The regulation applies to any food and food ingredient that has not been sold in the European Union to a significant degree before May 1997 and:
- consists of foods or food ingredients with a new or intentionally modified primary molecular structure
- consists of or is isolated from micro-organisms, fungi or algae
- consists of or is isolated from plants or food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices that have a history of safe food use
- to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances
Exemptions apply for food additives, flavourings, and extraction solvents used in the production of foodstuffs as these are subject to risk assessment under their specific regulations.
The Novel Foods Regulation also states that foods or food ingredients falling within the scope of the regulation must not:
- present a danger for the consumer
- mislead the consumer
- differ from foods or food ingredients that they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer
See the regulation on the European Commission website via the 'External sites' link on this page.