A Novel Food is defined as a food with no ‘history of consumption’ and/or made using a production process not used for food production within the EU or the United Kingdom before 15 May 1997.
This includes substances used as food supplements that have a history of use before 1997, but not as food or ingredients.
Determining Novel Food status can be complex – we advise that you speak to a regulatory expert for clarification. The main criteria to determine whether a food is novel, is its history of consumption in the UK or the European Union (EU) prior to 15th of May 1997. The next consideration is whether it is made using a production process not used within the EU or the United Kingdom before the same date.
If there is limited history of consumption and the food falls under one (or more) Novel Food categories defined by assimilated regulation (EU) 2015/2283, then it is likely to be novel. Typical examples include ingredients with a novel molecular structure, proteins derived from insects or products obtained from a novel method of production (e.g., precision fermentation, cellular agriculture).
Foods approved by the UK Food Standards Agency (FSA) are permitted in in England, Wales and Scotland. Post-Brexit, Novel Foods for sale in Northern Ireland must be approved by the EU. Foods approved in the EU are not authorised in Great Britain (GB). Consulting the EU and GB registers of authorised Novel Foods (EU NF list, GB NF list) and the EU Novel Food catalogue (EU NF catalogue) can provide information on Novel Foods already authorised and whether a food is likely to be considered novel.
These should not be considered as definitive, as they do not cover all Novel Food authorisations. If after consulting the available evidence there is still uncertainty regarding the potential Novel Food status of a product, Food Business Operators (FBOs) should formally contact the authorities for clarification (known as an Article 4 consultation request).
Although there are many similarities, post-Brexit Great Britain has its own approval process separate from the EU. In Northern Ireland (NI), application for Novel Food authorisation is regulated by EU laws and pre-market approval follows the EU authorisation process. Under the Windsor Framework arrangements, regulated products authorised in Great Britain may also be placed on the NI market, provided they are eligible for, and are moved through, the Northern Ireland Retail Movement Scheme (NIRMS) (Windsor Framework).
No mutual recognition currently exists between the UK Food Standards Agency and other safety agencies. Therefore, a separate pre-market authorisation is required to place a novel food in the GB market.
If a product is approved under the EU authorisation process it can be placed in the NI market.
You might still need approval if the food/ingredient has a history of consumption outside the UK or EU. In addition, if the product has been produced via novel technologies not used in the UK or EU before May 1997, pre-market approval is likely to be required.
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.
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.