Novel food

Introduction

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.

Traditional food is a subset of novel food and refers to food that is traditionally consumed anywhere outside Europe.

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. 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.