EU Novel Food Mushroom Supplements: What's Approved

Mushroom Supplement Regulation

May 15, 1997

EU Regulation 2015/2283 draws a legal line at this date. Any mushroom supplement form not consumed in Europe in significant quantities before then is a 'novel food' and cannot be sold without pre-market authorization from the European Commission, advised by the European Food Safety Authority.

Regulation (EU) 2015/2283 on novel foods, European Commission

Twice

Vitamin D2 mushroom powder has been authorized twice, for two different companies at two different specifications — authorization attaches to a dossier, not to an ingredient name

Authorized

Antrodia camphorata freeze-dried mycelia powder has been legal in EU food supplements since Commission Implementing Regulation 2022/2535, capped at 990 mg/day for ages 14 and above

2.56 years

Average time from novel food application to published decision across 292 EFSA applications submitted 2018-2024

Regulation (EU) 2015/2283 on novel foods, European Commission

View as image ↗

A mushroom supplement that sells freely in the United States can be illegal to sell in Germany without special authorization. The reason isn't potency or purity. It's a single date.

The European Union's Novel Food Regulation treats any food not consumed in Europe before May 15, 1997 in significant quantities as a "novel food." Selling it requires going through a pre-market approval process in which the European Food Safety Authority (EFSA) assesses safety and the European Commission decides whether to authorize.^[1] Traditional, widely-eaten mushrooms mostly escape this requirement. Less familiar species often don't. Neither do less traditional forms like concentrated mycelium powders.

No competitor article provides a clear, form-by-form reference for EU novel food status. The EU Novel Food Status Catalogue exists as a searchable database, but there is no editorial compilation explaining the key mushroom decisions in consumer-friendly terms. This article fills that gap. All information draws from Regulation (EU) 2015/2283, the EU Novel Food Status Catalogue, the Union list of authorized novel foods, and the individual Commission Implementing Regulations and EFSA opinions cited throughout. Because regulations update continuously, always verify current status at the official EU Novel Food Status Catalogue before making commercial or purchasing decisions. Status here is current as of August 2026.

The US regulatory framework operates on completely different logic: no pre-market authorization, manufacturer-driven safety determinations, much looser claims rules. For how the US approach contrasts with what you're reading here, see how the FDA regulates mushroom supplements under DSHEA.

The May 1997 Line That Decides Legal From Not Legal

Regulation (EU) 2015/2283 became the current operational framework in 2018, but the threshold it uses was established earlier: May 15, 1997.^[1]

Any food not consumed to a significant degree in the EU before that date is a "novel food" under the regulation. "Significant consumption" means a recognized role in the normal diet of a meaningful portion of the European population, not occasional or niche use.

For mushroom supplements, this creates two distinct tracks. Common culinary mushrooms have centuries of European food history. Selling Shiitake or Oyster mushrooms dried, fresh, or powdered in their conventional form does not trigger novel food rules. They are grandfathered in by demonstrated consumption history.

Unusual species with no meaningful pre-1997 presence in European diets fall on the other side. The burden falls entirely on the producer to prove either that the food has the required consumption history or that it is safe enough to authorize.

The regulation applies across all 27 EU member states. A product that is unauthorized in Germany is unauthorized in France, Italy, Spain, and every other member state simultaneously.

For a deeper explanation of the full regulatory framework and its historical context, see EU Novel Food Regulations and Mushroom Supplements, the companion article to this one.

Why the Form of the Mushroom Can Change Its Regulatory Status

Here is the part that surprises many people in the supplement industry: the form of the mushroom, not just the species, can determine its regulatory classification.

A dried Shiitake fruiting body is not a novel food. Europeans have been cooking and eating Shiitake for generations. That product has a documented pre-1997 consumption history.

