Dr David Jukes, The University of Reading, UK

Providng access to food law since May 1996

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Last updated: 3 October, 2023

GMOs, NGTs and PBOs

Providing access to EU and UK legislation

GMOs = Genetically modified organisms / NGTs = Novel Genomic Techniques (EU term) / PBOs - Precision Bred Organism (UK term)

On this page:


Note: This page considers the EU legislation on genetically modified (GM) foods and the more recent developments involving Novel Genomic Techniques (NGTs) (the EU tern) and Precision Bred Organisms (PBOs) (the UK term). Originally the controls were based on those applied to 'novel foods'. However in 2003 separate EU legislation was adopted on GM food. For details of legislation on 'novel foods', see the other page: Novel 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

Initial controls for the approval and use of genetically modified materials in agriculture were established by Directive 90/220 on the deliberate release into the environment of genetically modified organisms. These were subsequently updated and replaced by Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and repealing Directive 90/220/EEC.

The use of GM material for food was initially covered by Regulation 258/97 of the European Parliament and of the Council concerning novel foods and novel food ingredients which came into effect on the 15 May 1997 - foods used before this date would not be considered 'novel'. This contained provisions for the approval of GM material as food and for the possible requirement for labelling. However, before May 1997 two GM products (one soya and one maize) had been approved for use under Directive 90/220 and could not therefore be subject to the rquirements of Regulation 258/97 (since, by definition, they could not be considered 'novel'). Special controls were therefore adopted by Regulation 1813/97 to impose the same requirements for labelling on these two GM products as would have been required under the novel food controls. Howver as imports were just beginning to arrive, consumer concerns increased and additional special labelling rules were introduced, first by Regulation 1139/98 and then by Regulation 49/2000.

Major changes were introduced in 2003 with the adoption of specific controls applying to both food and feed - Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed. This removed GM food from the definition of 'novel food' and contained updated procedures for the approval of GM food and for the labelling of products derived from GM material.

Approval of GM material for food use has been controversial and Member States are divided on whether they should be used for food. Although the European Food Safety Authority has generally issued positive opinions on their safety (itself also controversial), Member States have subsequently failed to agree and adopt the necessary legal documents. Regulation 1829/2003 (and related procedural regulations) allows the Commission to adopt the approval if Member States fail to reach agreement within specified time limits and this has been the route for the adoption of most approvals. Similar issues have arisen under Directive 2001/18 but an amendment (by Directive 2015/412) allows Member States to restrict use in agriculture on their territory. To try and resolve the problem for food and feed, the Commission proposed (in COM(2015)177) a similar amendment to Regulation 1829/2003 allowing Member States to prohibit (under specified conditions) the use of approved GM foods in their territory. This though was rejected by the European Parliament; as the Commission did not withdraw the proposal, it is officially still awaiting the Council to reach a position at first readiing.

A case (C-528/16) was brought before the Court of Justice to clarify whether the more recent scientific techniques used to modify genes within a plant were classified as genetic modification under the EU legislation. The ruling, in July 2018, determined that such techniques, commonly known as 'gene editing' (GE) were covered by the detailed controls in Directive 2001/18. Debate has therefore been taking place to determine whether to amend the legislation so as to remove GE plants from the definitions within the Directive. In April 2021 the Commission started an 'open debate' and in September 2021 started the process of consultation on a new approach. In July 2023 the Commission published a proposal for a regulation on plants obtained by certain new genomic techniques and their food and feed, COM(2023)411. Similar initiatives have taken place within the UK. In March 2023, the Genetic Technology (Precision Breeding) Act 2023 was passed. Discussions on the develoopment of supporting regulations are now taking place. For updates on the EU and UK developments proposal, see the sections below - EU and NGTs / UK and PBOs.

For the Commission's page on this topic, see: Genetically Modified Organisms.

EU Legislation

Consolidated Texts:


Proposed EU Controls for Novel Genomic Techniques (NGTs) (Proposal published July 2023)

For the Commission's Proposal, see:

For News Items, see:

For the Commission's page on this issue, see: New techniques in biotechnology

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.


EU Legislation with links to amended for application in Great Britain:

UK Legislation: with links to

Note: Since the European controls on deliberate release were adopted as a Directive, all legal requirements were already contained in UK legislation. The following UK Regulations contain both the technical requirements and the enforcement provisions for deliberate release..


Requirements for implementation and enforcement of controls derived from EU Regulations are provided separately for the four parts of the United Kingdom.

Precision Bred Organisms (PBOs) - UK Developments

Key documents:

For News Items (with links to some relevant documents), see:

This page was first provided on 14 January 2016
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