B2B knowledge base

Compliance for products with functional mushrooms in the EU

Compliance means alignment of product communication with European Union food law. For brands launching food supplements, functional food, cosmetics and beverages with functional mushrooms in Poland and the EU, three regulatory pillars apply: Regulation (EC) 1924/2006 on nutrition and health claims, the Polish Food and Nutrition Safety Act, and supervision by GIS, UOKiK and URPL. This page is a practical FAQ for our B2B clients, based on the legal framework in force in 2026. Aloha Fungi is not a law firm. Treat this page as a map for first contact, not as a legal opinion.

Why compliance is critical for your brand

The most common problem for brands entering the functional mushroom category does not come from the raw material. It comes from language. The word "cures", "miraculous", "immunity boost" or "instant effect" on a label or in a product description can trigger one of three paths: GIS proceedings on the supplement notification, a UOKiK decision with a financial penalty for unfair advertising, or a URPL decision reclassifying your supplement as an unauthorised medicinal product. Each of these paths costs significantly more than a compliance consultation at the product design stage.

The second reason is commercial. In 2026, the informed consumer increasingly recognises the typical language of supplement marketing and distinguishes it from a description of mechanism. A brand that communicates in mechanistic mode builds trust. A brand promising miracles builds scepticism.

Frequently asked questions about functional mushroom compliance

  1. What are approved health claims and do they exist for functional mushrooms?

    Approved health claims are a list of statements about the effect of food ingredients on health which EFSA (European Food Safety Authority) has recognised as scientifically substantiated and which can be used on labels and in marketing communication in a precisely defined wording. The list is public and available in the EU Register of nutrition and health claims. For functional mushrooms (Reishi, Lion's Mane, Cordyceps, Chaga, Maitake, Shiitake, Coriolus, Tremella, Turkey Tail, Polyporus, Auricularia) there are no approved health claims as of 2026. This means you cannot promise specific health effects on the label or in marketing communication along the lines of "strengthens immunity", "improves concentration", "reduces stress".

  2. What are pending (on-hold) claims and can I use them?

    Pending claims are health claims for botanical ingredients (including mushrooms) that have been submitted to EFSA for assessment, but whose review was suspended by a European Commission decision in 2010. Formally, these claims exist on the list, but their status is "on-hold". Market practice differs across EU Member States. In Poland, GIS (the Polish Chief Sanitary Inspectorate) and UOKiK (the Polish Office of Competition and Consumer Protection) take a conservative position: using pending claims in marketing communication carries a risk of proceedings for unfair advertising. A safer strategy for brands is the mechanistic mode: describing composition and mechanism of action without promising a health effect.

  3. What is mechanistic communication?

    Mechanistic mode is a way of describing a functional product that focuses on composition, the mechanism of action of its ingredients and the context of use, rather than on promising a health effect for the consumer. Example: instead of "Reishi strengthens immunity" you write "Reishi contains β-glucans, polysaccharides with documented interaction with TLR4 receptors of the immune system". The first version is a non-authorised health claim. The second describes mechanism and structure, which under Polish and EU food law sits in a safer regulatory zone. Mechanistic mode requires concrete knowledge of bioactive compounds and laboratory documentation, but it also builds the trust of an informed consumer.

  4. Can I write "adaptogens" in the description of a beverage or supplement?

    The term "adaptogen" is not a recognised concept in European Union food law. EFSA has no authorised health claim associated with the word "adaptogen". Using this word in marketing communication sits in a grey area: it is not directly prohibited, but combined with a specific health promise (e.g. "adaptogens fight stress") it may be deemed unfair advertising by UOKiK. Safe practice: use the word "adaptogen" as a product-category label (e.g. "adaptogen blend"), avoiding any link to a specific health effect. Better to focus on describing composition and mechanism.

  5. How does a food supplement differ from a medicinal product?

    A food supplement is a foodstuff in concentrated form whose purpose is to supplement a normal diet. A food supplement cannot prevent, treat or diagnose diseases. A medicinal product is a substance with therapeutic or prophylactic properties in relation to human diseases. A medicinal product requires a marketing authorisation issued by URPL (the Polish Office for Registration of Medicinal Products). The line between these categories does not always run along composition — sometimes it runs along communication. A supplement containing Reishi, described as "treating anxiety disorders", may be reclassified by URPL as an unauthorised medicinal product, resulting in market withdrawal. That is why the language describing a product is part of its regulatory classification, not just marketing.

  6. Who supervises the food supplement market in Poland?

    In Poland, supervision of the food supplement market is exercised by three institutions. The Chief Sanitary Inspectorate (GIS) maintains the register of food supplement notifications and verifies the product's conformity with the notification declaration. The Office of Competition and Consumer Protection (UOKiK) supervises the fairness of advertising and marketing communication, including misleading health claims. The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) supervises the line between a supplement and a medicinal product and may reclassify a supplement as a medicinal product if its composition, action or communication indicates this. Each of these institutions can initiate proceedings independently.

