Novel foods

Regulation of novel foods

Guide

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 EU 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 European Commission Council 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 the EU Novel food catalogue or the European Commission's guidance on history of consumption.