What are novel foods and how do they reach the market?

Novel foods are one of the most dynamic frontiers in food innovation. Precision-fermented proteins, microalgae, fungal mycelium, cultured meat, edible insects: product development is moving fast, and so are the questions around evidence, approvals, and market acceptance.

This page introduces the core concepts of novel foods, outlines the main product types and technologies, and explains what it takes to move from a promising strain or process to an approved product on the market.

Here’s the short version

If your ingredient or production method wasn’t consumed to a significant degree in the EU before 15 May 1997, it will likely be treated as a novel food under EU rules, and will need a safety dossier and authorisation before launch.

On this page you’ll learn:

how to check whether your product is novel
what the EU approval path looks like in practice
what typically causes delays and clock-stops
how EU requirements compare with US GRAS

Quick links to content:

What is a novel food?
Is my product a novel food? A quick check
What types of products fall under novel food?
From concept to approval: How novel foods reach the market
What are the most common challenges?
GRAS in the United States
Novel foods FAQ
The future of novel foods
Glossary of novel food terms
Start your novel food journey with confidence

What is a novel food?

In the European Union, a novel food is defined as food that was not consumed to a significant degree before 15 May 1997. This includes new sources of nutrition, products created using novel processes, or ingredients traditionally eaten outside the EU.

Globally, the concept isn’t universal. Market access depends on how each region defines “newness” and “safety”. While this definition forms the backbone of EU food innovation policy, the term “novel food” is not used everywhere.

Regulatory approaches vary widely:

The United States: safety pathways typically rely on GRAS (Generally Recognized As Safe) for food ingredients and NDI (New Dietary Ingredient) for supplements.
Canada: uses a definition broadly aligned with the EU, requiring pre-market assessment for foods produced through new processes or with significantly altered composition.
Australia and New Zealand: operate under a shared food code with a formal safety evaluation process for novel foods.
China and Japan: maintain their own ingredient approval pathways for foods without a domestic history of use, even if the term “novel food” is not used formally.

These differences in definitions, requirements, and documentation make global market access a complex task for food innovators.
For more details about the legal definition, categories of novel foods, and how they’re assessed, see our in-depth article: What is novel food?

Is my product a novel food? A quick check

In practice, novelty is usually decided by a few core questions. If you answer “yes” to any of these, your product may fall under the EU Novel Food Regulation:

Significant EU consumption before 15 May 1997
Can you demonstrate meaningful use in the EU market before the cut-off date?
New source or new organism
Is it a new source of nutrition (e.g., insects, microalgae, fungal mycelium), or a new strain/species used as an ingredient?
Novel production process that changes the food
Does the production method materially change composition, structure, or nutritional characteristics compared to conventional foods?
Fermentation-derived or microbial ingredients
Is the ingredient produced via precision fermentation, biomass fermentation, or microbial processing, especially with limited EU history of use?

If you’re unsure, it’s often faster to do a structured novelty assessment early than to discover novelty issues mid-project.

Novel Foods: novel or not, that's the question

What types of products fall under novel food?

The category is broader than most expect. Novel food products include:

Microbial proteins grown via biomass or precision fermentation
Cell-cultured food, including cultivated meat and fat produced from animal cells
Microalgae and fungal mycelium with functional nutritional profiles
Animal-free dairy ingredients produced through microbial fermentation
Edible insects such as crickets and mealworms
Foods produced using new processes with material compositional changes (e.g., novel extraction or processing methods)

Explore key product types

From concept to approval: how novel foods reach the EU market

Novel food innovation is only half the story. Regulatory approval is the gatekeeper and the main driver of “time to market” for many new ingredient categories.

In the EU, novel foods are governed by Regulation (EU) 2015/2283, with requirements covering safety, nutritional considerations, and labelling. Applications are handled by the European Commission and assessed scientifically by EFSA.

A typical EU novel food pathway includes:

Regulatory classification and novelty assessment
Data gap analysis against EFSA expectations (identity, process, specs, safety)
Study plan and generation of missing evidence (as needed)
Dossier preparation (scientific + administrative + confidentiality handling)
Submission and validation
EFSA assessment and Q&A (clock-stops if information is missing)
Authorisation decision and conditions of use (including labelling where relevant)

What goes into a novel food dossier?

