There is no specific minimum production volume that is required for approval. However, the manufacturing process and batches produced and detailed in the authorisation submission dossier should comply with food manufacturing standards and regulations. They should also operate under a Hazard Analysis and Critical Control Points (HACCP) management systems and include batches representative of the final Novel Food to be placed in the market.
Microbiological and chemical contaminant testing requires a product-specific approach.
The Hazard Analysis and Critical Control Points (HACCP) plan associated with a food production should identify potential microbiological hazards and therefore inform on the required testing.
Consulting previous successful Novel Food applications in the UK (and other markets) can provide a number of useful insights on the type of data required for a Novel Food dossier submission. Applications submitted under the past Novel Food regulation (258/97 EC) to the UK are available here: Full applications submitted to the UK under Regulation 258/97. In addition, the Food Standard Agency and Food Standard Scotland opinions on past Novel Food applications can also be consulted (FSA website).
In NI/EU non-confidential versions of dossiers submitted to the EU can be accessed through the Public Consultations section on Open EFSA website (Open EFSA). Food Business Operators need to be aware that scientific data requirements might change over time and therefore companies need to consider the most recent guidance documents from regulatory authorities.
When preparing a Novel Food dossier, Food Business Operators should prioritise a clear analytical plan and narrative. It is critical to appropriately plan the required data and select suitable accredited analytical laboratories to perform the studies for the submission, avoiding missing information or repeating studies. This can be achieved by leveraging scientific guidance and seeking pre-submission advice from authorities and experts. Furthermore, leveraging existing literature and peer-reviewed studies might reduce the need to generate original data, thereby reducing time and costs.
Long term-use in another market is generally seen favourably by regulators, although applicants should focus on presenting robust safety evidence based on scientifically sound data (either self-generated or gathered from scientific literature). In the case of traditional food applications, focus needs to be on demonstrating long-term safe use outside of the UK and EU. Supporting evidence may also be drawn from the white literature.
The specific analytical methods used depends on the nature of the Novel Food. All physical and chemical data must be generated by certified laboratories following established international standards (accredited methodologies or ‘in-house’ validated methods). Toxicological studies must adhere to Good Laboratory Practice (GLP) and follow the appropriate OECD guidelines. Any deviations from these standards require thorough justification.
Yes, some information can be added by the applicant without a formal request for information by the authorities. However, this should be limited to newly produced data and/or information which was not available to the applicant at the time of the submission.
In Great Britain, pre-notification of studies is not currently required. However, it is a requirement for applications in Northern Ireland and the EU. Notification under Article 32b of the GFL is still necessary for stability studies and studies demonstrating the absence of viable cells and recombinant DNA from a production microorganism.
This applies even when data is submitted as certificates of analysis or as part of batch-to-batch variability analyses (EFSA FAQs practical arrangements). Applications will be deemed invalid if they do not include all pre-notified studies, unless a valid justification is provided for any omissions.