Compositional Data

The compositional data section requires full analytical characterisation of the novel food across representative production batches. This includes macronutrients (protein, fat, carbohydrates, moisture, ash), micronutrients, contaminants (heavy metals, mycotoxins, pesticide residues, microbiological criteria), and any substance-specific analytes relevant to the particular novel food.

EFSA's 2024 scientific guidance mandates analysis of a minimum of five independent, representative production batches. The data must demonstrate batch-to-batch consistency and must cover EFSA's six mandatory characterisation categories: carbohydrates, fat, protein, minerals, vitamins, and moisture.

Compositional data is among the sections with the largest variety of additional data requests across published opinions (Ververis et al., 2020). Common gaps include insufficient batch numbers, missing contaminant analyses, analytical methods that are not validated or not fit for purpose, and a mass balance that does not account for the full composition of the novel food.

The section must use validated analytical methods with stated limits of detection and quantification. Where standard methods exist (e.g. AOAC, ISO), EFSA expects these to be used unless a justified alternative is provided.