Regulatory Issues: EU rules on health claims take a step forward
Ten years in the works, the European Parliament’s review of health and nutrition claims on food labels may end a longstanding prohibition against claims relating to human diseases.
By David Joy, Contributing Editor | 06/30/2006
The European Parliament recently undertook its second review of a proposed regulation governing health claims and nutrition claims on food labels throughout the 25 member states of the European Union (EU).
These emerging requirements are of direct interest to anyone marketing food in the EU, and they also are likely to influence food labeling laws elsewhere around the globe. At the conclusion of the parliament’s second reading, the basic text of the regulation appears to be in place and will likely be adopted into law later this year.
The new regulation tackles two broad areas: nutrition claims and health claims.
Nutrition claims include familiar statements such as low-fat, sugar-free, high-protein, low- sodium and vitamin-enriched. These claims, essentially any message about the nutrient content of the food, will be subject to well-defined criteria. For example, a sugar-free claim can be made for foods that contain no more than 0.5g of sugar per 100g of food.
A more complex set of rules will apply to health claims. Health claims are divided into two categories:
- Those that describe the role of a substance in the growth, development, and normal functions of the body.
- Those that describe a reduced risk of disease or that pertain to children’s development and health.
The first category will be regulated by means of a list of permitted claims to be adopted in the next three to four years. Claims falling into the second category, dealing with reduction of disease risk and children’s development and health, will be subject to authorization through a petition process.
Claims must be based on substantiating scientific evidence. The current text also allows for consideration of “other legitimate factors” regarding health claims. This seems to set the stage for denial of a health claim petition even when it is supported by convincing scientific evidence.
One contentious aspect of the proposal is a provision to restrict the use of truthful nutrition and health claims on foods that are deemed to be nutritionally inferior. Under the terms of the current (and likely final) text, the EU will adopt, likely in 2008, specific nutrient profiles which certain categories of food must meet in order to be eligible to bear an authorized nutrition or health claim.
For example, a food containing a significant amount of trans fat might not be eligible to bear a saturated fat-free claim, even if truthful. However, the current text specifies that nutrition claims (but not health claims) shall be allowed on foods that contain a single nutrient (fat, saturated fat, trans fat, sugars or sodium) in excess of the nutrient profile amount, if the claim is accompanied by a disclaimer regarding the undesired nutrient.
The current text continues to allow for endorsements by national medical associations, consistent with national law. This language has been extended to include associations of “medical, nutrition or dietetic professionals.” This provision seems intended primarily to accommodate the various medical association seals that appear on European mineral waters.
An aspect of the EU regulation that sets it apart from U.S. law is its direct applicability to claims made in advertising, not just labeling. The proposed regulation applies to all commercial communications directed to final consumers of domestic or imported pre-packed foods. It also impacts trademarks and brand names that may be construed as health or nutrition claims.
As with many other pieces of EU legislation, a safeguard provision is established that would allow a member state to suspend temporarily the use of an authorized claim in its territory. This provision can be invoked when the member state has grounds for believing that scientific substantiation is lacking or the claim otherwise does not comply with the regulation.
Finally, the parliament has amended a provision that requires the European Commission to prepare a report six years from now evaluating the impact of the regulation and consumers’ understanding of claims. This report now will include an evaluation of the impact of the regulation on dietary choices and specifically on obesity and non-communicable diseases.
This piece of EU legislation has been in the works for more than 10 years. While there are certainly some provisions the food industry would prefer to change, the overall package represents a reasonable step forward. Importantly, the health claim provisions replace a longstanding prohibition against claims relating to human diseases.
About the Author
David Joy is a partner at the Washington, D.C. law firm of Keller and Heckman LLP. He specializes in food and drug law with emphasis on the domestic and international regulation of food, food additives, food labeling, antimicrobial pesticides, and medical devices. He is a member of the District of Columbia Bar and holds a bachelor’s degree in chemistry. For more information about Keller and Heckman, visit the firm’s web site at www.khlaw.com.