EFSA GMM Guidance

In the context of the incoming revision of the EFSA GMM guidance, Amfep decided in 2010 in agreement with the EFSA GMO Panel to prepare two "trial dossiers" describing the construction of enzyme-producing microorganisms:

The purpose of this work was to provide input to the GMO Panel working group on GMMs for the revision of the guidance document.

In these hypothetical dossiers, we looked at scenarios that may appear during the development of a genetically modified microorganism of a fungal or bacterial origin, and tried to anticipate the issues that might come up for debate.

The trial dossiers were built according to the present version of the EFSA guidance. However due to the fact that they are a collective work, they do not contain company-specific information. That level of detail will of course be found in the future real dossiers from individual applicants.

The two trial dossiers were submitted to EFSA in July 2010. The GMO Panel is expected to shortly issue an opinion on them, most probably at the same time the new guidance document will be released.

Should you wish to receive an electronic copy of the dossiers, please send a mail to amfep@agep.org, stating your name, organization, and the background for your request.