On 8 June 2017, the Court of Justice of the European Union (CJEU) issued a judgment in case Dextro Energy GmbH & Co. KG (Dextro) vs European Commission (Commission) (case C-296/16 P). The judgment confirms a March 2016 ruling of the General Court (GC), which found that the Commission was right in rejecting certain health claims relating to glucose as they encouraged sugar consumption in violation of generally accepted nutrition and health principles (case T-100/15).
The CJEU judgment confirms the necessity for the industry to ensure that a claim is not only scientifically substantiated but also aligned with generally accepted principles and good dietary practice prior to applying for authorisation of the claim. In particular, the Commission may consider a claim as incomplete, and thus ambiguous or misleading, if it highlights a certain quality of a product but does not inform the consumer as to the health risks inherent in its consumption as reflected by generally accepted principles. Therefore, such a claim may be rejected even if it has been regarded as scientifically accurate. During the risk management of the claim, the Commission has indeed to consider the presumed expectations of the average consumer in relation to the claim and, in particular, whether the consumer is in a position to make well-informed consumption choices.
Regulation (EC) No 1924/2006 on nutrition and health claims made on foods (NHCR) provides the framework for companies that wish to emphasise beneficial health properties of foodstuffs in commercial communications (health claims). In particular, health claims made on foods are prohibited unless they are authorised by the Commission in accordance with the NHCR and included in a positive list.
Article 13(5) of the NHCR states that any additions of claims based on newly developed scientific evidence and/or which include a request for the protection of proprietary data to the list of health claims (other than those referring to the reduction of disease risk and to children’s development and health) shall be adopted following the procedure laid down in Article 18. According to Article 18, food business operators intending to use a health claim not included in the list may request its inclusion by submitting an application for authorisation to the national competent authority of a Member State, which forwards it to the European Food Safety Authority (EFSA) for it to verify whether the health claims are based on scientific evidence, as well as to the Commission and the Member States for information. The Commission takes a final decision on the application taking into account EFSA’s scientific opinion, any relevant provisions of EU law and other legitimate factors relevant to the matter under consideration, after having consulted the Member States.
Article 3 of the NHCR prohibits the use of nutrition and health claims that are false, ambiguous or misleading, or that encourage or condone excess consumption of a food. These general principles are further clarified in Recital 18 of the NHCR, which states 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.
In 2011, Dextro, a German company manufacturing products made almost entirely of glucose under different formats (especially, tablets), requested an authorisation to use certain health claims pursuant to Article 13(5) of the NHCR. The proposed claims were: ‘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 granted a positive scientific opinion on the aforementioned claims as it considered that a cause and effect relationship had been established between the consumption of glucose and contribution to energy-yielding metabolism.
In 2015, the Commission issued Commission Regulation (EU) 2015/8 (Regulation 2015/8) refusing to authorise the claims. According to the Commission, authorisation may legitimately be withheld if health claims do not comply with general and specific requirements of the NHCR, even in the case of a favourable scientific assessment by EFSA. In this case, the use of the glucose related health claims contravened Article 3 of the NHCR which prohibits ambiguous or misleading claims. Indeed, the claims would convey a contradictory and confusing message to consumers as they would encourage consumption of sugars whereas national and international authorities recommend sugar intake reduction on the basis of generally accepted scientific advice. Furthermore, even if the claims were to be authorised under specific conditions of use or accompanied by additional statements or warnings, this would not suffice to ensure that consumers would not be misled. Consequently, the claims should not be authorised.
Proceedings before the General Court
In March 2016, the GC dismissed Dextro’s application for annulment of Regulation 2015/8. In the GC’s views, and in line with Recital 30 of the NHCR, the Commission should base its risk management decisions taking into account the applicable EU law and other legitimate factors in addition to EFSA’s opinion, where appropriate. Moreover, in line with Recital 18 of the NHCR, generally accepted nutritional and health principles constituted a legitimate factor relevant to the determination of whether the health claims could be authorised. As generally accepted nutrition and health principles call for a reduction in sugar intake (whether sugar added to food or pure sugar), the Commission was right in finding that the concerned claims, which highlight only the beneficial effects of glucose for energy metabolism without mentioning the dangers inherent in increased sugar intake, were likely to encourage sugar consumption and thus increase risks for consumers’ health inherent to excessive sugar consumption. Therefore, the claims were incomplete and, as such, ambiguous and misleading and contravened Article 3 of the NHCR. Furthermore, the claims were conflicting and confusing as, due to the fact that claims confer a positive image on the foods concerned, consumers could be encouraged to consume more sugar, such encouragement being however inconsistent with generally accepted nutrition and health principles. That applies especially because, according to EFSA’s scientific opinion, the product concerned must be a significant source of glucose to bear the claims. Consequently, said claims could not be authorised.
Proceedings before the Court of Justice of the European Union
The CJEU confirmed the GC judgment and dismissed certain pleas of Dextro as inadmissible.
For the CJEU, the GC evaluated the extent of the Commission’s discretionary powers and concluded that the Commission had acted in accordance with the principle of proportionality and within the limits of its discretion (such discretion being broad in the area foreseen by the NHCR, which entails political, economic and social considerations). The CJEU found that the GC’s view – aligned with the Commission’s – that the claims were ambiguous or misleading even if accompanied by statements or warnings remained a factual exercise and went thus beyond the CJEU’s control.
Furthermore, according to the CJEU, the GC identified the reasons that the Commission considered to justify refusal of authorisation of the claims but did not take a position itself as to whether said claims indeed encouraged sugar intake. Moreover, even if the GC found that the claims could indeed encourage sugar intake, it constituted a factual exercise and went thus beyond the CJEU’s control.
Importantly, the CJEU reminded that, pursuant to Recitals 17 and 18 of the NHCR, while scientific substantiation (provided by EFSA) is the main aspect to be taken into account for the use of a health claim, such 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. Therefore, the GC was right when it found that generally accepted nutrition and health principles, which help ensuring a high level of protection to consumers, constituted a legitimate factor for the Commission to assess whether the glucose related health claims could be authorised.
Finally, according to the CJEU, the GC was correct in finding that Dextro had not proven a violation of the principle of equal treatment. First, Dextro had failed to show to which extent the authorisation of various health claims relating to the contribution of specific vitamins and minerals to normal energy-yielding metabolism was comparable to the situation of the glucose related health claims. The mere fact that the claims related in both cases to the contribution of a substance to normal energy-yielding metabolism was not sufficient in that respect considering that glucose is a different nutrient from vitamins and minerals. Second, Dextro had also failed to show comparability with regards to the already authorised fructose related health claim ‘consumption of foods containing fructose leads to a lower blood glucose rise compared to foods containing sucrose or glucose’. This is because said claim refers to the replacement of glucose or sucrose by fructose in order to reduce or limit the increase in blood glucose. Therefore, there is no risk of an overall increase in sugar consumption as a result of the authorisation of the fructose health claim.