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Food Law

Novel Foods

Last updated: 8 March 2023

On this page:
  • Summary - Overview of the development of the controls
  • Current EU legislation - Listing of Regulations covering the topic including link to the “Union List”
  • UK Legislation - Listing of Regulations covering the topic
  • Guidance - Links to recommended supporting documents

Summary

Note: This page considers the controls applied to “Novel Foods”. Originally this included genetically modified (GM) material used as food. However in 2003 separate EU controls were adopted. For details of the controls on GM food, please see the other page: GM Food Legislation in the EU. The following diagram illustrates the development of both the GM controls and those for “novel foods”:

For a larger version of this figure, see: Diagram: GM and Novel Foods

Controls for “novel foods” were first proposed as part of the “Internal Market” programme in the early 1990s. Regulation 258/97 was eventually adopted in January 1997 and came into effect on the 15 May 1997. The date of 15 May 1997 has become important since any food or food ingredient commercially available in the EU prior to that date is not considered “novel”.

The Regulation applied to the following categories of foods and food ingredients (see Article 1(2)):

(a) foods and food ingredients containing or consisting of genetically modified organisms within the meaning of Directive 90/220/EEC;
(b) foods and food ingredients produced from, but not containing, genetically modified organisms;
(c) foods and food ingredients with a new or intentionally modified primary molecular structure;
(d) foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae;
(e) foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use;
(f) foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances.

The original regulation covered genetically modified foods and food ingredients - categories (a) and (b) above. These were however deleted when more detailed controls for GM foods were adopted in 2003.

Regulation 258/97 required “novel foods” to be subject to a risk assessment prior to their sale and use. This involved an initial assessment by a Member State and, in the event of an objection by another Member State to the initial assessment, a subsequent assessment by the European Food Safety Authority (EFSA). A significant number of novel foods were approved by this route and permitted by the adoption of Commission Regulations. Concerns were however raised by countries outside the EU that the Regulation created excessive barriers to foods which were common in other countries but which had not been commercially available within the EU prior to the 15 May 1997. The EU therefore agreed to amend and update the legislation.

The initial Commission proposal (COM(2002)0872) proved controversial in that it included procedures for the authorisation of nanotechnology and animal cloning in food production and, following a failed conciliation process, the proposal was not adopted. A subsequent proposal (COM(2013)0894), without the animal cloning element, was agreed and became Regulation 20015/2283. An extended definition of “novel food” is included - see Article 3(2). All risk assessments are now conducted by EFSA and a simplified route provides for the approval of “traditional foods from third countries”. All approved novel foods now appear in an official EU List published as Regulation 2017/2470 (as amended).

For the Commission's page on this topic, see: Novel Food. For an on-line “Novel Food Catalogue”, see the Commission's page: Novel Food Catalogue.

For details of the original EU controls and the process of adopting the current legislation, see: Novel Foods - Archive Page

Current EU Legislation

The following documents establish the updated controls on novel foods with effect from 1 January 2018

Regulation:

Administrative and Scientific Requirements:

Union List:

The following Regulation established the listing of approved novel foods. This Regulation has however been amended numerous times (approx.100) to include additional approved novel foods. Full details of the amending Regulation are not shown here but are given on a separate page - see: Novel Foods - Union List.

Consolidated Text: For a pdf consolidated text version of Regulation 2017/2470 with the full list in the Annex, see 2017/2470 Consolidated Text (published 29 August 2022). For any more recent amendments, see the Union List page mentioned above.

UK Legislation

Brexit: Prior to the IP Completion Day (31 December 2020), the legal requirements given in the EU Regulations listed above still applied to the UK. Since IP Completion Day, the EU Regulations above have been incorporated into UK legislation but with amendments to correct deficiencies. Information on this is given below. For more details of the process of incorporating EU legislation into UK law, see the separate page: UK Food Law: EU Legislation as Amended for the UK. Provisions for the enforcement of the controls (originally the EU Regulations but now as amended) have been provided in the UK Regulations listed below. For Northern Ireland, EU rules still apply.

1 January 2021: For interim guidance, see:

EU legislation with links to legislation.gov.uk: amended for application in the UK:

UK Legislation Post Brexit

Enforcement

Requirements for implementation and enforcement are provided separately for the four parts of the United Kingdom.

Guidance

Guidance for food business operators on the verification of the status of a new food under the new Novel Foods Regulation 2015/2283 (NFR)

Published by Food Supplements Europe in January 2019, this provides a detailed look at the operation of the 2015 Regulation

Administrative guidance on the submission of applications for authorisation of a novel food pursuant to Article 10 of Regulation (EU) 2015/2283

A copy of the guidance published by EFSA in February 2018 can be downloaded from Wiley online publications (click on image).

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

A copy of the guidance published by EFSA in November 2016 can be downloaded from Wiley online publications (click on image).

Information and Guidance Document “Human Consumption to a Significant Degree”

This Commission publication relates to the original Regulation 258/97 but as it is still provided on the Commission website it can be used to assist in the interpretation of the new Regulation (click on image).

This page was first provided on 12 July 2010