Regulation Renovation

New European regulations on nutrition and health claims will likely make differentiation difficult and investment necessary.

By Joerg Gruenwald

A new regulation for nutrition and health claims has been adopted, and discussions about its pros and cons are ongoing. The current law, governed by Article 2 of Directive 2000/13/EC on the labeling, presentation and advertising of foodstuffs, will be in effect for another few months, until such time when the new regulation will enter into force. Listening to the Commission, one might get the impression that the current Food Labeling Directive was too lax, permitting inaccurate information on labels and undermining consumers’ faith in statements printed on foodstuffs. Current legislation effectively bans any form of deceptive advertising, including: “attributing to the foodstuff effects or properties it does not possess” as well as attributing “to any foodstuff the property of preventing, treating or curing a human disease, or refer to such properties.” That does not sound very lax. So how will the new regulation expand on that premise, and what improvements will be made?

Nutrition Claims

Some of the highlights of the up-coming regulation include the definition of three types of claims—nutrition claims, which pertain to nutritional properties; health claims, which pertain to the relationship between a food and health; and risk-reduction claims, which suggest that the consumption of a food significantly reduces the risk of disease. More on these claim types later on. Other innovations, without going into detail, concern the formulation of general principles, which, on closer inspection, do not constitute significant changes over the existing legislation.

In contrast to these relatively small renovations, the introduction of “nutrient profiles” does indeed lead to a new concept, that of the regulation of nutrients potentially bad for human health like fat, saturated fatty acids, trans-fatty acids, sugars and salt. If the contents of a given nutrient exceed the limit set down for it in the profile, any health claim made must be accompanied by a statement “high content of (name of nutrient)”—in order to ensure that foods with a health claim containing high amounts of a “bad” nutrient will not be taken as a wholesome food by the consumer.

It is important to note that health and product producers voluntarily use nutrition claims as a marketing tool. If positive claims cannot be established, the regulation does not force anyone to make negative claims about the product.

The article on General Conditions establishes a number of conditions that go without saying, e.g. that a nutrient for which a claim is made should actually be contained in the product. It also states that only claims that “the average consumer can be expected to understand” are allowed, which implies that, under current legislation, labels are full of unintelligible claims, requiring a legal counter-measure. This, obviously, is not the case, as manufacturers have always tried to advertise their products in ways consumers can actually understand.

Permissible nutrition claims like “low-fat,” “high fiber,” “light” or “natural” are precisely laid out in the annex to the new regulation, including threshold values to be met in order to use them. This part of the new regulation leaves little room for problems and will probably be easiest to apply.

Health Claims

Unfortunately it is not that simple with regard to health claims. They come with a range of conditions and restrictions, such as compulsory additional labeling in case the claim is too general, statements “addressed to persons who should avoid using the food,” and an appropriate warning for products that are “likely to present a health risk if consumed to excess.” If followed, this might lead to a host of repetitive but required statements, as there is always someone who should not consume something, just as almost any food, consumed to excess, will be detrimental to one’s health.

Standard health claims such as “calcium is good for your bones” must conform to a Community list of permitted claims (and must be based on generally accepted scientific data, and be well understood by the average consumer). Changes or additions to that list re-quire application procedures. This means that any manufacturer wishing to make a claim not presently on the list should take measures for its inclusion as soon as possible if they wish to be able to use it before 2010.

The authorization of risk-reduction claims as a subgroup of health claims is predicted to require the greatest bureaucratic efforts of all the new claims. Permissible claims, too, will be entered on the Community list. If a risk-reduction claim is to be made, the regulation demands further labeling, in this case a statement “indicating that the disease to which the claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect,” which effectively counteracts any positive impression the consumer might have received from the claim in the first place. Applying for such a claim involves the filing of a comprehensive and detailed application with the national competent authority of the relevant Member State. The application is then passed on to the European Food Safety Authority (EFSA) and in turn forwarded to the other Member States and the Commission. The summary of the application must be made public. Application items include the nutrient, food or substance intended to receive the claim, a proposal for the wording of the health claim, and scientific material in support of the claim, and, of course, a summary.

EFSA will deliver an opinion on the application within five months of receiving a “valid” application (implying, of course, some possible back-and-forth before such an application will be considered “valid”). This opinion includes the recommended wording of the claim (which means that the wording may be changed from the applied-for wording by EFSA) and any additional statements or warnings the authority deems relevant.

Based on EFSA’s opinion, the Commission drafts its decision within three months after receipt and informs the applicant. As the summary of the application is public, the applicant and/or members of the public may comment on the authority’s opinion during that time. One can imagine the potential discussions surrounding politics, political correctness, or even religious comments. But even if this hurdle is successfully overcome, the Commission still maintains the right to modify, suspend or revoke authorization.

All this effort will conceivably lead to a dearth of risk-reduction claims in the future. However, there is the considerable upside of data protection to be considered, which is granted for five years if a successful claim is made. This could be a convincing incentive for many manufacturers to take on the bureaucracy involved. Also, there will be a transition period for existing products with claims—time that can be used for research and applying for new claims.

In spite of its potential setbacks, many industry representatives welcome the proposal as a means of regulating the marketplace, one that until now has been governed by very diverse national rules. Companies also see the new regulation as a way of preventing unfair competition from unscrupulous manufacturers using false or misleading claims.

For the Future

In summary, while some parts of the new regulation will become easier to implement due to precise lists that can be consulted, health claims will become more regulated, and risk-reduction claims will become a rarity. In the future, there will be either many products with the same claims and warnings, or investments made into solid clinical trials to prove proprietary claims. These even have a five-year data protection period, and so a patented substance/combination with supporting clinical data will get its own claim, while another with less investment will be just one more product in the crowd.NW