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 resistance to diseases 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
Latest
We are holding a public consultation on our draft scientific opinion on new developments in biotechnology (including synthetic biology and new genomic techniques) applied to animals for food, feed and other agricultural uses.
The draft opinion assesses the applicability and sufficiency of EFSA’s risk assessment guidance documents, covering aspects of molecular characterisation, food and feed safety, animal health and welfare, and environmental safety. The consultation runs until 19 March 2025.
We are holding a public consultation on our draft scientific opinion Opinions include risk assessments on general scientific issues, evaluations of an application for the authorisation of a product, substance or claim, or an evaluation of a risk assessment on current practice, challenges, and future opportunities in the safety assessment of newly expressed proteins in genetically modified plants. The consultation runs until 12 March 2025.
Milestones
2024
April
EFSA publishes an updated technical note on the quality of DNA A complex chain-like molecule that carries the genetic material, present in living organisms and some viruses. DNA (deoxyribonucleic acid) is capable of copying itself and carries the instructions for all the proteins used to create and sustain life sequencing for the molecular characterisation of genetically modified (GM) plants. This note replaces the previous version published in 2018.
2022
January
EFSA’s experts identify knowledge gaps in the prediction of allergenicity The ability to trigger an abnormal immune response that leads to an allergic reaction in a person of proteins and identify development and research needs for improving the allergenicity risk assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation of products derived from biotechnology.
2020
EFSA published its 100th assessment of the safety for human and animal health, and the environment of a new application for a genetically modified organism An organism which contains genetic material that has been deliberately altered and which does not occur naturally through breeding or selection.
2018
August
EFSA publishes an explanatory note on the determination of newly expressed protein A protein which is made to a particular DNA recipe. Typically used to mean a protein generated as a consequence of the genetic manipulation of an organism levels in the context of GM plant applications for EU market authorisation.
July
EFSA publishes a technical note providing recommendations and requirements for the sequencing information to be submitted when Sanger or next generation sequencing is used as part of GMO A genetically modified organism (GMO) is an organism which contains genetic material that has been deliberately altered and which does not occur naturally through breeding or selection applications for EU market authorisation. This note replaces the European Commission’s Joint Research Centre guideline of 2016.
2017
November
EFSA publishes guidance for assessing risks from the “unintended, adventitious or technically unavoidable presence” in food and feed of a low level of GM plant material intended for markets other than Europe. The presence at low level is defined by the European Commission to be a maximum of 0.9% of genetically modified plant material per ingredient Any substance deliberately added to a foodstuff which will remain in the finished product, even in an altered form (e.g. grain, flour, syrup).
July
EFSA publishes an explanatory note on DNA sequence The exact order of units in a DNA chain similarity searches in the context of the assessment of horizontal gene transfer from plants to microorganisms.
June
EFSA publishes supplementary guidance on allergenicity to further strengthen risk assessment of GM plants. The document considers new scientific and regulatory developments, complementing recommendations in existing guidance and regulations.
2015
July
EFSA updates its previous risk management recommendations to reduce the risk of exposure to Bt-maize pollen for the larvae of non-target butterflies and moths (Lepidoptera) in protected habitats.
June
EFSA issues guidance document on the information that companies need to provide when applying for renewed authorisation to import GM plants for food and feed into the EU.
EFSA publishes guidance clarifying the data needs for the agronomic and phenotypic characterisation of GM plants. The document complements existing guidance on data requirements for the risk assessment of GM plants.
2014
October
EFSA presents further details on how to design and conduct a 90-day feeding study as part of an application to place a GMO on the market in the EU. The explanatory statement builds on the principles set out in EFSA’s previous guidance document on 90-day whole food/feed studies in rodents published in 2011.
2012
October
EFSA delivers a scientific opinion on addressing the safety assessment of plants developed using Zinc Finger Nuclease 3 (ZFN-3) and other Site-Directed Nucleases with similar function.
January
EFSA publishes a scientific opinion addressing the safety assessment of plants developed through cisgenesis An approach that modifies the genetic material of an organism with a sequence from a donor from the same species or one closely related and intragenesis An approach that modifies the genetic material of an organism with a combination of different sequences from a donor that belongs to the same species or one closely related.
EFSA's role
EFSA assesses any possible risks 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 The name given to policies and laws in Europe which collectively protect the consumer 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 evaluate 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 The potential of a substance to cause harm to a living organism 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 Monitoring of the effects of a new product (e.g. a GM plant) following its release onto the market. This may reveal adverse effects which were not predicted in the risk assessment conducted prior to market release. It stands for post-market environmental monitoring).
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 Environmental risk assessment (ERA) is the process of assessing potential harm to the environment caused by a substance, activity or natural occurrence. This may include the introduction of GM plants, the use of pesticides, or the spread of plant pests), evaluating the overall impact of a GMO on the environment including biodiversity A term used to describe the variety of living organisms existing in a specific environment, ecosystem services Benefits to human or animal populations provided by an ecosystem, such as food or fuel provision, natural medicinal ingredients, and maintenance of soil fertility and endangered species A subdivision of the genus, a species is a group of closely related and similar-looking organisms; for example, in the case of Homo sapiens (humans), the second part of the name (sapiens) represents the 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.
FAQ
GMO guidance documents provide the scientific requirements for GMO applications and explain the risk assessment strategy according to which studies should be designed and conducted. Since each GMO may call for specific studies or protocol adaptations, these guidance documents cannot describe in full detail all study types and protocols that may be needed. The EFSA GMO Panel applies a case-by-case approach, treating each application as unique. When necessary, the EFSA GMO Panel asks for additional data, studies or tests to complete the evaluation of an application.
In several cases, test protocols recommended in the EFSA GMO guidance documents follow internationally recognised and harmonised methods. When applicants propose deviations from these methods, they must provide a scientific rationale to justify the derogation.
EFSA aims to deliver its overall opinion within six months of an application having passed the completeness check. The overall opinion of the GMO Panel includes the risk assessment of the GMO, as well as other information such as a post-market environmental monitoring plan and comments from Member States.
Whenever EFSA seeks supplementary information from the applicant, the clock is stopped until the requested information is supplied. The total time taken to carry out the risk assessment therefore varies. It can range from 2 to 24 months, depending on the type of additional information the applicant is requested to submit.
Under present EU legislation, the GMO applicant is responsible to demonstrate the safety of the GMO in question. Applicants are obliged to present a full application dossier containing all the information EFSA needs to carry out the risk assessment. The cost of these studies is borne by the applicant.
EFSA’s GMO risk assessment work is carried out by the GMO Panel of up to 21 scientific experts, supported by a team of EFSA scientists, with experience in a wide range of scientific disciplines: biochemistry, food and environmental food microbiology, soil microbiology, molecular biology, genetics, toxicology, animal pathology, immunology, biotechnology, food sciences, ecology, plant biology, agronomy, entomology and statistics. In addition, over 40 external scientific experts with additional expertise contribute to the work of the Panel as members of its working groups, which are created to deal with specific areas of GMO risk assessment.
Members of the GMO Panel and its working groups, as well as other external experts contributing to the work of EFSA, are selected based on their scientific competence and expertise, and according to objective and transparent criteria.
EFSA also benefits from the contribution of EU Member States to its GMO risk assessment work through a network of over 100 institutions and authorities across Europe as well as through the dedicated GMO network.
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