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.

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

Guidance documents on novel food and traditional

On 10 November 2016, EFSA published two guidance documents on novel food and on traditional food following the new European regulation on novel food. The regulation, which was adopted in November 2015, comes into effect in January 2018, introducing a centralised authorisation and assessment procedure.

EU risk managers decide whether new foods can enter the European market. In some cases, they may see the need for these foods to undergo a scientific risk assessment by EFSA to ensure consumer safety.

EFSA’s new guidance documents explain in detail the kind of information applicants need to provide when a risk assessment is required and how to present this information to EFSA.

Novel and traditional food: guidance finalised

Guidance on the preparation and presentation of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283

Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283

Stakeholders played an important role in the shaping of these guidance documents. A two-month public consultation and a dedicated meeting during that period gave them the opportunity to provide EFSA with their comments and feedback.

Novel food, traditional food – EFSA briefs stakeholders on draft guidance documents

Outcome of a public consultation on the draft guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283

Outcome of a public consultation on the draft guidance on the preparation and presentation of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283

Under current legislation, EFSA carries out a scientific risk assessment of a novel food application only if a Member State or the European Commission raises an objection to an intended market introduction of a novel food.

When the new EU regulation on novel food comes into effect in January 2018, the process will be centralised. EFSA will perform all risk assessments on the safety of a novel food upon request by EU risk managers.

Novel food

EFSA will carry out its safety assessment based on dossiers provided by applicants. Dossiers will 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.

Traditional food

Traditional food is a subset of novel food. EFSA, in parallel with Member States, will assess its safe use before its introduction into the EU based on information provided by the applicant. This evidence should demonstrate the safe use of the traditional food in at least one country outside the EU for a period of at least 25 years.

EFSA published two guidance documents to assist applicants in the preparation of their dossiers: one on novel food and a separate one on traditional food.

Guidance on the preparation and presentation of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283

Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283

Until the end of 2017, applications for novel food fall under the 1997 regulation on novel foods. Applicants who want to market a novel food in the EU submit a request for authorisation to the Member State in which the product will first be placed on the market. EFSA plays a role only if in the following steps any Member State or the Commission raises an objection to the intended introduction of the food.

New regulation

The European Parliament and the Council adopted a new regulation in November 2015 which introduces a centralised assessment and authorisation procedure that makes the overall process more efficient.

EU risk managers will decide on the market introduction of novel foods and may 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.