A dehydrated mycelium powder of a species whose fruiting body is perfectly familiar is a different question entirely. The EU does not just ask whether the species is familiar. It asks whether the specific form and production process has a significant consumption history. Mycelium is the fungal network, physiologically distinct from the fruiting body and typically produced in fermentation or grain-substrate conditions rather than through traditional cultivation. For both Lion's Mane and Reishi, the catalogue draws exactly this line: fruiting body and aqueous extract powder are treated as not novel, while dehydrated mycelium powder is novel and requires authorization.

Novel food status follows the form, not the species

Same Mushroom, Two Different Answers in the EU

For several of the best-selling functional mushrooms, the fruiting body carries a documented history of European consumption and the mycelium does not. That single distinction decides whether a product needs pre-market authorisation.

Species

Fruiting body / aqueous extract

Mycelium powder

Lion's Mane

Hericium erinaceus

Not novel

Fruiting body and aqueous extract powder

Novel

Dehydrated mycelium powder requires authorisation

Reishi

Ganoderma lucidum

Not novel

Fruiting body and aqueous extract powder

Novel

Dehydrated mycelium powder requires authorisation

Chaga

Inonotus obliquus

Category-dependent

Non-novel in food supplements only

Novel

Novel outside the food supplement category

Cordyceps

Cordyceps militaris

Novel

Novel in both forms — unlike C. sinensis

Novel

Novel in both forms — unlike C. sinensis

Turkey Tail

Trametes versicolor

Novel

Novel for any food application

Novel

Novel for any food application

Cordyceps is the clearest trap: C. sinensis is treated as non-novel in food supplements, while C. militaris — the species almost every commercial cordyceps product actually contains — is novel in both forms.

Status per the EU Novel Food status Catalogue under Regulation (EU) 2015/2283. The Catalogue is non-exhaustive and non-binding, entries are revised as Member States reach new views, and proving pre-1997 consumption remains the operator's responsibility. Verify current status before relying on any entry.

This principle is also illustrated by UV-treated vitamin D2 mushroom powder. Mushrooms naturally produce vitamin D2 when exposed to UV light. But a mushroom powder standardized through controlled UV-irradiation to deliver consistent vitamin D2 levels is a specific manufactured form, not a traditional food. The EU classified it as novel, and it required its own assessment before it could be legally sold.^[7]

EU Novel Food Status by Species and Form: The Reference Table

The table below summarizes EU novel food status for the mushroom supplement species and forms most commonly found on supplement shelves. Entries marked Authorized come from the Union list and the Commission Implementing Regulations that created them. All other entries reflect EU Novel Food Status Catalogue determinations.^[2]

Regulations change, and the catalogue is guidance rather than law. For any commercial decision, verify the specific species and form against the EU Novel Food Status Catalogue before selling or sourcing.

How to read this table: "Not novel" means the form has a recognized European consumption history before 1997 and no authorization is required. "Novel" means the form requires authorization and cannot be lawfully sold without one. "Authorized" means the ingredient completed assessment and was written into the Union list with defined conditions, which are binding.

Consumer and industry misconception

'This ingredient is EU-approved, so we can sell it'

The claim

“Once a novel food ingredient has been authorized in the EU, any company can put that ingredient in a product and sell it across the single market.”

Marketing shorthand that treats authorization as a property of the ingredient, the way GRAS is often described in the US.

What research shows

Misleading

Authorization attaches to a specific dossier: one applicant, one specification, named food categories, and defined maximum levels. Where the Commission grants data protection under Article 26, the applicant is the only company permitted to market the novel food for five years. Vitamin D2 mushroom powder carried exactly this restriction twice: Oakshire Naturals held exclusivity until 27 August 2025, and Luxidum GmbH holds it from 30 April 2025 until 30 April 2030.

Not every authorization comes with exclusivity. The Antrodia camphorata authorization in Regulation 2022/2535 was granted without a data protection period, so any operator meeting its specification and conditions may rely on it. The point is that you have to read the specific regulation rather than the word 'authorized'.

