On 8 June 2017, the CJEU in the case C-296/16 P, confirmed that the authorisation of a health claim may be rejected despite a positive scientific assessment by the European Food Safety Authority ("EFSA"), if the claim contradicts other general or specific requirements of the Health Claims Regulation (EC) No 1924/2006.
Facts of the case
The claimant Dextro Energy GmbH & Co. KG ("Dextro") produces products under the brand name “Dextro Energy", which almost entirely consist of glucose (sugar). Dextro applied for the authorisation of five health claims made on glucose pursuant to Art. 13 V, 18 Regulation (EC) No 1924/2006. (e.g., one claim addressed to the general public read as follows: "glucose contributes to a normal energy production metabolism").
Although a scientific assessment by the EFSA revealed that glucose plays a role in energy metabolism, the Commission rejected the inclusion of these claims in the EU list of admitted claims. The Commission argued that above all, a claim may not be inconsistent with generally accepted nutrition and health principles. An authorisation of the claims applied for would send a contradictory and confusing signal to consumers, as it would recommend the consumption of sugar although national and international authorities call upon the population to lower their sugar intake.
The General Court rejected the action for annulment against Regulation (EU) 2015/8 (GRUR- Prax 2016, 183 [Reinhart]). By entering its legal remedy the claimant, inter alia, claims that the Court did not sufficiently verify the Commission’s role of exercising its discretion and violated the principle of proportionality laid down by the legislation of the Union.
The CJEU dismissed the legal remedy entered by the claimant, partly as inadmissible and partly as unsubstantiated. It argued that the General Court assumed without error in law that the Commission had acted within the wide powers of discretion it enjoys when adopting Regulation (EU) 2015/8 and that it was entitled to take into consideration, besides a scientific substantiation of health claims, further relevant provisions of EU law as well as other legitimate factors. The Court added that upon reaching decisions pursuant to Regulation (EC) No 1924/2006 that require complex evaluations, the reviewing powers of Union judges should then be restricted to the examination of whether the exercising of discretion was incorrect or constituted an abuse of discretion, or whether the Commission evidently exceeded the boundaries of its discretion.
According to the CJEU, the principles of proportionality are violated if an action to reach an objective is obviously unsuitable. The Court rightly assumed that a refusal of authorisation of health claims made on glucose to ensure a high level of consumer protection, to provide appropriate and transparent information to consumers, as well as, to protect human health was in accordance with the objectives of Regulation (EC) No 1924/2006. It further stated that an ambiguous or misleading claim was not covered by freedom of speech, freedom of information, or entrepreneurial freedom. According to the CJEU, it is not clear whether warnings or other measures to reverse an intentional misinterpretation as submitted to the Court by the claimant will be subject to the CJEU’s supervision.
Following the judgement of the CJEU, it is now a fact that the Commission shall be allowed to take into account other aspects of EU law that go beyond the scientific substantiation when deciding on the authorisation of health claims, above all, the generally accepted nutrition and health principles as stated in recital 18 of Regulation 1924/2006. The latter is remarkable since this means that the Commission may reject the authorisation of health claims made on sugar, salt, fat, or on any other foods with regard to their content of sugar, salt, or fat on the basis of Art. 13 V, 18 Regulation (EC) No 1924/2006, although it has not yet executed its order to pass nutritional profiles pursuant to Art. 4 of the Regulation. When seeking legal remedies it has to be taken into consideration that the Commission has a wide discretion when deciding on the authorisation of health claims, whose exercise thereof is only verified to a limited extent.