Novel food assessments

Last updated:
11 July 2019

Overview

A Novel Food is defined as food that had not been consumed to a significant degree by humans in the EU before 15 May 1997, as defined by Regulation (EU) 2015/2283. Such foods are subject to a pre-market safety assessment before a decision is made on EU-wide authorisation.

Legislation

Legal Background

On 25 November 2015, the European Parliament and the Council adopted the Regulation of the European Parliament and of the Council on novel foods, which came into full effect on the 1st of January 2018 (Regulation (EU) 2015/2283). The Regulation requires that all applications for the authorisation of novel foods shall be submitted to the Commission who may then request a risk assessment from the European Food Safety Authority (EFSA). In assessing the safety of novel foods, EFSA shall, where appropriate, consider the following:

  1. Whether the novel food concerned is as safe as food from a comparable food category already existing on the market within the Union;
  2. Whether the composition of the novel food and the conditions of its use do not pose a safety risk to human health in the Union;
  3. A novel food, which is intended to replace another food, does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.

Submitting an application

Application Outline

Before a new novel food can be marketed, it must be subjected to a pre-market safety assessment before a decision is made on EU-wide authorisation. The ultimate aim of the assessment is to make sure the food is safe. During this:

  1. The applicant must prepare a dossier on the new novel food, providing the information needed so the European Food Standards Agency can carry out a safety assessment. Please follow the guidance on the preparation and presentation of an application for authorisation of novel food in the context of regulation (EU) 2015/2283. 
  2. The applicant must submit the dossier to the European Commission. Submission occurs via the e-submission system for Novel Foods. Please follow the e-submission system for Novel Foods User Guide.
  3. The European Commission must verify the validity of the dossier within 30 days.
  4. The dossier and novel food is subject to a risk assessment by the European Food Safety Authority over a 9-month period which can be extended if further information is required.
  5. An opinion on the novel food is formed if no further information is needed.
  6. The Commission have 7 months from a positive opinion to draft an implementing decision to update the Union List of novel foods which consists of a specification and conditions of use.
  7. The food is added to the Union list of Novel foods, which means it can now be market in the EU.