 20 business days. |
| Language and submission requirements | Estonian product information texts and artwork are required. Both can be uploaded via Client Portal. | Latvian product information texts in editable format (Word) and artworks required. | Lithuanian product information texts in editable format (Word) required. Artwork submission not required. |
| Costs | Notification is free of charge. Supervision fees may apply after controls. | State fee applies, with amount depending on origin of the product and registration scenario (e.g. EEA product, third-country product, first registration, variations). | State fee applies, with amount depending on origin of the product. |
Expert insight:
The most efficient approach for launching food supplements across the Baltics
For Estonia, Latvia and Lithuania, an efficient approach is to prepare one robust EU-compliant technical and labelling package and then adapt it to the national requirements of each market.
From a practical launch perspective, it can be beneficial to start the registration process in Latvia before proceeding with Estonia and Lithuania, particularly when a trilingual Baltic pack is planned.
Based on Medfiles’ experience, Latvia typically has the most demanding national procedure of the three Baltic States and tends to generate more authority questions. Starting with Latvia can therefore help identify issues that may affect the common Baltic packaging or documentation before the other national processes are finalised.
However, the optimal sequence should always be considered in relation to the specific product, documentation and planned launch schedule.
Checklist: What should companies prepare before starting a Baltic launch?
- Confirm that the product is a food supplement and not a medicinal product or another regulated product category.
- Check all ingredients, including botanicals, vitamin and mineral forms, additives and novel food status.
- Prepare country-specific labels in Estonian, Latvian and Lithuanian, ensuring that mandatory food supplement statements and warnings are included.
- Review nutrition and health claims against the EU Register and remove any unauthorised therapeutic or disease-related statements.
- Prepare notification or registration files separately for each country, reflecting national procedural requirements, including country-specific application forms, national-language label information, labelling artworks, fee documentation where applicable, and FBO certificate or equivalent operator confirmation where required.
- Ensure that online shops, distributor materials and advertisements are aligned with the notified label and do not include broader claims than the product file supports.
- Keep records of the product formula, specifications, supplier documentation, safety information, label versions, notification submissions and authority correspondence.
Keep in mind that notification and registration procedures are not product authorisations in the medicinal-product sense and do not transfer responsibility for compliance to the authority. The food business operator remains responsible for verifying that the product is safe, correctly classified, properly labelled in the national language and marketed without misleading or unauthorised claims.
How can Medfiles support food supplement market entry in the Baltic States?
Medfiles supports companies with food supplement market entry in Estonia, Latvia and Lithuania, from initial regulatory assessment to national notification or registration. Support can cover one specific regulatory question, an individual Baltic market or a coordinated launch across Estonia, Latvia and Lithuania.
Medfiles has 30 years of experience in food regulatory affairs, with local in-house experts across all three Baltic States and support available also at EU level.
Author: Veiko Sildever, Senior Regulatory Affairs Expert, Baltics
Veiko Sildever has worked at Medfiles since 2016 and has extensive experience in regulatory work across the Baltic countries. He has experience in leading the product portfolio of a major client operating in Estonia, Latvia and Lithuania, coordinating regulatory activities across a wide range of product categories.
Veiko graduated with honours from Tallinn Healthcare College. He has also completed additional studies in psychology at the University of Tartu, as well as several professional courses in regulatory affairs and distribution. Before joining Medfiles, Veiko worked in pharmaceutical companies and at the Tallinn City Ambulance.
At Medfiles, Veiko’s work includes managing product lifecycles, preparing and reviewing variation packages, coordinating CESP submissions for Estonia and Latvia, and maintaining communication with clients and regulatory authorities. Having worked with pan-Baltic regulatory projects for many years, he has strong practical knowledge of the regulatory requirements and working practices of the Estonian, Latvian and Lithuanian authorities. In addition to Estonian, he can work with documentation in neighbouring languages such as Finnish and Latvian, which helps streamline regulatory processes across the region.
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