Intertek’s novel food/food additive services support pre-market approvals in major jurisdictions across the globe.
Foods or food ingredients that do not have a history of use within a country are typically considered as “novel foods” or new food additives and will require pre-market authorization. See the “Regulatory Overview” section to see more information about the regulations in the different jurisdictions that we support.
With the differing pre-market requirements for novel food/ingredient approvals in different countries and the ever-evolving regulatory landscape, complexities in obtaining approvals requires careful planning and a solid strategy to support market success. Intertek has incredible depth and breadth of expert staff that have extensive experience in navigating the regulatory requirements for novel food/additive application and obtaining approvals in a wide-range of jurisdictions across the globe.
Today, a global strategy is essential to gaining approval in multiple markets efficiently and effectively. Intertek offers the regulatory and scientific expertise necessary to provide reliable advice on international novel food regulations and approvals.
Novel Food Services
Although “novel foods” are not defined in the United States (U.S.), any new food ingredient is considered either as a food additive (requiring a pre-market approval by the U.S. Food and Drug Administration (FDA)) or are Generally Recognized as Safe (GRAS) for specific uses, which can be determined by consensus of a panel of qualified experts. While GRAS notifications to the FDA are voluntary, a “no questions” response from FDA provides additional assurances of the regulatory status to end users of the ingredient and is useful in importing ingredients manufactured outside of the U.S. Typically, new (novel) food ingredients undergo a GRAS determination.
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.
A full Novel Foods application for each company’s ingredient is required unless "Substantial Equivalence" can be demonstrated to an existing authorization. A 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. We can also provide “not novel” opinions to support a history of use of an ingredient.
Note: New novel food regulations have been approved and will be implemented by end of 2017.
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