Back in January the Court of Justice delivered a noteworthy judgment in case C-524/18 Dr. Willmar Schwabe, on which we have not had a chance to comment so far. The case concerned the interpretation of Article 10(3) of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods and arose from a dispute between two competing producers of food supplements in Germany: Dr. Willmar Schwabe and Queisser Pharma, concerning the alleged misleading packaging of a ginseng-based supplement marketed by the latter.
To recall, Regulation No 1924/2006 harmonises national provisions relating to nutrition and health claims used in the labelling, presentation and advertising of foods placed on the EU market. Besides not being false, ambiguous or misleading, the use of nutrition and health claims should comply with a number of more specific conditions. Notably, the presence, absence or reduced content of a substance in respect of which the claim is made must have been shown to have a beneficial nutritional or physiological effect, as established by "generally accepted scientific evidence" (Article 5(1)(a)). What is more, reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being may only be made if accompanied by a specific health claim from the lists of permitted health claims in the Union Register (Article 10(3)). Under Commission's implementing Decision 2013/63/EU food business operators are responsible to "demonstrate the link" between specific claims included on the list and the general references made in relation to their products.
Visual link between general and specific claims
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| Source: apotheke-adhoc.de |
Core question in the case at hand revolved around the necessary link between general and specific claims. Specifically, the question was whether a general statement "B vitamins and zinc for the brain, nerves, concentration and memory" made on the front side of the packaging was sufficiently linked to the more specific health claims included on
the reverse side, considering that no visual link was established between the two.
The Court addressed the question referred using literal, systematic and teleological reasoning. Included in the analysis were among others: the use of the word "accompanied" in Article 10(3) of Regulation No 1924/2006, the regulation's purpose of providing "a high level of consumer protection", and the need to interpret derogations from the general prohibition of health claims in Article 10(1) strictly. Considering these factors together, the Court found that specific health claims should not only specify the content of general claims, but also the location of those two claims on the packaging of the product should enable an average consumer to understand the link between those claims. Accordingly, the concept of "accompanying" referred to in Article 10(3) must be interpreted as including both a substantive and a visual dimension (para. 40), the latter referring to an "immediate perception by the average consumer ... of a direct visual link between the reference to general, non-specific health benefits and the specific health claim" (para. 47). Interestingly, according to the Court, such a link requires, in principle, spatial proximity or immediate vicinity between the reference and the claim, yet the relevant requirement could exceptionally be satisfied by means of an explicit reference, such as an asterisk (*). The chosen method should ensure, in a manner that is "clear and perfectly
comprehensible to the consumer", that, in spatial terms, the content of
the health claims and the reference match (para. 48).
Evidential requirements for general claims
Applying a similar interpretative toolkit, the Court went on to analyse whether ‘general’ health claims, such as the ones made on the front of analysed packaging, should also be justified by scientific evidence in accordance with Articles 5(1)(a) and 6(1) of Regulation No 1924/2006. In this regard the Court opted for a reading which reduced the burden placed upon the food business operators. Thus, although the response to the second question referred was generally an affirmative one, the Court went on to conclude that the evidential requirements for general claims are satisfied when such claims are accompanied by specific health claims that are supported
by generally accepted scientific evidence which has been verified and
authorised and have been included in the Union register.
Overall, while the first part of the judgment applies a rather strict benchmark, the second part restores the balance for food business operators. Although the notion of an average consumer, who is reasonably well informed and reasonably observant and circumspect, features prominently in the judgment, the requirement to interpret exceptions strictly lends support to the application of a strongly protective test in the first part of the analysis. Importantly, food business operators should bear in mind that the use of an asterisk may, but does not necessarily have to, satisfy the requirement of sufficient visual link, and was accepted only exceptionally, due to large size or length of the specific health claims invoked. Whenever possible, spatial proximity or immediate vicinity between general and specific claims should be ensured. As long as the conditions of Article 10(3) are fulfilled, evidential requirements of Article 5(1)(a) are also satisfied.
Overall, while the first part of the judgment applies a rather strict benchmark, the second part restores the balance for food business operators. Although the notion of an average consumer, who is reasonably well informed and reasonably observant and circumspect, features prominently in the judgment, the requirement to interpret exceptions strictly lends support to the application of a strongly protective test in the first part of the analysis. Importantly, food business operators should bear in mind that the use of an asterisk may, but does not necessarily have to, satisfy the requirement of sufficient visual link, and was accepted only exceptionally, due to large size or length of the specific health claims invoked. Whenever possible, spatial proximity or immediate vicinity between general and specific claims should be ensured. As long as the conditions of Article 10(3) are fulfilled, evidential requirements of Article 5(1)(a) are also satisfied.
