FAQs

Generally, all Novel Foods require formal approval before they can be legally sold.

In GB, there are post-EU exit legislative transitional arrangements in place for four edible insect species (Tenebrio molitor, Acheta domesticus, Gryllodes sigillatus and Hermetia illucens). These can remain on the market as applications for them progress through the Regulated Products system. For any other insect species, an application must be submitted. These can only be placed on the market if the application is authorised./buttons

The key phases are:

1. Building a scientific dossier which provides comprehensive characterisation of your product
2. Providing an overview of the manufacturing process
3. Addressing considerations of the toxicological and allergenicity risks
4. Detailing the intended use levels and food categories. Providing a dietary intake assessment
5. Providing a safety substantiation.

The minimum timeline prescribed by legislation is up to 17 months. However, resource constraints and potential inquiries from authorities, could extend this timeline to 24 months or more. The authorisation process for traditional foods is typically faster, with minimum timelines of five months for notifications and seven months for applications.

Cost is highly dependent upon the type of Novel Food, and whether extensive safety studies including clinical, nutritional and/or toxicological testing are required. Food Business Operators should expect to spend between £200k – £400k (GBP) for a submission to cover the cost of consultancy, administrative costs and the generation of the necessary scientific and safety data.

The Novel Food application process is resource-intensive and demands significant resources from regulatory authorities. Processing time can be affected by high application volumes or complexity in the scientific assessment. Most frequently, delays are caused by poor or incomplete submissions by Food Business Operators leading to information requests and the need for supplemental data during the assessment phase.

For EU submissions, there can also be delays where safety and shelf-life studies were not notified to the authorities. Clear and well-structured dossiers avoid ‘stop-clock’ interruptions caused by missing information or poor data quality. To minimise delays, it is critical to be familiar with the scientific requirements and have a clear plan before submitting your scientific dossier.

According to assimilated regulation (EU) No 2015/2283 (GB 2015/2283), if a food or ingredient falls under the Novel Food definition, pre-market authorisation is required, with no exceptions. If there is an extensive history of consumption outside the UK or EU markets (at least 25 years) this can be considered a traditional food from a third country. While this still requires pre-market authorisation, the extent of scientific data required is usually less than a full Novel Food authorisation.

This route is only available for products falling into certain Novel Food categories (derived from plants, animals, microorganisms or fungi, or cell/tissue culture from one of them) that are derived from primary production, defined by assimilated Regulation (EC) No 178/2002 (General Food Law, GFL) as “…production, rearing or growing of primary products including harvesting, milking and farmed animal production prior to slaughter. It also includes hunting and fishing and the harvesting of wild products.”