According to the European Novel Food Regulation, EG 258/97, a substance is a Novel Food if it was not used for human consumption in substantial amounts in the European community before May 15, 1997, and if one or more of the following applies: it has a new or intentionally modified primary molecular structure; it consists of or was isolated from microorganisms, fungi or algae; it consists of or was isolated from plants or animals; or if it was produced using a production process that is not currently used and which causes significant changes in the composition or structure of the substance (an example is the natural sweetener stevia, since the plant is not indigenous to the EC, and the sweetener has been isolated from a plant).
If a manufacturer wishes to market such a Novel Food in the EU, the product must undergo the Novel Food authorization procedure. This consists of submitting a dossier on the history of the source of the novel food, information on its anticipated intake, information on previous human exposure, nutritional, biological and toxicological information, and information on labeling. Obviously this makes putting the dossier together a time-consuming, work-intensive and costly affair that most manufacturers probably want to avoid. And let’s not forget that it usually takes between 16 and—in extreme cases, e.g. phytosterol/phytostanol—60 months for the Commission to decide on an authorization. The reason for the wide time span is the lack of a time preset given in the regulation. Such a long time is, of course, not compatible with innovation.
So what’s a manufacturer to do? Is it in the manufacturer’s best interest to avoid the Novel Food authorization procedure altogether and try to find room for interpretation in the regulation, so that a given substance can be termed a non-novel food? This could be one solution.
There is room for interpretation in the regulation’s wording. For example: “Significant degree” of consumption before 15 May 1997 is as imprecise as “significant changes” during the production process. And so far, the EC has failed to provide examples or clear quantifications of the term “significant” in both instances, which gives manufacturers a little wiggle room, especially if they task experienced consultants with finding the loopholes.
One of the advantages of the current legislation is “me too” procedures, the so-called substantial equivalence application. If a substance or food can be proven to be similar (substantially equivalent) to a substance or food that has already been granted Novel Food status, the manufacturer of the equivalent substance could exploit a simplified authorization procedure that merely requires proof of safety.
Regulation Up for Revision
Novel Food regulation is up for revision in the near future (anticipated coming into force in 2012). The Commission’s goal is to simplify, centralize and accelerate the procedure. One of the changes will include a stipulated timeframe during which the Commission must decide on an application, with clear deadlines and an accelerated procedure. Another change will be a simplified authorization procedure for novel foods that are “common” foods outside the EU, while truly novel foods—just like additives, flavors or enzymes—will be put on a unified community list.
The problem is that the suggested revision is unlikely to meet the Commission’s goals, and will probably make things even more complicated for manufacturers. For one thing, the desired acceleration of the procedure probably won’t happen, since the suggested deadlines are too generous and can furthermore be extended indefinitely.
The notification procedure for “common” foods with a history of use in third countries (which, of course, includes industrialized nations such as the U.S. and Japan) is extremely difficult, and such a Novel Food would have to fulfill the following criteria in its country of origin: It must be used exclusively as food; it must have been part of the normal diet for at least one generation; and it must be consumed by the majority of the population. The specific requirement for a “generation” having consumed the novel food clearly goes beyond the definition of a novel food and is within the range of definition of a common food. It also fails to take into account changing food consumption habits over time. In other words, if a “generation” is considered to be 50 years, then it falls within the range of postwar times, when many foods that are common today were not part of the normal diet, even within the EU.
The suggested revision would also increase the scope of the novel food regulation considerably, since any food that has not been used in significant amounts before May 1997 in the EU would automatically be considered a Novel Food. No second criterion would need to apply, unlike in the current situation. It also means that foods that currently are not Novel Foods may, under the terms of the revision, suddenly be regarded as Novel Foods.
For now, it remains to be seen whether these valid concerns will be taken under advisement before the revision is passed.