EFSA to hold consultative workshop with stakeholders on draft guidance for GM plant comparators

The European Food Safety Authority (EFSA) today announced it will hold a consultative workshop in March 2011 with scientists and risk assessors from EU Member States, industry and non-governmental organisations (NGOs), to discuss its draft guidance document on the selection of comparators[1] for the risk assessment of GM plants. The workshop will be held following a public consultation on the draft guidance document.

The choice of an appropriate comparator is the cornerstone of the risk assessment of GMOs. The current approach followed by risks assessors worldwide is to carry out comparative assessments of the GM crop plant and its conventional crop counterpart to determine if the GM plant, such as for example GM maize, is as safe as its conventional non-GM counterpart.

EFSA’s GMO Panel took the initiative to strengthen the guidance to be followed by applicants when selecting appropriate comparators to be used in the risk assessment of GM plants. The draft document was launched for public consultation on 15 November: Scientists and other stakeholders can submit their comments to EFSA up to 15 January through the following link:

As part of its ongoing consultation with stakeholders, EFSA experts at the March workshop will discuss an analysis of the comments received during the public consultation and exchange views on the comparative assessment approach utilised to assess the safety of GM plants, as well as the underlying concept of substantial equivalence[2].

The GMO Panel regularly reviews its guidance taking into account scientific developments and experience gained through its risk assessments. In order to engage with interested parties and seek input to help inform its risk assessment work, EFSA always carries out a public consultation on its draft guidance documents. This was the case for instance for EFSA’s recently updated guidance for the environmental risk assessment (ERA) of GM applications submitted for authorisation in the European Union.

EFSA encourages all scientists, risk assessors, applicants and organisations with EU-wide representation who made contributions in the public consultation and who are interested in attending the March workshop to apply by sending an email to gmo [at] efsa.europa.eu by 20 January 2011. EFSA is mindful that places at the workshop need to be kept to such a number as to facilitate discussion and therefore advises those interested in scientific discussion to apply early and indicate their specific area of expertise in GM risk assessment.

[1] GM comparators are the non-GM plants with which the GM plant is compared during the safety evaluation. The underlying principle for the safety assessment of GM plants is that of substantial equivalence, meaning that the GM plant should be as safe as its conventional counterpart. The risk assessment of GMOs is carried out by identifying and evaluating the similarities and differences between the GM plant (regarding composition, nutrition or potential allergenicity or potential toxicity) and its conventional counterpart.
[2] The concept of substantial equivalence was developed in 1991 by the OECD (the Organisation for Economic Cooperation and Development).

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