European Union Novel Foods Regulation (EC 258-97) Services
Intertek has prepared and facilitated numerous successful novel food submissions in the European Union. Our team of experts can help your company navigate the scientific and regulatory requirements for novel foods.
The European Union’s (EU’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 15 May, 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 a traditional counterpart or existing approved food ingredient. This comparison is based on composition, nutritional value, metabolism, intended use and the level of undesirable substances.
EU Novel Foods Services
Intertek has extensive experience in negotiating with the European Commission and European Food Safety Authority (EFSA), as well as Member State Novel Food Competent Authorities and their Expert Committees, resulting in successful applications on behalf of our clients. Our services include:
- Determination of Novel / Not Novel classification Feasibility assessments to determine whether sufficient data is available to support a Novel Food application or Substantial Equivalence notification
- 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
- Preparation and submission of Novel Food dossiers and Substantial Equivalence notifications
- Stewardship of submissions at the Member State, EFSA, and Commission level to approval
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