Genetically modified organisms

Ever since we have grown plants and raised animals for food, or processed food, we have selected plants and animals with beneficial traits for further breeding or chosen the best-performing microorganisms.

Such traits reflected naturally occurring genetic variations and resulted, for example, in an increased yield or specific environmental conditions such as drought or flooding.

Modern technology has made it possible to alter genetic material to create novel traits or enhance or diminish existing ones in plants, animals, bacteria and fungi

Genetic technology has primarily been used in crops to increase insect resistance and herbicide tolerance, and in micro-organisms to produce enzymes.

Organisms that have had their genetic material altered this way are called genetically modified organisms (GMOs). Food and feed containing or consisting of GMOs or produced from GMOs are known as genetically modified (GM) food and feed.

Genomic techniques that were developed before the adoption of the EU’s legislation on GMOs in 2001 are known as established genomic techniques (EGTs). 

New genomic techniques (NGTs) refer to techniques that have been developed since 2001. 

The only GM crop currently cultivated in the EU is MON810, an insect-resistant GM maize variety, grown mainly in Spain and to a lesser extent in a handful of other EU countries, for animal feed. 

In other parts of the world, such as North and South America, many varieties of GM crops are grown for food and animal feed. The EU is a major importer of GM animal feed including maize and soybean. 

Most of our GM plant assessments relate to maize (50% of applications) or soybean (25%). Our other GM plant assessments relate to oilseed rape, cotton, potato, rice and sugar beet.

See also

• New advances in biotechnology
• New genomic techniques
• Genetically modified animals

EFSA's role

EFSA assesses any possible risks Viela vai darbība, kas potenciāli var izraisīt nelabvēlīgu iedarbību uz dzīviem organismiem vai vidi from genetically modified organisms (GMOs) to human and animal health, and the environment in Europe. 

Our role is to give scientific advice on the safety of GMOs to Europe’s risk managers i.e. the European Commission and EU Member States. They are responsible for deciding on the authorisation of GMOs and the conditions for their use on the European market.

Our experts apply the strict criteria laid down in the EU regulatory framework when evaluating the safety of GMOs before they can be authorised for use as food or feed or for cultivation in the EU.

Most of our assessments so far have related to GM plants including maize, soybean, oilseed rape, cotton, potato, rice and sugar beet, destined for animal feed and processing.

We also respond to ad hoc requests from the European Commission or the European Parliament on issues related to GMOs and their safety.

Assessment of GMO applications

Our experts evaluates the safety of new GMO products to inform market authorisation decisions taken by European Commission and EU Member States. 

Our assessments are based on scientific dossiers presented by applicants and any other relevant scientific information.

Our experts consider the following aspects:

• Molecular characterisation and bioinformatic analysis: assessment of the molecular structure of the new or modified genetic elements and their products (genes, proteins, RNAs), how they function and their potential interactions.
• Comparative analysis: comparison of the GM plant with its conventional counterpart. The aim is to detect differences in the plant’s appearance such as height and colour, agronomic characteristics such as yield, and nutritional value.
• Evaluation of potential toxicity and allergenicity.
• Evaluation of potential environmental impact.

Infographic: risk assessment of GM plants

Dossiers are made available to all EU Member States in a targeted consultation and the public is also consulted on the assessment so they can provide their opinion. We publish all comments and our replies alongside the final scientific evaluation.

Once a GMO has been authorised by the European Commission and EU Member States, it normally receives a 10-year licence for the EU market. 

After 10 years on the market, EFSA must reassess the safety of each GMO before any re-authorisation decision is taken.

Guidance documents

EFSA has prepared several guidance documents for the risk assessment of GMOs.

These documents detail how to compile GMO application dossiers and the type of scientific data and other information to be included. All guidance documents are publicly available on our website.

Post-authorisation monitoring

Under EU legislation, applications for cultivation of GM plants as well as for import and processing must contain a plan for detailed post-market environmental monitoring ( PMEM Jauna produkta (piemēram, ĢM auga) ietekmes uzraudzība pēc tā izlaišanas tirgū. Tā var atklāt nelabvēlīgas ietekmes, kas nebija paredzētas pirms izlaišanas tirgū veiktajā riska novērtējumā. Tas nozīmē vides uzraudzību pēc izlaišanas tirgū). 

This plan should describe how the GM plant material or GM microorganism will be monitored for possible adverse effects on the environment.

We assess the results of PMEM for cultivated GM plants annually, and we make recommendations to the European Commission when necessary.

Our GMO Panel carries out an environmental risk assessment ( ERA Vides risku novērtēšana (ERA) ir process, kurā tiek novērtēts vielas, darbības vai dabas parādības izraisīts iespējamais kaitējums videi. Tas var iekļaut ĢM augu ieviešanu, pesticīdu lietošanu vai augu kaitēkļu izplatīšanos), evaluating the overall impact of a GMO on the environment including biodiversity, ecosystem services and endangered species.

Taken together, ERA and PMEM are an important part of the range of measures in place to protect the environment.

In some cases, we recommend the post-market monitoring of GM plants for possible adverse effects on animal or human health. 

This is usually done when the GM food or feed has an altered nutritional composition, when the nutritional value of the GM food or feed differs from the conventional varieties, or when there is a likelihood of increased allergenicity due to the genetic modification.

GMO applications must contain adequate information to enable assessment of the potential long-term adverse effects of the GMO on human health, animal health and the environment.

Depending on the outcome of the risk assessment, applicants may be required to carry out additional long-term studies. In other cases, post-market monitoring (PMM) of GM food or feed may be considered. 

EU framework

The European Union (EU) has established a legal framework for the application of genetic modification technology to ensure a high level of protection of human and animal health, and the environment. 

This framework regulates the production of GM food and feed, GMO imports as well as the release of GMOs into the environment.

GM foods and feeds must pass a safety assessment by EFSA before they may be authorised in the EU. 

• Genetically modifies organisms - European Commission
• Overview of all regulations and guidance documents

Member States and GMO cultivation

Under EU legislation, a Member State has the right to decide on the cultivation of GM crops on its territory. 

During the authorisation procedure of an application, a Member State can request to have the geographical scope amended so that its territory will not be covered by that authorisation. 

In case of already authorised GMOs, a Member State can also prohibit or restrict the cultivation of GM crops on its territory.

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