Novel Foods Regulation for Fungal Ingredients
Navigate novel food, GRAS and equivalent approval pathways for fungal biomass, fermentation-derived and new mushroom-based ingredients.
Program identification
- 1.1Program name
- Novel Foods Regulation for Fungal Ingredients
- 1.2Type of qualification
- Course
- 1.3Provider / endorsing institution
- Fungaris – International Institute of Mycology, School of Fungal Fermentation & Food Science. A Fungaris program of its own, not endorsed by a university.
- 1.4Mode of study
- Online, with live sessions in a small group, recordings and a virtual campus.
- 1.5Duration (hours / ECTS credits)
- 3 months (12 weeks) · 72 hours in total · 6 modules of 12 hours · 12 live sessions of 2 hours. ECTS credits: not applicable (Fungaris own program, not an official university degree).
- 1.6Language
- English
- 1.7Start and end dates / intake
- Next intake: January 11, 2027 to April 2, 2027. Enrollment closes on January 4, 2027. Following intake: March 8, 2027. How intakes work →
Overview
2.1Program description
Many promising fungal ingredients, from new mycoprotein strains to fermentation-derived proteins and mushroom-based extracts, cannot be sold until they clear a regulatory approval route. Getting this wrong can delay a launch by years. This course explains what makes a food novel and how the main pathways work: novel food authorization in the European Union and the United Kingdom, GRAS notifications and FDA consultation in the United States, and the requirements in Mexico, Latin America and the Asia-Pacific region.
You will learn how a safety dossier is built, covering composition, production process, toxicology and allergenicity, and how to plan a realistic regulatory strategy with timelines and constructive dialogue with authorities. The course suits regulatory affairs staff, founders and technical teams in fungal food start-ups and ingredient companies. Sessions are led by a instructor selected for direct experience of regulatory submissions. For your final project, you will map the regulatory pathway for a fungal ingredient in two markets of your choice, outlining dossier contents, key risks and a strategic sequence of steps.
2.2Why it matters / what need it meets
It meets a practical need: applied, up-to-date knowledge in fermentation, useful in areas such as alternative proteins, food ingredients, regulatory consulting, food start-ups and investors.
Mycology is moving fast and good practical training is still scarce. This program gives you a structured path, taught live by people who work in the field, so you can apply what you learn with judgment and safety.
Objectives and competences
3.1General objective
To finish the program able to apply its content professionally and with judgment. In short:
Navigate novel food, GRAS and equivalent approval pathways for fungal biomass, fermentation-derived and new mushroom-based ingredients.
3.2Specific objectives
- Build the foundations: What makes a food novel: key definitions; EU and UK novel food authorization.
- Put them into practice: US GRAS notifications and FDA consultation; Pathways in Mexico, Latin America and Asia-Pacific.
- Apply everything to a real case: Building a safety dossier: composition, toxicology and allergenicity; Strategy, timelines and working with regulators.
- Complete a final project reviewed by your instructor.
3.3Competences you will gain
- Determine whether a fungal ingredient is likely to be novel.
- Compare approval routes in the EU, UK, US and other markets.
- Outline the contents of a novel food safety dossier.
- Identify data gaps in composition, toxicology and allergenicity.
- Build a market-entry regulatory strategy with realistic timelines.
Student profile
4.1Who it is for (entry profile)
Regulatory affairs staff and founders.
4.2Entry requirements
No legal background is required; a basic understanding of food science or the food industry is helpful.
4.3Career paths (exit profile)
- Regulatory affairs specialist in a food start-up
- Regulatory consultant for novel ingredients
- Technical founder of a fungal food company
- Compliance officer in an ingredients company
- Scientific dossier writer
Outcomes depend on your experience and on your local market.
Study plan
5.1Overall structure (modules and workload)
| Module | Title | Phase | Topics | Hours |
|---|---|---|---|---|
| 01 | What makes a food novel: key definitions | Foundations | 3 | 12 |
| 02 | EU and UK novel food authorization | Foundations | 3 | 12 |
| 03 | US GRAS notifications and FDA consultation | Practice | 3 | 12 |
| 04 | Pathways in Mexico, Latin America and Asia-Pacific | Practice | 3 | 12 |
| 05 | Building a safety dossier: composition, toxicology and allergenicity | Application & project | 3 | 12 |
| 06 | Strategy, timelines and working with regulators | Application & project | 3 | 12 |
| Total | 72 |
6 modules × 12 hours = 72 hours: 24 hours of live sessions, and the rest for campus study, exercises and the final project.
5.2Content by module
Hover or tap a module to follow the path from the first session to the final project. Open a module to see the topics it covers.
- Legal definitions of novel food
- History of safe use
- Common borderline cases
- The EU application process
- UK procedures after Brexit
- Data protection and confidentiality
- Self-affirmed and notified GRAS
- The FDA consultation process
- New dietary ingredients and other routes
- Mexico and COFEPRIS requirements
- Brazil and other Latin American markets
- Singapore, Australia, Japan and others
- Characterization and specifications
- Toxicological studies
- Allergenicity assessment
- Choosing target markets
- Realistic timelines and budgets
- Communicating with regulators
5.3Company placement
This program does not include a company placement. Practice is built into every module through exercises, case studies and the final project.
