Fermentation-derived ingredients are moving further into mainstream food and supplement development.<\/p>\n\n\n\n
On 3 July 2026, the European Commission adopted Commission Implementing Regulation (EU) 2026\/1507<\/strong>, authorising Rhizomucor pusillus<\/em> mycelium as a novel food and adding it to the EU Union list of authorised novel foods. The regulation entered into force on 26 July 2026<\/strong>. [European Commission, Commission Implementing Regulation (EU) 2026\/1507<\/em>]<\/p>\n\n\n\n For supplement brands, one number immediately stands out:<\/p>\n\n\n\n 6 g\/day.<\/strong><\/p>\n\n\n\n That is the maximum authorised daily intake in food supplements for the general adult population.<\/p>\n\n\n\n But the regulation is not simply permission to add up to 6 grams of fungal biomass to any supplement.<\/p>\n\n\n\n It defines a specific strain, production process, specification, target population, food categories, labelling conditions and five-year period of protected proprietary data.<\/p>\n\n\n\n Authorised does not mean unrestricted.<\/p>\n\n\n\n The novel food is the biomass of the filamentous fungus Rhizomucor pusillus<\/em>, strain CBS 143028<\/strong>.<\/p>\n\n\n\n According to the Union-list specification, the fungus is cultivated by fermentation. The biomass is then harvested, pasteurised to inactivate viable fungal cells, dried and milled into a whitish, odourless powder. [European Commission, Commission Implementing Regulation (EU) 2026\/1507<\/em>]<\/p>\n\n\n\n EFSA describes the material as a fermentation-derived fungal biomass consisting mainly of protein, dietary fibre and fat. The authorised specification sets crude protein at 44\u201368 g\/100 g<\/strong>, dietary fibre at 25\u201339 g\/100 g<\/strong> and fat at 4\u20138 g\/100 g<\/strong>. [EFSA NDA Panel, Safety of Rhizomucor pusillus biomass powder as a novel food pursuant to Regulation (EU) 2015\/2283<\/em>, 2025]<\/p>\n\n\n\n This distinction matters.<\/p>\n\n\n\n The authorisation does not cover fungal biomass in general.<\/p>\n\n\n\n It covers a defined novel food with a defined organism, process and specification.<\/p>\n\n\n\n Fermentation is increasingly used to manufacture proteins, functional ingredients and alternative food materials.<\/p>\n\n\n\n From a regulatory perspective, however, saying that an ingredient is \u201cfermentation-derived\u201d is not enough.<\/p>\n\n\n\n The production organism matters.<\/p>\n\n\n\n The strain matters.<\/p>\n\n\n\n The downstream process matters.<\/p>\n\n\n\n And the characteristics of the resulting biomass matter.<\/p>\n\n\n\n EFSA specifically evaluated R. pusillus<\/em> strain CBS 143028. The strain was characterised using molecular methods including whole-genome sequencing, and EFSA reviewed information covering the production process, composition, nutritional characteristics, toxicology, genotoxicity and allergenicity before concluding that the novel food was safe under the proposed conditions of use. [EFSA NDA Panel, Safety of Rhizomucor pusillus biomass powder as a novel food<\/em>, 2025]<\/p>\n\n\n\n A commercial ingredient therefore needs to correspond to the authorised material.<\/p>\n\n\n\n \u201cSame fungus\u201d is not automatically the same regulatory product.<\/p>\n\n\n\n Regulation 2026\/1507 authorises the ingredient across several food categories rather than limiting it to supplements.<\/p>\n\n\n\n These are legally defined conditions of use, not suggested formulation targets. [European Commission, Commission Implementing Regulation (EU) 2026\/1507, Annex<\/em>]<\/p>\n\n\n\n A product developer therefore needs to identify the correct food category before selecting the inclusion level.<\/p>\n\n\n\n The same ingredient can have different authorised maximums depending on how the final product is marketed and consumed.