EU Food Supplement Compliance: Notification, Claims, Labelling and Risks

25.3.2026 | ARROWS law firm

If you are planning to expand into the European market with your food supplements, you will face a complex regulatory environment that in practice often differs from your domestic one. This article provides a clear overview of the key obligations, risks, and practical steps you must strictly comply with to avoid costly mistakes and penalties. You will find specific answers to questions regarding notification, product composition, health claims, labelling, and other critical factors that determine the success of your expansion.

The photograph shows a lawyer / specialist focusing on the regulation of food supplements in the EU.

Key expansion steps: from notification to warehousing
Notification and registration: processes in individual EU countries
Product composition and permitted substances – stricter requirements than in the Czech Republic
Health claims and marketing restrictions
Distribution and warehousing – hygiene and registration requirements
Practical expansion examples and common mistakes
Certification and standards
Practical steps and an expansion timeline

Quick summary

Expanding a Czech manufacturer of food supplements into the EU market requires detailed knowledge of harmonised and national regulations, product notification in each target country, and compliance with strict labelling and health-claim rules. Many manufacturers are surprised that certain ingredient compositions permitted in the Czech Republic may not be acceptable in Germany or Italy.

Health claims used in one country are not automatically permissible across the EU. Without proper legal preparation, you risk sales bans, administrative fines, and mandatory product recalls, and each mistake can cost hundreds of thousands of Czech crowns or tens of thousands of euros.

Notification is not automatically universal: each EU Member State typically has its own notification procedure and specific requirements for the submitted documentation.
Harmonisation is not absolute: composition (especially herbs), vitamin limits, label warnings, and the interpretation of health claims differ from country to country.
Distribution and warehousing are subject to registration: if you plan your own distribution or warehousing abroad, you must meet local requirements for registering the establishment.

The EU regulatory environment and harmonisation of legislation

Familiarising yourself with the EU regulatory environment is the first essential step for any entrepreneur who wants to do business successfully in Europe. The European Union operates on the principle of harmonisation, where central legislation sets the basic rules for all Member States. Individual countries retain the right to implement their own rules in areas that are not fully harmonised.

For your business, the most important instruments are EU regulations, which are directly applicable in all Member States. Regulation (EC) No 178/2002 lays down the general principles of food law, including the primary responsibility of the food business operator and the traceability obligation. You must be able at any time to demonstrate where each ingredient in your product comes from and where you supplied the product.

It is important to understand one key point here: harmonisation is not total. Although the principle of mutual recognition (Cassis de Dijon) theoretically applies, for food supplements states often invoke exceptions on the grounds of “protection of public health”. ARROWS attorneys in Prague regularly encounter situations where a company safely sells a supplement in the Czech Republic, but in Germany or Austria a particular herb in the product is considered a medicinal product.

Key expansion steps: from notification to warehousing

If you want to enter the market in another EU Member State with a food supplement, you must proceed systematically. Skipping steps can lead to legal sanctions. The first step is always product classification. You must verify whether your product is indeed considered a food supplement in the target country. In the Czech Republic, the definition is set out in the Food Act, but abroad a product with a certain level of an active substance may already be considered a medicinal product. If you were to place an unregistered medicinal product on the market under the guise of a food supplement, this would be a serious offence.

The second step is preparing the documentation and the label. The label must be in the official language of the country where the product is placed on the market. A translation is not enough—it must be localised in accordance with Regulation (EU) No 1169/2011 and specific national decrees. For example, in Germany or France, specific warnings may be mandatory and must be stated using precisely prescribed wording.

The third step is checking the composition. Your supplement must contain only permitted forms of vitamins and minerals and other safe substances. Particular attention is required for so-called novel foods, which are subject to an EU-level authorisation process under Regulation (EU) 2015/2283. If your product contains exotic extracts or CBD, you must be certain about their status.

The fourth step is addressing health and nutrition claims. Regulation (EC) No 1924/2006 harmonises the rules, but interpretation differs, especially regarding the so-called “on-hold” list for botanicals. A claim that Czech supervisory authorities tolerate on the basis of the on-hold list may be assessed more strictly in another country, or specific efficacy documentation may be required.

Notification and registration: processes in individual EU countries

Notification (placing on the market notice) is mandatory for food supplements in many EU countries. In the Czech Republic, you fulfil this obligation towards the Ministry of Agriculture before the first placing on the market, and the data is entered into the RoBa register. The supervisory authority is the Czech Agriculture and Food Inspection Authority (SZPI).

Abroad, the processes differ:

Germany: Notification is carried out with the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL), and the process is strictly formal. The manufacturer or importer is obliged to notify the product via an online form on the BVL website before the first placing on the market; BVL itself does not assess or approve the product—responsibility therefore remains entirely with the manufacturer. The information is then forwarded to the competent authorities of the federal states and to the federal ministry.
Italy: Notification is carried out with the Ministry of Health (Ministero della Salute) via the NSIS online platform, which also publishes a list of notified supplements. The process requires detailed information on composition (botanical name, part of the plant, type of preparation, content of active substances), an Italian translation of the label, and payment of an administrative fee of €160.20 per product; after 90 days from filing without objections from the authority, the principle of tacit consent applies.
France: Uses the TeleIcare system (a portal operated by the DGCCRF – the Directorate General for Competition Policy, Consumer Affairs and Fraud Control); notification requires detailed composition information, including precise specification of herbal preparations and their safety warnings. For products containing substances outside the French positive list, a special preliminary procedure is required before sales begin; the competent supervisory authority is now the DGAL (Direction Générale de l'Alimentation).

Lawyers from ARROWS advokátní kanceláře handle notifications on behalf of the client, eliminating language barriers and procedural errors.

An important aspect is traceability. Under Article 18 of Regulation (EC) No 178/2002, you must have a system in place that identifies the supplier of each batch and the recipients (excluding final consumers). In the event of an inspection or the need to withdraw a dangerous product, you must respond immediately.

As regards registration in the EudraGMDP system, this primarily concerns medicinal products. For food supplements, the key requirement is registration of the food business operator with the locally competent supervisory authority, not in a medicinal products register.

Product composition and permitted substances – stricter requirements than in the Czech Republic

The list of permitted vitamins and minerals is harmonised in the EU, but maximum limits are not. The European Food Safety Authority (EFSA) issues recommendations, but countries set their own levels. Vitamin D may have a limit of 2,000 IU in one country and only 1,000 IU for food supplements in another.

The situation is even more complex for herbs and “other substances”. Some countries are trying to harmonise their lists, but Germany takes a very restrictive approach and considers many herbs primarily as medicinal products.

Control of contaminants is also important. Regulation (EU) 2023/915 sets strict limits for lead, cadmium and mercury, as well as for mycotoxins or PAHs in food supplements. The manufacturer must have documentation from raw material suppliers (COA – Certificate of Analysis) proving that the limits are met. Also watch out for prohibited substances such as titanium dioxide (E171).

Health claims and marketing restrictions

Regulation (EC) No 1924/2006 distinguishes between nutrition claims (“source of vitamin C”) and health claims (“vitamin C contributes to the normal function of the immune system”). Health claims must be authorised by the European Commission and listed in the so-called EU Register of Health Claims.

A specific category is botanicals (plant substances), for which an “on-hold” list exists. For these substances, claims that have been submitted for assessment may be used, provided they are scientifically substantiated and do not mislead consumers. However, Member States’ approaches to the “on-hold” list differ in the details of enforcement.

An absolute ban applies to medicinal claims. A food supplement must not “treat”, “cure” or “prevent” diseases. Only wording about supporting normal physiological functions is permitted.

Labelling and language requirements

Regulation (EU) No 1169/2011 on the provision of food information to consumers is the “bible” of labelling. Mandatory particulars include the name of the food, the list of ingredients, highlighting of allergens, the quantity of certain ingredients (QUID), the net quantity and the date of minimum durability. You must also state the name and address of the food business operator (FBO), instructions for use, dosage and specific warnings. Everything must be in a language understandable to consumers in the country of sale, typically the official language. The minimum font size is 1.2 mm.

Distribution and storage – hygiene and registration requirements

Unlike medicinal products, you do not need a special “distribution licence” in the EU to distribute food supplements. However, you are a food business operator. If you set up a warehouse abroad, you must register this establishment with the local food control authority. You must have an HACCP system (hazard analysis and critical control points) in place adapted for storage and comply with hygiene rules under Regulation (EC) No 852/2004. If you use external fulfilment, the obligation to register the warehouse falls on the fulfilment provider, but you remain the responsible person for the safety of the goods.