Commission Implementing Regulation (EU) 2020/1163; (EU) 2022/2535; (EU) 2025/691; Regulation (EU) 2015/2283 Article 26

What Is Actually on the Union List

The binding register of authorized novel foods is the Union list, established by Commission Implementing Regulation (EU) 2017/2470 and amended each time a new ingredient is authorized.^[11] Four mushroom-derived entries on it are worth reading side by side, because together they show what an EU authorization actually grants.

Authorisation attaches to a dossier, not an ingredient

Four Mushroom-Derived Authorisations, Read Side by Side

Four authorisations, four separate companies, and the same ingredient name appearing twice. Each one licenses a specific specification into specific food categories at specific doses — and three of the four came with a five-year window during which only the applicant could sell it.

Vitamin D2 mushroom powder

CIR (EU) 2020/1163 · 6 Aug 2020

UV-treated Agaricus bisporus, 1,000–1,300 µg vitamin D2/g

Applicant: Oakshire Naturals LP (US)

• Foods, beverages and FSMPs at defined levels
• Food supplements: max 15 µg vitamin D2/day
• Excludes infants

Exclusivity expired 27 Aug 2025

Antrodia camphorata mycelia powder

CIR (EU) 2022/2535 · 21 Dec 2022

Freeze-dried powder form, solid-state cultivated

Applicant: Golden Biotechnology Corp.

• Food supplements only — no general food use
• Maximum 990 mg/day
• Age 14 and above; mandatory label warning

No data protection granted

Pea and rice protein fermented by Shiitake mycelia

CIR (EU) 2023/6 · 3 Jan 2023

Lentinula edodes mycelia fermentation; ≥75% protein dry weight

Applicant: MycoTechnology, Inc. (US)

• 14 food categories, from 1 g/100 g to 93 g/100 g
• Includes bakery 5 g/100 g, breakfast cereals 33 g/100 g, meat analogues 40 g/100 g
• Label designation: "Pea and rice protein fermented by Shiitake mushroom mycelia"

MycoTechnology only until 24 Jan 2028

Vitamin D2 mushroom powder

CIR (EU) 2025/691 · 9 Apr 2025

UV-treated Agaricus bisporus, 245–460 µg vitamin D2/g

Applicant: Luxidum GmbH (DE)

• Breakfast cereals, breads, pasta, beverages, dairy, soups, snacks, FSMPs
• Food supplements: max 15 µg vitamin D2/day
• Excludes infants and young children from supplements

Luxidum only until 30 Apr 2030

Union list of authorised novel foods under Regulation (EU) 2015/2283, as amended by the Commission Implementing Regulations cited above. These are illustrative rather than the complete set of fungal entries — the Union list also carries further vitamin D2 mushroom powder and UV-treated mushroom authorisations. Status current as of August 2026; the list is amended continuously, so verify before relying on any entry.

These four are illustrative rather than exhaustive — the Union list also carries further vitamin D2 mushroom powder authorizations and a separate UV-treated mushrooms entry — but the pattern they show holds generally. Two things stand out. First, the same ingredient name appears twice, held by two different companies at two different specifications. Second, three of the four came with a five-year exclusivity window during which nobody but the applicant could sell the ingredient. "Authorized in the EU" and "available for your brand to use" are not the same statement.

The Shiitake entry is the sharpest illustration of the form principle. A dried Shiitake fruiting body is not a novel food at all and needs no authorization. But pea and rice protein fermented by Shiitake mycelia is a different product built by a different process, and it took a full dossier, an EFSA opinion, and Commission Implementing Regulation (EU) 2023/6 before MycoTechnology, Inc. could sell it.^[13] Same species, opposite regulatory answers.

Antrodia Camphorata: What an Authorization Actually Licenses

Antrodia camphorata grows almost exclusively on the ancient Cinnamomum kanehirae tree in Taiwan. It has centuries of traditional use in Taiwanese herbal medicine and no meaningful pre-1997 European consumption history, so it was a novel food from the start.

