Novel foods are foods and food ingredients that have not been used for human consumption to a significant degree within the Community before 15 May 1997. Regulation EC 258/97 of 27 January 1997 of the European Parliament and the Council lays out detailed rules for the authorisation of novel foods and novel food ingredients.

Foods commercialised in at least one Member State before the entry into force of the Regulation on Novel Foods on 15 May 1997, are on the EU market under the "principle of mutual recognition". In order to ensure the highest level of protection of human health, novel foods must undergo a safety assessment before being placed on the EU market. Only those products considered to be safe for human consumption are authorised for marketing.

Companies that want to place a novel food on the EU market need to submit their application in accordance with Commission Recommendation 97/618/EC that concerns the scientific information and the safety assessment report required.

A total of 53 applications have been made between May 1997 and May 2004. By May 2004, 14 novel foods were approved to be commercialised in the EU, for 2 products the placing on the market was refused.

Novel foods or novel food ingredients may follow a simplified procedure, only requiring notifications from the company, when they are considered by a national food assessment body as "substantially equivalent" to existing foods or food ingredients (as regards their composition, nutritional value, metabolism, intended use and the level of undesirable substances contained therein).

SCADPlus : Legislation on Novel foods and novel food ingredients.

List of Applications for authorisation of a novel food; updated 17-05/05

List of Notifications of novel foods; Updated 14-03-2006

Related Opinions of the Scientific Committee on Foodstuffs on novel foods;

See also : Genetically Modified Organisms (GMOs).