Table of risks and practical impacts

Risks and sanctions	How ARROWS can help (office@arws.cz)
Incorrect product classification: The product is considered a medicinal product (not a supplement) in the target country. This may result in withdrawal from the market and criminal prosecution for unlawfully placing a medicinal product on the market.	Legal analysis (borderline products): We will verify the status of the ingredients and the classification in the target country based on case law and administrative practice.
Failure to notify: The authority identifies an unnotified product. A fine and a sales ban may follow.	Arranging notification: We will handle the notification on your behalf with the relevant authorities (BVL, Min. Salute, etc.).
Non-compliant composition/contaminants: Exceeding contaminant limits (e.g., PAHs, heavy metals) or using a prohibited form of a vitamin. Batch recall, fine, entry in the RASFF system.	Compliance review: We will assess raw material specifications and propose the scope of laboratory testing under Regulation (EU) 2023/915.
Unauthorised claims: Use of medicinal claims or unauthorised health claims. Fine for misleading consumers.	Review of labels and marketing: We will review packaging, your website and social media and propose wording that is compliant yet still effective from a marketing perspective.
Labelling errors: Missing translation, incorrect font size, failure to list allergens. Order to relabel or withdraw packaging.	Label preparation: We will prepare text materials for designers in line with Regulation 1169/2011 and national decrees.
Traceability failure: Inability to document the origin of a raw material during an inspection. High fine under Czech food law.	Process audit: We will help set up contractual arrangements with suppliers and internal record-keeping processes.

Practical examples of expansion and common mistakes

A common scenario is a company exporting a product containing melatonin. In the Czech Republic, melatonin is permitted in food supplements, but in some EU countries it is considered exclusively a medicinal substance or the limits are significantly lower. A manufacturer that only translates the label will face an immediate ban.

Another example is CBD (cannabidiol). Although the situation is evolving, in many countries CBD in food supplements is considered an unauthorised novel food and authorities actively crack down on its sale.

A third example is failure to register for packaging recycling. When entering a market (e.g., Germany, Austria, France), you must comply with packaging take-back obligations (systems such as LUCID). Failure to do so leads to high fines that are unrelated to product quality but stem from waste legislation.

Certifications and standards

Retailers often require safety and quality certifications beyond what the law requires. These include HACCP, international GFSI standards (FSSC 22000, IFS Food) or organic (BIO) certification. ARROWS attorneys in Prague can assist you with the legal framework for contracts with certification bodies and preparation for audits.

Practical steps and an expansion timeline

A realistic market-entry timeline includes, in the first month, a legal analysis of the composition and a label gap analysis. In the second month, the recipe and texts are adjusted. The third month is dedicated to laboratory testing and notification. In the fourth month, registration in packaging systems and logistics are addressed.

International aspects and ARROWS International

The attorneys at ARROWS, a Prague-based law firm, specialise in international trade and food law. Thanks to our membership in international networks, we have partners in all EU countries and beyond (the UK, Switzerland, the USA). We can ensure not only regulatory compliance, but also legal support with setting up branches, structuring distribution agreements and tax registrations.

Conclusion

Expanding into EU markets is a major opportunity, but it requires meticulous regulatory preparation. Relying on the “single market” without understanding national specifics for food supplements is risky. The ARROWS attorneys in Prague are ready to guide you through this process, minimise the risk of sanctions and ensure a smooth entry into foreign markets. Contact us at office@arws.cz.

FAQ – Most common legal questions about expanding abroad

1. Is notification in the Czech Republic sufficient for sales across the EU?
No. Notification in the Czech Republic (with the Ministry of Agriculture) is valid only for the Czech market. To sell in another country, you must meet that state’s notification requirement, if it applies.

2. Do I need to have my own company abroad?
To sell food supplements, you generally do not need to set up a foreign subsidiary. You can sell as a Czech entity (directly to consumers or to a distributor). However, you must address VAT (OSS) and product liability.

3. What are the most common reasons for problems with authorities?
Use of unauthorised medicinal claims, exceeding national limits for vitamins/minerals, the presence of prohibited substances (novel foods, unauthorised herbs), and errors in mandatory labelling in the local language.

4. Can I change the recipe after notification?
If a change to the recipe affects mandatory information (list of ingredients, amounts of key substances, nutritional values), it is effectively a new product and the label must be updated and, as a rule, a new notification must be made or the change must be reported.

5. What are the sanctions?
Fines range from hundreds of euros for minor administrative errors to tens of thousands of euros for misleading consumers or endangering health. A significant sanction is also an order to withdraw the product from the market at the manufacturer’s expense.

6. How much do legal services for expansion cost?
The price depends on the number of products and target countries. A basic label review and notification in one country typically costs in the lower tens of thousands of Czech crowns. A comprehensive expansion set-up is priced individually. For a quote, email office@arws.cz.

Notice: The information contained in this article is of a general informational nature only and is intended to provide basic guidance based on the legal framework as of 2026. Although we strive for maximum accuracy, legal regulations and their interpretation evolve over time. We are ARROWS, a Prague-based law firm, an entity registered with the Czech Bar Association (our supervisory authority), and for maximum client protection we maintain professional liability insurance 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 directly (office@arws.cz). We accept no liability for any damages arising from the independent use of the information in this article without prior individual legal consultation.

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