Novel Foods

Intertek’s novel food services support pre-market approvals for ingredients in major jurisdictions across the globe.

Foods or food ingredients that do not have a history of use within a country are typically considered “novel foods” and will require pre-market authorization.

Obtaining approval for novel foods/ingredients requires careful planning and a solid strategy to support market success. Due to differing pre-market requirements for different countries and an ever-evolving regulatory landscape, obtaining approval can be quite complex. A global strategy is essential to gain approval in multiple markets efficiently and effectively.Intertek has the regulatory and scientific expertise necessary to provide reliable advice on international novel food regulations and approvals.

Novel Food Services

Assessing novelty status and availability of information to support a history of use
Conducting feasibility assessments to determine whether sufficient data are available to support a novel food application, a not-novel opinion, or a substantial equivalence application
Conducting comprehensive scientific literature searches to support safety of ingredients
Providing recommendations for generating additional data, where information gaps are identified
Designing, placing, and managing pre-clinical and clinical studies, where needed
Preparing manuscripts for scientific studies
Conducting dietary exposure assessments using recognized food consumption databases
Preparing novel food, Generally Recognized as Safe (GRAS), and substantial equivalence dossiers, or not-novel opinions
Providing stewardship of submissions for regulatory approval, including liaising with government authorities

Intertek’s expert staff has extensive experience navigating regulatory requirements for novel food applications and obtaining approvals across the globe. Our knowledgeable and well-connected global team can help at all stages of product development—from conception, to stewardship with authorities, to final approval.

Intertek Supports The Following Jurisdictions: