Division 1.3.4 Comparative analysis of composition

In addition to the analysis on the level of the newly expressed proteins (see Section 1.2.2.3), the compositional analysis shall be carried out on an appropriate range of compounds. In each case, the applicant shall provide at least analysis on proximates (including moisture and total ash), key macro- and micro-nutrients, anti-nutritional compounds, natural toxins, and already identified allergens, as well as other secondary plant metabolites characteristic for specific crop plant species, as referred to in the Organisation for Economic Cooperation and Development (OECD) consensus documents on compositional considerations for new plant varieties (OECD consensus documents)^f1. The vitamins and minerals selected for analysis shall be those which are present at levels which are nutritionally significant and/or which make nutritionally significant contributions to the diet at the levels at which the plant is consumed. The specific analyses required shall depend on the plant species examined, but shall include a detailed assessment appropriate to the intended effect of the genetic modification, the considered nutritional value and use of the plant. The applicant shall pay particular attention to key nutrients such as proteins, carbohydrates, lipids/fats, fibre, vitamins and minerals. For example, a fatty acid profile shall be included for oil-rich plants (main individual saturated, mono-unsaturated and poly-unsaturated fatty acids) and an amino acid profile (individual protein amino acids and main non-protein amino acids) for plants used as an important protein source. Analysis of plant cell wall components are also required for the vegetative parts of plants used for feed purposes.

The applicant shall also provide an analysis on key toxins inherently present in the recipient plant which may adversely affect human/animal health depending on their toxic potency and levels. The concentrations of such compounds shall be assessed according to plant species and the proposed use of the food and feed product. Similarly, anti-nutritional compounds, such as digestive enzyme inhibitors, and already identified allergens shall be studied.

The characteristics of the introduced trait may trigger further analysis of specific compounds including metabolites of potentially modified metabolic pathways. The applicant shall consider when appropriate, the inclusion of compounds other than the key nutrients, key toxins, anti-nutrients and allergens identified by the OECD consensus documents and justify the selection of these compounds.