EU Novel Foods Regulation (EC 258/97) Services
Intertek provides scientific and regulatory support for compliance with the EU Novel Foods Regulation.
The European Union’s Novel Foods Regulation (EC) No 258/97 applies to foods and food ingredients that have not been used for human consumption to a significant degree within the European Community before May 15, 1997.
The EU Novel Foods Regulation states that novel foods falling within scope MUST NOT:
- Present a danger to consumers
- Mislead consumers
- differ from foods or food ingredients for which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer
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.
EU Novel Foods Regulation Services
Today, a global perspective is essential to gaining approval in multiple markets. Intertek 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. Intertek has the expertise, resources and global reach to support its customers. Our services include:
- Novel / Not Novel classification assessment
- Feasibility assessments to determine whether sufficient data is available to support a Novel Food application or Substantial Equivalence application
- Provide recommendations for the generation of additional data where information gaps exist
- Design and placement of pre-clinical and clinical studies where needed
- Dietary exposure assessments using recognized food consumption databases
- Prepare and submit Novel Food dossiers and Substantial Equivalence applications
- Provide stewardship for submissions at the Member State and EU level
Additional Food Services
Request more information to see how Intertek can help your organization with EU Novel Foods Regulation (EC 258/97) Services.