5.4Final project
Map the regulatory pathway for a fungal ingredient in two chosen markets, including dossier outline and strategy.
Methodology
6.1How it is taught
- Live online sessions, usually weekly, with a working professional and a small group.
- Recordings of every session, so you can catch up if work or time zones get in the way.
- Exercises and real case studies in every module.
- Tutoring: your instructor answers questions and gives feedback on your exercises and project.
6.2Platform and resources
A Moodle virtual campus with session recordings, readings, exercises and forums for each module. You need a computer, an up-to-date browser and a stable connection; a webcam and microphone are recommended.
Technical requirements →6.3Estimated weekly workload
About 6 hours a week for 12 weeks: one 2-hour live session on a weekday evening, plus study and exercises on the campus at your own pace.
Assessment
7.1Assessment system and weighting
Progress is assessed through participation in live sessions and case exercises in each module. The instructor reviews the final project with individual feedback.
7.2Requirements to pass
- Complete every module, by attending the live sessions or watching the recordings.
- Hand in the module exercises.
- Have your final project approved by your instructor.
Teaching team
8.1Academic direction
At Fungaris, the Fermentation school coordinates the content and quality of this program. The academic director of each intake is named in the intake guide.
8.2Faculty
Taught by professionals who work in the field. The instructor for each intake is confirmed before the start.
Meet our faculty →Certificate
9.1Certificate awarded
Course Certificate
On completing the program and its project, Fungaris issues a Course Certificate. Fungaris certificates are the institute's own. Whether an employer, school or authority recognizes them depends on that organization and on local rules in each country.
9.2Issuing body / recognition
Issued by Fungaris (operated by Nexora Generation, S.L.) as a digital certificate. It is a Fungaris certificate of its own: it is not an official university degree and does not award ECTS credits.
About our certificates →Admission and enrollment
10.1Admission process (steps)
- Send your request through the form or write to admissions.
- Admissions reviews your profile and confirms the start date, the session schedule and the fee.
- You secure your place with full payment or a 40% reservation.
- You receive your campus access and welcome guide before the first session.
10.2Documents required
- A valid identity document.
- Contact and billing details (personal or company).
10.3Deadlines
Enrollment for the intake starting on January 11, 2027 is open until January 4, 2027, or until the group is full (maximum 20 students).
10.4Fee and payment options
Fee: $450
- Full payment before the start: $360 (20% reduction).
- 40% reservation ($180) and 3 monthly installments of $90.
10.5Grants, discounts and funding
Discounts: 10% for Fungaris alumni and 15% for groups of three or more people from the same organization. Discounts cannot be combined with each other or with the full-payment reduction.
Your employer can pay for the program and receive the invoice in the company name. Whether a public or employer training budget can cover the fee depends on your country, so check with them.
10.6Cancellation policy
The conditions for canceling, withdrawing or moving to a later intake are explained in our cancellation policy and in your enrollment confirmation. Nothing there limits your rights under the consumer law that applies to you.
Cancellation and refunds →Additional information
11.1Frequently asked questions
Do I need experience to study Novel Foods Regulation for Fungal Ingredients?
No legal background is required; a basic understanding of food science or the food industry is helpful.
How is Novel Foods Regulation for Fungal Ingredients taught?
Live online, in 6 modules with a working professional, a small group and a final project.
How am I assessed?
Progress is assessed through participation in live sessions and case exercises in each module. The instructor reviews the final project with individual feedback.
What is the final project?
Map the regulatory pathway for a fungal ingredient in two chosen markets, including dossier outline and strategy.
What certificate do I get?
On completing the program and its project, Fungaris issues a Course Certificate. Fungaris certificates are the institute's own. Whether an employer, school or authority recognizes them depends on that organization and on local rules in each country.
What can I study after Novel Foods Regulation for Fungal Ingredients?
The natural next step is Diploma in Koji & Japanese Fermentation.
11.2Alumni testimonials
We only publish verified testimonials from real students. This program does not have any published yet; they will appear here once its first intakes finish.
11.3Admissions contact
Write to info@fungaris.institute or use the contact form. Admissions answers in your language.
Read before you start.
FermentationHow to Make Tempeh at Home: Rhizopus, Incubation, SafetyTempeh is one of the easiest mold ferments to master at home. Here is how Rhizopus works, how to incubate it and how to tell good tempeh from bad.Read the article 
FermentationKoji Fermentation Guide: Miso, Shoyu, Amazake and GarumKoji is the mold behind miso, soy sauce and sake. Learn how it works, how to grow it safely at home and how chefs use it today.Read the article Keep branching.
Join the next intake.
Pay in full with a 20% reduction, or reserve your place with 40% and pay the rest in monthly installments. All prices are stated in US dollars (USD).