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Novel food

18 January 2010
by Ina Dimireva -- last modified 21 January 2010

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.


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Novel food

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.

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 27-11-2009

List of Notifications of novel foods; Updated 13-01-2010

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

Legislation

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;
  • 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.

Notified Foods

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).

List of Notifications of novel foods

Source: European Commission

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