FOREIGN AGRICULTURAL SERVICE
U.S. MISSION TO THE EUROPEAN UNION

Last update: August 24, 2010

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	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 foods and food ingredients obtained by traditional propagating or breeding practices with a history of safe use
	foods and food ingredients to which a production process not currently used has been applied, 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

Novel foods must undergo a safety assessment before they can be placed on the EU market.  Applications must be submitted in accordance with Commission Recommendation 97/618/EC concerning the scientific aspects and the presentation of information required to support an application.  Products considered "substantially equivalent" by a national competent food authority as regards their composition , nutritional value, metabolism, intended use and the level of undesirable substances, may follow a simplified procedure.

The EU's new rules for GM food & feed  provide for the establishment of a separate regime to deal with the authorization and traceability of novel foods and novel food ingredients that consist of or contain or are derived from GMO’s.  Article 46(1) of the new regulation on GM food & feed (Regulation 1829/2003) provides that applications for the authorization of a GM food made under Novel Foods Regulation, which have received a final scientific assessment before the coming into force of the new regulation, are still to be processed under the Novel Foods Regulation. Pre-market approval of non-GM novel foods will continue under Regulation 258/97.

	Update on the status of the Novel Foods Proposal (April 2010)
	"European Parliament Report on Novel Foods Proposal" (GAIN report E49149 - Dec. 2008)
	"Proposal for a New Novel Foods Framework Regulation" (GAIN report E48014 - Feb. 2008)
	List of novel foods approved to be commercialized in the EU (DG Sanco)