Guide

Novel foods

Regulation of novel foods

The Novel Foods Regulation sets out detailed rules 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 major extent in the EU before 15 May 1997.

The scope of the regulation

The regulation covers food and food ingredients that:

  • have a new or intentionally modified primary molecular structure
  • consist of - or come from - micro-organisms, fungi or algae
  • consist of - or come from - plants, or food ingredients from animals (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 major 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 regulations 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 Novel Foods Regulation 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