Regulation (EC) 258/97 of 27 January 1997 concerns the placing on the market of novel foods and novel foods ingredients. Regulation (EC) 258/97 is also applying to food and food ingredients that have not been on the EU market to a significant degree before the entry into force of the Regulation in May 1997 and that fall under the following categories :

• foods and food ingredients containing or consisting of genetically modified organisms (GMOs) within the meaning of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms.
• foods and food ingredients produced from, but not containing GMOs;
• foods and food ingredients with a new or intentionally modified primary molecular structure;
• foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae;
• foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for food and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use;
• foods and food ingredients 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 :

• food additives, falling within the scope of Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption;
• flavourings for use in foodstuffs, falling within the scope of Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production; Also refer to : Flavourings
• extraction solvents used in the production of foodstuffs, falling within the scope of Council Directive 88/344/EEC of 13 June 1988 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients.