Novel foods authorisation in Great Britain

If you are developing or importing a food product that has not been widely consumed in the UK or EU before 15 May 1997, it is likely classified as a novel food. You must obtain authorisation from the Food Standards Agency (FSA) before you can legally sell it in Great Britain. Placing an unauthorised novel food on the market is a criminal offence.

This guide explains how to determine whether your product qualifies as a novel food, how the authorisation process works, and what you need to prepare for a successful application.

What counts as a novel food

A novel food is any food that was not used for human consumption to a significant degree within the UK or EU before 15 May 1997. The definition is set out in assimilated Regulation (EU) 2015/2283 and covers a broad range of products:

• Foods with a new or intentionally modified molecular structure
• Foods consisting of, isolated from, or produced from micro-organisms, fungi, or algae (where no history of safe consumption exists)
• Foods derived from plants or animals with no established consumption history
• Foods produced using cell culture or tissue culture from animals, plants, micro-organisms, fungi, or algae
• Foods resulting from a production process not used before 15 May 1997 that causes significant changes in composition or structure
• Foods consisting of engineered nanomaterials
• Vitamins, minerals, and other substances in forms not previously used in food

Common examples that require or have required novel food authorisation include CBD (cannabidiol) food products, edible insects, new plant extracts and concentrates, and UV-treated foods.

Checking whether your product needs authorisation

Before submitting a full application, you should determine whether your product falls within the scope of the novel food regulations:

1. Check the GB novel foods register. The FSA maintains a register of foods already authorised for the GB market. If your product (or its key ingredient) appears on the register with conditions that match your intended use, you may not need a new authorisation.
2. Review the consumption history. Gather evidence of whether the food was consumed to a significant degree in the UK or EU before 15 May 1997. Trade statistics, historical literature, and sales records can support this assessment.
3. Contact the FSA. If you are uncertain about your product's status, the FSA can provide informal guidance on whether it is likely to be classified as novel. This is not a formal determination but can help you plan.

The application process

If your product requires authorisation, you submit an application through the FSA's regulated products application portal. The process involves several stages, and you should allow sufficient time — the typical timeline from valid application to authorisation decision is 18 months or more.

Step 1: Prepare your safety dossier. The application must include comprehensive scientific evidence demonstrating the safety of your novel food. This includes:

• Toxicological studies (acute, sub-chronic, and where appropriate chronic toxicity, genotoxicity, reproductive toxicity)
• Nutritional data (composition, nutritional profile, expected intake levels)
• Allergenicity assessment
• Proposed specifications (identity, purity, composition)
• Proposed conditions of use (target population, maximum intake levels, food categories in which it will be used)
• Proposed labelling requirements

The data requirements are set out in assimilated Regulation (EU) 2017/2469 (with Regulation (EU) 2017/2468 covering traditional foods from third countries). Insufficient or poorly presented evidence is the most common reason for application delays.

Step 2: Submit via the FSA portal. Applications are submitted online through the FSA's regulated products application system. The FSA will validate your application and confirm whether it is complete.

Step 3: Safety assessment. The Advisory Committee on Novel Foods and Processes (ACNFP) evaluates the scientific evidence. The committee may request additional data or studies. You should budget for the possibility of responding to supplementary information requests, which can add several months to the timeline.

Step 4: Public consultation. The FSA publishes the risk assessment outcome for public consultation before making a recommendation to ministers.

Step 5: Ministerial decision. Ministers in England, Scotland, and Wales (the appropriate authorities) decide whether to authorise the novel food for the GB market.

Step 6: Addition to GB register. If authorised, your novel food is added to the GB novel foods register, with any conditions of use, specifications, and labelling requirements that apply. Since 1 April 2025, under the FSA's regulated products reform, the authorisation takes legal effect when the entry is added to the register — a separate statutory instrument is no longer required. Authorisations are also no longer subject to renewal: existing authorisations have lost their expiry dates.

Relationship to the EU novel foods list

Since 1 January 2021, the GB novel foods register has been separate from the EU Union list of novel foods. A novel food authorised in the EU is not automatically authorised in Great Britain, and vice versa. If you wish to sell your novel food in both the GB and EU markets, you will need separate authorisations through the FSA (for GB) and the European Commission/EFSA (for the EU).

Transitional provisions: Novel foods that were on the EU Union list as of 31 December 2020 were carried over to the GB register at that date. These remain authorised in GB under their original conditions unless and until the FSA amends or revokes the authorisation.

Traditional foods from third countries

If your food has a history of safe use in a country outside the UK and EU for at least 25 years as part of the customary diet of a significant number of people, a simplified notification route may be available. This is faster than the full authorisation process but still requires submission of evidence demonstrating the consumption history. The FSA and ACNFP assess whether the evidence is sufficient.