Novel Foods

The "Novel Foods Regulation" [Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients] applies to foods and food ingredients that have not been used for human consumption to a significant degree within the European Community before 15 May 1997.

New food ingredients used in foods for particular nutritional uses (PARNUTS), Food Supplements, and Fortified Foods currently also fall within the scope of the Novel Foods Regulation.

A full Novel Foods application for each company’s ingredient is required unless "Substantial Equivalence" can be demonstrated. Substantial Equivalence "notification" provides a quicker route to market based on comparison to an existing approved food ingredient. This comparison is based on composition, nutritional value, metabolism, intended use and the level of undesirable substances.

Intertek Cantox has extensive experience in negotiating with both the EU and Member State Novel Food Competent Authorities and Expert Committees, resulting in successful applications on behalf of our clients.

Our services include:

• Assessing Novel/Not Novel classification;
• Conducting feasibility assessments to determine whether sufficient data are available to support a Novel Food application or Substantial Equivalence application;
• Where information gaps exist, providing recommendations for the generation of additional data;
• Designing and placement of pre-clinical and clinical studies where needed;
• Conducting dietary exposure assessments using recognized food consumption databases;
• Preparing and submitting Novel Food dossiers and Substantial Equivalence applications; and
• Providing stewardship for submissions at the Member State and EU level.