While requirements vary by product type, most dossiers cover:

Identity and specifications (what it is, how it’s defined, purity/limits)
Production process (including controls and consistency)
Compositional data (including contaminants and batch data)
Stability and shelf-life considerations
Proposed uses and use levels
Dietary exposure assessment
Nutritional assessment (including potential disadvantages)
Toxicology (as needed, depending on novelty and evidence base)
Allergenicity considerations
Labelling and conditions of use

A strong dossier is the right data presented consistently, with a clear regulatory logic. In practice, that means aligning identity, specifications, production description, and batch data so they tell one consistent story.

If you want a practical view of how dossiers succeed or stall – where clarity matters, where clock-stops happen, and how teams build robust submissions – read:
EU Novel Food Regulation: expert insights from regulatory practice

The EU Biotech Act

Policy changes also shape what “efficient approval” could mean in the coming years. We’re following the EU Biotech Act proposals closely, with a specific lens on what they change (and what they don’t) for food and feed innovation: What the EU Biotech Act really means for food and feed: modernisation or missed opportunity?

Need help building the right pathway early, before studies and timelines are locked in? Start with a novelty assessment and data gap analysis.

Novel EFSA guidance for Novel Foods — are you ready?

Common challenges in novel food projects

Bringing a novel food to market involves scientific, regulatory, and commercial hurdles. Many of the hardest questions appear before the first study starts.

Common points that determine dossier strength and review speed include:

How do we confirm whether the product is novel (and what evidence is acceptable)?
How representative does pilot production need to be compared with commercial scale?
What toxicology studies are expected and when can existing evidence reduce the study burden?
What does EFSA expect on identity, specifications, and batch data?
When is WGS needed for microbial ingredients, and what is considered “current” bioinformatics?
How do clock-stops happen and how do you prevent avoidable delays?
How do we address antibiotic resistance and strain characterisation in a way EFSA accepts?
How do we minimise avoidable animal testing without weakening the safety case?

We address recurring pitfalls and best practices in our technical FAQ:
Biosafe FAQ: The dos and don’ts in the development of novel microbial products

GRAS in the United States

Unlike the EU’s centralised approval system, the United States allows companies to self-affirm the safety of novel ingredients under the GRAS (Generally Recognized as Safe) pathway. That pathway is facing increasing scrutiny, and changes in enforcement expectations can affect strategy, documentation depth, and risk appetite.

Learn what’s changing and how it may affect novel food innovation in the US:
Read more: RFK Jr. pushes to end self-affirmed GRAS: Impacts on the food industry

Novel foods FAQ

What does “novel food” mean in the EU?
Food that wasn’t consumed to a significant degree in the EU before 15 May 1997, including new sources, new processes, and some foods with limited EU history of use.

How long does EU novel food approval take?
Timelines vary widely by product type and dossier readiness. In practice, delays often come from data gaps and Q&A rounds rather than the initial submission itself.

Can genome sequencing alone prove antibiotic resistance safety?
Not always. For microbial cases, phenotypic testing may still be needed depending on the organism and the safety questions being asked.

Can I avoid animal testing?
Sometimes. It depends on novelty, existing evidence, and whether safety can be demonstrated through alternative data. The strategy needs to be built case-by-case.

What causes “clock-stops” at EFSA?
Most commonly: unclear identity/specs, insufficient batch/compositional data, missing rationale for study design, or gaps in exposure/safety justification.

The future of novel foods

Novel foods are not just “innovation.” They are also a response to supply chain resilience, sustainability pressures, and the need to diversify protein and functional ingredient production.

Microbial foods, cultivated meat, and fermentation-derived ingredients are positioned to play a larger role, but only if regulatory evidence packages and safety narratives keep pace with technology.

Explore our long-term outlook:
The Future of Food, Innovations and Safety in 2034

Glossary of novel food terms

Novel food – food not widely consumed in the EU before 15 May 1997
Precision fermentation – using engineered microbes to produce specific functional ingredients
QPS – EFSA’s Qualified Presumption of Safety status for a list of selected microbial species
WGS – Whole Genome Sequencing, often required for microbial strain characterisation
GRAS – Generally Recognized as Safe (US FDA designation)