Novel Food & Food Additive Services

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 

 

  • Assessing novel/not novel classification 
  • Conducting feasibility assessments to determine whether sufficient data are available to support a novel food application or a not-novel opinion or substantial equivalence application (as applicable)
  • Conducting comprehensive scientific literature searches
  • Where information gaps are identified, providing recommendations for the generation of additional data 
  • Design and placement of pre-clinical and clinical studies, where needed
  • Manuscript preparation for scientific studies.
  • Conducting dietary exposure assessments using recognized food consumption databases
  • Preparing novel food, GRAS, substantial equivalence dossiers or not-novel opinions
  • Convening expert GRAS panels.
  • Providing stewardship of submissions for regulatory approval, including liaising with government authorities
Jurisdictional Regulation Overview

 

 

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. 

In Canada, under the Food and Drugs Act and Regulations, novel foods are defined as foods/ingredients without a history of safe use as a food in Canada, are produced via novel processes, or have been modified by genetic manipulation. These novel foods require a pre-market assessment by Health Canada prior to being put on the market.
The regulation of novel food and ingredients in China are regulated according to the Administrative Measures for Safety Review of New Food Materials (2013).  Novel foods encompass animal, plant, or micro-organisms or substances derived from these sources, food substances with structural changes, or newly developed food materials.  Pre-market approval of novel food materials is conducted by the National Health and Family Planning Commission (NHFPC).
In Japan, different regulatory requirements are applied depending on the classification of a new food ingredient of interest. If the new food ingredient is a food, no pre-market assessment and authorization by the Ministry of Health, Labour and Welfare (MHLW) is required, but it must be ensured that the ingredient is compliant with the Food Sanitation Act (Act No. 233, 1947). On the other hand, if the new food ingredient is a food additive, a pre-market assessment and authorization is required prior to filing an Import Notification.
Novel foods in Australia/New Zealand are regulated under the Food Standards Code, specifically Standard 1.5.1, by Food Standards Australia/New Zealand (FSANZ). Additional considerations include whether a food is considered “traditional” or not.
Intertek has experience with novel food applications for countries not listed above as well, including South Korea, Brazil, Thailand, and others.
 

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Need help or have a question? +1 905 542 2900
 

Need help or have a question?

+1 905 542 2900
China
+86 10 5657 6600
Europe
+44 1252 392 464
Japan
+81 3 5643 8643