New rules regarding the nutrition and health claims made in the advertising, labeling and presentation of foodstuffs took effect in the European Union on July 1, 2007. The new rules redefine what constitutes legitimate nutrition and health claims, and they pose a challenge to the legitimacy of many commonplace nutrition claims such as "low fat" and "sugar free". Companies which produce and market foodstuffs in the EU need to understand the new rules, which are mandated by European Commission Regulation no. 1924/2006 of December 20, 2006, the so-called "Health Claims Regulation" (HCR). The HCR imposed new restrictions on the advertising and labeling of foodstuffs, which took effect immediately, and additional provisions of the legislation will gradually increase those restrictions even more in the next few years. As enforcement of the HCR and the new rules on nutrition and health claims gradually increases, a flood of lawsuits is expected, especially from consumer protection associations. This article provides an overview of the HCR and the new nutrition and health claims rules.

By enacting the HCR, European legislators have significantly tightened the legal framework for the advertising of foodstuffs. In addition to the stricter substantive legal requirements concerning nutrition and health claims, the HCR also implements a system change: Nutrition and health claims are no longer solely subject to inspection after products reach the market. In the future, the only nutrition and health claims to be allowed are those that are expressly permitted by the regulation. Statements relating to health will be subject to an official authorization procedure which must be completed before a product may be sold.

1. Current Effects

Standard Conditions for Acceptable Claims

The HCR's standard for acceptable nutrition and health claims has introduced several new requirements: First, the HCR requires that any claims about the nutritional or physiological effects of a product be scientifically provable. Second, the new regulation requires that a substance with a claimed beneficial effect be found in the product in a form and quantity that are available to the human body—i.e., the claimed beneficial effect must be realizable with the substance in the form and quantity found in the product. If a company is not able to prove this in a disputed case, then its advertising will be deemed illegal.

In many cases of claims related to nutrients, the proof of such beneficial effect will not be difficult (e.g., "rich in natural vitamin C", given that no vitamin additive was used and the product is in fact naturally rich in vitamin C). However, nutrition claims that refer to so-called "other substances" are subject to increased scrutiny under the HCR.

Broadening of the Meaning of the Term "Nutrition Claim"

Under the HCR, the term "nutrition claim" is broadly defined; indeed, the regulation expressly applies to "other substances" in addition to nutrients. Until now, German and EU law understood the term to be solely substances with nutritional characteristics. In this respect, any food ingredient that is not a nutrient (e.g. enzymes), was not of concern. But the HCR defines a "'nutrition claim' as any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to (a) the energy (caloric value) ... and/or (b) the nutrients or other substances it (i) contains, (ii) contains in reduced or increased proportions, or (iii) does not contain." According to the HCR, "'another substance' means a substance other than a nutrient that has a nutritional or physiological effect."

The HCR does not define specifically what this includes, however a conservative reading of the regulation would include plant and herbal extracts in the category of "nutritional claim." Thus, the mention of plant and herbal extracts on a product label, for example, could easily be understood as a nutrition claim, with the result that the selling company would have to prove scientifically the positive nutritional or physiological effect of an extract. This could pose problems for many products now on the market, as advertisements for herbal candies (such as cough drops, throat lozenges and peppermint candy) may include one or more claims which could be deemed illegal under the HCR.

Special Conditions for Use of Certain Nutrition Claims

In addition to these general conditions, there are special conditions for nutrition claims under the HCR. Certain claims such as "low fat," "rich in fiber," "rich in vitamin C" or "sugar free" can only be used for advertising and on labels if they fulfill the "conditions for use"—conditions which are defined in a list which is attached as an annex to the HCR. "Sugar free" is, for example, only permitted if the product does not contain more than 0.5 grams of sugar per 100 grams or milliliters. The claim "low sugar" could be applied if the product does not contain more than five grams of sugar per 100 grams or milliliters. Nutrition claims other than those contained in the annex and which were legally used in a member country before January 1, 2006, may continue to be used until January 19, 2010. After this cut-off date, however the conditions specified in the annex are definitive, and any claims which do not satisfy those conditions are forbidden.

