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Novel food

New kinds of food come to our tables all the time. Increasing globalisation, growing ethnic diversity and the search for new sources of nutrients are the key drivers.

The notion of “novel food” 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, phytosterols or plant sterols as a new substance or nanotechnology as a new way of 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 is a subset of novel food and refers to food that is traditionally consumed anywhere outside Europe.

Latest

January 2021 – EFSA published its first completed assessment of a proposed insect-derived food product. Our safety evaluations are a necessary step in the regulation of novel food, as our scientific advice supports EU and national decision-makers who authorise these products for the European market.

Milestones

2021 The first EFSA assessment of an insect product as novel food comes out

2018 EFSA issues administrative guidance for applicants and publishes the first opinion – shrimp peptide concentrate – following the new procedures.

2018 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 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 the new novel food regulation introduces a centralised assessment and authorisation procedure.

2004 EFSA publishes its first scientific opinion of a novel food application – the use of enova oil

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.

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.

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