As Sweet As It Gets - Can Sugar Ever Carry a Health Claim?

Dextro Energy GmbH @ Co KG v Commission – Case T-100/15Dextro Energy, a German firm that manufactures products consisting primarily of glucose, a simple sugar, has lodged an appeal with the ECJ, to a decision of the EU General Court upholding the European Commission’s veto of the authorisation of the following health claims related to glucose:Glucose is metabolised within the body's normal energy metabolism.Glucose supports normal physical activity.Glucose contributes to n...

Dextro Energy GmbH & Co KG v Commission – Case T-100/15

Dextro Energy, a German firm that manufactures products consisting primarily of glucose, a simple sugar, has lodged an appeal with the ECJ, to a decision of the EU General Court upholding the European Commission’s veto of the authorisation of the following health claims related to glucose:

• Glucose is metabolised within the body's normal energy metabolism.
• Glucose supports normal physical activity.
• Glucose contributes to normal energy-yielding metabolism.
• Glucose contributes to normal energy-yielding metabolism during exercise.
• Glucose contributes to normal muscle function.

The case highlights the potential for differing viewpoints among evidence-based risk assessors such as those within the European Food Safety Authority (EFSA), and policy-based risk managers such as those within the European Commission. The case also stands as an example of the balancing exercise, taking place in Europe and many other jurisdictions, between consumers and industry. In a global market where consumers have become increasingly sensitive to such claims (as their appreciation of the link between nutritional choices and health has developed), the important process of pre-market substantiation and approval of health claims, designed to protect consumers from misleading information, can also give rise to a disproportionately high burden for industry and regulatory authorities that can outweigh the potential for healthier, or at least better informed food choices on the part of consumers.

Regulation 1924/2006 (“the Regulation”)

Designed with the aim of ensuring that health claims on food sold in the EU are clear, substantiated by scientific evidence, and useful to consumers in terms of choosing a healthy diet, EU Regulation1924/2006 provides a harmonised approach to how health claims are made on foods throughout all Member States.

The Regulation provides for a number of categories of claim:

• General function claims (Article 13);
• New general functions claims that were not in use prior to 2008 (Article 13(5));
• ‘Reduction of disease risk’ claims (Article 14(1)(a));
• Children’s development and disease risk claims (Article 14(1)(b)).

Given the wide scope and complexity of the Regulation, a number of issues of concern have been identified since its implementation:

1. A highly bureaucratic decision-making process;
2. Issues surrounding inconsistencies in implementation and enforcement at national level;
3. The arguably quasi-judicial function of EFSA;
4. Delays owing to an unexpectedly high volume of Article 13.1 health claims (which did not require use of a dossier and were subject to ‘a different type of assessment’ by EFSA);
5. Initially limited guidance on the detailed content to be included in application dossiers for Article 13.5 and Article 14 claims;
6. Difficulty on the part of food businesses in interpreting the Regulation; and
7. Significant delays in the creation of a nutrient profiling system, originally scheduled for introduction in 2009, and yet to be established.

Notwithstanding the above, the Regulation does sets out the process by which applications to authorise a health claim are submitted and assessed. EFSA has also published detailed and general guidelines on the preparation of applications.

Dextro Energy GmbH & Co KG v Commission – Case T-100/15

In the case of Dextro Energy’s health claims related to glucose, EFSA considered that the presented data evidenced a link between the consumption of glucose and a good metabolism. The five claims were therefore approved by EFSA in 2012 [EFSA Journal 2012; 10(5) 2694-2698]. However, the Commission subsequently refused to authorise the health claims on the basis that the claims would, in the Commission’s view, convey a conflicting message to consumers, the rationale being that the authorisation of such claims would encourage the consumption of sugars in circumstances where national and international authorities were recommending reduced sugar intake. The EU General Court agreed, with a subsequent CURIA Press Release reporting the Court’s rationale as follows:

“Since, according to generally accepted principles of nutrition and health, the average consumer must reduce their consumption of sugar, the Commission did not err in finding that the health claims in question, which highlight only the beneficial effects of glucose for energy metabolism without mentioning the dangers inherent in increased sugar consumption, were ambiguous and misleading and, accordingly, could not be authorised.”

In a similar move, MEPs have recently voted to back a motion, aimed at vetoing a number of controversial health claims related to caffeine which have been stalled due to public health concerns on the part of various member states. Whereas the disputed caffeine claims are not scientifically false, debate at policy level has focused primarily on the marketing of high-sugar and high-caffeine energy drinks to children and teenagers, and the ‘health halo’ that can attach to a product carrying a health claim.

In this jurisdiction, related concerns arising from the potential for confusion amongst young consumers targeted by the sports nutrition sector have been identified and addressed by the Food Safety Authority of Ireland at a Food Safety Consultative Council Meeting in April of this year.

Meanwhile however, the EC have authorised a claim relating to a carbohydrate based sports recovery product marketed by French firm, Aptonia. The winning formula for approval in this instance appears to have been the combination of a condition that the claim was addressed to populations of active individuals performing strenuous exercise (Dextro Energy’s claim is addressed to the general population), and data based on commonly admitted scientific principles extrapolated from over a dozen trials dating from the 1970s to the present.

Notwithstanding the nuance and complexity involved in the actual application for authorisation of a health claim, the General Council’s ruling in Dextro Energy stands as authority for the proposition that the generally accepted nutrition and health principles taken into account by the EU Commission in that case constitute a factor that is legitimate and relevant to the decision to veto authorisation of a health claim. The ruling may also be important in that it can be interpreted as giving rise to a requirement on the part of regulators to consider generally accepted nutrition and health principles when assessing claims on certain products, even in the absence of the formal nutrient profiling system envisaged in the Regulation.

With the appeal lodged, spokesperson for the company Professor Moritz Hagenmayer, who famously brought a case to Europe challenging the Regulation on a rejected water-hydration claim (and lost) has been reported as saying that the appeal will likely not be heard this year.

For the time being at least, ‘common sense’ policy considerations appear to be trumping a strictly scientific, evidence-based approach to the use of health claims promoted and preferred by industry. As far as the Commission and our elected MEP’s are concerned, there’s no sugar coating the truth that whereas glucose may indeed support normal physical activity, our diets are already sweet enough.