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
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;
List of Notifications of novel foods;
Related Opinions of the Scientific Committee on Foodstuffs on novel foods;
See also : Genetically
Modified Organisms (GMOs).