Every novel food dossier is assessed against the same ten mandatory sections. Here is what each one covers and why it matters.
Every novel food application submitted under Regulation (EU) 2015/2283 is assessed by EFSA's NDA Panel against the same ten mandatory sections. Whether the product is an insect flour, a precision fermentation protein, or a microalgal extract, the structure is identical.
Understanding what each section requires — and why — is the first step toward preparing a dossier that does not stall.
What exactly is the product? This section establishes the novel food's taxonomic or chemical identity, its molecular characterisation, and how it is unambiguously distinguished from other substances. For biological sources, species and strain-level identification is required. For chemical substances, the full structural characterisation.
This is the most common trigger for additional data requests.
A complete, step-by-step description of how the novel food is manufactured, from raw materials to final product. EFSA needs enough detail to assess whether the process introduces safety concerns — contaminants, residual solvents, microbiological risks. For products derived from genetically modified microorganisms, the GMO status of the production strain must be addressed.
Full analytical characterisation across a minimum of five independent, representative production batches. This covers macronutrients, micronutrients, contaminants, and any substance-specific analytes. The data must demonstrate batch-to-batch consistency.
EFSA's six mandatory characterisation categories: carbohydrates, fat, protein, minerals, vitamins, and moisture.
Evidence that the novel food remains safe and within specification throughout its proposed shelf life under the intended storage conditions. Both chemical and microbiological stability must be demonstrated. Accelerated studies may supplement, but cannot replace, real-time data.
The specific food categories (using FoodEx2 classification), maximum use levels, and target population groups. This section directly determines the scope of the dietary exposure assessment. Vague descriptions are not accepted — EFSA requires precise use levels per food category.
The impact of the novel food on the overall nutritional quality of the diet. This includes any nutritional benefits or concerns, and an assessment of whether the novel food could displace other foods with established nutritional profiles.
The safety studies: typically an in vitro genotoxicity battery and a 90-day oral toxicity study in rodents (OECD Test Guideline 408). Depending on the product and intended use, additional studies may be required. All studies must be conducted under Good Laboratory Practice. The test material must match the product described in the identity and compositional data sections.
This is often the most extensive section in a dossier.
Absorption, distribution, metabolism, and excretion studies. Required primarily for novel foods of chemical origin. For whole foods or complex biological matrices, a reasoned justification for omission may be accepted.
Clinical safety or tolerance data in humans, where available or required. The study design, population, and endpoints must be appropriate for the novel food type and the proposed conditions of use.
Assessment of the novel food's potential to cause allergic reactions. This includes bioinformatics analysis against allergen databases, evaluation of cross-reactivity with known allergens, and for protein-containing products, characterisation of the allergenic potential of the source organism.
Particularly critical for insect-derived novel foods due to cross-reactivity with crustacean allergens.
Beyond the ten individual sections, EFSA also assesses consistency across sections. Data in the compositional analysis must match the specifications in the identity section. The toxicological test material must be representative of the product described in the production process section. The proposed use levels must be consistent with the exposure assessment.
Cross-cutting inconsistencies are among the most consequential findings — they suggest the dossier was assembled from disconnected pieces rather than constructed as a coherent whole.
- EFSA (2024). Scientific Guidance for the preparation of applications for authorisation of novel foods. *EFSA Journal*. DOI: 10.2903/j.efsa.2024.8961. - Regulation (EU) 2015/2283 on novel foods. - Regulation (EU) 2017/2469 laying down administrative and scientific requirements for applications.
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