Stability Data

The stability section must demonstrate that the novel food remains within its specifications throughout the proposed shelf life under the intended storage conditions. EFSA requires data on both chemical and microbiological stability.

Stability studies should cover the parameters defined in the specifications section, with particular attention to degradation products, changes in the compositional profile over time, and microbiological safety. Accelerated stability studies may supplement real-time data but cannot replace it.

The storage conditions tested must reflect real-world conditions — temperature, humidity, light exposure, and packaging. If the novel food is intended for use as an ingredient in other food products, stability data should also address the ingredient's behaviour in the food matrix.

Common gaps include insufficient study duration relative to the proposed shelf life, missing data on degradation products, and failure to test under the actual storage conditions proposed on the label.