<\/p>\n\n\n\n For supplements, the authorised maximum is 6 grams per day<\/strong>.<\/p>\n\n\n\n That means the calculation needs to follow the recommended daily intake.<\/p>\n\n\n\n For example, a capsule containing 2 g may appear comfortably below the limit.<\/p>\n\n\n\n But if the recommended dosage is four capsules per day, the daily exposure becomes 8 g and would exceed the authorised condition of use.<\/p>\n\n\n\n The correct calculation is therefore:<\/p>\n\n\n\n amount per unit \u00d7 maximum recommended units per day<\/strong><\/p>\n\n\n\n Not simply the amount inside one capsule, sachet or scoop.<\/p>\n\n\n\n Dose instructions are part of compliance.<\/p>\n\n\n\n Food supplements containing the novel food are authorised for the general adult population<\/strong>, excluding pregnant and lactating women.<\/p>\n\n\n\n The regulation goes further and requires the supplement label to state that the product should not be consumed by persons under 18 years of age, pregnant women or lactating women<\/strong>. [European Commission, Commission Implementing Regulation (EU) 2026\/1507<\/em>]<\/p>\n\n\n\n That means an otherwise compliant 6 g\/day formulation can still fail the novel-food conditions if it is positioned for teenagers or if the required warning is omitted.<\/p>\n\n\n\n The target group is not merely marketing.<\/p>\n\n\n\n It is part of the authorisation.<\/p>\n\n\n\n The required designation of the novel food on foods containing it is:<\/p>\n\n\n\n \u201cRhizomucor pusillus mycelium\u201d<\/strong><\/p>\n\n\n\n [European Commission, Commission Implementing Regulation (EU) 2026\/1507, Annex<\/em>]<\/p>\n\n\n\n This matters when suppliers market the ingredient under proprietary names or broader commercial descriptions such as \u201cfermented mycoprotein\u201d, \u201cfungal protein\u201d or \u201cfermentation protein\u201d.<\/p>\n\n\n\n A trade name can be useful commercially.<\/p>\n\n\n\n It does not automatically replace the legally required ingredient designation.<\/p>\n\n\n\n Brand name and regulatory identity need to remain aligned.<\/p>\n\n\n\n Because the ingredient is produced from fungal biomass, microbiological quality is a central part of its specification.<\/p>\n\n\n\n The Union-list entry establishes limits for total aerobic microbial count, Bacillus cereus<\/em>, Clostridium perfringens<\/em>, coagulase-positive staphylococci, Enterobacteriaceae, E. coli<\/em>, yeasts and moulds.<\/p>\n\n\n\n It also requires Listeria monocytogenes<\/strong><\/em> and Salmonella<\/strong><\/em> to be absent in 25 g. [European Commission, Commission Implementing Regulation (EU) 2026\/1507, Table 2 specification<\/em>]<\/p>\n\n\n\n The production process includes pasteurisation specifically to inactivate viable fungal cells.<\/p>\n\n\n\n EFSA also reported that no viable cells were present in the assessed novel food and considered the production and microbiological evidence sufficient under the proposed conditions. [EFSA NDA Panel, Safety of Rhizomucor pusillus biomass powder as a novel food<\/em>, 2025]<\/p>\n\n\n\n This creates an important supplier-verification question:<\/p>\n\n\n\n Does the supplied batch meet the microbiological specification of the authorised novel food?<\/p>\n\n\n\n A general statement such as \u201cfood grade\u201d does not answer that.<\/p>\n\n\n\n The specification also contains defined maximum concentrations for four heavy metals:<\/p>\n\n\n\n Arsenic: \u2264 0.1 mg\/kg<\/strong><\/p>\n\n\n\n Cadmium: \u2264 0.1 mg\/kg<\/strong><\/p>\n\n\n\n Lead: \u2264 0.1 mg\/kg<\/strong><\/p>\n\n\n\n Mercury: \u2264 0.1 mg\/kg<\/strong><\/p>\n\n\n\n [European Commission, Commission Implementing Regulation (EU) 2026\/1507<\/em>]<\/p>\n\n\n\n This is particularly relevant because the limits form part of the actual novel-food specification.