  7. What exactly does Regulation (EC) 1924/2006 regulate?

    Regulation (EC) 1924/2006 is a European Union legal act directly applicable in all Member States, including Poland. It governs the use of nutrition claims (e.g. "rich in vitamin C") and health claims (e.g. "vitamin C contributes to the normal functioning of the immune system") on food labels, in presentation and in advertising. The main rule: a health claim may be used only if it appears on the EFSA list of authorised claims and is applied in the precise wording defined for the given ingredient. The Regulation applies to food supplements, conventional food, functional food and beverages. It does not apply to medicinal products (these are under URPL), cosmetics (these are under the Cosmetic Regulation EC 1223/2009) or medical devices.

  8. Can I cite scientific studies in a product description?

    Yes, but with caution and under specific conditions. Citing a scientific study on an ingredient of your product is permitted if: you describe the mechanism of action rather than promising a health effect for a specific consumer; you cite the source (DOI, PubMed ID, author, journal); you do not draw conclusions the study does not contain (e.g. an in vitro study does not allow conclusions about effects in humans); you use qualifiers ("the study suggests", "effect observed under laboratory conditions", "mechanism described"). It is not permitted to cite a study in a way that creates the impression of an authorised health claim. Example of a safe formula: "Lion's Mane contains hericenones, whose effect on nerve growth factor (NGF) expression was described in in vitro studies (Mori et al., 2008, DOI: 10.1248/bpb.31.1727)".

  9. What regulatory disclaimer should appear on the packaging of a food supplement?

    In Poland, disclaimers stem from the Food and Nutrition Safety Act and GIS practice. The minimum is: "Food supplement. Do not exceed the recommended daily portion. A food supplement cannot be used as a substitute for a varied diet. Store out of reach of small children." In addition, it is good practice to include the disclaimer: "If in doubt, consult a doctor or pharmacist, especially if you are taking medication, are pregnant or breastfeeding." For products with functional mushrooms, consider an additional disclaimer regarding possible interactions (e.g. β-glucans and immunosuppressive drugs, triterpenes and anticoagulant drugs). The full wording of disclaimers should be reviewed with a lawyer before label production.

  10. Do the same rules apply to social media communication as on the label?

    Yes. Regulation (EC) 1924/2006 governs nutrition and health claims on labels, in product presentation and in advertising. Social media communication is a form of advertising, regardless of the channel. An Instagram post, a TikTok reel, sponsored content with an influencer and an email newsletter are subject to the same rules as text on the box. In decisions from 2023-2025, UOKiK has repeatedly opened proceedings concerning misleading advertising of food supplements on social media. Fines reached several million zlotys. Practice: all communication materials, regardless of channel, should undergo compliance review before publication.

  11. How does the communication of a conventional food product differ from that of a food supplement?

    Conventional food products (e.g. chocolate with added Reishi sold as food, not as a supplement) are subject to Regulation (EC) 1924/2006 in a similar way to supplements: only authorised health claims are permitted. The difference lies in labelling and the nutrition declaration. A food product must carry a full nutrition information table, a food supplement must carry a declaration of active ingredients per unit portion. Food supplements must be notified to GIS, conventional food products do not. From a communications-compliance perspective, both are subject to the same restrictions on health claims. A food supplement has an additional layer: it cannot communicate as a medicinal product or aspire to that category.

  12. What happens when I receive a notice from UOKiK or GIS?

    GIS proceedings most often start with a request to submit explanations regarding a food supplement notification, usually after a market inspection or following a report. UOKiK initiates proceedings on unfair market practice, often after a complaint from a consumer or competitor, or ex officio. In both cases you have a defined time to respond (usually 14 days). First rule: do not ignore official correspondence. Second rule: contact a lawyer specialising in food law before responding. Third rule: during proceedings do not remove the contested content without legal consultation, as this can be interpreted as an admission of fault. Aloha Fungi does not provide legal services. We can, however, help with technical analysis of the product's composition and documentation when proceedings require it.

Compliance per market

Compliance differs across product categories. Check the specific requirements for your market:

How Aloha Fungi supports your brand with compliance

Compliance is not our core service. Our core service is supplying fruiting-body extracts of functional mushrooms in documented quality. Compliance is what our clients receive as part of the package when they work with us on product development or when they draw on our experience of the Polish and EU markets.

This is our practice, not a promise. Aloha Fungi is not a law firm and does not provide legal services within the meaning of the Polish Act on Legal Advisors. A full legal analysis of a specific product always requires consultation with a legal advisor or attorney specialising in food law.

Does your brand need compliance support at product launch?

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Regulatory disclaimer

The content on this page is provided for informational and educational purposes only. Aloha Fungi (ALOHA WEALTH AND WELLNESS Sp. z o.o.) does not provide legal services within the meaning of the Polish Act on Legal Advisors or legal advisory services within the meaning of the Polish Act on Legal Advice. The information presented on this page does not constitute a legal opinion, is not a substitute for individual consultation with a legal advisor or attorney specialising in food law, and should not be used as the sole basis for legal decisions concerning your brand, product or marketing communication. The legal framework in force in 2026 may change. A full compliance analysis of a specific product requires individual legal consultation.