It is no longer waiting. On 18 May 2022 the EFSA Panel on Nutrition, Novel Foods and Food Allergens adopted a positive opinion on freeze-dried mycelia of Antrodia camphorata, concluding that it is safe at the proposed use level for individuals aged 14 years and above. The Panel derived a safe level of 16.5 mg per kg of body weight per day from a 90-day repeated dose toxicity study and a prenatal developmental toxicity study, found no genotoxicity concerns, and found the proposed use nutritionally acceptable.^[4] On 21 December 2022 the Commission acted on that opinion and adopted Implementing Regulation (EU) 2022/2535, authorizing the freeze-dried powder form of Antrodia camphorata mycelia and writing it into the Union list.^[3]

The conditions are narrow and worth reading closely. The authorization covers food supplements as defined in Directive 2002/46/EC and nothing else: there is no general food use. The maximum is 990 mg per day. The designation on the label must be "Antrodia camphorata mycelia powder." And the label must carry a statement that the supplement should not be consumed by infants, children, and adolescents younger than 14 years of age. The specification is equally specific, including moisture below 10%, total triterpenoids of 1.0 to 10.0 g/100 g, and antroquinonol of 1.0 to 20.0 mg/g.^[3]

The applicant was Golden Biotechnology Corp. Unlike the two vitamin D2 authorizations, this one was granted without an Article 26 data protection period, which means other operators may rely on it provided their product meets the same specification and conditions.

Regulatory conditions of use

Moderate

The Antrodia camphorata authorization excludes everyone under 14

Concern

The EU authorization for freeze-dried Antrodia camphorata mycelia powder applies only to individuals aged 14 years and above, at a maximum of 990 mg per day, and only in food supplements. EFSA's safety conclusion was drawn for that population and that intake; it does not extend to children, to higher doses, or to general food use. Products sold outside those limits are outside the authorization.

What the research says

Check that any Antrodia camphorata supplement sold in the EU carries the designation 'Antrodia camphorata mycelia powder' and the mandatory statement that it should not be consumed by infants, children, and adolescents younger than 14 years of age. A product missing that statement, or exceeding 990 mg/day, is not being sold in line with the authorization it depends on.

Particularly relevant for: Anyone under 14, and adults comparing Antrodia products against the authorized dose ceiling

Commission Implementing Regulation (EU) 2022/2535; EFSA Journal 2022;20(6):e07380

For the clinical research on what Antrodia does in the body, see Antrodia for Liver Health: Taiwan's Most-Studied Hepatoprotective Mushroom.

Vitamin D2 Mushroom Powder: One Name, Four Dossiers

Vitamin D2 mushroom powder is the clearest case study in how EU authorization really works, because the same nominal ingredient has been assessed by EFSA at least four separate times.

Mushrooms naturally produce vitamin D2 when exposed to UV light. The ingredient that gets authorized is not "mushrooms exposed to sunlight." It is Agaricus bisporus powder put through a controlled UV-irradiation process that converts provitamin D2 (ergosterol) into vitamin D2 (ergocalciferol), standardized to a declared concentration. At least four separate dossiers have been filed for a product answering that description, and EFSA assessed each on its own specification rather than carrying the first one across.^[7][8][9]

One ingredient name, four safety assessments

Why “Vitamin D2 Mushroom Powder Is Approved” Is Not a Useful Sentence

At least four dossiers were filed for UV-treated Agaricus bisporus powder. EFSA assessed each separately, because each one specified a different product. The strongest specification is more than ten times the concentration of the weakest.

Reached the Union listAssessed under its own dossier

Concentration ranges as specified in each EFSA NDA Panel scientific opinion on vitamin D2 mushroom powder under Regulation (EU) 2015/2283. A positive EFSA opinion is a safety conclusion on one dossier; the decision to authorise, and the conditions attached, are the European Commission's.

