Regulation of novel foods
Overview of the foods, ingredients and food processes covered by the Novel Foods Regulation, and what may be exempt from the regulation.
The Novel Foods Regulation sets out details for how novel foods, ingredients and processes are approved for use. The regulation defines a novel food as one that wasn't sold to any significant extent in the European Union before 15 May 1997.
The scope of the regulation
The regulation covers a wide range of food and food ingredients, including those that:
- have a new or intentionally modified primary molecular structure
- consist of - or are isolated from - micro-organisms, fungi or algae
- consist of, are isolated from, or produced from minerals
- consist of, are isolated from, or produced from plants or their parts (but not food and food ingredients obtained by traditional propagating or breeding methods with a history of safe food use)
- are produced using a new process that leads to significant changes in their composition or structure affecting their nutritional value, their metabolism or the level of undesirable substances they contain
Food and food ingredients covered by the regulation must not:
- be dangerous to consumers
- mislead consumers
- be so different from the food or food ingredients that they're intended to replace that normal consumption of them would be nutritionally disadvantageous
When the regulation does not apply
If a food or food ingredient was sold commercially in at least one EU member state before 15 May 1997, the regulation on novel foods does not apply. The product can be marketed anywhere else in the EU.
Exemptions from the regulation
Some products are exempt from the regulation because they're regulated by other directives. These include:
- food additives
- flavourings
- extraction solvents used to produce food and food ingredients
- genetically modified organisms
It is your responsibility to know if the novel foods regulation applies to a product you want to sell. To help you determine novel status, you may want to check or the European Commission's .
Under current operating arrangements for Northern Ireland, businesses seeking a new authorisation for novel foods placed on the NI market will continue to follow EU food rules. From Autumn 2023, the Windsor Framework will allow GB public health standards to apply for pre-packed retail goods moved via a new NI retail movement scheme and placed on the NI market. Therefore, goods moving via this route containing GB authorised products will be able to be placed on the NI market.
To apply for an authorisation of a novel food in Great Britain, use the UK's .