Health Claims: CJEU confirms a claim can be refused on grounds of generally accepted nutrition and health principles despite scientific substantiation

The CJEU decision puts an end to a dispute started in 2015 by Dextro Energy GmbH & Co. KG (“Dextro”) following the refusal of health claims related to glucose by the Commission (Regulation 2015/8), which Dextro had unsuccessfully challenged before the General Court of the European Union (Case T-100/15, judgment of 16 March 2016).

Background of the case

Dextro sells products in Germany and Europe that are almost entirely made of glucose. Their most popular product is a cube consisting of eight tablets of glucose weighing 6 grams each.

In 2011, pursuant to Article 13(5) and Article 18 of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods ("NHCR"), the company requested authorisation for using five health claims related to glucose (the final wording of which was “glucose is metabolised within 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” and “glucose contributes to normal muscle function”).

EFSA's assessment of the five claims led to a favourable outcome. On the basis of the data submitted, EFSA indeed found that a cause-and-effect link can be established between the consumption of glucose and a normal, energy-yielding metabolism and that the claimed effects referred to the contribution of glucose to energy-yielding metabolism. EFSA therefore rendered a positive opinion on the authorisation of the claims.

However, on 6 January 2015, the European Commission refused to authorise those claims and adopted Commission Regulation (EU) 2015/8. According to the Commission, the use of the proposed claims would be inconsistent with generally accepted nutrition and health principles and would convey a conflicting and confusing message to consumers because it would encourage consumption of sugars for which, on the basis of generally accepted scientific advice, national and international authorities inform the consumer that their intake should be reduced.

Dextro challenged the relevance and legitimacy of the grounds of Regulation 2015/8 before the General Court. The General Court rejected the appeal and confirmed the Commission’s decision by judgment of 16 March 2015.

CJEU proceedings and ruling

Dextro appealed to the CJEU inter alia claiming a violation of Article 18 (4) of the NHCR by the General Court, read in conjunction with Recital 17 of the NHCR. These provide that the Commission decides on health claims applications taking into account the scientific evaluation by EFSA, being understood that this scientific evaluation should be the main aspect to be taken into account in the decision-making process. Although recital 18 clarifies that a nutrition or health claim should not be made if it is inconsistent with generally accepted nutrition and health principles or if it encourages or condones excessive consumption of any food or disparages good dietary practice, Dextro Energy submitted that generally accepted nutritional and health principles should not justify a rejection of scientifically validated claims positively assessed by EFSA and that by rejecting the claims, the Commission adopted a disproportionate decision and wrongfully exercised its discretion.

The CJEU confirmed that the Commission enjoys broad discretionary powers in assessing the admissibility of health claims as this process is highly complex, involving the consideration of scientific fact as well as decisions on political, economic and social issues. Further, the CJEU found that the General Court did not fail to scrutinise the Commission's exercise of discretionary powers. In such cases, the revision by the courts is restricted to determining whether there has been a manifest error of assessment or a misuse of powers, or whether the competent authorities have clearly exceeded the limits of their discretion. This was negated in the present case. The Commission decision was found neither disproportionate nor in breach of the principle of equal treatment. To the contrary, the CJEU considered that the Commission based its decision on legitimate factors.

The further grounds for appeal put forth by Dextro essentially repeated the pleas in law against the Commission’s decision already submitted to the General Court. Consequently, the CJEU already dismissed these grounds for procedural reasons, arguing that an appeal merely repeating the arguments before the GC without specifically identifying the error in law which allegedly affects the contested judgment does not satisfy the requirements for an appeal at the CJEU.

Comments

In the case at issue, the CJEU confirmed the findings of the General Court and the reasoning of the Commission: the EFSA scientific opinion is only one of the elements that the Commission shall take into consideration when evaluating the approval of a health claim, whereas the Commission is not bound by it. The scope of EFSA’s opinion is in fact limited to verify the scientific substantiation of the health claims, i.e. in the present case the existence of a cause-and-effect relationship between the intake of glucose and the claimed effects. Still, the Commission shall also take into account any relevant provision of Community law, as well as any other legitimate factor.

In the present case, the Commission argued that a health claim on glucose would convey a conflicting and confusing message to consumers. It would encourage consumption of sugars for which, on the basis of generally accepted scientific advice, national and international authorities advise consumers to reduce their intake.

In June 2016, similar considerations led the European Parliament's Environment and Public Health Committee ("ENVI") to adopt a motion which called on the Commission to withdraw the draft regulation authorising four health claims on caffeine ("caffeine contributes to an increase in endurance performance", "caffeine contributes to an increase in endurace capacity", "caffeine helps to increase alertness" and "caffeine helps to improve concentration"). Members of Parliament expressed concerns on the possibility that the health claims would create a health halo on sugary energy drinks which are largely consumed by adolescents. In that case too, however, EFSA had delivered a positive opinion on the existence of a cause-and-effect relationship between the consumption of caffeine and the claimed effects.

These cases relight the debate on the need to adopt nutrient profiles as required by Article 4 of the Health Claim Regulation. Although such profiles were meant to be adopted by January 2009, they had not been finalised until now, notably due to various concerns expressed by Member States' experts and EU Parliament members (MEPs), as well as consumer associations.

In June 2016 in particular, MEPs even invited the European Commission to eliminate the concept of nutrient profiles in the view of the serious and persistent problems that have arisen in the implementation of Health Claim Regulation. According to MEPs, there is no need for nutrient profiles, and these profiles could even be misleading for consumers because specific information concerning fat, sugar and salt content already has to be provided in accordance with Regulation (EU) No 1169/2011 on the provision of food information to consumers.

By contrast, the industry frequently calls for the adoption of nutrient profiles, the absence of which is seen as undermining the level playing field that the industry needs to compete fairly and to innovate for health. In May this year, several major actors in the food industry and health and consumer organisations published an open letter to that purpose.

The adoption of nutrient profiles would serve legal certainty, and might avoid disputes like the case discussed herein, which illustrates that food business operators are exposed to the discretionary (with risk of arbitrary) power of the Commission. Not having in place general and binding nutrition profiles also increases uncertainty for food businesses. Even if businesses are able to scientifically prove health claims that they intend to use, they still have to fear that the Commission may find them inadmissible for other reasons that may be hardly foreseeable in some cases.

The Dextro case could have been a good opportunity to hear the CJEU's position on the nutrient profiles issue. However, no plea in law submitted to the General Court was based on the absence of nutrient profiles, and while Dextro submitted such a plea in its appeal, it was dismissed because the rules of procedure do not allow a plea that had not been made by the appellant before the General Court to be included in an appeal.