
EFSA guidance on analytes, analytical methods, data presentation, and statistical analysis for comparative compositional analysis
Compounds | •Selection of compounds: the OECD consensus documents on compositional considerations for new plant varieties |
- Proximates, key macro- and micro-nutrients, anti-nutritional compounds, plant metabolites characteristic for the plant species, and vitamins and minerals in case they are present at nutritionally significant levels | |
•Specific analytes depending on the intended effect of the genetic modification and the nutritional value | |
- Oil-rich plant: fatty acid profile | |
- Plants serving as a major protein source: amino acid profile | |
- The characteristics of the introduced trait: specific compounds, including metabolites of the potentially modified metabolic pathways | |
Analytical methods | •Validated laboratory (good laboratory practice, analytical laboratory) |
•Standardized and validated analytical method: | |
- Association of Official Analytical Chemists (AOAC), American Oil Chemists’ Society (AOCS), Literature, Korea Ministry of Food and Drug Safety official methods (MFDS) | |
Data presentation | •A clear format using standardized scientific units |
•Individual data by location per year | |
•Combined data across locations and years | |
Statistical analysis | •A test of difference between GM plants and comparators |
•A test of equivalence between GM plants and non-GM reference varieties | |
•Consider logarithmic data transformation to ensure normality | |
•A linear mixed statistical model for calculation of the confidence limits for both tests |