A consistently broad interpretation of "health claim" emerges in Europe

April 2014

A decision recently handed down by the German Federal Court of Justice (Bundesgerichtshof – BGH) has confirmed the broad interpretation of the term “health claim” in the context of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods (the “Health Claims Regulation”) and a strict application of the regulation when it comes to exceptions.

The Health Claims Regulation

The Health Claims Regulation lays down harmonised rules across the EU for the use of nutrition claims such as “low fat”, “high fibre” or health claims such as “reducing blood cholesterol”. A health claim is defined as any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents, and health. Food business operators are not free to use any health claim for marketing their food products. Only health claims listed on the Community list adopted by the European Commission (the "Commission") based on generally accepted scientific evidence are permitted. If a food business operator desires to use an unlisted health claim, it may apply for the inclusion of the claim on the approved list.

The latest BGH decision on the Health Claims Regulation

baby bottlesIn the present BGH case, a producer of infant nutrition had marked a baby milk product with its trade marks "Praebiotik® + Probiotik®" as well as with the slogan “Praebiotik® + Probiotik® with natural lactic acid cultures - Praebiotik® for the support of a healthy intestinal flora”. The BGH considered both declarations as health claims.

Regarding the use of the trade marks "Praebiotik® + Probiotik®", the BGH held that the average consumer does not simply understand this labelling as an objective description of consistency and content, as had been assumed by the lower court. Rather, the average consumer would interpret it as a reference to the attributes “prebiotic” and “probiotic” which stand for the ability to stimulate the natural intestinal and immune functions. As a consequence, the BGH concluded that "Praebiotik® + Probiotik®" has to be considered as a health claim within the meaning of the Health Claims Regulation since it suggests that there is a relationship between the baby milk and a baby's health.

The broad interpretation of "health claims" in the CJEU

With this decision and its broad interpretation of the term “health claim”, the BGH confirmed previous decisions on this topic. The Court of Justice of the European Union (the "CJEU") stated in its judgment “Deutsches Weintor eG” (6 September 2012 - C-544/10), that the wording of Article 2 (2) No. 5 of the Health Claims Regulation provides no information as to whether the relationship that must exist between a food and health must be direct or indirect, or as to its intensity or duration. In these circumstances, the court concluded that the term ‘relationship’ must be understood in a broad sense.

In another matter referred to the CJEU for preliminary ruling in December 2012, the BGH had classified the slogan “Just as important as the daily glass of milk!” used with a fruit quark (a type of dairy product) as a health claim. According to the BGH, the claim alludes to the widely held view that children should drink a glass of milk every day because of its health-promoting effect and presents the fruit quark as being equal to a glass of milk in respect of its positive health-promoting effects. The Court concluded that, by the suggestion of a connection between the fruit quark and the health of its consumers, the claim had to be considered as a health claim.

Furthermore, the “Praebiotik“ decision is in line with the point of view of the Commission as expressed in the “Guidance on the implementation of Regulation (EC) No 1924/2006” where the statement "contains probiotics/prebiotics“ is classified as a health claim on the grounds that the reference to probiotic/prebiotic implies a health benefit.

The transitional provisions in the Health Claims Regulation

Regarding the slogan ““Praebiotik® + Probiotik® with natural lactic acid cultures - Praebiotik® for the support of a healthy intestinal flora”, the BGH had to decide whether the claim “Praebiotik® for the support of a healthy intestinal flora” was filed for registration before 19 January 2008 and could thereby profit from the transitional provisions contained in Art. 28 (6)(b) of the Health Claims Regulation.

trademark signThe BGH denied the above, stating that only a descriptive declaration of an ingredient ("Prebiotic fibre supports development of healthy intestinal flora") had been filed for registration, meaning the word “Praebiotik®" in the particular claim would be understood as a trade mark that designated a certain company. According to the BGH, the transitional provisions cannot justify the usage of a claim in cases where the wording of the used claim differs from the claim filed for registration. This is because the Health Claims Regulation aims to provide  a high level of consumer protection, an aim which can only be reached by a strict application of the transitional provisions.

As regards the claim "Praebiotik® + Probiotik®", the BGH remitted the matter to the previous instance to verify if the claim was already used before January 2005. According to Art 28 (2) of the Health Claims Regulation, products bearing trade marks or brand names existing before 1 January 2005 which do not comply with this regulation may continue to be marketed until 2022. As the CJEU stated in its judgement “Green-Swan Pharmaceuticals” (18 July 2013 – C‑299/12), the trade mark has to be used with the particular food product in question before January 2005 to justify the application of the transitional provision. It is not sufficient that the trade mark only existed.

At the end of its judgment, the BGH raised the additional question as to whether the trade mark had to be used with the identical and unchanged food product before January 2005, or whether changes to the product, e.g. changes corresponding to a normal life cycle management, were permissible. This question will have to be answered by the lower instance court, if relevant for the decision.

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Manja is a partner in our Munich office and Head of Life Sciences in Germany.

"The Health Claims Regulation aims to provide a high level of consumer protection, an aim which can only be reached by a strict application of the transactional provisions."