Section 2 — a complete description of how the novel food is manufactured, including safety-relevant controls.
The production process section requires a detailed, step-by-step description of how the novel food is manufactured, from raw materials to the final product. EFSA expects enough detail to assess whether the process introduces any safety concerns — process contaminants, residual solvents, microbiological risks, or unintended modifications to the product.
Production process documentation is among the most common triggers for additional data requests. It is frequently flagged alongside identity and specifications: if EFSA cannot understand how the product is made, it cannot assess whether the specifications are achievable or whether the compositional data is representative.
Key elements include: identification of starting materials and their sources, critical process parameters and control points, any use of extraction solvents (which must comply with Directive 2009/32/EC), sterilisation or pasteurisation steps, and evidence that the described process produces the product represented by the batch data.
For novel foods produced using genetically modified microorganisms, the production process section must additionally address the GMO status of the production organism and confirm the absence of viable GMOs and newly introduced DNA in the final product.
Paste a section and Borgh will flag the gaps that matter — with references to the relevant EFSA guidance.
Try a section →