EU Novel Food Regulation (EU) 2015/2283 is one of the most important compliance frameworks for mushroom supplement brands operating in European markets. Understanding which species are affected — and how to navigate authorisation — is essential for market access.
EU Novel Food Regulation (EU) 2015/2283 governs the safety assessment and authorisation of food and food ingredients that were not consumed to a significant degree in the EU before 15 May 1997. For medicinal mushroom supplement brands, this regulation is one of the most important compliance considerations when entering or expanding in European markets — and one of the most frequently misunderstood. Getting it wrong can mean placing an unauthorised product on the market, with serious legal and commercial consequences.
What Is a Novel Food?
Under Regulation (EU) 2015/2283, a food or food ingredient is considered
The Fruiting Body vs. Mycelium Distinction
One of the most practically important aspects of EU Novel Food regulation for mushroom supplement manufacturers is that the classification can differ depending on the part of the organism used. For several species, the fruiting body (the visible mushroom) has an established history of use in the EU and is therefore not classified as novel, while the dehydrated mycelium powder from the same species is classified as a Novel Food requiring pre-market authorisation. This distinction has significant implications for product formulation and sourcing decisions. Brands using mycelium-based extracts must verify the Novel Food status of that specific form, not simply the species in general.
Novel Food Status of Key Medicinal Mushroom Species
The following table is based on information from the official EU Novel Food Catalogue, maintained by the European Commission (ec.europa.eu/food/food-feed-portal/screen/novel-food-catalogue). It reflects the status of specific forms of each species as recorded in the catalogue. This information is provided for general guidance only — Novel Food status is determined on a case-by-case basis by national competent authorities and the European Food Safety Authority (EFSA). Brands must obtain a formal regulatory opinion for their specific product, form, and target markets before launch.
| Species | Common Name | Fruiting Body Status | Mycelium / Extract Status | Notes |
|---|---|---|---|---|
| Trametes versicolor | Turkey Tail | NOVEL FOOD | NOVEL FOOD | Whole mushroom classified as Novel Food. Pre-market authorisation required for all food uses. |
| Hericium erinaceus | Lion's Mane | Traditional food | NOVEL FOOD | Fruiting body has history of use as food. Mycelium/extract requires Novel Food authorisation. |
| Ganoderma lucidum | Reishi | Traditional food | NOVEL FOOD | Fruiting body has history of use. Concentrated extracts may require authorisation depending on concentration. |
| Inonotus obliquus | Chaga | NOVEL FOOD | NOVEL FOOD | No significant history of consumption in EU. Full Novel Food authorisation required. |
| Ophiocordyceps sinensis | Cordyceps | NOVEL FOOD | NOVEL FOOD | No significant history of consumption in EU. Full Novel Food authorisation required. |
| Cordyceps militaris | Cordyceps Militaris | Traditional food | NOVEL FOOD | Fruiting body has limited history of use. Extracts require authorisation. |
| Grifola frondosa | Maitake | Traditional food | Traditional food | History of use as food in EU. Standard food safety rules apply. |
| Lentinula edodes | Shiitake | Traditional food | Traditional food | Widely consumed as food in EU. Standard food safety rules apply. |
| Agaricus subrufescens | Agaricus Blazei | NOVEL FOOD | NOVEL FOOD | No significant history of consumption in EU. Full Novel Food authorisation required. |
| Phellinus linteus | Meshima | NOVEL FOOD | NOVEL FOOD | No significant history of consumption in EU. Full Novel Food authorisation required. |
Important: This table is provided as general guidance only and reflects the EU Novel Food Catalogue as of early 2026. Novel Food status can change as new assessments are completed. The absence of a species from the EU Novel Food Catalogue does not automatically mean it is not novel — it may simply mean it has not yet been assessed. Always verify the current status with the official EU Novel Food Catalogue and consult a qualified regulatory specialist before placing any product on the EU market.
Turkey Tail and Cordyceps: A Critical Note for Brands
Two species that are frequently mischaracterised in industry discussions deserve particular attention. Turkey Tail (Trametes versicolor) is classified as a Novel Food in the EU for all food uses — it cannot legally be sold as a food supplement in the EU without prior authorisation under Regulation (EU) 2015/2283. Despite its long history of use in Asia and its significant clinical research profile, it does not have an established history of significant consumption in the EU before 1997. Similarly, Cordyceps militaris — the orange cultivated Cordyceps species — is also classified as a Novel Food in the EU, meaning that both the fruiting body and mycelium require pre-market authorisation. This is an important distinction from Ophiocordyceps sinensis (formerly Cordyceps sinensis, the wild-harvested caterpillar fungus), which is classified as not novel in food supplements under the EU Novel Food Catalogue, having been used in EU food supplements before 15 May 1997. Brands formulating with Turkey Tail or Cordyceps militaris for EU markets must obtain appropriate authorisation or use an ingredient that already holds a valid Novel Food authorisation.
The Novel Food Authorisation Process
If your target ingredient is classified as a Novel Food, you have two primary pathways to market in the EU. The standard authorisation pathway involves submitting a safety dossier to EFSA via the relevant national competent authority. This process typically takes 18–24 months and requires substantial investment in toxicological and safety data. The traditional food notification pathway is available only for foods with a history of safe use in a third country outside the EU — it is faster (typically 4–6 months if no safety objections are raised), but has strict eligibility criteria and requires documented evidence of traditional use.
- Standard authorisation: Submit a safety dossier to EFSA via the national competent authority. Timeline: 18–24 months. Cost: €50,000–€200,000+ depending on data requirements.
- Traditional food notification: Available for foods with a history of safe use in a third country. Timeline: 4–6 months if no safety objections are raised. Requires documented evidence of traditional use.
- Authorisation transfer: If an ingredient already holds a Novel Food authorisation, you may be able to use it under the same conditions without a new application — subject to the authorisation holder
Practical Implications for Supplement Brands
For brands formulating with species such as Lion
"The most common regulatory mistake we see from brands entering the EU market is not verifying the Novel Food status of their specific ingredient form before launch. The species-level classification is only the starting point — the form of the ingredient (fruiting body, extract, mycelium powder) and the intended food category can change the regulatory picture entirely. Always verify with the official EU Novel Food Catalogue and a qualified regulatory specialist."
How FUNGY Supports Regulatory Compliance
FUNGY provides regulatory guidance as part of our white label and private label manufacturing service. Our regulatory team can advise on Novel Food status for your target species and ingredient forms, review your labelling for compliance with EU food supplement regulations, and provide the documentation required by national competent authorities — including Certificates of Analysis, extraction specifications, and supply chain traceability records. For brands entering multiple EU markets simultaneously, we can coordinate country-specific regulatory reviews.
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