<\/p>\n\n\n\n They are not simply optional internal quality targets.<\/p>\n\n\n\n For brands and ingredient purchasers, the supplier COA should therefore be reviewed against the Union-list specification rather than against an unrelated house specification.<\/p>\n\n\n\n Makrolife Biotech offers elemental analysis and contaminant testing for foods and supplements, including analytical assessment of minerals and trace elements and broader food-safety compliance. [Makrolife Biotech, Food & Supplements<\/em>; Food Safety, Contaminants & Compliance<\/em>]<\/p>\n\n\n\n The authorisation establishes maximum concentrations for a broad panel of mycotoxins.<\/p>\n\n\n\n These include aflatoxins B1, B2, G1 and G2, fumonisins B1 and B2, ochratoxin A, deoxynivalenol, zearalenone, nivalenol, T-2 toxin, HT-2 toxin and diacetoxyscirpenol. [European Commission, Commission Implementing Regulation (EU) 2026\/1507, Novel Food Specification<\/em>]<\/p>\n\n\n\n That scope reflects an important aspect of fungal novel-food assessment.<\/p>\n\n\n\n The fact that a microorganism is used intentionally for food production does not mean possible secondary metabolites can simply be ignored.<\/p>\n\n\n\n EFSA noted that Rhizomucor<\/em> does not benefit from a blanket Qualified Presumption of Safety status for this application. The specific strain therefore underwent an individual assessment, including genome analysis and investigation of potential mycotoxin and secondary-metabolite concerns. EFSA ultimately concluded that the available molecular, toxicological and microbiological evidence did not raise a safety concern under the authorised conditions. [EFSA NDA Panel, Safety of Rhizomucor pusillus biomass powder as a novel food<\/em>, 2025]<\/p>\n\n\n\n The lesson for manufacturers is straightforward:<\/p>\n\n\n\n Fermentation can produce an innovative ingredient.<\/p>\n\n\n\n It also creates a specific analytical control strategy.<\/p>\n\n\n\n EFSA concluded that the novel food is safe under the proposed conditions of use<\/strong>. [EFSA NDA Panel, Safety of Rhizomucor pusillus biomass powder as a novel food<\/em>, 2025]<\/p>\n\n\n\n That wording matters.<\/p>\n\n\n\n It does not mean that any concentration, food category or target population has been declared safe without restriction.<\/p>\n\n\n\n The conclusion relates to the assessed uses and exposure levels.<\/p>\n\n\n\n For a supplement, that means:<\/p>\n\n\n\n adult population<\/strong><\/p>\n\n\n\n maximum 6 g\/day<\/strong><\/p>\n\n\n\n excluding pregnancy and lactation<\/strong><\/p>\n\n\n\n and the specific authorised ingredient.<\/p>\n\n\n\n Regulatory safety assessments need to be read with their conditions attached.<\/p>\n\n\n\n Regulation 2026\/1507 includes proprietary-data protection.<\/p>\n\n\n\n The applicant is The Protein Brewery B.V.<\/strong><\/p>\n\n\n\n During the protected period, the regulation states that only this company is authorised to place the novel food on the EU market under this authorisation.<\/p>\n\n\n\n The protection runs from 26 July 2026 until 26 July 2031<\/strong>. [European Commission, Commission Implementing Regulation (EU) 2026\/1507, Articles 2\u20133<\/em>]<\/p>\n\n\n\n This is one of the easiest points for brands to misunderstand.<\/p>\n\n\n\n Seeing an ingredient on the Union list does not automatically mean that any supplier can manufacture an apparently equivalent Rhizomucor pusillus<\/em> ingredient and immediately sell it under the same authorisation.<\/p>\n\n\n\n Under Articles 26 and 27 of the Novel Food Regulation, newly developed proprietary scientific evidence may be protected for five years when specific conditions are met.