What is novel food?

An overview of what qualifies as a novel food in the EU, how it’s regulated, and how definitions vary across key markets.

In the European Union (EU), novel food refers to food that was not consumed to a significant degree by humans within the EU before 15 May 1997. This includes:

Foods traditionally consumed outside the EU
For example chia seeds and other plants with a history of use in non-European diets
Foods produced using new technologies or processes
Fox example UV-treated foods, cell-cultured ingredients, and protein isolates obtained through novel extraction methods such as rapeseed protein
New sources of food
For example edible insects, algae-derived oils, fungal proteins, and ingredients produced from microorganisms
Newly developed or innovative foods
For example products obtained through biomass fermentation or precision fermentation, including microbial proteins and functional compounds not previously present in the food supply

The EU Regulatory Framework

Novel foods are regulated under Regulation (EU) 2015/2283, which entered into force on 1 January 2018. The European Commission is the authority responsible defining what is a novel food and for authorising them, while the European Food Safety Authority (EFSA) supports the process by providing independent scientific opinions to assess safety, but it does not make regulatory decisions.

Applications must be submitted through the European Commission’s electronic portal. The process is centralised and aims to ensure consistent evaluation across all Member States.

Key regulatory criteria include:

The food must be safe for human consumption
It must not be nutritionally disadvantageous
It must be clearly and accurately labelled
It must not mislead consumers

Traditional foods from third countries

There is also a simplified notification procedure for traditional foods from third countries. has a documented history of safe use for at least 25 years outside the EU, and no safety concerns are raised, it may be placed on the market without a full novel food application.

Data protection and transparency

To encourage innovation, the regulation allows applicants to request data protection for proprietary scientific evidence submitted as part of their application. This protection lasts five years and prevents other applicants from using the protected data without consent.

The European Commission also maintains a publicly accessible Novel Food Catalogue, which serves as a non-binding reference to help determine whether a product is considered novel. It is regularly updated to support transparency and consistency.

Novel food regulation — Global Comparison

Outside the European Union, the regulation of novel foods varies significantly across jurisdictions, reflecting different legal traditions, risk assessment frameworks, and market priorities.

United States

There is no specific "novel food" category. New ingredients are assessed under the GRAS (Generally Recognized As Safe) framework or the NDI (New Dietary Ingredient) pathway for dietary supplements. The Food and Drug Administration (FDA) oversees these processes, and companies are responsible for ensuring the safety of their products before they enter the market. While the GRAS process allows for self-determination of safety in some cases, the FDA can intervene if safety concerns arise.

Canada

Canada’s definition of novel food is closely aligned with the EU. They are regulated under the Food and Drugs Act, and any food that has been significantly changed through processes or ingredients not previously used in the food supply must undergo a pre-market safety assessment. This evaluation is conducted by Health Canada, which reviews the scientific evidence to ensure the product is safe for consumption.

Australia and New Zealand

Australia and New Zealand share a joint food regulatory system managed by Food Standards Australia New Zealand (FSANZ). Novel foods in this region require pre-market approval, and the assessment process includes a thorough evaluation of safety, nutritional impact, and technological justification. FSANZ also considers consumer expectations and labelling requirements as part of its regulatory oversight.

China

In China, the regulation of novel food ingredients is overseen by the National Health Commission of the People’s Republic of China (NHC). Ingredients not previously used in the Chinese food supply must be approved and listed in the Catalogue of New Food Ingredients before they can be marketed. The regulatory process includes a safety assessment and, increasingly, considerations related to labelling and traceability.

Japan

Japan does not have a formal "novel food" category, but new ingredients are regulated under the Food Sanitation Act, which is monitored by the Ministry of Health, Labour and Welfare of Japan. Japan has developed specific frameworks for functional foods, such as Foods for Specified Health Uses (FOSHU) and Food with Nutrient Function Claims (FNFC). These systems focus on the health benefits of foods and require scientific substantiation of claims, though they do not necessarily involve a full novel food assessment as seen in the EU.

Novel food market outlook

As of 2025, the novel food market continues to expand, supported by sustained investment and growing demand for sustainable, functional, and alternative food sources. Areas of particular activity include plant-based proteins, microbial ingredients, and products developed through technologies such as precision fermentation and cell cultivation.

In the European Union and other key regions, this momentum is reflected in a steady rise in novel food applications. However, regulatory complexity remains a limiting factor for market entry.

In the EU, the updated application guidelines introduced in February 2025 aim to improve clarity and streamline data requirements. Despite these improvements, authorisation timelines often still exceed one year. This is due to the volume and complexity of the required safety data, as well as administrative procedures introduced by the Transparency Regulation (EU) 2019/1381.

At the international level, regulatory fragmentation presents further challenges. Jurisdictions such as the United States, China, and Japan maintain distinct definitions, approval pathways, and documentation standards. The lack of harmonisation increases compliance requirements and can delay global market access for novel food developers.

Biosafe supports novel food approvals

Biosafe helps companies bring new ingredients and food products to market by providing scientific and regulatory support tailored to EU and international requirements. Our services include:

Novel food classification and regulatory strategy
Dossier preparation and EFSA submission support
Strain characterisation and QPS evaluations
Study design for toxicological and microbiological testing
Guidance on global regulatory alignment

For companies developing microbial, fermentation-based, or functional ingredients, early regulatory planning is essential. Biosafe provides the expertise needed to navigate the process with clarity and confidence.