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Genetically Modified Organisms

Genetically Modified Organisms

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.

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. For more details see EFSA Actions on the Council conclusions on GMOs (36 KB) .

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 role in the GMO regulatory framework. (41 KB)

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.

Renewal applications

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.

Guidance documents

The GMO Panel has prepared a range of  guidance documents in line with the regulatory framework. These concern the type of data that applicants must include in GMO applications and the risk assessment approach applied by the GMO Panel. The main general guidance document concerns EFSA’s overall risk assessment approach for GM plants and derived food and feed. Specific guidance is also provided on GM microorganisms and their derived products, on GM plants containing stacked transformation events, on the assessment of renewal applications and on GM plants developed for non-food or non-feed purposes to produce for example medicinal products or raw materials for the production of biofuels and paper.

The Panel regularly reviews its guidance taking into account scientific developments and experience gained through its risk assessments. In June 2008 it published its updated general guidance document for the risk assessment of GM plants, and derived food and feed . The updated guidance has been presented to the European Commission and Member States and will be used by the Commission to draft a Commission Regulation, including guidance for assessing the risks of GM plants and derived food and feed.

The Panel is further elaborating its general guidance document in 2009, as outlined in the section on environmental risk assessment.

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

Before a GM plant may be cultivated in the European Union it has to undergo an extensive Environmental Risk Assessment (ERA) to identify any possible adverse effects it may have on the environment. According to the legal framework for cultivation applications for GM plants, an initial ERA is to be carried out by one Member State. EFSA welcomes the Council's recommendation that Member States performing the initial ERA could assist each other and share expertise.

Each GM application for cultivation includes data covering several seasons of field growing trials, so that possible adverse effects on the environment can be detected. It also has to be accompanied by an environmental monitoring plan demonstrating how the applicant will monitor the GMO for adverse environmental impacts. The GMO Panel published an opinion on Post Market Environmental Monitoring in 2006 to support this process.

Based on mandates agreed in early 2008, the GMO Panel is further elaborating its guidance on environmental risk assessment. The updated guidance will cover non-target organisms, criteria for setting up field trials to assess environmental impact, EU geographical regions where GM plants might be grown and approaches to assess long-term cumulative effects on the environment. This work is based on extensive analysis by the GMO Panel and its Working Groups in open consultation with the European Commission and the Member States.

The GMO Panel is updating the sections of its general guidance document concerning environmental risk assessment. It expects to hold a public consultation on the draft updated guidance before finalising its work in March 2010.

Safeguard clauses

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 ARMG 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.



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