Comments on the European Food Safety Authority draft guidance on selection of comparators for the risk assessment of genetically modified plants

EFSA has launched an open consultation on a draft guidance document on the selection of comparators for the risk assessment of genetically modified (GM) plants. This document is an extension of subparagraph 2.3.1 ‘Cross cutting considerations for the choice of comparators’ of the recently published EFSA guidance document ‘the Environmental Risk Assessment of genetically modified plants’, which is currently submitted for authorisation in The European Union. 

The risk assessment strategy for GM plants and derived food/feed comprises a molecular characterisation of the genetic modification, a comparative analysis of the compositional, agronomic and phenotypic characteristics of the GM plant and its appropriate comparator(s), and an assessment of their potential adverse environmental effects. To date, EFSA has required the use of non-GM lines with comparable genetic background, i.e. near-isogenic in the case of sexually propagated crops, or isogenic in the case of vegetatively propagated crops, as comparators in its evaluation of GMO applications.  Moreover, the non-GM lines should have a well-established history of safe use.

Comparator selection has to be considered from different points of view, each focusing on other aspects. Factors taken into account are for instance the number of introduced events, differences in genetical modification techniques used, and differences in the extent that the plant metabolism is affected. Due to the increasing complexity of GM plants, the ease in the identification of appropriate comparators is decreasing. In the draft guidance document, EFSA has extended her considerations on comparator selection.

COGEM welcomes the initiative of EFSA and acknowledges the difficulties in the selection of appropriate comparators due to the increasing complexity of GM plants. She supports the EFSA statement that the non-GM line which has a genetic background ‘as close as possible’ to the GM plant, is selected as comparator. However, COGEM has a few criticisms concerning the document. Starting with general comments, specific comments are listed according to the order in the text in the draft guidance. Numbered paragraph headings refer to the exact paragraph as found in the document.

In The Netherlands a food/feed risk assessment is carried out by other organizations and, therefore, the COGEM confines her comments on the selection of comparators concerning the environmental risk assessment (ERA).