Global Regulation of Novel Foods

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.

Another market of interest to many companies is Japan. While there is no term or definition for novel food in Japan, Foods for Specific Health Use (FOSHU) is a term used to define a similar class of goods, as well as representing the name of the regulations governing such articles, and is overseen by the Ministry of Health, Labor & Welfare (MHLW). As a side note, the term food function, which does not appear in the regulations, is thought to have first been used in Japan in the early 1980s to assist in describing and creating regulations for this class of goods.

In order to sell a food as FOSHU, an assessment of the safety of the food and effectiveness of the functions for health is required, with claims approved by the MHLW. Applicants must submit data on the effectiveness and safety of the food or ingredient to the MHLW, where consultation is provided prior to the data being reviewed by an expert group or commission. In addition to regular FOSHU, there are three other types, each with specific definitions: Qualified FOSHU, Standardized FOSHU, and Reduction of Risk FOSHU.

In China, the regulation of novel foods and ingredients is congruent with the EU model and methodology of risk assessment. The Administrative Measures on Novel Food regulations, adopted by the PRC Ministry of Health (MOH) in December 2007, superseded regulations adopted in the early 1990s and replaced regulations on genetically modified foods. The novel foods regulations categorize novel foods and ingredients in four broad categories of goods that have not traditionally been consumed in China, and an Expert Assessment Committee on Novel Foods is responsible for conducting a safety assessment review on all applications. The MOH then conducts an administrative review to determine approval.

Finally, the Food Supplements and Safety Act (FFSA) came into force in October 2006 in India to govern novel foods, defined as an article of food for which standards have not been specified but is not unsafe, provided that such food does not contain any of the foods and ingredients prohibited under [this] Act and the regulations made thereunder. Functional foods and/or nutraceuticals are not categorized separately in India, as seen in the United States or EU. In India, functional foods can include herbal extracts, spices, fruits, and nutritionally improved foods or food products with added functional ingredients. 

Devon Powell is the chief operations officer of the American Herbal Products Association (AHPA); contact him at [email protected]. This information was excerpted from the e-book Reviewing Global Regulation of Novel Foods, available for free download at NaturalProductsINSIDER.com.