Novel food

Last reviewed date:

25 January 2024

5 minutes read

New kinds of food arrive on our table all the time. Increasing globalisation, ethnic diversity and the search for new sources of nutrients are the key drivers.

The notion of “ novel food Foodstuff or food ingredient that was not used for human consumption to a significant degree within the European Union before 15 May 1997.” is not new. Throughout history new types of food, food ingredients or ways of producing food have found their way to Europe from all corners of the globe. Bananas, tomatoes, pasta, tropical fruit, maize, rice, a wide range of spices – all originally came to Europe as novel foods. Among the recent arrivals are chia seeds, algae-based foods, baobab fruit and physalis (Peruvian groundcherry or Cape gooseberries).

Under EU regulations, any food that was not consumed “significantly” prior to May 1997 is considered to be a novel food. The category covers new foods, food from new sources, new substances used in food as well as new ways and technologies for producing food. Examples include oil rich in omega-3 fatty acids from krill as a new source of food, edible insects, or plant sterols as a new substance or nanotechnology as a new way of producing food.

Traditional food Traditional food is a subset of novel food. The term relates to food traditionally consumed in countries outside the EU. It includes foods made from plants, microorganisms, fungi, algae and animals (e.g. chia seeds, baobab fruit, insects, water chestnuts). is a subset of novel food and refers to food that is traditionally consumed anywhere outside Europe.

Latest

February 2024 – after several years of assessing novel foods and traditional foods under the 2015 Novel Food Regulation, we’re updating our guidance for applicants. We’re looking for scientific insights and information from experts, our partners and stakeholders who have an interest in these food innovations. The deadline for feedback is 14 April.

The updated guidance documents – one for novel foods, a second for traditional foods from third countries – reflect recent EU regulatory updates in the novel food area, consider advances in food research and innovation, and capitalise on EFSA’s increased experience in assessing novel foods and traditional foods since the centralisation of the process in January 2018.

The scientific areas covered in relation to novel food include compositional data, identity, production process, toxicological information, exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time., nutritional information, and allergenicity The ability to trigger an abnormal immune response that leads to an allergic reaction in a person.. In addition to these, the traditional food guidance also updates requirements for data on experience of continued use.

The goal is that the guidance documents remain practical and up-to-date tools for applicants as well as reference documents for risk assessors.

Have your say by 14 April!

You can also join us for a webinar on the novel foods guidance update on 21 March. Register by 19 March!

January 2024 – EFSA is calling on stakeholders involved in the production, use, distribution and/or research and innovation related to novel proteins to support EFSA’s future risk assessments by taking a short survey.

Our scientists routinely evaluate the safety of novel proteins in the GMO A genetically modified organism (GMO) is an organism which contains genetic material that has been deliberately altered and which does not occur naturally through breeding or selection. and novel foods areas. This includes the safety of the production process used to manufacture the product under assessment.

The survey takes approximately 10-20 minutes to complete. The deadline for replies is 23 February 2024. Please help us keep Europe’s food safe and take the survey now

Milestones

2023
EFSA holds a scientific colloquium on the safety of cell culture-derived food to ensure its preparedness for scientific evaluations in this area.
2022
EFSA's cannabidiol novel food evaluations are put on hold pending extensive new data requirements.
2021
The first EFSA assessment of an insect product as novel food comes out.
2018
February and May
EFSA issues administrative guidance for applicants and publishes the first opinion – shrimp peptide concentrate – following the new procedures.
January
The new regulation takes effect from January with the Commission responsible for authorising novel foods after an EFSA safety evaluation.
2017
EFSA holds a webinar on the scientific aspects to consider when preparing a novel food application.
2016
EFSA issues new guidance on the requirements for submission of novel food and traditional foods from the third countries applications.
2015
November
The new novel food regulation introduces a centralised assessment and authorisation procedure.
October
EFSA addresses growing interest in the potential use of farmed insects farmed insects in food and feed with a risk profile that identifies their potential biological, chemical, allergenicity and environmental hazards.
2004
EFSA publishes its first scientific opinion of a novel food application – the use of enova oil.

EFSA's role

Since the new EU regulation on novel food came into effect in January 2018, the process for scientific risk assessment of a novel food application has been centralised. EFSA performs risk assessments on the safety of a novel food upon request by the European Commission.

Novel food

EFSA carries out its safety assessment based on dossiers provided by applicants. Dossiers need to contain data on the compositional, nutritional, toxicological and allergenic properties of the novel food as well as information on respective production processes, and the proposed uses and use levels. See Guidance.

Traditional food

Traditional food is a subset of novel food. EFSA, in parallel with Member States, assesses the safe use of traditional food products based on information provided by the applicant and available data in the literature. This evidence has to demonstrate the safe use of the traditional food in at least one country outside the EU for a period of at least 25 years. See Guidance.

EFSA does not decide whether a food is considered as a novel food or a traditional food from a third country; this is the responsibility of EU risk managers. Similarly, risk managers decide whether a novel food or a traditional food from a third country can be placed on the EU market, including its authorised conditions of use. See European Commission.

Future trends

The types of novel food applications EFSA assesses is evolving in new directions. For example, there is greater emphasis on ingredients and sources of ingredients in food. Our scientists are preparing for such developments both by learning from experience and by ensuring the necessary scientific disciplines and data sources will be available.

In December 2020 our Novel Foods scientists delivered a series of presentations – available on video below – looking at these trends.

Introduction – an overview of the novel food area and EFSA’s role.

Alternative proteins and their sources – this includes both animal-derived alternative proteins such as insects and cultured meat, and non-animal alternatives such as plants and algae.

Novel carbohydrates A family of nutritional substances that includes sugars, starches and fibres. as novel food – this comprises novel fibre, human identical milk oligosaccharides (e.g. sucrose, lactose), and novel foods intended to replace sugars.

Novel food as food supplements – this focuses on plant extracts, synthetic cannabidiol and engineered nanomaterials.

EU framework

The European Parliament and the Council adopted a new regulation in November 2015, repealing Regulation (EC) No 258/97. Regulation (EU) 2015/2283 on novel foods introduces a centralised assessment and authorisation procedure that makes the overall process more efficient.

Since 1 January 2018, the European Commission has been responsible for authorising novel foods and, as part of the procedure, can ask EFSA to conduct a scientific risk assessment to establish their safety.

For the notification of traditional foods from third countries the new regulation simplifies the authorisation process by requiring evidence of safe use in at least one country outside the EU for a period of 25 years. A notification is sent to the European Commission and then forwarded to all Member States and EFSA. Within four months of receipt of a valid notification, a Member States or EFSA may submit safety objections to the placing on the market of the notified traditional food.