Struggle continues to harmonise health claims across Europe

Worldwide Regulatory Review: Europe

Food law specialist Patricia Ponsonby examines the ongoing debate surrounding European health claims. With a proposal to regulate such claims now before the European Parliament, she considers the changes that may lie ahead for health food manufacturers that sell products in the EU

In July 2003, the European Commission proposed a draft regulation on the use of nutrition and health claims for foods marketed in the European Union.1 If adopted, the proposal will establish a new harmonised regulatory framework for the use of such claims in reference to all foods, including food supplements, functional foods, fortified foods, diet foods and traditional products.

The proposal sparked considerable debate during the last session of the European Parliament. This was intensified by the desire of some to try to have the proposal adopted before the parliament expanded to include representatives of the new Eastern European accession countries.

While adoption did not occur within this ambitious time frame, the momentum to legislate remains, and the proposal is expected to be taken forward by the new parliament when it convenes this autumn. Companies that market foods in Europe may want to consider the impact this proposal, or a modified version of this proposal, may have on their European business.

Some companies may also want to consider lobbying at the EU or national level. This can be done through existing trade associations, ad hoc coalitions or on an individual basis.

Legislative Origins
Nutrition and health claims are currently regulated at the community level by the Food Labelling Directive,2 the Nutrition Labelling Directive,3 and, more generally, by the Misleading and Comparative Advertising Directives.4 Certain claims and descriptions are also regulated by other community legislation that will not be detailed here.

The Food Labelling Directive prohibits misleading claims and claims that a food may prevent, treat or cure a human disease, or refer to such properties. The Nutrition Labelling Directive establishes certain labelling requirements for foods (other than food supplements) where a nutrition claim is made. Food claims are also generally regulated by the Misleading and Comparative Advertising Directives, which prohibit misleading and unfair comparative advertising.

The above rules provide a basic but incomplete regulatory framework for nutrition and health claims. This, together with other factors like cultural and language differences, have created inconsistencies about what may be said in Europe about the nutrient content or health benefit of a particular food.

The new proposal sets out a more complete regulatory framework. Its stated purpose is to better protect consumers when nutrition and health claims are made, to facilitate the free movement of health foods within the community, to provide better legal security and other protection to manufacturers who make health claims, and to promote food innovation.

In content, the proposal reflects a recent tendency of community regulators to control in more detail the products that may be placed on the community market. The trend is to move away from not only trying to protect consumers from dangerous products but to control the rationale of product ingredients and ingredient formulations. This is also occurring in the area of medicines and cosmetics, and carries with it a clear risk of paternalism and overregulation.

General Requirements As expected, the proposal sets out basic claim definitions, and, in doing so, creates a new health claim category known as the ?reduction of disease risk claim.? This category is defined as including ?any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease.? The category has been generally welcomed by most stakeholders, unlike some of the category and claim restrictions that have been set out in the proposal and that are discussed separately in the contentious issues section below.

Health food legislation
The health claims proposal is one of several pieces of legislation that has and will continue to be formulated by the commission on health foods. Other legislation includes, but is not limited to, the Food Supplements Directive, the Proposed Regulation on Fortified Foods (which was also considered by parliament over the past year and will also continue to be considered this autumn), and a new proposal on nutrition labelling.
In addition, the proposal also sets out five basic conditions that must be met in order to make a nutrition or health claim. First, the beneficial effect of the presence, absence or reduced content of a particular substance must be established by generally accepted scientific data. Second, the substance for which the claim is made must be sufficiently present or absent to produce the effect claimed. Third, the substance for which the claim is made must be in ?a form that is available for use by the body.? Fourth, the substance must be provided in a quantity that would produce the claimed effect; and, fifth, the claim must comply with any other conditions that are set out in reference to the use of that claim.

The proposal also requires claims to be based on and substantiated by generally accepted scientific data. Claims may be made only in instances where the average consumer can be expected to understand the beneficial effects expressed in the claim. All claims must also relate to the food as ready-to-eat in accordance with the manufacturer?s instructions and, except for generic advertising, nutrition labelling will be required.

The proposal prohibits false or misleading claims, claims that disparage the safety or nutritional adequacy of another food, claims that state or imply that a balanced and varied diet does not provide appropriate quantities of nutrients, and claims that refer to changes in bodily functions ?in improper or alarming terms.?

The proposal also requires the commission to establish a community register of nutrition and health claims. The register would identify and contain information on nutrition claims and the conditions under which such claims may be made and details on all authorised and rejected health claims.

Specific dos and don?ts
The proposal establishes specific composition requirements for nutrition claims (such as ?low,? ?high? and ?light?) and general requirements for comparative nutrient claims. To date, general and specific comments have been made about the criteria that have been proposed. For example, the listings do not contain entries for omega-3 fatty acids, poly-unsaturated fatty acids, and mono-unsaturated fats. Space is now expected to be provided for these specific entries.

