FOREIGN AGRICULTURAL SERVICE
Novel Food Regulation (European Parliament and Council Regulation 258/97)
lays down detailed rules for the authorization of novel foods and novel food
ingredients. It defines novel foods as foods and food ingredients that were not
used to a significant degree in the EU before May 15, 1997, which fall into the
following specific categories:
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.