Novel foods classification: An EU and global perspective
This article discusses the regulatory classification of novel foods, providing guidance for companies on the procedures that apply to novel foods and ingredients in the EU and internationally. It addresses how to navigate current regulatory complexity to realize commercial opportunities, as well as the challenges and opportunities for bringing food and food supplement products containing innovative ingredients or production techniques to markets worldwide.Keywords – novel food, food supplement, dietary supplement, premarket approval process, GRAS
Introduction
Food safety is essential to ensuring that food and food supplements on the market are safe for human consumption. Around the world, regulatory approaches differ by jurisdiction. Some jurisdictions require notification at the time of marketing or premarket approval for products and ingredients, while others do not. Within this context, the concept of novel food plays a key role in ensuring consumer safety.Novel food regulations vary significantly worldwide, with key frameworks requiring premarket safety assessments and/or authorizations before new foods can be placed on the market. Given this regulatory environment for novel foods, companies must be aware of the critical requirements and conditions in order to identify challenges and opportunities when developing marketing strategies.
Novel foods in international law
While some jurisdictions have their own definitions of what constitutes a novel food, there is currently no international definition. However, novel foods can be broadly understood as foods or ingredients without a significant history of human consumption in a specific country or region that require a food safety assessment before they can be marketed. Novel foods can include entirely new food sources, products that are the result of new production systems, or traditional foods that have a history of use in one region but are new to another market. The regulation surrounding novel foods aims to ensure that innovative foods and production systems are safe for consumers and that accurate information is provided about their characteristics and nutritional benefits.International organizations such as the Food and Agriculture Organization of the United Nations (FAO) and the Codex Alimentarius Commission use the term new food sources and production systems (NFPS) to refer to novel foods. The Codex Alimentarius Commission is an international food standards-setting body, established in 1963 by the FAO and the World Health Organization with a dual mandate to protect the health of consumers and ensure fair international food trade.
Food and Agriculture Organization of the United Nations
The FAO highlights the critical role that NFPS can play in transforming agri-food systems by diversifying current food production methods. With this in mind, the FAO’s Food Systems and Food Safety Division, through its Food Safety Foresight Programme, organized a meeting on 13-17 November 2023 to discuss the food safety aspects of a selected NFPS – specifically plant-based food products, new applications of precision fermentation, and 3D food printing – and to consider possible future developments.1 The FAO report summarized several overarching conclusions, including:
- Whereas “the food safety hazards associated with the NFPS are similar to those linked with conventional foods, new production and processing technologies may introduce conditions that are unique to a particular NFPS and may require close attention from a food safety perspective.”
- In safety assessments on new food sources, “the intended uses of final products should be a key consideration.”
- “Provisions contained in the Codex standards [e.g., food hygiene, contaminants, labeling] are applicable to NFPS. However, there may be some unique food safety aspects and impacts of NFPS which may need further risk analysis and could lead to revision of existing standards and/or the drafting of new ones.”
- “…the importance of applying forward-thinking approaches to stay abreast of emerging areas with food safety implications, such as within the sector of NFPS.”
Codex Alimentarius
The 46th Session of the Codex Alimentarius Commission (CAC46), held from 27 November to 2 December 2023, addressed the question of how Codex, as an international standard-setting body, could contribute to addressing issues related to NFPS.
Delegates recognized the importance and relevance of NFPS and the key role that Codex could play in this area. Although a range of ideas were shared regarding the type of work that Codex might undertake, such as developing of a standardized definition of NFPS, CAC46 concluded that the existing working mechanisms were adequate to address any new NFPS work proposals. The Commission therefore encouraged Codex Members to submit discussion papers or new work proposals on this topic.2
Several proposals and draft standards related to novel foods are currently under consideration within Codex member countries and committees, such as:
- Proposals to develop guidance on the safety assessment of cell culture media components in cell-based food production and on hygiene practices for the manufacture of cell-based foods, at the Codex Committees on Food Additives and Food Hygiene, respectively.
- A draft standard for microbial omega-3 oils at the Codex Committee on Fats and Oils, which also recently adopted the inclusion of calanus oil in the Standard for Fish Oils.
