With the advent of the health claims regulation, the European regulatory landscape has become unified throughout the various member states. Whereas before each country could more or less decide independently on the stringency, or lack thereof, of its national claim regulations, today there is a firm European-wide framework in place. Most important is the definition of two types of claims: “nutrition claims” and “functional claims.” The latter are subdivided into “well-accepted claims,” “innovative claims” and “risk-reduction claims.” There are lists of accepted claims for both nutrition and well-accepted claims. As for innovative and risk-reduction claims, manufacturers were urged to submit proprietary claims for approval by the commission.

The first batch of about 500 opinions on article 13.1 health claim applications (pertaining to well-accepted claims for food components such as vitamins and minerals, dietary fibers, probiotics and botanical substances) was published on October 1, 2009. About 66% of these opinions were negative.

That sounds harsh, but is in fact a much more favorable outcome than feared by the industry, especially in view of the large number of rejected article 13.5 and 14 claims that far outweigh the number of positive rulings by EFSA, the European Food Safety Authority. Out of about 295 submitted claims (as of September 2009), 55 were rejected and only 13 were approved.

Many negative rulings are based on insufficient clinical evidence. The study groups often were not relevant to the target groups, as studies submitted for health claims must be done on healthy volunteers and not on patients with specific health problems. Also, products targeting children must have studies done on children in the equivalent age group. There were also study dosage problems, in that the study dosage was not equivalent to the recommended dosage. In many cases, the observed effects were not clinically relevant, such as reduction of waist circumference of 1 cm or less.

So far, the products and ingredients that have been granted health claims have been scant: calcium and vitamin D for bone health, plant sterols and stanols for cholesterol reduction, DHA for children’s eye health, and tomato extract for blood circulation. Since evaluations have not been completed, the next year will be interesting as the industry waits and watches.

However, it seems safe to say that a consequence of the new health claims regulation will be a major shift in the functional food market in Europe by 2011, when the grace period for functional products already on shelves will end. Clearly, times will be hard for ingredients for which proprietary claims cannot be made. This will make it difficult to market new, innovative ingredients with new claims. Already, manufacturers seem to be moving away from functional placement of products, and instead are going for “softer” claims that do not require scientific backing. Consequently, manufacturers will have to find new ways to position and differentiate their products.

Consumer Awareness

There is still considerable consumer skepticism toward claims on foods, despite the fact that the functional food sector in Europe is an area of major growth and interesting development. Consumers are aware of the link between food and health, and the majority of shoppers make their purchasing decisions based on the presence of naturally healthy ingredients and the absence of artificial additives. Younger consumers are especially interested in the preventative aspects of functional foods and the accompanying better quality of life.

Clearly, consumers understand naturally healthy food. They are equally skeptical about claims made on ingredients they don’t know. The obvious way to go then, and one some manufacturers in Europe are already treading, is to advertise the benefits of well-known, naturally functional ingredients and to make claims based on them. An example is Weetabix’s Oatibix brand, which uses oats as a source of energy that is released slowly, as opposed to the more bioavailable wheat. Products such as this require little to no consumer education; manufacturers will not be required to back up their claims with studies and risk rejection by the commission, and the products already have consumer backing since they are known to be healthy.

One way to ensure consumer education is to provide helpful information on the label. According to a recent Datamonitor survey, more than half of Europeans are very interested in label information, with only 12% of respondents disagreeing with that notion. However, this does not mean that consumers will buy a product that merely mentions unknown active ingredients. Without knowledge of the corresponding health effects, consumers are more liable to buy products that have “clean,” (i.e., short) lists of ingredients.

The future of the European functional food market will not be boring, even in the absence of new, innovative claims and ingredients. New impulses from the American functional food market are adopted all the time. A current example is the proliferation of so-called energy shots, which are a part of the energy drinks segment. Arguably, this market was non-existent in Europe a year ago. Convenience and new delivery systems seem to be watchwords, and they serve to highlight new opportunities for differentiation, even when the regulatory landscape makes it difficult to make new health claims.

In summary, it has become obvious that the majority of products currently on the market will not be able to continue carrying the claims they do today. This means that the EU market will be free from products with unsubstantiated claims, which increases the chances for high quality extracts. In the long run, new regulations will increase consumer confidence, and ideally, do away with the skepticism toward functional food that is still prevalent. At the same time, “natural” products with no specific health claims will gain more attention in the marketplace.