The term genetically modified organism (GMO) means an organism in which the genetic material has been altered in a way that does not occur naturally through fertilisation and/or natural recombination. GMOs may be plants, animals or micro-organisms, such as bacteria, parasites and fungi.
EU regulatory framework
Genetically modified (GM) foods can only be authorised in the European Union if they have passed a rigorous safety assessment. The procedures for evaluation and authorisation of GM foods are laid down in Regulation (EC) No 1829/2003 on GM food and feed, which came into force in April 2004, and in Directive 2001/18/EC on the release of GMOs into the environment, which came into force in March 2001.
- EU regulatory framework on GMOs – European Commission, DG Health and Consumers
In December 2008 the Environment Council concluded that the implementation of the EU legal framework for GMOs should be reinforced. Along with the other partners involved including the European Commission and Member States, EFSA is taking a number of relevant actions within its remit as outlined in this section, through an ongoing process of applying the latest scientific knowledge and assessment approaches. EFSA’s actions are detailed in the document below.
- Council conclusions on GMOs – Council of the European Union
EFSA’s role and activities
EFSA’s role in regard to GMOs is defined by Regulation (EC) No 1829/2003 and Directive 2001/18/EC. EFSA’s core task is to independently assess any possible risks of GMOs to human and animal health and the environment. EFSA does not authorise GMOs, which is done by the European Commission and Member States in their role as risk managers. EFSA’s role is strictly limited to giving scientific advice. For more details see
EFSA’s assessments are carried out by the GMO Panel, which is composed of independent scientific experts supported by a number of specialised Working Groups drawing on a pool of more than 40 external experts in fields such as allergenicity, ecology, microbiology, toxicology, plant physiology and molecular genetics. All Scientific Panel and Working Group members are required to comply with EFSA’s policy on Declaration of Interests including declaring any potential conflicting interests in advance of each meeting. Their Declarations are thoroughly screened by EFSA following strict internal procedures.
Assessment of GMO applications
As in other areas where EFSA evaluates the safety of new products before a market authorisation decision is taken, EFSA’s GMO assessments are based on scientific dossiers presented by applicants and any other relevant scientific information.
EFSA’s GMO Panel applies the strict criteria laid down in the EU regulatory framework in relation to GMO applications to ensure its evaluations meet the highest scientific standards. This is reflected in the GMO Panel guidance, which describes the data applicants must include in their application dossiers, including all the necessary studies on human and animal safety and on environmental impact.
The Panel frequently asks applicants for further scientific information, study results or clarifications before processing their applications if it is not satisfied with the original dossier – this happens in around 95% of cases. Please see the FAQ on GMOs for more details on GMO assessments.
Each of the following aspects is considered for all applications:
- Molecular characterisation of the GM product, taking into account the characteristics of the donor and recipient organism.
- Compositional, nutritional, and agronomic characteristics of the GM product.
- Potential toxicity and allergenicity of the GM product.
- Potential environmental impact following a deliberate release of the GM product and taking into account its intended uses either for import, processing or cultivation.
Under EU legislation, if an applicant wishes to continue to market an authorised GMO following the original 10 year approval decision, it must be assessed by EFSA prior to any re-authorization decision by Member States. In 2007 and 2008 the Panel received a total of 25 renewal applications for a range of GMOs including MON810 and other maize, cotton and soybean varieties. It has adopted opinions for instance on the renewal applications for GA21,Bt 11 and MON810 maize and T45 oilseed rape. EFSA has also held a meeting with Member States in the context of the renewal application for MON810 in order to exchange information and address concerns expressed by some Member States.
EFSA has prepared several guidance documents for the risk assessment of GMOs and derived food and feed. These documents detail the type of scientific data that applicants must include in GMO applications and outline the risk assessment approach to be applied. All guidance documents are publicly available on the website.
There are seven main guidance documents:
- Risk assessment of food and feed from GM plants (2011)
- Environmental risk assessment of GM plants (2010)
- Guidance on the submission of applications for authorisation of GM food and feed and GM plants for food and feed (2011)
- Risk assessment of GM microorganisms and their products intended for food and feed use (2011)
- Risk assessment of GM plants used for non-food or non-feed purposes (2009)
- Renewal of authorisations of existing GMO products (2006)
- Risk assessment of food and feed from GM animals and on animal health and welfare aspects (2012)
The first two documents, compiling all relevant information from earlier EFSA documents on different aspects of GMO risk assessment, provide a comprehensive overview of the principles and data requirements for food and/or feed and environmental risk assessment, respectively. The third document – submission guidance – provides instructions to applicants on how to prepare and present data in an application to be submitted to EFSA.
The above main guidance documents replace four previous documents:
- Working document GM plants and plant protection products interplay (2008)
- Guidance document on stacked transformation events (2007)
- Guidance on risk assessment of GM plants and derived food and feed (2006)
- Risk assessment of GM microorganisms and their derived products intended for food and feed use (2006)
In addition, EFSA has published several other documents which support the main guidance documents and/or provide additional information.
