by Devon Powell
The definition of what constitutes a “novel food” varies depending on global location or area of interest, as some countries have adopted specific term(s) and definitions (and regulations), while others have not. However, the widely accepted general definition of a novel food is a food or food ingredient that has not been traditionally used as a food. Other terms/phrases that are utilized and may be in some ways similar to novel food include “functional food” (though in some countries, such as China, there are separate regulations and definitions for this term), “foods for special dietary uses” and “non-traditional foods.”
Novel foods and ingredients are regulated in a varying manner by country, with the majority of systems based on a risk or safety assessment review model, with most also requiring notification and approval. Lists of approved novel foods are typically maintained by regulators and are made publicly available.
Interestingly, the United States has no formal regulations or definitions for “novel foods.” FDA considers food ingredients as novel “that have not previously been used as food ingredients.” There has also been some discussion amongst stakeholders and FDA regarding “functional foods,” but no definitive regulatory decision has resulted. In the interim, it may behoove suppliers and marketers to turn to the Dietary Supplement Health and Education Act of 1994 (DSHEA), which amended federal law to establish a definition for the term “new dietary ingredient” (NDI). There are specific procedures, including a notification process that companies intending to market an NDI must follow. In these notifications, FDA is seeking documentation similarly required by countries that require safety data on novel foods, including scientific studies and related research.
On a global basis, there may be similarities in the way different countries approach regulating novel foods, and although the final outcomes may be the same in some cases, the processes to arrive there can be very different. Understanding the regulations for each country will assist companies in getting their novel products and ingredients to market in the timeliest manner.
The European Union (EU) is one of the most active markets in the area of novel foods, which are defined by the EU as foods and food ingredients that have not been used for human consumption to a significant degree within the EU before May 15, 1997. The regulation governing novel foods is EC/258/97, and companies wishing to place ingredients or products on the market need to submit an application and assessment dossier in accordance with Commission Recommendation 97/618/EC, which outlines the scientific data and safety assessment report that is required.
Joerg Gruenwald, president of the consulting firm Analyze & Realize, estimated relative costs to complete a novel food application in the EU can range from US$125,000 upwards of US$615,000. He explained, “If solid documentation about broad usage in other parts of the world can be supplied and some toxicological data are available, costs can be on the low end. If the substance is completely new, for instance, a highly concentrated food ingredient, companies can expect to spend €500,000 or more.”
