GMO

Introduction

Ever since humans have grown plants and raised animals for food, they have selected plants and animals with beneficial traits for further breeding. Such traits reflected naturally occurring genetic variations and resulted, for example, in an increased yield or resistance to diseases or environmental pressures.

Modern technology makes it possible to alter genetic material to create novel traits in plants, animals, bacteria and fungi. This 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.

Milestones

June 2018 EFSA adopts a technical note that provides recommendations and requirements on the sequencing information to be submitted when Sanger sequencing or Next generation sequencing (NGS) is used as part of GMO applications for EU market authorisation. This note replaces the European Commission’s Joint Research Centre guideline of 2016.

November 2017 EFSA publishes new guidance for assessing risks from the “unintended, adventitious or technically unavoidable presence” in food and feed of a low level of genetically modified 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 (e.g. grain, flour, syrup).

The European Commission asked EFSA to produce this guidance document to clarify to applicants the scientific requirements they must meet when submitting their scientific data for assessment by EFSA.

June 2017 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.

June 2015 EFSA publishes new 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. It gives applicants seeking market approval for a GM plant in the European Union recommendations on how to generate, analyse and interpret agronomic and phenotypic data of the GM plant.

June 2015 EFSA issues a new 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 European Union. The European Commission grants authorisations to place GM food and feed on the European market for a period of ten years. Interview with working group chair on guidance for renewal of authorisations.

July 2015 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.

October 2014 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.

2011 EFSA launches a project to evaluate eight new plant breeding techniques. Experts were asked to assess whether the current guidance documents are applicable to plants developed using these novel methods. The techniques earmarked for evaluation included intragenesis, cisgenesis and zinc finger nuclease technique (ZFN). EFSA delivers the first of these opinions on cisgenesis and intragenesis in January 2012 followed by a second opinion on zinc finger nuclease 3 (ZFN-3) in October 2012.

EFSA’s role

EFSA assesses any possible risks from GMOs to human and animal health, and the environment in Europe. EFSA’s 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. It is their responsibility as risk managers to decide on the authorisation of GMOs for the European market.

EFSA applies the strict criteria laid down in the European Union 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.

A large part of EFSA’s work relates to the safety assessment of GMOs before they are considered for market approval. The majority of assessments relate to GM plants.

EFSA also responds to urgent requests by the European Commission or the European Parliament on issues related to GMOs and their safety.

Assessment of GMO applications

EFSA evaluates the safety of new GMO products before a market authorisation decision is taken by risk managers. This evaluation encompasses the assessment of the potential impact of GMOs on human health, animal health and the environment. EFSA’s assessments are based on scientific dossiers presented by applicants and any other relevant scientific information.

EFSA applies the principles of GMO risk assessment considering the following aspects:

  • Molecular characterisation: assessment of the molecular structure of the newly created proteins, their functioning 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 observable appearance such as height and colour – phenotypic characteristics – and its agronomic characteristics such as yield. The analysis also compares the nutritional values of the GM plant and its conventional counterpart.
  • Evaluation of potential toxicity and allergenicity.
  • Evaluation of potential environmental impact.

Once a GMO has been authorised by risk managers, it normally receives a 10-year licence for the EU market. After 10 years, it must be re-assessed by EFSA before any re-authorisation decision is taken.

Guidance documents

EFSA has prepared several guidance documents for the risk assessment of GMOs and their derived food and feed. 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 EFSA’s website.

Post-authorisation monitoring

Under EU legislation, applications for import and processing as well as for cultivation of GM plants must contain a plan for detailed post-market environmental monitoring (PMEM). This plan should describe how the GM plant will be monitored for possible adverse effects on the environment. EFSA assesses the results of PMEM for cultivated GM plants annually. It makes recommendations to the European Commission when necessary.

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

In some cases, EFSA recommends 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. The aim of post-market monitoring is to ensure the continued safety of the new GMO.

Stacks

EFSA is carrying out an increasing number of assessments on the safety of plants containing more than one genetic modification. The combination of two or more modifications within one plant is called a stack. Such a plant does not represent a new genetic modification. The plant contains several existing genetic modifications that have been combined through conventional breeding techniques. The aim is to benefit from the combination in one single plant of several properties created by the individual genetic modifications, such as insect resistance and herbicide tolerance.

In the international context, the European Union applies some of the most rigorous standards in the world when assessing the safety of plants containing multiple genetic modifications.

EU framework

The European Union 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 strictly regulates the production of GM food and feed, GMO imports as well as the release of GMOs into the environment.

GM foods and feeds can be authorised in the EU only if they have passed a rigorous safety assessment. The procedures for evaluation and authorisation of GM foods and feeds are laid down in the following 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 prohibit or restrict the cultivation of GM crops on its territory.

FAQ

1. What is EFSA’s role in the risk assessment of GMOs?

EFSA’s Panel on Genetically Modified Organisms (GMO) carries out risk assessments of GMO applications. The Panel consists of up to 21 independent scientific experts who assess all GMO applications received by EFSA. The Panel assesses each GMO application to ensure that it poses no risk to human and animal health, and the environment. The Panel operates within a strict EU regulatory framework.

The GMO Panel has developed guidance documents explaining how to compile an application and what kind of data to include. The required information includes studies relevant for human and animal safety, as well as on the environment.

2. How does EFSA carry out its risk assessments?

EFSA evaluates the safety of new GMO products before risk managers take a market authorisation decision. (This infographic explains the different roles of risk assessment and risk management.)

EFSA evaluates the potential impact of GMOs on human health, animal health and the environment. Its assessments are based on scientific dossiers presented by applicants and any other available relevant scientific information.

