Foodlaw-Reading

Dr David Jukes, The University of Reading, UK

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Last updated: 27 March, 2019

Novel Food Legislation in the European Union

On this page:
  • Summary - Overview of the development of the controls
  • Current legislation - Quick links to the legal documents including the 'Union List'
  • Original EU law - Links to the orginal 1997 text, amendments and a consolidated version
  • Development of the new EU Controls - Information and links relating to the development of the updated controls adopted in 2015 and applicable from January 2018

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).


Current Legislation

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

Regulation:

Administrative and Sientific Requirements:

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 February 2019)

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

Guidance and Supporting Documentation:

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).


Original EU Law

The orginal regulation was:

Consolidated Text: A consolidated version of the final text of the Regulation incorporating these amendments is available. See: Regulation 258/1997 - Consolidated text (January 2009)

For more details about the legislation, supporting documents, approvals and procedures see:

For a register of novel foods approved under this former Regulation, see the Commission's page at: https://ec.europa.eu/food/safety/novel_food/authorisations/list_authorisations_en


Development of the new EU Controls

In December 2007 the Commission adotped a proposal for updating the novel food legislation. This was published in January 2008. However there was no agreement between the Institutions - particularly the Council and the European Parliament. Ultimately, despite conciliation, the proposal was not adopted and lapsed in March 2011. The main areas of disagreement related to nanotechnology and animal cloning. The Commission published revised proposals in December 2013. This included one which would replace the original novel food regulation and two others specifically on animal cloning. Although there has been little progress on the issue of animal cloning, the revised regulation on novel foods was adopted in November 2015.

First Proposal (2007-2011)

This figure shows the EU procedure for adopting legislation. The coloured items refer to stages which were followed. It can be seen that in March 2011, the discussions concluded without the adoption of new controls. The work ceased and the Commission had to bring forward new proposals to start the whole procedure again.

Click here for full size version (pdf file)

Key documents:

News items:

Key links to relevant news items are given here:

Second Proposal (2013-2015)

It can be noted that at this second attempt, there was a much greater willingness to reach compromise. Detailed discussions were held between the European Parliament and the Council to achieve an agreed document. As shown in this diagram, the discussions led to an agreed text such that the amendments adopted by the European Parliament at First Reading were all accepted by the Council:

Click here for full size version (pdf file)

News Items:

Key links to relevant news items are given here:

UK Enforcement:


This page was first provided on 12 July 2010
To go to main Foodlaw-Reading Index page, click here.