The specifications are not close to each other. One dossier declared 1,000 to 1,300 µg of vitamin D2 per gram of powder; another declared 125 to 375 µg/g. That is more than a tenfold spread inside a single ingredient name, which is precisely why each application had to be evaluated separately rather than waved through on the strength of the first.

Two of those dossiers can be traced straight through to the Union list. Commission Implementing Regulation (EU) 2020/1163 of 6 August 2020 authorized Oakshire Naturals LP's powder, at 1,000 to 1,300 µg/g, with five-year data protection that expired on 27 August 2025.^[5] Commission Implementing Regulation (EU) 2025/691 of 9 April 2025 authorized Luxidum GmbH's powder, at 245 to 460 µg/g, across a wide list of food categories including breakfast cereals, breads, pasta, beverages, dairy and soups, with food supplements capped at 15 µg of vitamin D2 per day. That authorization carries data protection running from 30 April 2025 to 30 April 2030, meaning Luxidum is currently the only company that may place that novel food on the EU market under that authorization.^[6]

EU novel food authorizations are not blanket approvals. They authorize a specific ingredient at specific levels for specific uses, to a specific applicant. A manufacturer who wants to use vitamin D2 mushroom powder at different levels or in different categories than the authorization specifies would need its own authorization.

This specificity is what distinguishes EU authorization from the US approach, where a manufacturer can generally determine internally whether their ingredient is safe and bring it to market without an equivalent pre-market gate. For more on the US framework and what GRAS status means compared to EU novel food authorization, see GRAS Status for Mushroom Ingredients: What It Means.

The Authorization Process: What Getting Approved Actually Takes

The EU novel food authorization process runs through EFSA, which conducts an independent scientific assessment of every dossier submitted. Understanding what that process involves explains both why it takes years and why a successful outcome carries regulatory weight.

A complete authorization dossier must contain:

• Compositional data: full characterization of what the ingredient contains, including identification of all major and minor compounds, contaminants, and batch-to-batch variability
• Production process: how the ingredient is made, what inputs are used, what quality controls apply at each stage
• Proposed specifications: purity standards, stability data, shelf-life evidence
• History of use: evidence of consumption in other regions, relevant for establishing a safety baseline in populations that have been consuming the ingredient
• Toxicological data: including studies or evidence bearing on absorption, distribution, metabolism, elimination, and potential for toxicity at proposed use levels
• Proposed conditions of use: which foods, which dose levels, for which population groups

EFSA then conducts its own scientific review, may request additional data, and issues a scientific opinion. The European Commission uses that opinion as the basis for an authorization decision.

How long does that take in practice? An analysis of 292 novel food applications submitted to EFSA between 2018 and 2024 found an average of 2.56 years, with a standard deviation of 1.19 years, from submission to publication of the decision. The authors attributed much of the variability to suitability checks and requests for additional data.^[10] That figure is worth two caveats: the authors are employed by a consultancy that manages ingredient authorizations for clients, which is a disclosed commercial interest in the process being seen as slow, and an average conceals long tails. The Antrodia camphorata file is a useful illustration of the spread: the Commission asked EFSA to assess it on 12 May 2020, EFSA adopted its opinion on 18 May 2022, and authorization followed on 21 December 2022 — roughly two and a half years from referral to authorization, closely tracking that average.

This remains a meaningful investment for any company seeking EU market access. Dossier preparation alone, independent of EFSA fees, typically requires significant scientific resources, and novel ingredients with limited published safety data require more comprehensive packages.

For supplement buyers, this cost and timeline structure creates a quality signal worth understanding. Brands that have completed EU novel food authorization have made a substantial, documented commitment to demonstrating their ingredient's safety profile. That is not present in markets where no pre-market authorization is required at all.

For a comparison of how these authorization requirements compare to what Canada and Australia require for their markets, see how international mushroom regulations differ from US rules.