Novel foods definitions and global frameworks
EuropeEuropean Union. The EU introduced its own concept of novel foods in 1997, later refined through Regulation (EU) 2015/2283 on novel foods,3 which defines a novel food as any food that was not used for human consumption to a significant degree within the EU before 15 May 1997 – the date the first regulation on novel foods came into force.
In the EU, novel foods can include newly developed or innovative foods, foods produced using new technologies or production processes, as well as food that is or has been traditionally consumed outside of the EU. Examples include new sources of vitamin K (menaquinone), extracts from existing foods (such as Antarctic krill oil rich in phospholipids), agricultural products from countries outside of the EU (such as chia seeds and noni fruit juice), and foods derived from new production processes (such as UV-treated milk, bread, mushrooms, and yeast). Novel foods must adhere to underlying principles: they must be safe for consumers, properly labelled, and, if intended to replace another food, must not be nutritionally disadvantageous.4
Foods and ingredients that fall within the scope of the EU Novel Foods Regulation require a premarket authorization after a thorough safety assessment carried out by the European Food Safety Authority (EFSA). In addition to the Commission Implementing Regulation (EU) 2017/2469, which sets out the administrative and scientific requirements for novel food applications,5 EFSA has developed its own step-by-step guide detailing these requirements.6
Only novel foods that are authorized and included in the EU’s list of authorized novel foods may be placed on the market or used in or on foods, in accordance with their specified conditions of use and the labeling. This authorization applies across all 27 EU member states, as well as Iceland, Liechtenstein, Norway, and Switzerland.
The authorization process – from submission of an application to the European Commission, validation, evaluation by EFSA, to the final authorization adopted by the European Commission and EU member states – typically takes 15-36 months for a full dossier or 15-24 months for a simplified procedure for traditionally used foods from countries outside of the EU.
In 2024, the European Commission initiated an evaluation of EFSA’s performance, pursuant to the EU regulation on transparency and sustainability of the EU risk assessment in the food chain.7 The process included a call for evidence, a public consultation, and a survey, with feedback due in April 2025. Many respondents were primarily concerned by the lengthy assessment timelines, including those related to novel foods. The evaluation process requires the European Commission to publish its evaluation and recommendations by 28 March 2026.8
When a food or ingredient’s status is unclear, the European Commission’s EU Novel Food Catalogue serves as a non-binding instrument. It provides guidance to help determine whether a food or ingredient may be considered novel based on information and experiences from EUMS. The novel foods regulation also provides the option for food business operators to consult with EUMS directly to determine whether a food or food supplement falls within the scope of the novel foods regulation. Although not exhaustive, the catalogue is a helpful tool for identifying foods and ingredients that may be considered novel. It can also identify which foods and ingredients are not novel when used in food supplements.9
United Kingdom. Since 1 January 2021, the UK has not been a member of the EU. In general, EU law no longer applies to Great Britain, which consists of England, Scotland, and Wales. However, under the terms of the withdrawal agreement, EU law continues to apply to products on the Northern Ireland market. Therefore, any business seeking to market novel foods or food supplements in Northern Ireland must comply with EU requirements and procedures.
UK law on novel foods remains based on the EU Novel Foods Regulation. The Food Standards Agency (FSA) is responsible for food safety in England and Wales, while Food Standards Scotland (FSS) is responsible for Scotland. Substances authorized in the EU as novel foods before 1 January 2021 remain authorized in Great Britain. Following that date, new novel food applications are required to be submitted to the FSA for approval; separate applications to FSS are not required. The FSA has published guidance on the requirements for novel food applications.10
A key regulatory distinction between the UK and EU regulatory process on novel foods lies in the final decision-making process. In the EU, decisions are made by the European Commission and representatives from the 27 EU member states, following on a safety evaluation by EFSA. In the UK, this responsibility rests with UK government ministers, based on FSA assessment and the opinion of the FSA’s Advisory Committee on Novel Foods and Processes.
In contrast with the EU, the FSA has taken a different approach regarding novel food products that were already on the market before the need to assess their authorization as novel foods was identified. For example, the FSA has allowed businesses to continue selling products containing cannabidiol provided that the products were safe, correctly labeled, and linked to a novel foods application submitted and subsequently validated. On the other hand, FSS does not allow ingredients classed as novel food to be sold on the Scottish market until they receive full authorization.
