The European Food Safety Authority (EFSA) has published updated guidance for the risk assessment of food and feed derived from genetically modified (GM) plants. The document expands on previous EFSA guidance and reflects the latest scientific developments in areas such as assessment of allergenicity and selection of the comparator plant against which the GM plant is compared. It also establishes a new statistical methodology to further strengthen the risk assessment of GM plants.
As with all EFSA guidance documents on genetically modified organisms (GMOs), the Authority engaged in consultation at different stages during its development with Member States and a broad range of stakeholders. The guidance 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. These are explained in detail in relation to the different components of the risk assessment, including molecular characterisation, field trial design, compositional analysis, toxicological assessment, allergenicity and nutritional assessment. The guidance will also support the European Commission in preparing a legal framework for the risk assessment of genetically modified food and feed.
Riitta Maijala, EFSA’s Director of Scientific Evaluation of Regulated Products, commented: “This important document is the result of several years work by the EFSA GMO Panel. It will ensure continued rigor in the application process, strengthen and promote consistency in data provided by applicants and, ultimately, contribute to an even higher level of consumer protection from potential risks associated with the use of GM food and feed.”
The guidance was developed taking into account the experience gained by the GMO Panel during the evaluation of past applications as well as specific guidance on different aspects of GMO risk assessment such as assessment of possible allergenicity, statistical analysis and the selection of comparators. It does not cover the environmental risk assessment of GM plants which is addressed in a separate, stand-alone EFSA guidance document.
The cornerstone of GM plant risk assessment is a comparison between the GM plant and an appropriate conventional crop with a history of safe use (the ‘comparator’). Such comparisons are usually performed using a so-called test of difference – which verifies whether the GM plant is different from its comparator. In the updated guidance, the GMO Panel establishes the use of two tests to perform the comparison: 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 updated guidance also incorporates a new statistical methodology allowing for a reliable measurement of such natural variation.
The general principles for the selection of comparators are described in detail in a related guidance document which was developed to take into account the increasing complexity of GM plants, particularly those which are created by ‘stacking’ GM events. In the related guidance, the GMO Panel also addresses situations where additional comparators may be required and scenarios where appropriate comparators are not available.
The views of Member States, industry, non-governmental organisations and academia were carefully considered by the EFSA GMO Panel before the guidance documents were adopted. Most recently, on 31 March 2011, EFSA held a consultative workshop in Brussels in which Member States and stakeholders were invited to present their views on the draft version of the guidance for selection of comparators.
EFSA’s guidance for risk assessment of food and feed from GM plants was adopted by the EFSA GMO Panel at a plenary meeting on 14 April 2011. During the same meeting, the Panel also adopted guidance on the selection of comparators, the principles of which are incorporated in EFSA’s updated guidance on risk assessment of food and feed from GM plants. A previous draft of the updated guidance was published by EFSA in 2008.