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 significant extent in the EU prior to 15 May 1997.
Which food and food ingredients are covered by the regulation?
The food and food ingredients covered by the regulation are those that:
- have a new or intentionally modified primary molecular structure
- consist of - or are isolated from - micro-organisms, fungi or algae
- consist of - or are isolated from - plants, or food ingredients isolated from animals (but not food and food ingredients obtained by traditional propagating or breeding methods with a history of safe food use)
- have been 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 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
- extraction solvents used to produce food and food ingredients