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Regulation

How does a genetically modified crop actually get approved for sale?

A binder of regulatory application documents open on a desk beside a pen
The EU, the UK and the US each route a GM or gene-edited crop through a different sequence of agencies before it can be sold.

It gets approved through a sequence of separate assessments rather than a single global sign-off, because no international body grants market authorisation directly. The European Union, the United Kingdom and the United States each run their own pathway, built around different agencies and different legal starting points, and a variety cleared in one of them still has to go through the others before it can be grown or sold there. The Codex Alimentarius Commission, the joint FAO/WHO standard-setting body, publishes shared guidance on assessing biotechnology-derived foods, but applying that guidance is left to each country's own regulators.

How does the EU's approval route work?

In the European Union, a company seeking to place a GM food or feed product on the market submits a dossier assessed by the European Food Safety Authority, EFSA, which evaluates the scientific evidence and issues an opinion; the European Commission and EU member states then take the formal authorisation decision under Regulation (EC) No 1829/2003. Cultivation is handled separately from import under Directive 2001/18/EC, and it is at the cultivation stage that the EU has been most restrictive — very few GM varieties have cleared that step for growing on EU soil, even though a much larger number of GM commodities are authorised for import as food and feed ingredients.

How does the UK's route differ now that it sits outside the EU system?

The Food Standards Agency assesses the food safety case for GM and gene-edited products intended for the UK market, working alongside Food Standards Scotland. Since the Genetic Technology (Precision Breeding) Act 2023, England has run two parallel tracks: transgenic GM crops continue through a GMO-style authorisation process, while gene-edited "precision bred" plants that carry no foreign DNA can use a lighter, notification-based route overseen by the FSA. That split does not currently extend across the whole of the UK in the same form, because genetically modified organism policy is devolved, and Scotland, Wales and Northern Ireland have not adopted identical precision breeding rules.

How does the US system split responsibility across three agencies?

The United States uses what is generally called a coordinated framework rather than one authority. The US Department of Agriculture, through its Animal and Plant Health Inspection Service, assesses whether a GM plant poses a plant pest risk; the Food and Drug Administration runs a consultation process — voluntary in structure but followed as standard practice by developers — on food and feed safety; and the Environmental Protection Agency regulates plant-incorporated protectants, which is the category that covers a trait such as the Bt insecticidal protein. A single crop with a Bt trait can therefore need sign-off input from all three agencies before it reaches commercial fields, each looking at a different piece of the same plant.

How the three systems divide the work
MarketLead body for food/feed safetyCultivation approval handled by
European UnionEuropean Food Safety Authority (EFSA)European Commission and member states
United KingdomFood Standards AgencyDefra / devolved administrations
United StatesFood and Drug AdministrationUSDA APHIS, with EPA for pesticidal traits

What does this mean for how a product is labelled on the shelf?

Labelling rules follow the same national divide as approval. The US operates a National Bioengineered Food Disclosure Standard administered by the USDA, under which covered products must carry a disclosure through text, a symbol or a digital link such as a QR code. The UK and the EU instead require GM content above a set threshold to be declared on the label as containing genetically modified organisms, a stricter default than the US disclosure model. Because gene-edited "precision bred" foods without foreign DNA are treated as a separate category in England, they do not automatically carry the same GMO labelling requirement, which is one of the more practical consequences of the technique-based distinction described elsewhere on this site.