Article 10(3) of Regulation 1924/2006 on nutrition and health claims made on foods (the “NHC Regulation”) permits references to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being, if such a claim is “accompanied” by a specific health claim included in the Union lists.

In Case C-524/18, Dr. Willmar Schwabe v. Queisser Pharma, the German Bundesgerichtshof asked the Court of Justice of the European Union (“CJEU”) to clarify if a general, non-specific claim included on the front of the outer packaging was “accompanied” by a specific health claim within the meaning of Article 10(3) of the NHC Regulation, if the non-specific claim was included on the front of the packaging and the specific health claim on the back, without an apparent link between the two.

In his Opinion, Advocate General Hogan had suggested a three step approach to interpreting Article 10(3) of the NHC Regulation: (1) the specific health claim has to be authorised, (2) the specific health claim must support the general health claim and (3) the relationship between the two claims must be determined by reference to the “average consumer who is reasonably well informed, and reasonably observant and circumspect.”  He concluded, that the national Court had to consider whether the relationship between the two claims was sufficiently clear to an average consumer.  In his view, it would be “sufficient that the specific health claims are given sufficient prominence such that they are accessible and can be read by the consumer”, without the need for the two claims to be placed “next to, or follow or otherwise immediately adjacent” to each other, nor did the law require an asterisk.

The CJEU handed down its judgment on 30 January 2020.  The judgment takes a slightly different approach than the Advocate General Opinion in the way in which it sets out the test for the meaning of “accompanied” under Article 10(3) of the NHC Regulation.  Specifically, the Court considered that the word had to be interpreted taking into account both a “substantive and a visual dimension” and that it was for the national court to determine whether the product in question met the test.

As for the “substantive dimension”, the CJEU noted that the general and the specific health claim had to “match, implying, in substance, that the former fully supported the latter.”  However, such a clear link between the claims’ content, irrespective of their location on the packaging, was insufficient in itself.  Rather, the CJEU noted that both claims had to be located on the packaging in such a way to enable an average consumer to understand the link between the two (the “visual dimension”).  According to the CJEU, a direct visual link between the general and the specific health claim requires, in principle, “spatial proximity” or “immediate vicinity” between those claims, so that the average consumer can immediately recognize the link between the two claims.  In its reasoning, the CJEU also cites the European Commission Guidelines on Article 10 of NHC Regulation (Implementing Decision 2013/63) to demonstrate that the visual dimension has some role to play in the interpretation of the meaning of “accompanied.”

However, the CJEU also noted that “exceptionally”, it may be possible for a general, non-specific and the “accompanying” specific health claim not to appear on the same side of the packaging, provided that an “explicit reference, such as an asterisk” allows the consumer to make the connection between the two claims.

While the main focus of the case was on the interpretation of the word “accompany” for the purposes of Article 10(3) of the NHC Regulation, the CJEU also clarified in the same case that any general, non-specific claims had to be substantiated in accordance with the requirements of the NHC Regulation.  However, it was sufficient to that end, if the non-specific claim was “accompanied” by a specific health claim.

Print:
Email this postTweet this postLike this postShare this post on LinkedIn
Photo of Brian Kelly Brian Kelly

Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Brian’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union…

Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Brian’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union law, and product liability and safety. The Chambers Europe Guide to the legal profession lists Brian as part of our “world-class [regulatory and public affairs] team and describes him as a notable practitioner who is “very ambitious, thorough with a sharp intellect”. The Chambers UK Guide quotes clients saying: “his communication and work ethic stand out, he is very hard-working and dedicated when it comes to his cases.”

Brian’s advice on general regulatory matters across all sectors includes borderline determinations, food classifications, tissue and stem cell regulation, adverse event and other reporting obligations, manufacturing controls, labeling and promotion, pricing and reimbursement/procurement, procurement/tenders (including emergency use tenders, EU-wide tenders, Covid-19-related tenders), product life cycle management (foods and medicines), nanotechnology, and anti-bribery and corruption advice. Brian has also been advising on UK and European “Brexit” related issues including tariffs. 

Brian has also advised and co-ordinated international projects on advertising/promotion, clinical research, data protection, the regulatory status of borderline products, food/cosmetic ingredient reviews and advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.

Brian is also experienced in representing clients in administrative and enforcement proceedings before regulatory authorities and in the UK and EU courts. 

Brian is an honorary lecturer at University College London.

Photo of Katharina Ewert Katharina Ewert

Katharina Ewert helps major national and multinational companies in the food, medical device, pharmaceutical and cosmetics sectors to navigate regulatory, litigation and procurement risks. With a strong background in general EU law and procedure, Katharina provides strategic advice to clients in a changing…

Katharina Ewert helps major national and multinational companies in the food, medical device, pharmaceutical and cosmetics sectors to navigate regulatory, litigation and procurement risks. With a strong background in general EU law and procedure, Katharina provides strategic advice to clients in a changing regulatory environment. Katharina is a member of Covington’s Diversity and Inclusion Committee.

In her work with a broad range of life sciences companies, Katharina regularly:

  • advises clients on all aspects of food development and marketing, including the regulation of ingredients, labelling and advertising;
  • helps companies in evaluating health and nutrition claims for foods and food supplements, as well as marketing claims for cosmetics;
  • provides strategic advice to major companies in the medicines and device space on national and EU public procurement considerations;
  • assists clients in navigating the implications of Brexit; and
  • represents clients in administrative proceedings in the national and EU courts.

Katharina’s pro bono work includes advising charities on corporate, commercial and public procurement matters.

Katharina gained valuable experience during a secondment the in-house legal team of a global pharmaceutical company.