In order to accelerate the regulatory process for novel foods, the UK government provided funding in 2024 for the FSA to establish a regulatory sandbox focused on cultivated meat products (i.e., meat produced directly from cells). A regulatory sandbox offers space to assess new products under the oversight of a regulator. This innovative initiative, overseen by the FSA, allows collaboration between regulatory bodies, industry leaders, and scientists to gather scientific data and refine regulatory approaches. It remains to be seen how widely this instrument will be applied to other novel foods in the future.
Asia
China, Singapore, South Korea, and Thailand have developed specific regulations and guidelines on novel foods, which vary significantly.
China. Under China’s national regulation on the safety review of new food ingredients,11 novel foods are defined as foods that do not have a history of human consumption in China, generally for at least 30 years, including foods whose original components have been modified or produced using new technology. Novel foods require premarket approval by the National Health Commission, following a safety assessment by its National Center for Food Safety Risk Assessment.
Singapore. The Singapore Food Agency (SFA) has developed a regulatory framework under which novel food comprises food or food ingredients that do not have a history of human consumption over the past 20 years. It also includes traditionally consumed food ingredients produced through advances in technology (e.g., proteins produced through precision fermentation). The framework requires all novel food to undergo case-by-case safety assessments by the SFA and obtain approval before they can be sold in Singapore.12 The SFA has published guidance that outlines the safety assessment requirements, which typically takes 9-12 months.13
South Korea. Novel foods in South Korea are defined as foods or ingredients that have not been significantly consumed before and may include new food sources or ingredients produced using new technologies. Novel foods also require a safety assessment and registration with the Ministry of Food and Drug Safety through a process referred to as the temporary standard specification recognition. This allows for the ingredient to be temporarily added to South Korea’s list of permitted food ingredients. Ingredients temporarily added to this list can be used over a specified period of time. If no side effects are shown during this time, it may be added to the official list of food ingredients.
Thailand. The 2016 Thai Food and Drug Administration national guidance on novel food defines it as any substance used as food or a food ingredient with a consumption history in Thailand of less than 15 years. It also includes foods produced using new production processes that significantly alter the composition or structure of the food in a way that affects nutritional value, metabolism, or the presence of harmful substances. Novel foods require premarket authorization.14
Oceania
Australia-New Zealand. The harmonized Australia New Zealand Food Standards Code defines novel food as a non-traditional food with no history of human consumption in Australia and New Zealand, requiring premarket safety assessment by Food Standards Australia New Zealand based on its composition or structure, process of preparation, source, or patterns and levels of consumption.
The code details the application process for premarket approval and requires that novel foods may only be sold if they are listed in the relevant schedule of permitted novel foods, along with specified conditions for use, such as allowable levels, restrictions, and labeling requirements.15
Latin America
Brazil. The first regulation on novel foods in Brazil was adopted in 1999. It was later replaced by a 2023 resolution establishing procedures for verifying the safety and authorizing the use of novel foods and ingredients.16 Under this framework, novel foods are defined as foods and food ingredients with no history of safe consumption in Brazil, obtained from plants, animals, minerals, microorganisms, fungi, algae, or synthetic sources. Novel foods and ingredients require prior authorization from the Brazilian Health Surveillance Agency upon proof of safety for consumption.
Chile. In July 2025, the Chilean Ministry of Health launched a public consultation requesting comments until 6 September on a draft technical standard for evaluating and incorporating new foods into the national list of foods for human consumption.17 The proposal defines novel food, ingredients, and food materials as those obtained through physical-chemical synthesis or natural processes that result in molecules or compounds without a history of safe human consumption. Novel foods require premarket approval by the Ministry of Health after conducting a safety assessment.
Mexico. There is currently no specific regulatory framework for novel foods in Mexico. However, companies may request an opinion from the Federal Commission for the Protection against Sanitary Risk on whether a new ingredient is suitable for use in foods or food supplements. This process requires the submission of a dossier letter, after which the commission issues an official opinion that is shared only with the requesting company.
