The European Food Safety Authority (EFSA) presents further details on how to design and conduct a 90-day feeding study as part of an application to place a genetically modified organism on the market in the European Union (EU). The explanatory statement builds on the principles set out in EFSA’s previous guidance document on 90-day whole food/feed studies in rodents published in 2011.
The explanatory statement explains how to comply with an EU regulation introduced in 2013 that made it mandatory for all applications containing a single genetic modification to include a 90-day trial on rodents using whole food or feed. This ruling, known as Implementing Regulation 503/2013, was proposed by the European Commission and approved by Member States. As a result, the evaluation of 90-day feeding studies is now a standard part of the safety assessment of GM plants.
EFSA’s statement has three main objectives. Firstly, it clarifies the possible approaches for carrying out whole food and feed 90-day studies in GM plant risk assessment within the new regulatory context. Secondly, the document gives detailed instructions on how to apply the general principles presented in EFSA’s 2011 guidance for 90-day whole-food/feed studies, describing technical details such as the choice of test materials, dose levels and environmental conditions for test animals. It also provides instructions on the collection, interpretation and reporting of data. The statement seeks to ensure consistency among the GM applications submitted to the Authority.
EFSA also makes a recommendation to further develop the experimental design and methodology for 90-day feeding studies as part of GM risk assessment.