Nutrition Labeling Also for Health Claims

The obligation to apply nutrition labeling in the case of the voluntary use of nutrition claims, which resulted some time ago out of the directive 90/496/EEC, now extends to (voluntary) health claims as a result of the HCR. Based on the product's nutrition labeling, consumers should be able to determine the concentration of calories, fat, protein, carbohydrates and other nutrients such as salt, sugar and saturated fatty acids. Additionally, the regulation requires that substances that are the subject of a nutrition or health claim, but previously did not have to be included in the nutrition labeling, must be given with their quantity in the same field of vision in the direct vicinity of the nutrition labeling (e.g. peppermint extracts 0.1 g).

2. Future Effects

Nutrition Profiles

In addition to the new rules on nutrition and health claims which took effect on July 1, 2007, the HCR stipulates that the European Commission issue nutrition profiles. The profiles, to be issued by January 19, 2009, will specify threshold conditions of nutritional and health value and will serve as a prerequisite to making any nutrition and health claims going forward. That is to say, certain foodstuffs and products in certain food categories will be required to meet the conditions set out in the nutrition profiles in order to be able to display any nutrition or health claims at all. For example, if a food does not meet the requirements of a nutrition profile with respect to sugar, fat or salt content, then any nutrition and health claim advertisement and label information will be forbidden—without any consideration of the truth of such information. This means that food must be conducive to healthy and balanced nutrition when viewed from its overall nutrition profile—in particular, with regard to fat, sugar and salt content—in order to be advertised with nutrition and health claims at all. Thus, for example, it would not be permissible to advertise that a product is "low fat" if it has a high sugar content which makes it not conducive to healthy and balanced nutrition.

Stricter Requirements for Health Claims

Under the HCR, health claims (e.g., "strengthens your natural defenses" or "promotes bone formation") will be subject to even stricter requirements in the future. The HCR divides these claims into three categories: (1) claims concerning the reduction of the risk of diseases, (2) claims about the development and health of children, and (3) other health claims, for example, those that refer to the role of a nutrient or other substance. Interestingly, the health claims in the first category (i.e., risk reduction claims)—for example, "the regular consumption of sufficient amounts of calcium reduces the risk of contracting osteoporosis as you get older"—are not permitted currently under German law even if they are demonstrably true. However, they will be permitted under the new regime mandated by the HCR.

In this new regime, health claims in the third category will be permitted only if they are included in a list of permissible claims which still must be prepared by the European Commission. The Commission's list will only contain claims which have a scientific basis, and claims included in the list can be used without approval. The HCR mandates that the list be published by the Commission and approved by European legislators no later than January 31, 2010. Health claims in the first and second categories are only permitted after completion of an official approval procedure.

3. Miscellaneous

Effects on Trademarks and Brand Names

Food producers and distributors must take precautions that their trade names and brand names do not violate the rules on nutrition and health claims of the HCR. If trade names and brand names—not supplemented by a permitted claim—can be interpreted as nutrition or health claims (e.g. the well-known "High C" fruit beverage ("Hohes C") or the Aldi brand, "BeLight"), and those claims are not permitted under the HCR regime, they will be illegal in the future—after a period of transition to full implementation of the HCR. However, products that had a trademark or brand name before January 1, 2005 and do not meet the requirements of the HCR, can continue to be placed in circulation until January 19, 2022.

Transitional Provisions

The regulation contains various other transitional provisions intended to make it easier for producers and dealers to adjust to the regulation. However, they are confusing and complicated. Only in a small number of cases is it possible to determine from the HCR how long a company has to dispose of existing inventories of products. Foodstuffs that were placed in circulation before July 1, 2007, or were labeled before this date can continue to be placed in circulation without consideration of the new provisions until their expiration date, but no later than July 31, 2009. However, there are a large number of additional unsettled legal questions connected with the transitional provisions. For example, even the wording of the transitional measure raises the question of whether it is sufficient only that the finished package was labeled before the cut-off date or whether the food must also have been placed into the package by this time. It would appear that after the expiration of the various transition periods the HCR will be widely applicable in four to five years.

4. Summary and Outlook

Looking forward, the principle that "what is not expressly permitted is forbidden" will apply to nutrition and health claims in the advertising, labeling and presentation of foodstuffs in the EU. Some health claims will be subject to prior approval. Other nutrition and health claims will have to be grounded in scientific evaluation and be affirmatively published in lists approved by EU regulators. Given that these lists have yet to be written, that the HCR introduces a complicated regulatory regime, and that legal terms associated with nutrition and health claims are being redefined, there are tremendous uncertainties for producers and distributors of food products in the EU. The Health Care Regulation and the new rules it mandates will give competitors and consumer protection associations sufficient cause to go before the courts.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.