<\/p>\n\n\n\n During that period, the protected evidence cannot be used for the benefit of a subsequent applicant without the initial applicant’s agreement. The Union-list entry must identify the original applicant and indicate that only that applicant may place the food on the EU market under the protected authorisation unless another company obtains its own authorisation or has the initial applicant’s agreement. [European Parliament and Council, Regulation (EU) 2015\/2283, Articles 26\u201327<\/em>]<\/p>\n\n\n\n For Regulation 2026\/1507, protected information includes evidence relating to identity, production, composition, toxicology, genotoxicity, human data and allergenicity. The Commission concluded that EFSA could not have completed its safety assessment without these proprietary data. [European Commission, Commission Implementing Regulation (EU) 2026\/1507, recitals 8\u201310<\/em>]<\/p>\n\n\n\n Authorised ingredient does not therefore mean unrestricted sourcing.<\/p>\n\n\n\n Potentially, yes.<\/p>\n\n\n\n Data protection is not a permanent monopoly over R. pusillus<\/em> mycelium as a concept.<\/p>\n\n\n\n Regulation 2015\/2283 allows another applicant to obtain authorisation if that application is supported by legally obtained information that does not rely on the protected evidence, or if the original applicant agrees to the use of its protected data. [European Parliament and Council, Regulation (EU) 2015\/2283, Articles 26\u201327<\/em>]<\/p>\n\n\n\n Regulation 2026\/1507 explicitly preserves that possibility. [European Commission, Commission Implementing Regulation (EU) 2026\/1507<\/em>]<\/p>\n\n\n\n For procurement teams, the relevant question is therefore not merely:<\/p>\n\n\n\n \u201cCan you supply Rhizomucor pusillus mycelium?\u201d<\/strong><\/p>\n\n\n\n It is:<\/p>\n\n\n\n \u201cWhat regulatory basis allows you to place this exact ingredient on the EU market?\u201d<\/strong><\/p>\n\n\n\n Before a supplement brand signs off on this ingredient, the supplier file should establish the regulatory basis, identity of strain CBS 143028, manufacturing route, authorised specification, batch microbiology, heavy-metal compliance and relevant mycotoxin results.<\/p>\n\n\n\n It should also establish whether the supplier is operating under the protected authorisation of The Protein Brewery B.V., has the applicant’s agreement or holds another valid regulatory basis.<\/p>\n\n\n\n That is especially important during the 2026\u20132031 protected period.<\/p>\n\n\n\n A technically similar powder can still have the wrong regulatory status.<\/p>\n\n\n\n A compliant novel-food ingredient does not automatically create a compliant supplement.<\/p>\n\n\n\n The finished product still needs to satisfy the broader EU framework applicable to food supplements.<\/p>\n\n\n\n That includes formulation, daily dose, food-information requirements, target group, claims and applicable national market-entry requirements.<\/p>\n\n\n\n The novel-food authorisation answers one question:<\/p>\n\n\n\n Can this particular ingredient be used under these defined conditions?<\/strong><\/p>\n\n\n\n It does not answer:<\/p>\n\n\n\n Is the entire finished product ready for launch?<\/strong><\/p>\n\n\n\n Makrolife supports manufacturers with product analysis, regulatory classification, label review and compliance assessment for food and dietary supplements. Its food-safety portfolio also includes heavy metals, mycotoxins, pesticides, allergens and other contaminant testing. [Makrolife Biotech, Food & Supplements<\/em>; Food Safety, Contaminants & Compliance<\/em>]<\/p>\n\n\n\n The fact that Rhizomucor pusillus<\/em> mycelium is authorised as a novel food does not create an authorised health claim.<\/p>\n\n\n\n Any nutrition or health communication must still comply with the separate EU claims framework.