The proposal permits the use of health claims that generally describe the accepted role of a nutrient or other substances provided that they are contained in the community register on health and nutrition claims. Reduction of disease risk health claims will also be permitted provided that they are reviewed, approved and authorised at the community level.

Companies that use health claims may also be required to provide additional health information on their labels, such as a statement on the importance of a balanced diet and healthy lifestyle.

Contentious issues
The proposal completely prohibits the use of nutrition or health claims for foods that do not meet established nutrient profiles and strictly limits the claims that may be made about alcoholic beverages. In principle, the profiles are intended to prevent the use of health claims for products like candies and snack foods that do not have a ?desirable? overall profile.

While consumer groups have generally embraced this idea, the industry has expressed doubt about the usefulness of overall profiles and has questioned exactly how the categories and profile contents should be determined. In addition, technical and scientific discussions will continue on the inherent judgments that must be made in order to establish profiles. By way of example, issues have already been raised about whether differences can and should be drawn between naturally present and added sugars.

The proposal has also sparked debate about the restrictions that it imposes—and fails to impose—on certain health claims
The proposal has also sparked debate over the restrictions that it imposes—and fails to impose—on certain health claims. In particular, the proposal prohibits claims that refer to general benefits for overall well being, to psychological and behavioural functions and to the advice of health professionals. It also prohibits slimming and weight loss claims, although certain slimming claims may be made for meal and complete diet replacement products through other community legislation.

These restrictions have been heavily criticised as overly broad and prohibiting claims that are useful to consumers. Particular concerns have arisen over the fact the proposal prohibits the use of ?healthy eating? product ranges and other slogans protected by trademark. There is also dissatisfaction that the restriction will ban references to health professionals and concern that the restrictions prohibit claims that are truthful and capable of substantiation.

Interestingly, the proposal does not restrict claims aimed at children, although reference is made to youth as a justification for rules proposed on alcoholic beverages. This issue was most recently taken up by the Irish presidency and the parliament?s Environment, Public Health and Consumer Policy Committee. Some member states believe, however, that the proposal should not contain an outright ban and that the issue should be considered when formulating the nutrient profiles, where specific consideration may be given to vulnerable consumers.

Issues have also been raised about the need for adequate transition rules and the authorisation procedure that has been proposed for the reduction of disease risk claims. By way of example, while stakeholders have generally embraced the fact that the proposal permits the use of disease risk claims, there have been significant debates about the details of the authorisation procedure, which many member states view as unworkable and burdensome.

Additional concerns have also been raised about the general time deadlines set out in the proposal and the fact that the proposal requires the European Food Safety Authority (EFSA) to ensure that the claim is understandable and meaningful to consumers, an exercise that the EFSA has indicated is not a risk assessment and is therefore not within its normal remit.

The Road Ahead
While further legislative action cannot be taken until the new European Parliament convenes this autumn, member states continue to discuss the outstanding issues in preparation of the common position, which will have to be adopted after the proposal is considered by the new parliament. It has been reported that member states have reached general agreement on some issues, but are still struggling to reach agreement on key aspects.

Finally, as the political debate moves forward, so do the concerns on food safety, obesity and other public health and consumer issues that have helped trigger the formulation of this proposal. These are also likely to continue to affect the political process, as is the industry and consumer reaction to such developments.

For example, the momentum to better inform consumers in the UK has caused one supermarket chain to decide to test a new ?traffic light? labelling system this autumn that will highlight the total fat, saturated fat, salt and sugar in a product by red, amber and green colour coding next to the calorie and carbohydrate information.

It will be interesting to see how this and other developments may influence the debate and eventual legislation that is adopted and implemented in Europe on nutrition and health claims.

1 Proposal for a regulation of the European Parliament and the council on the nutrition and health claims made on foods, COM (2003) 424 final.
2 European Parliament and Council Directive 2000/13/EC on the labelling, presentation and advertising of foods, OJ L 109, 2000 May 6; p 29.
3 Council Directive 90/496/EEC on nutrition labeling of foodstuffs, OJ L 276, 2990 Oct 6; p 40.
4 Council Directive 84/450/EEC concerning misleading advertising, OJ L 250, 1984 Sep 19; p 17, and European Parliament and Council Directive concerning misleading advertising so as to include comparative advertising, OJ L 290, 1997 Oct 23; p 18.

Patricia Ponsonby is a specialist in food law based in international law firm Covington & Burling?s London office. She has been ranked for several years as one of the top five food law specialists in the UK by Chambers Legal Directory.
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