North America
Canada. Division 28 of Canada’s Food and Drug Regulations18 defines novel foods as any substance or food (other than a supplemental ingredient or supplemented food) that meet at least one of the following criteria: have no history of safe use; are manufactured using a process that has not been previously applied to that food, undergo a major change in composition or structure; or are derived from a plant, animal, or microorganism that has been genetically modified.
Novel foods require premarket authorization by Health Canada. To guide petitioners, Health Canada published guidelines for the safety assessment of novel foods in 2022, outlining information needed for a novel food notification and a safety assessment. Novel food safety assessments are conducted by the Food Directorate within the Health Products and Food Branch of Health Canada.19
United States. The US does not have a distinct novel foods regulation. However, there are two pathways for approving new ingredients under the US Food and Drug Administration (FDA).
- New dietary ingredient (NDI) notification: Applies to novel ingredients used in dietary supplements.20
- Generally recognized as safe (GRAS) designation: Applies to common food ingredients and some dietary supplements.21
While an NDI requires a premarket notification to the FDA before it can be sold, the GRAS designation can be either self-affirmed (i.e., companies declare the safety of a substance without having to notify the FDA) or submitted to the FDA for evaluation, depending on the ingredient. Under 21 CFR 170.30(c) and 170.3(f), safety can be established through general recognition based on a substantial history of consumption by a significant number of consumers.
Conclusion
The concept of novel foods originated in Europe and remains a key characteristic in European regulatory frameworks at both regional and national levels. Outside Europe, only a few countries have developed specific novel food regulations, though many require premarket authorization for food and food supplements in general. As a result, novel food procedures coexist alongside more general premarket approval systems.The concept and definition of novel foods are not globally harmonized, despite ongoing international efforts. However, commonalities exist among current novel food regulations, even though definitions and administrative market access processes vary. These commonalities include:
- Novel foods are commonly defined as those without a history of human consumption in a given jurisdiction and may include newly developed foods, foods produced using innovative technologies or processes, or foods that have been traditionally consumed outside a given market; and
- Novel foods typically require premarket safety assessment and authorization, evaluated on a case-by-case basis.
The key differences among global novel food frameworks include:
- A few jurisdictions specify a reference date (e.g., EU) or a specific consumption period (e.g., Singapore and Thailand) when defining a novel food.
- Safety assessment requirements and decision-making processes vary; some authorities provide detailed guidance and tools, while others offer more general frameworks.
- In most cases, government authorities grant authorization based on the opinion of the scientific experts under the same organizational structure, while the EU involves the European Commission and EFSA.
- In certain jurisdictions (e.g., EU, South Korea, Australia/New Zealand), novel foods require inclusion on a positive list in order to be marketed.
- In a few markets (i.e., Brazil and the EU), exclusive use of an authorized novel food may be granted for a limited period to the applicant company that submitted the confidential information.
- Some jurisdictions have introduced simplified approval procedures. In addition, the UK’s regulatory sandbox has been designed to accelerate the regulatory process for novel foods through collaboration between regulatory bodies, industry leaders, and scientists.
One question that persists is how novel food frameworks and procedures will impact the future of innovation in food and food supplements. As the food industry continues to evolve, so too must the systems that govern it. Novel foods and technologies present challenges and opportunities that require regulators to not only ensure food safety but also facilitate food innovation.
In this evolving regulatory environment, companies must stay informed, identify business opportunities, develop successful marketing strategies, and launch procedures for novel foods and ingredients with a strong strategic mindset to optimize their chances of success.
About the author
David Pineda Ereño, LLM, is managing director of DPE International Consulting, an international consultancy firm that provides strategic and regulatory advice on the policy, regulation, and trade of foods and food supplements. Pineda has more than 20 years of experience providing strategic solutions to companies, trade associations, and government bodies at the national, regional, and international levels in Europe, Latin America, Asia, the Middle East and Africa, and the US. Pineda holds a law degree from the University of Deusto, Bilbao, and a master’s degree in comparative law and European law from the University of Maastricht. He can be contacted at [email protected]
Citation Pineda Ereño D. Novel foods classification: An EU and global perspective. Regulatory Focus. Published online 7 November 2025. https://www.raps.org/news-and-articles/News-Articles/2025/11/Novel-foods-classification-An-EU-and-global-perspe
References
All references were last checked and verified on 7 November 2025.
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