EFSA Issues Guidance for Two-Year Whole Food Studies

The European Food Safety Authority (EFSA) has issued guidance principles for
conducting two-year whole food studies “to assess the risk of cancer and/or
toxicity from the long-term consumption of such foods by humans.” Acting at
the behest of the European Commission, EFSA relied on testing guidance (TG)
453 from the Organization for Economic Co-operation and Development in
addition to considering the views of member state experts consulted through
the Scientific Network for the Risk Assessment of GMOs. The agency has
cautioned, however, that testing individual chemicals in animal models “may
result in adverse effects caused by dietary imbalance rather than any potential
toxicity of the whole food itself,” urging researchers to carefully design
studies to avoid this outcome and to use a larger number of animals when
conducting whole food studies.

“[I]t is essential that scientists implementing its guiding principles should
define clear and specific objectives before starting a two-year feeding study
for whole food. Identifying the exact nature of the risk that the study seeks to
assess is key to this process if potential hazards have previously been identified
which warrant further investigation,” noted EFSA in a July 31, 2013, news
release. “The decision on the need for a two-year study should be based on an
evaluation of all available information, such as results from previous analyses
of the food’s composition and findings from earlier nutritional and toxicological
studies.”