Post-Brexit UK: The Same Threshold, a Separate Process

When the UK left the EU, it retained the novel food regulatory framework but created its own parallel process administered by the Food Standards Agency (FSA) and Food Standards Scotland (FSS).^[12]

The 1997 threshold applies in the same way. Products authorized in the EU before Brexit carry recognition in the UK. But new applications go to the UK FSA separately from the EU process. An EU novel food authorization obtained after Brexit does not automatically give a company UK market access. The two processes now run in parallel.

In practical terms, a mushroom supplement brand targeting both EU and UK markets after Brexit must navigate two authorization processes for any genuinely novel ingredient. The UK FSA maintains its own novel food catalogue, searchable at the FSA website.

For supplement buyers, the regulatory status question is the same in both jurisdictions. A product on shelf in a UK or EU market should either have established traditional-food status or carry a valid authorization. The criteria for determining which applies have not changed in either market.

What EU Novel Food Status Tells a Supplement Buyer

The practical question for someone buying mushroom supplements is whether regulatory status says anything meaningful about what they are buying.

In the EU context, the answer is yes, more than in most markets.

A mushroom supplement legally sold in Germany, France, or another EU member state has either: (1) been made from a species and form with a recognized pre-1997 history of significant European consumption, which means it was eaten as normal food for generations, or (2) passed an independent scientific safety review and received authorization under defined conditions.

Both pathways represent something. Track one establishes that the ingredient has a documented human consumption history. Track two means it has cleared a rigorous, externally-validated safety assessment. Neither the US DSHEA system nor most other major supplement markets require either track before a product reaches store shelves. For a closer look at how US companies navigate claims and safety in the absence of pre-market authorization, see how DSHEA shapes what mushroom supplement companies can say.

This does not make EU-sold products superior in potency, beta-glucan content, extraction quality, or any efficacy measure. EU novel food authorization addresses safety, not effectiveness. But it does mean the ingredient has been evaluated against a formal safety standard that many of its international competitors have never faced.

The inverse is also informative, and this is where the form-level detail earns its keep. A product sold in the EU as a Lion's Mane or Reishi mycelium powder is selling a form the catalogue treats as novel, and no authorization for it exists on the Union list. A product sold as "cordyceps" that contains C. militaris rather than C. sinensis is in the same position. Knowing which species and forms the EU classifies as novel gives buyers a concrete reference point for evaluating whether a product's regulatory standing matches its marketing.

For information about how these same quality signals play out when brands pursue authorization across multiple markets, see Selling Mushroom Supplements Globally: Regulatory Challenges.

The Bottom Line

The EU Novel Food Regulation draws a legal line at May 15, 1997: mushroom supplement forms without significant European consumption before that date are novel foods requiring authorization before sale. Traditional culinary mushrooms in standard forms are generally exempt, and so are the fruiting bodies and aqueous extracts of Lion's Mane and Reishi — but the dehydrated mycelium powders of those same species are novel. Mushroom-derived entries on the Union list include Antrodia camphorata freeze-dried mycelia powder, authorized in December 2022 for food supplements at up to 990 mg/day for ages 14 and above; pea and rice protein fermented by Shiitake mycelia, authorized in January 2023; and two separate vitamin D2 mushroom powder authorizations held by two different companies at two different specifications. That duplication is the central lesson: authorization attaches to one applicant's dossier and often comes with a five-year exclusivity window, so "EU approved" says less than it appears to. Applications averaged 2.56 years from submission to decision across 292 files between 2018 and 2024.

Frequently Asked Questions

What mushroom supplements are approved in the EU?