EFSA applies the principles of GMO risk assessment considering the following aspects:

  • Molecular characterisation: assessment of the molecular structure of the newly created proteins, their functioning 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 observable appearance such as height and colour – phenotypic characteristics – and its agronomic characteristics such as yield. The analysis also compares the nutritional value of the GM plant and its conventional counterpart.
  • Evaluation of potential toxicity and allergenicity.
  • Evaluation of potential environmental impact.

Once a GMO is authorised by risk managers, it receives a 10-year licence for the EU market. After 10 years, it must be re-assessed by EFSA before a re-authorisation decision can be taken by risk managers.

3. What type of applications does EFSA examine?

GMO applications can cover the import and processing of GM plant materials in the EU for food and/or feed uses, and their import for cultivation. EFSA’s GMO Panel takes into account the scope of the GMO application and the intended uses of the GM product when performing the risk assessment.

The majority of assessments carried out by EFSA so far relate to GM plants including maize, soybean, oilseed rape, cotton, potato, rice and sugar beet.

4. What type of data is involved?

Depending on the scope and the submission date of an application, different criteria apply. EFSA’s guidance documents set out what the GMO Panel requires in terms of information and tests to be carried out in the area of molecular characterisation, toxicity, allergenicity, nutrition and environmental risk assessment.

5. Do the same tests have to be carried out on each GMO?

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.

6. What happens if the data provided are insufficient or incomplete?

When the information provided by an applicant is insufficient for EFSA’s GMO Panel to complete the risk assessment or incomplete, the applicant is required to submit the missing information. To date, this has happened in 95% of cases. If applicants do not provide the requested information within established deadlines, EFSA reserves the right to proceed with the risk assessment using the information available.

7. How long does it take for EFSA to carry out a GMO risk assessment?

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 (see previous question), 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.

8. Why does EFSA not carry out its own studies?

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.

9. What is EFSA’s role in the renewal of GMO authorisations?

Authorisations for the import of genetically modified (GM) food and feed into the European Union are granted by the European Commission and Member States for a period of 10 years. Applicants wishing to extend this period can apply for a renewal. EFSA then evaluates whether or not the original risk assessment remains valid.

In June 2015, EFSA published new guidance detailing the data that applicants need to submit when applying for re-authorisation. These data allow EFSA to evaluate whether there is any new evidence that would have an impact on the conclusions of the original risk assessment: for example, are there any new hazards, modified exposure scenarios or new scientific uncertainties? To be able to answer these questions, EFSA requires applicants to provide all available information on the GM food or feed including new scientific publications, unpublished information available to the applicant and post-market monitoring reports including environmental monitoring.

10. Can the public access GMO applications?

All EFSA opinions and the summaries of GMO applications are published on the EFSA website. The public may also request access to the full documentation submitted to EFSA by applicants and third parties. Access is usually allowed to such documentation except where information is claimed to be confidential by the applicant. It is up to the European Commission or a Member State to decide whether or not the claim for confidentiality is justified.

There is also an opportunity to monitor the status and progress of EFSA’s ongoing scientific work including its evaluation of applications. For more details consult the status tracker in the Applications section.

11. Who is involved in assessing GMOs?

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. All scientific experts selected to contribute to the work of the Panel or any of the working groups have to make Declarations of Interests (DoIs) which are published on the EFSA website. This policy helps EFSA to ensure the independence of its scientific advice.

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.

12. Does the European Food Safety Authority assess environmental issues when assessing GMOs?

Assessing the impact of a GMO on the environment is an intrinsic part of EFSA’s safety assessment of GMOs. The inclusion of an environmental risk assessment (ERA) stems from the legal framework regulating the risk assessment of GMOs.

When carrying out an ERA, the GMO Panel evaluates the overall impact of a GMO on the environment including biodiversity, ecosystem services and endangered species. Is a GM plant, for example, more persistent and/or invasive than its conventional counterpart? Does it have any adverse effects on organisms that are not meant to be affected by the GMO, the so-called non-target organisms?

The guidance document for the environmental risk assessment of GM plants assists applicants in the preparation of the environmental aspects of an application. Applicants must include a plan for detailed post-market environmental monitoring (PMEM) irrespective of whether they apply for authorisation to import and/or process, or for cultivation. This plan should describe how the GM plant will be monitored for possible adverse effects on the environment. EFSA assesses the results of PMEM for cultivated GM plants annually. It makes recommendations to the European Commission when necessary.

For more information see the topic on environmental risk assessment.

13. How does EFSA take account of the long-term effects of GMOs on human health and the environment?

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. Post-market environmental monitoring (PMEM) activities are obligatory for all GMOs that are put on the EU market. These mechanisms help in identifying and managing potential long-term adverse effects of GMOs on the environment.

14. How does EFSA keep its risk assessments of GMOs at the forefront of science?

In addition to evaluating new products before market authorisation, EFSA also initiates its own work (“self-tasking activities”), in order to stay at the forefront of new scientific developments and to further develop GMO risk assessment approaches. This may range from the development or updating of guidance documents to scientific opinions on particular areas of science relevant to GMOs, such as animal feeding trials, non-target organisms or allergenicity.

15. What about uncertainties in the risk assessment of GMOs?

Uncertainties are part of the reality of scientific risk assessment. At EFSA uncertainties are understood as “all types of limitations in the knowledge available to assessors at the time an assessment is conducted and within the time and resources available for the assessment”. Identifying and describing uncertainties and explaining their implications for assessment conclusions, are crucial parts of providing transparent scientific advice. It is up to risk managers to consider such uncertainties in their decision-making.