Considerations on Absorption Distribution Metabolism and Excretion (ADME) are required as a part of a Novel Food dossier submission. These requirements take a tiered approach. The extent of data required, including the need of human clinical studies, is on a case-by-case scenario. When the Novel Food is composed of substances commonly found in the body / diet or consists of polymers (with evidence provided that they do not degrade in the gastrointestinal tract), ADME studies may not be needed.
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.
Beside the initial cost required to prepare and submit a dossier for Novel Food pre-market approval, there are no costs after approval other than the usual validation, verification and monitoring required under Hazard Analysis and Critical Control Points (HACCP) in food risk management systems, unless post-marketing surveillance is a requirement of the authorisation.
Novel food authorisation and patents do not guarantee the same level of protection, although in the UK (and EU) Novel Food authorisation may grant market exclusivity for five years under certain conditions. Therefore, if another operator wants to use the same Novel Food before this period, they will either need to license the technology or apply for Novel Food pre-market authorisation separately.
Because Novel Foods are approved for a specific process and use, simply resembling an approved Novel Food does not grant automatic authorisation. Furthermore, in the UK and EU, a Novel Food application may include exclusive data protection for five years if authorisation depended on unique scientific data. If another food business operator wishes to use the same Novel Food within that five-year period, they must either obtain a license for the technology or submit their own pre-market authorisation application.
Once a Novel Food is authorised for use, re-submission is generally not required. However, because the authorisation covers specific uses and quantities, re-submission might be necessary if changes in the manufacturing process significantly affect its composition, or if the intended scope of use differs in level or food categories from what was originally authorised.
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.