Strengthening GM risk assessment - new EFSA guidance explained

New EFSA guidance identifies data that companies need to supply when applying for renewed authorisation to import genetically modified (GM) plants for food and feed into the European Union (EU).

The European Commission grants authorisations to place GM food and feed on the European market for a period of ten years. Companies that want to continue importing GM food and feed into the EU need to renew the initial authorisation.

The new guidance ensures a sound scientific basis for the risk assessment of GM food and feed in the interest of the European consumer. EFSA’s task is to evaluate the validity of previous risk assessments of these GM products. It needs to verify if any changes, new hazards, modified exposure scenarios or new scientific uncertainties have surfaced. On that basis, EFSA advises the European Commission and Member States who decide whether or not to renew the authorisation.

Working group chair provides more details

Prof Hanspeter Naegeli is a member of EFSA’s Panel on Genetically Modified Organisms. He chaired the expert working group that prepared the draft for the current guidance document. Prof Naegeli sheds more light on what the guidance means, why it was necessary and what applicants are required to do.




Hanspeter Naegeli
Member of EFSA’s Panel on Genetically Modified Organisms (GMO)

Why do we need a new guidance document on applications for the renewal of authorised GM food or feed?

EFSA has to assess whether the conclusions of the original risk assessment of the respective GM food or feed are still valid. Has anything new come up that would have an impact on the original conclusions? This question needs to be answered. Consequently, the information that companies have to provide for renewal differs from what they had to provide for the original application for authorisation. The new guidance details what kind of information they have to submit in support of their application for renewal authorisation. 

What do applicants need to provide in support of their renewal application?

Over the years as scientific research has moved on, more information has become available on the respective GM food or feed. Companies have to search for and provide all relevant new information which has become available during the years of commercialisation. The required information includes new scientific publications and all unpublished information available to them. They also need to provide all post-market monitoring reports including from environmental monitoring, where available. In accordance with current European legislation, companies do not have to generate new data in support of their applications for the authorisation renewal.

Which genetically modified food and feed plants are covered by this new guidance?

GM food and feed listed under Regulation (EC) 1829/2003 are within the scope of this new guidance. These include all those plants that have already been assessed by EFSA – such as maize, oilseed rape, soybean and cotton. It is important to point out that these authorisations are for the import or processing of GM food or feed, not for the cultivation of the GM plant.

EFSA consulted the public and EU Member States on its draft guidance. What did those consultations bring to the process?

Consultation with the public and with Member States ensures an open scientific debate on the work of EFSA, in this case on the development of this guidance. We saw opposite opinions expressed at these consultations. On one side we were criticised for requesting too much, on the other we were called on to ask for much more information. But, clearly, we have to remain within the confines of the law. In any case, these consultations helped us to be clearer with the wording in our guidance. We managed to explain several issues better.

Why is the guidance important?

The guidance will shape a large part of EFSA’s work in the area of GMOs for many years to come. Many authorisations given over the last ten years will have to be renewed in the coming years.

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