The Food Standards Agency (FSA) and Food Standards Scotland (FSS) work alongside each other to enforce Novel Food legislation in the UK. They define the pre-approval process for Novel Foods, examine data provided and offer opinion on the safety of the proposed Novel Food.
Allergenicity considerations should be always addressed in a dossier, although the extent of allergenicity data required for a Novel Food dossier submission depends on the nature of the food and its production process. Allergenicity data is particularly critical for novel proteins, traditional proteins generated by novel production methods or from novel sources.
At a minimum, literature searches should be provided to supply information about the potential risks and the protein should be clearly identified and compared to determine homology with known allergens. This comparison involves analysing the amino acid sequence against those of known allergens in established databases. In cases of high cross-allergenicity risks, in-vitro and even clinical data might have to be provided.
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
Any Novel Food placed in the market without authorisation would be considered unsafe and illegal by default as it had not been assessed as safe to consume. Breaching UK food laws can have very serious consequences for business operators, including fines, removal of the product from the market and potential criminal charges.
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.
A scientific dossier should detail the applicant, Novel Food identity, composition, production process, stability data and its intended use, target population and dietary intake assessment. It should also include nutritional, toxicological and allergenicity data to ensure that if introduced into the market it is safe and not disadvantageous nutritionally.
For authorisation in Great Britain, scientific dossiers are submitted electronically to the Food Standards Agency via the dedicated FSA portal.
In the EU and Northern Ireland, pre-application documents (notification of studies and tests included in the dossier) should be submitted on Connect EFSA. The dossier should be submitted via the dedicated EU Commission e-submission portal (EFSA ESFC portal).
Yes, the process and scientific requirements in GB and EU are similar and Food Business Operators can refer to the EFSA’s Novel Food scientific guidance for authorisations in both regions. However, because the review processes are independent and involve different scientific committees, Food Business Operators may receive specific requests for clarifications / additional information when submitting their dossier to the Food Standards Agency and Food Standards Scotland in GB.
A minimum of five independent batches are required, and they should be sampled in a manner adequate to address potential compositional variations (e.g. seasonal) of the raw materials. If several production processes are proposed and/or different forms of the Novel Food (e.g. powder, liquid), five batches are required for each proposed format variation. Similarly, shelf-life studies should be provided for each primary packaging material and format intended to be used. The batches should be within proposed specifications and be representative of the product as intended for consumption.
The need of in-vivo studies is highly dependent on the nature of the Novel Food and the other data provided. There is a general effort to minimise the number of animal studies and use model systems wherever possible. However, in some cases, there are no alternatives.