Foodlaw-Reading

Dr David Jukes, The University of Reading, UK

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Last updated: 14 August, 2018

Novel Food Legislation in the European Union

On this page:

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


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:

Amendments:

 

Guidance and Supporting Documentation:

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).


Original EU Law

Agreed EU-wide controls were first adopted in 1997 having been proposed as part of the 'Internal Market' programme in the early 1990s. The Regulation 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 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. Categories (a) and (b) were however deleted when more detailed controls for GM foods were adopted in 2003.

The orginal regulation was:

As amended by:

Consolidated Text: A consolidated version of the 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 approved novel foods, see the Commission's page at: http://ec.europa.eu/food/safety/novel_food/authorisations/list_authorisations/index_en.htm


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.