- Guidance on the selection of comparators (2011)
- Opinion on statistical considerations including field trials (2010)
- Opinion on the assessment of allergenicity of GM plants and microorganisms (2010)
- Opinion on potential impacts on non-target organisms (2010)
- Report on animal feeding trials (2008)
- Guidance on the Post-Market Environmental Monitoring (PMEM) of GM plants (2011)
Cooperation with Member States
EFSA works closely with Member States during the GMO assessment process through a network of over 100 organisations and authorities across Europe including over 250 experts. Member States are able to give input to EFSA on its GMO assessments during a commenting period. To ensure transparency, EFSA provides a summary of how comments and input from Member States are followed up in each of its GMO opinions.
EFSA is building on its existing network and will strengthen the involvement of Member States, welcoming scientific comments also on the additional scientific information supplied by applicants when requested by EFSA. These comments will be communicated to the Panel, while it will remain necessary for EFSA to respect the legal deadlines.
Environmental Risk Assessment & Post-Market Monitoring of GM plants
Before a GM plant can be cultivated in the European Union, it has to undergo a comprehensive Environmental Risk Assessment (ERA) so that any possible adverse effects it may have on the environment can be identified. According to the legal framework applications for GM plants intended for cultivation must include an initial environmental risk assessment that has to be carried out by one Member State.
EFSA provides guidance on the type of data which applicants must include in applications and on the risk assessment approach applied for the environmental risk assessment (ERA) of GM plants. An updated guidance document was published in November 2010.
The environmental risk assessment of every GM plant follows a systematic approach consisting of six defined steps. The steps have to be addressed by the applicants and risk assessors for each of the specific areas of concern required for the ERA of a GM plant. In addition, the ERA also takes into account cross-cutting considerations such as the possible long-term effects of the GMO. The full approach is detailed below.
Environmental risk assessment approach for a GM plant
The ERA guidance was updated, on the basis of an extensive analysis of all relevant aspects in an open consultation with the Member States, stakeholders and other interested parties.
Each GM application has to be accompanied by a so called Post-Market Environmental Monitoring (PMEM) plan demonstrating how the applicant will monitor the GM plant for possible adverse environmental effects. PMEM aims at identifying possible unanticipated adverse effects on the environment which could arise directly or indirectly from GM plants. It is a key feature of the legislative framework on GMOs and Member States are responsible for its implementation.
In 2006, EFSA’s GMO Panel provided applicants with guidance for developing PMEM plans. This guidance was updated in 2011. In carrying out risk assessments on GM plants, the Panel gives its opinion on the scientific quality of the plans proposed by applicants.
From 2010 onwards, EFSA’s GMO Panel will be assessing the annual reports containing information gathered from the monitoring of GM plants authorised for cultivation in the EU. Applicants submit reports for each authorised GM crop to the European Commission on an annual basis. EFSA will work in close cooperation with Member States to support risk managers in their assessment of the reports.
Under EU legislation, a Member State can invoke a specific safeguard clause to provisionally prohibit the cultivation or use of a GMO in its territory based on scientifically based concerns regarding the safety of the GMO. To support the legal decision-making process, the Commission may ask EFSA to provide a scientific opinion on the information presented by Member States. In these cases, EFSA’s GMO Panel assesses the new evidence provided by the Member State in the form of a scientific opinion.
Use of antibiotic resistance marker genes in GM plants
Marker genes encoding resistance to specific antibiotics may be used in genetic modification to help identify GM cells among the untransformed cells.
In June 2009 EFSA published a consolidated overview on the use of antibiotic resistant marker genes in GM plants, including a joint scientific opinion by the GMO and BIOHAZ Panels. The Panels concluded that, according to information currently available, adverse effects on human health and the environment resulting from the transfer of the two antibiotic resistance marker genes, nptII and aadA, from GM plants to bacteria, associated with use of GM plants, are unlikely. Uncertainties in this opinion are due to limitations related, among others, to sampling and detection, as well as challenges in estimating exposure levels and the inability to assign transferable resistance genes to a defined source. Two members of the BIOHAZ Panel expressed minority opinions concerning the possibility of adverse effects of antibiotic resistance marker genes on human health and the environment.
In another opinion, the GMO Panel reviewed its previous assessments of individual GM plants containing antibiotic resistance marker genes taking into account the findings and conclusions of the joint opinion of the GMO and BIOHAZ Panels. The GMO Panel concluded that its previous risk assessments on the use of the nptII marker gene in GM plants are consistent with the risk assessment strategy described in the joint opinion and that no new scientific evidence has become available that would prompt it to change its previous opinions on these GM plants.
Following the adoption of the joint opinion of the GMO and BIOHAZ Panels, EFSA asked the panels to consider whether the minority opinions required any clarification of the joint opinion or additional scientific work. The Panel chairs responded that the minority opinions had been extensively considered during the preparation of the joint opinion and no further clarification or scientific work were needed at this time.