The updated guidance on risk assessment of food and feed derived from genetically modified (GM) plants reflects recent scientific developments in areas such as assessment of allergenicity and selection of the comparator plant against which the GM plant is compared.
24 May 2011: The European Food Safety Authority (EFSA) has published updated guidance documents on the risk assessment of food and feed derived from genetically modified (GM) plants.
The first document expands on previous EFSA guidance and reflects recent scientific developments, including on assessment of allergenicity, and a new statistical methodology allowing for a reliable measurement of natural variation, to strengthen the risk assessment of GM plants. The methodology outlines methods and approaches for data generation, collection and analysis that must be followed by those submitting applications to EFSA for GM plant risk assessment. It also seeks to support the European Commission in preparing a legal framework for GM plant risk assessment.
The second document addresses the selection of comparator plants. A comparator plant is the conventional crop with a history of safe use against which the GM plant is compared. Comparator plants are used to perform “tests of difference” to verify whether a GM plant is different from its comparator. The updated guidance establishes a test of difference and a complementary test of equivalence that verifies whether the characteristics of the GM plant fall within the range of natural variation found in conventional crops.
The guidance for risk assessment and for selection of comparators was adopted by the EFSA Panel on genetically modified organisms (GMOs) at a plenary meeting on 14 April 2011. [EFSA Press Release] [Guidance on Risk Assessment] [Guidance on Selection of Comparators]