Mushroom-derived ingredients on the EU Union list of authorized novel foods include freeze-dried Antrodia camphorata mycelia powder, authorized by Commission Implementing Regulation (EU) 2022/2535; pea and rice protein fermented by Shiitake mycelia, authorized by Regulation (EU) 2023/6; and vitamin D2 mushroom powder, authorized twice — by Regulation (EU) 2020/1163 in August 2020 and again by Regulation (EU) 2025/691 in April 2025, to two different companies at two different specifications. Separately, traditional culinary mushrooms in their standard forms (Shiitake, Oyster, Porcini, Chanterelle) are generally not classified as novel foods at all and can be sold without any authorization.

Is Lion's Mane a novel food in Europe?

It depends entirely on the form. The EU Novel Food Status Catalogue treats Lion's Mane fruiting body and aqueous extract powder as not novel, so those forms can be sold without authorization. Dehydrated Lion's Mane mycelium powder is treated as novel and requires authorization, and no such authorization currently appears on the Union list. Because most reputable Lion's Mane supplements use fruiting body or hot-water extract, most are in the non-novel category — but mycelium-on-grain products are a different regulatory question, and the label is where you check.

Is Reishi mushroom extract a novel food in the EU?

Reishi fruiting body and aqueous extract powder are treated as not novel by the EU catalogue, which covers standard hot-water Reishi extracts. Reishi dehydrated mycelium powder is treated as novel and requires authorization. This is the EU's key distinction: even when the fruiting body of a species is well established in European consumption, the mycelium preparation of the same species is assessed separately and can land in a different regulatory category.

Is cordyceps legal to sell in the EU?

This is the most common trap in the category. Cordyceps sinensis mycelium and fruiting body are treated as not novel in food supplements, so that species can be sold in supplement form. Cordyceps militaris, however, is treated as novel in every form — and C. militaris is the species that most commercial cordyceps supplements actually contain, because C. sinensis is extremely difficult to cultivate. Check which species a product declares before assuming its regulatory status.

Does 'EU authorized' mean any company can sell that ingredient?

Not necessarily. Under Article 26 of Regulation (EU) 2015/2283 the Commission can grant data protection, giving the applicant an exclusive five-year window in which no other company may market the novel food under that authorization. Both vitamin D2 mushroom powder authorizations carried one: Oakshire Naturals held exclusivity until 27 August 2025, and Luxidum GmbH holds it from 30 April 2025 to 30 April 2030. The Antrodia camphorata authorization was granted without data protection, so other operators may rely on it if they meet its specification and conditions. You have to read the individual regulation.

What is the EU novel food catalogue for mushrooms?

The EU Novel Food Status Catalogue is a searchable database maintained by the European Commission that records novel food status views for specific ingredients and forms, based on information supplied by member states. For mushrooms, it documents which species and product forms are considered traditional (exempt from novel food rules) and which are considered novel. Importantly, it is explicitly non-binding and non-exhaustive: it exists for orientation, individual member states can still restrict products under national legislation, and where the catalogue does not settle the question, Article 4 of the regulation requires the business to consult the member state where it first intends to sell. The binding instrument is the Union list of authorized novel foods.

