Novel foods are one of the most dynamic frontiers in food innovation. From precision-fermented proteins and microalgae-based ingredients to cultured meat and edible insects, the category is rapidly expanding and so are the questions around how these products are regulated, approved, and accepted.
On this page, we introduce the core concepts of novel foods, explore the latest trends and technologies, and explain how products navigate the complex journey from lab bench to market shelf.
Quick links to content:
- What is a novel food?
- What types of products fall under novel food?
- From concept to approval: How novel foods reach the market
- What are the most common challenges?
- The role of GRAS in the US
- 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.
While this definition forms the backbone of EU food innovation policy, “novel food” as a concept does not exist in every part of the world. Regulatory approaches vary widely:
-
The United States assesses new ingredients under the GRAS (Generally Recognized As Safe) or NDI (New Dietary Ingredient) frameworks.
-
Canada uses a definition closely aligned with the EU, requiring pre-market approval for foods produced through new processes or significantly altered compositions.
-
Australia and New Zealand operate under a shared food code that requires full safety evaluations for novel foods.
-
China and Japan maintain their own approval pathways for ingredients not previously consumed in their domestic markets, though neither uses the term “novel food” 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?
What types of products fall under novel food?
The category is broader than most expect. Novel food products include:
-
Microbial proteins grown via precision fermentation
-
Cultured meat produced from animal cells
-
Microalgae and fungal mycelium with functional nutritional profiles
-
Edible insects such as crickets and mealworms
-
Dairy foods made without animals through microbial fermentation
Explore some of these emerging product types:
- Milking microorganisms for the next novel dairy foods
- Cell-cultured meat takes shape
- Edible insects as novel foods in the EU (coming soon)
- Fungal mycelium in novel foods (coming soon)
- Microalgae to market: regulatory essentials for food innovators (coming soon)
From concept to approval: How novel foods reach the market
Novel food innovation is only half the story. Regulatory approval is the gatekeeper.
In the EU, novel foods are governed by Regulation (EU) 2015/2283, which sets out requirements for safety, nutritional value, and labelling. Applications are assessed by the European Commission and the European Food Safety Authority (EFSA).
Our practical guide breaks it down:
Novel food regulation in the EU: A practical guide for innovators (coming soon)
Need help navigating it?
What are the most common challenges?
Bringing a novel food to market involves scientific, regulatory, and commercial hurdles. Developers often face questions like:
-
How representative does pilot production need to be?
-
What are the requirements for toxicological studies?
-
When is WGS data necessary?
-
Can I avoid animal testing?
We address all these and more in our technical FAQ:
Biosafe FAQ: The dos and don’ts in the development of novel microbial products
The role of GRAS in the US
While the EU has a centralised approval system, the United States allows companies to self-affirm the safety of novel ingredients under the GRAS (Generally Recognized as Safe) notification pathway. But this route is under increased scrutiny.
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
The future of novel foods
Novel foods are not just about innovation — they’re also a response to global challenges. As the world seeks more sustainable, resilient food systems, microbial food, cultured meat, and plant-based proteins are positioned to play a central role.
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 functional ingredients
-
QPS – EFSA’s Qualified Presumption of Safety list for microbial strains
-
WGS – Whole Genome Sequencing, often required for microbial strain characterisation
-
GRAS – Generally Recognized as Safe (US FDA designation
Start your novel food journey with confidence
Whether you're developing a microbial ingredient, scaling up a fermentation process, or preparing a novel food dossier for EFSA or FDA, Biosafe can help.
Contact our experts!
|
|
|
 Meeri Sutinen Quality Manager, PhD +358 40 574 9191 meeri.sutinen@biosafe.fi |
 Anne Ukkonen Regulatory Manager, PhD +358 40 581 3160 anne.ukkonen@biosafe.fi |