<\/p>\n\n\n\n Novel-food authorisation concerns market access and safety under specified conditions.<\/p>\n\n\n\n Health-claim authorisation concerns what benefits may legally be communicated to consumers.<\/p>\n\n\n\n Those are different regulatory processes.<\/p>\n\n\n\n Makrolife provides separate regulatory and health-claim support for food and supplement brands entering the EU market. [Makrolife Biotech, Regulatory & Health Claims<\/em>]<\/p>\n\n\n\n An ingredient can be authorised.<\/p>\n\n\n\n Its marketing can still be non-compliant.<\/p>\n\n\n\n For a brand considering Rhizomucor pusillus<\/em> mycelium, the review should cover one connected chain: confirm the exact authorised ingredient and supplier’s legal basis; match the material to the Union-list specification; verify microbiology, heavy metals and relevant mycotoxins; calculate daily intake from the finished dosage instructions; restrict supplement use to the authorised adult population; include the mandatory under-18\/pregnancy\/lactation statement; review the ingredient designation; and separately assess claims and national launch requirements.<\/p>\n\n\n\n The important point is sequence.<\/p>\n\n\n\n Do not build the entire product first and ask whether the ingredient is usable afterwards.<\/p>\n\n\n\n Novel-food status should be verified before formulation and packaging are locked.<\/p>\n\n\n\n A few errors are particularly likely with this authorisation: interpreting 6 g\/day<\/strong> as a per-capsule limit rather than total daily intake; assuming the ingredient can be sourced from any fungal-biomass supplier because it appears on the Union list; ignoring the mandatory age and pregnancy\/lactation warning; checking protein content but not the microbiological, heavy-metal and mycotoxin specification; assuming EFSA’s safety opinion permits unrestricted use; and treating novel-food authorisation as permission to make health claims.<\/p>\n\n\n\n Each mistake comes from the same problem:<\/p>\n\n\n\n Reading one headline from the authorisation instead of the complete entry.<\/p>\n\n\n\n Fermentation-derived foods sit at the intersection of biotechnology, analytical chemistry and regulatory affairs.<\/p>\n\n\n\n That makes them especially unsuitable for a document-only compliance approach.<\/p>\n\n\n\n Makrolife Biotech supports food and supplement manufacturers with regulatory classification, ingredient and finished-product analysis, specification verification, heavy-metal analysis, mycotoxin testing, microbiological assessment, label review and EU market-entry support<\/strong>. [Makrolife Biotech, Food & Supplements<\/em>; Food Safety, Contaminants & Compliance<\/em>]<\/p>\n\n\n\n For emerging fermentation ingredients, the strongest approach is to connect the regulation directly to the laboratory specification.<\/p>\n\n\n\n Confirm what the law requires.<\/p>\n\n\n\n Then verify that the material actually meets it.<\/p>\n\n\n\n Regulation 2026\/1507 is interesting because it shows how quickly the novel-food landscape is expanding beyond conventional botanicals and isolated nutrients.<\/p>\n\n\n\n A fermentation-derived fungal biomass can now be incorporated into multiple mainstream food categories and adult supplements in the EU.<\/p>\n\n\n\n But the authorisation is highly specific.<\/p>\n\n\n\n It identifies:<\/p>\n\n\n\n one strain<\/strong><\/p>\n\n\n\n one production concept<\/strong><\/p>\n\n\n\n defined composition<\/strong><\/p>\n\n\n\n defined contaminant specifications<\/strong><\/p>\n\n\n\n specific food categories<\/strong><\/p>\n\n\n\n specific use levels<\/strong><\/p>\n\n\n\n a specific supplement population<\/strong><\/p>\n\n\n\n and<\/p>\n\n\n\n protected data until July 2031.<\/strong><\/p>\n\n\n\n For product developers, that is the real takeaway.<\/p>\n\n\n\n Innovation may begin in fermentation.