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Regulatory Sources

1. European Parliament and Council. Regulation (EU) 2015/2283 of 25 November 2015 on novel foods. Defines novel food as any food not used for human consumption to a significant degree in the Union before 15 May 1997; establishes the authorisation procedure, the Article 4 consultation procedure for determining status, and the Article 26 data protection mechanism. eur-lex.europa.eu
2. European Commission. Novel Food Status Catalogue. Non-binding, non-exhaustive database of novel food status views compiled from member state information, covering fungal species and forms including Hericium erinaceus, Ganoderma lucidum, Inonotus obliquus, Cordyceps sinensis, Cordyceps militaris and Trametes versicolor. Provided for orientation only; member states may restrict products under national legislation. food.ec.europa.eu
3. European Commission. Commission Implementing Regulation (EU) 2022/2535 of 21 December 2022 authorising the placing on the market of the freeze-dried powder form of Antrodia camphorata mycelia as a novel food. Applicant Golden Biotechnology Corp. Authorises food supplements only, maximum 990 mg/day, individuals aged 14 years and above; designation "Antrodia camphorata mycelia powder"; mandatory label statement excluding infants, children and adolescents under 14. eur-lex.europa.eu
4. EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA). Safety of freeze-dried mycelia of Antrodia camphorata as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 2022;20(6):e07380, adopted 18 May 2022. Derives a safe level of 16.5 mg/kg body weight per day; concludes the novel food is safe at the proposed use level for individuals aged 14 years and above. PMID 35784815
5. European Commission. Commission Implementing Regulation (EU) 2020/1163 of 6 August 2020 authorising the placing on the market of vitamin D2 mushroom powder as a novel food. Applicant Oakshire Naturals LP; specification 1,000–1,300 µg vitamin D2/g; food supplements at 15 µg/day excluding infants; five-year data protection expiring 27 August 2025. eur-lex.europa.eu
6. European Commission. Commission Implementing Regulation (EU) 2025/691 of 9 April 2025 authorising the placing on the market of vitamin D2 mushroom powder as a novel food. Applicant Luxidum GmbH; specification 245–460 µg vitamin D2/g; authorised across breakfast cereals, breads, pasta, beverages, dairy, soups, snacks and FSMPs, with food supplements at 15 µg/day; data protection 30 April 2025 to 30 April 2030. eur-lex.europa.eu
7. EFSA NDA Panel. Safety of vitamin D2 mushroom powder as a Novel food pursuant to Regulation (EU) 2015/2283 (NF 2020/2226). EFSA Journal 2024;22(6):e8817, adopted 30 April 2024. Specification 245–460 µg vitamin D2/g; concludes the novel food is safe under the proposed conditions of use. Basis for Regulation (EU) 2025/691. PMID 38868108
8. EFSA NDA Panel. Safety of vitamin D2 mushroom powder as a Novel food pursuant to Regulation (EU) 2015/2283 (NF 2019/1471). EFSA Journal 2022;20(6):e7326. Specification 125–375 µg vitamin D2/g; concludes the novel food is safe under the proposed conditions of use, while noting uncertainty about combined vitamin D exposure given the growing range of fortified foods. PMID 35706680
9. EFSA NDA Panel. Safety of Vitamin D2 mushroom powder (Agaricus bisporus) as a Novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 2021;19(4):e6516. Specification 580–595 µg vitamin D2/g; concludes the novel food is safe for the general population at the proposed conditions of use and as a food supplement for individuals above 1 year. PMID 33854579
10. Le Bloch J, et al. The novel food evaluation process delays access to food innovation in the European Union. npj Science of Food 2025;9(1):117. Analysis of 292 novel food applications submitted to EFSA 2018–2024; mean duration from submission to publication 2.56 ± 1.19 years. Declared competing interest: all authors are employed by FoodChain ID, a consultancy managing ingredient authorisations in Europe and the US on behalf of clients. PMID 40593922
11. European Commission. Union list of novel foods, Commission Implementing Regulation (EU) 2017/2470. The binding register of authorised novel foods and the conditions attached to each, as amended by the implementing regulations cited above. food.ec.europa.eu
12. Food Standards Agency (UK). Novel Foods Guidance. Post-Brexit UK novel food authorisation process administered by FSA/FSS; mirrors the EU 15 May 1997 threshold; products authorised in the EU before Brexit are recognised, but new applications are assessed separately. food.gov.uk
13. European Commission. Commission Implementing Regulation (EU) 2023/6 of 3 January 2023 authorising the placing on the market of pea and rice protein fermented by Lentinula edodes (Shiitake mushroom) mycelia as a novel food. Applicant MycoTechnology, Inc.; authorised across 14 food categories at levels from 1 g/100 g to 93 g/100 g; label designation "Pea and rice protein fermented by Shiitake mushroom mycelia"; Article 26 data protection 24 January 2023 to 24 January 2028. eur-lex.europa.eu