Guidance

Developing genetically modified organisms (GMOs) if there’s no Brexit deal

Updated 19 December 2018

This guidance was withdrawn on

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Delivering the deal negotiated with the EU remains the government’s top priority. This has not changed.

However, the government must prepare for every eventuality, including a no deal scenario. For two years, the government has been implementing a significant programme of work to ensure that the UK is prepared to leave the EU on March 29 2019.

It has always been the case that as we get nearer to that date, preparations for a no deal scenario would have to be accelerated. We must ensure plans are in place should they need to be relied upon.

In the summer, the government published a series of 106 Technical Notices setting out information to allow businesses and citizens to understand what they would need to do in a no deal scenario so they can make informed plans and preparations.

This Technical Notice offers guidance for continued planning in the event of no deal.

Also included is an overarching framing notice explaining the government’s approach to preparing the UK for this outcome in order to minimise disruption and ensure a smooth and orderly exit.

We are working with the devolved administrations on Technical Notices and we will continue to do so as plans develop.

Purpose

This notice explains how controls on the release of genetically modified organisms (GMOs) into the environment would be affected if the UK leaves the EU in March 2019 without a deal.

Before 29 March 2019

The release of GMOs into the UK environment is currently regulated in line with EU Directive 2001/18. Prior approval has to be sought to undertake a GMO trial release or market a GMO.

Decisions on proposed trials are taken by the UK government or devolved administrations. Decisions on marketing GMOs are made at EU level. In either case, approval is only granted if a risk assessment shows human health and the environment will not be compromised.

Only one type of GM crop seed currently has EU approval for commercial cultivation, known as MON 810 maize. It is not being marketed or grown in the UK, and is not expected to be in the future. Five different varieties of GM carnation are currently authorised under Directive 2001/18 for marketing as cut flowers, and may be sold in the UK.

The export of GMOs intended for environmental release from the UK to third (non-EU) countries is currently regulated in line with EU Regulation 1946/2003. This implements in the EU the requirements of the Cartagena Biosafety Protocol to the United Nations Convention on Biological Diversity. The key requirement is for companies planning the first export of a GMO to a third country to notify the country in advance and await its approval.

After 29 March 2019 if there’s no deal

There would be no significant implications for UK stakeholders. Through the European Union (Withdrawal) Act 2018 existing UK domestic laws implementing Directive 2001/18 and Regulation 1946/2003, and Regulation 1946/2003 itself, would continue to apply as UK law after we have left the EU.

The government would amend the legislation to ensure it is operable in the new UK-only context, for example by replacing references to ‘Member States’. All current EU requirements would be maintained across the UK in equivalent terms. The release of GMOs would continue to require prior authorisation, and this would only be granted if there are no safety concerns. In this context:

  • Regulatory decisions on proposed GMO trials will continue to be made within the UK as they are now on a devolved basis.
  • Regulatory decisions on marketing GMOs will be made within the UK rather than at EU level, but the same risk assessment process will be applied. Defra and the devolved administrations are discussing whether decisions will be taken jointly on a UK-wide basis, or separately in England, Wales, Scotland and Northern Ireland.
  • In terms of trade, in a no-deal scenario the UK will be treated as a third country by the EU. Therefore UK businesses would only be able to export GMO products to the EU if the GMO in question has EU marketing approval. Similarly, EU exports to the UK of GM products would be dependent on there being approval for marketing here.
  • Any EU decisions authorising the marketing of GMOs which are in force on the day we leave the EU will remain applicable here until the expiry of the current EU consent period (details of EU decisions under Directive 2001/18).
  • For UK exports of GMOs to non-EU countries, the rules in Regulation 1946/2003 as converted into UK law will continue to apply.

This notice is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations.

It is part of the government’s ongoing programme of planning for all possible outcomes. We expect to negotiate a successful deal with the EU.

Norway, Iceland and Liechtenstein are party to the Agreement on the European Economic Area and participate in other EU arrangements. As such, in many areas, these countries adopt EU rules. Where this is the case, these technical notices may also apply to them, and EEA businesses and citizens should consider whether they need to take any steps to prepare for a ‘no deal’ scenario.