<\/p>\n\n\n\n EU market access begins with the exact authorisation.<\/p>\n\n\n\n <\/p>\n","protected":false},"excerpt":{"rendered":" EU Regulation 2026\/1507 authorises fermentation-derived Rhizomucor pusillus mycelium for multiple foods and adult supplements. The new entry sets use levels, microbiological and contaminant specifications, mandatory warnings and protected-data conditions through 2031.<\/p>\n","protected":false},"author":2,"featured_media":274,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[75,9],"tags":[78,113,114,80,61,117,72,116,115,99,89,112],"class_list":["post-273","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-food-supplements-regulatory","category-regulatory","tag-eu-compliance","tag-eu-regulation-2026-1507","tag-fermentation","tag-food-safety","tag-food-supplements","tag-heavy-metals","tag-makrolife-biotech","tag-mycoprotein","tag-mycotoxins","tag-novel-food","tag-regulatory-affairs","tag-rhizomucor-pusillus"],"_links":{"self":[{"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/posts\/273","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/comments?post=273"}],"version-history":[{"count":1,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/posts\/273\/revisions"}],"predecessor-version":[{"id":275,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/posts\/273\/revisions\/275"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/media\/274"}],"wp:attachment":[{"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/media?parent=273"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/categories?post=273"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/makrolife-biotech.com\/blog\/wp-json\/wp\/v2\/tags?post=273"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}What Exactly Has Been Authorised?<\/h2>\n\n\n\n
Fermentation Is Part of the Regulatory Identity<\/h2>\n\n\n\n
Where Can It Be Used?<\/h2>\n\n\n\n
Authorised application<\/th> Maximum level<\/th><\/tr><\/thead> Breakfast cereals and cereal-, fruit- or vegetable-based snacks<\/td> 30 g\/100 g<\/td><\/tr> Biscuits<\/td> 10 g\/100 g<\/td><\/tr> Cereal bars<\/td> 35 g\/100 g<\/td><\/tr> Dairy analogues, except drinks<\/td> 20 g\/100 g<\/td><\/tr> Non-alcoholic beverages<\/td> 10 g\/100 g<\/td><\/tr> Flatbread and steamed breads<\/td> 20 g\/100 g<\/td><\/tr> Chocolate confectionery<\/td> 15 g\/100 g<\/td><\/tr> Cocoa-based spreads<\/td> 20 g\/100 g<\/td><\/tr> Meal replacements for weight control, adults<\/td> Max. 2 meals\/day, up to 40 g\/day<\/td><\/tr> Food supplements, general adult population excluding pregnant and lactating women<\/td> 6 g\/day<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n The 6 g\/day Supplement Limit Applies to Daily Intake<\/h2>\n\n\n\n
Supplements Are Restricted to Adults<\/h2>\n\n\n\n
The Ingredient Name Is Also Prescribed<\/h2>\n\n\n\n
Microbiological Specifications Are Part of the Authorisation<\/h2>\n\n\n\n
Heavy Metals Are Explicitly Limited<\/h2>\n\n\n\n
Mycotoxin Control Is Even More Extensive<\/h2>\n\n\n\n
\u201cEFSA Safe\u201d Does Not Mean \u201cUse Without Conditions\u201d<\/h2>\n\n\n\n
The Most Important Commercial Issue: Five Years of Protected Data<\/h2>\n\n\n\n
What Does Data Protection Actually Protect?<\/h2>\n\n\n\n
Can Another Supplier Enter the Market Before 2031?<\/h2>\n\n\n\n
Supplier Qualification Needs to Go Beyond the Product Name<\/h2>\n\n\n\n
The Finished Supplement Still Needs Its Own Compliance Review<\/h2>\n\n\n\n
Health Claims Are Still a Separate Issue<\/h2>\n\n\n\n
A Practical Pre-Launch Review<\/h2>\n\n\n\n
Common Mistakes to Avoid<\/h2>\n\n\n\n
How Makrolife Biotech Can Support Fermentation-Derived Novel Foods<\/h2>\n\n\n\n
Fermentation Is Opening New Markets, but the Specification Still Controls<\/h2>\n\n\n\n
Sources<\/h2>\n\n\n\n
\n